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2019 Vol. 1 www.medicaldevice-developments.com £31.00 €49.00 $65.00 Skeleton key How glass opens the door for new implantable devices

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From the editor

On reflection

here is a famous scene in the 1967 film The Graduate, where a family friend takes aside Benjamin Braddock, played by Dustin Hoffman, and On the web... T whispers to him, “Plastics… There’s a great future in plastics.” This seems Find the latest features, market odd today, particularly in light of increasing concerns about sustainability, but analysis and supplier information at at the time this material was new and exciting. www.medicaldevice-developments.com If film-makers had been able to see into the future, they would have Medical Device Developments inevitably made a reference to the digital age in which we find ourselves today. Vol. 1 2019 An age where new technologies are transforming a number of industries, not Editorial least medical devices, where there is an ever-increasing number of possibilities Editor Emma Green to improve efficiencies in manufacturing, create more advanced devices and [email protected] Chief sub-editor Thom Atkinson address unmet health needs, all of which we explore in this issue. Sub-editor Todd Palmer We investigate the use of new materials, such as using glass for implantables, Senior feature writer Greg Noone Feature writers Tim Gunn, Will Moffi tt which we dive into with Professor Julian Jones from Imperial College London Production manager Dave Stanford Group art director Henrik Williams on page 102. We also find out about potential medical devices made through Designer Martin Faulkner the use of flexible photonics that are capable of bending and stretching in a Commercial discussion with MIT associate professor Juejun Hu on page 57. Client services executive Derek Deschamps In addition to widening opportunities for devices, the definition of what Division sales manager Martin John Publication manager Steve Norris constitutes a device is also expanding. This has resulted in more companies [email protected] Subscriptions marketing manager Dorothy Musariri entering the market, with unique offerings and new ways of working. The Publisher William Crocker means with which consumers are interacting with devices is also shifting, where they can now be active agents, rather than passive patients, with regard to their care. We discuss these issues with Sundeep Karnik and Matt Singer from ZS in Medical Device Developments is published by Compelo, light of the new FDA regulation on ‘software as a medical device’ on page 12. Registered in England No. 09901510. These advances all demand greater engagement between humans and John Carpenter House, John Carpenter Street London, EC4Y 0AN, UK technology, both inside and outside the body. It’s an exciting time for the Tel: +44 207 936 6400 industry and I am thrilled to be able to provide a platform for stimulating www.compelo.com www.medicaldevice-developments.com discussions and debates on these topics.

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turkishcargo.com Contents In this issue Cover story 102

20 27 10 News & numbers 19 A test of character disadvantages of insourcing versus The headlines and vital statistics Wickham Laboratories outsourcing in manufacturing. impacting the market. However, recently, companies 20 Change on the horizon have become more interested in Regulatory With uncertainty around Brexit new ways of working. Within the 12 Your own devices and what it means for the NHS, it is UK this has taken the form of The FDA plans to develop a new easy to have missed some important partnerships with Academic Health regulatory framework for reviewing signals that support the greater use Science Networks in order to ‘software as a medical device’. of structured data within the health capitalise on the expertise of Aiming for a more ‘streamlined’ service. Global Medical Device academia and industry. review, it has updated the software Nomenclature Agency’s Mark Wasmuth pre-certification pilot programme outlines how medical devices can be 31 Using stock components can and a working model of this will more accurately identified. reduce time to market soon be released. Emma Green Qosina speaks to Sundeep Karnik and 25 Strategic medical writing Matt Singer from ZS about the for device submissions 33 Advanced photochemical implications of this new regulation Trilogy Writing & Consulting etching solutions for the industry. Micrometal Contract manufacturing 16 Navigate the regulations 27 Act together 35 The art of science for in vitro devices There has been ongoing debate Developing a metal medical NSF about the relative merits and device requires balancing a budget,

Medical Device Developments / www.medicaldevice-developments.com 5 Contents

deadlines, design considerations and from industry and academia. Ben industry 4.0, manufacturers have more. In light of rapid technological Wicks from Team Consulting speaks begun to explore a wide range of new advances, deciding upon the best to Emma Green about the status technologies. Karen Taylor, director process to maximise manufacturing of sustainability within medical of the Centre for Health Solutions efficiencies can be challenging. device manufacturing. at Deloitte, speaks to Emma Green about how to best implement these 38 Myopic medicine 42 Your perfect technologies into manufacturing In order to achieve sustainability in moulding partner processes to maximise efficiency manufacturing operations, it needs Accumold while minimising cost. to be incorporated in all stages of the supply chain. One key aspect is Manufacturing technology 48 Connect the bots obtaining sustainable components 43 Break the fourth wall Collaborative robots, or cobots, are a from eligible suppliers. Recently, this Since we entered the fourth age of new class of robots that are bridging topic has gained greater attention the industrial revolution, known as the gap between fully manual assemblies and fully automated manufacturing lines. Lightweight, flexible, easily programmable and safe to implement, collaborative robots ¨Ž¡®Š£¤Ž¤Š“—န can meet some of the challenges associated with these processes in an efficient and effective way. Astrid Weiss of the Vienna University of Technology speaks to Emma Green about how best to integrate these cobots into manufacturing processes.

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6 Medical Device Developments / www.medicaldevice-developments.com Contents

64 Produce customised silicon, which, though the cheapest speaks to Lan Yue, assistant professor medical devices material available, is not the most of research at USC, about the TRUMPF efficient. Now, a team of engineers potential of this technology for at the Massachusetts Institute of medical device manufacturers. Electronics Technology has developed a new way 66 Smash the ultrasound barrier to fabricate ultra-thin semiconducting 81 B is for bonding Scientists at the University of British films made from a host of exotic DATA MODUL Columbia, Canada, have developed a materials. Michael Shaw talks to portable ultrasound device that can Jeehwan Kim, the class of 1947 Microelectronics connect to a smartphone and costs career development assistant 82 The power to succeed only $100. The new transducer can professor in the departments of In vivo networking (IVN) is a be used to look at any part of the mechanical engineering and materials novel approach to powering – and body producing instant and clear science and engineering, about the communicating with – implanted images. Research lead Carlos Gerardo potential applications of this research. medical devices. Jim Banks talks to talks to David Callaghan about the assistant professor Fadel Adib, one potential for this new device, which 75 Negotiate the MDR checklist of the researchers involved in an includes patients wearing it for RECOM Power IVN project at MIT, about how monitoring purposes. the research could bring about a 76 Next evolutionary step paradigm shift. 71 Decrease work pressure, Thanks to bioelectronics, devices are improve patient well-being starting to replace drugs for a wide Materials and gain insight range of conditions. Bioelectronic 85 The shape of things to come Fujitsu medicine explores how targeted Tim Gunn talks to Dr Andrew Weems electrical signals can harness the of the University of Birmingham, 72 The heart of the problem body’s natural mechanisms to diagnose Professor Lorenzo Moroni of The vast majority of semiconductors and treat a range of diseases, helping Maastricht University, and Dr in medical devices are made from the body heal itself. Emma Green Christophe Marquette of Lyon’s 3D

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Fabric of Advanced Biology laboratory service life, cost, speed and about what 4D printing can do to temperature conditions, as well as the disrupt the medical device market. huge range of potential applications of the technology, can be a challenge. 90 Take the tube to Emma Green speaks with Thomas the next level Mayer from Sonceboz and Carl Bugej, New England Tubing Technologies an embedded-software developer, about how to effectively navigate 92 Sweat the small stuff decisions about motors. An interdisciplinary team of scientists at the University of Massachusetts Coatings & surface treatment Amherst has produced a new class 112 Old spark, new ideas of sustainable electronic materials, Although the use of plasma treatments which may lead to a greener future in for medical device coatings has biomedical and environmental sensing. been around for some time, in recent Alexander Smith, a biomedical years it is enjoying something of a engineering PhD student and the renaissance. Andrew Tunnicliffe talks founder of the start-up e-Biologics, with Professor Denis Dowling about speaks to Abi Millar about the value its potential and its limitations. of these materials for medical devices. 112Packaging 115 Coat with confidence 130 Many hands make light work 97 The right design choices Formacoat The global market for sustainable have lasting implications packaging is rapidly developing. Lapp Tannehill 117 A point well made However, medical device companies Argon Medical are still lagging behind their 99 Medical devices – it all comes counterparts. Peylina Chu, executive down to the wire Microfluidics director of Healthcare Plastics Sandvik 118 Cancer detector Recycling Council, discusses key Cancer DNA changes in response to principles to consider in bringing the 101 Catheter safety and its environment, favouring alterations medical device industry up to speed. performance with tie layer that help it survive long term. These Zeus include large and small changes, and 135 Seal the deal the latter can be almost invisible. Atlas Vac Machine Biomaterials Chrissy O’Keefe and a team at Johns 102 Glass healing Hopkins University have created a 137 Design outside of the box Bouncing, bending and bonding to digital microfluidics platform to help Brentwood bone, glass is looking more and more detect these changes. She talks to like a miracle material. The liquid-like Kerry Taylor-Smith about how this Logistics solid is showing its worth in everything technology could revolutionise 138 Chains of command from healing wounds to replacing cancer detection. Heavy regulation from design to intervertebral discs. Tim Gunn talks delivery can make optimising the to Professor Julian Jones of Imperial Filtration & fluid control logistics process highly challenging. College London and Professor Aldo 123 Liquid flow Kim Thomas talks to Bruce J Stanley, Boccaccini from the University of A number of disposable sensors are president-principal at the Stanley Erlangen-Nuremberg about the now available to monitor fluid control East Consulting Group, about key properties of bioactive glass that make in medical devices and these tend strategies designed to maximise the it so valuable for medical devices. to be low-cost because there are efficiency of logistics procedures. no electronics located in the sensor. 107 Patented textile- IVAM CEO Dr Thomas R Dietrich 141 Considerable care from forming technologies discusses the potential of these origin to destination Secant Group sensors for mobile and point- Turkish Cargo of-care diagnostics. Motors & motion control 142 Your cargo is special 108 Make it stick 127 Cutting-edge AirBridgeCargo When choosing a motor, the need porous solutions to balance multiple factors such as Porex 144 Product showcase

Medical Device Developments / www.medicaldevice-developments.com 9 News & numbers

Number of citizens from 27 European countries that contributed to the 2012—17 Eurobarometer data on robots. 80,396 Gnambs and Appel Barriers to AI in healthcare systems

Given the effectiveness of artificial quickly scanning patient data and delivering the types of populations used to train the intelligence-enabled software in other diagnoses efficiently and more accurately software will have significant impact on domains, AI has been introduced into many than humans. The Duke Margolis Centre regulators’ and clinicians’ assessment of areas of medicine. According to Becker’s for Health Policy published a white paper the risk to patients. Healthcare, these tools will save the identifying some of the challenges facing The final challenge identified in the report healthcare industry $52 billion by 2021. the integration of AI. The first of these is concerns the ethical implications of using AI. One such application is clinical decision the need for more evidence demonstrating It is essential that these technologies are support software, which falls into the the effectiveness of these technologies, ethically trained and flexible. Developers category of software as a medical device. In including the impact of the software on must assess the ability to apply data inputs light of the prevalence of diagnostic errors patient outcomes, care quality, costs of care, to other settings different to the original o and the potential impact on patients, there is workflow, the usability of the software, its assess the scalability of these technologies. an increasing drive for technologies that can accuracy and the potential reimbursement support these decisions. It is estimated that by payers. The second barrier is the these mistakes account for almost 60% of all requirement of more data about the risk medical errors and result in an estimated to patients of such technologies. The degree $52 billion 40,000–80,000 deaths each year. AI offers to which a software product comes with Projected amount saved by AI by 2021. huge potential to reduce this error rate by information that explains how it works and Becker’s Healthcare

Soft-bodied robots Increasing scepticism about robots as a novel method The use of robotics is becoming more 2014 and 2017 Eurobarometer data, which of drug delivery common in a number of different industries, included 80,396 citizens from 27 European Researchers at City University Hong with many researchers suggesting that we countries. In their research, participants Kong (CityU) have just created a tiny, are on the brink of a robotic era. Despite first saw a general description of robots soft robot with caterpillar-like legs that can be directed using magnets to deliver their widespread use, public perceptions as machines that could assist people with drugs around the body. The robot can of robotics have rarely been investigated. daily activities, such as cleaning robots, carry a therapeutic payload of more than Timo Gnambs from Johannes Kepler or as machines working in environments 100 times its own weight and has been Universität Linz and Markus Appel from that were too dangerous for humans, such specifically designed to carry drugs to areas like the stomach. Julius-Maximilians-Universität Würzburg as rescue missions. Responses were very The robot's body thickness measures addressed this gap in the literature and different when presented with specific approximately 0.15mm, with each published their findings in Computers in applications, such as self-driving cars. conical leg measuring 0.65mm long Human Behaviour. According to their From these results, it appears as though and the gap between the legs measuring cross-European data analysis, robots are Europeans are relatively positive about approximately 0.6mm. This makes the leg-length-to-gap ratio around 1:1. more negatively evaluated than five years robots. However, they are critical when When an external magnetic field is ago. Gnambs and Appel analysed the 2012, the robot is specified and personalised. applied, the soft body of the robot will locate and experience a torque and a force proportional to the strength of the field. The torque aligns the millirobot FDA releases draft guidance for with the magnetisation field, raising the body. Meanwhile, the magnetic force provides a driving force and drags the brain-computer interface devices millirobot towards the local maximum magnetic field. The robot deforms under The FDA has recently issued draft patients. The FDA added that the devices the magnetic field, which is controlled guidance to drive the development of also have the potential to help people living precisely during the accurate permanent brain-computer interface (BCI) devices, with severe disabilities by improving their magnet motion. This allows the robot to a new generation of implants that could ability to interact with their environment. move fluidly in the body. The robot will be used as a prototype provide users with direct control. The document outlines recommendations as the team works towards creating a fully BCI devices are often used to regulate for developers on non-clinical and clinical biodegradable robot that will naturally limb prosthesis. These can significantly study design to create BCI devices for decompose after drug delivery. improve mobility and independence for patients with paralysis or amputation.

10 Medical Device Developments / www.medicaldevice-developments.com News & numbers Internet of medical things 51% The number of med-tech companies implementing new business models. 71% Those who believe that healthcare providers and clinicians are not ready to use data generated The estimated increase in value of the internet of medical things from connected medical devices. market, by region between 2017-22

50 - ■ 2017:20177: totalt $40$44040 billion 51 45 44 ■ 40 - 2022:20202 total $158$158 billionbillion IncreaseIInnc of $118 billionliioon 67% 30 - Those who

Billions ($) 20 - believe that 13 11 12 the regulatory 10 - 9 9 framework will not catch up 2 2 with what is possible today for 0 - another fi ve years. North America South America Middle East Asia-Pacifi c Europe and Africa

Med-tech companies are transforming from innovative product suppliers to insightful partners 31% 39% 43%

Implementing new funding Adopting a value-based Using real-world evidence models for data as a service. approach to pricing. to drive business decisions.

Source: Medtech and the Internet of Medical Things, Deloitte.

Medical Device Developments / www.medicaldevice-developments.com 11 Regulatory Your own devices The US FDA plans to develop a new regulatory framework for reviewing ‘software as a medical device’ and has also issued guidance regarding the FDA’s regulatory process for digital tools. Aiming for a more ‘streamlined’ review, the FDA has updated the software pre-certifi cation pilot programme and a working model of this will soon be released. Stephanie Webster speaks to Sundeep Karnik and Matt Singer from ZS about the implications of this new regulation for the industry.

s technology continues to advance all Use of SaMD is continuing to increase. It can be facets of healthcare, software has become used across a broad range of platforms, including A an important part of products and is medical device platforms, commercial off-the-shelf now integrated widely into digital platforms serving platforms and virtual networks, to name a few. Such a range of purposes. Software as a medical device software was previously referred to by the industry, (SaMD) is one of three types of software related international regulators and healthcare providers as to medical devices. The other two types include ‘stand-alone software’, ‘medical device software’ or software that is integral to a device, and software ‘health software’, causing considerable confusion. used in the manufacture or maintenance of a Due to the rapid evolution of devices based on medical device. It is the former that is associated this technology, the FDA has recently taken action with the most uncertainty, as it’s a relatively new to modernise its approach to regulation. It released a technology and has less clearly defined boundaries ‘digital health innovation action plan’, involving piloting than the other types. a new digital health recertification programme to

12 Medical Device Developments / www.medicaldevice-developments.com Regulatory

ensure that patients are able to have access to safe this,’” says Karnick. “If you have thought about it and effective devices as quickly as possible. carefully, done all that homework and brought the These changes by the FDA have been a long time right information to the FDA, the process should, coming, with the former 510(k) process having been technically, go faster.” in place since 1976. This was heavily based upon the concept of substantive equivalence, the idea of “Companies will be forced to think more deeply a new device being sufficiently similar to an existing about how either a physician or a patient lives one – a predicate device. If this could be supported by data, this provided manufacturers with a fast-track with a particular device.” to market. “While that worked for a lot of medical Sundeep Karnik devices, over the past few years, as innovations have been coming to market, especially around software These new regulations mean that manufacturers and digital services, this has pushed the limits of need to think differently about the products that what the original intent was,” explains Sundeep they want to bring to market. “I think something the Karnik, a consultant at ZS.

The rule of three The new regulations bring about three key changes for manufacturers. The Are you ready for first one relates to the selection of the predicate device. “You have to be the new EU MDR? much more careful when making your selection,” says Karnik. “If you choose a predicate device that was approved Ensure you have the knowledge and skills to comply with the new medical device requirements in the EU. for particular patents, you cannot add Join TOPRA to gain access to a full range of educational and networking on new features that are software and opportunities for regulatory professionals building their career in medical digital that are over and above what it devices, combination products and in vitro diagnostics. originally had.” The second aspect centres on the Opportunities with TOPRA concept of ‘substantive’. “Before, you trusted could get around this and say ‘look, • Provision of highly respected regulatory training for over 40 years my device is substantively equivalent • World-leading postgraduate qualifications open to this device, just give it approval,’” for medical device specialists says Karnik. “Now, you can’t simply • Unique competency accreditation professional introduce new software features that programme for device regulatory are unproven or untested.” professionals The third element of the new FDA • Peer-to-peer networking and quality responsive regulations pertains to the data being resources for members used in support of a device. “The FDA • The leading Annual Symposium on authoritative wants more data than just that of the Medical Devices in the EU device performance that you could measure in some animal studies,” Find more TOPRA benefits at www.topra.org/MDD explains Karnik. “When there are new software features, these need to be tested in a different way, and the data presented to the FDA also has to be a different kind of data.” Although these are significant changes, they don’t necessarily mean a longer time to market. “Part of the intent here is to actually make it faster by saying, ‘before you even come here, be careful about what predicates you choose, be strategic about what differences you’re going to try and argue, and be very intentional about what data you’re going to use to support

Medical Device Developments / www.medicaldevice-developments.com 13 Regulatory

industry should think about now is whether they “The new regulations cause you to rethink have products that they would have brought to some of that less innovative life-cycle management market in the past because it was easier, even though and focus more time on where you can actually they didn’t really bring much value to customers or differentiate or bring value.” the company because it was just the red version of This doesn’t automatically mean less revenue, the blue and green one that they already have,” says however. “Maybe at the end of the day, it costs the Matt Singer, also a consultant at ZS. company less money because it’s spread across fewer products than before and is instead focused “The new regulations cause you to rethink on the ones that are really going to bring value to some of that less innovative life-cycle the marketplace,” says Singer. management and focus more time on where The regulation has a number of implications, particularly for SaMD. “It legitimises that software you can actually differentiate or bring value.” has reached a majority, and that there is data that Matt Singer supports that it can, and should, be regarded as a medical device,” explains Karnick. “These kind of approvals from the Analytical Chemistry: Unknowns are Unacceptable™ FDA impact the physicians to perceive something approved by the FDA as being ‘real’ and something they need to take action on. It also gives the same message to patients who will be more trusting about using it because the government has looked at it.” However, the perception of these changes is likely to be substantially different between companies. “If you’re a newer healthcare player, you might look at this and see it as a huge move forward for you, because now the solutions developed have a clearer and faster path to market,” says Singer. “If you are a classical med-tech company, and used to bringing new products to market that typically take three to five years or longer to develop, you might view this as the stakes having been raised a little bit.” WuXi AppTec Laboratory Testing Division Medical Device Platform is the The new regulations also have leader in complete identifi cation—to us, Unknowns are Unacceptable™. important implications for patient- centricity, a concept gaining traction 80 – 85% of the time we are able to meet biocompatibility systemic throughout the industry. “Most med- endpoints with chemical characterization and risk assessments. tech companies have the product Unknowns can delay testing up to 27 weeks and can cost more than $75,000. at the centre,” says Singer. “They’re very innovative; they have amazing WuXi AppTec has completed more than 4,500 materials characterizations. engineers, and research and Contact us today and let our team design a chemistry program tailored development departments, which to meet your analytical needs. can create incredible products that move medicine forward and make a substantial impact on the health of EMAIL: patients worldwide. The customer at [email protected] the centre, whether that’s a patient, VISIT OUR WEBSITE: doctor or hospital, is more cutting- medicaldevice.wuxiapptec.com edge thinking, which these changes TELEPHONE: could accelerate.” +86 888-794-0077 This means thinking in a more holistic way than has been necessary in the

14 Medical Device Developments / www.medicaldevice-developments.com Regulatory

A new approach The FDA’s Total Product Life-cycle (TPLC) approach enables the evaluation and monitoring of a software product from its pre-market development to post-market performance, along with continued demonstration of the organisation’s excellence.

Excellence appraisal Identifying the objective criteria and methodology that the FDA will use to pre-certify a company and decide whether a company can keep its pre-certification status. The FDA is currently basing the pilot programme’s criteria on five excellence principles: patient safety, product quality, clinical responsibility, cybersecurity responsibility and proactive culture. The FDA is currently considering two levels of pre- certification based on how a company meets the excellence principles and whether it has demonstrated a track record in delivering safe and effective software products.

Review determination Developing a risk-based framework so that a pre-certified company can determine the pre-market review pathway for their products. Potentially pre-certified companies could market their lower-risk devices without FDA pre-market review, or only a streamlined pre-market review, based on the company’s pre-certification level and international medical device regulators forum (IMDRF) risk categorisation. The FDA is planning to leverage the IMDRF framework to help determine the risk past. “Companies will be forced to think more categorisation of an SaMD product, incorporating information about the medical deeply about how either a physician or a patient purpose of the SaMD and the seriousness of the medical condition that the SaMD is intended to treat. lives with a particular device,” says Karnick. “Digital The FDA is also considering appropriate means to educate patients and providers and software-based solutions imply a fundamentally about the pre-market review and post-market monitoring obligations for each SaMD different engagement model, one which is integral risk category. to the effectiveness of the device.” Streamlined review This involves identifying the type of information that a pre-certified company would Time to get engaged include in its pre-market submission for the FDA to review software products for safety Historically, most devices have been relatively and effectiveness before patients access them. passive, and those that have been interactive The FDA is exploring using an interactive streamlined review of a SaMD with have been limited in their scope. In contrast, information the agency has already gained from the process to pre-certify a company, and additional information the company would share about the SaMD’s newer technologies facilitate a much higher product performance, clinical association between the SaMD output and a clinical level of engagement with the patient. “If we condition, and safety measures. take a more interactive device, let’s say you have a high-glucose problem, or diabetes, and Real-world performance Identifying the type of information that a pre-certified company may have access to you have a device that tells you when your blood about how its software product is performing with patients to support the regulatory glucose is high – you would pop a drop of blood status of the product, and new and evolving product functions. on there, it would say your blood glucose was The FDA is considering how best to work with a company to collect and high and then it was up to you what you did interpret real-world information about an SaMD, and evolve the product’s safety and effectiveness to address any emerging risks. The sources of real-world performance with that information,” says Karnick. “But when data may include information about a user’s experience, software performance data you start to add software services, now that and clinical outcomes. device is going to provide you with suggestions Source: FDA in real time on how to manage your health or glucose better.” and demonstrating how you do that better than Above left: Newer This influences the approach needed for the alternatives, you’re going to be a winner,” says technologies facilitate a much higher level entire product development process. “In order for Singer. “That is the sustainable advantage that of engagement with us to be able to provide those kind of suggestions you can have in any market.” patients – for example, in blood-glucose testing and nudges to people, it means we have to think Central to remaining competitive is for diabetes patients. carefully about what patients need, how we transitioning away from the traditional way of articulate those needs, and create software and working towards a newer, more agile approach. features that serve them and measure the impact “We have to move from the ‘build it and they’ll to inform the value proposition of the device,” come’ model to becoming a lot more thoughtful explains Karnick. and intentional about what you are going to Although it has been over 40 years since the build and why,” says Karnick. “Once we’ve 510(k) pathway has been updated, it likely won’t decided, we then have to move a lot faster than be much longer. Being prepared for potential we did in the past, because if we don’t, someone future changes is therefore key. “If you’re is going to bring it to the market faster – and focused on solving important customer problems we’ll be left behind.” ●

Medical Device Developments / www.medicaldevice-developments.com 15 Company insight Navigate the regulations for in vitro devices In vitro diagnostic devices (IVDs) are subject to stringent regulation across the EU. Robyn Meurant, executive director for the IVD and medical devices regulatory team at NSF International, talks to Medical Device Developments about the full import of these rules, and how the product-testing company can help original equipment manufacturers deliver fully compliant IVDs.

What are the main points for in vitro device (IVD) manufacturers to be aware of with regard to IVD Regulation 2017/746? Robyn Meurant: Under the IVD Directive 98/79/EC (IVDD) a majority of IVDs (as many as 80%) were exempt from the requirement to submit to a notified body to obtain CE marking. This did not mean that they were exempt from the regulatory requirements, but rather that they could self-declare that a product was in conformity. With the introduction of a risk-based classification scheme in the IVD Regulation 2017/746 (IVDR), all medium to high-risk IVDs Up to 80% of IVDs will now need notified body intervention. must have assessment of conformity by a notified body. It is now believed that at new, but a common approach that does What are the clinical evidence least 80% of IVDs will need notified body not apply is to reduce risk to as far as requirements for the IVDR? intervention. This requirement will impact reasonably possible. Manufacturers who Manufacturers must demonstrate clinical not only new products to the market, but have taken this approach must revisit their evidence based on a continuous process also those already CE marked. risk assessments and associated solutions. of performance evaluation. It means that manufacturers must now include evidence of scientific validity, a term “Many IVD manufacturers think that because used to describe clinical association they have an FDA 510(k) for their IVD then they of a marker with a disease state. For will not have many gaps to fill. Worryingly, this established IVDs, evidence in peer- is not the case. Equivalence of IVDs is much reviewed literature can be used to support scientific validity and clinical harder to demonstrate.” performance; analytical performance must always be demonstrated by actual Product manufacturers should also be There are also a lot of new requirements studies using the IVD. When evaluating aware that, under the new system, there for labelling, including the addition of the performance of an IVD, the process will be no grand-fathering. a unique device identification (UDI), as must take into consideration favourable The concept of risk management is well as additional roles and responsibilities and unfavourable data. strengthened in the new regulations, for economic operators within the pre especially its implementation throughout and post-market arena, whether that What is Eudamed? the life cycle of the IVD. Of note are the be the authorised representative, legal Eudamed is an acronym for the European requirements to continuously review the manufacturer, importer or distributor. As electronic database on medical devices, risk assessment, as well as the need to a result, the performance of the IVD will and is the tool designed for competent eliminate or reduce the risk as far as come under much greater scrutiny than authorities primarily to strengthen market possible. This later requirement is not under the previous regime. surveillance and transparency of IVDs and

16 Medical Device Developments / www.medicaldevice-developments.com Company insight

other medical devices by providing the authorities with fast access to information. It consists of the electronic systems for the registration of devices, the UDI database; the electronic systems for registration of economic operators, notified bodies and certificates; performance studies; vigilance and post-market surveillance; and electronic systems on market surveillance. Manufacturers, or their authorised representatives, have a number of obligations under the IVDR with respect to registration and data input with Eudamed.

What is a PRRC? A PRRC is a ‘person responsible for regulatory compliance’. This is a new role that must be fulfilled for all manufacturers and is similar to that of a qualified person Contrary to popular belief, equivalence of IVDs is hard to demonstrate. in pharma. Each manufacturer shall have at least one person responsible have to be prepared. As most IVDs do extent of the impact and support the for regulatory compliance who possess not have certificates of conformity issued transition. Companies may need to the requisite expertise in the field of IVD by a notified body, these products will rationalise their product range as well and medical devices. need to meet the new requirements by as decide whether they are going to Small and micro enterprises do not have May 2022. hire additional resources to keep to have this person within their organisation Preparations among manufacturers manufacturing in-house or if they will use but must have one permanently at their should typically start with a gap analysis, third parties for some of these functions. disposal. This person, as the name infers, which compares the current processes is responsible for regulatory compliance, and procedures with what the new How does NSF International including ensuring reporting obligations are regulation requires. From there, they help companies implement fulfilled. Authorised representatives are also need to march though a very methodical, these procedures? required to have a PRRC permanently and project-managed time line to start An impressive offering at NSF continuously at their disposal. handling some of those gaps. International is its regulatory and quality training. We are continually producing “The main deadline for the EU IVDR is May 2022. e-learning resources and face-to-face training because regulations are Manufacturers are allowed to maintain their constantly changing. If people haven’t current certifications until they expire but there thought of some of these things, there are a number of new post-market activities they is a fantastic e-learning module on are obliged to incorporate after May 2022.” the new regulation. Our staff includes ex-regulators from the EU, ex-notified body staff and internationally recognised What are the time frames Many IVD manufacturers think IVD experts. NSF International goes for the EU IVDR and how that because they have an FDA 510(k) beyond traditional consulting. There are can manufacturers prepare? for their IVD that they will not have people involved in clinical evaluation The main deadline for the EU IVDR is many gaps to fill. Worryingly, this is not reports, technical file remediation and May 2022. Manufacturers are allowed the case. Equivalence of IVDs is much performance evaluation reports. They are to maintain their current certifications harder to demonstrate, especially now helping companies remediate those until they expire but there are a number with the emphasis in European law on files and keep them updated. A call to of new post-market activities they are demonstrating state-of-the-art capabilities action is the biggest message. Companies obliged to incorporate after May 2022 in the product. cannot wait for more guidance – they and the end of the certificate. Indeed, the IVDR impacts on almost need to act now. ● However, if a manufacturer makes a all functions of a manufacturing company, ‘significant change’ after May 2022, they not just the regulatory affairs and quality have to switch to the new regulation. It assurance departments. It is imperative For further information goes without saying, therefore, that they that senior management are aware of the www.nsf.org

Medical Device Developments / www.medicaldevice-developments.com 17

Company insight A test of character

Wickham Laboratories carries out biological assessment reports (ISO 10993-1) on a range of medical devices, working with clients to determine the appropriate regulatory pathway, saving them money and reducing unnecessary testing.

edical device testing is one of the more complex services offered M in the life sciences sector, both in terms of the diversity of the products tested and the different levels of safety or biocompatibility required prior to approval for use in patients. There is a high demand for reliable testing services for medical devices as it is one of the fastest-growing industries in healthcare. The European medical device industry, constituting a third of the global market, is thought to be worth approximately €100 billion. Within the US, the FDA’s Center for Wickham Laboratories is committed to determining the appropriate regulatory pathway for clients. Devices and Radiological Health (CDRH) is responsible for ensuring the safety manufacturer to identify any hazards or USP Plastic Class I-VI series; and effectiveness of medical devices. associated with the device. These they include: The FDA was given authority to begin specifications should always be adhered ■10993-3: Genotoxicity regulating all medical devices in 1976, to and the standard is applicable to all ■10993-4: Haemocompatibility when President Ford signed the Medical stages of the medical device life cycle. ■10993-5/USP 87: Cytotoxicity Device Amendments Act. In addition, pharmaceutical and medical ■10993-6/USP 88: Implantation The EU’s rules relating to performance device manufacturers should always ■10993-10/USP 88: Sensitisation and safety of medical devices were consider environmental monitoring before and skin irritation harmonised during the 1990s and recently manufacturing, as this can lower the ■10993-11/USP 88: Acute, sub- updated in 2017 with two applicable risk of contamination and help them to acute, chronic systemic toxicity regulations: the medical device understand the levels of microorganisms and pyrogenicity regulations (MDR) and the in vitro within their environments. ■10993-13: Identification and diagnostic device regulations (IVDR). quantification of degradation In the lab products from polymers Medical device testing overview Before considering testing, Wickham ■10993-14: Identification and The classification of a medical device covers Laboratories works with clients to quantification of degradation a wide range of device types, each requiring determine the appropriate regulatory products from ceramics various levels of safety or biocompatibility pathway for their situation, keeping ■10993-15: Identification and testing before market release. its ethical obligations at the forefront. quantification of degradation All biocompatibility testing carried out It recommends biological assessment products from coated and should adopt a tiered approach in order reports (ISO 10993-1) instead of testing, uncoated metals and alloys to minimise the amount of in vivo testing ultimately saving the client money and ■10993-18: Chemical characterisation required. This means that before any reducing unnecessary testing. of materials. testing takes place, it is essential to have Biocompatibility testing, or ‘Biological both the device and materials used for Evaluation of Medical Devices’ (as There are a variety of other tests that manufacturing assessed to ensure the set out in ISO standard series 10993), may also be required, including 11135-1 correct route of testing or evaluation is a set of guidelines and testing and 11737-2: Sterility testing, and 11737-1: is taken. parameters for assessment of medical Bioburden determination. ● ISO 14971, the application of risk device safety before any medical device management to medical devices, is a comes to market. The required tests For further information standard that specifies a process for the are generally referred to as the ISO 10993 www.wickhamlabs.co.uk

Medical Device Developments / www.medicaldevice-developments.com 19 Regulatory

Change on the horizon With uncertainty around Brexit and what it means for the NHS, along with news about the government’s 10-year plan, it is easy to have missed some important signals that support the greater use of structured data within the health service. The Global Medical Device Nomenclature Agency’s chief executive, Mark Wasmuth, gives some insight into how medical devices can be more accurately identified to optimise patient safety.

HS medical device suppliers have been told The NHS e-procurement strategy directs trusts to prepare product data to comply with to ensure that the medical devices they purchase N procurement contract standards introduced are barcoded and their relevant product data is by the 2014 NHS e-procurement strategy. collected in a central database. Despite challenges around new IT systems Most people are familiar with barcodes in the introduced to the health service, the policy is supermarket, and they also appear on medicine still intact. In fact, the latest initiative from the packets, but, surprisingly to many, they are only Department of Health and Social Care, NHSX, takes starting to appear on medical devices. the digital transformation to a new level, promising Barcode numbers are individual to each product “a new joint organisation for digital, data and from each manufacturer and often also contain technology” for the NHS. additional information, such as the batch number or

20 Medical Device Developments / www.medicaldevice-developments.com Regulatory

expiry date. They are especially useful for need to compare the use of similar medical devices managing the stock level of individual items, from a range of providers. The GMDN groups whether that is baked beans or syringes. medical devices that have the same use, which is Putting aside the odd problem at the self-service also vital when it is discovered that the problem checkout, they are a powerful aid to helping with a medical device is not limited to one retailers know exactly what they have in stock, manufacturer but may also be shared by other planning future demand and knowing when extra products that use the same technology or materials. supplies need to be ordered or when to cut back. A good example of this is metal-on-metal hip The use of barcodes on products is particularly joints, which were found to cause problems and helpful when you need to locate a batch that needs were produced by several different manufacturers. to be returned to the manufacturer or has exceeded The GMDN would enable this systematic problem its expiry date. For instance, supermarkets use to be identified early, whereas the barcode is only barcodes to instantly identify and remove specific useful for identifying an issue with a specific device packs of food that have been identified by the from one manufacturer. manufacturer as having a safety issue. Hospitals are also starting to make use of “The GMDN groups medical devices that have this technology to help them better manage the same use, which is also vital when it is their supplies and capital equipment. discovered that the problem with a medical Examples of how barcodes can bring dramatic healthcare benefits include the use of barcoded device is not limited to one manufacturer but wristbands to improve the identification of patients, may also be shared by other products that use enabling the reduction of errors in their care. the same technology or materials.” For instance, the medical implants used to treat a patient can be scanned before an operation and The GMDN can be used to identify all the linked to a specific patient, making them easier to different products in the market that might have monitor after the operation. the same problem, so hospitals can quickly be But barcodes are not so useful when you alerted to remove the faulty products, thereby need to compare similar devices made by several reducing risks to patients. manufacturers; invariably, the codes they use will The key to the success of using the barcode be different, because the barcode relates just to the and the related product information, including the specific product from one specific manufacturer. GMDN, is that the database lists all the products to form a catalogue. This is used to retrieve data when Device categorisations the barcode is scanned. The need for a standardised system for naming and grouping medical devices has led to the creation of Data mining the Global Medical Device Nomenclature (GMDN) A central catalogue of products is being created for international categorisation of medical devices the NHS, primarily using the existing GS1 data pool by those responsible for medical device safety. network, which borrows its specifications from the This categorisation system is important for requirements used by the US FDA in its UDI Rule. several reasons, ranging from improving hospital The US FDA has been collecting product data from efficiency and patient protection, to helping long- manufacturers as part of a continuous programme term medical studies find out what devices are to ensure it has a complete list of medical devices most effective. on the US market. For instance, at a basic level, a hospital may The programme started in 2014 with higher-risk well want to know how many 50ml syringes or devices, and is being phased in to include all devices bedside scanners it has. The GMDN enables them by 2022. It has been a considerable challenge for to quickly answer this as it helps hospitals measure manufacturers to consolidate the large amounts of and control inventories where they have similar data necessary to identify all the devices on the US devices by different manufacturers. FDA database system, called GUDID. The GMDN can also be used to improve The NHS catalogue is being built as part of efficiency. It allows easy comparison when an new contractual arrangements between trusts and improved or more cost-effective device comes on suppliers. The new NHS pre-acquisition questionnaire the market while older versions are still in use – (PAQ Form) is already being seen, which may also whether it’s beds, operating tables, syringe pumps form part of a new contract. The PAQ Form uses the or respirators. Another example of how the GMDN GMDN code to identify the general description of the is used is in long-term medical studies, which often medical device.

Medical Device Developments / www.medicaldevice-developments.com 21 Regulatory

of all these items is difficult even when their Agency for change names are clear and succinct. But often names The GMDN Agency is a non-profit organisation responsible for the ongoing are far from clear, with many manufacturers using maintenance of the GMDN, a system of internationally agreed descriptors used widely different terminology for the same type to identify medical device products that will meet a global need for identification purposes. It is a registered UK charity, subject to an independent audit each of device. year and regulated by the UK Charites Commission. The agency’s objectives are For example, a carotid artery stent, used to to preserve and protect health, and to relieve sickness for the public benefit by treat the narrowing of arteries and thereby decrease developing and maintaining the GMDN. the risk of strokes, is named by three different Source: Global Medical Device Nomenclature Agency manufacturers as a ‘closed cell self-expanding stent’, It is taking some time to get trusts to implement ‘carotid stent system’ and ‘nitinol stent system’. the new catalogue and barcoding systems into These devices are medically the same yet general use. Soon, new regulation will reinforce sound completely different to anyone other than a the work started by the NHS across several specialist. Imagine this problem across each of the demonstrator sites. complex products a hospital needs to treat patients The planned introduction of the new European in a modern health system. regulations for medical devices (MDR/IVDR) On top of the sheer amount of extra time and will mandate the barcoding and collection of data effort needed for sourcing the right devices and elements, including the use of the GMDN. The data comparing alternatives, such confusion creates will be included in the central European database, further complications that may lead to wrong devices called EUDAMED. The new regulations are being ordered and better alternatives overlooked. planned to be introduced in 2020, and deadlines for The GMDN standardises the name by providing an providing data for different risk groups of products official term for each medical device on the market. are planned until 2027. This also includes a five-digit code and a full But what about Brexit – what happens if the UK definition, to further clarify important differences leaves the single market? and similarities between products. A simple example of this is a scalpel, which can The ‘B’ word be either single or multiple use. Anyone seeking a In its latest guidance on a no-deal Brexit, the UK single-use scalpel can go to suppliers and request regulator (MHRA) is planning “the expansion of the items with the GMDN number 47569 to confidently MHRA’s registration system to all classes of medical ensure they have the right item, regardless of how device”. The MHRA is fully committed to using it is described by the manufacturer or distributor. the GMDN following its recent introduction, For other types of scalpel there are different codes in early 2018, of requiring the GMDN code for all to avoid any confusion. registrations for low-risk devices. The most recent The GMDN system, and online database, provide evidence has been the publication of the draft device manufacturers and hospital staff with the regulation ‘The Medical Devices (amendment etc.) information they need to determine the standard (EU exit) Regulations 2019’, which borrows heavily name for each device, so every item of stock within a from the EU regulations. hospital’s vast inventory can be clearly identified and So, there will be no getting away from the need organised using the GMDN, efficiently and accurately. to organise and provide large amounts of product The global importance of the GMDN is obvious information, and manufacturers unfamiliar with when you consider that the database is translated the requirements should get a hold of the new into over 25 languages. In many countries, European regulation and see what is needed. This the GMDN is required by the national regulator, may require bringing together product data from and therefore it is growing in popularity with different parts of an organisation and assembling manufacturers and healthcare providers. it in a new database. This supports communication between hospitals The GMDN Agency is a charity that works and international suppliers, and helps reduce the closely with manufacturers to make sure the dangerous misuse of medical equipment due to GMDN represents all medical device products on misidentification. It is also intended that regulators use the market, as well as keeping it up to date with the new larger data sets to quickly identify the signals the latest innovations. It provides the GMDN to that would single out problem devices, such as those hospitals and helps them improve their barcode that might be counterfeit or substandard, and remove systems for managing the products they use – them from the market before they do any harm. thereby supporting patient safety. Hospitals worldwide now benefit from the GMDN’s Each hospital uses thousands of different medical consistent naming – useful when your phrase book devices daily to treat patients. Trying to keep track does not stretch to ‘carotid artery stent’. ●

22 Medical Device Developments / www.medicaldevice-developments.com Are you thinking about enhancing your medical devices with software?

When trying to come up with new and innovative solutions to support patients and healthcare Our specialists and experts providers in the medical device industry, medical device manufacturers often end up with solutions will provide modular that include software. In fact, there are many opportunities to enhance existing products with support along the entire software: for example, by complementing existing products with a mobile phone app that patients value chain of your can use from home. products. Visit our website Nevertheless, medical device manufacturers often need a better understanding of the requirements at www.knoell.com for detailed information. for placing medical device software on the market and providing post-market support. knoell Germany GmbH Our medical device experts can support you in all aspects when it comes to medical Business Development device software: Medical Devices  Regulatory requirements for your kind of software and relating to your intended market Tel +49 621 718858-0  Best practices when it comes to working with external software development companies [email protected]  Software development strategies when you decide to develop software inhouse Implications for your quality management system (pre- and post-market) www.knoell.com

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Over 40 years experience, helping companies across the world successfully enter and obtain market approval in the United States, Europe and Canada. We offer the following services: • MDSAP (Medical Device Single Audit Program) audit preparation and assistance • FDA/cGMP/ISO Compliance • On-site/Third Party/Mock FDA Audits • 510(k)/PMA/ANDA/NDA submission services (Over 3000 successful 510k submissions) • FDA Crisis Intervention (Inspections, 483 & Warning letter responses) • FDA Electronic Drug Listing & Registration • e-DMR fi ling and UDI assistance • Device Listing & Registration • Label Reviews for OTC Drugs and Food Products • Interactive Online FDA Training Courses in - Understanding QSR - Intro to Design Control - Understanding CAPA mdi Consultants also acts as an Official Correspondent and U.S. Agent (for more than 300 non-U.S. companies), Initial Importer and distributor assistance, sales force performance improvement, and marketing assistance. Tel: +1 516-482 9001 Email: [email protected] Web: www.mdiconsultants.com Dr. Julia Forjanic Klapproth, Senior Partner Master Skills — Owning the process, leading with expertise, lighting up a room

The Trilogy experience will change the way you think about medical writing. Our writers are masters of their trade. Experts in engaging reviewers through crystallized messages, able to guide and manage complex teams, Trilogy offers precision writing backed by years of dedication to the craft. Which means one less thing for you to worry about.

