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Media partners: www.eucomed.org 2019 Vol. 1 www.medicaldevice-developments.com £31.00 €49.00 $65.00 Skeleton key How glass opens the door for new implantable devices Light touch Creating new possibilities with flexible photonics Go digital The FDA regulation changing the future of the industry 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 emmag@compelo.com 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 steve.norris@compelo.com 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. ISSN 1747-9610 © 2019 Compelo. All rights reserved. No part of this publication may be Emma Green, editor reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying or otherwise, without prior permission of the publisher and copyright owner. While every effort has been made to ensure the accuracy of the information in this publication, the publisher accepts no responsibility for errors or omissions. The products and services advertised are those of individual authors and are not necessarily endorsed by or connected with the publisher. The opinions expressed in the articles within this publication are those of individual authors and not necessarily those of the publisher. SUBSCRIPTIONS Single issue price: UK £31 EU €49 US $65 RoW $65 One year: UK £48 EU €76 US $99 RoW $100 Two year: UK £77 EU €120 US $158 RoW $159 Tel: +44 845 073 9607 (local rate) Fax: +44 207 458 4032 Customer services: cs@compelo.com Compelo Customer Subscriptions Department, Riverbridge House, Ground Floor, South Tower, Anchor Boulevard. Crossways, Kent DA2 6SL Printed by Stephens & George Print Group Glass is demonstrating potential in healing everything from wounds to broken bones. Medical Device Developments / www.medicaldevice-developments.com 3 THE WORLD'S HEALTH IS IN THE SAFE HANDS OF TURKISH CARGO As the cargo airline that flies to more countries than any other, we carry all your health and wellness needs, from pharmaceuticals to medical supplies without ever interrupting the temperature-controlled cold chain. 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 ¨¡®£¤¤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. 51 3D-printed for long- term implantation Apium 53 Perform at a higher level DSM Detail. The unwavering common thread that runs through everything we do. 55 Always one step ahead Mikron It permeates our culture and is the driving force behind our role as a trusted resource for OEMs of precision, high-quality, medical wire components. Lasers & photonics When your deadline is down to the wire, choose CWT. 57 Everything is illuminated 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. 61 The leading trade show for lasers and photonics LASER World of PHOTONICS ISO 9001 • ISO 13485 • FDA Registered 63 Possible polariser ϮϲϮͳϮϲϴͳϵϯϴϴͻh^dKDt/Zd,͘KDͬD application requirements CODIXX 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

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