Phillips-Medisize HUMAN-CENTRED DESIGN AT THE HEART OF A SUCCESSFUL PRODUCT DEVELOPMENT PROCESS In this article, Bill Welch, Chief Technology Officer, and Jeremy Odegard, Design & Development Center, both of Phillips-Medisize, provide an insight into how the company’s human centred design approach fits into its integrated product development process. During the development phases, pharma to higher-volume commercial production. and medical device companies can encoun- The most minor detail can derail the devel- ter obstacles complying with the US FDA’s opment of a successful product, resulting drug and medical device regulations, as well in lost time and resources and deadlines as other global regulations that determine missed. This could cause product devel- which current good manufacturing practices opment or regulatory submission to stall (cGMPs) and quality system regulations before it ever reaches the market. apply for product manufacturing. There Project complications and delays can is also the need to manage complicated arise as a result of collaboration among dis- supply chain logistics from design, testing parate organisations. For example, a design and development to low-volume clinical firm might not understand what can be trial manufacturing as well as the scale-up achieved in injection moulding processes. Bill Welch Chief Technology Officer T: +1 715 386 4320 E: [email protected] Mr Jeremy Odegard Design & Development Centre (DDC) engineering Phillips-Medisize Corporation 1201 Hanley Rd Hudson WI 54555-5401 United States European Headquarters: Phillips-Medisize Edisonstraat 1 2181 AB Hillegom The Netherlands T: +31 252 576 888 E: [email protected] Figure 1: Phillips-Medisize’s integrated product development cycle. www.phillipsmedisize.com 28 www.ondrugdelivery.com Copyright © 2015 Frederick Furness Publishing Ltd Phillips-Medisize Further, designs may not be optimised for manufacturing or assembly. By applying adequate due diligence in choosing the right partner, pharmaceutical or biotechnology and medical companies can improve the odds of launching a successful new drug product into the marketplace – on time, and on budget. INTEGRATED PRODUCT DEVELOPMENT Phillips-Medisize’s integrated product development process combines human-cen- tred design principles with a solid design for manufacturing (DFM) and design for Figure 2: Design research is typically conducted at the front end of a development assembly (DFA) philosophy. It address- cycle in order to establish a firm foundation for future design work. es design research, industrial design and Industrial Design ences must be considered as early as pos- human factors engineering (HFE) focusing Industrial designers build upon the founda- sible. Proper planning, execution and docu- on product usefulness, usability, desirability tion of design research, translating discover- mentation of HFE activities throughout the and manufacturability (see Figure 1). ies, product performance goals and market- development process should streamline the The key benefits of this are prod- ing objectives into tangible concept direc- submission process for regulatory approval. uct adoption and compliance; predict- tions. Product form, user interface, ergo- A focused Human-Centered Design able processing; overall product quality nomics, aesthetic detail treatment, material approach promotes intuitive, usable, and improvement; cycle time reduction and selection, and manufacturing approaches are desirable devices (Figure 3). stakeholder satisfaction. all considered during this phase which typi- “Almost all of the extremely diverse medi- The human-centered approach is not cally begins with collaborative brainstorm- cal sectors use and benefit from our HCD limited to a single phase nor is it a stand- ing from multiple professional disciplines. approach, among them diabetes, ophthalmol- alone module that can simply be attached Industrial designers then narrow their focus ogy, oncology, gynecology, cardio-vascular to the front-end of a program. It needs to to a manageable set of concepts that may be surgical intervention. In the field of medical be embedded into the cultural fabric of an evaluated through illustrations, preliminary devices, we are involved in the development organisation in order to be effective. CAD models, and physical prototypes. of ‘knock-your-socks-off’ technologies and applications – developed all the time – for HUMAN-CENTRED DESIGN Human Factors Engineering ever more complex Class III devices, those PRINCIPLES The objective of HFE is to minimise use- still requiring pre-market approval. Class III related risks and ultimately to ensure safe and devices are usually those that support or sus- Design Research effective use. HFE activities may include prod- tain human life,” said Phillips-Medisize Chief Design research activities are typically con- uct handling studies, usability testing with rep- Technology Officer Bill Welch. ducted at the front end of a development resentative users, and final verification/valida- cycle in order to establish a firm founda- tion studies to satisfy regulatory expectations. DFM AND DFA tion for future design work (Figure 2). HFE methods are applied throughout the This is required to determine the needs of development cycle to mitigate product related Design for manufacturing (DFM) and end users, uncovering attributes that will safety risks and justify design decisions. design for assembly (DFA) are also foundation- resonate with them on an emotional level. HFE starts early in a design cycle and al elements of a robust product development Common design research methods include should be an integral part of the development process. Much like human-centred design prin- targeted interviews, contextual observation process. Design inputs such as user profiles, ciples, a sound DFM/DFA philosophy should (for example, witnessing a surgical pro- use environment, and other contextual influ- be a cultural mindset, becoming ingrained in cedure in an operating room, or shadow- ing a diabetic patient through their daily USABLE: INTUITIVE: DESIRABLE: testing and insulin injection routine in the • Proven minimised risk • Predictable device • Fitting into the home), participatory workshops, analogous of use error behaviour lifestyle of the product benchmarking, and trend tracking. "• Comfortably • Simple operating intended user These processes allow a cross-functional " achievable user input sequence • Comfortable touchpoints and development team to appreciate circum- forces • Alignment with mental models emotional appeal stances, environmental conditions, and user • Accommodation of user group abilities / • Simple user actions / • High perceived value expectations in an effort to identify design limitations motions opportunities. Discoveries made through • Meaningful form design research inform the development language process, improving the likelihood of success upon market introduction. Figure 3: Summary of criteria for achieving usable, intuitive desirable device design. Copyright © 2015 Frederick Furness Publishing Ltd www.ondrugdelivery.com 29 Phillips-Medisize all phases of development. While HFE evalua- most of the product cost (as well as quality the product development process by a fully tion throughout the process is typically focused and risk) are driven by decisions early in engaged multidisciplinary team including on the user’s experience, DFM and DFA are the design cycle, the product development manufacturing representatives. DFM can- focused on manufacturing quality, cost and team must include expertise in DFM for the not be viewed simply as a checklist to be risk. Certain aspects of DFM, such as design intended manufacturing processes. In the completed or a task in the development guidelines for moulded plastic or metal parts, spirit of innovation and creating improved cycle. Early manufacturing involvement have proven manufacturing process principles patient outcomes at a lower cost, it is recog- not only brings DFM expertise to the prod- behind them and applying just a handful of nised that DFM guidelines must sometimes uct development team, it also promotes established DFM guidelines for moulded parts be challenged. In these cases, the product concurrent early learning and buy-in by the can prevent a majority of design issues. development team must be committed to manufacturing team, reducing lead time The same can be said for DFA, in which risk mitigation by applying computer aided and risk downstream. planning for manual, semi-automated, or engineering (CAE) tools such as mouldflow, automated assembly from the early stages finite element analysis (FEA), and tolerance COST-DRIVEN SOLUTIONS can prevent issues that would otherwise be analysis to an unfinished design, and subse- found during clinical, pilot, or manufactur- quent prototyping to verify the CAE output. Many customers are interested in get- ing launch builds when mitigation of issues In the case of injection moulded plastic ting their ideas transformed into a func- becomes much more costly. Designers, engi- components, the design team understands tional product, relying on the expertise of neers and manufacturing representatives must that part design dictates mould design and the Phillips-Medisize Design Development collaborate early and often to develop designs can envision how steel is wrapped around Center (DDC) to handle all the industry- that meet targeted quality and cost objectives, part geometry to create tooling capable of critical factors in