Visit us at TrilogyWriting.com [email protected] Company insight Strategic medical writing for device submissions Julia Forjanic Klapproth of Trilogy Writing & Consulting explains why it is time to start using strategic medical writing in the world of device submissions.

ntil recently, the documents needed these documents do what they need to. Furthermore, although scientists for device evaluations were not well More than ever, the medical writer is there understand the principles and ideas behind U defined and were generally written as an advisor to provide knowledge gleaned the science of what they are working on, by one person (often a medical writer), from writing many regulatory documents many are not skilled at communicating essentially on their own. Now, with the in the arena of drug development and those ideas in the written form. For device increased regulatory requirements brought understanding the needs of regulatory documentation, the science behind the on by the EU medical device regulations guidelines. With larger teams, the role of product is an important part of the story to from 2017, more people are getting involved the medical writer becomes more strategic, be told. There is a lot of non-medical data in preparing the clinical evaluation reports as they serve to ensure all functions on a to be described in addition to the clinical (CERs) and the writing game is changing. CER team (medical affairs, clinical, safety data. The scope of scientific knowledge that Input is needed from a team of CER surveillance and research and development) medical writers bring to these documents contributors and reviewers, including a provide necessary input while helping is very relevant in order to effectively tell clinical specialist who understands the mediate cross-functional differences of the whole story of the device. Experienced environment the device is to be applied opinion on what messages there are to tell. medical writers have the skills to interpret in; a regulatory expert who has knowledge Writing scientific documents as a scientific data and present it in a way that of the regulatory background for the class collaborative process, instead of as a meets the regulatory goals, ensuring that of device and who can inform the medical single author, does not come naturally to agency reviewers will clearly understand writer about the assessor’s expectations many contributors. Experienced medical the messages to be told. based on prior discussions with the writers often serve as a kind of glue for the CER regulatory assessor; the safety different functions on the CER team. They Well-honed tricks for new sectors surveillance group to provide details pull team members together by focusing In the world of drug development, this of post-marketing surveillance; and them on telling a cohesive narrative – this role of strategic medical writing to assist someone who can provide depth of is achieved by effective interpersonal skills. dossier writing teams in pulling ideas knowledge on the technical development Strong argumentation and leadership skills together has been applied for decades. and characteristics of the product. are needed to challenge and guide a team Now that the world of devices has become Many of these newly formed teams do to find the best way of presenting complex more regulated, this role of the medical not have experience in preparing regulatory data sets, and telling the story consistently writer has become important to efficiently documents and are unsure of how to make and clearly. produce CERs that aid the clinical evaluation of devices. Medical writers experienced in writing submission dossiers for drug applications are well versed in applying the evidence-based principles required by the new EU medical device regulations. By tapping into this experience, device manufacturers have access to a well-developed skill set that will make producing and updating CERs less of a burden, and ensure these documents are truly fit for purpose. ●

References available on request.

For further information The strategic medical writer is a ‘glue’ to hold the CER team together. www.trilogywriting.com

Medical Device Developments / www.medicaldevice-developments.com 25 Together with

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Act together There has been ongoing debate about the relative merits and disadvantages of insourcing versus outsourcing in manufacturing. However, recently, companies have become more interested in new ways of working. Within the UK, this has taken the form of partnerships with Academic Health Science Networks (AHSNs) in order to capitalise on the expertise of academia and industry. Louise Thomas takes a look at these developments.

t is an exciting time for the industry. Fresh A model that has begun to be more heavily opportunities are increasing each day, driven used in the UK is the partnering of industry I by the needs of healthcare systems to improve with Academic Health Science Networks (AHSNs). patient diagnosis, treatment and experience. This These are UK organisations, first licensed in 2013, has not only led to greater demand for innovative which are pioneering new ways of developing devices, but also the potential to work in a new, and implementing innovations for use within the more collaborative way, breaking down the traditional UK’s NHS in the disease areas defined as being the silos between industry and academia, as well as highest priorities. AHSNs have established a med- interacting with healthcare professionals throughout tech innovation national network to accelerate the development process. this process for medical devices, which includes

Medical Device Developments / www.medicaldevice-developments.com 27 Contract manufacturing

physical devices and in vitro diagnostics. This manufacturers seeking to tap into this market, remit therefore excludes software as a medical which aimed to ensure that the resulting products device and large devices, such as MRI scanners. meet patients’ needs as well as being commercially The Eastern Academic Science Network (Eastern successful. Throughout this process there are a AHSN) has reported that the NHS currently spends number of areas for collaboration with academics £6 billion a year on medical devices, highlighting and healthcare professionals. the huge potential for manufacturers. “The health and science infrastructure in The medical device landscape is shifting and the UK is uniquely positioned to take advantage faces challenges in the form of new regulatory of the opportunities for economic growth and requirements, as well as the strong market forces improved patient outcomes created by med-tech,” demanding competitively priced products for says Piers Ricketts, vice-chairman of the AHSN a complex and diverse healthcare procurement and CEO of the Eastern AHSN. “However, there environment. In their 2019 report, the Eastern is a risk of companies getting lost as they navigate AHSN proposed an innovation pathway aimed at the innovation maze.”

Take the stages The first of the stages outlined in the report is ‘creation’. As the name suggests, this involves identifying the market value of the concept, the impact on health outcomes and identifying market access barriers. To assist in this stage, AHSNs offer Innovation Exchanges, funded by the UK’s Office for Life Sciences, where potential medical devices can be linked with existing local healthcare system challenges. This stage might also involve patient and public involvement, including direct interaction with NHS trusts, AHSNs and medical charities, as well as the National Institute for Health Research (NIHR)’s national advisory group, INVOLVE. Development is the second stage, where the product is refined for regulatory assessment and clinical evaluation. The first step in this process is prototyping, in which there are a number of opportunities for collaboration. For example, through catapult centre, which are non-profits that facilitate UK businesses, scientists and engineers to work together on late-stage research and development. There are 11 of these centres in the UK, spanning a diverse range of areas, including cell and gene therapy, digital, high-value manufacturing and precision medicine. There is also the NHS Innovation Accelerator, an NHS England initiative delivered Currier Plastics is in partnership with AHSNs. It was ISO 13485:2016 Certified FDA Registered launched in July 2015 to support delivery of the NHS ‘five year forward view’. It supports the uptake and

28 Medical Device Developments / www.medicaldevice-developments.com Contract manufacturing

spread of high-impact, evidence-based innovations Regulation is the following stage, which is invariably across the NHS. complex with the huge amount of legislation to The second step in the development process is navigate. To help with this process, there are med- £6 testing through clinical trials. This will, of course, tech innovation briefings, commissioned by NHS vary significantly, depending on whether the device England, which provide evidence-based advice to billion is in vitro or not, and its perceived level of risk. those considering the implementation of new medical The amount Collaboration in this stage may involve interaction devices or diagnostics. These aim to be fast, flexible spent each year with the newly formed NIHR med-tech and in vitro and responsive to the need for timely advice about by the NHS on diagnostics co-operatives (MICs), which act as novel technologies. The National Institute of Clinical medical devices. centres of expertise, bringing together patients, Excellence (NICE) organises these to avoid local NHS Eastern Academic clinicians, researchers, commissioners, and industry organisations having to produce similar information Science Network to support the development and evaluation of for local use. medical devices within clinical settings. There are a number of MICs in the UK, each with a different “The health and science infrastructure in the theme and led by a specific NHS organisation. UK is uniquely positioned to take advantage It is also in this stage that contract research of the opportunities for economic growth and organisations might be used for the clinical testing of the product. With the increasing demand improved patient outcomes created by med-tech.” from regulators for real-world patient data, use Piers Ricketts, AHSN of Health Data UK’s digital innovation hubs can be useful to obtain health-related data at scale for NICE plays a large role in reviewing the evidence research and innovation. The HealthTech Connect for a specific technology once it has received a horizon scanning database can also be valuable, CE mark. The NHIR, hosted by the University of as it provides a record of medical devices at all Newcastle, undertakes horizon scanning to inform different stages of development. This aims to NICE of any products early in their development, reduce duplication and provide a smoother route to help ensure that guidance can be published as to market in the UK. close as possible to the launch date.

Medical Device Developments / www.medicaldevice-developments.com 29 Contract manufacturing

Relationships of convenience Case study: CMR Surgical Working more collaboratively with academia can CMR Surgical, from Cambridge, has developed a next-generation surgical robotic also take the form of ‘clustering’, when companies system that aims to transform minimal access surgery (MAS) over the next few years. The system, named Versius, is designed to be more portable, versatile and cost- concentrate efforts in a particular geographical effective than existing systems. The CMR vision is to make MAS universally accessible, location. The NIHR has designated 11 MICs to thereby improving healthcare outcomes at lower cost. The Versius system is specifically build expertise and capacity in the NHS to develop designed to meet this vision. The medical robotic market is highly competitive, with new medical technologies and provide evidence an established global leader and emerging competition from several companies the backing of which includes the likes of Google and Johnson & Johnson. Global annual on commercially supplied diagnostics. These revenues for robot-assisted MAS are presently approximately $4 billion and anticipated bring together patients, clinicians, researchers to reach $20 billion by 2025. The Versius system takes up a smaller footprint, is commissioners and industry. portable and flexible, and is intended to come to market at a significantly lower cost. There is growing interest in these clusters, with CMR recently attracted $100 million in the largest ever series B investment deal raised by a European medical device company. a current network of more than 100 science and “Typically, medical device development, from idea or design through to technology parks in England. Although there is no commercialisation, is normally a 10-year journey, and we will have done that in single formula for a cluster, the Eastern AHSN has around five,” says ECO Martin Frost. “You can only do that by having clear focus on identified a number of key success factors. what you want to deliver and why, recruiting excellent people and creating a culture that facilitates creative, responsive thinking. The first of these is academic strengths, as “We identified an unmet need – 95% of minimal access procedures are not yet done facilities can provide world-leading expertise from robotically,” he continues. “We then looked at why this was the case and what we researchers in physical sciences and engineering. could do to address that need. From the beginning, we had a plan of how we would The interdisciplinary way of working also allows areas get our product to market and our commercial advantage.” Source: ‘The MedTech Landscape Review’ by the AHSN Office for Life Sciences and the NHS of convergence to be capitalised upon. In addition, clusters facilitate access to leading research Commissioning and adoption is the next stage. clinicians, patient populations and real-world data. The NHS supply chain has a new operating model Effective business networking can also take place that aims to deliver improved procurement and within these clusters, as they bring together small logistics support to the NHS. This will be achieved and large companies in a structured way. Regional in three ways: increasing uptake of products sponsorship is another potential advantage. These published via the national route to market, environments are attractive in terms of schools, increasing the use of a standard range of products housing and transport. There are also opportunities for by the NHS, and using enhanced buying power to funding of relocation and supportive business rates. influence purchasing behaviours and ensure that Furthermore, the ecosystem also includes legal advice, the best products are provided in a cost-effective specialist design consultancy and manufacturing, way to the NHS. and access to investors. The infrastructure not only provides specialist facilitates and equipment but also “The potential of cutting-edge technologies local capabilities such as advanced manufacturing. “The potential of cutting-edge technologies to to support preventative, predictive and support preventative, predictive and personalised personalised care is huge, and the UK has care is huge, and the UK has the chance to lead the chance to lead the world.” the world,” says Richard Phillips, director of healthcare policy at the Association of British Richard Phillips, Association of British HealthTech Industries HealthTech Industries, who co-authored the report. “We have the opportunity to build an ecosystem that There are six main routes to market for continually creates the best technology that can be companies interested in supplying their products exported, alongside new methods and insights that to the NHS. These are direct to trusts or primary can contribute to health outcomes globally.” care organisations, through the NHS supply chain, The AHSN’s work remains in an early stage but through collaborative purchasing arrangements, offers huge potential for OEMs to work in a more national framework contracts, government tenders collaborative way – in manufacturing and the other and contracts, as well as selling to companies aspects of the product development process. The that use the product to deliver their service in AHSNs have outlined the next steps of their work. the NHS. AHSNs play a key role in supporting This includes rigorously assessing and prioritising adoption of new devices into the NHS, which technologies for national support in the UK, has been supported by a recent study by the facilitating access to cutting-edge research and King’s Fund. Findings highlighted the need for development, connecting companies to high-tech new technologies to be incorporated into a wider manufacturing advice, partnering with NHS providers service redesign in order to positively impact seeking to adopt novel technologies and supporting health outcomes. OEMs in market access activities. ●

30 Medical Device Developments / www.medicaldevice-developments.com Company insight Using stock components can reduce time to market

As one of the leading medical device component suppliers of OEM components to medical and pharmaceutical industries, Qosina is there every step of the way, from prototyping, through sourcing and customising components, to providing material and technical specifications.

etting your product to market is rarely an easy task. In fact, G it can be quite daunting. As engineers, you may feel that you spend much more time searching for and developing parts than actually creating products. Qosina hopes to alleviate this stress by providing medical OEM components and innovative solutions to make your device concept a reality. Here’s how Qosina helps to eliminate your go-to-market challenges.

Prototyping – easier and cheaper If you’re still in the prototyping phase of research and development, you don’t Qosina provides 3D CAD models and material specifications that allow the easy implementation of components into designs. want to order a bulk quantity of a part that might not work for you. Sampling Easy access to quoting secondary operations for secure is key early in the process, and Qosina’s required documentation supply chains, will streamline your vendor selection of over 5,000 in-stock SKUs is With the ever-increasing demands on list and prevent complicated outsourcing. perfect for building out your prototypes engineers, a certified, technically proficient Consolidating purchases and suppliers without committing to large orders. component distributor should offer with one order can also significantly Qosina offers complimentary samples additional value propositions to reduce reduce overheads. on most of its products, so you can any supply-chain-related burdens. Qosina explore a wide range of materials, colours provides 3D CAD models and material Education on relevant and configurations. This allows you to specifications that allow you to easily industry topics evaluate and test in advance of purchase, implement components into your designs, Qosina keeps you in the loop regarding removing technical risk from the product while staying up to date with government complex and pressing subject matter in development process. and safety regulations. Qosina offers CAD the medical device industry. Download files in a variety of formats, which can white papers and case studies, and Sourcing and be helpful for everything from adapting read the company’s latest blog posts customising components engineering drawings to sharing visuals for information, guidance and solutions Using stock components can significantly with non-technical team members. on hot-button issues. lower the cost and time of creating Qosina also provides comprehensive Qosina’s number one priority is to offer a mould, since one may already exist. technical specifications, such as material the best solutions to fit its customers’ However, if the item you require is not in safety and data sheets, technical data needs and adapt as the development Qosina’s inventory, it will work to develop sheets, material certification and process continues. The company is the part to your exact specifications. A compatibility information on all of its constantly adding new products to slight alteration of an existing mould can products. You can easily access these its line, and providing cost-effective be a cost-effective way to create a new resources on the company’s website. solutions to help you get your project part to meet your requirements. Qosina’s off the ground and into production. ● knowledgeable product development team Streamline your vendors can easily adjust stock design, size, colour Using one supplier for everything, from For further information and material for your purposes. running materials through tooling to www.qosina.com

Medical Device Developments / www.medicaldevice-developments.com 31 0,1 mm

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Karl Martinson, Micrometal’s North American sales director, looks at the challenges involved in the design and manufacture of photochemically etched metal components for the medical industry, and the advancements in technology and increased levels of precision achieved to address them.

any medical devices and applications require small metal M components that demand very specific characteristics. These can include: ■ultra-high precision ■very thin material ■unique physical features ■unique surface textures ■identification features ■extreme consistency part-to-part ■ease of integration into the final device Etched parts can be manufactured in thicknesses as low as 0.025mm (0.001in), up to 0.500mm (0.020in). ■competitive cost. Parts can be manufactured in thicknesses Because the process is non-mechanical, as low as 0.025mm (0.001in), up to there are no residual artefacts such as Also, different medical applications 0.500mm (0.020in) with hole/feature sizes burrs or material stresses that must be require components made from a variety smaller than the material thickness. removed. A non-mechanical process of different metals including stainless steel, Advancements in etching technology also ensures that there is no wear or copper, alloys and clad materials. It is allow levels of precision, both in physical degradation of tooling over time, a significant challenge to balance the feature size and in dimensional tolerances, providing the ultimate consistency from combination of the above characteristics that were previously considered part to part. Production capacity from with the desired material, while maintaining unachievable for volume production a single set of photomask tooling is cost and production requirements. components. Micron-level precision is essentially limitless; the first component While numerous manufacturing common for many applications. will be identical to the 10 millionth technologies exist to create precision metal component. Also, because the process components, one technology in particular A focus on precision generates very little heat, there are offers the capability to incorporate all of The precision in physical feature size no thermal stresses and no localised these characteristics in one seamless comes from a combination of technology hardening of the material (as would result manufacturing process. Photochemical developments. Thinner photoresist layers from a process like laser machining). etching – also referred to as photochemical and high-resolution photomask tools, such In summary, photochemical etching machining or chemical milling – possesses as those used by Micrometal, provide provides a compelling solution to many the unique ability to meet all of the above exceptionally tight tolerances. of the medical industry’s demands for demands when compared with technologies These, combined with extremely precise high-precision metal components. The such as stamping or laser machining. monitoring and control of the chemical technology has evolved and improved Photochemical etching also eliminates etching rate, allow features and precision dramatically in recent years. By offering a the need for certain post-processing, such that cannot be achieved in production with distinct combination of precision, unique as removal of burrs and thermal stresses, other manufacturing technologies such as physical features and competitive cost, sharpening of blades, for example. The stamping or laser cutting. etching may be the ideal manufacturing development of continuous ‘reel-to-reel’ Most importantly, etching offers technology for many applications. etching production has dramatically exceptional design freedom; features are Component designers have new improved production capacity while reducing not limited to two dimensions. Blade edges, options for designs that they may have cost and improving consistency in quality. capillary grooves, conical holes and textures considered to be impossible in the past. ● Common examples of etched components can be included in the design. Etching are surgical blades, surgical needles and allows medical component designers to lancets, micro-separation filters, screens, ‘think outside the box’ with regard to For further information implants, springs and electrical contacts. component size, shape and features. www.micrometal.de/en

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Cleaning Production Champion PTCA Guide Wire - for cardiology (CAR) 06 - for highly stenosed lesions (CTO) Surfaces Quality and conformity 04 Coating 05 of medical devices and components Accessories: Dispensers J-straighteners Cendres+Métaux SA Female Luerlocks [email protected] We develop and manufacture Guide Wires and dispensers under www.cmsa.ch the brand names Accoat, Poseidon and Champion. We are one of the largest manufacturers in this field in Europe. www.sp-medical.com Contract manufacturing The art of science Developing a metal medical device requires balancing a budget, deadlines, design considerations and more. In light of rapid technological advances, deciding upon the best process to maximise manufacturing effi ciencies can be challenging. Louise Thomas explores the important factors to consider when making this selection.

anufacturing all the components for tools When millions of components are needed on and devices in the industry is an ongoing a weekly basis, this can be easily achieved with M effort involving balancing precision and stamping. Machining these quantities could require quality. With the growing needs of life sciences, over 100 machining centres, making it unfeasible metal components have become an integral part for this purpose. of building medical devices for the treatment of Tooling costs are another important a range of diseases. consideration. As machining is more versatile Biocompatibility is a constant challenge as and precise, it is preferable for devices requiring devices need to be used internally and externally tight tolerances that need to be produced in high within a range of medical applications. For this volumes. As long as a suitable machining centre reason, designs are continually changing and is available, it can be relatively easily programmed require rapid prototyping to ensure that they are to accommodate the part geometry. In contrast, fit for purpose. The ability to meet these demands a progressive stamping die takes much longer in an efficient and effective way is the result to design and build, and is much more costly. of rapid advancements in metals and alloys for Part geometry is also an important variable to components that are small or complex. bear in mind as there are some components that When manufacturing a device that involves are not able to be stamped. Certain diameters metal, a key decision lies between machining and cannot be pierced using stamping. In such cases, stamping. These choices are determined by the fit, machining is a better option, which can be form and function of a particular component, along combined with laser technology. with the geometry of the part and material used. Material selection factors are also significant If a medical device is designed for a large number in making a decision between stamping and of uses, then machining works best, as it produces machining, particularly thickness and hardness. complex parts that support durability. For products For example, stamping can be limiting because that are meant to be used just once, stamping is thickness must be uniform throughout the part and more suitable as it produces precision parts that hardness needs to be carefully considered because tend to be less durable. Volume is another key of the potential for cracking during forming. In driver in the decision-making process. contrast, almost any hardness can be machined.

Medical Device Developments / www.medicaldevice-developments.com 35 Contract manufacturing

Most red metals, stainless steels, titanium and with pressure sensors in each cavity, as well as cold-rolled steel can be stamped. Titanium and in runner systems. stainless steel are the most commonly used MIM is essentially a four-step process, consisting materials for stamping. Both are popular for of compounding, moulding, debind and sintering. implantable medical devices due to their The biggest disadvantage with MIM is the lead time. biocompatibility. However, titanium is often only However, the choice of materials makes it a popular available in wire, rod and sheet forms, rather than choice for OEMs. It is best suited to shaping complex in continuous strips, the latter of which tends to components in high volumes and when higher material be needed for the majority of stamping operations. properties, or implantable materials, are needed. The heavier the gauge and higher the hardness, Many OEMs have considered bringing MIM the more difficult it is to use stamping. manufacturing in-house, but this has been met with There is also less room for error with stamping mixed success. Start-up costs can be several million than with machining; it is thus hugely important dollars for the equipment alone, which includes that the designs are reviewed and approved by compounding, moulding, debind, sintering and the manufacturer early in the design process. secondary apparatus. With machining, it is difficult to re-engineer MIM has been proposed to be 85% science and the part using stamping to reduce costs without 15% art. Understanding the dynamics of sintering, making fundamental design changes. and how to minimise the effect of gravity and friction, is essential, and developing a consistent process often “Metal injection moulding can be a takes years of experience. This can be minimised with the hiring of experienced useful middle ground to minimise costs personnel, but they are in high demand and thus can while gaining the benefits of machining. be hard to find. A further issue is how to design for MIM has been increasingly used in recent the MIM process. Most specialists will help with redesigning components, but this can take time, years by manufacturers to expand their as most also serve as programme managers. design capabilities.” In recent years, some companies have started to help OEMs design components to optimise the Meet in the middle advantages of MIM. This can save time and money, Metal injection moulding (MIM), or metal injection as they can go directly into production without any moulding plus machining, can be a useful middle expensive redesigns during the production process. ground to minimise costs while gaining the benefits Such organisations are also able to manage the entire of machining. MIM has been increasingly used in journey from design, through production, and can recent years by manufacturers to expand their teach the OEM about the process throughout. design capabilities. Increasingly complex applications mean that A big decision sometimes MIM is the only suitable process. With the Finding the right supplier can be difficult, with inclusion of biocompatible and implantable materials, hundreds of qualified contractors worldwide. Often components that were routinely machined can now be newer suppliers will underestimate the amount of work ‘MIMed’ for a fraction of the cost. Some OEMs have needed to get a medical component into production. brought this process in-house, but as it demands An established facility with substantial experience is specialised skills and equipment, contract thus likely to better meet required timelines and have manufacturing can be an attractive alternative. a comprehensive understanding of the procedures Orthoscopics was one of the first fields to adopt required to meet medical specifications. However, MIM. Graspers, blades, staplers and cauterising the additional work created by increased quality cutters are small, geometrically complex and must requirements, along with the required documentation, be manufactured in a biocompatible material. Early means that established MIM facilities will be more designs were machined, which meant each component expensive than newer suppliers. was expensive. However, as MIM become more Companies unfamiliar with requirements may established, suppliers became more consistent, initially be cheaper, but will soon discover they need and more companies began using the process. additional resources or training to meet the needs of a Today, MIM applications are broad, including particular device, so may not be cheaper over the long bone drills, robotic arms for surgery, bone rasps, term. It is therefore essential for OEMs to do their cutting jaws, biopsy jaws, needle guides, saw guides homework and prequalify any potential supplier well in and hundreds of endoscopic instruments. Over time, advance of making a decision. This can be assisted by a moulding has become much more sophisticated, visit to a potential supplier’s manufacturing facility to

36 Medical Device Developments / www.medicaldevice-developments.com Contract manufacturing

discuss the device requirements and learn more about the processes that would be implemented. The MIM process MIM brings together the shape-making capabilities of plastic injection moulding with Contractor considerations the strength of metal. The four-step process begins with compounding, where a fine metal powder is mixed with a plastic binder. There are a number of considerations once a supplier This compounded material is then placed in a modified plastic-injection-moulding has been selected, whether for stamping, machining machine and injected into a mould. The component is called a ‘green’ part. This or MIM, to ensure that the process runs smoothly. is then put into a chemical bath and most of the plastic binder is removed. Some Instigating a dialogue right from the start is key. An binder remains in order to keep the metal powder in the moulded form. The process can take up to five hours, dependent on thickness and size. OEM cannot assume that the current contractor will The green part is subsequently put into an oven where the plastic binder is removed work in an identical way to their previous contractor. through evaporation. This process can last between hours and days, based on the Each organisation is different and has its own part size. However, Most MIM companies are moving away from this process. specific, potentially idiosyncratic, working practices. After debind, the green part becomes ‘brown’, and goes into a furnace, either vacuum or continuous, where any remaining binder is removed and the temperature Communication might therefore involve confronting increased to close to the metal’s melting point. The component then shrinks by around the contract manufacturer directly if there are any 20% to reach its final size. concerns or suspicions. Source: Powder Technology In situations where there is a clear mismatch between OEM and supplier, it can be tempting to finish recommendations about where those capabilities what has been started to avoid unnecessary delays. would be better served. In addition, the contract However, in most cases, it is better to accept a setback manufacturer should also feel able to provide and find a contractor who will be a more favourable suggestions and take a degree of ownership as part fit over the long term. As in all outsourcing situations, of the process. First and foremost, the OEM must cultural affinity is crucial, and both parties need to feel pay close attention to its own design first, and that they’re aligned in working towards a common goal. there needs to be a balance between complete Dialogue is of course a two-way street. It is prescriptivism and an overly lax approach. When crucial that the OEM understands the contractor’s relying on multiple contract manufacturers, it manufacturing processes and capabilities, and remains absolutely crucial that all parties are on allows its designers and engineers to provide the same page throughout the process. ●

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Medical Device Developments / www.medicaldevice-developments.com 37 Contract manufacturing

Myopic medicine In order to achieve sustainability in manufacturing operations, it needs to be incorporated in all stages of the supply chain. One key aspect is obtaining sustainable components from eligible suppliers. Recently, this topic has gained greater attention from industry and academia. Ben Wicks from Team Consulting speaks to Emma Green about the status of sustainability within medical device manufacturing.

iscussion of sustainability is increasing immunology and virology, as well as a PhD in in all sectors. Loosely defined as the ability clinical biochemistry, he certainly isn’t short of D to meet the present needs of an industry credentials. He also isn’t afraid of holding back without compromising those of future generations, in a discussion about sustainability within medical its principles have not been readily adopted by device manufacturing. most OEMs. This is largely because in relation “For much of the industry, I don’t think to the wealth and gravity of other factors to sustainability is very important,” he says. “We’ve consider within medical device manufacturing, got a ton of other regulation to worry about, it pales into insignificance. everyone is concerned with FDA and the European This is certainly the view of Ben Wicks, a med- notifying bodies because they hold the key to you tech consultant with over 20 years’ experience in having a product on sale or not. Sustainability the industry. With a background in microbiology, is not in their world or in their remit.”

38 Medical Device Developments / www.medicaldevice-developments.com Contract manufacturing

Although legislation on sustainability is currently benefit, I’ll save some money and the user lacking, this may change in the near future. will be happier.” Wicks remains unconcerned about this possibility, however. “I suspect it will Fix the flaws of perception start becoming something you’re It’s not just the perception of sustainability that asked to think about, and we are hinders its implementation; there are also a number seeing and hearing patient groups of practical considerations when attempting to and industry start to get it on the integrate its principles into the manufacturing Ben Wicks table for discussion,” he admits. process. “For many people in the industry, we’re “But it’s still often an almost sweating bringing the product to market, and once inconsequential issue.” we have brought it to market, it’s difficult to make In light of this context, it is changes to the product without doing a ton of thus unsurprising that, unlike reverification,” Wicks explains. “If it’s just the other sectors, the industry has secondary packaging, I might be able to cope with been reluctant to embrace that. But if I’ve got a complex medical device and sustainability. The responsibility to want to change its primary packaging, I might have ensure patient safety has also been a to reverify my sterilisation or my stability trials, and large contributor. “We are focused on that might cost several million pounds.” This means trying to save people’s lives –right here, that any benefit to sustainability is likely outweighed right now,” Wicks says. “Rightly by the hassle of successfully achieving it. or wrongly as an industry, we think that we have a “For much of the industry, I don’t think higher calling. sustainability is very important. We’ve got a ton of other regulation to worry about, everyone is concerned with FDA and the European notifying bodies because they hold the key to you having a product on sale or not.”

This is in stark contrast with direct-to-consumer products where sustainability is not only high on the priority list but also much more feasible to implement. “For a consumer product, you think ‘Well, if I can just save 20% of the packaging by a bit of a change here and there... bish, bash, bosh, off you go and do it. You That allows us to think that we don’t have get the product out there, everything continues and to care about it.” you’re happy, but you just can’t often do that in the Sustainability is not uniformly rejected but it medical device industry.” remains low on the agenda for most companies, For Wicks, and many others in the industry, especially when developing novel products, where sustainability is perceived as a luxury, an expensive time and money are particularly pertinent factors. indulgence that often isn’t deemed worthy of “It’s just very far down on the list, particularly if consideration. “Sustainability is in everyone’s 0.85°C you’re developing something new and clever,” says thinking in the developed world, and during design The average Wicks. “Bringing it successfully to market is the and development, you’d give it a thought,” says global temperature most important thing, whether it slightly damages Wicks. “In a sense, it’s in people’s minds but it’s increased during the planet or not, or some of the parts could be always down the priority list, certainly with 1880–2012. recycled but aren’t at the moment, just doesn’t complex devices.” UN come into your thinking.” If sustainability was on the agenda, selecting For more established devices, there is greater a sustainable supplier would be an important openness to exploring sustainability. “If your step in the process. However, for Wicks, as with 19cm product is mature and the risks are low and well manufacturing in general, it remains a relative The rise in understood, then you can turn your attention to footnote when making a decision. “I think about if sea levels sustainability,” explains Wicks. “And why wouldn’t they’ve got a high-quality system, if they’re reliable, 1901–2010. I think about reducing its carbon footprint? I if they’ll continue to give me parts that work and UN

Medical Device Developments / www.medicaldevice-developments.com 39 Contract manufacturing

can ensure that the end device means that but now you have to because that’s standard patients get better and don’t get worse,” says practice.” One rare case where sustainability did Wicks. “Sustainability hardly makes it onto that become more important was the use of propellant checklist for supplier selection.” in metered-dose inhalers (MDIs). “They originally used chlorofluorocarbons as propellants, which The status sphere have a serious ozone-depleting effect,” explains The low status of sustainability within the industry Wicks. These were discontinued in January 1996, is also driven by the relative lack of consequences except in a few rare cases. if its principles are not adhered to. “You screwing it A new class of propellant, called up, if that product fails and people die, lawsuits fly hydrofluoroalkanes took over, which was much around, products come off the market, companies more environmentally friendly. However, they go bust,” says Wicks. “Nobody loses their job or are certainly not carbon-neutral. “These are way dies if I use a printed circuit board that wasn’t as better but they are still a serious greenhouse gas recyclable as another one.” contributor,” says Wicks. For large companies, the use of these propellants contributes a significant “If a product fails and people die, lawsuits amount to their overall carbon footprint. There are currently discussions about moving fly around, products come off the market, to an alternative propellant, but manufactures are companies go bust. Nobody loses their job or reluctant to make any changes unless it becomes dies if I use a printed circuit board that wasn’t mandatory. “The industry doesn’t want to make the switch if it can help it because it will be a pain as recyclable as another one.” to do all the reverification and revalidation,” says Wicks. “Nobody wants to spend the time or money, It’s clear that from a purely business perspective, or cause potential risk to their patients.” sustainability just does not come into the Although clearly unlikely to immediately jump equation. “It’s not like someone running off with a to the top of the priority list for OEMs, public commercial advantage saying ‘look at our devices, perception looks set to be a future driver of they’re all biodegradable,’” says Wicks. “That just sustainability within the industry. “We are isn’t a thing.” seeing patients and users, such as healthcare Nevertheless, there are small indicators of change professionals, starting to recognise these issues,” The search is on in the industry, such as batteries in disposable admits Wicks. “But even though they say that, for a propellant with minimal goods. “Nowadays you would expect a disposable as a device developer, it’s a secondary or tertiary environmental effects. medical device that has a battery in it for you to issue. Ultimately, if this device doesn’t work safely, be able to take the battery out it might not be commercially viable or, worse still, in accordance with the Waste it might harm someone. Of course, that is not okay.” Electrical and Electronic Despite the reluctance from industry to embrace Equipment Directive,” says sustainability, it is likely that small steps will Wicks. “There are examples continue to happen, largely driven by legislation. where, in the past, you’d have “I would expect that within the coming years, not cared about getting the we’ll see a nod towards sustainability from the batteries out before you regulator,” says Wicks. “But it’s never going to chucked the device away, be high on their priority list.” ●

40 Medical Device Developments / www.medicaldevice-developments.com Delivering Innovative Technology and Service A progressive, USA Contract Manufacturer, we work with OEMs worldwide to create custom interconnect solutions for your application. We do everything- so you don’t have to. Partner with us and we’ll handle the details. ISO 13485:2016 and ISO 9001:2015

Connect with Us. We’d Like to Hear from You. P: 540.772.7950 • [email protected] 6591 Merriman Rd, Roanoke, VA 24018 Plastics1.com Company insight Your perfect moulding partner Maintaining an efficient micromoulding project is a delicate balancing act. Having a clear plan, understanding the risks and, not least, choosing the correct partner are all crucial to success. Aaron Johnson, vice-president of marketing and customer strategy at Accumold, talks about the challenges involved in the moulding process.

s minimally invasive procedures have become more prevalent, A demand for smaller, more complex medical devices has increased. This has put more pressure on original equipment manufacturers (OEMs) to design specialised components with thinner walls and more intricate features. One of the technologies used to support this ever-shrinking world is micromoulding, a highly specialised manufacturing process that produces small, high-precision thermoplastic components that are used in a variety of medical tools. With over 30 years of industry Accumold is one of the leaders in the field of micromoulding and has over 30 years of experience. experience, Accumold is one of the leaders in this field, producing plastic components Given that these tolerances can be down the ISO 14001 environmental standard. for microelectronics, micro-optics and to a few microns – a fifth the size of a human It is also championing a zero waste sensors in a range of medical devices. hair – there is precious room for error here. manufacturing initiative, collaborating These include surgical tools, hearing aids, “There has to be a clear and efficient with Mega Recycling to ensure that all handheld devices and micro-connectors. infrastructure dedicated to micromoulding,” of its components are reused. As a vice-president for marketing Johnson says. “We feel like we have made a great at Accumold, Aaron Johnson is acutely Because of the nature of the business, accomplishment by being as productive with aware of the steps required in overseeing partners also need to make extremely small our resources as we possibly can,” Johnson a successful micromoulding project. and sophisticated parts a million times over. says. “Of course, it doesn’t hurt that our For Johnson, ensuring design for “If you are making a disposable, you need products that we make are very tiny.” manufacturability (DFM) is the single to know the system can provide, not only Asked about the future, Johnson is most important part of the process. from the prototype, but all the way through adamant that things are going to get smaller. “We always say, start with your ideal to production,” says Johnson. “We are amazed at the innovation and design in mind,” he says. “And then let’s And the final requirement is concerned ingenuity in the industry, whether we are have a conversation about where you with sustainability. making wearable devices for diagnostics can push the limits, or what is capable “Once they get approved, medical or delivery, or a transcatheter that is with microplastics.” devices don’t tend to like change, so you delivering a new way to treat patients need to find a partner that can be with inside the body,” he says. “The more creative Pick a partner you for the life of that product,” says the industry becomes, the more it pushes For Johnson, a good moulding partner needs Johnson. “Sometimes that can be for a limits and the more we can provide. We will to provide three things: capability, scalability very long time.” continue to help customers do more in the and sustainability. Over the course of its 30-year history, same space or do more in less space – and When it comes to the former, precisely Accumold has consistently focused on that trend isn’t going to stop.” ● the right equipment is required to ensure sustainability, endeavouring to make that specific micro-level features or smaller components more efficiently, tolerances can be made in a detailed and with less waste. The company continues For further information efficient manner. to endorse that mantra by committing to www.accu-mold.com

42 Medical Device Developments / www.medicaldevice-developments.com Manufacturing technology

Break the fourth wall Since we entered the fourth age of the industrial revolution, known as industry 4.0, manufacturers have begun to explore a wide range of new technologies. Karen Taylor, director of the Centre for Health Solutions at Deloitte, speaks to Stephanie Webster about how to best implement these technologies into manufacturing processes to maximise efficiency while minimising cost.

e are all aware of the rapid pace of change approach to implementation is taken. However, there across multiple industries due to significant remain huge opportunities for industry 4.0 to enhance W technological developments and the manufacturing processes. reduced costs of using them. These trends are distinct One such technology is factory automation, from the greater level of process automation, driven which makes production lines more efficient, by advances in electronics and information technology, enhances resource effectiveness and improves since the 1970s. The greater adoption of industry 4.0 is productivity. Although seemingly simple to integrate, paving the way for disruptive approaches in a number they can be complex to manage on a daily basis. of areas, including medical device manufacturing. “Factory automation is probably the simplest It’s important to note that these technologies are not application of robotic process automation,” says new. “What’s changed is the cost, and the fact that the Taylor. “But these technologies, especially if they’re connectivity, miniaturisation, computer speeds and going to have connected sensors embedded in infrastructure has all changed to make it a reality to them, are very sensitive to change and need to apply it at scale,” says Karen Taylor, director of the be highly monitored.” Centre for Health Solutions at Deloitte. This is in line Cobots, or collaborative robots, are expected to with Moore’s Law, which predicts that the capacity of be used increasingly within manufacturing. Recent microchips, bandwidth and computers doubles every research has predicted this market will grow from 18 months, representing exponential growth. $710 million in 2018 to $12.3 billion by 2025. This is largely due to the technology being safer, more Humans and robots adaptable and compact than ever before. However, In light of the highly regulated nature of the medical such technologies are not yet able to replace humans. device industry, it is imperative that a strategic “There is a need for human-in-the-loop, but you

Medical Device Developments / www.medicaldevice-developments.com 43 Manufacturing technology

also be used to get support from an engineer remotely, Define industry 4.0 who could use mixed reality to be able to see what Although the term industry 4.0 is widely used, it is rarely defined. Deloitte has the problem is in the manufacturing process and described it as involving a move from traditional linear data and communication quickly rectify it. towards real-time access to data and intelligence. As part of this shift, there is a need for the integration of digital information from many different sources. Industry 4.0 also brings challenges, of course, Throughout this process, real-time access to data and intelligence is driven by including dealing with compatibility issues and the continuous and cyclical flow of informationn and actions between the physical ensuring systems are secure. Overcoming these and digital worlds, known as the physical-to-digital-to-physical loop. This consists of challenges is possible, though, presenting considerable three stages: 1. Physical to digital: information is used from the physical world to create a opportunities for manufacturers. digital record. 2. Digital to digital: information is shared to create insights using advanced Risky business analytics, scenario analysis and artificial intelligence. Despite the opportunity for these technologies to 3. Digital to physical: algorithms are applied to translate digital-world decisions to effective data, to spur action and change in the physical world. improve manufacturing processes, they do raise new issues. “With all of these, you get new challenges, like In order to achieve this, industry 4.0 combines a variety of technologies, data security, privacy cybersecurity – all of those are, including analytics, additive manufacturing, robotics, high-performance computing, as a result of the innovation on the one hand, raising natural language processing, artificial intelligence and cognitive technologies, challenges on the other side,” says Taylor. advanced materials and augmented reality. Source: Deloitte A 2015 Deloitte report found that the level of cybersecurity risk could increase strongly (35%) probably won’t need as many humans,” explains or very strongly (48%) among respondents across Taylor. “You are already seeing this in the car industry a number of industries as a result of industry 4.0. and in other industries where you’ve got highly Cyberattacks and viruses could be hugely problematic, automated processes.” bringing networked and smart production systems to Such technologies might not result in a reduction a halt, creating substantial costs. of workers, due to increased demand in other aspects However, such difficulties are not insurmountable, of manufacturing. “You will also need new types of but they do require tailored risk management staff to make sense of all the information that is being and security strategies to be put in place. It is also generated, so you’ll need data scientists and analytical important to note that as technologies continue skills and talents, which haven’t been something that to develop, this will also bring an improvement has traditionally been needed,” explains Taylor. in cybersecurity systems. The limiting factor will A 2018 Deloitte report indicated that, while largely come down to implementation, rather than companies are increasing their expenditure on their technological capability. When integrating these operational and IT budgets, they are reducing their systems, it is important that they can prevent and research and development budgets. On average, they treat cyberattacks effectively. are spending 30% of their operational/IT budget on Although there is increasing discussion about digital transformation but only 11% of their research the challenges and opportunities for industry 4.0, and development budgets on this area. implementation is still at an early stage. “There are One cost-effective solution to this issue might be to a number of global surveys, which my colleagues outsource, rather than recruiting or training in-house. have done, that show that in terms of digital maturity “These individuals are in short supply and that’s where and the adoption of technology, life sciences are maybe the best solution is – to partner with people lagging behind some of the other industries,” says and companies who have those skills,” says Taylor. Taylor. “However, we cannot underestimate the There are also a number of emerging technologies impact that the regulatory environment has. It that are likely to become increasingly implemented, is an enabler for innovation but at the same time such as digital twins. These are exact virtual replicas also stymies it because of concerns about meeting of physical products or processes, which can be the requirements.” updated in real time. They could be used to run simulations, and machine-learning technologies Four paradoxes could be implemented to predict breakdowns and In light of the increasing technologies available, as schedule maintenance. well as the opportunities and challenges they bring, Virtual, augmented and mixed reality is another many companies remain in inertia. A Deloitte report, valuable tool for the industry. This can be integrated ‘The industry 4.0 paradox’, marks the discrepancy into manufacturing in a number of different ways. For between the enthusiasm for these technologies and example, this technology can be used to design a new their implementation in a survey of 361 executives product, which can be refined in the virtual world across 11 countries. While results show a strong will, before developing a prototype to test further. It could balancing current operations with the opportunities

44 Medical Device Developments / www.medicaldevice-developments.com Manufacturing technology

of industry 4.0 remains difficult, manifesting in for innovation of manufacturing processes, such four paradoxes. opportunities should not be overlooked. $12.3 The first is the strategy paradox. Nearly 94% of respondents identified digital transformation as a top Make the most of it priority but this didn’t correspond with exploration In order to close the gap between conceptualisation billion within their organisation. Interestingly, only 68% and implementation, it is clear that action is needed. The predicted value believed industry 4.0 was an avenue for profitability, In the report ‘Forces of change: Industry 4.0’, Deloitte of the collaborative which likely is part responsible for this incongruity. identifies five steps that are needed in order to robots market in The supply chain paradox was also prevalent. optimise the use of these technologies. 2025, up from Although this was an area indicated to be fruitful It is imperative that companies immerse themselves $710 million for current and future investment by executives, in innovation, exploring the potential of industry in 2018. those outside the C-suite who were more involved to transform manufacturing processes, rather than MarketsandMarkets with the daily management of the supply chain merely improving them. did not have a voice in decisions about digital Building an ecosystem is key to ensure that these transformation investments. technologies can be successfully integrated. This Another paradox was present with regard to talent. might involve leveraging existing resources, as well as Despite respondents asserting confidence that they attaining new ones, either internally or externally. had sufficient capabilities within their organisation to Although there is a tendency to want to make implement industry 4.0, with only 15% admitting that dramatic and rapid changes, it is better to start with any changes to skill sets of workers was necessary, smaller stakes, testing and refining, before scaling up they also acknowledged that obtaining, training and where the consequences are more significant. This retaining the right people was an ongoing challenge. can help to gain confidence in the capabilities of these Innovation was the subject of the fourth paradox technologies, ultimately leading to greater innovation. identified. Executives reported that their strategies And above all, it is important that companies do not for industry 4.0 largely revolved around improving expect perfection from industry 4.0. It is still evolving, existing operations, rather than using them in a more and it is important to learn from previous experiences transformative way. In light of the huge potential to inform future initiatives and priorities. ● Our part is saving lives.

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Medical Device Developments / www.medicaldevice-developments.com 45

Manufacturing technology

Connect the bots Collaborative robots, or cobots, are a new class of robots that are bridging the gap between fully manual assemblies and fully automated manufacturing lines. Lightweight, flexible, easily programmable and safe to implement, cobots can meet some of the challenges associated with these processes in an efficient and effective way. Astrid Weiss, senior researcher at Vienna University of Technology, speaks to Emma Green about how best to integrate these cobots into manufacturing processes.

obots have long fascinated authors, scientists robots, as well as of service robots, to grow with and the general public. Despite the high double-digit margins over the next few years. R levels of interest, not all predictions about Researchers have suggested that many societies robot capabilities have materialised. It is notable are currently on the verge of a robotic era, which that Blade Runner, a world of humans and human- will result in robots soon being commonplace in like robotic replicates, was set in the year 2019. people’s daily lives worldwide. Nevertheless, the momentum of these technologies The perception of robotics is not uniformly is stronger than ever. The International Federation positive, however. A 2019 study by scientists of Robotics has predicted the sale of industrial at the University of Würzburg reported increasing

48 Medical Device Developments / www.medicaldevice-developments.com Manufacturing technology

scepticism to their use, particularly within the workplace. This is likely to be in large part down to the ongoing concern of robots replacing people, resulting in job losses. However, interestingly, the use of robots in this setting was rated more favourably by participants than in surgeries or autonomous cars. It is clear when discussing the applications of robotics that humans are a major consideration and play a much more significant role than the technology itself. This is particularly true within a new class of collaborative robots, known as cobots. Astrid Weiss, a senior researcher at Vienna University of Technology, knows a lot about cobots. With a background in sociology, social psychology and human-computer interaction, the focus of her work is how humans interact with new technology. As developments in this area are progressing at a rapid pace, it is essential to not only explore the capabilities of the technologies themselves but also the way in which to best integrate these with current working practices. ©VTT Studio/Shutterstock.com Cobots offer a number of benefits compared with costs around $24,000. “They must be able to be Designed by Softbank Robotics, Pepper traditional robots, if used mindfully. “Collaborative implemented safely without expensive safety is a semi-humanoid robots may reduce some of the environmental hardware, like dedicated workspace or fences,” robot that is able and spatial dangers traditional robots may cause, explains Weiss. to read emotions. allowing them to work alongside humans,” explains The second relates to the amount and nature of Weiss. “However, this is only true if the robots human input needed for a particular task. “Cobots are very easily reprogrammed, ideally by naive offer most benefit to smaller production volumes operators, and if safety is ensured.” and lot sizes that require frequent reprogramming It’s important to bear in mind that, although – ideally without expensive software tools or robot possessing a wide range of abilities, these cobots and computer vision specialists.” are not suitable for all manufacturing activities. “In cases where very precise manufacturing “Collaborative robots may reduce some of the tasks are done, such as polishing small metal parts, collaborative robots could not achieve satisfying environmental and spatial dangers traditional results,” admits Weiss. “For other domains, such robots may cause, allowing them to work as screwing or gluing parts together, they are much alongside humans.” more effective.” There are also a number of challenges that Question to consider come with using cobots. “Traditional robot systems When considering whether cobots offer are mostly programmed offline, with text-based an advantage to a particular manufacturing programming languages or by complex CAD/CAM- application, Weiss suggests considering three based simulation tools,” explains Weiss. “That is key questions: can safe human-robot collaboration only suitable for specialised situations such as without a fence be guaranteed? Do I have a use optimised and fenced working environments, case in which the robot increases productivity? Do I which only exist within the context of high have a use case in which the robot performs equally production volumes.” well or better than the human in its specific task? In response to such concerns, robot Cobots are best suited to small and mid-sized manufacturers have already begun to optimise production applications, where they are much their safety and ease of use. Work in this area has more likely to represent a good return on included “limiting system power and implementing investment. When using this technology in such safe control system structures and functionalities, $24,000 situations, Weiss highlights two key success factors such as restricting speed or the workspace they can Average cost that must be met. The first of these relates to cost, operate in”. This ensures that use meets the DIN of a cobot. an important consideration when the average cobot ISO 10218, a piece of regulation specifically Barclays

Medical Device Developments / www.medicaldevice-developments.com 49 Manufacturing technology

Efforts within this area have also focused on The AssistMe project the paradigm of joint/shared attention. As the Astrid Weiss was involved in a two-year, collaborative project involving a name suggests, this describes the shared focus number of parties, including Acin, Vienna University of Technology, Profactor, BMW and GPN. The research focused on user experiences of novel robotic of two individuals on an object. Joint/shared assistance systems. attention is achieved when one individual alerts AssistMe used haptic (force feedback) interaction technology, which recreates another to an object by verbal or non-verbal means the sense of touch by applying forces, vibrations or motions to the user, by means through gestures such as eye-gazing or pointing. of machine vision. This was combined with methods from the fi eld of spatial augmented reality. “Due to ambient noise in the manufacturing One of the components of the project was a case study that explored the use environment, gesture and touch-based interfaces of an industrial robotic prototype in the context of human-robot cooperation within are preferable compared with speech-based an automotive assembly line. Workers were interviewed about their experiences interfaces,” says Weiss. after working with the cobot for three weeks. It was found that cooperation with a robot that executes predefi ned working steps impeded the user in terms of Enhancing these capabilities also helps with fl exibility and speed. This changed the working routine and has the potential to improving the perception of cobots by workers, decrease productivity. The project highlighted the need to ensure that robots can an area of particular interest to Weiss. “A lack of better adapt to the needs of workers and to a dynamic smart factory environment. flexibility can increase perceived shortcomings, Source: AssistMe such as usability aspects and general helpfulness of the novel technology.” Weiss’s research in this pertaining to the implementation of cobots area found that direct interaction with the cobot within manufacturing. improved opinion of its capabilities, including its Unfortunately, safety and performance do not helpfulness and anticipated future performance. always go hand in hand, especially in terms of Conversely, collaboration could be negatively speed and accuracy. A promising approach in this affected if individuals need to adapt their working area is the use of pressure-sensitive skins, which practices to accommodate the robot. More work can be mounted onto existing factory robots, in this area is needed, which includes ensuring Astrid Weiss turning a normal robot into a cobot. that cobot behaviour can be anticipated. Recent work has also involved attempting to The issue of predictability is not unique to standardise human-robot interfaces for teaching robotics. Related technologies, such as AI and and controlling robotic systems. This aims to allow automation, have often been described as a ‘black cobots to handle more complex scenarios while box’, whereby their inputs and outputs are known also being simpler to use, so that they can be but there remains uncertainty about the exact operated by non-specialised members of staff. process between the two. Weiss’s research in this area found that more Shared control has also been a focus of recent generalised solutions weren’t ideal, and that it is efforts within collaborative robotics. A well- better to adapt interfaces for specific use cases. established idea within teleoperated robotics, shared control entails the user having a level “As robots work closer with humans, there of governance over the robot. “Transferring is a great need for them to be able to respond this approach to collaborative robots will enable to users and adapt their behaviours. Newly more-complex collaboration tasks,” explains Weiss. Although there have been a number of exciting introduced robotic systems allow a high level developments within cobot technology, the of adaptiveness towards the user’s individual realisation of their use within a smart factory rhythm, speed and working steps.” paradigm has not yet been achieved. Cobots currently demand a relatively rigid production line, The new guy seems nice which is at odds with the dynamic requirements Progress has also been made in making these of a smart factory. robots better able to work with humans. “As robots There is also a need for robots to be able work closer with humans, there is a great need for to sense and respond to changes in the them to be able to respond to users and adapt their environment, which is essential in order to behaviours,” explains Weiss. prevent slowdowns in manufacturing processes “Newly introduced robotic systems allow a or drops in output quality. high level of adaptiveness towards the user’s “Clearly there is a lot of potential for more individual rhythm, speed and working steps.” complex capabilities,” Weiss admits. “It will be Such capabilities could be achieved through the crucial that the robot can adapt to unexpected use of additional sensors for posture recognition, circumstances – like missing tools or working with in order to measure the worker’s movements and humans who deviate from the plan – and adapting waiting positions. to the capabilities of different operators.” ●

50 Medical Device Developments / www.medicaldevice-developments.com Company insight 3D-printed for long- term implantation

State-of-the-art technology from Apium makes 3D printing of medical grade PEEK possible, without affecting its biocompatibility and sterilisation properties.

pium, the innovative professional The best-in-class temperature 3D printing company from management system of the Apium M220 A Germany, is the pioneer and 3D printer enables temperature regulation one of the world leaders in processing in the processing of the 3D-printed medical speciality polymers. devices for the best possible results, and The company’s activities focus on together with the integrated filtration the key industrial 3D printing trends, system, prevents contamination of the high-performance polymers, metals printed part. and medical 3D printing. The medical-grade PEEK filament Apium is a technology leader in processed by Apium’s M220 3D printer PEEK 3D printing and the first company is developed from the VESTAKEEP worldwide to make 3D printing of long- i4 resin by the speciality chemical The M220 3D printer from Apium features a term implantable PEEK medical devices producer Evonik. best-in-class temperature management system. commercially available. The company’s The 3D printing of this medical-grade design and development activities have PEEK, using Apium M220 3D printers, The necessary certificates of resulted in advanced products and meets the biocompatibility criteria biocompatibility for material and improvement in time-to-market for required to produce medical implants and machine can be provided upon request medical devices. devices in the areas of craniomaxillofacial and are included in the delivery of and hand. the product. Apium M220 Series 3D printers: a game-changer technology in healthcare “Apium is a technology leader in PEEK 3D Apium’s engineers have developed printing and the first company worldwide to a professional material extrusion 3D make 3D printing of long-term implantable printing technology, which enables the PEEK medical devices commercially available.” 3D printing of medical-grade PEEK, without affecting its biocompatibility and sterilisation properties. This new production technology Some of the statements and claims is guaranteed to reduce lead times in this article may be forward-looking and the cost of implant manufacturing. statements or statements of future With medical-grade 3D printing, expectations based on currently production can now be performed available information. Such statements on-site in hospitals, and medical are naturally subject to risks and devices can be supplied with shorter uncertainties. Actual results or lead times, saving patients’ lives in developments may vary depending on time-critical surgeries. changes in the operating environment. Neither Apium Additive Technologies Disclaimer for Apium M220 nor Evonik Resource Efficiency assume and Apium PEEK an obligation to update the forecasts, The additive manufacturing device expectations or statements contained Apium M220 is not covered by the in this article. ● guidelines on medical devices. However, it is suitable for clean rooms and for For further information The processed medical-grade PEEK filament meets key biocompatibility criteria for implants and devices. the production of medical devices. www.apiumtec.com

Medical Device Developments / www.medicaldevice-developments.com 51

Somos® materials Things are evolving...

Somos® from DSM Additive Manufacturing has been at the forefront of 3D Printing since its inception over 30 years ago. During that time, many ground-breaking materials have been launched which revolutionized various applications and industries. As times are changing and the technology has evolved, the need for innovative materials with higher performance keeps growing. As material experts, we have been and will continue to be your trusted partner on this journey.

Follow DSM Additive Manufacturing on LinkedIn. Company insight Perform at a higher level Dutch multinational DSM is helping world-leading medical equipment maker GE Healthcare improve imaging equipment for patients and clinicians.

hen GE Healthcare began elastomeric resin families. Even so, AM test that mirrored a metal tool, MGS developing a new imaging generated tooling rarely moulded greater used Somos PerFORM to produce printed W device component, it partnered than 50 parts before failure.” inserts to successfully mould more than with MGS Mfg. Group and chose DSM GE Healthcare has partnered with MGS 100 parts. Several other 3D-printed additive manufacturing materials for the to help refine and optimise its product materials performed admirably during application. GE Healthcare and MGS have design and development process, similar testing, but none performed transformed the product development specifically targeting shorter lead times, nearly as well as the DSM material. process for this component, resulting lower costs and high-performance resins. in faster prototype production and cost Benefits to be had savings of nearly 70%. Enabling manufacturability DSM materials are playing a key role in “GE Healthcare’s partnership with MGS, “Early involvement by MGS and DSM in helping businesses reduce cost and time and use of DSM materials, has resulted in design considerations for manufacturability to manufacture, and bring new products streamlining new product development,” for customers like GE Healthcare has to market. For the GE Healthcare medical says Jesse Schrimpf, senior AME – significantly improved the prototyping instrument project, Somos PerFORM additive, GE Healthcare. “The ability to stages of product development, which enabled MGS to produce tooling three 3D print moulding inserts and then test leads to a seamless transition from times faster than traditional steel tooling, design iterations with real materials has prototype tooling to high-quality at a third of the cost. The tool produced made product development much more production-grade tooling,” says Klotz. using Somos PerFORM inserts cost near robust. It also has the added benefit of Development of an imaging $6,000, compared with a steel tool that making the designs more ‘mouldable’ as device component for GE Healthcare would have cost upwards of $20,000. we transition towards the creation of demonstrated how MGS partners with Furthermore, the quality of the moulded expensive production tooling.” customer product design teams to parts using Somos PerFORM inserts was identify the best 3D machine/material so good that GE Healthcare was able to Challenges to overcome system to generate rapid tooling and use them for customer testing. Reducing lead time and costs to make moulded prototypes. Another key benefit is being able to prototypes that perform like the final A key part of this is how MGS helped quickly and cost-effectively produce a product is a significant challenge faced GE Healthcare build its injection mould tool when changes are needed. This helps by all product development teams. GE design skills early in the production make product design and development Healthcare successfully produces ‘printed’ process. For the GE Healthcare imaging more effective. Using Somos PerFORM, prototypes for its product development device, and many other projects, MGS designers are able to produce a realistic groups in-house but needed to expand its had recommended DSM additive physical part, test it, and, if necessary, capability to include printing tooling inserts manufacturing materials. make changes and quickly produce that can make ‘moulded’ prototypes. GE another tool. Healthcare knows that for truly effective Solution on offer In addition, producing tools out of new-product testing, it is imperative that “DSM products, like Somos PerFORM, Somos PerFORM makes the moulding of prototype parts closely match the finished make possible additive manufactured prototypes possible in materials such as product in terms of colour, strength and tooling inserts that perform exceptionally glass-filled nylons, polyesters and even chemical resistance. well during injection-mould processing filled polyetherimide materials. Kevin Klotz, engineering manager at of various resins. Somos PerFORM MGS is now providing this service to MGS – a DSM business partner and a US tool inserts withstand the pressures, several clients. Klotz says, “The ability rapid prototyping specialist – says, “3D temperatures and abrasive characteristics to successfully provide prototype parts printing additive materials have been of high-performance moulding resins moulded of engineering-grade materials used to print tooling inserts for several that other additive manufacturing is the differentiating factor between years. However, optional injection materials simply cannot withstand,” Somos PerFORM and inserts printed in moulding resins that can be processed explains Klotz. alternative SL resins.” ● using additive manufacturing (AM) The GE Healthcare imaging device tooling was limited to resins that process component needed 100 or more parts at low temperature and pressure. Typical moulded of a material that demanded For further information examples include the polyolefin and challenging process conditions. In one www.dsm.com/additive-manufacturing

Medical Device Developments / www.medicaldevice-developments.com 53 THE AUTOMATION SOLUTION

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In order to best meet customer needs, Mikron specialises in highly modular assembly solutions that are easy to evolve during the different stages of a product life cycle – from the development phase through to the highest-performance solutions.

hether in the pharmaceutical, medical technology, W automotive or electrical industries, the demands from customers have risen sharply in recent years. In an extremely competitive market, pressure on performance is rising and the lead time for new products is getting ever shorter. An assembly solution often has to be ready before all the details of the new product are even known. In many cases, assembly solutions also need to be frequently switched to another variant. So it is no wonder that demand for innovative, cost-optimised solutions has risen dramatically over the past few years. Mikron Automation scalable solutions. The future belongs to agile automation the validation process through to the greatly shortens delivery times. What systems that can be expanded and pilot line, and to the highest-performance is more, using the company’s standard enhanced easily and cost-effectively – production, our full range of G05 platforms, process stations are validated from the development phase through automation and feeding platforms at an early stage and can be transferred to fully automatic production. serves our customers in the long term.” from one automation level to the next.

Minimum risk with flexible “The future belongs to agile automation systems production starts that can be expanded and enhanced easily and cost- The key word in the brave new world of effectively – from the development phase through to flexible automation systems is ‘scalability’. fully automatic production.” “For customers, the new approach means minimum risk, and a faster, reliable and more flexible production start – in From the first prototypes up to fully “A major factor in our success is that several stages if required,” says Arrieta. automatic production lines we have a close partnership with our For many years, Mikron Automation Will production trials continue in low customers in order to understand their has enjoyed an excellent international quantities? Or is it now time to search for a needs, allowing us to react immediately,” reputation as a partner for high-performance fully automated solution for large volumes? says Rolf Rihs, president of the Mikron automation solutions in the large-scale When looking for assembly solutions, Automation division. “That is why the manufacture of precision products. manufacturers need a partner that leaves scalability of our automation systems is “For many, however, the fact that all options open to them. With its modular so important.” Mikron Automation is also one of the and scalable platforms, Mikron is always Mikron’s customers can count on leading providers of scalable and flexible thinking and acting one step ahead. a knowledgeable, experienced and automation systems is the base for the “Customers appreciate the cooperation trustworthy partner. Thanks to its future,” adds Arrieta. with Mikron because, with our many years standardised platform philosophy, going Mikron is thus strengthening its of experience, we think beyond the horizon from the manual workplace to the fully industry position as a first-choice, and advise them on how to prepare the automatic cell, Mikron offers almost long-term partner. ● line for the next steps,” points out Félix unlimited layout options. Throughout the Arrieta, general manager of Mikron SA whole process, it is easy to redeploy and Boudry in Switzerland. “From the design reconfigure whenever necessary. This For further information for assembly to the proof of principle, from considerably increases cost efficiency and www.mikron.com

Medical Device Developments / www.medicaldevice-developments.com 55 Lab-on-a-Chip Components, Flow Cells and Bio-Chips Micro-channels, wave-guides and electrodes for sensing, screening and analytical applications

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Everything is illuminated Traditional photonic devices have been fabricated from rigid materials on rigid substrates, limiting their applicability in the healthcare sector. Now, researchers at the Massachusetts Institute of Technology (MIT) have developed a method for making photonic devices that can bend and stretch without damage and without compromising optical performance. Patrick Kingsland speaks to MIT associate professor Juejun Hu about the application of this technology for medical device manufacturing.

t is a word that is rarely used in common technologies, new possibilities are emerging in the parlance, but over the past few decades, diagnosis, treatment and prevention of disease. I photonics – the science of generating, “Light is an extremely important probe that controlling and detecting light – has become people can use to investigate biomedical an integral part of our everyday lives. phenomena,” says Juejun Hu, associate professor In the manufacturing sector, laser-based of materials science and engineering at the technologies are enabling cleaner, higher-volume Massachusetts Institute of Technology (MIT). and lower-cost methods of production. In the field At the cutting edge of the technology are new of communications, photonic technology is driving designs and materials for flexible photonic sensors, advances in optical fibres – the backbone of which can be bent, folded, rolled, twisted and today’s internet. stretched to conform to human skin without Perhaps the most life-changing – or saving – field compromising optical performance. of photonics can be found in the medical device Hu, and other researchers at MIT, say such sector. From oil candles to electricity, light sources devices could be used in a range of skin-mounted, have been used in healthcare throughout human wearable health monitors, potentially revolutionising history. But with modern optic and photonic the medical device manufacturing sector.

Medical Device Developments / www.medicaldevice-developments.com 57 Lasers & photonics

A key enabling technology strongly scattered, others weakly scattered – One of the key benefits of using light for healthcare providing detailed information about biological is that it is non-invasive. Procedures involving activities, such as oxygen concentration, heart photonic devices – which use systems of mirrors, rate and blood pressure. lenses and LEDs to process light beams directly “A simple example is oximetry,” Hu says. “This – do not require needles or knives or other is a machine that allows a doctor or nurse to read instruments that penetrate the skin. This means out the oxygen level in the blood. The basic idea is Professor Juejun Hu less pain for patients and less complicated that you are sending different wavelengths of light operations for medical practitioners. to penetrate through a human finger, which is “Instead of using a physical probe you use light actually translucent. By looking at the absorption to penetrate human skin and get images or chemical of light at these different wavelengths you can information about the human body,” says Hu. work out various different things.” Photons are also used to directly affect biological “Instead of using a physical probe you use light tissue, serving a number of therapeutic and surgical purposes. Light-based therapy is used to treat to penetrate human skin and get images or a range of dermatological conditions; laser chemical information about the human body.” procedures are used to correct near and far- sightedness in vision; in oncology, photonics Photonic technology has been particularly central immunotherapy has been used to treat cancer. in the development of modern imaging techniques The photonics field is making such strong such as optical coherence tomography – a non- progress that, last year, it was named as one of invasive test that uses light to capture high- six key enabling technologies by the European resolution images of tissue. Optical coherence Commission’s Horizon 2020 – a research and tomography is now used in a wide range of medical innovation programme designed to help the applications, including ophthalmology, dentistry, EU become a front runner in “market-creating gastrointestinal endoscopy and dermatology. innovation”. The programme’s proposed budget “With optical coherence tomography, people use allocation between 2021 and 2027 is a mouth- light to generate and reconstruct three-dimensional watering €100 billion. $56 images of tissue that would be difficult to obtain using “Medical photonics research and innovation is other techniques,” Hu explains. “It does no damage to leading towards the development of easy-to-use, human tissue and has been used very widely in eye low-cost screening methods that can be carried out billion surgery as well in examining skin conditions.” at a general doctors premises, or even at home,” Projected value The ability of light to carry information in said a European Commission Horizon 2020 press of the photonics multiple dimensions means photonics is also used release. “These photonic point-of-care technologies industry in 2020. for medical sensing. Different wavelengths interact can provide a risk assessment of age and lifestyle- German Federal Ministry of Education and Research with biological tissues in different ways – some are related diseases within a few minutes.”

58 Medical Device Developments / www.medicaldevice-developments.com Lasers & photonics

Unsurprisingly, photonics has been identified as on rigid substrates, such as semiconductors or glass, one of the fastest-growing areas within healthcare. which are deemed inappropriate for soft, curvilinear €100 The global market is projected to increase from human bodies. approximately $32 billion in 2011 to $56 billion in “If you look at how people conventionally make 2020 according to recent market research published these miniaturised, integrated photonic devices, it is on billion jointly by the German Federal Ministry of Education some kind of rigid substrate,” says Hu. “But if you look Proposed budget and Research, the Mechanical Engineering Industry at biological tissues in human beings, we are made of allocation, between Association, the German Electrical and Electronic this soft, squishy stuff. That means there is a very large 2021–27, of Manufacturers’ Association and the German High elastic mismatch with traditional photonic devices.” the European Tech Industry Association. The obvious candidates to overcome this elastic Commission’s “Photonic devices are penetrating into many mismatch are organic polymers, from which most Horizon 2020. different fields and biomedical applications,” says Hu. flexible photonic devices have traditionally been European Commission fabricated. But while these polymers have inherent Photonics flexing its muscles mechanical flexibility, they also present their own While many photonic devices have already been problem: a low refractive index and poor ability to clinically validated and are widely used in the confine light beams. medical sector, there is still a great deal of work “Most of the polymers have more or less the to be done according to Hu. The researcher, who same refractive index,” Hu explains. “This could be is a principal investigator at the Photonic Materials problematic because for a lot of cases you want to Group, is particularly interested in developing be able to manipulate the light probe with freedom. integrated photonic structures that are smaller Polymers do not allow you to do that.” and more practical than traditional devices. Hu and other researchers have therefore been “Current optical coherence tomography searching for a method to make photonic devices instruments are pretty big, bulky machines and that can do two things simultaneously – bend, twist, can really only be used in a dedicated laboratory stretch and seamlessly integrate with biological or a doctors clinic,” he says. “We are looking into tissues such as human skin while also maintaining essentially trying to miniaturise this and make strong optical performance. it more accessible. This is the emerging area within photonics.” “If you look at how people conventionally make Hu’s group is also focused on making new materials for integrated photonics that are flexible these miniaturised, integrated photonic devices, and can be mechanically deformed. Photonic it is on some kind of rigid substrate. But if you devices that could stretch and bend like human skin look at biological tissues in human beings, we could be used in a range of medical applications, are made of this soft, squishy stuff. That means such as skin-mounted monitoring devices to detect heart rate, blood oxygen levels and blood pressure. there is a very large elastic mismatch with “We anticipate that the identification of new traditional photonic devices.” application fields, where mechanical flexibility either constitutes the key feature enabling the target “My group has been working on that for the past applications or contributes to significantly improved six to seven years, and we have developed a whole device performance, will certainly accelerate array of different components along the line,” Hu penetration of the technology into diverse market says. “Components must exhibit good mechanical sectors in the future,” Hu’s team said in a recent ruggedness and flexibility that does not compromise paper titled ‘Flexible integrated photonics: where the optical properties.” materials, mechanics and optics meet’. Flexible devices of this kind are not a novel idea. A hybrid platform The concept of flexible electronics dates back to the Searching for a material that does this, Hu’s group 1960s and is now a $5.13 billion global industry. has turned to an unusual source – a specialised kind Lighter and more durable than what came before, of glass called chalcogenide. Though regarded as a flexible electronic devices have seen widespread fragile substrate, the glass material is widely used in adoption in the consumer electronics and healthcare the microelectronics industry and possess a high market, where they are used in lab-on-chip devices, refractive index with strong optical confinement. X-ray detectors and health monitors. “The glass materials’ success in the But bringing this technology to the biomedical microelectronics industry, coupled with their field has proved challenging. This is because the vast superior optical performance, point to chalcogenide majority of integrated photonic devices are fabricated glass micro-photonics as the natural next step of

Medical Device Developments / www.medicaldevice-developments.com 59 Lasers & photonics

we developed this kind of hybrid platform that leverages most polymers and this inorganic material to take the best from both worlds,” he says. technology evolution,” Hu’s research group said While this breakthrough is significant, Hu believes in the paper ‘Chalcogenide glass micro-photonics: there is still a great deal of work to be done. So far stepping into the spotlight’. his team has demonstrated a device that allows them To overcome the inherently brittle nature of glass, to transmit light and exhibit desirable mechanical Hu’s team has formed the stiff material into a spring- properties, “but it doesn’t really carry any specific like coil. The process has been compared with steel, function per se”, he says. which can be made to stretch and bend when formed “That is something we are working towards,” into a spring. he adds. “We are trying to integrate this component, “The architecture of this glass coil allows it specifically either for biomedical applications or for to stretch and bend freely while maintaining its high-speed data communication.” desirable optical properties,” said MIT in a press It is estimated the technology could be commercially release. “Tests have shown that such spring-like applied within the next two to three years. While Hu configurations, made directly on a polymer substrate, may spend most of his time in laboratories and at his can undergo thousands of stretching cycles with no desk, drafting academic papers, he says this is his real detectable degradation in their optical performance.” ambition. “My dream is to see some of the things I With this breakthrough, Hu believes his team now develop at MIT have an impact in the real world and has a device that offers versatile light manipulation benefit the society as a whole,” Hu said in an interview and transmission, and excellent mechanical flexibility. with MIT’s news service. “That’s why I am interested in “I think what is new about our research here is that entrepreneurship, to push them to application.” ●

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60 Medical Device Developments / www.medicaldevice-developments.com Company insight The leading trade show for lasers and photonics The international trade fair for photonics components, systems and applications, LASER World of PHOTONICS offers a complete market overview – from optoelectronics to lasers in production and imaging – bringing together key players from the fields of analytics, diagnostics and biotechnological research, as well as celebrating new talent.

ore than 1,300 exhibitors from cutting edge of progress in the A platform for young talent around 45 countries will present semiconductor and electronics field, or Growth dynamics is a reason why photonics M their innovations at LASER contributing to quality assurance in the provides a very good environment for World of PHOTONICS on 24–27 June 2019 food industry with new imaging techniques. founders. The market has more than at the fairgrounds in Munich. Also awaiting doubled in ten years. The Start-Up Area at visitors in parallel is a trend-setting Prizes for viable solutions LASER World of PHOTONICS offers young conference boasting seven individual Two awards at once are being handed talents a platform in the middle of the trade conferences and more than 5,000 experts out at this year’s LASER World of show. Additionally, the Makeathon again from around the world. In a nutshell, PHOTONICS; the Innovation Award, provides young engineers and students with Munich is awaiting an event of superlatives being conferred for the first time, honours a platform for demonstrating their expertise that will provide deep insights into the the best product premieres by exhibitors, in the photonics arena. future of photonics. while the Start-Up Award, being presented The trade show offers a complete market for the third time, is directed at young World of Photonics Congress overview – from optoelectronics to lasers entrepreneurs offering innovative with well-known speakers in production and imaging. One of the solutions. The awards are worth €5,000. This time, Europe’s leading congress topics will also be biophotonics and how “The Start-Up Award contestants are comprises seven conferences – the it is enabling ever more accurate medical living proof just how many innovative ideas newcomer is the OSA conference ‘Imaging diagnoses. LASER World of PHOTONICS are being generated by photonics,” says and Applied Optics’. In addition, the 2019 brings together key players from Katja Stolle, the trade fair’s exhibition ‘European Conference on Lasers and the fields of analytics, diagnostics and director. “Which is why it isn’t just Electro-Optics and the European Quantum bio-technological research. Many of the established Start-Up Award being Electronics Conference’ (CLEO/Europe – the exhibitors are developing optical conferred at LASER World of PHOTONICS EQEC) will again be shining the spotlight systems and components, but not for one 2019 but the Innovation Award as well. on basic research in the laser technology application area alone; they may also be This enables us to give innovation an even and quantum optics fields. active in the aerospace industry, or at the bigger platform.” Professor Anton Zeilinger will also address quantum technologies in a keynote speech, offering insights into the work of his group at the Vienna Institute for Quantum Optics and Quantum Information. The opening keynote speech for the congress on the first day of the trade show will be by Prof Karsten Danzmann, director of the Institute for Gravitational Physics at the University of Hanover and director of the Albert Einstein Institute. Anyone wanting to gain a clearer idea of the future in photonics should schedule a visit to the trade fair in Munich on 24–27 June 2019. ●

For further information LASER World of PHOTONICS 2019 brings together key players from multiple industry fields and offers a complete market overview – from optoelectronics to lasers in production and imaging. www.world-of-photonics.com

Medical Device Developments / www.medicaldevice-developments.com 61 FRORU3ROŠ SRODUL]HUV 0DGHWRPDWFK\RXUDSSOLFDWLRQ

*ODVVSRODUL]HUVIRU899,61,5 0,5 ‡7UDQVPLVVLRQXSWR  ‡&RQWUDVWUDWLRRI  G% DQGJUHDWHU    ‡2SHUDWLRQWHPSHUDWXUHVEHWZHHQƒ&DQGƒ&     ‡5HVLVWDQWWR89UDGLDWLRQDQGPRVWFKHPLFDOV ‡0DGHRIJODVVEXWWKLQOLNHSRODUL]DWLRQIRLO  ‡(DV\KDQGOLQJDQGSURFHVVLQJ ‡&XVWRPL]HG  &2',;; ZZZFRGL[[GH ‡FRORU3RO#FRGL[[GH Company insight Possible polariser application requirements German polariser specialist CODIXX knows the most common requirements for choosing the right polariser for your application.

s discussed in the previous purer the transmitted light, the higher ■Size: due to the manufacturing process, volume of Medical Device the value, which ranges between 100:1 some polarisers are limited in size A Developments, polarisation for low-budget sheet polarisers and 106:1 and are not available in larger sizes. is a singular property of light that for high-quality birefringent polarisers, or The most common sizes are up to can significantly improve medical even 107:1 for dichroic glass polarisers. around 40–50mm. applications, but only if the right polariser is selected. Different polariser types “The requirements of the application should be are available with vastly different specifications. To find the right one, the defined and matched with the polariser.” requirements of the application should be defined and matched with the polariser. A high contrast is not essential to ■Thickness: some polarisers are thicker There are several important remove glare, but analysing contents than others due to the optical path application characteristics: or concentrations of a pharmaceutical length required for the polarisation. The ■Wavelength range: which wavelength substance requires a very high contrast. thickness, and therefore the required range is used to be the light source or space within the application, varies monitored effect? Applications can use Secondary specifications between 0.2mm and 35mm. the whole spectrum or just a smaller On top of these three main specifications, ■Durability: possible environmental range; for example, UV, visible or IR. secondary ones need to be considered: influences like temperature, chemical Most polarisers are optimised for ■Wavefront distortion: describes the or radiation exposure should be a smaller wavelength range, so the wavefront distortion caused by passing considered as well to avoid damage wavelength range plus-minus a few through a transmitting component. It or destruction of the polariser. nanometres should be known. might cause focus shifts and spot size ■Handling: some polarisers require ■Transmission: this describes the ability increases, thus causing a blurred image. special handling to protect the of the polariser to let light pass through ■Laser damage threshold (LDT): polarisation properties during as a percentage. An ideal polariser another key factor to consider when installation or regular usage. would transmit 100% of the light dealing with a laser light source. ■Cost: last but not least, the cost needs parallel to the polarisation axis and 50% The LDT per square centimetre can to be considered as polarisers can range of unpolarised light. As there are no range 1W to 500kW depending on from the price of a cup of coffee to that ideal polarisers, usually between 40% the polariser. of a small car. In general, the lower or and 98% of optimally polarised light ■Acceptance angle: should be chosen fewer the requirements, the lower the is transmitted. adequately if uncollimated light is price. Should one of the more expensive ■Extinction ratio or contrast: the evident on the polariser. It usually polarisers be required, the cost can be ratio between p-wave and s-wave. The ranges from ±2° to ±25°. reduced by choosing a smaller size.

These are the most common factors, which should be known in order to enable you to find the most suitable polariser for any application. Now you need to know what every polariser type can, or cannot, provide, which will be discussed in the next issue of Medical Device Developments, 2019 Vol. 2. ●

For further information Finding the right polariser can be tricky, but CODIXX’s expertise can help. www.codixx.de

Medical Device Developments / www.medicaldevice-developments.com 63 Company insight Produce customised medical devices

3D printing solutions from TRUMPF, including the TruPrint 1000 3D printer, produce intricate, made-to- measure implants with excellent material properties that save medical device companies time and money.

dditive manufacturing is ideal for producing medical devices. A When designing an implant, a CAD engineer will first create a computer model based on patient data and then set the 3D printer to work. What’s more, products made using this technology have excellent material properties – for example, polymer devices that are robust but elastic and shock-absorbent, or implants with a porous structure that fuse well with healthy tissue but remain stable and durable. Additive manufacturing is also suitable for producing custom-fit implants on a cost-effective basis. A further benefit is that, unlike conventional Conmet uses TRUMPF’s TruPrint 1000 3D printer to produce customised craniomaxillofacial implants. machining methods, 3D printing does not produce any waste in the form of shavings clear that the ideal set-up was TRUMPF’s the surgeon; and the machine prints it or swarf. And in the manufacture of own TruPrint 1000 3D printer with the out. “We currently produce 60 implants medical implants, where the material of laser focused to a diameter of 30μm. a month with the TruPrint 1000, and choice is generally an expensive titanium Equipped with a 200W fibre laser we’re planning to increase our output alloy, this means genuine savings. developed by TRUMPF, the machine has by 10%,” says Nadeschda Morozova, Furthermore, there are none of the no problems working with the titanium project manager at Conmet. The retooling costs of conventional methods. alloys generally used to produce implants. implants not only have an especially Conmet, a market leader in TRUMPF also proved its expertise to fine high quality level overall – they are craniomaxillofacial surgery and tune the focal diameter at which the laser also substantially cheaper. implantology, first looked at additive beam hits the powder bed. “Our tests “Compared with conventional manufacturing 10 years ago. At the showed that reducing the focal diameter machining methods, such as turning time, however, the technology was still to 30μm improves the surface smoothness and milling, the new process saves insufficiently mature for such applications. of the implants by around 20%,” Margolf us 40% in production costs,” Morozova In 2017, the company decided to explains. This makes the process slower reports. In the near future, Conmet approach TRUMPF to find out how far and slightly more expensive but reduces intends to start producing custom- the technology had evolved. “TRUMPF the cost of post-processing the surface.” fit spinal fixation devices using 3D is the only supplier on the market for printing. The company also has plans to 3D printing that develops its own lasers 40% saved in production costs manufacture mass-produced prosthetics and all the optical components,” explains Conmet has been operating with the with the TruPrint 1000. For this, Conmet Andreas Margolf, project manager for TruPrint 1000 at its Moscow production will be investing in new machinery additive manufacturing at TRUMPF. facilities since the beginning of 2018. and has once again opted for TRUMPF “We also have a wealth of experience in The company uses the new machine technology. As Morozova explains, the the areas of machine tools and services. to produce dental components and new machine will be a TruPrint 3000, That means we’re able to assist Conmet craniomaxillofacial implants for, among with a larger construction chamber. ● with any aspect of the process.” others, cancer patients. Hospitals The first task was to determine the provide Conmet with CT data of right machine for Conmet, along with the patients; engineers at Conmet then For further information relevant process parameters. It was soon design the implant, in consultation with www.trumpf.com

64 Medical Device Developments / www.medicaldevice-developments.com Utmost reliability - even after 24-hour shifts Robust additive manufacturing systems by TRUMPF

TRUMPF is the market leader for machine tools and lasers for industrial manufacturing. We are also your knowledgeable partner for additive technologies. Additive manufac- turing enables precise and reliable series production of medical equipment or implants in compliance with the usual quality requirements – layer by layer and component by component. www.trumpf.com/s/additivemanufacturing Electronics

Smash the ultrasound barrier Scientists at the University of British Columbia, Canada, have developed a portable ultrasound device that can connect to a smartphone and costs only $100. The new transducer can be used to look at any part of the body, producing instant and clear images. Research lead Carlos Gerardo talks to David Callaghan about the potential for this new device, which includes patients wearing it for monitoring purposes.

he future of ultrasound devices could be bright can produce clearer images with more detail. Each with the development by scientists in Canada of drum, which is the diameter of a human hair – T a portable scanner that embraces radical new 100μm, or 1/10th of a millimetre – vibrates according technology and can be powered by a smartphone. to the level of high-frequency sound waves received Using different materials to the traditional ultrasound by the device. The resin, which is cheap and quick machines, researchers at the University of British to produce, is made from polymer capacitive micro- Columbia (UBC) have produced a scanning device machined ultrasound transducers, or polyCMUTs. the size of a plaster that costs just $100. In the scanners currently used around the world the The new device has the potential to be woven piezoelectric crystals act as a transducer by changing into clothes or wrapped around the body to monitor shape under an electrical current, and emitting sound changes in performance of a person’s internal organs. waves that can then pass into the body. Once the There are also plans for a patch-type scanner, or waves hit an obstacle they bounce back and the even tiny versions of the device being used to look crystals convert them into electric currents, which inside arteries and veins. are then processed into a sonogram image. The issues University engineers have replaced piezoelectric with this ultrasound technology are that it is expensive crystals, commonly found in ultrasound scanners, to produce, has limited bandwidth and the images are with minute drums made from a polymer resin, which not always as clear as they could be.

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CMUT technology is not new, but, despite its plastic transducer that can replace the existing Left: Portable scanner for ultrasound high efficiency rating, it was restricted in the way technology. It is simpler to fabricate, and the devices, developed it could be used in ultrasound due to the material manufacturing costs are much lower.” by researchers at the used to make the drums. Rigid silicone materials The question now is what happens next, and how University of British Columbia, Canada. have been adapted, which are costly to produce, can this product be further developed? are sometimes subject to acoustic crosstalk, and “We have ambitions for an ultrasound ‘patch’ that there has been a limit to how deep into tissue can be placed under the skin to monitor the heart these scanners can penetrate. for a few days or weeks. An ultrasound ‘probe’ With the new polymer drum technology, the could be attached to the body and used to send $7.3 manufacturing process is much cheaper than with information remotely,” Gerardo says. silicone, meaning that CMUTs become a much more The new device is not limited in its use to billion attractive option to use in ultrasound scanners. The a particular part of the body, and can be used Current global polymer is also strong but sensitive, the impedance in exactly the same way as existing ultrasound value of the factor is lessened and the voltage required to make scanners, including for cardiovascular examinations ultrasound market. it work is low, at just 10V. and obstetrics, for example. GBI Research An electrode is held within a membrane made of a light-activated resin and sacrificial layer, as opposed “We have ambitions for an ultrasound to the silicone used in previous versions of CMUTs. An optically transparent shell will be an advantage during ‘patch’ that can be placed under the skin to manufacturing, as it will allow a visual inspection monitor the heart for a few days or weeks. of devices after fabrication. This contrasts with An ultrasound ‘probe’ could be attached to the piezoelectric technology, where defects are detected after you create all the electrical connections. body and used to send information remotely.”

Inside out Good news moves fast “This new fabrication process has the potential News of the device has spread fast, prompting to increase the use of CMUTs in the ultrasound interest and contact from around the world, including market, including the market for wearable the UK, Germany, Australia, the US and Canada. The transducers,” says Carlos Gerardo, one of the UBC research team has already held meetings with co-authors of the project at UBC. biomedical manufacturers, who are interested in Earlier development of polyCMUTs was producing the new device commercially. hampered by the need for high voltages, in the Enquiries have also come from other industries, hundreds, to make ultrasound work. This has such as gaming and virtual-reality companies, which been overcome by embedding the electrode in wanted to know how this development could be used the membrane of the device instead of on top, in their fields. and thereby reducing the power required. The “We have been overwhelmed,” Gerardo says. “It is frequencies achieved are comparable to the all positive and exciting though, and we have been CMUTs made of silicone nitride or polysilicon. discussing which way to proceed from here.” A basic microfabrication facility operating at There are a few questions for the researchers to relatively low temperatures of less than 150ºC can consider, such as how much time they spend on other be used to produce the polyCMUTs, which helps uses for the technology, while accepting the medical to make the process even more attractive to purposes are their main area of concentration. They potential manufacturers. also have to balance the commercial and legal aspects Possible improvements to the techniques used to of developing a new technology with the need for produce polyCMUTs could include water-bonding further academic research. technology with the SU-8 polymer, or roll-to-roll “We have the potential to save lives, but at the same methods, where the cavities and membranes are time we have to pass the regulations,” Gerardo says. bonded together in a vacuum environment. The team will probably look at non-medical uses “This could decrease production times and costs in areas covered with less regulation, which makes even further, with the possibility of fabricating ultra- it easier, and at the same time not compromise on low-cost ultrasound transducers,” Gerardo explains. their efforts to keep working on the ultrasound The product still needs to be developed further. scanning device. “The implementation is not immediate – we need There are dangers in this approach, Gerardo to do a lot of experiments, and in the US and admits. “If we try to be too broad we won’t be Canada there are many regulations to be met,” says able to go very far, so we have keep it narrow to Gerardo. “We have produced a high-performance some extent.”

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Enlarged microscopic “We are creating prototypes and seeing which ones ultrasound device attached to a smartphone is a image of CMUT cells. to go with,” he says. The team are going to create vision the team has for their product. a small start-up company in the next few months, “We have a dream, but we have to take it step with a view to a partnership with a commercial by step,” Gerardo says. “Our dream is something manufacturer and possibly a contract. portable that uses batteries and is affordable. A Next year, if all goes well, the research team hope patch would require a low voltage – we need to to see the polyCMUT ultrasound device on the market produce several prototypes.” and available to buy. The establishment of a patent, to Certainly the cost of the device will be crucial if it ensure the technology developed by the UBC team is is to be used in developing countries, where money properly protected from being copied, is a priority. is scarce but the need is great. If the cost can By dealing with all aspects of the development of a be brought down below $100 then it may become new product it will eventually lead to a better device, a possibility for those countries. The ultrasound Gerardo says. “We need to invest this time, as it market was forecast to grow from a global figure means we will better design things in the lab. of $4.6 billion in 2012 to $7.3 billion this year, “We can tell people how it is done, and with the according to figures from GBI Research, meaning research community we have to do this. A basic lab there is enormous potential for these products. can replicate the results – you don’t need expensive The UBC team’s polyCMUT device could be a equipment. But the key parameters and the tiny breakthrough development that transforms the details we keep to ourselves for commercial purposes,” ultrasound market and its use of technology. he says. It is also important on the flip side to ensure If the product costs less than $100 yet produces they don’t infringe on someone else’s design. better images than existing scanners, there will $100 For example, there is a US company called surely be many takers from all over the world. Proposed cost of Butterfly Network, which has developed a handheld Ultrasound could become available in parts of UBC’s new scanner. ultrasound scanner that can produce images of the the world where it is currently only dreamt about. In contrast, current whole body. Conditions such as liver disease or heart With the current price tag of between $10,000 for portable scanners disease can be diagnosed relatively easily. It costs portable scanners and $250,000 for top of the range cost a minimum $2,000 to purchase with a user licence fee on top. scanners, it’s not difficult to see why the cost is of $10,000. This device doesn’t use the traditional piezocrystal currently prohibitive to some communities. UBC technology, replacing it with a single silicone Existing scanners using piezoelectric crystals chip. It is battery-powered, and can be used with could be phased out, with all the implications a a smartphone. “They have an amazing product”, much cheaper alternative would have for the big- 100μm Gerardo says. “Their technology uses something name manufacturers. Wearable ultrasound devices Diameter of the completely different to existing machines in hospitals stand to become the go-to products for health drums, made from a and is similar to ours.” professionals, and the ease-of-use and portability polymer resin, inside certainly make UBS’s product a strong contender. UBC’s ultrasound On the phone As the device can be used with a smartphone, scanner – the same Compatibility with smartphones is one aspect then the sky may well be the limit in terms of as a strand of hair. Gerardo sees as really important in any new its potential uses, and the possibilities for future UBC ultrasound device. In fact, a portable transducer ideas are endless. ●

68 Medical Device Developments / www.medicaldevice-developments.com Driving Reliability

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www.fujitsu.com/IoT Company insight Decrease work pressure, improve patient well-being and gain insight Fujitsu’s IoT connectivity solutions are powerful tools for hospitals when it comes to improving efficiency and keeping track of supplies.

ospitals deal with a large number appointments, waiting times and routes, of patients on a daily basis, which therefore contributing towards a positive H involves the movement of an even hospital experience. Indoor navigation greater amount of supplies and equipment. also allows insight into visitor and patient Today’s healthcare facilities are under traffic and enables detailed profiling of serious pressure to have equipment visitor behaviour. available at the right time and location. Fujitsu Smart Beacon is a Bluetooth Combining nursery tasks with tracing smart transmitter that broadcasts specific hospital equipment is an inefficient use of data in the form of a unique identification resources when alternatives are available. number, information on transmission Fujitsu Components has developed power or a URL. The unique identification an IoT solution to cover hospital asset number enables smart devices – such as a management; the solution can also monitor phone or tablet – to recognise the beacon environmental conditions, such as room and relate it to a specific app. The number temperature, acceleration and humidity. also identifies the group or groups to which that specific beacon belongs. Information Hospital asset management Fujitsu has developed a solution that can trace any about the transmission power can be used hospital asset equipped with Fujitsu tags. Fujitsu has developed a solution that for navigation and localisation purposes. can trace any hospital asset equipped solution can also be applied to avoid Combining information provided on with Fujitsu tags. It is based upon mesh picking errors in hospital warehousing transmission power and information networking, which allows communication or in patient medication distribution. retrieved from the unique identification between all assets. This way, anchor nodes number enables precise navigation and build a network that allows the asset tags Monitoring environmental conditions localisation – right down to specific rooms to communicate data to the gateway. By In hospitals, monitoring environmental and areas. Indoor navigation requires a using the mesh network, an unlimited data can be of great importance for the predictable transmitting characteristic, amount of assets can be added or removed patient and for a medical device’s life cycle. and the Fujitsu beacons are able to do without the need for network maintenance; Fujitsu Sensor Beacons can be used to this consistently. Beacons are also able to the assets tags simply reroute the data. monitor various environmental values, broadcast a URL that will be displayed on The solution offers operators a live like temperature, humidity or acceleration, smart devices and can be activated by the view of where assets are located and how providing a wealth of information that user. This provides web-based interaction many are available – even maintenance can contribute to patient well-being with the user that can then involve any information can be added. In real life, and provide insight on variables that can type of information. this enables the maintenance department, influence device maintenance and stock The Fujitsu IoT Connectivity Solutions nurses and any member of staff to locate control of medical devices. offer great advantages for nursing and assets such as hospital beds, and monitor maintenance staff, as well for management. their occupation and maintenance. But the Patient experience and The solution provides insight on usage, solution is not limited to just hospital beds; traffic flow monitoring efficiency and maintenance, which offers all types of hospital equipment can have Whether used to monitor visitor great potential for process optimisation. ● Fujitsu tags, from various medical devices experience or patient-traffic flow, indoor and wheelchairs, to life-saving equipment navigation provides multiple advantages. like a defibrillator. Plus the possibilities are App-based indoor navigation can offer For further information not restricted to only tracking assets; the the visitor tailored information about www.fujitsu.com/iot

Medical Device Developments / www.medicaldevice-developments.com 71 Electronics

The vast majority of semiconductors in medical devices are made from silicon, which, though the cheapest material available, is not the most efficient. Now, a team of engineers at the Massachusetts Institute of Technology (MIT) has developed a new way to fabricate ultra-thin semiconducting films made from a host of exotic materials. Michael Shaw talks to Jeehwan Kim, the university’s class of 1947 career development assistant professor in the departments of mechanical engineering and materials science and engineering, about the potential applications of this research.

he baby was delivered stillborn and Mark C and into the ventricle of his tiny heart. The spindle Lidwill was running out of ideas. Artificial was connected to a generator, which – Lidwill T respiration and injections of adrenalin hoped – would deliver the 16V necessary to restart had failed; now, the only option left open to the the patient’s pacemaker. doctor and his assistant was a highly experimental Remarkably, the procedure worked. “The heart technique of cardiac therapy. Together they responded to each impulse,” Lidwell wrote in an plunged a needle straight into the baby’s chest article describing the procedure. “At the end of 10

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minutes the current was stopped and it was found the heart would beat of its own accord.” The child would eventually leave the Royal Prince Alfred Hospital, in Sydney, Australia, fully recovered, and living proof of the first successful artificial pacemaker. Lidwell’s actions in 1928 were groundbreaking but quickly forgotten. The contraption he’d jerry- rigged with his assistant was incredibly complicated to operate, and any patient who needed to have the electrical impulses in their pacemaker regulated instead of jump-started would be tied to it, needle and cable, for life. What was needed was a wearable device, or better yet an implanted artificial pacemaker that could regulate the patient’s heartbeat autonomously. It would not be until the 1950s, with the advent of the silicon transistor, to make this a reality. And yet, even as this development led to a succession of medical devices with ever-greater MIT ©Jose-Luis Olivares, capabilities, another wall has inevitably been hit. vaunted compound in the process – graphene. First A layer of graphene – a substance that has In a medical market that yearns for more flexible synthesised by two scientists at the University of been declared a miracle electronics, affordable manufacturing methods that Manchester, UK, after they accidentally removed material due to its high produce the thin semiconducting films necessary for slices of carbon from graphite using scotch tape, the conductive potential. such devices remain elusive. The electronics industry’s substance has since been hailed as a miracle material continued marriage of convenience with silicon – thanks to its own remarkable conductive potential. which, as the seventh-most abundant element on Even so, graphene is also prohibitively expensive the planet, remains the cheapest semiconductor out to synthesise. What Kim and his team discovered there – is also a sad indictment of the sector’s lack of in their research, however, was that the thinness progress in fulfilling its true potential. of graphene – the molecule is only one atom thick Why? The mobility of electrons in silicon is – lends itself to the wholesale fabrication of other simply not as good as that encountered in other compounds. Using a manufacturing method called compounds, like gallium arsenide or gallium nitride. ‘remote epitaxy’, they could produce new and exotic In fact, ‘not as good’ is a radical understatement; the semiconducting films inexpensively and at scale. way electrons zoom through gallium arsenide makes their passage through silicon look like a leisurely stroll, and it’s the reason why the compound can “Typically, the electrical and optical properties be found in almost every mobile phone, the better of single crystalline films are much better than for it to parse the radio waves beamed down to it any other electronic functional materials.” via satellite into interpretable speech. And yet, for all its advantages, compounds like gallium arsenide remain prohibitively expensive to The team began by taking a layer of graphene manufacture compared with silicon, which comprises and placing it over an existing semiconductor just over a quarter of the Earth’s crust in weight. By compound, such as a gallium nitride wafer. comparison, making an 8in wafer of gallium arsenide Constituent atoms of this compound were then – a compound of gallium and arsenic, this time placed on top of the graphene. These particles occupying a more productive role than its traditional began to form a pattern that mirrored the application as a poison – costs up to $5,000, a crystalline structure of the underlying wafer at the thousand times more than its silicon equivalent. bottom of the structure, until an entirely new copy What is needed, it seems, is a revolutionary new of the bottom section could be peeled from the method of manufacturing semiconductor films, one top of the stack. This process, says Kim, is called that Professor Jeehwan Kim and his colleagues at remote epitaxy, and effectively allows the user MIT may have just discovered. to “copy and paste the crystal information of the underlying substrate”, he explains. “In principle, Wafer thick you can do this on and on, because you go on the The key to the professor’s new manufacturing same material on the thin graphene and peel off… method is, as it turns out, including another much- the wafer just becomes a template.”

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graphene. The professor and his team deduced that they weren’t able to copy and paste germanium and silicon because the ionic charge in the substrate and the top layer was identical, as they were from the same atomic group on the periodic table. Gallium and nitrogen, meanwhile, retain opposite charges. Not that the professor was overly concerned. “Silicon’s a chip anyway,” says Kim, referring to the ubiquity of semiconductors made out of the material in multitudes of devices around the world. In the grand cost-benefit analysis, using remote epitaxy to create copied versions of an original silicon substrate might not make as much of a difference as an equivalent made out of gallium arsenide.

Epic potentials What difference, then, would remote epitaxy make to the field of medical devices? According

©Jose-Luis Olivares, MIT ©Jose-Luis Olivares, to Kim, by laying each of these films produced Above: Jeehwan Kim Kim and his team quickly discovered limits through remote epitaxy on to one another, it could (front centre) and his team at MIT. to this new manufacturing method. While they be possible to design new and more flexible types experienced success in their creation of gallium of devices. Below: LEDs that arsenide and gallium nitride films, when they “Typically, the electrical and optical properties have been grown on decided to conduct new experiments on the same of single crystalline films are much better than graphene and then peeled off. lines with germanium and silicon, they were not any other electronic functional materials,” he says. able to peel off any new layers of either material The use of these films in medical device design from the middle graphene section. could, Kim argues, lead to the first viable implants embeddable inside skin. After all, the largest organ “There’s no way to put those semiconductors on in the body yields a variety of symptoms and signs to clinicians that might be more easily interpreted the skin, because the semiconductor is rigid. By with such devices. using our technology, you can make this and put “In order to sense that kind of information from it on the skin. By putting [a device in] the skin the skin pore, you need to have high-quality silicon conductors,” explains Kim. “But there’s no way patch, you can then acquire instant information to put those semiconductors on the skin, because from the body through the skin pore.” the semiconductor is rigid. By using our technology, you can make this and put it on the skin. By The reason why remote epitaxy failed to copy putting [a device in] the skin patch, you can then anything similar was, according to the professor, acquire instant information from the body through down to the ionic bonding properties of both the skin pore.” materials. “Silicon does not have polarity,” explains Kim also envisions health-monitoring devices Kim, referring to the interactions between the implanted in or near major organs, the better to atoms in the substrate and those lain on top of the communicate with individual cells. He concedes, though, that this is all speculation. The full practical potential of remote epitaxy is yet to be realised. “I think it will be five to 10 years,” says Kim, on how long before medical OEMs will be able to use this new manufacturing method. Even so, the work of Kim and his team at MIT points towards new and exciting developments in the form and potential of medical devices. Just as it took the invention of the silicon chip to popularise the pacemaker and revolutionise the medical device industry, so new manufacturing methods like remote epitaxy might lead to the flexible clinical implants and wearables ● ©Professor Jeehwan Kim et al ©Professor to transform healthcare.

74 Medical Device Developments / www.medicaldevice-developments.com Company insight Negotiate the MDR checklist The European Commission’s new medical device regulations puts the onus on medical device manufacturers to ensure they conform to increasingly stringent regulations. RECOM Power knows the new legislation and advises companies on remaining compliant.

he European Commission (EC) chain management and production, but will need to be an ongoing and has decided that the existing EU you will struggle to meet the regulatory regular re-assessment. You will need to T medical device directive (MDD) is requirements for traceability and contact each and every customer who not rigorous enough and it has been recast post-market surveillance. has purchased the product on a regular to the medical device regulation (MDR). The difference between a directive “The MDR will apply to all medical device and a regulation is that all member states manufacturers, meaning every manufacturer of a in the EU are legally bound to abide by medical device or accessory will have new obligations.” a regulation without any modifications (it enters law immediately), and the EC 2. As a manufacturer of a component that basis over the lifetime of the product. can take measures to punish countries, in itself is not a medical device (for It would be advisable to enter into manufacturers, importers, distributors instance, a power supply), you will not a contractual arrangement with or even individuals if it feels that any be required to carry out clinical trials or customers to formalise this procedure. transgressions have been made and apply for a unique identification code. 4. There are not enough notified the local authorities have not been However, you will still need to support bodies (NBs) accredited to meet the zealous enough in ensuring compliance. and react to any adverse results arising requirements for the MDR. It can be The wording used in a regulation is from the use of the product inside the that a new medical product may have a necessarily dictatorial. medical device over its lifetime. It is delayed market entry because there is no advisable to create a serial number NB available to take on the responsibility Check it out for every product supplied, linked of monitoring it. Plan also for increased The following checklist from RECOM may to full documentation (production costs as demand outstrips supply. help manufacturers wanting to stay in the testing results, quality control, bill 5. Manufacturers will be required to medical market after 2024: of materials). A simple date code have someone within the organisation 1. If you are an importer or distributor, identifier will probably be insufficient. responsible for regulatory compliance you will have the same responsibilities 3. If the supplied part has a potential hazard who possesses expert knowledge in and liabilities as if you were a (electrical, thermal, sharp-edges or the field of medical devices. If there manufacturer. Unless you have direct radiation), you will be required to carry is no such specialist in-house, you will contact with the original manufacturer out a risk assessment. This goes beyond need to make arrangements with an with access to the design team, supply the simple safety or EMC certifications, external consultant.

The MDR will apply to all medical device manufacturers, meaning every manufacturer of a medical device or accessory will have new obligations. The MDR is perhaps unique in defining job descriptions of staff that must be employed by manufacturers if they wish to stay in the medical market and by giving the notified bodies extra duties to act as policing organisations, rather than just industry certification partners. ●

For further information RECOM is ideally positioned to help device manufacturers navigate the new regulations from the EU, which are comprehensive and will have an impact on all medical device manufacturers. www.recom-power.com/medical

Medical Device Developments / www.medicaldevice-developments.com 75 Electronics Next evolutionary step

Thanks to bioelectronics, devices are starting to replace drugs for a wide range of conditions. Bioelectronic medicine explores how targeted electrical signals can harness the body’s natural mechanisms to diagnose and treat a range of diseases, helping the body heal itself. Emma Green speaks to Lan Yue, assistant professor of research at USC, about the potential of this technology for medical device manufacturers.

y definition, bioelectronics is the convergence of applications of bioelectronics within common use, of biology and electronics. We tend to think of including pacemakers and medical imaging technology. B it as a new term but the first reference was in Despite these developments, it was not until the mid- 1912. According to a 2009 report by the US National 1990s when the term became more commonly used Institute of Standard and Technology, this was in within the scientific literature. Today, bioelectronics is relation to the measurement of electrical signals used to describe a range of applications for electronics generated by the body. We already have a number within biology and medicine.

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A number of different types of devices have Reliability is a particular area of concern. The been developed using bioelectronics. This includes majority of micro-fabricated bioelectronic devices a large variety of diagnostic, monitoring and are either fabricated by small custom suppliers or therapeutic electronic devices, from the organ level are manufactured within academic facilities. While to the cellular or subcellular level. For example, semiconductor technologies can be used to fabricate there are devices that use biosensors to detect small features, they are not yet able to fabricate and characterise biological materials, such as DNA, complex bioelectronics. However, with the rapid protein and cells. In addition, there are implantable development of these technologies, it is likely devices that interface with biological systems to only a matter of time before this is possible. repair, restore or enhance physiological functions. Another technological challenge is ensuring Biolectronics also includes implantable devices, that a device is sustainable within the body. such as pacemakers, deep-brain stimulators, “Proper encapsulation is essential to the longevity cochlear implants, visual implants, electrical of a device in the physiological environment,” bladder controllers, muscle implants, spinal cord explains Yue. and peripheral nerve stimulators. Lan Yue, assistant professor of research ophthalmology at University ™ of Southern California (USC) is committed to advancing bioelectronics and is currently focused on retinal applications of this technology. HIGH PERFORMANCE Despite a great deal of progress made within the field and exciting future applications, there are also a number of challenges. This is exacerbated because of the inherent convergent nature of bioelectronics. Barriers can thus arise from a lack of technological advancement, biological understanding SMT Enclosure Coin Cell Contacts or a combination of the two. Although there is a requirement for innovation across a number of different fields, this also allows cross-discipline collaboration among researchers and a productive platform for creative thinking.

Small problems In terms of technological difficulties, the inherent challenge is making devices small enough to be used inside the body and producing these at a high volume. “Device miniaturisation demands advancement in microelectronics and fabrication,” explains Yue. sAccommodates coin cell diameters 12mm to 30mm sAccommodates all coin cell heights (1.2mm to 10mm) sIdeal for enclosures with self contained battery compartments sEasy battery access, removal and installation sUltra low profile sFeatures gold-plated Fabrication methods for other fields, stainless steel contacts sSpring tension contacts adjust to variations in battery diameter for a dependable connection such as the semiconductor industry, are sAvailable on Tape & Reel sPositive and Negative contacts can be used as a design set or individually on a PCB optimised for minimising trace widths and feature sizes. A wide variety of IT’S WHAT’S ON THE INSIDE THAT COUNTS ® materials have been incorporated into the fabrication processes to improve ELECTRONICS CORP. performance while reducing costs. www.keyelco.com s (516) 328-7500 s(800) 221-5510 However, in biology and medicine, methods for building microdevices REQUEST CATALOG! are not well established.

Medical Device Developments / www.medicaldevice-developments.com 77 Electronics

There are a number of strategies to improve achieve a healthy tissue-electronic interface. biocompatibility. These include employing Optimising the battery lifetime, functional capacity biocompatible materials, limiting implant rejection and heat management of devices is also imperative and minimising heat generation, which all help to in order to obtain power efficiency and data management capabilities. Another key challenge for Micro Systems Technologies – engineering for life bioelectronics is customisation. “A closed-loop system is desired in many cases to customise a bioelectronics device for optimised therapeutic effects,” explains Yue. “This often demands advanced acquisition and interpretation of the biological signals.” Similar to other personalised treatments, as gene therapy and cell tissue engineering, bioelectronics production could be decentralised with manufacturing taking place at sites close to specialist hospitals. However, achieving personalisation while navigating the pressure to reduce cost – through the high-volume manufacture of devices and their components – is inherently difficult. One solution is 3D-printing technologies, which offer huge potential in their ability to produce devices that meet the needs of different users in a quick and cost- effective manner. Although these Innovative solutions for medical devices technologies are still in their relative infancy; they are likely to from concept to series production be an increased area of focus over > Medical microelectronics (design service, manufacturing the next few years because of their of organic and ceramic substrates, semiconductor ability to drive progress, not only packaging, board assembly, test services) in bioelectronics, but within medical devices as a whole. > Batteries and battery packs for active implants There are also physiological challenges within bioelectronics. Micro Systems Technologies Management AG “A better understanding of the Neuhofstrasse 4, CH-6340 Baar, Switzerland Phone +41 (44) 804 63 00, [email protected], www.mst.com fundamental issues of the target

MST Group. Active around the globe, the Micro Systems Technologies (MST) Group physiological systems, particularly consists of four technology companies with more than 1100 employees in three coun- the processing at the bioelectronic tries: DYCONEX AG, Switzerland, LITRONIK Batterietechnologie GmbH, Germany, Micro Systems Engineering GmbH, Germany, Micro Systems Engineering, Inc., USA. www.mst.com interface and beyond, is required,” says Yue. “This will enable design of

78 Medical Device Developments / www.medicaldevice-developments.com The current status of bioelectronics in the medical device industry The rapid evolution within the field since the mid-1990s has been referred to as the ‘bioelectronic revolution’. This is characterised by large companies, which are currently making significant investments in the area. These include the big players in the medical device space, such as Medtronic and Boston Scientific, as well as those from other scientific disciplines, such as data mining and the pharmaceutical industry. Public and private organisations, such as the National Institute of Health, the Defense Advanced Research Projects Agency and GlaxoSmithKline, are dedicating substantial resources to drive efforts within bioelectronics worldwide, with a view towards building new markets, clinical translation and adoption. Propelled by capital injection and by the discoveries of the scientific community, a growing number of start-ups are proposing new target diseases for intervention, releasing preliminary data that can demonstrate the validity of the bioelectronic medicine approach while accepting the risks associated with early stage technology development. As a result of these efforts from the private and public sector, it is becoming easier to envision continuous improvement of these devices, leading to new models of clinical care. Source: ‘Bioelectronics: the promise of leveraging the body’s circuitry to treat disease.’ the devices that better mimic the impaired functions of the target tissue while reducing biofouling.” Biofouling is a process wher a build-up of biological material accumulates on wetted surfaces. This is problematic in a number of bioelectronic devices, such as pacemakers. It affects their functionality by altering the electrical properties of the electrodes attached to the heart, making sensing and actuation difficult. The key challenge is that bioelectronic devices must interact with living tissues that are not inherently compatible. Due to the high level of sophistication of digital electronics, the signal processing of these devices is far more advanced than the front-facing aspect of the device. Such issues are likely to be solved by the increasing work within systems biology – the study of the interactions that occur within the body. Insights from this area will allow the development of devices that are more compatible with biological systems and tissue. In particular, there is an increasing amount of research in miniaturised and automated microfluidics and nanotechnology platforms, which is a key area of focus for Yue.

Eye for detail Although Yue is passionate about advancing bioelectronics more generally, her particular area of expertise is in retinal medical devices. She began her research in this area when working towards her PhD, during which time she became fascinated with bioelectronic visual prostheses, often referred to as bionic eyes. After completion of her PhD, she joined the research team of Dr Mark Humayun, a world-renowned pioneer in retinal implants. For her postdoctoral studies, she evaluated the efficacy and safety of these devices. This experience had a profound impact on her research goals and motivation. “It inspired my current work in the development of new stimulation strategies and nanoelectronic prosthesis that will, hopefully one day, restore colour vision and high visual acuity in the blind,” Yue explains.

Medical Device Developments / www.medicaldevice-developments.com 79 Electronics

Yue is currently working with blind patients who human retina to electrical stimuli,” Yue explains. have retinal implants. She is evaluating the implant- Further research is required to learn more about retina interface and their visual functions with the the different patterns of electrical stimulation in assistance of the device. Alongside this research, Yue order to optimise the functioning of visual prosthesis. is developing novel stimulation strategies to enhance In addition, as with all medical devices, safety is the visual experience of the otherwise blind patients. a top priority in visual prosthesis. However, this The aim when creating a complex bioelectronic raises new challenges in the ability to improve its device, such as visual prosthesis, is to harness effectiveness. “It comes with the compromise in electrical power to produce highly specific and the fabrication capability and functional capacity localised stimulation. Although an area with a lot of the device,” says Yue. of potential, there have also been a number of Yue is determined to stay focused on her current challenges that Yue has had to navigate in her work. area of work. “The overarching goal of my research “A lot of the difficulties that we encounter stem from will remain to be enhancing visual ability of prosthetic insufficient understanding of signal processing of vision in the blind,” Yue states. In order to achieve this, she intends to study two areas in parallel. The first of these is the development of new stimulation paradigms through continued investigation of electrical stimulation All Technologies. of the visual system. The second is All Competencies. creating and testing non-conventional One Specialist. bioelectronic prosthetic devices that use novel materials, such as organoelectronics and nanoelectronics. In looking ahead in bioelectronics more generally, Yue remains optimistic, saying, “Advancement of material technology with fabrication and information technology will profoundly impact bioelectronics in the future, possibly leading to a revolutionary breakthrough.” These material developments open up the possibility to make devices that are more flexible, biocompatible, immune tolerant MEDICAL SOLUTIONS and with a higher energy conversion efficiency. In addition, the progress in AI and related technologies will allow DATA MODUL is a leading specialist in the development the decoding of biological signals at an and manufacture of customized medical solutions. impressive speed and depth. Together these provide the opportunity to address difficult questions in precisely OEM Monitors and Panel PCs DIN EN ISO harnessing electrical power to serve Superior display and touch technologies 13485:2016 for biological purposes. The devices certified of the future may be able to not only X86 and ARM based COM modules and SBCs match the level of human functioning Easy-to-clean housing concepts but also improve upon it. “It is imaginable that with the advancement Product compliance following standard IEC60601-1 in bioelectronic technology, Extended product-life-cycle management conventional devices that aim to monitor or mimic human physiological functions may one day progress to devices that can enable enhanced DATA MODUL AG | [email protected] | www.data-modul.com performance; for example, in sensory functions and memory,” says Yue. ●

80 Medical Device Developments / www.medicaldevice-developments.com Company insight B is for bonding PCAP touchscreens have conquered the medical industry, but it is rare to see manufacturers offering TFT displays bonded with a touchscreen unit. In Europe, only DATA MODUL currently offers the in-house availability of all common bonding technologies.

hanks to developments in gloved Detailed structure of the single components and bonding layers. operation or operating through T liquids, as well as the optimisation of touchscreens through optical bonding, increasing numbers of PCAP touch monitors are being used at PoC and in other medical areas. However, it is rare to see manufacturers offering TFT displays bonded with a touchscreen unit. For this reason, DATA MODUL established in-house expertise in optical bonding in 2011 and has been improving it ever since. Bonding means the connection of device components using an optical, transparent adhesive – the refractive index of which must match that of the media to be bonded. A distinction is made here between the bonding of cover glass and PCAP Touch, cover glass, and TFT. Bonding minimises distracting reflections, does not dampen to-soft). The top OCA of the touch sensor the capacitive touch field, and achieves is used here, so that no additional bonding further developed from LOCA and OCA user stability against interference factors. glue is required. The major advantage processes. This bonds and glues touch, glass In addition, it is not possible for dust to of OCA bonding is that projects can be and display (hard-to-hard) automatically. enter in-between the PCAP sensor and completed quickly and cost-effectively. This method is particularly suitable for high- the glass. Due to the increasing demand volume projects with special requirements, for medical PCAP solutions with customer- AirGap bonding like the manufacturing of medical devices. specific glass surfaces, DATA MODUL This method was used for resistive touch is constantly expanding the range and sensors and is the forerunner of bonding Gap filling optimising quality standards. technology. In contrast to LOCA, in AirGap After the assembly of a PCAP touch Current bonding technologies such as bonding, a double-sided adhesive tape is monitor/HMI/embedded display in a housing AirGap, LOCA, OCA, gel and the new applied around the TFT frame, which bonds there is always a gap between the screen hybrid bonding provide the best possible the TFT and the touch or glass to one and the housing frame that cannot be optimisation solutions for all display and another. An air gap is maintained between avoided during manufacturing. Particularly touch variants available on the market. the two components in the process. in the development of medical products, there are high hygiene requirements. One LOCA (liquid optical clear adhesive) Gel pads example is that gaps on devices must be This liquid glue method is flexible and can This method is used in processing frameless avoided. Through gap filling, gaps are filled be used at all display sizes. It is suited to displays. Gel pads are tailored to the size with a special glue and sealed securely. This hard-to-hard bonding and cured via UV of the display surface and bond the glass stops impurities or liquids from entering or light. The LOCA adhesive is used for or touch sensors to the TFT. This would getting stuck in there. At DATA MODUL, a bonding cover glass to glass-based touch not be possible in LOCA. Diagonals from pick and place machine carries out the gap sensors and industrial TFT displays with 1.3–14in and mobile applications with filling under cleanroom conditions. The metal frames (bezels) to a cover glass round memory-in-pixel displays can also special adhesive is suitable for temperatures (with or without touch). be realised. from -40°C to 100°C and covers all requirements for medical devices. ● OCA (optical clear adhesive) Hybrid Dry bonding or OCA roll lamination applies DATA MODUL is one of a few companies to For further information a touch sensor film to the cover glass (hard- provide this new process, which has been www.data-modul.com

Medical Device Developments / www.medicaldevice-developments.com 81 Microelectronics

The power to succeed In vivo networking (IVN) is a novel approach to powering – and communicating with – implanted medical devices. Jim Banks talks to assistant professor Fadel Adib, one of the researchers involved in an IVN project at MIT, about how the research could bring about a paradigm shift.

ajor steps forward in microtechnology instructions from clinicians – the reliability of that and new biomaterials have greatly improved power supply becomes even more critical. Implantable M the biocompatibility of devices that can be medical devices (IMDs) are becoming smaller and implanted in the human body, thus opening the door lighter, but the need for a battery severely limits how to a host of therapeutic uses. small they can become and, therefore, how they can Imagine devices that can monitor the condition be used for diagnostics or treatment. of highly specific areas of the body, or deliver drug The fact is that if a device is equipped with a battery, therapy at precisely the right time, or stimulate the power supply accounts for most of the space on the otherwise impenetrable areas of the brain. The device and often means it has a limited lifespan. For opportunities are seemingly endless, but there has instance, cardiac pacemakers rely on non-rechargeable hitherto been one problem that has been hard to batteries due to regulatory restrictions on the use of solve – power. rechargeable batteries, which a patient might forget Devices that reside inside the body must be kept to charge or which, due to a technical fault, might not small, but they must also receive a sufficient and recharge effectively. continuous source of power if they are to operate “One of the most important things about the effectively. As these devices increasingly rely on new generation of implantable devices is that we the ability to communicate wirelessly – to deliver want them to last a long time to enable monitoring, data about conditions within the body or to receive diagnosis and treatment,” says Fadel Adib, assistant

82 Medical Device Developments / www.medicaldevice-developments.com Microelectronics

professor in the Media Lab at the Massachusetts amplification and transmission of the signal. That’s why Institute of Technology (MIT). “We also want them the battery is the largest part of a smartphone. We to be small, so that we are not putting a large alien wanted to enable communication without the device body into a human being. So, we need a long-term generating its own signal, instead reflecting it from and continuous power source in a small device that outside, because that uses the least power,” he adds. can operate in different parts of the body.” The benefits of in vivo networking Size limitations By looking at power through the lens of communication Fadel Adib Fadel’s group at MIT focuses on the development of with the device, Adib’s group came up with a solution new wireless systems and, recognising the application that addresses both needs in a highly innovative way. of its work in smaller implantable systems for drug So was born in vivo networking (IVN), which can delivery, long-term monitoring and deep brain wirelessly power and communicate with tiny devices simulation, he soon came up against the limitations implanted deep within the human body. on size created by the current crop of systems for Adib had been working on the possibility of powering these devices. wirelessly powering implantable devices with radio “When you are designing a tiny device that must waves emitted by antennas outside the body, but the last for a long period of time and is not anatomically techniques focused on sensors and devices located in specific, so that they can work anywhere in the human specific areas of the body. The new approach he and body, you soon come up against the question of how his team, along with Brigham and Women’s Hospital you power it,” he remarks. “The existing literature (BWH), have developed does not require clinicians to shows a number of different approaches, all of which know the exact location of the sensors in the body. IVN have their own limitations.” transmits power over a large area, can power multiple Researchers have tried a number of ingenious devices simultaneously and trigger a device to relay approaches to powering IMDs. One that is in the early information back to the antennae that deliver the stages of development is the biological supercapacitor electrical charge. under development at UCLA and the University of IVN enables wireless power delivery and Connecticut. Using graphene combined with modified communication with deep-tissue medical devices human proteins as an electrode, the system uses thanks to an innovative beamforming algorithm that electrolytes from in-body fluids such as blood serum can focus its energy towards an in vivo sensor. Using and urine to power the supercapacitor. In theory, the a multiple-input and multiple-output (MIMO) method system could provide an endless supply of energy for that multiplies the capacity of a radio link, and a IMDs at a size far smaller than the existing alternatives. multi-antenna array, the system delivers focused Body movement is another potential source of power energy in such a way as to overcome the threshold for IMDs. Whether it is the beating of the heart, the voltage, which hinders the delivery of power, regardless bellows-like movement of the lungs, or the movement of radio frequency attenuation and despite the sensor’s of the arms or legs, power is generated constantly just small size. As the radio waves travel they overlap and by the act of living, so it makes sense that some of combine, and at certain points, where the high points it could be harvested to power a small device like a of the waves overlap, they can deliver enough energy pacemaker or an internal sensor. Charged by internal to power an IMD. vibrations or through wearable piezoelectric energy “One of the biggest challenges was that wireless harvesters, there is potential for many devices to be signals die exponentially fast in the body,” Adib powered indefinitely without the need to regularly explains. “The signals are absorbed quickly by replace batteries. water, and up to 70% of the human body is water. Adib, however, sees some limitations with many To overcome this, we used power techniques that of these approaches. combine signals from multiple antennae. It is similar “Powering a device with body movement can work to the Wi-Fi infrastructure used to increase data rates.” well in some areas in the body but does not work so “Using IVN, the device can either reflect or absorb well in the brain, where there is very little movement,” the signal, which effectively creates a zero or a one, he remarks. “Harvesting power from movement is not, which is the basis for most electronic communication,” therefore, a universal solution. Generating power from he continues. “It powers the device and enables low- chemicals within the body also only really works if the power communication with high-fidelity signals.” device is located in the stomach. A beamformer serves to precode transmitted signals “We were working on both powering a device and so that they constructively interfere at the receiver, communicating with it, so we looked at the lowest- which maximises the amount of energy received. power communication technology that is available. The IVN is the first system to bring the benefits of MIMO most power-consuming part of communication is the beamforming to in vivo battery-free sensors, and

Medical Device Developments / www.medicaldevice-developments.com 83 Microelectronics

eliminates the need for the transmitter to be close to or medication. We have not built the device yet, but it is in direct contact with the body. an example of how the technology could be used.” To absorb the energy, a battery-free sensor must The extended charging distance that IVN offers, and convert RF signals in the environment into a DC that this eliminates the need to locate an IMD before voltage, which is achieved through an energy harvester, charging and communication can take place, will be or rectifier. In Adib’s experiments, battery-free tags crucial for the development of real-world applications. fitted with rectifiers were implanted in a pig to evaluate “In-body sensors have no batteries, so they must be IVN’s ability to deliver power and communicate, both powered before they can send a message, so we had to in subcutaneous and intragastric placements. It was find a way to focus on them without knowing where in capable of powering devices the size of a grain of rice the body they are,” says Adib. “Our technology allows located 10cm deep in tissue from a distance of 1m. us to focus on devices in unknown locations, although At the moment, implantable electrodes that can the ability to charge the device does depend on how deliver electrical current for deep brain stimulation are deep it is within the body. normally controlled by a device similar to a pacemaker, “The deepest, so far, is about 12cm below the skin, which is implanted under the skin. With a wireless and we can charge that device from 1m away, so the power source outside the body, this second device system could be at the side of the bed. If the device would no longer be required. is closer to the skin, it can work from up to 30m.” “We are hoping to develop end-to-end applications,” The paper on IVN delivered at the Association for says Adib. “Now, we are looking at extending the Computing Machinery Special Interest Group on Data device to include a pH sensor, which could monitor Communication conference, in August last year, was reflux in the stomach. If we can measure and well received, and Adib hopes it will be the springboard continuously monitor pH, we could design a device for a raft of new therapeutic devices. that delivers treatment by sending a command to “The research represented the first time a miniature release part of a drug when a particular threshold computer was put inside a human body,” he notes. is reached. That kind of device, which senses “There is a real need for these systems to have real- the environment, could be useful for patients with world applications, and it will enable a paradigm shift Alzheimer’s disease who might forget to take their that will allow tiny sensors to be used in the body.” ●

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The shape of things to come

While the world continues to come to terms with the potential of 3D printing, engineers have been working on introducing a whole new dimension to additive manufacturing processes. Tim Gunn talks to Dr Andrew Weems of the University of Birmingham, Professor Lorenzo Moroni of Maastricht University, and Dr Christophe Marquette of Lyon’s 3D Fabric of Advanced Biology laboratory about what four-dimensional printing can do to disrupt the medical device market.

eople care a lot about change. It’s the time, and it allows us to bestow upon them the everything and nothing that we make and are existential burden of becoming what they are. P made by. It orients our lives, our innermost Like many philosophical categories, what exactly thoughts and our politics. Change is struggled for, sold 4D printing encompasses is up for debate. Dr Andrew against, theorised, disproved, weaponised, dreamed of Weems, an expert in shape-memory polymers at the and feared. Now it can be printed, too. University of Birmingham, suggests that anyone 3D In one sense, printing has always been an printing a degradable material could argue that they exemplary form of change. Whether it’s 2D or 3D, were actually 4D printing, simply because degradable what goes into a printer comes out different. But, materials change through time. Not that he would as the name might suggest, four-dimensional (4D) personally make such a claim, preferring to reserve printing adds something extra. From reclining chairs the appellation for objects that go through more without mechanical parts to advanced implantable controlled changes. devices that only deform to carry out their functions Weems is currently applying his expertise in when they reach the relevant area of the body, it advanced materials as part of a team halfway through creates objects that are able to alter themselves over an EU-funded project to produce a 4D stent. “We can

Medical Device Developments / www.medicaldevice-developments.com 85 Materials

same calcification capability with a biosensor that emitted light in the presence of glucose. There may not be a specific use for such a tool, but it does show the range of potential applications for the group’s work. “Usually [the descriptor 4D is] based on the morphology of what’s printed,” says Marquette. “Different parts change shape when they encounter moisture or heat. But in our case the trick is that we are printing with different compositions. If you want to have one part that emits light and another that doesn’t, then you have to mix different inks with different biological components together.” This is possible because of the team’s use of polyethylene glycol diacrylate (PEG-DA) hydrogel inks, which provide a moisturised environment suitable for immobilising active biomolecules, catalysts and antibodies. To quote the fanciful Simplified models print shape-memory materials in one configuration ball paper, it points towards a “new field of of the 4D stents and research in tissue engineering and particularly porous scaffolds being and then deform them into some temporary shape,” tested at the University he explains. “Then they will return to their original bone reconstruction, in which cells and programmed of Birmingham in their shape once we apply a stimulus.” Unlike traditional calcification might be printed together to enable the uncompressed position. stents, which are compressed over a balloon catheter in vitro reconstruction of cellularised bone defects.” and mechanically opened inside blood vessels, the Though he wouldn’t dispute the value of the team’s 4D stent polymers are tuned around body research, Professor Lorenzo Moroni of Maastricht temperature, which means they can be printed in University is critical of the ‘overhype philosophy’ and their open configuration and compressed for insertion lack of precision in the use of the term ‘4D’, preferring before reopening in the artery. to classify much of the work in the field as the 3D printing of stimuli-responsive materials. “Technically,” “A 4D-printed object is something that you 3D he explains, “I think that one should only talk about 4D print and that is going to change according to printing when the change happens as the 3D-printed a stimulus, whatever the stimulus is.” object is being produced.” He gives the example of his work on bioprinting Dr Christophe Marquette, 3D Fabric of Advanced Biology tissue constructs. “Calling this 4D bioprinting simply because, in time, the cells that you print in a hydrogel Debate over definition carrier change the composition of the matter Dr Christophe Marquette, director of research at the surrounding them by digesting the hydrogel and University of Lyon’s 3D FAB biotechnology innovation producing their own proteins seems to me a stretch,” platform, thinks a 4D object can do more than just he says. “This is bioprinting, which is 3D and where, if change shape. For his team, “a 4D-printed object you make the construct well, the cells should do what is something that you 3D print and that is going to they normally do – make proteins.” change according to a stimulus, whatever the stimulus Then again, engineers don’t work in this field for is. Specifically, what we are doing here [at 3D FAB] is the semantics. As Marquette explains, for the 3D FAB printing 3D objects that incorporate biomolecules that laboratory, “the driving force was thinking, ‘can we change when they encounter other biomolecules.” make sensing layers for in vitro diagnostics through The 3D FAB group’s most recent paper introduces a 3D printing and not moulding or grafting?’” Then, method for 4D-printed hydrogels loaded with multiple he continues, “We wanted to see if we could get active enzymes to reproduce biological functions in new features or new activities or new functions from a complex shape. By co-immobilising thrombin and a polymer with enzymes inside when this polymer alkaline phosphatase in a hydrogel ink precisely has a certain shape.” engineered to release the former and retain the latter, This mimics sequential enzymatic reactions in the they caused fibrin deposition, which creates a biofilm body, where macromolecular structures catalyse to entrap living endothelial cells, and controlled metabolic processes across multiple steps. The ease calcification of different parts of a biomimetic construct of 3D printing different molecule combinations in of vascularised bone. In an earlier paper, ‘3D–4D different shapes lets the 3D FAB team exercise their Printed Objects: New Bioactive Material Opportunities’, creativity in modelling and testing their own complex the team printed a ‘fanciful ball’ that combined the enzyme systems. Previously impossible experiments

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become something like child’s play. “We are printing memory polymers with kirigami structures to enable puzzles, or Lego, and each piece is entrapping a a bifurcated tube to pass through a tight cylindrical different enzyme,” says Marquette. “We can put one pathway before unfolding in response to a temperature enzyme close to another, but not close to a third, stimulus. This particular approach needs further study constructing and changing the order of these pieces to before it can be trialled in a patient, but active origami see if we get any new features or new functions from has been proposed as a solution for everything from the system. That’s one more dimension,” he laughs. microsurgery robots to heart catheters.

“I think that one should only talk about 4D Opportunities and obstacles printing when the change happens as the Whether discussed under the rubric of space-time, 3D-printed object is being produced.” origami, or stimuli-responsiveness, these devices have immense potential for decreasing the invasiveness Professor Lorenzo Moroni, Maastricht University of medical procedures and treatments. Children who once relied on paralytics to stay alive have been freed Progress in the wider field to inhabit their own bodies without fear of sudden Weems’s team isn’t the only one working on 3D printing suffocation, and it didn’t require clinicians relearning shape-memory polymers to improve the quality of how to use and apply external airway splints. stents. They might be some way from a consensus on “It’s very compatible with what’s being done what exactly 4D means, but researchers and engineers currently,” explains Weems of his 4D stent. “And the all over the planet believe it will prove important for other really positive aspect of these materials is that patients who need implants to support arteries and they take on the geometry of the native vessel. If there airways. Under an FDA emergency use exemption, was some catastrophic failure in a stent, if something the technology has already saved the lives of infants had broken during processing, which does happen, suffering from severe tracheobronchomalacia, it will still take on its original shape when it opens. a condition that causes the airways to collapse. Compared with materials that just have an elastic Researchers from the University of Michigan used response it can withstand a little bit more deformation CT scans to develop 3D-printed splints for three and still return to its optimal, useful configuration children, including one who couldn’t have food in its without failing.” stomach without having a heart attack and another That doesn’t mean there aren’t still issues to whose windpipe had the floppy consistency of a “wet overcome. The prototype for Lee and Kim’s bifurcated noodle”, according to his mother. kirigami stent is too large for clinical use, for instance. Unlike airway stents, these resorbable Similarly, Marquette’s work at the 3D FAB Lab has polycaprolactone devices provide external support, shown promise ‘on the centimetre scale’, but the preventing collapse or compression but allowing intention is to make devices 100 or 1,000 times smaller. internal expansion, thus accommodating growth. “The idea hiding behind all this,” he reveals, “is to In follow-ups over the next three years, all patients inject some 3D-printed high-resolution sensors or showed significant improvements in their symptoms as active components into the bloodstream.” However, a result of receiving the experimental treatment. This the team first needs to work out whether its enzymes time frame is particularly important for children with function in the same way and provide enough of a tracheobronchomalacia. Though newborns suffering signal when contained in 5–10μm vessels. from the disease have average life expectancies of days For Weems, the challenge is more dissemination to weeks, the airways of those that make it to three than containment. “We can put technology in clinicians’ usually grow strong enough to overcome the disorder. hands, and they can say, ‘Oh, that’s really cool, I might Polycaprolactone is used because it takes around three be able to use it,’ but they approach problems very years to functionally degrade. differently to how we do. That’s great – they’re doing a Similarly, Professors Yu-Gong Lee and Taeyoung Kim very different job; but it’s ultimately about convincing at the Gwangju Institute of Science and Technology, them that what we have is worthwhile.” South Korea, have used shape-memory technology to At Birmingham, Weems is part of what he calls a model a unique bifurcated stent for use in branching ‘translational’ team that brings together chemists and blood vessels. What’s more, they have a whole different clinicians working in very specific areas. It’s taught him vocabulary with which to explain it. that, “any medical device manufacturer that’s going for Whereas the fourth dimension is a concept most a novel approach needs to find clinicians who are just familiar to mathematicians and physicists, kirigami as eager to try new therapies for their patients and is origami with scissors. Practitioners precisely find new ways to involve new techniques.” We can cut and fold a single piece of paper to create a three print change, and maybe even hype, but understanding dimensional form. Lee and Kim’s stents combine shape- is harder to come by. ●

88 Medical Device Developments / www.medicaldevice-developments.com TYLER SHULTZ Theranos Whistleblower & Entrepreneur

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presented by: boston.devicetalks.com @DeviceTalks Sponsorship opportunities are available for future DeviceTalks programs. For more information, contact Mary Ann Cooke. 781.710.4659 | [email protected] Company insight Take the tube to the next level New England Tubing Technologies’ eTubing technology is designed to meet the demands of medical device OEMs by combining conductors with electrical requirements into the walls of tubing to increase design functionally, and reduce device footprint and assembly time.

he tubing market is certainly growing, performance targets on new devices as well thinner walls with the same or more with continued development being as next-gen redesigns. Smaller tubing and functionality. A good example is the T undertaken to improve all types of thinner walls are being pushed to make company’s eTubing line. It is integrating medical procedures – from neurology, to procedures less and less invasive. When the knowledge and capabilities of its parent cardiovascular, to medical robotics. Advances possible, customers are looking for more company, New England Wire Technologies in technology and science are opening doors performance out of their tubing, whether and New England Tubing, to combine to new procedures that were not possible in it is physical characteristics, materials or conductors with electrical requirements the past and also highlighting improvements maybe even including an electrical element into the walls of tubing. This increases that can be made on existing procedures. within the tubing. functionally of the design, reduces Minimally invasive surgery has become Every form of minimally invasive surgery device footprint and can also reduce the preferred choice for scores of surgical uses some kind of tubing that is inserted assembly time. procedures. It is used in bariatric (gastric into the patient’s body. Tubing can deliver New England Tubing Technologies can bypass) surgery, hernia repair, urological stents, as in balloon angioplasty; they may customise a tube with added elements, treatments, colon resection, gallbladder provide a camera, illumination and tools to such as ultra-miniature coaxial cables, and tumour removal, and is favoured as the manipulate the patient’s internal anatomy, high-frequency cables, thermocouples and preferred treatment for many gynaecological, as in an ablation or resection; the very high-strength/high-flex alloys to provide pulmonary and cardiac conditions. Many of design of tubing is what makes minimally more functionality in the same tubular these surgeries can be done with incisions of invasive surgery possible. cross-section – critical for today’s no more than a few millimetres. minimally invasive surgeries. The eTubing Minimally invasive surgery reduces blood Less is more designs can add analogue and digital loss, shortens recovery time and reduces OEMs are always pushing the transmission of electrical signals for in-patient time at the hospital. It also envelope when it comes to designs sensor capabilities, powering devices and reduces the risk of infection, and gives and requirements. New England Tubing temperature/oxygen monitoring features the patient less scarring and pain, which, Technologies are tasked with meeting by incorporating these customised wires in turn, reduces the need for pain and these requirements or providing or cables within the wall of the tube itself. antibiotic medications. alternatives. Recently, the biggest Typical elements for eTubing include: OEMs are looking for more performance challenge is getting less to do more. ■power supply out of their tubing. They are pushing Everyone is looking for smaller tubes with ■measuring/monitoring capabilities ■signal carrying capabilities ■strength members ■one or more lumen.

The benefits are more functionality in the same cross-section and a return signal wire, among others. Etubing can be used for a wide range of applications, including handheld electrosurgical devices, cauterisation, ultrasonic devices, monitoring devices, borescopes/endoscopes, power supply and cooling combinations. ●

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90 Medical Device Developments / www.medicaldevice-developments.com

Materials Sweat the small stuff An interdisciplinary team of scientists at the University of Massachusetts Amherst has produced a new class of sustainable electronic materials, which may lead to a greener future in biomedical and environmental sensing. Alexander Smith, a biomedical engineering PhD student and the founder of the start-up e-Biologics, speaks to Abi Millar about the value of these materials for medical devices.

n 1987, the microbiologist Derek Lovley made a “The bacteria produce these protein nanowires surprising discovery. While digging through the as part of their metabolism and also to communicate I mud of the Potomac River in Washington DC, he with their neighbours,” explains Alexander Smith, encountered a strain of bacteria with properties that a biomedical engineering PhD student at the had never been seen before. University of Massachusetts (UMass) Amherst, who The bacteria, which he christened Geobacter works with Lovley. “Because of that, these microbial metallireducens, were able to survive without oxygen filaments are electrically conductive, and that’s a or sunlight thanks to their unusual dietary habits. They pretty interesting property – they’re basically like ‘eat’ and ‘breathe’ metals such as iron, feeding on waste a biologically made electronic material. You can fit compounds and passing their energy onto metal oxides thousands of these protein nanowires in the width outside the cell. of one human hair.” It didn’t take Lovley long to realise the implications: Over the decades since Geobacter were discovered, since these bacteria ‘eat’ organic compounds, they research in the field has advanced rapidly. Most could potentially be used to clean toxic waste. By the recently, Lovley’s team has found a way to combine early 2000s, Lovley had found 70 types of Geobacter, the protein nanowires with a non-conductive polymer, which were variously used to decontaminate an oil spill producing a flexible electronic composite material. and a uranium mine. The material in question, which can function even The possibilities, however, didn’t end there. under harsh conditions, is suitable for manufacturing When a Geobacter bacterium ‘breathes’, it excretes sensors and electronic devices. electrons, passing them down tiny wires that protrude Once limited to small quantities of protein nanowires from its surface. These wires – dubbed ‘microbial (those that were produced naturally), the researchers protein nanowires’ – make the bacteria a natural are now working on scaling up production, generating electricity source. the nanowires in commercially useful quantities.

92 Medical Device Developments / www.medicaldevice-developments.com Materials

“We can genetically modify the bacteria to produce even more of these protein nanowires in abundance. We’re then able to purify the protein nanowires and discard the rest of the cell, so that we can use the nanowires to make materials,” explains Smith. They have made the jump from microbiology to engineering, from mud to material science. This could open the door to all kinds of commercial applications. “In the past, Derek’s research has been about characterising these microbes and studying their properties,” says Smith. “He was also involved in projects where they were using the microbes for different applications such as bioremediation and fuel cells. But it wasn’t until recently that we discovered how these protein filaments could be purified from the bacteria and used as a material. All of a sudden we have the opportunity to produce a biologically made material that can be used to make devices for Solving this challenge has been Smith’s key e-Biologics is developing different applications.” focus during his PhD career. An enterprising and a skin sensor patch, which can be used to commercially minded young researcher, he had read detect the early signs Green electricity about Lovley’s work in the field, and quickly caught of diabetic ketoacidosis. The advantages are obvious. Not only are these protein wind of the possibilities. nanowires electrically conductive and super-sensitive “I was on a mission to look for technologies – easily rivalling human-made materials such as carbon at the UMass Amherst campus that could be viable nanotubes or silicon nanowires – but they’re highly products,” he says. “I came across Dr Lovley’s patent sustainable to produce. for biological microbial protein nanowires, and as In fact, protein nanowires could spell the I was reading about them I decided I needed to talk beginning of a truly green field of electronics, free to this man more. So I sent him an email out of the from the toxic components that make electronic waste blue, and he agreed to meet with me the next day. such a concern. While today’s electronic devices are As he was telling me about them I just became more predominantly considered disposable, they are non- and more fascinated and saw the potential. I said, biodegradable and difficult to recycle. With the dawn wow, we need to commercialise these, they’re of electronic biologics, this could be about to change. so cool. Derek said that one of the big challenges, “The process to make carbon nanotubes and other though, is finding the right application and the right traditional materials is pretty nasty, requiring toxic businessperson to translate the research. So I rounded chemicals and reactions,” says Smith. “By contrast, up some business mentors and we formed a team.” these protein nanowires are produced by the Geobacter naturally – all we have to do is feed “The process to make carbon nanotubes and the bacteria with renewable feedstocks. So we have this sustainable and inexpensive way to produce other traditional materials is pretty nasty, the protein nanowires even at scale, eliminating requiring toxic chemicals and reactions. By a lot of the toxic chemical production that’s used contrast, these protein nanowires are produced with current technology.” Another benefit of the nanowires is their by the Geobacter naturally – all we have to do versatility. Through tweaking the Geobacter, it is is feed the bacteria with renewable feedstocks.” possible to produce different types of nanowires suitable for different forms of biomedical and The result was e-Biologics, a start-up dedicated environmental sensing. to commercialising the protein nanowires. Five “Since it’s a biologically made protein, we can months after Smith’s meeting with Lovley, his genetically modify different strains of protein fledgling company won first prize in the UMass nanowires so they are sensitive to very specific Amherst 2018 Innovation Challenge, going home analytes,” says Smith. “One of the biggest challenges with $30,000 in funding. in sensors nowadays is making them really selective, That summer, he participated in the so that’s a challenge we can conquer with our protein Berthiaume Centre Summer Accelerator, which nanowires, by functionalising them with highly provided further funding and gave him a crash selective molecules.” course in launching ventures. The company is

Medical Device Developments / www.medicaldevice-developments.com 93 Materials

now moving towards making device prototypes and “Because the sensor is so small and applying for patents. biocompatible, our vision is that it could be “My PhD research is focused on developing the placed pretty much anywhere in or on the body technology for the protein nanowire devices, and with a very small footprint, and would be able to then my activities with the start-up company will be measure many analytes simultaneously, providing taking the technology that I’m developing and putting a comprehensives assessment of a patient’s health,” it to use for practical applications,” explains Smith. says Smith. “Not just diseases, but applications To begin with, the e-Biologics team is focusing like nutrition and fitness tracking as well. Providing Alexander Smith on a single biomedical application, which Smith personalised monitoring of a person’s health in real describes as the original vision for their minimum time is very exciting.” viable product – something that will pave the way for more complex biomedical sensors. It is a skin sensor Industrial use patch, worn like an Elastoplast, which can be used Since the nanowires can also be used as gas sensors, to detect the early signs of diabetic ketoacidosis there are potential industrial uses in the works too. Protein nanowires can be stabilised in water, In these cases, the sensor would be integrated into which makes them ideal for detecting metabolites something like a microchip, which could be used for in sweat. They are particularly good at gauging gas sensing within chemical processing. This in itself acidity, with their conductivity changing in could have implications for human health. response to changes in pH. “During production of industrial materials such “With the help of my business mentors, I came as fertiliser, if toxic gases are produced and people up with the concept of a wearable device that inhale them that can make them sick,” says Smith. would analyse your sweat continuously and non- “So we can make sensors that detect the presence invasively to measure biomarkers that can indicate of dangerous gases to prevent health problems the early onset of diseases,” says Smith. “Sure from occurring.” enough, there’s a condition called diabetic While e-Biologics is still in its early stages, ketoacidosis, which particularly affects people with the future certainly looks promising. The next type 1 diabetes and is indicated by changes in pH.” step, says Smith, will be to rent a space in the The device will be linked to a smartphone app University Of Massachusetts Institute for Applied that alerts the wearer to the possible onset of Life Sciences, where the company will set up shop ketoacidosis. It will be marketed to high-risk and continue to produce the technology. He is also patients with type 1 diabetes, and could ultimately looking to apply for further sources of funding, such prevent many hospital bills and trips to the as non-dilutive government grants. emergency room. Over the next few years, the team hopes to move on to testing their sensing devices with animals and eventually humans. Eventually, they “With the help of my business mentors, I came want to move beyond their prototypes into a whole up with the concept of a wearable device that host of applications. would analyse your sweat continuously and For Smith, putting these protein nanowires to non-invasively to measure biomarkers that good use is “a goal not just for the start-up but also for my life”. And for his mentor, Lovley, can indicate the early onset of diseases.” who has spent over three decades focusing on the Geobacter bacteria, the latest developments This, however, is only the beginning. As Smith are no less exciting. explains, the protein nanowires constitute a kind of “Derek has studied these protein nanowires for platform technology that could be used for all kinds their interesting microbiological properties, but he’s of purposes in the future. thrilled to see them used in an actual application “While these protein nanowires are responsive to that is clinically relevant and can help people,” says pH initially, we can genetically tune them so they Smith. “He loves the interdisciplinary nature of the can respond to other analytes as well,” he says. project, combining microbiologists with engineers “The vision is that we could measure many analytes and businesspeople – it’s this whole new start- simultaneously in a very small space.” up environment that has been super productive They would look not just at sweat, but also at for research and for translating the research. other biological fluids such as urine, saliva and At one point he told me, ‘I never imagined that breath. This could provide an assessment of many these applications could arise when I was studying diseases, such as Parkinson’s disease, Alzheimer’s Geobacter rolling around in the mud.’ And now disease and cancers. it’s got the potential to save people’s lives.” ●

94 Medical Device Developments / www.medicaldevice-developments.com x

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Company insight The right design choices have lasting implications As an authorised distribution partner for TE Connectivity medical tubing, ODU medical connectors, and AlphaWire medical wire and cable, Lapp Tannehill partners with medical device and equipment development and manufacturing companies to help them make the right design decisions.

n today’s medical market, integrity and physical robustness front-end decisions that designers that has always been essential. I make can have a lasting impact AlphaWire EcoCable and EcoFlex on manufacturability, patient and control cables in flexible and practitioner satisfaction, and time shielded/unshielded configurations to market. are up to 47% smaller and 65% lighter than traditional PVC Designing for jacketed cable, while EcoWire manufacturability hook-up wire provides similar of interventional devices benefits for internal wiring Selecting the right process aids of equipment. while designing for manufacturability The AlphaWire Micro Coax series (DFM) of interventional devices of coaxial cables are available down such as stents can have a significant to a smaller 50 AWG size with impact on manufacturing time and outstanding dielectric properties for costs. Use of traditional FEP medical the low capacitance and consistent tubing process aids may cause impedance required for coaxial difficulties and inefficiencies that are applications, such as medical easily avoided with strategic design probes, endoscopy, oximetry Lapp Tannehill works alongside a range of manufacturing companies and concurrent engineering. The use developing many different devices. systems and more. of flexible polyolefin-based solutions, such as TE Connectivity’s MT-LWA for emergency release can also be Finding the right partnerships medical tubing, can realise processing essential in critical situations. Successful medical device and equipment efficiencies with an easy-to-peel (without Medical connectors such as the ODU design goes beyond achieving design targets the use of blades), no-need-to-skive MEDI-SNAP Break-Away connector provide and selecting the right componentry. The design, or eliminating adhesives and effortless, ergonomic connection, while also right partnerships can go a long way in mastics in joining operations. featuring ‘snap locks’ that can unmate the ensuring that a successful design translates MT-LWA is perfect for reflow applications connector with one pull of a specified force into equal success for patients, practitioners, where FEP shrink ratios are not suitable, on the cable. An over-moulded plastic, plug- regulatory processes, organisational goals has excellent tear propagation, and its and-play design shortens development time, and business financial goals. optical clarity and optional controlled shrink and reduces cost and weight. Lapp Tannehill has been partnering force make it an exceptional process aid for with medical device and equipment hot jaw bonding and laser-weld applications Fit-for-purpose wire and cable development and manufacturing companies such as balloon bonding. As medical equipment technology for several decades. As an authorised becomes ever more capable, intelligent distribution partner for TE Connectivity The right medical electrical and complex, the need for space-saving medical tubing, ODU medical connectors connectors for signal and solutions to wire routing and harnessing and AlphaWire medical wire and cable, power transmission challenges becomes more pronounced. it are able to assist in early stage design Choosing the right medical connector The AlphaWire ECOGEN and MicroCoax selection, while also ensuring an optimised for patient monitoring and diagnostic series of medical-equipment-focused manufacturing and supply chain. ● equipment often requires easy, wire and cable are ready to meet the ergonomic electrical connections over miniaturisation, space-efficiency and many mating cycles. Additionally, weight-savings demands of the industry, For further information requirements for a ‘break-away’ function while providing the requisite signal www.lapptannehill.com/medical

Medical Device Developments / www.medicaldevice-developments.com 97

Company insight Medical devices – it all comes down to the wire

Ultra-fine medical wire is an essential component in many medical devices. Gary Davies, production unit manager at Sandvik, talks about the company’s collaborative approach to designing EXERA wire, and how this leads to highly specialised products that increase the efficiency of automation processes.

t’s no secret that medical devices making things easier for developers,” A creative and collaborative approach are developing at a rapid rate. Davies says. is the key to achieving these efficient, I Increasingly, smaller, more intricate Partnership with medical device polished products. solutions are required to reduce the manufacturers has led to the development “We’re not afraid to try new alloys or invasive nature of surgical and diagnostic of ultra-flexible leads capable of new coatings to meet the requirements procedures, minimising patient trauma stimulating multiple nerves with the same that developers have, whether that and limiting recovery time. As well transmitter, as well as composite wire involves doing some preliminary lab-scale as demanding high-quality products, configurations that combine steerable melting of alloys or trying out different developers are frequently looking strength members with highly conductive coatings. It’s always rewarding going for unique materials to solve design- signal-transmission materials. EXERA down the development path with our related problems. As demand grows, wire is available in a wide range of surface customers,” Davies says. manufacturers are partnering with treatments. Single-wire configurations can In its quest to help medical device specialists to help automate their be electroplated with custom thicknesses manufacturers refine and develop new methods of production. of gold or nickel and layered in polymer, processes and products, Sandvik is at Sandvik, a manufacturer of ultra-fine PTFE and multilayer coatings. Customised the cutting edge of health technology. precision medical wire, is satiating this multi-filar arrangements and cabled wire It is also a company willing to help demand, working with manufacturers are also available. developers of all shapes and sizes. to develop high-tech medical devices. According to Gary Davies, production unit manager at Sandvik, the high “One thing we do, aside from the manufacturing, is quality of EXERA wire, which is made tweaking certain products to suit the needs of our with diamond dies by experienced craftspeople, is the result of a rigorous clients – whether we are coiling the wire, stranding development process. “We follow strict it, cutting it to a particular length or stripping the internal qualification and validation ends. It’s about making things easier for developers.” guidelines in order to fine-tune processes to meet our customers’ high-precision requirements,” he says. Sandvik’s wide variety of alloys, forms, “We’re willing to work with anyone,” EXERA wire can be used in cochlear thicknesses, arrangements and coatings says Davies. “Not just large corporations, implants, in lead wires; vascular therapy, provides developers with a range of but smaller innovators, to support them in guide wires and pacing leads; for options. The configuration and materials and help make their new idea a reality.” monitoring thermal and glucose levels; used in EXERA wire allows device For Davies, it is motivating to know and for neurostimulation. manufacturers to automate production that such devices are improving people’s methods more efficiently. lives in subtle and drastic ways. Unique designs “Many of our customers are embracing “We’ve had end users come into the Fulfilling these demands often involves automation. So they’re looking for factory and shared their story about a altering certain products to unique solutions that can add value to their certain implant that has made their life design preferences. “One thing we do, products. We work with companies to easier, and it really hits home. It’s great aside from the manufacturing, is tweaking solve those design-related problems, to know that you’re helping people,” certain products to suit the needs of our whether that involves using a specific he says. ● clients – whether we are coiling the wire, type of material, not only on the stranding it, cutting it to a particular alloy side, but also the coating side,” For further information length or stripping the ends. It’s about explains Davies. https://exera.sandvik

Medical Device Developments / www.medicaldevice-developments.com 99 New Zeus Tie Layer for catheters.

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Five decades of extrusion experience have made us a leader in the medical industry. As we continue our commitment to supplying products that emphasize safety and performance where it counts, let’s see what we can develop together. AMERICAS: +1 803.268.9500 EUROPE: +353 (0)74 9109700 Call for more information or visit ASIA/PACIFIC: +(86) 20-38254909 zeusinc.com/tielayer for free samples! [email protected] | zeusinc.com Company insight Catheter safety and performance with tie layer Headquartered in Orangeburg, South Carolina, US, Zeus is the leading extruder of performance polymers, serving multiple industries with a long-standing and reputable presence in the medical sector.

s engineers and medical professionals continue probing A for improved products to boost patient care, they face the daunting challenge of getting new concepts to manufacturing reality. Often, the ideas are there to tackle a specific problem or issue but not the manufacturing know-how. For Zeus, meeting such challenges is its strength. One of the company’s guiding The increased layer bond strength of catheters made with the tie layer helps to address the serious principles is to innovate and lead with safety concern that come with delamination. new products and designs to address jacket, creating a like-for-like bond Tie layer – versatility and safety application needs just like these. during jacket reflow. With the tie layer The tie layer is versatile and suitable bonded to the liner during the coating for a variety of applications, and can Performance catheter components process, the summary effect of the tie be produced in a variety of durometers. A core element of Zeus performance layer is to increase the liner-to-jacket While currently offered in a variety extrusions for the medical industry is bond strength. Preliminary testing has of materials, including Pebax, nylons its components for catheter construction. shown that the tie layer increases liner- and polyurethanes, Zeus will also FluoroPEELZ peelable fusing sleeve to-jacket bond strength up to two-and-a- continue to make tie layers available vastly improved the removal process after half times compared with catheters made in other materials. the reflow step of catheter construction. without it. Depending on the material In keeping with its history of leading LCP monofilament is an MRI-compatible and durometer chosen, the tie layer the way, Zeus has identified a tie layer non-metal braiding material and Zeus’s has been shown to improve catheter to be an ideal solution for those catheter polytetrafluoroethylene (PTFE) base performance, deliverability and increased manufacturers wanting to secure a PTFE liners are the thinnest available for use column strength. liner to the ID of a metallic tube, such as a free extrusion. The tie layer’s most important as a laser-cut hypotube. This versatility Now, adding to these is Zeus’s new tie advantage is safety. The increased layer afforded by the tie layer allows device layer – a thin polymeric coating applied bond strength of catheters made with designers and makers to precisely tailor to the etched OD of the PTFE liner the tie layer addresses the serious safety the performance of their device to deliver designed to reduce delamination and concern of delamination – the separation life-saving therapies in some of the most improve mechanical attributes of the of layers within the catheter. Aside from tortuous vascularture. finished catheter shaft. delamination defects discovered during With industry buzz words like final inspection – the most costly yield ‘continuous improvement’, Zeus catheter Catheter tie layer – loss and a major contributor to raising componentry is advancing this industry. continuing innovation production costs – it carries high liability And, as exemplified by the tie layer, any This new tie layer represents a significant of delamination problems occurring in a improvement to manufacture, design or step forward for catheter construction. clinical environment. There, delamination device implementation will undoubtedly The tie layer is applied as a coating to an failures have direct repercussions for result in improved patient safety. ● etched PTFE extruded liner – a process patient safety. The increased bond unique to Zeus. Applied in this way, the strength from the tie layer also supports a Pebax is a registered trademark of Arkema France. tie layer promotes more uniform adhesion more mechanically consistent device with of the reflowed jacket to the etched more reliable performance characteristics. PTFE liner. These attributes lead to more efficient Secondarily, the tie layer will typically catheterisation procedures and lower For further information be of a similar or same material as the risk to patients. www.zeusinc.com

Medical Device Developments / www.medicaldevice-developments.com 101 Biomaterials

Glass healing

Bouncing, bending and bonding to bone, glass is looking more and more like a miracle material. The liquid-like solid is showing its worth in everything from healing wounds to replacing intervertebral discs. Tim Gunn talks to Professor Julian Jones of Imperial College London and Professor Aldo Boccaccini from the University of Erlangen-Nuremberg about the properties of bioactive glass that make it so valuable for medical devices.

amburger. Hot dog. Ice cream,” hospital in 1984, your hearing restored by the whispered Professor Gerry Merwin, unprecedented ministrations of a lunch-deprived “H the very hungry ENT surgeon who man, but cry hamburger, hot dog and ice cream? had just implanted the world’s first Bioglass It was with that calorific mantra that a human- device into another human being. made material, Bioglass 45S5, first began to bond “Hamburger! Hot dog! Ice cream!” repeated with living tissues inside a human body. On the his joyous patient. She could hear again. The surface of the device, a rapid series of chemical glass prosthesis in her middle ear was conducting reactions were forming hydroxyl carbonated apatite sound waves, just as the tiny bones she had lost (HCA), which, due to its similarity to bone mineral to infection once did. She would not be deaf to her – hydroxyapatite (HA) – is able to interact and second child’s first cries, nor the voice confirming integrate with living tissue. The cells in the stapes her order at the drive-through. What would you and ear drum were using it as the basis for the new do as the local anaesthetic wore off in a Florida bioactive bonds that would hold the prosthesis in

102 Medical Device Developments / www.medicaldevice-developments.com Biomaterials

place as securely as bone itself. Unlike the bioinert Injury luck alternatives, this implant would neither slip nor “That was an accident,” laughs Professor Julian be pushed out of place, thus protecting the young Jones, in an offhand reference to the time he made mother’s ears from further damage. a glass that could heal itself. The team Jones leads 15 It had been 15 years since materials scientist and at Imperial College London was trying to engineer The gap, in years, children’s author Professor Larry Hench discovered a bioactive material capable of taking cyclic loads. between the discovery of Bioglass and Bioglass, but even after he watched over the success He was messing about with one of their latest its first in-human trials. of its first in-human trials, he could hardly claim that 3D-printed test cylinders. Unlike melt-derived he fully understood its potential. In fact, over the glasses, it had been formed through the sol-gel next few years, Hench and his research team began method, a chemical process whereby solid ceramics to realise that, more than simply bonding to living and metals are grown from small molecules, and tissue, the material was capable of regenerating it. printed before they have fully solidified. “I was This too was attributed to the formation of HCA on squeezing it going, ‘It’s almost there, I think that’s the surface of implants in the body, although that almost what we’re looking for,’” Jones recalls. “It didn’t explain why synthetic HA was comparatively was just a bit stiff, and by squeezing it I cracked ineffective. Whereas HA supported new bone growth it across the diameter.” at the bone-implant interface, 45S5 also did so within As far as Jones was concerned, that crack the implant itself. showed why ‘almost there’ wasn’t good enough. Insufficiently intrigued by the fact that the chunk Second life had not just exploded, he put it down and turned It was not until the early 2000s that Hench and to his fellow researchers to discuss how to improve his new research partner, pathologist and tissue on the design. The sol-gel method made it possible engineer Professor Dame Julia Polak, developed for the team to mix biodegradable polymers into a clearer idea of what was going on. The most bioactive glass on the molecular level by growing pronounced healing effects of bioactive glass are them together through a series of chemical caused by the release of ionic dissolution products reactions. Unlike a composite, the resulting hybrid as the material reacts with the body. In particular, would act as one material. The team just had to get as 45S5 glass degrades it releases sodium ions, the mixture right and their bioactive glass would calcium ions and soluble silica, a process that be able to take the cyclic loads the human body stimulates osteoprogenitor cells and facilitates the exerts on its constituent parts. After 20 minutes production of new bone. This realisation marked of brainstorming, Jones picked up his stress-tested the beginning of what Professor Aldo Boccaccini glass again. “I checked all the others to make sure calls the “second life” of bioactive glass. “The gene I hadn’t mistaken the one I put down, but I hadn’t. expression of bone cells was being activated by the The crack was gone.” ions released from the glass,” he explains. “They were moulding the formation of new bone tissue “What people want and really need is by acting directly on the cells.” Shortly after, Boccaccini’s own team demonstrated regeneration of cartilage lost due to arthritis. that ions released from bioactive glass devices could If we can develop better ways of detecting also promote angiogenesis in soft tissue. As was the onset of arthritis, then these sorts of clarified later, calcium ions assist in the migration technologies may translate to that once we’ve and proliferation of epidermal cells and accelerate blood-clotting, while silicon ions advance proved them in sports.” neovascularisation and stimulate the formation of Professor Julian Jones collagen. For Boccaccini and others, it was becoming clear that, “If we control particular aspects of the The accident of creating a self-healing implant chemical composition and the kinetics of releasing material was one of a few strokes of luck in the ions, these glasses can communicate with different story of bioactive glass. Incredibly, Hench chose cells and provide different biological responses.” the optimal chemical composition for his Bioglass Indeed, bioactive glasses are now found in on the first try. Jones and his team’s attempts to toothpastes and cosmetics, as well as orthopaedic develop the best possible bioactive bone implants particulates and wound-healing systems. Until also resulted in a glass hybrid that could bounce recently, however, such materials had not overcome and bend – a perfect fit for repairing cartilage, their primary limitation. Bioactive glass is still glass, which is even more difficult than regrowing bone. and glass is far too brittle for many functions At present, sports injuries like a torn meniscus can required by the human body. take months to heal. Regenerating the cartilage

Medical Device Developments / www.medicaldevice-developments.com 103 Biomaterials

Bouncy bioglass is requires surgeons to dig into the surrounding bone As Boccaccini explains, the discovery of the effect flexible (left) and can be 3D printed into scaffolds to release stem cells, but these can only produce of bioactive glass ion products on vascularisation (centre). When the a dense and fibrous form of scar-like tissue, which made the material applicable across the whole scaffolds have a certain lacks elasticity and quickly wears out. By contrast, human body. Cartilage is a notable exception, which pore size they stimulate cartilage cells to when Jones’s bouncy scaffolds are printed in the is why it is so difficult to regenerate, but most of the produce a high-quality correct channel size, they can enhance and guide body is vascularised. “The blood is everywhere, so articular cartilage matrix (right) unlike any other stem cells to produce the particular architecture you are not necessarily bound to use glass simply existing device. of joint cartilage, which grows through microscopic for bone repair,” he says. holes in the glass as it biodegrades. To take one example, nickel and cobalt ions can “If you’re repairing bone, you need big channels be added to bioactive glasses to mimic hypoxia and that bone and blood vessels can grow into,” explains aid wound healing. “In simple terms, when the glass Jones. “For cartilage you don’t need any of that; what starts dissolving, those ions will absorb oxygen from you want are channels small enough for individual the area of the wound,” explains Boccaccini. “Low cartilage cells to communicate with each other.” oxygen content triggers a number of mechanisms, Furthermore, the material’s ability to bond with recruiting endothelial cells to build blood vessels tissue and take cyclic loads means that patients and attract oxygen via the bloodstream.” Equally, could return to pre-injury activity levels within bioactive glasses could be used for drug delivery a few days of receiving the implant. That would devices that synergistically release therapeutic be a boon for sportspeople in the short and long dissolution products alongside their drug payloads; term, minimising recovery time while ensuring or as a coating for wound dressings and other that the damaged tissue regenerates to meet implants, where they can release antibacterial the demands of continued stress and activity. ions as required. Sports injuries are a relatively limited application, In fact, Jones believes ETS Healthcare’s Mirragen but non-biodegradable variants of the ‘bouncy’ bioactive glass wound dressings have the potential bioactive glass scaffolds could also be used to to take the chronic wound care industry by storm. replace intervertebral discs. “Obviously,” admits “There isn’t a good way to regenerate diabetic Jones, “what people want and really need is ulcers at the moment,” he says, “and bioactive glass regeneration of cartilage lost due to arthritis. If could be the next big thing.” The product can heal we can develop better ways of detecting the onset wounds up to 40% faster than its direct competitors. of arthritis, then these sorts of technologies may Boccaccini is similarly excited by Mirragen, but translate to that once we’ve proved them in sports.” urges caution. “All these things are coming, but more research has to be done,” he stresses. “There Never can say goodbye is still a gap in the data on the long-term effects Jones and Boccaccini began their work on bioactive of the release of ions and the degradation effects glasses with Hench in the late 1990s and early of bioactive glasses in realistic in vivo models. It’s 2000s. “He used to say, ‘Oh, I will retire in three the obvious thing to do, but it’s very expensive.” or four years, so you can take over some of my As Hench once wrote, “Being a pioneer and research,’” recalls the more Argentinian of the ahead of one’s time is, on the whole, not desirable.” pair. “But 10 years later, he was still there.” Today, Still, since his death at 77 in 2015, Jones, only Jones remains at Imperial, but both material Boccaccini and others have been happy to take scientists have defined and been defined by the on that mantle. However long the next stage second lives of bioactive glass. of development takes, it is quite a legacy. ●

104 Medical Device Developments / www.medicaldevice-developments.com BIOACTIVE GLASSES have the ability to bond to soft and/or hard tissue and are biodegradable in the body. Our staff of glass engineers and technicians can research, develop, and produce glass which is custom-made to fit your particular application.

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Glass is a clean and inexpensive material that is easily manufactured One-Time Use Applications frequently required in the medical fi eld • Glass can be shaped, cut, polished, and marked • Glass is clean, clear, strong, and can be sterilized • Glass is inexpensive, making it perfect for disposable • Medical or clinical laboratory applications Properties & Tolerances • Precision ID Tolerance to ± 0.0001" • Custom Volumetric Size Capabilities • Precision Volumetric Marking Measures • Chemically and Physically Unaffected by Sterilization • Inert and Non-Reactive with Most drugs, Bodily Fluids, or Gases • Safe for Direct Human Contact Types of Glass used for Medical Device Applications • Borosilicate Glass – fl ow restrictors • Soda Lime Glass – Its wide range of uses includes capillary, hematocrit, blood measurement, volumetric, and micropipette tubes with various coatings and calibrated markings, as well as crushable ampoules. • Specialty Formulations – Glass chemistries can be tailored to meet specifi c needs for a variety of applications and properties Precision Glass Tubing Products including Capillary Tubes are used for... • Collecting and dispensing specifi c volumes of blood and other liquids • Capillary fl ow restrictors / regulators for mobile infusion pumps and fl ush devices • Ferrule tubing for diagnostic kits, and ampoules for urgent care applications +1 (314) 423 0300 [email protected] www.accu-glass.com Device Design Possibilities with Biomedical Textiles Let’s talk about your next project. Contact us at www.secant.com Company insight Patented textile- forming technologies Secant Group combines textile engineering expertise with speciality manufacturing technology to create high-performance biomedical structures to facilitate repair and recovery of the body.

ecant Group offers several market- leading capabilities, such as its S patented Drop End technology. Tubular woven implants are manufactured with this technology, which drops warp ends circumferentially within the tapered region to maintain a consistent density around the entire construct. In other technologies, the ends are dropped next to each other, rather than circumferentially, leading to regions with different porosity. The Secant method is superior for maintaining specific Secant Group can use patented manufacturing capabilities to customise implantable devices. characteristics, such as porosity and flexibility along the length of the textile fine mesh. The coarse and fine mesh a disadvantage with woven textiles is structure. Tubular woven fabrics may be filaments are then braided together with their lack of flexibility due to the warp used during surgery to repair or replace the resilient filamentary members to form and weft yarns interlacing at 90° angles, various damaged or diseased lumens the construct. The finer mesh built with causing them to lock in place. within the human body; for example, flexible fibres creates small interstices that By tuning the flexibility within certain in vascular surgery, in which a woven provide a bed adapted for growing living regions of a woven graft using elastic tubular prosthesis is used to repair a cells in a two-dimensional array across the materials and tensioning techniques, blood vessel. cell cultivation lattice. Secant can provide areas with more radial expansion and others with less radial “Another patent granted to the Secant Group is for its expansion. By weaving in radial flexibility, the graft can radially expand to match supported lattice for cell cultivation technology. It saw the diameter and shape of the artery. In a need to create a lattice for cultivating living cells to regions where a set diameter is desired, form living tissue, so surgical implants could act as and no radial expansion is wanted, Secant can apply greater tension on the weft, grafts to heal damaged tissue and correct disorders.” which inhibits the yarn from expanding any further. For example, the region Another notable patent granted to the This creates a substantial continuous adjacent to an aneurysm needs to Secant Group is for its supported lattice surface of living tissue that forms a maintain a set diameter so that the for cell cultivation technology. Secant tube usable as a graft for a coronary hydraulic pressure of the blood as it is saw a need to create a lattice for cultivating bypass operation. pumped through the artery can relieve living cells to form living tissue, so surgical pressure on the aneurysm. The same implants could act as grafts to heal damaged Woven tubular grafts techniques can be used when making tissue and correct various disorders. One Woven tubular grafts with regions of straight or bifurcated tubular grafts. example for this application is a tubular varying flexibility is another Secant Visit the Secant Group website via the support lattice for a coronary bypass graft. Group patent. Woven grafts have address below to learn how it can use This tubular support substrate is numerous advantages, such as patented manufacturing capabilities to comprised of resilient filamentary members impermeability, low porosity and small customise your next implantable device. ● interlaced together to form a coarse mesh bulk, which are important characteristics and another plurality of flexible filamentary for several medical procedures, such as For further information members braided together to form a repairing a vascular aneurysm. However, www.secant.com

Medical Device Developments / www.medicaldevice-developments.com 107 Motors & motion control

Make it stick When choosing a motor, the need to balance multiple factors such as service life, cost, speed and temperature conditions, as well as the huge range of potential applications of the technology, can be a challenge. Emma Green speaks with Thomas Mayer from Sonceboz and Carl Bugeja, an embedded-software developer, about how to effectively navigate decisions about motors and the magnets that allow them to run.

t the heart of many pioneering medical are made of iron laminations with copper wire coils devices are new designs of electric motor around them. Later, alnico and ferrite, also known as A and motion-control systems. In pushing ceramic magnets, were incorporated. Since magnets forward their design parameters, technology were expensive and not particularly strong, motor companies are continually seeking higher efficiency, designers tried to use iron to contain, direct and focus more speed, and increased power from smaller, the magnetic flux within the motor. more robust and quieter equipment. It is therefore Magnetic iron is relatively cheap as a bulk material. up to the designer and manufacturer to ensure However, the machines needed to punch, stack, glue that motors can meet these needs, regardless of and grind these metal components are expensive. the particular application and setting. With the advent of more powerful magnets, it is now Central to motor technology, past and present, are possible to make motors that don’t incorporate iron magnets. The initial discovery of magnetism began into the switched magnetic circuit. A large diameter with lodestones, which are very weak, naturally motor has more volume available for magnets and occurring magnets. Next came electromagnets, which coils, which allows the designer to choose between

108 Medical Device Developments / www.medicaldevice-developments.com Motors & motion control

maximising torque or efficiency by reducing power density. This action allows the temperature to be more easily controlled, which is critical for a number of medical devices. For Carl Bugeja, an embedded-software developer, the attraction of working with motors is the ability to use them for robotics. Although his work has not yet been applied in medical devices, it has huge potential for the industry. After graduating from an electronics engineering degree from the University of Malta, he immediately began working on a drone start-up, co-founded with a fellow classmate, but soon ran into a challenge. “We were trying to design a tennis-ball-size coaxial drone, but after some time we had to end the project because of funding issues,” he recalls. Despite this unfortunate outcome, Bugeja was not put off by the experience and instead was keen to have it close to the patient, you want to keep the heat Bugeja has recently developed a PCB motor build upon it going forward. emission as low as possible and you also need the with an axial flux motor “I learned a lot, especially from going through the ability to control the revolutions of the motor.” that uses PCB traces for design process of trying to miniaturise every piece of Unlike SBZ and most other medical device electromagnetic coils. electronics that goes into tiny drones,” he says. manufacturers, efficiency and power are not the primary goals of Bugeja’s work. Fit for purpose “What I’m mostly interested in is designing motors Companies are also pushing boundaries in the motor that are cheap and easy to manufacture, which are still technology space. One such organisation is Sonceboz good enough to power tiny lightweight robots,” he says. (SBZ), which has a strong track-record in developing innovative electric motors and mechatronic drive “Most healthcare systems and economies solutions. For Thomas Mayer, sales and application manager in the MedTech department at SBZ – and on a global scale are facing a challenge a former Boston Scientific employee – getting to the when it comes to cost-efficiency and those heart of the issue is key when developing a motor. two factors combined lead to an increase “When we are in a discussion with a particular customer, we ask what problem they have, where they in home-based care.” want to use it and what is ruling out the selection of a standard motor,” he explains. “We focus on solving Printed circuit board traces complex problems that you can’t fix with something One of Bugeja’s recent developments is a printed off the shelf.” circuit board (PCB) motor with an axial flux motor Although some of the important factors, such that uses PCB traces for electromagnetic coils. as efficiency, speed and power, remain consistent Unlike conventional electric motors, which have when working to optimise motor technology, there is copper wire windings, Bugeja’s designs put those certainly not a one-size fits all when it comes to using windings on the PCB itself as traces. This allows for them for medical devices. The solution implemented inexpensive integration of low-torque electric motors could vary immensely depending on the application. into a device without having to add an electric motor “A motor that is used in a ventilator for respiratory to the bill of materials. care is a different story than the kind of device you use Oftentimes, motors used in medical devices were in dialysis or a lung machine,” acknowledges Mayer. not originally intended for this application. However, The MedTech department in SBZ caters to a developments in the technology tend to offer benefits wide range of medical device applications so Mayer to a number of sectors, including med-tech. This is used to juggling shifting priorities depending on cross-pollination serves as a key driver of progress the context. within and between industries. Bugeja’s PCB motor, “In laboratory analysis equipment, you want to have while not being developed specifically for medical precision, but also compactness and reproducibility so devices, holds great promise in this area. that you always get the same result with each motor,” “This motor can be a simple solution for he explains. “In haemodialysis, the most important anything that requires low torque and high speed,” thing is to have a low-noise motor, and because you Bugeja explains.

Medical Device Developments / www.medicaldevice-developments.com 109 Motors & motion control

Carl Bugeja’s axial flux motor Bugeja developed an axial flux motor that uses printed circuit board (PCB) traces for electromagnetic coils, an idea he came up with while trying to design a new quadcopter. From his previous experience in designing drones, he knew that the size of the motors would define how small the robot could be. Bugeja tried to minimise this by integrating the motor’s stator on the same PCB as the drone. Although he was confident about using this approach on a large scale, he initially struggled with trying to miniaturise it to the same size as other micro brushless motors. However, he soon found a solution, by defining a maximum 16mm diameter limit and trying to fit as many windings as possible. Despite the success of Bugeja’s original motor design, he recently tried to make the PCB motor smaller still by adding two extra layers, which enabled him to reduce the number of turns per layer and get it to 11mm. The total height of the motor is 3.6mm and its weight is just 0.5g. Currently, Bugeja is doing further testing on his PCB motor and designing more porotypes in order to further improve the torque.

Similarly, SBZ is currently focused on modifying existing motors that have been used for an alternate While the effect of this movement on medical purpose. “Right now we are working on adapting devices may not be immediately obvious, it also automotive technology to be able to use in a wearable entails a transformation of patient care from being tracker device,” Mayer explains. based in hospitals and outpatient clinics to taking Although this technology is a highly promising area place within the home. In light of an ageing population, of development, the work at SBZ has not been without and the associated increase in chronic conditions, its difficulties. the application of the patient-centric approach is “We had to modify the overall geometry somewhat becoming more important than ever. and then also find ways of controlling the motor Mayer is acutely aware of the need to cater to squeeze out as much torque and power, while motors for devices that can be used outside of maintaining a high level of efficiency,” Mayer says. traditional care settings. “Most healthcare systems and economies on a global The rise of home-based care scale are facing a challenge when it comes to cost- Another facilitator of innovation is the rise in patient- efficiency and those two factors combined lead

Above: Bugeja’s PCB centric models of care, which has implications for to an increase in home-based care,” Mayer explains. motor in action. a number of fields, including the pharmaceutical “Putting more responsibility into the patient’s hand, medical device industries. This approach aims to taking medication in their home environment, is an Below: Unlike achieve a more precise picture of the disease by area where we believe we can add value.” conventional electric motors, which have considering the specific circumstances of the patient. Constantly improving motor technology is a key part copper wire windings, This information can then be used to design and of achieving sustained success both inside and outside Bugeja’s designs put those windings on the administer an individualised treatment option that the med-tech industry. The inherent challenge in the PCB itself as traces. will produce better patient outcomes. refinement process is what keeps Bugeja engaged and excited. Clearly a creative thinker, he is currently exploring other ideas based on his PCB technology. “I recently tried to put the same electromagnetic PCB coils on flexible PCBs,” he explains. “I am now trying to integrate flexible PCB electromagnets into lightweight robots, to act as their legs and even fish fins.” For SBZ, staying in its lane and maximising efforts within that space are key strategies to ensure longevity in the field. Although excited about the technology, Mayer is keen to emphasise that motors are only one aspect of the work at SBZ. “We are not trying to compete with other motor manufacturers,” he says. “Our goal is to find a challenging application where we can add value by combining our motor technology with electronics and also gearboxes. I think that is an important part of our business success.” ●

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Old spark, new ideas Although the use of plasma treatments for medical For several years now the medical device sector device coatings has been around for some time, in has been increasingly turning to plasma to coat its products. In 2016, industry experts spoke of the recent years it is enjoying something of a renaissance. growing use of plasma-enhanced chemical vapour Andrew Tunnicliffe talks with Professor Denis Dowling deposition (PECVD) as a means of depositing about its potential and its limitations. coatings to protect products against corrosion and wear. rom the often magnificent lightning displays in Today, plasma has become commonplace the sky or the aurora borealis, to its use in car during the manufacturing of medical devices. F headlights and the televisions we watch, plasma “Almost every medical device company looking is everywhere. Said to be the fourth state of matter – at polymer processing will have a use for plasma,” the first three being solids, liquids and gasses – it is an explains Professor Denis Dowling, director of the excited gas produced by adding energy to it, causing I-Form Advanced Manufacturing Research Centre electrons to leave the atom. While natural plasma has at University College Dublin. been in existence for as long as time itself, it wasn’t Plasma can be used to prepare surfaces prior until the 1920s that American physicist Irving Langmuir to printing, for adhesive bonding, as well as for first recorded and then researched its properties. He depositing metals and functional coatings – all of coined the name plasma to describe the ionised gas as it which have uses in applications ranging from the reminded him of a blood plasma. Since then it has been fabrication of medical device sensors, to enhancing used for myriad applications, not least in industry. cell attachment to metallic implants.

112 Medical Device Developments / www.medicaldevice-developments.com Coatings & surface treatment

“There is a diverse range of either surface This is why he uses the term ‘surface engineering’ a activation treatments, etching treatments, or functional lot, but rightly so. Clearly the success of any coating is 10% coating treatments where the technology is applied,” hugely dependant on understanding its compatibility The amount in which Dowling adds. with the material being used, and the ultimate fabricate polymer Although medical devices aren’t the only products application of the device. materials are thinner to require coatings – others include semiconductors, with the application engine parts, and packaging, to name but a few – the An unbreakable bond of plasma technology. challenge they pose is unique because of the nature of One of the areas plasma coating has really changed University College Dublin their use for clinical application. The ultimate aim is to is bonding, says Dowling. On his visits to device increase hardness, gripping surface and resistance to manufacturers’ plants in Ireland, he has seen a shift wear; but with a coating that is biocompatible. towards the use of atmospheric plasmas for bonding. “10 years ago there were very few, but now you see Plasma spray coatings them routinely,” he says. “Before, they [manufacturers] In recent years medical device original equipment would have stopped the production line and put the manufacturers (OEMs) have turned their attention to devices into a chamber where they were bonded. Now hydroxyapatite coatings deposited by plasma-spraying, plasma is in the process, making it continuous and particularly in the field of orthopaedic implants. This meaning you can avoid that. Increasingly, as newer coating is vital as it has the same composition as bone; devices come through, the use of these plasma this means the metal implant knits with the bone, processes are built in, making it is so much quicker.” otherwise there is potential for loosening of the As Dowling eludes to, traditionally plasmas for use device. For plasma spray coatings to perform at in manufacturing were applied using a vacuum process. their optimum, the surface and its preparation is The component was placed into a chamber, the essential, as Dowling explains. pressure of the chamber was then reduced and “It comes down to the surface – tailoring the surface gas was introduced to treat the surface by forming for what you want to achieve,” he says. “For example, a discharge. Once complete, the chamber was you can use plasma to put down a layer of diamond repressurised. Today, for some plasma treatments a few microns thick. However, if that layer goes on to there are atmospheric pressure alternatives thanks a surface that is not particularly hard, effectively you to technological developments in recent years. won’t get the form of layer that is a harder resistance Not only is this more cost effective, there are because the structure underneath doesn’t support it. benefits for the environment, and health and safety. It is like an egg; it has a hard shell, but it is soft “Polymers can be activated by dipping them into underneath. So it provides some protection but it a solvent,” says Dowling. “If you took a polymer and won’t take any impact.” dipped it in an alcohol you have the effect of activating Therefore, Dowling says that when it comes to the surface and, as a result, you enhance its wettability. selecting the coating it is essential to understand However, you then have the problem of these organic how the material will perform and how the device solvents evaporating off, with health and safety issues is ultimately going to be used. there, whereas plasmas are much cleaner and generally “You are tailoring the type of energy that you put very well contained. in to the material properties, mechanical properties, “They are also very fast; the process can range from thermo properties, of what you are applying it to and seconds to minutes. So they are environmentally a lot what you want to do,” he explains. cleaner and much more controllable than conventional Going back to his example of diamond, he says, chemical processing.” the plasma used to deposit it could be a microwave For medical devices, bonding is critically important. discharge operating at 900°C. However, if you are Therefore, plasmas are routinely used in order to using a polymer or a low melting-point metal such enhance the surface of a medical device prior to the as aluminium, it will melt and decompose before bonding of two polymers. Dowling and his colleagues you can apply the coating. For these substrates, are currently carrying out some significant research in you would have to select a different wear-resistant this field. coating such as metal nitrides, which could be “In our own research we have shown that a deposited at much lower temperatures. type of coating known as plasma polymerised can “You select the deposition conditions that are be used to deposit nanometre-thick layers that 2,000°C appropriate for the substrate you are working with,” exhibit superhydrophobic properties, with a water The temperature at Dowling says. “If you are dealing with polymers, contact angle >150°C,” he explains. “One application which it is possible generally you don’t go over 50°C or 80°C to avoid any of these non-wetting surfaces, for example, is to to deposit from damage to the substrate, whereas if you select protect the electronics of mobile phones when they ceramic materials. ceramics you can go to much higher temperatures.” fall into water. University College Dublin

Medical Device Developments / www.medicaldevice-developments.com 113 Coatings & surface treatment

“There are a range of different types of discharges,” says Dowling. “You engineer the type of discharge according to what type of material you want to deposit. For example, because of the energy contained in a thermo discharge, they are best suited to things that require a lot of energy to break bonds. “If you’re thinking of a ceramic material, such as hydroxyapatite, you have to go up to about 2,000°C in order to be able to deposit from that. If you are talking about putting down a polymer layer, there is a technique known as plasma polymerisation, where Left: Plasma technology “Another application of plasmas is to produce you take a monomer of the polymer and spray it into being used to properly surfaces that wet very easily; the term is ‘activated’. We the discharge, where it gets crosslinked to form the prepare a surface for a biomedical application. are using this approach to activate polymer particles.” polymer layer. That is done under much lower energy These particles were subsequently used in either conditions. So much like surface engineering, you

Right: kINPen by injection moulding or 3D printing. tailor the type of discharge according to what you NeoPlas uses cold In the case of the injection moulding, the polymer want to apply.” atmospheric plasma Although atmospheric plasma has gained traction in to treat wounds and particles were passed directly into the moulding skin ageing. equipment, while for 3D printing the particles were recent years, it isn’t suitable for everything, particularly melted and extruded into a filament, which was then for the deposition of metal coatings. used for printing. Dowling says the parts produced “With coating, it comes down to the process and exhibited an approximately 10% enhancement in what is required,” Dowling explains. “Is it metal, a mechanical performance. polymer layer, a low-friction coating and so on? So, This is associated with the cleaning of the particles for those applications involving metal coatings, you with the removal of weakly bound water and organic do have to stop and take them [devices] out; it wouldn’t molecules. Their removal increased the bonding be something you could put in line because it’s simply between the particles, therefore enhancing the not technically feasible.” mechanical strength of the fabricated polymer part. However, when atmospheric plasma can be used, “We started out with a barrel plasma source that the cost benefits and more positive impact it has on could treat approximately 1g of polymer particles,” the environment are a real bonus. says Dowling. “The capacity of the source was initially Although plasmas can be applied simply for increased to 20g at laboratory scale and then to 500g applications such as polymer activation, once you for pilot scale treatment.” move away from those simple applications and start One application of the developed technology is to putting down functional layers, the skill set increases fabricate polymer medical devices that are at least considerably. The level of time and expertise required 10% thinner but exhibit the same mechanical strength. to carry out those processes would be substantial. “A high level of technical know-how is required “At a basic level, plasmas can be used routinely when using plasmas for advanced coating and etching as a low-tech solution,” says Dowling. “But once you applications in sectors such as medical devices and in are trying to achieve superior coating performance semiconductor processing,” says Dowling. “Manmade or etching, the degree of complexity of the process, plasmas are usually in the form of discharges formed and the cost associated with those processes, go between two electrodes.” up considerably. It then becomes a cost-benefit That discharge is formed, under low pressure or consideration. There will be a point where it may the opposite, via myriad different systems of varying or may not be worth it in terms of the value added design, shape and size, but fundamentally they all of the component.” are used for the same purpose; either for removing It may have some limitations but the use of plasma material, to etch, or for deposition. For coating, says for medical device coating has been around for a Dowling, typically a line of sight method has been the while and is here to stay – and it may very well one of choice. evolve still further. “In other words, it is anything that the source “There is much wider adoption of plasma than can see, that the electrode can see, that gets coated,” previously, with a range of newer coatings that are he says. being deposited,” Dowling concludes. “Almost all surfaces can be coated. However, the choice of coating Discharges: benefits and complexity should be appropriate.” However, although in principle it seems simple, That is the conundrum for device manufacturers, it isn’t. one they seem to be getting to grips with. ●

114 Medical Device Developments / www.medicaldevice-developments.com Company insight Coat with confidence Formacoat has cultivated an enviable reputation as one of the world’s pre-eminent providers of coating services for clinical instruments. Medical Device Developments talks to Mark Gross and Jesse Manley, the company’s CEO, and research and development engineer, respectively, about how they are reacting to new developments in the coating market.

ormacoat is moving, says its founder producing lower levels of particulates,” Formacoat has also joined with another and chief executive Mark Gross. explains Gross. coating vendor to offer a chemical grafting F In need of new warehouse space, Formacoat anticipates being at the coating for catheters. the company’s headquarters will up forefront of delivering coating options and “It does require heat, but the coating is sticks from its current base in Savage, services to customers that live up to these formed in liquid and is a very good coating Minnesota, US, to the town of Chaska, new standards. for doing IDs of products,” explains Gross. some 12 miles down the freeway. “Part of our response to particulate “We are currently performing cutting- “For some, it’s a longer drive,” Gross generation is that we are going to begin edge research and development towards cheerfully points out. “For me, it is only doing in-house particulate testing earlier commercialisation with this coating.” a mile and a half.” in the development process,” says Jesse In the past year, Formacoat has also New travel arrangements for certain Manley, a research and development developed new methods for encapsulation employees aside, the move is just another engineer at the company. “We are going with polymers of substrate materials sign of Formacoat’s burgeoning reputation to do dynamic testing that integrates and has made inroads into creating new in the coating sphere. Incorporated in not only liquid particle counting, but does heatable coatings with partner vendors. 2002, the contract manufacturer for so with the standard lubricity-durability Looking ahead, Gross and Manley medical device coating services has pinch testing that we do to qualify all anticipate greater interest among proven expertise in pairing the right coatings, for all customers.” customers in coatings that do more than hydrophilic or hydrophobic coating with passively provide lubricity to individual some of the most intricate and advanced The right coating for the job medical devices. A great example of clinical instruments. Its success in Because Formacoat does not manufacture this would be Formacoat’s use of a this area has been demonstrated by or sell coatings – instead sourcing coatings hydrophobic, ‘matrix-entrained liquid’ its expanding customer base and rising from corporate and academic partners – coating, which possesses a high degree staff numbers. the company has a vast array of options of repellence against materials that might “We have reached a point where the open to it in order to find the most lie against it inside the body. space we are in no longer works for us,” appropriate coating for any device. “It has valuable applications for Gross explains. “So, we are building a “What I learned early on in the antimicrobial activity, but without there new facility that will increase our square business is that not all coatings are being any drugs involved,” explains Gross. footage fourfold.” equal,” says Gross. “Bacteria simply can’t adhere to its surface. That means it is great for dosing and “By offering different coatings from different stripping applications, where you’re trying to remove products or contaminants from vendors, if one doesn’t work, we can switch to a surface during a medical procedure.” another very easily.” That coating is still in its nascent commercialisation stage, but Formacoat This will provide room enough for new “By offering different coatings from has plenty of other projects to keep it busy ultrasonic spraying tools and equipment different vendors, if one doesn’t work, as its staff wait to make their move into for precision coating applications. we can switch to another very easily.” the new facility. Some expansion space and funds This versatility also allows Formacoat “We have got coatings that are will support Formacoat’s pursuit to break away from traditional thinking heatable and surface-blocking coatings to help medical OEMs navigate the surrounding how certain coatings fit that prevent proteins from bonding to US Food & Drug Administration’s with certain applications. device exteriors,” Gross says, confidently. position on particulate generation in For example, Gross and his “Our world of coating applications is pretty certain coatings. colleagues are currently working with much exploding.” ● “It has pushed coating manufacturers coating vendors to develop soft-touch to develop new formulas and strengthen coatings that, the CEO says, “feel like For further information their products so that they are better at peach skin”. www.formacoat.com

Medical Device Developments / www.medicaldevice-developments.com 115 Proven Solutions from a Trusted Partner

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rusted, high-quality needles are From custom point geometries to required for interventional procedures specific cannula designs, Argon Medical T such as kyphoplasty, vertebroplasty, OEM offers CNC Swiss Machining, and bone access and bone marrow biopsy, as a variety of metal processes, such as well as orthopaedic and spine surgeries. swaging, bending, flaring, electrochemical Although the need for such bone needles ‘burr-free’ cutting and chemical etching. is common, finding a specialised needle Another important feature of a bone that specifically matches your requirements needle is the ergonomic handle design. can be a challenge because the procedural Handle designs have improved greatly outcome, ease of use, and patient and over the years to improve needle control clinician comfort is greatly impacted by and clinician comfort. the needle’s point geometry, cannula design Additionally, adding custom features to and handle ergonomics. the handle design, such as a pad-printed As a leading provider of bone access needles, Argon Grinding the needle point geometry logo or a specific handle colour, can Medical OEM offers a wide variety of ergonomically is a critical process in manufacturing a enhance marketing efforts and increase designed handles in many shapes and colours. perfect needle. This is especially evident brand awareness. and cement delivery, with leading edge in bone access and bone marrow harvest As a leading provider of bone access design features built in for optimal ease- needles where the point geometry directly needles, Argon Medical OEM offers a of-use and patient outcomes. affects insertion force and patient comfort, comprehensive range of ergonomically Packaging is another important and can impact the overall success of designed handles in a variety of shapes consideration for your bone needle project. the procedure. and colours. Packaging options range from bulk non- sterile to custom single-pack sterile. Although sourcing your needle bulk “Grinding the needle point geometry is a critical non-sterile might seem to be the easiest process in manufacturing a perfect bone needle.” and least-expensive solution, partnering with a supplier in order to provide a Argon Medical OEM provides a wide Off-the-shelf and sterile, private-label-finished device can variety of point geometries, including: packaging options help reduce overall lead time and total the double-diamond point designed to Some projects prioritise speed and time-to- cost of ownership. easily penetrate hard bone; an industry- market, when there simply isn’t enough Argon Medical OEM offers a wide variety leading ‘match-ground’ tip where the time or budget to source a customised of both custom and standard packaging needle and stylet are uniquely matched bone needle. For such situations, there options, including form-fill-seal, vacuum one-to-one during grinding, for a perfect are off-the-shelf options that are ideal. forming blister trays, peel pouching, and needle point; and electrochemical grinding Argon Medical OEM has a vast portfolio private label and custom packaging. and notching for custom features specific of ready-to-order needles specifically to customer needs. designed for bone access, bone biopsy Quality as standard Argon Medical OEM is a proven quality Cannula and ergonomic supplier of needles for bone, biopsy and handle design vascular access, and a respected leader Cannula design is also an important in medical device manufacturing, with feature for bone needles. Some design custom and standard product offerings options to consider are shaping the for components, accessories and private- tubing or wire to strengthen the hub label-finished devices. bond, modifying the funnel entry for Argon’s experts are available for the accepting a device into the tubing inner company’s clients to contact and discuss diameter, designing the cannula to their projects. ● capture and retain outstanding-quality bone marrow specimens, or adding For further information Argon Medical OEM provides a wide variety of point centimetre depth markings. geometries to cater to customer needs. www.argonmedicaloem.com

Medical Device Developments / www.medicaldevice-developments.com 117 Microfl uidics

Cancer detector Cancer DNA changes in response to its environment, favouring alterations that help it survive long term. These include large and small changes, and the latter can be almost invisible. Chrissy O’Keefe and a team at Johns Hopkins University have created a digital microfl uidics platform to help detect these changes. She talks to Kerry Taylor-Smith about how this technology could revolutionise cancer detection.

dentifying scientific markers of cancer is key to HYPER-Melt – or high-density profiling and early disease detection and treatment planning enumeration by melt – is a digital, microfluidics-based I – often possible long before a diagnosis has been platform that allows researchers to manipulate and made or symptoms develop. It can also help doctors analyse minute volumes of fluid. By separating blood to track disease progression and guide treatment in samples into smaller and smaller chunks, the device established cases. makes them easier to individualise and analyse. This However, searching healthy cells for small changes makes it easier to identify disease-carrying DNA and to DNA in cancer cells is akin to searching for needles to separate it from healthy DNA. in haystacks. That’s because while some changes are HYPER-Melt is the brainchild of Chrissy O’Keefe, significant – and relatively easy to detect – others are a PhD student who has been under the mentorship so small they evade analysis. And it’s these changes of Professor Jeff Wang, a microfluidics expert in the that can give cancer DNA an edge and affect patient university’s Department of Mechanical Engineering outcomes – early detection can boost survival rates by and at the Institute for NanoBioTechnology (INBT), as much as 90% in some cancers. In what could signal and senior INBT research scientist Tom Pisanic. a major breakthrough for oncology research, a team O’Keefe and her team have published their from the Department of Biomedical Engineering at work on HYPER-Met in a Science Advances paper Johns Hopkins University has developed an innovative entitled ‘Facile profiling of molecular heterogeneity device to help make identifying these small changes by microfluidic digital melt’. The research is the easier and more efficient. culmination of more than five years’ work in the field.

118 Medical Device Developments / www.medicaldevice-developments.com Microfluidics

O’Keefe says the device, which is based on hardware and software components, evolved from an interest in studying the heterogeneity of a sample on a molecule- by-molecule level. “Cancer, along with many other diseases, is highly adaptable and contains many heterogeneous cell types,” she says. “It is constantly changing and evolving to ensure it can survive and thrive in its environment – in the body. We wanted to develop a technology that could detect and quantify this variability so we could better understand tumour evolution. We wanted to look at this at its earliest stages, as well as at later stages where the cancer adapts and avoids treatment or causes a relapse. In particular, we were interested in studying cases where molecules may be very rare – such as cell-free DNA from a blood sample.” pave the way for an increased understanding of disease This new microfluidics Collecting signatures development and progression. digital platfrom can aid those searching for HYPER-Melt works by investigating small sequence “HYPER-Melt is readily extendible to applications subtle DNA changes in variations of tens to thousands of single molecules like precision medicine. The ability to profile disease cancer cells. of DNA. It digitises molecules into 4,096nL chambers populations within a patient can help identify genetic and uses a thermal-optical platform to simultaneously or epigenetic therapeutic targets, as well as small amplify and obtain the high-resolution melt signatures clonal populations that may be resistant, which could of each chamber. help in developing and adjusting treatment regimens.” In practice, the workflow is similar to a standard The device is best suited to samples with rare and bench top PCR experiment. The user prepares their heterogeneous molecules. Liquid biopsies, which mastermix and target on the bench top, and loads the contain trace amounts of cell-free DNA in the plasma, mixture into a syringe. When the syringe punctures could be a key focus of HYPER-Melt-based research. the seal of the chip, the mixture enters the device “Many diseases, such as cancer, are highly variable by vacuum-assisted loading, and a partitioning fluid so that they can adapt and grow in their environment,” is pressurised through the channels to digitise each says O’Keefe. “HYPER-Melt can be used to assess this chamber. This process is fast and efficient, taking no variability throughout the development of disease by longer than five minutes. simply taking a routine blood sample.” The final step involves the device being placed on In particular, it could benefit doctors working the flatbed heater to undergo digital PCR and high- to detect cancers that ordinarily require invasive resolution melt (dPCR-HRM) using the same time procedures like biopsies, endoscopies and frame as a microtiter plate experiment. colonoscopies to secure accurate diagnoses. O’Keefe says there are a number of reasons why She said the device could also be used to monitor the technology could revolutionise cancer detection. cancer evolution in response to therapy. “The ability to “HYPER-Melt allows highly parallelised molecular detect small, rare sequence changes could give an early profiling of rare molecules,” she says. “The platform indication of evolving therapeutic resistance.” uses a simple, all-in-one workflow and demonstrates highly sensitive detection that is roughly two to three The impact of high-resolution orders of magnitude higher than current techniques. melt technology “For example, digital analysis in a microtiter-plate Similar current devices are based on digital PCR system is limited to tens of molecules, which limits platforms, with the most popular version being droplet the amount of information that can be collected. digital PCR (ddPCR), which can isolate and detect Microfluidic manipulation, on the other hand, enables single molecules. It’s a sensitive technique that can find the acquisition of more information per sample from rare biomarkers; however, it is limited to a few known thousands of individual molecules in parallel, while or targeted sequences. minimising reagent usage. In addition, the ability HYPER-Melt, on the other hand, offers greater to assess various sequence changes of a given locus insights through its ability to assess unknown provides more in-depth information than current sequences, and identify a spectrum of modifications PCR-based gold standards.” using high-resolution melt. She says HYPER-Melt could be used to study the “Typically, digital PCR produces a binary yes/no genetic and epigenetic make-up of a population and result for each chamber. However, high-resolution melt

Medical Device Developments / www.medicaldevice-developments.com 119 Microfl uidics

allows us to acquire additional sequence information are seeing more and more digital microfluidics about each amplicon,” says O’Keefe. “High-resolution being used in cancer studies to detect single melt measures sequence variations by using an nucleotide polymorphisms and rare mutations, intercalating dye to detect changes in fluorescence especially in liquid biopsies.” during a thermal ramp. For example, in this study we looked at methylation changes – an epigenetic Bringing the device to market modification that affects gene expression. High- Each of the prototype devices consists of a Chrissy O’Keefe resolution melt allows us to assess the whole range single polydimethylsiloxane (PDMS) pattern layer of potential methylation changes, even those relating sandwiched between glass, and is made using an to unknown targets. One of the largest technical ultra-thin soft lithography technique. PDMS has challenges in developing this platform was detecting several advantages, such as ease of fabrication, real-time variations in fluorescence from thousands of biocompatibility and optical properties, says O’Keefe. nanolitre-volumes in parallel. Once acquired, though, “In addition, the gas permeability of PDMS we can obtain the sample’s entire sequence profile.” allows rapid, vacuum-assisted loading. Glass, which Hyper-MELT could offer clinicians significant can be easily bonded to PDMS, serves to provide cost and time savings compared with other current a flat, rigid surface for heating while maintaining technologies, such as sequencing, says O’Keefe. optical transparency.” “Sequencing, which is commonly used for genetic Having a beta-ready version of HYPER-Melt profiling, can provide exact sequence information,” available within three years is a key target. says O’Keefe. “However, it is an expensive technology “There are still many improvements that we need and it also takes a long time to achieve the requisite to make before a packageable version of HYPER-Melt sensitivity (<0.1%) for challenging samples with rare is ready for market,” O’Keefe concedes. “One major molecules, so it is not particularly suited to clinical use. milestone would be to establish sufficient sensitivity “By comparison, HYPER-Melt can achieve much and specificity of the platform in a clinical setting. If higher sensitivity – 0.00005% – with much lower cost; the platform demonstrates sufficient performance, then in fact, for roughly the same cost as a microtiter plate. we can start to tackle scalable manufacturing methods In addition, it has a simple, rapid workflow with few and high-throughput assessment of samples. hands-on steps, and provides an easy-to-interpret “Currently, one of the device’s biggest drawbacks is result, making it an efficient and relatively simple the relatively low throughput of the system. HYPER- means for molecular profiling.” Melt can analyse roughly five samples at a time, which limits its use in large studies that require the “Cancer is constantly changing and evolving assessment of hundreds to thousands of samples. to ensure it can survive and thrive in its We’re therefore looking to improve the throughput for environment – in the body. We wanted to larger-scale studies by focusing on developing a more advanced thermal-optical platform.” develop a technology that could detect and O’Keefe and her team are working with partners quantify this variability so we could better at Johns Hopkins University and other medical understand tumour evolution.” institutions to advance and refine the HYPER-Melt technology and usability to prepare it for market. O’Keefe said HYPER-Melt was aimed at achieving The team hopes to evolve the technology so it can be the outcomes of digital PCR and sequencing, and then used as a diagnostic tool to detect tumour-derived DNA building on these outcomes in terms of developing in liquid biopsies. “We believe that the high sensitivity better sensitivity, efficiency and reliability. of this platform, coupled with the multidimensional O’Keefe says the pace of development in data set, can improve early detection of some types microfluidics is presenting exciting opportunities for of cancer, especially those without reliable screening the scientific community. The improved performance techniques,” she says. and reliability of commercial microfluidic technologies, Follow-up studies are focused in particular on lung such as ddPCR, have sparked a boom in research. cancer and ovarian cancer. Using lung cancer as an “One simple advantage of digital techniques like example, O’Keefe says the technique could be used microfluidics is absolute quantification,” she says. following a CT scan to provide secondary, non-evasive “Researchers can simply count positive chambers to analysis, potentially replacing the need to run a biopsy. exactly quantify their sample without using standards, In the case of ovarian cancer, which does not currently and this enables more accurate measurements for have a reliable diagnostic technique that can be used applications such as copy number variation. prior to symptom evolution, there is real potential to “Another powerful advantage is the ability to develop new biomarkers that could pave the way for detect extremely rare molecules. As a result, we early detection, diagnosis and treatment. ●

120 Medical Device Developments / www.medicaldevice-developments.com Compelo readers save €100 off delegate rate, quote CompeloReader CLICK HERE FOR DETAILS 25 - 26 June 2019 Meliá Berlin, Berlin, Germany

The international conference on polymeric medical tubing and catheters, covering design, materials, production and applications www.ami.international Bringing the plastics industry together. @Contact_AMI #AMITubing  Hemodialysis  Drug Delivery WE HAVE  Infusion Pumps  Heart/Lung Machines YOUR  Blood Processing SENSOR

Celebrating the PAST Changing the introtek.com FUTURE Filtration & fl uid control Liquid flow A number of disposable sensors are now available to monitor fl uid control in medical devices, and these tend to be low-cost because there are no electronics located in the sensor. IVAM CEO Dr Thomas R Dietrich talks to Kerry Taylor-Smith about the potential of these sensors for mobile and point-of-care diagnostics.

uring medical treatments, the outcome Smart chips of therapy and the overall well-being of a Disposable liquid flow sensors containing smart D patient so often depends on the reliable and chips could be a game-changer in the biomedical continuous administration of drugs or intravenous field, from controlling the flow of valuable ingredients fluids at low or ultra-low flow rates. However, such in bioreactors to monitoring infusion therapies at procedures and therapies are faced with the same low and ultra-low flow rates in a clinical environment. challenges – precisely measuring and regulating They have been designed for single-use, high-volume lowest flow rates of medicines and/or fluids down biomedical applications such as drug delivery to the microlitre per hour. systems, and their in-built failure detection features Smart infusion pumps provide well-controlled drug can help counteract failures such as cross flow delivery over an extended period of time, but are and extravasation. unfortunately susceptible to failure. The technology Smart chips within the sensor can combine lacks the ability to directly measure the flow rate of microelectro mechanical systems (MEMS) and CMOS the drug inside tubing, leading to undetected failures (complementary metal-oxide-semiconductor, a class of or oversensitive pumps giving false alarms. integrated circuits) on a single silicon wafer, and have Typical failures include occlusion (a blockage or the potential to improve diagnostics and automation. closing of the blood vessel or a hollow organ); air in This unique technology is safe and reliable, not to the line; free flow; cross flow, where multiple infusions mention highly precise, and is capable of detecting the are taking place at the same time; and infiltration smallest change in liquid flow rate in real time at the or extravasation, where intravenous fluid seeps into point of interest. The integration of single-use liquid tissue surrounding the canular inserted in the vein. flow sensors within medical devices, such as urinary

Medical Device Developments / www.medicaldevice-developments.com 123 Filtration & fluid control

catheters or infusion sets, is simple: the sensor chip Intelligent, compact and cost-effective is completely isolated, encased in a plastic housing – Single-use liquid flow sensors have the potential to meaning it cannot come into contact with bodily fluids revolutionise drug delivery. They are considered more or medications – that can be secured in the fluidic line effective as it is easier to oversee and regulate the flow using standard Luer lock fittings. The sensor is also of medication or IV fluids, and their smart chips are low-cost – it has been stripped back to a bare minimum helping to improve diagnostics and automation. The without sacrificing mechanical, electrical and fluidic result is better patient treatments, improved safety connections, making it ideal for disposal after use. and support for overworked hospital staff. The straight, open-flow channel has no moving parts “Treatments will become more effective as (meaning nothing to break or fail), which provides they become easier to monitor and control,” says excellent reliability, and its small size results in efficient Dietrich. “Patients’ safety is improved by the automatic and highly repeatable measurements in real time, detection of failure modes like clogging, free flow, air offering unprecedented reliability and safety. It can, bubbles, or leaks in the tubing connection.” This serves for example, spot occlusion in a matter of seconds to increase the accuracy of drug delivery and automatic by noticing a decrease in flow rate even at ultra-low diagnostic equipment. flow ranges. Medical-grade wetted materials also Such single-use liquid flow sensors can detect a drop offer excellent chemical resistance and outstanding in a primary infusion flow due to cross-flow errors from biocompatibility as well as sterilised operation. a secondary line where multiple infusions are taking “A disposable liquid flow sensor provides liquid place simultaneously, and includes bubble detection flow measurement capability from inside medical to identify air inside the infusion tubing. tubing, such as an infusion set or a catheter,” Furthermore, the sensors are so sensitive that they explains Dr Thomas R Dietrich, CEO of IVAM, an can even detect a heartbeat, a direct indication of an international microtechnology business network and intact connection of the infusion cannula to the vein technology marketing expert based in Dortmund, of the patient. The absence of a pulse could indicate Germany. “Because of its low cost, it is suitable for an interrupted connection caused by a kinked disposable applications.” tube, ruptured tubing or a dislodged cannula, which could lead to infiltration or extravasation (leaking Treatments will become more effective as they of intravenous fluid into the tissue surrounding the become easier to monitor and control. Patients’ vein). Such incidents can occur when damage is safety is improved by the automatic detection caused to the vein during catheter insertion and can cause irritation if the fluid is a non-vesicant agent, or of failure modes like clogging, free flow, air damage to nerves, tendons and joints if the fluid is a bubbles, or leaks in the tubing connection. vesicant agent such as a chemotherapy drug. These intelligent, compact and cost-effective liquid Drug delivery from an infusion set, an infusion pump flow sensors have the potential to change drug delivery or other medical devices can be measured precisely from the ground up, offering safer, more mobile and and in real time. “Inside a disposable liquid flow sensor, reliable care in hospitals and peoples’ homes. a microchip measures the flow inside a fluidic channel,” “Disposable liquid flow sensors make the use of says Dietrich. “Flow rates, typically in the range of zero point-of-care diagnostic tools affordable for everyday to several 100ml per hour are measured with a typical use,” says Dietrich. “Even patients and family members accuracy of 5% of the measured value. Inert medical- without any medical education can use automatic grade wetted materials are used to ensure sterile equipment for diagnostics and drug delivery.” operation with no contamination of the fluid.” The use of these devices at home is made possible The sensors’ measurement method is based on a as the sensors are cheap and easy to use. “This will micro-thermal principle; an incredibly tiny heating give elderly and chronically ill people the opportunity element on the chip releases an insignificantly small to stay longer at home and avoid long clinical stays amount of heat into a bypassing liquid to obtain a or movement to nursing homes,” explains Dietrich. thermal flow measurement. The shape of its heat cloud is monitored by two temperature sensors positioned Multiple benefits symmetrically up and downstream of the heat source, It is known that being mobile can reduce the length of which detect minute temperature differences with a patient’s hospital stay while simultaneously improving incredible sensitivity: these fluctuations are directly their quality of life. However, ambulatory infusion related to the flow rate inside the fluidic channel. pumps can be problematic in terms of ensuring the Using this principle, liquid flow sensors can required flow rate is accurate – during a typical day continuously and reliably measure low flow rates it can be difficult for a patient to follow the handling typical of medical applications. instructions that ensure the specified performance,

124 Medical Device Developments / www.medicaldevice-developments.com JOIN THE EAST COAST’S LEADING MEDTECH EVENT

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resulting in real-life flow rates deviating drastically excreted fluids are also being monitored – as well as from the intended values. overcoming other common failures related to current The use of a single-use liquid flow sensor could infusion technology quickly and reliably. help overcome this by allowing the continuous But these sensors aren’t just for administering drugs delivery of highly concentrated medication over and fluid to the body, they can also measure and record several days. This could be especially useful for things coming out of it. They can also help to diagnose those receiving chemotherapy where the constant acute kidney injury (AKI) by automatically measuring administration of chemotherapy drugs over time has and recording urine output, a task currently carried a better pharmacodynamic influence on effectiveness out manually at regular intervals by nurses. Using and toxicity compared with traditional bolus injections disposable liquid flow sensors in this manner could every day. There is even the potential for these allow for a timelier diagnosis and potentially prevent single-use liquid flow sensors to be incorporated into the onset of AKI, while also eradicating human error wearable drug delivery devices, further enhancing a and freeing up medical staff’s time. patient’s quality of life while they undergo treatment. Integrating disposable liquid flow sensors into Another issue is the clogging of the restrictor of the infusion tube sets has the potential to progress infusion pump – usually a thin capillary in the pressure drop therapies and allow for controlled drug delivery on element – or at the injection site. It can take hours a much broader scale. Measurements and vital signs before an occlusion is noticed by the medical team could be obtained and stored automatically and or the patient themselves, but the use of a disposable electronically, eliminating human error and saving liquid flow sensor within the infusion set can spot such valuable time, which medical staff can dedicate to a failure much more quickly – even within seconds. actually treating patients. Such disposable liquid flow sensors can also prove They could detect currently unnoticed failures and useful in treating babies and young children who maybe even prevent them, increasing patient safety require much smaller doses of drugs due to their low and well-being. Introducing such a ground-breaking body weight. Once integrated into an infusion set, the technology could also present massive savings for the single-use liquid flow sensor allows for the accurate healthcare system, while decreasing workloads and monitoring of administered flow rates – critical if stress for hospital staff. ●

Decode the future

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126 Medical Device Developments / www.medicaldevice-developments.com Company insight Cutting-edge porous solutions Jack Chan, global marketing director for medical segment at Porex (Filtration Group), explains how the company’s sintered POREX Virtek PTFE solutions are designed to address today’s diverse medical device challenges.

hether used to treat Sintered PTFE: touch strength and able to illnesses, injuries or anywhere and versatile work W in-between, medical devices Design manufacturers seeking to alone. are essential tools that help to improve increase safety, functionality and health and well-being, and save the lives reliability in current and next-generation Furthermore, using expanded PTFE of billions worldwide. As critical as it medical devices can utilise a sintered (ePTFE) films, often regarded as the is to have access to these devices, it polytetrafluoroethylene (PTFE) industry standard, actually prevents is also vital that they are functioning membrane as a component. This durable, effective assembly and can even cripple properly to safeguard both patients and high-performing technology, which more production during rapid medical device medical professionals. effectively vents, diffuses and filters air, The medical-grade PTFE hydrophobic material Recently, the EU updated its current gas and liquid, allows medical devices provides a high bacterial filtration efficiency of directive for the regulation of medical to perform exactly the same every time. 99.99% or higher, superior water-entry pressure, optimal airflow and a fluid barrier. devices. The EU’s medical device The medical-grade PTFE hydrophobic regulation (MDR), set to come into material provides a high bacterial manufacturing processes, due to their effect in May 2020, requires medical filtration efficiency of 99.99% or higher, delicate nature. Sintered PTFE, which device manufacturers to provide more superior water-entry pressure, optimal can retain its properties through the in-depth clinical data to prove safety and airflow and a fluid barrier. rigours of high-speed automation or performance claims, and more stringent Sintered PTFE, a membrane featuring heat, pressure or vibration welding, can equivalency standards, in order to get an open-cell, omnidirectional 3D pore be used in a wide range of applications. their products to market. Thus, it is structure that is design-flexible, is This material is optimal for infection imperative that manufacturers carefully extremely versatile. It can be tailored control, injection therapy, and medical consider the components at the core in thickness, porosity and pore and pharmaceutical packaging, among of their medical device design to ensure volume to individual device needs. The other applications that promote safer the safety of individuals in any healthcare unique composition, comprised of well- medical device usage and performance. environment, whether in a hospital or controlled particles, creates additional Components, particularly those that laboratory facility. robust strength. enable venting, play a critical role in how well medical devices function and “POREX Virtek sintered PTFE venting solutions perform. POREX Virtek sintered PTFE venting solutions are designed to address are designed to address today’s diverse medical today’s diverse medical device challenges device challenges.” and replace the production and operation of faulty, unreliable devices that can harm When a medical device is not outfitted This, in turn, permits greater durability the individuals they are meant to aid. correctly, everyday procedures can and reliability of the porous PTFE Learn more about the applications for present critical risks. For example, an components, potentially extending their POREX Virtek PTFE solutions that are instance in which a defective vent causes use and the lifespan of the medical device creating a safer, healthier and more a safety IV catheter to leak can expose as a whole. The sintered PTFE material productive world at the Porex website. ● healthcare professionals to blood-borne is unlike other porous PTFE membranes pathogens, putting them in harm’s way. that product designers and manufacturers References available on request. When properly designed with porous may use to vent medical device venting components, medical devices applications. Traditional porous PTFE such as the arterial syringe, IV catheters membranes often require a supporting and others can prevent an incident like layer or scrim to reinforce the strength, For further information this from occurring. whereas sintered PTFE is superior in www.porex.com

Medical Device Developments / www.medicaldevice-developments.com 127 Innovation in Miniature BRING PERFORMANCE THE LEE COMPANY AND RELIABILITY Patient Monitoring TO A SMALLER PLACE

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Westbrook • London • Paris • Frankfurt • Milan • Stockholm Packaging

Many hands make light work

The global market for sustainable packaging is rapidly developing. However, medical device companies are still lagging behind their personal-care, food service and shipping counterparts. Peylina Chu, executive director of Healthcare Plastics Recycling Council, speaks to Emma Green about key principles to consider in bringing the medical device industry up to speed.

t is estimated that one million tonnes per year Over the past few decades, there has been growing of non-infectious medical plastics are available awareness of the environmental hazards related to I for recycling in the US, with equivalent amounts the disposal and recycling of packaging, numerous in Europe and Asia. However, notwithstanding its government initiatives and increasingly stringent

Opposite page: environmental impact, plastics have offered huge regulations. Despite these drivers, the complex and Northshore OR bags benefits to the industry. These include enhancing dynamic nature of the medical device industry makes specifying their use patient safety and making lighter packaging to save it more difficult to implement environmentally for recyclables or hazardous waste. fuel and costs when transporting supplies. friendly practices into the supply chain.

130 Medical Device Developments / www.medicaldevice-developments.com Packaging

Peylina Chu, director of Healthcare Plastics Recycling Council (HPRC), is up for the challenge. She is passionate about identifying and addressing barriers throughout the supply chain. Together with a small, but highly active, group of members and advisory board, Chu is keen to educate relevant individuals and organisations, and promote opportunities to recycle medical plastics more widely. Two aspects are particularly problematic within the industry. The first of these is the amount of regulation around patient safety. “They need to be able to get approval of a particular plastic device or plastic packaging to make sure that it is safe for patient use,” explains Chu. “This means that any design changes need to go through that rigorous approval process, which is very expensive.” The second is what Chu calls the ‘ick factor’. “After being used and disposed of, a lot of recyclers are concerned about infectious materials, perhaps a syringe, or stuff that’s not the usual consumer or residential trash.” Further complications arise due to he lightweight nature of the materials, which makes them expensive to transport, and the lack of recycling centres. In light of these difficulties, adopting a collaborative approach is key. In order to ameliorate issues further down the supply chain, it is imperative to make packaging recycling friendly right from the start. “This is where we’ve been working with the sustainable packaging coalition to make sure that we are talking about the same issues when it comes to designing the packaging,” explains Chu. “Things like not mixing materials within a single package, not having a metal screw cap on a plastic bottle and trying to minimise the paper labels that are used on plastic packaging.” Although all of these issues can be dealt with by recyclers, this is an extra step. “It costs more money, it takes more energy and it just makes that whole recycling process less profitable,” says Chu. It is thus better to prevent these problems from occurring in the first place.

Medical Device Developments / www.medicaldevice-developments.com 131 Packaging

Get the word out There are also efforts by the HPRC to teach hospital staff about what and how to recycle. This includes being proactive about identifying materials and treating them appropriately. “One of the best practices that we like to talk to hospitals about is removing packaging before the patient is even brought into the operating room,” Chu explains. “That way, you can make sure that those plastic packaging materials are kept clean, they don’t have infectious materials or blood on them, and instruments are not accidentally tossed into the bin.” At the end of the chain, the HPRC are tackling the practices of recyclers. This includes providing education and encouraging more communication. “There’s a lot of this material out there and they may not have thought to talk to hospitals about recycling,” Chu says. Emphasising the value of these plastics, particularly compared with consumer materials, is central to getting this buy in from recyclers. Implant Syringe “They have a tighter spec, and in a lot of cases the materials are sterile,” Chu The implant syringe is used to place rod-shaped, retarding explains. “The material is also denser, tablets into the tissue coatings of the patient. The tablet is so if it’s properly sorted it can actually intserted through the needle. have a higher market value.” Although the HPRC is only concerned EASY USAGE After removing the safety clip ant the protective with recycling efforts, this is addressed cap the implant is placed on the disgnated area from multiple angles because of the and the tablet is injected into the tissue. variety of companies involved. This includes suppliers, medical device BENEFIT & CONVENIENCE manufacturers, academic healthcare - Smooth and constant injection process facilities, healthcare systems and - Injuries in the fabric layers are avoided 3UHÀOOHGV\ULQJHUHGXFHVWKHULVNRIPLVXVH recyclers. “I like to say that we’re an - Less pain for the patient inch wide and a mile deep,” Chu says. 1RULVNIRUWKHXVHUWKURXJKLQWHJUDWHGQHHGOHSURWHFWLRQ “We only focus on recycling but we look at recycling from a lot of different APPLICATION AREAS perspectives, and I believe that our Hormone implants Vaccination group does some quite meaningful things for the industry.” One of the surprising aspects of the HPRC is that members are often companies who would not otherwise be working together. “Even though this group includes competitors, this is an area where they can come together and see that by collaborating they’ve got a better chance of being successful in the industry,” explains Chu. Central to the success of this cooperation is the enthusiasm and dedication of the individuals and Contact Gaplast | Wurmansauer Strasse 22 | 82442 Saulgrub-Altenau | Germany companies involved. “They are phone +49 (0)8845 7413-0 | e-mail [email protected] individually passionate about the

132 Medical Device Developments / www.medicaldevice-developments.com Computer Aided Design

CNC Tooling

environment and the planet but at the end of the day, it’s got to make sense for their own business,” Chu says. The result of this collaboration has been a number of publicly available resources for individuals and organisations interested in expanding their sustainability Controlled efforts. “We have a toolkit that’s free for hospitals to Environment download, it’s called HospiCycle,” explains Chu. “It’s for hospitals that are interested in starting up a recycling programme or improving or expanding upon an existing Nowhere are the stringent requirements of recycling programme.” cleanliness, consistency and continuing This also includes resources to help aid the design of more performance more important than in the sustainable design methods. “We also have guidance for medical industry – and nowhere is it more manufacturers, talking about how designing for recycling is important to work with the company that really important,” says Chu. “There’s things that make it easy understands those needs. to recycle, and things that make it more difficult to recycle.” Phase 3 Plastics specialise in the design and manufacture of customised thermoformed packaging. Across the pond We offer a product that provides the practical solutions to To date, the majority of the work of the HPRC has been packaging needs using the latest CAD, computer tooling conducted within the US. However, in recent years the and clean room technology. We are confident that our coalition has begun to expand its remit to Europe. Chu is experience and expertise offer the best possible service from initial concept to final result. acutely aware of the large differences between countries in Europe, as well as those between Europe and the US. Phase 3 Plastics Interestingly, the environment within Europe has tended 2-4 William Street to be permissive rather than restrictive in integrating Southampton recycling into working practices. “In some ways, the Hampshire regulatory landscape, economy and healthcare systems SO14 5QH actually help the recycling scenario in Europe compared United Kingdom with the US,” Chu says. “We’re finding that some of the Tel: +44 (0)23 8022 9844 challenges that we find within the US aren’t as big of an Fax: +44 (0)23 8023 2928 issue, or even an issue at all, within Europe.” For further information contact: Terry Lucas, Sales Director on Technological progress within Europe has also been beneficial for the aims of the HPRC. “There are a lot more +44 (0)23 8022 9844 or [email protected] drivers and I think there’s greater urgency and advancement www.phase3plastics.co.uk in technology in Europe than in the US.”

Medical Device Developments / www.medicaldevice-developments.com 133 Packaging

Learning from these other sectors has also been helpful as they face similar issues with plastic packaging. “One of the issues that we’re working with here in the US is multilaminate packaging, which is also a challenge within food, beverage and consumer types of packaging,” Chu explains. “You can now get a piece of clear-looking packaging that looks like polypropylene or high-density polyethylene but is actually sandwich materials, but you can’t tell from just looking at it.” Although the HPRC has a narrow focus, Chu acknowledges that other strategies are needed to improve sustainability within the medical industry. “We are concentrating on recycling specifically but I know that all of our member companies are also focused on reducing the amount of plastics used in their packaging,” says Chu. “That’s something that’s very important as well.” Above: Employees at the Significant international events, such as the Looking to the future, it is clear that there is Casella sorting facility. China ban on waste imports, might be expected still a lot to be done to improve the sustainability Page 132: Many recyclers to cause disruption to recycling efforts but have of medical packaging. This involves action from are concerned about actually been a positive influence. “One of the a number of different stakeholders, including infectious materials, such as syringes, or things that I see here in the US is that now, manufacturers. “They could look at improving their other materials that are because of the China ban, the return on investing packaging design,” says Chu. “There are still paper not typical consumer or residential waste. in a recycling facility or new recycling technology labels being used but there needs to be a transition in the US is becoming better,” explains Chu. to recyclable plastic labels or even printing directly Page 133: Designing packaging to make This is having a much wider impact than just on the packaging.” Such developments have already it easier to recycle is medical plastics. “We’re now seeing investment in begun to be implemented in the food industry hugely important. recycling facilities and technology within the US and this trend is likely to continue over the next that will certainly benefit the medical industry if few years. not other industries that we would never have seen At the other end of the chain, increases in without the China ban.” sustainability efforts will open up new avenues for financial gains. “We’re focusing on those “We’re focusing on those unique nuances of unique nuances of healthcare packaging, educating healthcare packaging, educating recyclers recyclers and hospitals about how to generate that clean stream of materials so that it doesn’t and hospitals about how to generate that have blood and other yucky stuff on there,” Chu clean stream of materials so that it doesn’t explains. “As recyclers better understand this, have blood and other yucky stuff on there.” there will be a market pull for these materials – brand-owners stepping up and saying yes we want to buy recycled materials.” Healthcare Plastics Recycling Council Although the medical industry is inherently complex, Chu remains optimistic about the The HPRC is a private technical coalition focused on inspiring and enabling the recycling of plastic packaging and products used in the delivery of healthcare. sustainability of packaging. “It’s a time of a lot of It adopts a unique approach through identifying barriers to recycling along the different moving parts right now, which I think are value chain. It then develops resources to remove, or at least minimise, those going to be positive for much of healthcare plastic issues. Some of their past and current work includes: recycling and plastic recycling in general,” Chu says. ■ Design guidance: intended for manufacturers, this guidance provides ‘dos and don’ts’ to improve recyclability of healthcare plastics. The drive for more environmentally friendly ■ HospiCycle: a free toolkit for hospitals looking to start or expand their plastics practices across industries is only going to increase in recycling programme. upcoming years. However, it is imperative that large- ■ Materials testing phase 1 and phase 2: targeted to recyclers, HPRC is testing scale changes to the environment are made to be hard-to-recycle flexible films to assess various technical properties so that recyclers can see the value of these materials. able to accommodate these strategies. “We’re hoping ■ Chicago project: a regional recycling project involving multiple hospitals and that, with this new-found momentum and visibility, recyclers to better understand challenges and factors for success within a a lot of large organisations will start rethinking our geographic region. recycling infrastructure, how that can be improved Source: HPRC and the capital investments that need to be made.” ●

134 Medical Device Developments / www.medicaldevice-developments.com Company insight Seal the deal Atlas Vac Machine is the oldest medical device tray sealer brand solely focused on cleanroom packaging applications. President John A Abraham explains how the tray sealer technology, as well as the seal tooling nests, calibration, field service and correct operation training, is the company’s core expertise.

or the medical device manufacturer, manual is essential to provide the packaging packaging is one of many issues to engineer with the ability to train others F be considered when launching a (maintenance, calibration, operators), as new device. However, all too often the well as to find IQ data recommended by packaging, as well as its core process the OEM. elements, is afforded little attention on the project timeline. Just as any The importance of OEM training deficiency in the medical device itself Training at the OEM factory – which is can result in a recall, so can the failure free at Atlas Vac – can offer numerous of the packaging performance. advantages. Something as simple as The capabilities and productivity of the reviewing an IQ checklist, and the related latest tray sealers have been enhanced equipment features, can save a packaging with automatic shuttles, safety-rated light engineer hours of backtracking should curtains, servo-driven presses and, most someone who is uninformed install the importantly, data acquisition. This can equipment incorrectly upon receipt. result in better payback on the capital The new Model 1830S All Electric Medical Device OEM factory training is essential, as well Tray Sealer from Atlas Vac Machine. equipment investment – but only if the as required by ISO, for the maintenance features are fully understood and utilised. operation so the operator can provide tech supporting the equipment. Predictably, As with most validated capital additional value-added labour internal to injuries can occur where an untrained equipment, a tray sealer is in operation each cycle period. Servo presses produce technician who knows nothing about the for years, and often well over a decade a different and more exact sealing pressure controls and functions bypasses all the or even two; therein lies a drawback. profile compared with pneumatic systems. safety systems in a trial and error attempt to address some reported ‘malfunction’. “Something as simple as reviewing an IQ checklist We often see third-party calibration services brought in who are ISO 17025 can save a packaging engineer hours of backtracking certified, but have zero familiarisation or should someone who is uninformed install the training (an ISO requirement) in the equipment incorrectly upon receipt.” operation, maintenance and calibration of Atlas Vac tray sealer control systems. When it is time to acquire new Important advances have been made in This has resulted in damaged components, equipment, user specifications are often data acquisition, down to the exact details adjustments to system components based on equipment perceptions and rigid of each package that is sealed at this nexus specifically designated as ‘non-adjustable’, processes rooted in older technology. of device, package and label before it leaves undocumented software modifications, and Understanding what is available now and the clean room. Potentially, such data incorrect temperature, pressure or timing how it can be applied productively may capabilities challenge the upstream and performance. This results in customer create some competitive advantages if downstream systems to integrate thinking packaging sealed unknowingly at inaccurate curiosity overtakes rooted perception. to the betterment of the enterprise. recipe values. Atlas Vac offers technical Remember, the equipment designer has Given that these new features may not support for your designated third-party been listening to many ‘voices of the have been available on an in-use tray sealer calibration service provider. consumer’ as a guide to what features that has been in the facility for 10–20 years, Providing production with the most are valued in this specific market. it would be a wise (but too frequently advanced equipment is an investment overlooked) step to take a day to learn the that will payoff over the next decade Multiple benefits details for proper set-up, use and calibration (or two), but free training is priceless Automatic shuttles provide repeatable cycle of a newly acquired tray sealer. Yes, it is all in more ways than one. ● times, while reducing package component in the equipment manual (which is often displacement and repetitive motion injury. shelved, skimmed and/or lost), and a hand- For further information Light curtains provide safe hands-free in-hand review through the equipment www.atlasvac.com

Medical Device Developments / www.medicaldevice-developments.com 135 CREATE WITH CONFIDENCE.

A partner you can rely on. At Brentwood, we want you to have confidence in your product. Our design team works with you every step of the way from concept through production. We are here to ensure that you achieve a final product that not only meets your specifications but makes both your team andd ours proud.

Contact us today! 610.347.5109 or visit us at www.brentwoodindustries.com/medical/medical Company insight Design outside of the box

Innovative packaging designs from Brentwood, a global provider of formed plastic solutions to multiple consumer, manufacturing and environmental industries, resulted in significant time and cost savings for dental solutions manufacturer Dentsply Sirona.

entsply, a US-based company, and Sirona, a European-based D company, formed Dentsply Sirona in 2016. Dentsply Sirona manufactures professional dental solutions that include preventative, restorative, implants, imaging services, treatment centres and software solutions. Dentsply Sirona’s headquarters are in York, Pennsylvania, US, a short one-hour drive to Brentwood’s Specialty Products Group located in premium look that Reading, Pennsylvania. was easier to use and significantly reduced The challenge costs compared with its On 25 October 2017, Dentsply Sirona current packaging. came to Brentwood looking for an Brentwood’s engineers Dentsply Sirona wanted to make sure that the packaging improved packaging solution to its developed a detailed action plan design reflected the company’s global brand image, so an additional aspect in the design was making the lids of all current off-the-shelf injection-moulded and began work on the first round the packaging a specific blue colour. polycarbonate boxes sourced from of designs. They produced concept China. These boxes held the company’s drawings within 24 hours (beating other and dentures. The abutment design restorative dental products including companies by several days). Brentwood’s is a nested, sliding tray that can be crowns, abutments, screws and dentures. quick turnaround time was a critical factor opened with a thumb, moving forward or For the new packaging designs, Dentsply in decision-making for Dentsply Sirona’s backward. This design keeps the implants Sirona wanted to focus on a premium product line manager in Spain. secure during transport and allows look, easier-to-use packaging, and a Dentsply Sirona held focus groups the dental care provider to access the solution that reduced costs. These to test the original designs and identify abutments with ease. new packages will be used for Dentsply areas of improvement. A pivotal design Since these customised boxes will Sirona’s Atlantis product line, a fully change involved the condition that the eventually be available worldwide, customisable treatment box tailored to abutment trays needed to be opened Dentsply Sirona wanted to make sure each patient’s specific implant needs. with one hand. Brentwood’s team of that the packaging design reflected designers delivered new concepts to the company’s global brand image. This The solution Dentsply Sirona’s product line manager additional aspect in the design involved Brentwood and Dentsply met for the within 24 hours. Three days after the making the lids of all the packaging a first time within 12 hours of receiving the designs were provided, a 3D prototype specific blue colour. Brentwood’s team initial project specifications. Brentwood part was also sent to the product line worked with several material suppliers to understood that Dentsply wanted a manager at no charge. formulate the perfect blue material that matched the Pantone colour of Dentsply The result Sirona’s brand. Each tray and box Brentwood’s team of engineers developed packaging includes a clear bottom and multiple aesthetically pleasing package Dentsply Sirona blue lid. designs, abutment trays that are easy to In summary, Brentwood’s talented open with one hand and a solution that packaging design engineering team reduced costs for Dentsply Sirona. successfully met the unique and The new packaging line includes three challenging needs of Dentsply Sirona. ● different styles of abutment trays to Three days after the designs were provided, a hold screws and implants, and two For further information 3D-printed prototype part was sent to Dentsply Sirona’s product line manager in Spain at no charge. different-sized box designs to hold guides www.brentwoodindustries.com

Medical Device Developments / www.medicaldevice-developments.com 137 Logistics

Chains of command Heavy regulation from design to delivery can make logistics highly challenging. Optimising the shipping process provides time and cost savings, as well as the ability to offer exceptional customer service. Kim Thomas talks to Bruce J Stanley, president-principal at the Stanley East Consulting Group, about key strategies designed to maximise the effi ciency of logistics procedures.

n efficient, well-oiled supply chain is The biggest concerns, he says, continue to essential to the smooth operation of any be geopolitical issues, and regional regulation A business, whether that business is selling of medical devices and healthcare. There was food, cars or clothing. However, it is particularly an optimism in the industry a few years ago that important in the world of medical devices, a sector companies “could create a product and ship it that is highly regulated and where companies anywhere around the world like it was Amazon”, typically carry large amounts of inventory. but this has proved not to be the case. Bruce J Stanley, president-principal at the Stanley More recently, Brexit has made it harder East Consulting Group, has a wealth of supply chain to know where to place facilities to serve EU experience in the healthcare industry, and now countries. Before Brexit, “You could put a facility advises global biotech, medical device and pharma anywhere in that geopolitical area. businesses in the management of their supply Now it is not so easy any longer. If anything, chains. So what does he see as the main challenges Stanley adds, “The geopolitical and regulatory facing medical device companies aiming to make issues are probably even more paramount today their logistics procedures as efficient as possible? than they were five years ago.”

138 Medical Device Developments / www.medicaldevice-developments.com Logistics

This is why one of the major pieces of advice he organisations to manage their data. Although he gives clients is, “Stay close to your regulating body, agrees about the importance of security, he is whether it is in London, whether it is in Washington also a strong advocate of making use of the global DC, whether it is in Singapore.” It doesn’t matter standards organisation GS1, which he describes how innovative the client’s logistic model is, he says, as an “industry forum that helps create the “The reality is you have still got to play by the local mechanisms so that organisations, companies, regional jurisdiction because if you don’t, you won’t hospitals and governments can actually have be able to ship the product.” consistent, clean data.”

Medical products are not like DVDs When it comes to managing distribution, says “Organisations like GS1 provide the platform Stanley, some medical device businesses imagine for companies to stay current 24 hours a day, that it is possible to mimic the innovative seven days a week, every day of the week, distribution model of companies such as Amazon. without missing a beat.” “They think, ‘If they can do it in DVDs and books, we can certainly do that in healthcare’,” say Stanley, urging caution. Predictability leads to success “It takes a lot of courage for companies to make The ability to have consistent data that adheres to that leap because people don’t die if they don’t the same naming conventions makes a substantial get their DVD on time, but people can be injured difference to an organisation’s ability to keep track physically and die if the [medical] products aren’t of crucial information in supplier and customer where they need to be when they need to be, so databases. GS1’s Traceability in Healthcare there is some degree of hesitancy about saying, ‘Well, standard, for example, makes it possible to see we will just use that model and drop it in here’.” the movement of medical devices right across In fact, Stanley says, the real reason for Amazon’s the supply chain, tracing backward to identify success lies in its collection and analysis of customer the product’s transfer history, and forward to data. It has, he points out, “figured out a way to see its route to the hospital or clinic. translate the data into really workable operating “Take the identifier for what a customer is – parameters”, resulting in near-seamless logistics. you could have 10 different identifiers, or a product Many in the medical devices industry are keeping could have five different catalogue numbers,” says an eye on Amazon’s expansionist tendencies. Stanley. “Organisations like GS1 are trying to drive “This is what scares a lot of the people in my global standardisation in such a way that when industry, because once Amazon figures out some you pick up a syringe in the US it has got the same of the other stuff, they are going to be a force to be classification, the same catalogue number, as in reckoned with, because they do understand how to Belgium or Germany or Norway.” use their pristine data, turn it around, capture it, reuse Keeping data up to date is a major challenge, it in such a way that everybody benefits,” says Stanley. he points out – data that is correct today could It follows that the companies that have risen be wrong by tomorrow. most successfully to the challenges of medical “Organisations like GS1 provide the platform device distribution, he says, are those that maintain for companies to stay current 24 hours a day, “pristine data, whether it is customer data, product seven days a week, every day of the year, without data or patient data”. missing a beat,” he says. “That is what is different As companies come to realise that their data is now from maybe 10 years ago when each entity a type of intellectual property, they become keen thought they had to create their own data profile. to protect it, and some of Stanley’s work involves Now they can use organisations that help them offering advice on the multiplicity of tools they keep it consistent and current all across the can use to manage their data more effectively. board, everywhere.” “They have CRM tools for pricing and contracts The impact of having data that is both clean and sales, and distribution and so on – and at the and up-to-the-minute is transformative when it end of the day, they are all the same,” he points out. comes to managing the supply chain. “Basically, they have all the same functionality.” “What we see now in healthcare is predictability The important thing is not which tools businesses models being utilised in such a way that use but how they make best use of the data. manufacturers can start to predict with a better So how can businesses make sure that their data degree of certainty what their customers are is pristine? Stanley says that many companies are going to need or what surgeries are being done,” reluctant, for security reasons, to use third-party Stanley explains.

Medical Device Developments / www.medicaldevice-developments.com 139 Logistics

They can even take into account what regulations another area that he believes is essential is stock government agencies are creating and how that keeping unit (SKU) rationalisation. affects manufacturers upstream, to the extent “You see any kind of company and they say, ‘We that now they have, “good predictability on product have been making this for 50 years and everyone flow, product consumption, product usage and, loves it’, and the reality is that they may not love for that matter, product discontinuation with some it as much as people think,” he says. “Companies degree of certainty that they couldn’t do before”. that tend to be state-of-the-art now are the ones Bruce J Stanley that make the hard choices on SKU rationalisation. Look beyond healthcare for They look at their cost. They look at their sale data analysts price. They look at their market, they look at In a world where collecting and understanding their gross profit on those products.” data has become essential to keeping the supply It is a very hard decision to make, he chain running, the key skill set, says Stanley, is acknowledges, but one that is “crucial to this that of the data analyst. optimisation of supply chain, because it affects “You just can’t have anyone looking at data,” everything from the end-user patient all the way he says. “Now you need analysts who can ask, upstream to the supplier or the items that the ‘How do we use this in such a way that actually manufacturer makes on behalf of the patient”. creates optimisation up and down the network?’” So, what are the big mistakes Stanley sees Data analysts, he notes, “can pick trends, and businesses making time and time again? predictability is hugely helpful”. “The first one is that they are going to latch This makes it imperative, he says, that businesses on to what they think is the new state-of-the-art employ staff with excellent data analysis skills. technology and never really take a pause to see “In healthcare you see a lot of data analysts how that is going to affect how they work and coming from banking, because people in healthcare what they do, and their market, their customers realise that these people think differently than we and their product line,” he says. “So in many do. It is one thing to have an esoteric view of, ‘Well, cases, the biggest mistake they do is apply new we are in healthcare because we help patients and technology on old processes. And then there is cure cancer’, but in order to optimise the system just a mishmash and it never works right.” or process you need people to think differently.” It is surprisingly common, he adds, for Stanley and his colleagues have done a lot businesses to implement technology without of work with the banking industry, learning how understanding how it is going to help their its approach to data analytics could be applied bottom line. to healthcare. “Often I have asked a lot of CEOs and company “They deal with billions of bits of information leaders, ‘How do you work? How do you know what routinely – financial, transactional and customers you do?’ And I am shocked many times that good and identifiers, all the kind of stuff that healthcare companies with good leaders can’t really tell me wrestles with,” Stanley explains. “So I always how they work.” encourage healthcare providers and manufacturers Too often, he says, companies “have never to look to these other industries that may not seem done the heavy lifting to do a self-assessment connected, but are really connected when it comes and research what they do, how they do it, and to the capabilities of the people that do the work.” what the costs are.” Once you have that knowledge, At the same time, it is more important than he says, ”Bringing in systems is so much easier ever to understand the different regulatory because then you go, ‘Well, this one really helps environments under which data is held. us get to that level’. So that is probably the biggest “Data is protected differently from region mistake – that people want to rush to new to region around the world,” Stanley points out. technology because they think it is great.” “Companies that are global always have to always Ultimately, he says, success is predicated take that into consideration.” on mastery of the business’s core data. This is another reason, he says, why he “Once I know with crystal clarity what my encourages global clients to have a presence customers are, where they are, what their needs in the country where they are doing business. are, where they are moving – because they could be moving to a new technology or new procedure – Sometimes you have to make once I have got that in my hands, all the other things hard choices are somewhat ancillary because it will tell you where Although Stanley sees good management of data to go. It will become so obvious to someone looking as integral to successful supply chain management, at that data that the rest of it is simple.” ●

140 Medical Device Developments / www.medicaldevice-developments.com Company insight Considerable care from origin to destination

Transporting pharmaceutical products from origin to destination by air is an exclusive and specialist service that requires high levels of care and attention. Turkish Cargo flies to most countries in the world and supports a huge network, including freighter destinations.

urkish Cargo maintains its ongoing All in regulation activities in order to realise the The company regularly monitors sector T best transportation of time and requirements in order to transport temperature-sensitive pharma and according to Operational Quality and healthcare products, to make the Turkish Pharma GDP standards, completes the Airlines network even more integrated via deficiencies and continues to realise Envirotainer operation requirements by activities in this direction. adding QEP accreditation to its most In this respect, the company is a important stations. member of Pharma.Aero, which aims Envirotainer’s QEP accreditation to achieve excellence in reliable end-to- is proof of the brand reliability within end air transportation of pharmaceutical the temperature-controlled freight products. CEIV Pharma certificate is industry, and the result of hard work accepted as the standard by the Pharma. and dedication to the customers. Aero organisation. Negotiations with Dokasch-TS, an active In order to keep up with the times, container supplier, have been concluded some investments should be made successfully and the operation started. continuously in pharma air cargo. Turkish Cargo’s biggest difference The investments must first be made into on cargo business is its network the facilities, training, and certification that enables customers to send required to transport pharmaceuticals pharmaceuticals shipments to almost Turkish Cargo operates the best equipment to safely and securely. Recent cold-chain ensure that pharmaceuticals maintain temperature. 260 destinations, with new passenger technology developments provide ensuring routes consistently opening in Europe risk mitigation and lane assessment. temperature condition that are maintain and Asia. In order to ensure a high level SOPs cover handling, storage within acceptable limits during transport. of reliability and security throughout and transportation processes Using the right cold chain equipment pharmaceutical shipment, QEP of pharma shipments. is important to reassure pharmaceutical accreditation provides the improvement of ramp-handling processes. “Turkish Cargo has increased the number of

The only way is up QEP-accredited stations to 40 for handling Turkish Cargo has increased the number pharmaceutical products.” of QEP-accredited stations to 40 for handling pharmaceutical products; Turkish Cargo was awarded IATA’s products maintain optimum temperature. moreover, last in/ first out procedure, Pharmaceutical and Healthcare Products Cold chain equipment can be used prioritised loading and unloading, Transportation certificate ‘Center of especially healthcare products. In this a total of 90 minutes on tarmac for Excellence for Independent Validators’ way, Turkish Cargo builds a bigger and transit shipments, quick ramp transfer (CEIV) at its Istanbul Hub, in more special dedicated pharma facility and thermal dolly are implemented August 2016. at Istanbul Airport. ● to minimise the ambient exposure in The company successfully maintains the pharmaceutical-handling process. the recertification process that will be Also, specific SLAs/SOPs are signed performed by IATA every three years. with esteemed global solution partners The process of CEIV Pharma-certification For further information and valuable forwarding agencies for for new airport has already begun. www.turkishcargo.com

Medical Device Developments / www.medicaldevice-developments.com 141 Company insight Your cargo is special

Equipped to carry all types of air cargo in full compliance with global industry standards, and with an in-depth knowledge of the healthcare and pharmaceutical industry, AirBridgeCargo has been providing high-quality cargo carrier services to clients around the globe since 2004.

irBridgeCargo (ABC) is a global operations and procurement – helping it with effective connections to cargo carrier with an expanded to reinforce the handling procedures and deliver cargo worldwide A international route network control processes required during all stages ■tailor-made logistics solutions based that connects customers in the of transportation. Creation of special on your individual requirements largest trans-regional markets of Asia, services is proof of ABC’s commitment ■sophisticated, cohesive and Europe and North America, and covers to every single detail before and during forward-thinking approach based more than 30 major cargo gateways, transportation, especially for pharmaceutical on peer learning and networking accommodating trade flows worldwide. goods that require special attention. through industry-related initiatives: All the flights are operated via ABC’s cargo hub in Moscow Sheremetyevo airport, which features up-to-date “ABC’s cargo hub features up-to-date equipment equipment and guarantees seamless and guarantees seamless connection throughout connection throughout the airline’s the airline’s expanded international network within expanded international network within a 48-hour delivery time.” a 48-hour delivery time – including handling – all managed by highly skilled and qualified ground-handling personnel. Benefits and special solutions these are Pharma.Aero, Pharma ABC’s fleet consists of 18 Boeing 747 of abc pharma include: Gateway Amsterdam (PGA) and others freighters, and is one of the youngest ■exact temperature monitoring from ■24/7/365 Control Tower (CT) operation and most modern in the airline industry. acceptance to delivery to monitor and manage transportation Operating in the market since 2004, ■special packaging solutions and thermal of special cargo consignments ABC is committed to catering to the blankets for palletised shipments ■adoption of the latest digital needs of its customers worldwide with ■abc pharma Active and abc pharma technologies (Sky Fresh for automated high-quality services. The excellent Passive solutions – the first is for time and notifications, temperature data operating advantages of ABC’s freighter temperature-sensitive pharmaceutical loggers to monitor consignment fleet, the performance of its highly skilled products that need to be shipped in conditions and more). personnel, and constant improvements active containers (including dry ice to its internal processes enable the technologies) and the second is for Continuous improvements guarantee airline to carry all types of air cargo prepackaged pharmaceutical products the best logistics solutions in full compliance with global industry ■dedicated, skilled staff trained From vaccines, laboratory equipment standards, including those requiring in handling healthcare products and MRI/MRT machines to blood samples observance of special handling conditions, ■full compliance with IATA TCR and beyond – ABC, will always find the such as temperature-sensitive products. and CEIV certifications best logistics solutions to cater your The company is constantly reviewing ■Envirotainer QEP-accredited stations needs and expectations. its existing service offers in order to within ABC network ABC aims to continuously improve realign them with both market and ■customer service support, online track its service quality, embracing all the customer expectations. and trace option for all shipments company’s key components – equipment, ■Boeing 747-8 and 747-400 with three personnel, technologies, internal abc pharma – a part of the compartments enabling different processes and procedures – with mission to heal temperature settings from 4°C to 29°C implementation of the recent ABC is the best partner when it comes to ■fast temperature pull down times developments and cooperation with an in-depth knowledge of the healthcare after take-off partners, sharing its values in terms and pharmaceutical industry. ABC has ■temperature-controlled facilities at of high quality standards. ● developed a special abc pharma product the majority of stations throughout as well as verticals within the company the ABC network comprising dedicated and qualified staff ■high-tech pharma hub at Moscow For further information at all levels – sales, customer service, Sheremetyevo International Airport www.airbridgecargo.com

142 Medical Device Developments / www.medicaldevice-developments.com We love to make it happen.

| Efficient fleet of B747 freighters | Active and passive pharma solutions #ī÷ƃƈƜƢĬ÷ #ŎÜƕƈƧćƋƢƯ÷Ŏ | Exact cargo temperature monitoring from acceptance to delivery #ÜëƂxƄƚƦ #ůĴƑƥòƖƈƝƞ#ÜƈŇƁƫƢòƆ÷ƜƀŇƆƨ | CEIV and QEP certifed stations

| Certified and highly-skilled personnel | Dedicated customer service support | Online track & trace

www.airbridgecargo.com Product showcase

Glass versus plastic they interface, leading to Advantech Medical DMS is to Custom- undesirable results. become the strategic partner manufactured Accu-Glass’s precision of the leading healthcare radiopaque glass manufacturing process providers. Advantech provides clad wires is capable of holding tolerances a wide range of customised as low as ±1μ. This lends itself medical-certified computing to processes and applications solutions. Its product portfolio requiring highly controlled includes medical computing volumes, flow rates and systems, medical panel PCs/

Accu-Glass’s products have many physical barriers. Large AIOs, medical tablet PCs and advantages over conventional plastic. quantities of glass parts may fitness computing consoles. With Many advances in manufacturing be produced with a known size strong customisation capability technology have brought tolerance at a time and cost- and experience in medical-grade forth new products made effective rate. systems, Medical DMS not only from glass, which may have delivers qualified medical Anomet’s clad composite wires offer significant advantages over Further information computing products to its an alternative to typical medical wires. Accu-Glass conventional plastics. customers but also acts as the Anomet Products has introduced www.accu-glass.com Glass is a clean and strategic and innovative partner custom-manufactured clad inexpensive material that is for medical customers. composite wire − an effective easily manufactured for single- Advantech medical Reasons to choose Advantech alternative to solid precious- use applications that are equipment builders for your next project include: metal wires with marker bands frequently required in the ■ complete and integrated − to improve the visibility of medical field. Some of its back-end infrastructure to implantable devices. This clad benefits include: streamline design-in processes wire is a proven alternative to ■ can be shaped, cut, ■ expert engineering, project wires typically used in medical polished and marked management and design disciplines, such as: ■ is clean, clear, strong and capabilities for efficient ■ cardiac rhythm management can be sterilised Advantech product portfolio includes product development (pacing and defibrillation) a range of medical computing systems. ■ is inexpensive, making ■ broad customisation ■ neurostimulation it perfect for disposable Advantech has been delivering scope for diverse needs ■ vascular therapy (stents, medical or clinical IoT products for over 30 years. in vertical markets catheters and guidewires) laboratory applications. To best serve its outsourcing ■ global design, service and ■ biosensors customers, Medical DMS – a manufacturing centres ■ monitors. Choosing glass over dedicated team – was created ■ reliable and long-lasting plastic may be a way to avoid to provide professional design solutions Anomet radiopaque clad undesirable chemical reactions customisation services for ■ one-stop shopping and a faster wires allow original equipment and unwanted alterations in the industrial-grade computing time to market manufacturers (OEMs) to specify properties of the fluid collection systems. Advantech specialises ■ trusted business model with the degree of visibility they or storage method. A wide range in the design and manufacture global partner desire under fluoroscopy by of custom shapes, containers and of high-quality industrial ■ technical feasibility study selecting the radiopaque alloys collection devices are available in hardware and tailored software ■ new product developments and cladding thickness best glass. Glass offers a non-leachable that fulfil exact needs for (CPU cards, chassis suited to their products. Easier interface between liquid (such sectors such as gaming, and systems) to see than solid wires with as fluids, drugs or chemicals) healthcare, portable devices, ■ design verifications marker bands, they are offered and container (such as syringes, retail and embedded systems. ■ changes management in sizes between 0.05mm and capillary tubes or ampoules). DMS offers not only ■ EOL or LTB management 1.52mm (outside diameter) for Disposable devices are collaborative design, flexible ■ product life-cycle management use with stents, guide wires and commonplace in medical manufacturing and European ■ refined design, manufacturing related devices. and electrical industries. Glass support, but also a service that and quality processes Featuring platinum-iridium, devices offer the advantage gives customers a dramatic to meet the medical tantalum and tantalum-tungsten of being chemically inert, non- market advantage. Embracing customer’s requirements alloys, as well as similar alloys leaching and stable at a wider the value of altruism, the ■ medical product safety and metallurgically bonded to high- range of temperatures than company is as a long-term EMC certifications. strength wires, such as 316LVM plastic. Leachables from plastic partner that helps customers stainless steel, nitinol and Further information have the potential to chemically maintain prosperity, now and Advantech Europe MP35N with cladding thickness alter the substance with which in the future. The mission of select.advantech.com/dms of 2% or higher, Anomet

144 Medical Device Developments / www.medicaldevice-developments.com Product showcase

radiopaque clad wires have a 9001 and AS9100), Apple Rubber ■ autoclaves smooth, consistent finish. They can assure precise quality control ■ DNA analysis are supplied on spools and for every product. ■ respirators manufactured to precise ■ incubators. OEM specifications. Further information Apple Rubber Anomet is well known as a In conjunction with Backer www.applerubber.com leader in innovative composite Calesco’s foil heating elements, metal products. Founded in Apple Rubber takes the proper it is usually necessary to measures to ensure high-quality 1976, it specialises in the products and processes that meet From concept arrange some form of control manufacture of custom-clad and exceed expectations. to solution to ensure that the desired metal composites featuring must be tested – from raw temperature is maintained. A a true metallurgical bond. materials to finished products. foil element has a tiny mass and The company is dedicated Apple Rubber has a refined is quickly heated, so accurate to developing new products testing process that includes temperature control is needed. using advanced metallurgical vision-measuring machine This can be achieved in many technology, resulting in long- dimensioning, durometer, different ways, depending on lasting, reliable, cost-effective tensile, density and FTIR customers’ needs. Backer materials. With material costs testing. These tests are Calesco can confidently design Backer Calesco’s heating products, today representing 90% of the a confirmation for the together with its control devices, offer and fit thermal-management overall cost of products, Anomet manufacturer and customers complete solutions. systems (such as rigid/flex specialises in helping to reduce that the parts leaving the Backer Calesco develops new PCB controllers), a negative costs, while improving material facility are exceptional and products and solutions in close temperature coefficient, properties and quality. meet set specifications. cooperation with its customers, thermostats, temperature Producing clad wire, rod, Apple Rubber operates state- transforming client requests fuses and sensors directly to bars, ribbon and plates, Anomet of-the-art custom moulding into working solutions. The elements, in accordance with Products offers a wide range of in-house, allowing them to process is successfully achieved customer specifications. This metal alloy compositions that produce the highest-quality through a combination of the helps to ensure reliable control. are available with virtually any moulds at the lowest cost and company’s broad experience, ratio or thickness. The major with the shortest lead times. advanced design tools and Further information Backer Calesco industries the company serves To ensure quality control, it efficient production capabilities. www.backercalesco.com include aerospace, automotive, uses sophisticated CAD and Backer Calesco supports appliance, corrosion protection, CAM software to efficiently many segments of the life defence, electrochemical, design and manage the sciences and medical industries, Innovation partner electronic, industrial, medical, fabrication and machining of offering a variety of heating for med-tech and oil and gas. custom rubber moulds. The options. By understanding that applications quality of the moulds is verified new tools and equipment are Further information with contact, optical and laser integral parts of advancing the Anomet Products measuring equipment. A high- industry to make new scientific www.anometproducts.com quality product starts with a discoveries, and recognising the high-quality mould. importance of technological Precise quality Cleanroom facilities offer advancements, Backer Calesco control heightened quality assurance, is able to develop and design

Quality control is a crucial allowing manufacturers heating solutions that work in Cendres+Métaux manufactures high- aspect of any manufacturing to completely produce and the medical field. Its expertise precision implantable components processes to ensure customers package products that cannot regarding heating products Sophisticated solutions in the are receiving exactly what risk contamination, such as allows it to produce heaters field of medical device implants they’re looking for. Apple medical devices and electronic that can meet individual often require a range of skills Rubber takes proper care in components. Apple Rubber’s heating specifications, and that a single company can providing customers with Class 10,000, ISO 7-certified among Backer Calesco’s hardly master alone. Such precise, high-quality products cleanroom facilities feature customers are globally developments require close through rigorous product and cleanroom processing, recognised companies. Typical cooperation with partners material testing, broad ranges LSR moulding and full- applications include: who offer complementary of experience, superior design lot traceability. ■ surgical tables and beds competencies. Cendres+Métaux, knowledge and state-of-the-art Through advanced technology, ■ sterilisation equipment a Swiss manufacturer of mould making. In order to meet rigorous testing and certified ■ research equipment high-precision implantable quality standards, everything quality control systems (ISO for laboratories components, has specialised in

Medical Device Developments / www.medicaldevice-developments.com 145 Product showcase

offering related skills and such as casting, forming, performance requirements ■ proof of concept services to further the market turning, milling or injection adequately. As a result, designs ■ detailed design success of its customers. moulding, through to surface have become very complex, with ■ prototyping Cendres+Métaux is a treating, cleaning, assembly, different materials required in ■ soft tooling valued engineering partner packaging to supply chain and different areas of the catheter. ■ production tooling for numerous manufacturers end-to-end order management. For example, for a typical ■ product roll-out. of medical devices, ranging balloon catheter the inner from maxillodental implants Futher information diameter needs to be very The proof of concept, Cendres+Métaux to cardiac pacemakers, joint smooth and lubricious so that a prototype and soft tooling www.cmsa.ch respiration vascular prostheses guide wire can slide with minimal phases are typically staged as up to highly sophisticated effort along the tortuous path serial path functions, each with devices such as permanently Innovation required of the anatomy to the treatment a design feedback loop. Using implanted hearing aids, or site. Though fluoropolymers are 3D-printed moulds allows interface connectors for traditionally used as lubricious Currier Plastics to combine haemodialysis patients. catheter liner materials, they these three phases into a Medical technology present bonding and processing single one, which means a developments require the challenges. A proven alternative significant reduction in the interdisciplinary cooperation would be HDPE loaded with product development cycle. of partners with comparably Compounding Solutions’ Mobilize The lead time to print a high levels of competence technology. Mobilize effectively 3D mould is virtually as short in the field. An important reduces the coefficient of friction as 3D printing a part, and prerequisite is an in-depth of the catheter inner layer. in some cases it can be less

experience with the rules Compounding Solutions develops Polyolefins are also suggested than 24 hours from design to and prescriptions governing innovative materials for manufacturers. as they are easier to process and mould print. Some secondary the activities related to the The medical device industry bond with traditional equipment. operations may be required, but development and approval is trending towards minimally The healthcare industry these are minimal and typically of medical technology products. invasive surgical techniques, demands that OEMs and only add a few hours to the In the early stages of such a which requires the development suppliers produce devices phase before the moulds can project, an assessment of the of devices that are smaller engineered to diagnose and be run in an injection or blow- basic feasibility of expectations and materials that are stronger. treat patients using innovative moulding press. and of the processes that Devices for vascular and other design, requiring state-of- Design iterations can quickly might be suited to master such applications continue the-art manufacturing and be realised, improving final the production of the desired to reach deeper into the technology. In order to support part performance and avoiding device often plays a decisive anatomy with more therapeutic the changing needs and costly production tool rework. role. This, in turn, means that technology, and medical requirements of medical device 3D moulds can be tested prior a positive outcome of such a device manufacturers are manufacturers, Compounding to releasing the design for project is more likely the earlier demanding polymeric tubing Solutions has developed hard tooling, and because the in the development process that boasts greater precision, innovative materials such as parts are made with the actual the partners begin to cooperate. tighter tolerances and Mobilize, ReZilok and ReZilient. engineering-grade material, For such endeavours, increased functionality. they can be tested for Cendres+Métaux can contribute In catheter design, the Further information compliance, including Compounding Solutions a host of very experienced designer must not only consider www.compoundingsolutions.net specialist teams along the the functional requirements whole value chain. The number of the application but also be and extent of customer projects cognisant of the manufacturing Accelerating product that the company has been process required to produce development able to foster until market the device. The designer must One of the challenges of maturity and successful identify the key performance providing custom manufacturing commercialisation underscores requirements of the medical services is providing a high- its role as a competent and tubing, such as flexibility, quality product in as short a trustworthy partner for new lubricity, clarity, kink resistance, time span as possible. Speed development undertakings. push strength, torque transfer to market wins. Cendres+Métaux masters characteristics, hoop strength, The phase-gated product the full range of manufacturing radiopacity and bondability. development cycle goes: technologies in its sector, from Generally, a single polymer ■ concept The lead time to print a 3D mould is basic production processing, material will not meet all of the ■ initial design virtually as short as 3D printing a part.

146 Medical Device Developments / www.medicaldevice-developments.com Product showcase

functional assemblies, chemical they are continually searching throughout each process using compatibility and stability, for new tools to improve a system based on ISO 9001 pressure and leak tests, minimally invasive procedures. standards, and advanced life-cycle tests and more. With this demand in mind, CWT statistical process control Currier’s moulding expertise also provides services such as is used to monitor material includes blow moulding and coiling (custom coils, continuous properties and mixing, moulding injection moulding. The company coils and reinforcement coils), operations and final product is ISO 13485:2016-certified and wire forming for medical conformance to specification. FDA registered with a Class device parts or subassemblies, Da/Pro Rubber’s products meet The final proof of the success 8-certified cleanroom at its grinding, fine-wire assemblies, demanding standards. of these efforts is the part itself. New York manufacturing site. laser and plasma welding, and Its facilities are located To ensure quality, all parts are It offers design, blow moulding custom compression springs. in Oklahoma, California and visually inspected to check that and injection moulding all from While wire technology’s Massachusetts in the US, as they conform to design criteria. one team. uses are vast, it is not a rapidly well as Singapore, and it has In addition, leak and deflection evolving industry. Rather, it is ISO 9001-certified facilities testing for diaphragms and Further information the design and application of and a Class 10,000 cleanroom. insulation testing for connector Currier Plastics the wire and tubing in medical Known for high-precision, close- inserts may be specified. www.currierplastics.com products that continue to tolerance moulding services, Whatever the customer’s change. In spite of this, CWT’s Da/Pro Rubber can manufacture moulding needs, Da/Pro has Down to the wire team of designers continue LIM/LSR products to these same the expertise, experience and to push the boundaries of demanding standards. world-class service necessary to conventional wire processing. The compression and find a solution. CWT provides flexibility with transfer moulding consists of its micro-laser welding machines, proprietary processes developed Further information Da/Pro Rubber which are capable of rotary and by Da/Pro Rubber. The presses www.daprorubber.com stationary welding. The latter are designed to adjust for option is typical for custom compound or part-configuration prototypes and small orders, variables. The moulding Solving resuspension but automated rotary welding process is computer controlled with advanced CWT offers micro-coiling services for is used in larger production runs and monitored to maintain technology wire used in medical device parts. to ensure quality, consistency consistent moulding conditions, In a world where wireless and quick turnaround times. assuring the duplication dominates discussions about Another of the company’s of the product throughout technological advancement, the capabilities is its printing the moulding cycles. lowly wire is easily forgotten. prowess. With 360° rotational When it comes to material However, in the medical device printing, it can provide marking development and qualification, industry, it is an essential indicators and product logos Da/Pro staff chemists component in the development on a variety of medical devices are available to develop and manufacturing of and components. CWT boasts organic, inorganic or silicone life-saving equipment. an ISO Class 7 cleanroom compounds to satisfy specific

US-based Custom Wire for assemblies and packaging customer requirements. Dexter has an ISO 13485 certification for Technologies (CWT) is a to ensure products meet the The physical properties of all medical device quality systems. leading medical device original cleanliness requirements rubber compounds that are The challenge of using equipment manufacturer demanded by customers. critical to the function of the magnetic beads in assays for (OEM) with experience in moulded product are monitored the life science and IVD (in vitro diagnostic and interventional Further information in the Da/Pro Rubber laboratory. diagnostics) fields is maintaining Custom Wire Technologies guidewires. As the company’s Da/Pro has a complete a consistent bead concentration, www.customwiretech.com name suggests, it is equipped to in-house engineering and finding a verification customise its wire products for department to assist with process that measures successful a variety of applications, such as Quality rubber the mouldability of components. separation and resuspension. guidewire coils and assemblies, products The company’s CAD/CAM The use of magnetic beads Kirschner wires and profile Da/Pro Rubber manufactures capabilities guarantee to isolate DNA, RNA, proteins ground-custom tubing. custom products including effective precision tooling and other biomolecules Many of CWT’s clients are diaphragms, seals, connectors, at competitive prices. for particle separation is a OEMs providing innovative custom shapes, rubber-to-metal To ensure product common practice among many solutions to their customers, and parts and more. consistency, quality is monitored healthcare professionals.

Medical Device Developments / www.medicaldevice-developments.com 147 Product showcase

Dexter Magnetic Technologies’ can achieve a sufficient The company’s reputation engineers have developed hermeticity for exposures for quality (Fluigent is magnetic bead-resuspension in harsh environments. certified ISO 9001 since 2010), technology to automatically keep Processing techniques for customer satisfaction and the bead solution homogenous in LCP substrates are the same flexibility make it the company a variety of vessel configurations, as for other substrate materials. of choice for microfluidic allowing bead concentrations Resolution of lines, spaces OEM instrumentation. to be quantitatively verified. and vias are comparable and A magnetic field is created multilayer structures can be Further information Fluigent to increase bead agitation built-up. Part of the metal layers contact@fluigent.com that causes the magnetic beads can be used to form a coil for Fluigent’s reputation for quality is www.fluigent.com/oem to remain in suspension in the near-field communication evident in the PX pressure controller. reagent container. Continuous (NFC). LCP is transparent to pressure to drive liquid flow verification guarantees that the electromagnetic fields, providing provides unmatched flow Award-winning beads are properly suspended. excellent readability for stability and fast response implant syringes The device is ideal for standard RFID tag readers. times to any changes. Such automated liquid-handling The substrates can be systems also enable easy systems, and can be easily assembled with standard handling of disposable modified to accommodate SMT processes. Furthermore, reservoirs of different sizes to a variety of reagent containers embedding of active and adapt any requirement. Since used throughout the life passive components within the its inception in 2006, Fluigent sciences and IVD fields. multilayer system is possible. innovations have advanced The LCP substrates can pressure actuation technology Further information be connected and sealed to become the standard for Dexter Magnetic Technologies without the need for any microfluidic-based devices. www.dextermag.com adhesives, a benefit of their The company is now expanding Gaplast’s innovative syringe application thermoplastic properties. its OEM offering. system has garnered much praise. Ultra-small NFC LCP is a homogenous material Fluigent has recently Implantation syringes are sensor modules and can be easily machined with introduced the new PX used for the application of UV lasers with a precision down pressure controller for medication (for instance, in to the micrometre scale. Cavities integrated fluid handling in cancer therapy) when the and openings for recessed OEM systems. This series of treatment is necessary over components can be integrated. miniaturised systems combines a long period of time. The PBS and sulphuric acid the excellent performance medication is delivered in the soak tests with an embedded, of the patented, field- form of a rod-shaped tablet moisture-sensitive test chip proven Fastab technology placed subcutaneously. This Miniaturised NFC sensor module. have demonstrated long-term for optimal flow control procedure is often very painful DYCONEX has developed a stability (over 14 months) with the robustness required and usually requires a local novel approach that delivers in aggressive environments. in demanding industrial anaesthetic. There is also the miniaturised, hermetic, biostable LCP allows miniaturised environments at an chance that the medication can and highly reliable smart-sensor smart sensor modules used affordable price. either be pushed deeper into modules as small as 6mm in in medical, food processing, The PX module is a CE the tissue than necessary or not diameter and 2.5mm in height. pharmaceutical, chemical and RoHS-compliant single deep enough, resulting in the The tiny modules are based on or industrial applications. controller available in three tablet sticking out of the tissue. liquid-crystal polymer (LCP), a pressure ranges: PX-1 at Thanks to Gaplast’s thermoplastic dielectric material Further information 0–1,000mbar, PX-2 at innovative syringe application DYCONEX with very-low water absorption 0–2,000mbar and PX-V at system, this is no longer the www.mst.com/dyconex (less than 0.04%), high chemical -600–0mbar (vacuum). It has case. The function of the stability and low thermal been designed to maximise implant syringe ensures that expansion. LCP is best suited Precise pressure versatility with its dual- the drug is reliably placed in as both a substrate material control for interface USB and RS232 the puncture channel and not and an encapsulate. LCP’s fluid delivery ports, and is delivered with a pushed deeper into the tissue, permeability for water and gases Fluigent is well known for its full software package (SDK) enabling safe and precise is the lowest among all polymeric high-quality and innovative to ease integration into injection of the medication materials. With proper design fluid delivery systems based Windows or Linux-based into the subcutaneous tissue. considerations, LCP packages on pressure actuation. Using software platforms. This has, of course, greatly

148 Medical Device Developments / www.medicaldevice-developments.com Product showcase

increased the comfort for the the mid-position, and then 10993-compliant, DEHP-free economies of scale – patient and a local anaesthetic new tubing can be inserted. and are made without natural IMT can offer customised is no longer necessary. Reversing the procedure rubber latex. The luer is also glass components at The reliable and simple closes the clamp over all ISO 594-2 compatible. competitive prices. application is also of particular four tubes and retains IMT has over 50 years’ benefit to the doctor. In them securely in position Further information experience as a supplier of Halkey-Roberts fact, the syringe received during use. custom-made glass components www.halkeyroberts.com the German Packaging This, and many other exciting for a wide range of optical ‘Functionality and new products designed for and sensor applications convenience’ award due to use by the medical equipment Cost-effective including delineated optics, its “innovative combination manufacturing industry, glass components reticles, gratings, mirrors of medical packaging and can be seen on the new and filters. The company’s syringe applicator”. Geeplus website. core expertise is the coating and structuring of thin films Further information Further information using microlithography. Gaplast GeePlus Its production environment www.gaplast.de www.geeplus.com IMT produces customised high- – which includes 1,300m² precision, low-cost glass components. of cleanrooms and a fully New changeover Adaptable and Glass remains the material of automated process line for valve with reliable luer valves choice for many biophotonic 200mm glass wafers – is four channels and microfluidic applications. well suited to the mass It is inert to most chemicals, production of lab-on-a-chip has unsurpassed well-defined glass components, flow cells optical properties, and has containing microchannels, good temperature and pressure and metallic and dielectric The MLVs are currently available in stability. However, glass microstructures, in four configurations. components also have combination with waveguides Halkey-Roberts Robertsite a reputation for being and gratings. Male Luer Valves (MLVs) are prohibitively expensive to ideal for flushing and drainage manufacture, which means that Further information IMT applications, IV solutions using them as a consumable www.imtag.ch All of GeePlus’s products can and home healthcare. They or semi-consumable in high- be found on its new website. incorporate proven valve quantity applications is not The new PT24-2CO pinch technology, are high flow, and cost-effective. In several cases, Non-invasive valves from Geeplus have a eliminate dripping and leakage it appears to be the cost of the free-entry fluid new changeover design with when disconnected, with no consumable glass components flow monitoring two NO and two NC channels. clamping required. that prevents a new analytic Available in a wide range of The MLVs are currently method or technology from operating voltages, the PV24 available in four configurations: entering the mainstream. can be supplied with different female luer lock, a 0.125in barb, Realising the market springs in order to develop the a 4mm tube port and a 6.6mm potential of high-precision required force to close the NC tube port. They are designed but low-cost glass components, channels when the device is to attach directly to tubing. IMT of Switzerland is applying Introtek’s IntroFlow flow-detection de-energised. Ideally suited The MLV with female luer the foundry concept to the devices incorporate the latest to use with tubing that has a lock can be attached directly production of glass components ultrasonic technology. diameter of up to 3mm and to a syringe or male luer for life sciences, such as Introtek’s IntroFlow non- wall thicknesses ranging connector. All four valves can microchannels, through-holes, invasive flow detection 0.5–1mm, the pinch valve be used to access a mating electrodes and waveguides. devices incorporate the latest has a tubing clamp that female luer connector or luer- By combining the ultrasonic technology for flow secures the tubing in place activated valve. development and production measurement. The non-invasive during operation. The MLVs are made of of glass components for many concept provides a platform To replace the tubes, a clear polycarbonate body, companies at one site and for non-contact measurement the specially designed clamp a clear silicone valve stem, applying manufacturing where safety, hygiene and can be lifted, rotated through and a clear polypropylene technologies from the cleaning are of concern. This 90° to clear the tubing channels luer and retainer. All materials semiconductor industry – free-entry sensor is designed and raise the pinch bar to are gamma-resistant, ISO and thereby reaching attractive for easy tube installation and

Medical Device Developments / www.medicaldevice-developments.com 149 Product showcase

can be accommodated for in Sablé, Dagneux and cutting-edge inspection and be shipped quickly to aid in various tube sizes. Pouzauges. The company also calibration systems, it can product evaluations. Fully integrated electronics owns a fourth gamma plant in ensure that customers’ most Further information yield the smallest footprint, Tallinn, Estonia. IONISOS has exacting requirements are met. John Evans’ Sons with a simple interface three ebeam plants in Europe: The engineering group www.springcompany.com to medical and industrial one in Chaumesnil, France; consists of skilled applications. another in Taracon, Spain; professionals with broad The standard configuration and a third cross-linking plant experience in the design and Interconnection outputs a voltage frequency in Bautzen, Germany. It has development of all types of expert that is proportional to liquid- two EO plants in France, springs. The group is backed by flow velocity. Absent tube and at Gien and Civrieux. an unusually high level of air detection are fault outputs Additionally, IONISOS expertise – due to having more for added value. Features of is a service provider for than 160 years in business – the devices include: sterilisation, decontamination and the latest in spring ■ non-invasive ultrasonic of medical devices, implants, manufacturing equipment. ■ integrated electronics packaging for drugs, raw The company provides three Keystone manufactures products suitable ■ dry coupled materials, drugs, API, different types of spring: for a huge range of applications. ■ compact, free-entry design cosmetics and cross-linking ■ Constant-force springs For more than 71 years, ■ low cost polymer applications. provide a smooth range of Keystone Electronics has ■ fast output-response time motion and a constant load been manufacturing quality ■ low power consumption Further information in the extending or retracting interconnect components and IONISOS ■ high EMI and RFI direction. This spring design hardware for original equipment www.ionisos.com noise immunity. has no inertia to overcome designers and engineers when considering the initial- worldwide. Be it portable The options for the devices Motion control and position starting forces. ultrasound devices, defibrillators, include a wide range of tubing counterbalancing Constant-force springs are implantable pacemakers or sizes (custom prototypes), through precision compact and mount easily mobile electrosurgical instruments, custom configurations and spring products to existing hardware. Keystone’s precision capabilities options available upon request. ■ Spiral torsion springs allow reach the highest standards. The applications for the devices rotation in two directions While its full line of include medical technology, the and a ‘return to centre’ catalogue-M65 products meet biopharmaceutical industry, capability. Spiral torsion most standard requirements, liquid dispensing, and fluid- springs are normally used in modifications and custom handling and process technology. applications requiring less fabrications are manufactured than 360° rotation. They are to meet special needs. Further information John Evans’ Sons serves many of the generally used to obtain a Keystone’s engineering team Introtek world’s largest medical companies. large amount of torque with uses manufacturing equipment, www.introtek.com John Evans’ Sons is ‘America’s a small amount of rotation. including progressive dies, oldest springmaker’. Founded ■ Helical spring or wire four-slide stamping, wire- French leader in in 1850, the company forms and custom spring forming, in-die tapping and sterilisation services manufactures precision springs, assemblies can be designed high-speed blanking, along wire forms, mechanical to meet challenging with automated machining, assemblies and stampings. space and mounting to produce tight tolerance It is a leading manufacturer configurations. The standards and custom products: for the medical-equipment company is experienced ■ Battery clips, contacts industry and has provided with many stainless and alloy and holders: cylindrical, spring assemblies for many materials used in critical coin-cell, 9V, lithium-battery, of the world’s largest medical applications. steel, aluminium and plastic

IONISOS has the facilities for ionising medical corporations. holders; battery contacts radiations and EO. Evans’ quality assurance John Evans’ Sons is and component clips; and IONISOS is a leading service procedures have been surveyed eager to discuss the design battery straps. provider for treatment using and approved by more than requirements and spring ■ Fuse clips and holders: ionising radiations and ethylene 300 of the world’s largest challenges in clients’ various auto fuses; subminiature; oxide (EO). It has nine plants corporations. By employing design and prototype phases. midget fuses; cylindrical in Europe. There are three ISO 13485:2003 and ISO Many choices of springs and glass 2ag, 3ag and 5ag; and gamma plants in France, based 9001:2008, in conjunction with reels are stock items that can 5mm-style fuses.

150 Medical Device Developments / www.medicaldevice-developments.com Product showcase

■ Terminals and test points: as an isolated development categories. This critical feature PC quick-fit; male and female; project. You need to consider secures parameters from solderless; PC test points and interrelations with experts alteration and accidental loss. screw terminals; and SMT/THM from a medical background, All parameter changes are test points. regulatory experts, and recorded and saved in a log. ■ Spacers and standoffs: nylon, various other stakeholders This feature makes it possible brass, aluminium and ceramic who provide support during to track who accessed

materials; and clear hole, Developing medical device software development and once the information, and where and swage or force-fit, hinged calls for a specialised approach. software system is used live. when data for process and threaded styles in imperial manufacturers frequently hire ■ Do not underestimate the modifications were initiated. and metric threads. software development companies maintenance effort once the A newly developed web- ■ Panel hardware: handles; to create this component. medical device software is based human-machine interface mounting screws; fan and However, software development live. Changing medical device (HMI) makes integrating the finger guards; LED spacer companies are not always software requires a sound Basic S quick and intuitive. mount and lens caps; knobs familiar with the regulatory impact analysis and should be Digital, as well as analogue and instrumentation cases. requirements for medical device understood as a project itself. signals, are clearly displayed ■ Pins, plugs, jacks and software, especially when it graphically and in real time. sockets: USB and firewire comes to the maintenance Further information This new functionality makes it Knoell plugs and sockets; banana, requirements in the post- possible to detect which signals www.knoell.com/en/business- audio and phono plugs; binding market phase. units/medical-devices are on and off in the Basic S posts; test and micro jacks; A sole software developer system at all times. Process micro and push-in pins; and is often not prepared to support parameters can be set using modular Rj45 jacks. a medical device manufacturer Medical-standard the web HMI or directly with ■ PC board and multipurpose throughout the whole life welding the LCD display on the front hardware: computer, cycle of the medical device of the system. threaded and mounting containing its software. To The Basic S can be operated brackets; PCB accessories; avoid the failure of such with the innovative, modular clamps; ties; grommets; projects and frustration on both Leister laser optics. In contrast bushings; bumpers; washers; sides, software development to the BT line, premium AT eyelets; rivets; tool kits companies need to become optics offer fibre connection and turret terminals. software development partners. monitoring, laser power ■ Terminal board They need to understand measurement and pyrometer The Leister Basic S is essential for and strips: scored and the needs of medical device effectively welding plastic components. functionality. In April, the new turret terminal boards; companies and be prepared The new Basic S from Leister Leister Basic S was presented and terminal strips. for long-lasting relationships. is the perfect integrable plastic for the first time at MedTec The following key rules should laser-welding system for the Europe 2018 in Germany. Keystone is ISO be considered by software medical industry. Incorporating 9001:2015-certified by DNV development companies when a unique, state-of-the-art Further information Leister Certifications under the RAB developing software that is a for cooling system that was www.leister.com and RvA accreditations, and a medical device or is intended developed in-house, the Basic compliant with RoHS and to be part of a medical device: S is set to redefine the market. REACH directives. It is ■ Employ considerate software The permanent cooling of Custom solenoid headquartered in the US developers who wish to the laser ensures the precise valves improve with offices in Canada, think about a robust software and repeatable welding of medical device Europe, Australia and Asia. architecture before they plastic components. performance start programming, and who To ensure products can and design Further information document their decisions be welded in accordance with With over 20 years’ experience Keystone Electronics and source code. stringent medical industry in manufacturing medical www.keyelco.com ■ Think about regulatory requirements, the Basic S is application solenoids, LISK requirements and risks coupled with powerful software has grown its expertise Helping companies related to the software that can record and output and knowledge of customer to evolve system from the beginning. all welding-process data and requirements, and created strong Innovative solutions in They are important inputs parameters in a single file. partnerships with its clients. the medical device industry to your software design Newly developed management The company’s solenoids help often contain software. For and architecture. profiles divide users into its medical device manufacturing this purpose, medical device ■ Do not view the project operator, expert and service partners to use energy more

Medical Device Developments / www.medicaldevice-developments.com 151 Product showcase

3,000 510(k) applications table, Bowden cable for ■ crisis intervention – 483 endoscopes and draw-wire and W/L responses and encoder for MRT machines. third-party inspections The performance of Ming ■ electronic drug listing Tai’s steel strip springs and and registration with FDA the company’s manufacturing ■ device listing and registration service have gained much LISK solenoid valves are manufactured ■ for use in dialysis and anaesthesia US agent services for praise and appreciation Mo-Sci produces technical glass equipment, ventilators and respirators. foreign companies from customers. materials for medical devices. efficiently, and build more ■ assistance with e-MDR Ming Tai is capable of found in numerous medical compact and portable equipment. ■ assist with the UDI for providing customers with devices on the market today. LISK’s expert solutions are used medical devices technical support during the The company has melting in dialysis equipment, and for ■ FDA labelling guide reviews development procedure and capabilities for temperatures the critical control of fluid and for food products, and dietary prototype, through to trial up to 1,600°C and quantities ventilation applications. In-house and nutritional supplements runs, mass production, spring from a few kilograms up to design customisation enables mounting and assembly. Each several thousand kilograms Further information the company to optimise its manufacturing procedure, annually. Its unique in-house mdi Consultants compact, low-energy proportional [email protected] including steel strip slitting, capabilities allow it to melt control solutions. www.mdiconsultants.com heat treatment, edge trimming larger quantities in a variety of Key features of the solenoid and forming process, is a crucible types. Customers look valves include: consistent production and to Mo-Sci when they need high- ■ proportional flow control Developing high- completed in-house to ensure purity implant or medical-grade ■ long-life-cycle-tested product quality springs the highest quality is achieved. glass materials, or custom glass ■ custom preset and Ming Tai also has precision compositions specific to their adjustments enabled instruments to do force, torque application needs. Other ■ low noise operation and product-life testing to service capabilities offered ■ interface can be changed ensure quality. Ming Tai is include glass analytics, to customer application. certificated with ISO 9001:2008 coatings, spheroidisation and and RoHs. There are a number glass development. Further information of different spring design Mo-Sci also serves the LISK www.gwlisk.ie possibilities for a given aerospace, energy, automotive application, and Ming Tai and defence industries among suggests consultation with others. MO-SCI is ISO 9001 and Ming Tai Industrial is an expert in More than just FDA producing medical device springs. one of its engineers early in AS9100-certified. regulatory assistance Ming Tai Industrial is a the design phase. mdi Consultants has been in the professional manufacturer of Ming Tai is pleased to create Further information Mo-Sci regulatory business for over 40 steel strip springs for medical an optimised solution for any www.mo-sci.com years and has the expertise to device applications, including spring demand. Custom designs provide exceptional professional constant force springs, are available as well. aid in: constant torque springs, Protect patients ■ US FDA compliance, constant force springs for Further information and brands Ming Tai Industrial regulatory strategy carbon brush, power springs Recent controversy surrounding www.powerspring.com.tw development and clinical and prestressed power springs, the safety of medical devices trial development/ variable force springs and has made it clear that the management, as well as spring-strip tubes. Medical-grade industry needs to put quality QSR/CGMP compliance As of today, Ming Tai has custom glass and safety first. ■ assist with MDSAP helped lots of medical device manufacturing Medical device recalls implementation and manufacturers to successfully Mo-Sci specialises in cost the industry $2.5–5 certification preparation develop new products. All manufacturing technical billion a year, and companies ■ on-site audits – mock FDA innovative products include glass materials such as glass associated with a recall can audits by lead auditors that a pen-type drug injector, powders, microspheres, and expect an average 10% drop are ex-FDA investigators highly adjustable monitor-and- ingots specifically designed and in share price. ■ PMA/ANDA/NDA/510(k) keyboard-integrated medical manufactured for the medical Lost revenue and increased application submission workstation, highly adjustable industry. Mo-Sci materials, like spending on public relations services – mdi has a 100% patient bed trapeze, highly bioactive glass and precision and crisis communications are success rate after more than adjustable patient bedside glass microspheres, can be inevitable additions to the cost

152 Medical Device Developments / www.medicaldevice-developments.com Product showcase

tracing capabilities – everything fully automated Plastics One’s manufacturing medical device manufacturers manufacturing processes. experience is reflected in need to secure their supply excellent quality over complete chain and put patients’ minds Phase 3 Plastics’ product lines, including: at ease. product range includes: ■ patient-monitoring cables ■ blister packs or ■ medical cables and electrodes Further information double blister packs for EEG, ECG, EKG and OPTEL Group ■ insert trays and EMG studies www.optelgroup.com/medical- OPTEL offers turnkey vision handling systems ■ medical cables for sleep studies inspection solutions that protect devices patients and brands. ■ testing trays and ■ custom medical cables and of doing business without a protective profiles. touch-proof connectors for solid brand-protection strategy. Innovative synergies various medical devices Companies with products that and packaging The materials the company ■ cables for EMS, rescue, police represent potential health and solutions uses include amorphous and media communications safety risks, such as medical polyethylene terephthalate, ■ cables and connectors for implants, often face especially polyethylene terephthalate, custom applications. high costs, both financial high-impact polystyrene, and reputational. polycarbonate and acrylonitrile Plastics One’s facility The bottom line is patients butadiene styrene. encompasses 100,000ft² and need to know and trust in the Extensive market experience boasts an in-house design quality, integrity and, above ensures that the designs of department that uses 3D all, safety of medical implants Phase 3 Plastics’ products software and a fully equipped and other sensitive medical provide the right combination mould-making shop, with the devices – and brands need Phase 3 produces high-quality and of performance and economy latest in plastic injection- to protect themselves. secure medical device packaging. of scale for successful solutions. moulding technology. Plastics How can medical device Phase 3 Plastics designs and The company is always on One also employs a dedicated companies make sure their manufactures thermoformed hand to assess the packaging research and development team products are safe, were plastic packaging solutions for requirements of its customers. that is constantly searching carefully handled and stored, medical, healthcare, electronic for cutting-edge methods and are not counterfeited and and defence industry clients. products. This allows the Further information do not contain any noxious The company adopts a Phase 3 Plastics company to produce quality substance? The answer lies in synergistic approach with www.phase3plastics.co.uk products from concept to vision inspection and supply clients to achieve high- creation and design, and to build chain traceability. standard packaging solutions Custom cables for its own customised machines, as OPTEL, a global leader in throughout the thermoformed your specific needs well as retrofit existing machines both fields, provides efficient, plastics market. to meet specialised needs. cost-effective solutions to Its philosophy is to provide Plastics One realised a need precisely inspect medical clients with solutions that for cleanroom manufacturing in devices on the production will help them to improve the medical device industry and and packaging lines. performance, integrity, added a Class 10,000 cleanroom,

Leveraging three security and economy. This Plastics One is at the cutting edge of in addition to the eight already decades of proven expertise, is done through research and medical moulding. in the facility. OPTEL develops world-class innovation, with a strong focus Plastics One has been partnering The new 760ft² cleanroom vision inspection solutions on design. Phase 3 Plastics’ directly with original equipment is fully maintained and certified that ensure the quality products also meet the manufacturers worldwide since as required by ISO 7, and will be and integrity of the product BS EN ISO 2001:2015 1949, working together to provide used for moulding, assembly and and its packaging, improve standards, which ensure solutions for industry needs. packaging parts for the medical the performance of lines the following: The company specialises in the device industry. and stations, and also ■ packaging designed for design, moulding, and assembly Further information minimise risk. performance, security of components and electronics Plastics One The company’s turnkey, and economy for the medical device industry. www.plastics1.com scalable solutions provide ■ device transit protection Each product is designed with inspection of seals, packaging, and security features tight tolerances to fit even the printing and labels, component ■ J-Class 10,000 smallest device, including Precision saves lives presence in trays and kits, cleanroom manufacturing parts that are assembled under Protomatic is a prototype and serialisation, and tracking and facilities with a microscope. production computer numerical

Medical Device Developments / www.medicaldevice-developments.com 153 Product showcase

and orthopaedic. If a client designs multiparticulate drug. The it through cleaning, disinfection it, Protomatic can make it with oral syringe is connected to or handling. A well-thought-out any material, including aluminium, the container so that the drug system solution is a key factor titanium, medical-grade plastic and can be precisely dosed, drawn for reliability and completes stainless steel. and administered. A plastic the individual application. part in the syringe allows The special cable Further information the dosage to be set safely manufacturer SAB is expanding Design it, and Protomatic can Protomatic Medical make it from any material. and transparently. This its range of medical cables with www.protomaticmedical.com control (CNC) contract easy handling means the a new plug-and-play solution manufacturer specialising in multiparticulate drugs can be with over-moulding, made orthopaedic, cardiovascular An innovative oral administered as precisely and of medical-grade silicone or and medical devices. It ‘always delivery system safely as liquid drugs. With the thermoplastic elastomers as a strives to enhance product oral syringe, users can rely on consistent implementation of quality, while also improving a trusted and proven system market requirements. In order the quality of human lives’. that is standard with liquid to achieve a secure and smooth Gearing the company’s drugs. Moreover, it is spill- material connection between manufacturing capabilities proof, clog-resistant and has the electrical line and the plug, to the medical industry enables a chew-resitant outer shell. all the necessary components it to reduce development time, The system can equally are fine-tuned to each other. The Sympfiny system makes for bringing about faster easier treatment of children. be used for dry powder or The results flow directly commercial launches. It has It is often difficult to orally microsphere drug formulations. into production. This benefits proved itself as a provider of administer the correct The reusable syringe comes the manufacturers of medical quality orthopaedic devices, amount of medicine to children in two sizes and has selectable components as they can rely forming long-lasting accurately and safely. Young dose settings. The 1ml and 2ml on the proven support of the partnerships with customers patients refuse the medicines variations have been tested for biocompatible base material that require high-quality, because many of them dose accuracy and satisfy the prototype and 0 series through precision medical products. are bitter tasting. To solve requirements of ISO 7886-1 manufacturing lengths starting Protomatic manufactures this problem, a new way 2017. The system fits common at 100m. orthopaedic tools, of administering drugs has bottle sizes and can be prefilled “This can only be achieved cardiovascular pump been developed, known as or filled at a pharmacy. through constant dialogue components and precision multiparticulate drugs: tiny with customers,” explains Further information medical device components spheres, measuring 0.1–0.6mm, Marc Gerlatzek, SAB’s medical Röchling Medical for diagnostic instruments, with a protective coating. The www.roechling.com/medical/ product mananger. “We count and is an ISO 9001:2015 and coating neutralises the taste pharmaceutics/sympfiny on our material diversity, ISO 13485:2016-registered of the active ingredient without experience and constant company. Its talented, impairing its effectiveness. Over-moulded investment in the machine dedicated staff take pride Together, HS Design cable solutions for park at our site in Viersen.” in the superior quality of its from Gladstone, US, and medical technology Possibilities for over-moulded wares. Among the products the medical division of plugs and nozzles are available created at Protomatic are: the Röchling Group have for almost the complete cabling ■ cardiovascular medical developed the new drug solution of the SABmed Line equipment components delivery system Sympfiny material family. Medical cables ■ trocar devices (registered trademark), with the flexible and smooth ■ tunellers and cannulas specifically designed for this SAB Bröckskes offers a comprehensive SABmed T can be engineered ■ peristaltic pump components new way of administering range of quality cable solutions. and customer customised to ■ left ventricular assist drugs. It allows simple and Cable system manufacturer and produce thermoplastic and device components reliable administration, and cable specialist SAB Bröckskes elastomeric materials with ■ surgical tools the exact dosage of the drug. offers high-quality cable solutions better haptics than ■ sampling components This innovation makes the with high material diversity as a conventional thermoplastics ■ optical stages, lenses safe treatment of children plug-and-play solution for system If a medical cable with UL and filter holders. considerably easier. equipment, even for prototypes approval is needed then the Sympfiny consists of a and small series. material SABmed S UL is used. Protomatic also offers container for the drug, and Connection cables for The base material can be CNC precision machining an accurately fitting oral medical devices and treatments offered as a platinum cross- for all medical industries, including syringe for drawing and are often subject to demanding linked variant, with an ultra- biomedical, dental, cardiovascular administering the requirements in daily use, be flexible sheath or with a non-

154 Medical Device Developments / www.medicaldevice-developments.com Product showcase

adhesive surface. New devices. Eclipta’s easy assembly disposable and reusable sides, developments, such as and high-density design scalability, customisation and autoclavable USB 3.0 cables, makes it the ideal connector the possibility to be reworked are already being designed by system for disposable on the reusable side. SAB Bröckskes with an outlook medical applications. to possible over-moulding. For electrophysiology Further information Smiths Interconnect Manufacturers of medical catheter applications, Eclipta www.smithsinterconnect.com devices will be able to use connectors bridge the gap this complete system solution between the catheter and the as a tailor-made plug-and-play extension cable. Quality guide wires The cross-roller ring RF. product from a single source, A standout feature of Eclipta rings, with a particular suitability allowing greater design is the fact that the printed as rotary bearing for robots. freedom in the development circuit board (PCB) acts as The cross-roller ring RF reduces of devices. the contact in the connector. the total weight of a construction, SAB Bröckskes is a world- Since the board is part of a due to its unique design with leading manufacturer of cables disposable device, it eliminates SP Medical offers a wide range of guide a flange. It also allows direct and wires, cable harnessing the cost of using a contact wires for use in angiography, cardiology, mounting to the shaft and urology and gastroenterology. and temperature measuring system. In addition, its plug- housing, making a housing flange techniques. More than 60 and-play design provides SP Medical is a Danish unnecessary, which reduces the years of experience in cable effortless termination and company with more than 30 number of assembly steps and manufacturing, as well as virtually eliminates the years of experience in the parts required. in temperature measuring potential contact damage development, manufacture THK’s cross-roller rings are techniques, has turned a one- associated with the termination and sale of guide wires for particularly powerful cylindrical man business into a company process. An added benefit the medical industry. Over roller bearings for momentary with almost 500 staff members. of incorporating the the past 30 years, SP Medical loads and loads from all directions, The strength of SAB board inside the connector has built up its knowledge of including those from the axial and Bröckskes is not only the is the ability to add active- polytetrafluoroethylene-coated radial directions. This is achieved manufacturing of standard surface mount components, products and medical devices by the crosswise arrangement of cables, but also the such as electrically erasable for leading suppliers, such the cylindrical rollers, which roll in construction of special items. programmable read-only as those that supply sterile- right-angle ground raceways. Every year, SAB manufactures memory (EEPROM), to packed guide wires, or offer THK offers the cross-roller ring more than 1,500 special cables either side of the board. guide wires on an original RF with or without an inner flange. on the requests of customers. Eclipta’s storage/processing equipment manufacturer basis. With an inner flange, the bearings temperature range is -40°C to It is SP Medical’s goal to are offered with inner diameters Further information SAB Bröckskes 135°C, which allows use with offer its customers a complete of 20–95mm, and without www.sab-cable.com standard sterilisation protocols, range of high-quality guide wires an inner flange that has inner including autoclave, ethylene and special features, if required. diameters of 40–120mm. A reliable, cost- oxide (EtO) and STERRAD. The company focuses on Further information effective and Its high-mating lifetime of up core competency within the THK disposable to 2,500 cycles increases the discipline of its guide-wire www.thk.com connector system mean time between failures manufacturing process, so (MTBF), and the fingerproof as to be able to offer optimal All the information contacts on the reusable side professional consultancy in one place contribute to the safety of and development to all of The Organisation for patients and medical personnel. its customers at all stages Professionals in Regulatory Eclipta is suitable for disposable Eclipta has been developed of their projects. Affairs (TOPRA) is the one- medical applications. to deliver benefits to healthcare stop shop for EU training Smiths Interconnect’s Eclipta providers, while addressing Further information resources on medical devices, SP Medical ECL series features high- their real-world manufacturing in vitro diagnostics and www.sp-medical.com performance, edge-card process needs, as its combination products. technology designed to component design facilitates The company provides: enable quick and reliable easy assembly and increased Cross-roller ring ■ essential overviews of connections, while delivering labour efficiency. Additional for robots medical device regulatory the serviceability and benefits include the mass With the new cross-roller ring RF, affairs for new recruits, affordability required by a termination of catheter wires THK is expanding its already large, and intensive introductory broad range of critical medical directly to the PCB in the unrivalled range of cross-roller courses for those committed

Medical Device Developments / www.medicaldevice-developments.com 155 Product showcase

to building a career in medicines, devices and veterinary verify and manufacture Class I, this speciality regulatory affairs’. II and III medical devices. ■ topic-focused continuing Organised with the Health It offers a wide variety of regulatory education Products Regulatory Authority services, ranging from short-run and development courses, (HPRA) Ireland, the programme prototypes and preproduction and masterclasses for will cover topics such as units to long-range production. senior professional as the impact of technology, Value-added services include well as a highly respected implementing new medical devices experienced engineering staff Regulators will look for extraction master’s qualification and in vitro diagnostic regulations. to develop electromechanical conditions that demonstrate a device in medical device Delegates will have the chance to: and electro-optical equipment, has been challenged. regulatory affairs ■ benefit from an extensive from concept to full production; Full characterisation of all ■ small-scale roundtables EU-focused programme hardware and software design; chemicals is required for an to summits and international ■ meet regulators from around packaging; qualification testing; accurate assessment of risk, symposia where regulatory the world and printed circuit board and it is WuXi AppTec’s goal leaders and influencers ■ network with innovators and layout, from through-hole to identify all of the potential network with regulators opinion leaders in healthcare to surface-mount. chemicals that could come out and policymakers. regulatory affairs Whether a client is looking for of your product. Using multiple ■ share experiences with peers a complete turnkey solution or analytical methods, WuXi TOPRA is the gateway to and discuss potential solutions is just supplementing its internal AppTec’s team of chemistry building an extensive European- to regulatory issues capabilities, TRICOR has the experts work tirelessly to focused network of medical device ■ navigate the practical background and flexibility understand your materials, and IVD professionals from across implications of disruptive to meet every requirement. processes and products to the world. technologies and a changing TRICOR offers customers detect a full range of organic, Join TOPRA and the vibrant regulatory landscape. the opportunity to confidently semi-volatile and volatile community of over 1,000 medical outsource project needs. chemicals, providing you with Further information device professionals in the Medical the data you need to make TOPRA Further information Technologies Special Interest www.topra.org informed decisions and meet TRICOR Systems Network; take part in the current regulatory requirements. www.tricor-systems.com members-only online community Some benefits of using WuXi discussions; access free SPIN High-quality AppTec include: webinars on a wide range electronic Analytical chemistry ■ 80–85% of the time, the of topics, including vigilance manufacturing – unknowns are company is able to meet changes, incident reporting and and design unacceptable biocompatibility systemic clinical evidence requirements. In accordance with ISO 10993- endpoints with chemical Read the latest legal news and 1, ‘Biological evaluation of characterisation and developments in the monthly medical devices – evaluation risk assessments. ‘MedDev update’ newsletter, and and testing within a risk ■ Unknowns can delay testing in-depth review articles in the management process’, material up to 27 weeks and can cost peer-reviewed Regulatory characterisations should be more than $75,000. Rapporteur journal. considered for every device. ■ WuXi AppTec has The theme of this year’s Extractable and leachable completed more than 4,500

TOPRA Annual Symposium, TRICOR Systems provides award- studies are conducted to get material characterisations. 30 September to 2 October, winning contract manufacturing. a full characterisation of all is ‘Europe at the forefront of TRICOR Systems, a US full- chemicals, which is then WuXi AppTec Laboratory global healthcare regulation – service contract manufacturer, used to create an accurate Testing Division’s medical device Driving innovation through is a US FDA-registered, ISO assessment of risk. platform is the leader in complete convergent approaches in 9001:2015, AS9100D and The expectation is that all identification – to WuXi AppTec, ISO 13485:2016-certified chemicals are identified, so unknowns are unacceptable. electronic design and medical avoiding unknowns in chemistry Let its team design a chemistry manufacturing facility. reports is paramount. If unknown programme tailored to meet your Founded in 1976, TRICOR chemicals are listed in a report, analytical needs. has successfully provided high- be prepared for regulators quality products and services to require you to complete Further information to the medical marketplace. the identification – complete WuXi AppTec Laboratory Testing TRICOR possesses the material characterisation TOPRA is the one-stop shop for a Division Medical Devices Platform range of EU training resources. expertise to design, develop, cannot exist with unknowns. medicaldevice.wuxiapptec.com

156 Medical Device Developments / www.medicaldevice-developments.com Suppliers guide

AirBridgeCargo ...... 143 DATA MODUL ...... 80 Laser World of Photonics ...... 60 www.airbridgecargo.com www.data-modul.com www.world-of-photonics.com

Accu-Glass ...... 105 Device Talks Boston ...... 89 Laservorm ...... 56 www.accu-glass.com www.boston.devicetalks.com www.laservorm.com

Accumold ...... IFC Dexter Magnetic Technologies...... 84 Lécureux ...... 46 www.accu-mold.com www.dextermag.com www.lecureux.ch

Advantech ...... 69 DSM ...... 52 Lee Company ...... 128 www.advantech.com/dms www.dsm.com/additive-manufacturing www.theleeco.com

Anomet Products ...... 95 Fluigent Industrial ...... 121 Leister ...... 84 www.anometproducts.com www.fluigent.com/oem www.leister.com

Apium ...... 51 Formacoat ...... 8 LISK...... 126 www.apiumtec.com www.formacoat.com www.gwlisk.ie

AR Medical ...... 87 Fujitsu...... 70 MD&M East ...... 125 www.armedicalseals.com www.fujitsu.com/iot www.mdmeast.com/expo

Argon Medical ...... 116 Gaplast ...... 132 mdi Consultants ...... 23 www.argonmedical.com/oem www.gaplast.de www.mdiconsultants.com

Atlas Vac Machine ...... 135 Geeplus ...... 111 Medical Technology Ireland ...... 158 www.atlasvac.com www.geeplus.com www.medicaltechnologyireland.com

Backer Calesco...... 7 Halkey-Roberts ...... 122 Medical Tubing...... 121 www.backercalesco.com www.halkeyroberts.com www.ami.international

Brentwood Medical ...... 136 IMT ...... 56 MedtecLIVE ...... 26 www.brentwoodindustries.com/medical www.imtag.ch www.medteclive.com/become-visitor

Cendres+Métaux ...... 34 Introtek ...... 122 Micrometal ...... 32 www.cmsa.ch www.introtek.com www.micrometal.de

CODIXX...... 62 IONISOS ...... 34 Mikron ...... 54 www.codixx.de www.ionisos.com www.mikron.com/automation

Compounding Solutions ...... 95 John Evans’ Sons ...... 29 Ming Tai Industrial Co ...... 41 www.compoundingsolutions.net www.springcompany.com www.powerspring.com.tw

Currier Plastics ...... 28 Keystone Electronics ...... 77 Mo-Sci ...... 105 www.currierplastics.com www.keyelco.com www.mo-sci.com

Custom Wire Technologies ...... 6 Knoell Germany ...... 23 MST ...... 78 www.customwiretech.com/mdd www.knoell.com www.mst.com

Da/Pro Rubber ...... 37 Lapp Tannehill ...... 96 New England Tubing Technologies ..91 www.daprorubber.com www.lapptannehill.com/medical www.newenglandtubing.com

Medical Device Developments / www.medicaldevice-developments.com 157 Suppliers guide

NSF International ...... OBC RECOM Power ...... 75 TOPRA ...... 13 www.nsf.learnupon.com/store www.recom-power.com/medical www.topra.org/mdd

OPTEL Group ...... 131 Röchling ...... 87 TRICOR Systems ...... 41 www.optelgroup.com/medical-devices/ www.roechling.com/medical www.tricor-systems.com

Phase 3 Plastics ...... 133 SAB Bröckskes ...... 79 Trilogy Writing & Consulting ...... 24 www.phase3plastics.co.uk www.sab-cable.com www.trilogywriting.com

Plastics One ...... 41 Sandvik ...... 98 TRUMPF ...... 65 www.plastics1.com www.exera.sandvik www.trumpf.com

Porex ...... IBC Secant Group ...... 106 Turkish Cargo ...... 4 www.porex.com www.secant.com www.turkishcargo.com

Protega Global ...... 23 Smiths Interconnect ...... 69 Wickham Laboratories ...... 18 www.protega-global.com www.smithsinterconnect.com www.wickhamlabs.co.uk

Protomatic Medical ...... 45 SP Medical ...... 34 WuXi AppTec ...... 14 www.protomaticmedical.com www.sp-medical.com www.medicaldevice.wuxiapptec.com

Qosina ...... 31 THK ...... 111 Zeus ...... 100 www.qosina.com www.thk.com www.zeusinc.com

158 Medical Device Developments / www.medicaldevice-developments.com TO EVERY MEDICAL DEVICE CHALLENGE, POREX BRINGS AN INNOVATIVE SOLUTION.

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> Design Controls for Medical Devices and IVDs NSF International’s web-based virtual training course provides a basic understanding of Design Controls for medical devices and IVDs. > European Union Medical Device Regulation – EU MDR This on-line course provides comprehensive instruction on the EU MDR. It walks students through every aspect of the regulation and identifying key topics and changes, including the new roles associated with EU MDR; standard requirements that must be met by all manufacturers regardless of class; and the requirements for conformity assessments. The module also provides pre and postmarket requirements of conformity assessment. > FDA Medical Device Reporting (MDR) The U.S. Medical Device Reporting regulation (21 CFR Part 803) contains mandatory requirements for manufactures, importers and device user facilities to report certain device-related adverse events and product problems to the FDA. This course provides critical information to ensure mandatory reporters maintain compliance with the regulation. > FDA Presubmission (Q-Sub) Program – Requesting FDA Feedback The presubmission or Q-Sub program is a voluntary mechanism to get FDA’s feedback on specifi c questions necessary to guide product development and/or application preparation. This course provides instruction critical to prepare for a successful meeting with the FDA. > MDSAP and Regulatory Transitions – The Basics Virtual Training This course provides the basic knowledge to prepare for the Medical Device Single Audit Program (MDSAP). It helps key personnel realize the urgency regarding MDSAP readiness and offers answers to vital questions direct from global Quality Systems expert, Kim Trautman, a former U.S. FDA offi cial and key member of the original MDSAP development team. Learn about the MDSAP audit model, and grading nonconformancies, and regulatory transition timelines, to name just a few highlights of the course. > Medical Device Regulatory Requirements (5 course bundle) Medical devices regulatory requirements for the United States, Japan, Australia, Brazil and Canada. A comprehensive overview of each countries’ medical device regulatory framework, including both premarket and postmarket requirements.

Register today at nsf.learnupon.com/store Use code MDD20OFF to receive 20% off all courses

Contact us at: [email protected] or call +1 202 822 1850 www.nsf.org