Steerable Catheter User Interface
A client developed a new steerable catheter for the cardiovascular market, which required support through to production.
Synecco supported the client from concept through to transfer to production and component supply for catheter handle.
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Prescriptive Approach
Steve Welch talks to Mark Costello about Synecco’s design
processes and work in the medical device sector.
New Design Magazine
Mark Costello is Head of Design at Synecco, responsible for creating better product experiences for their customers and users through industrial design, usability design and product engineering.
Synecco was founded in Ireland in 2004 initially providing managed manufacturing services in China for US and European customers across a range of sectors. In 2007 focus shifted to the medical device industry and in 2009 Synecco opened its design offices at the Galway headquarters. This enabled them to provide turnkey design, development and manufacturing solutions. In 2017 Synecco acquired a manufacturing facility in Ireland allowing for the more localised design to manufacturing solutions.
Steve Welch: What are your company’s key activities within the medical / healthcare sector? Is this your main focus?
Mark Costello: Life Sciences (Medical, Pharmaceutical, Diagnostics) has become the focus of Synecco and represents more than 75% of what we do. Outside of this our Irish manufacturing site still maintains an automotive capability and our industrial design team’s remit can at times extend into consumer and industrial products for legacy customers. In the design and development group, we work on quite a lot of hand-held devices used to carry out medical procedures, we’re also working on wearable and IOMT devices where usability and aesthetics are critical.
SW: How does designing for medical devices differ to your work in other sectors (such as consumer or industrial)?
MC: The key difference is risk management, which leads to increased regulations, testing, trials and documentation for our customers, their suppliers and every process and subprocess within the system. These regulations extend to design and usability. Regulatory bodies require a UEF (Usability Engineering File) to be submitted as part of the regulatory approvals process in compliance with IEC 62366 and the FDA guidance document: “Applying Human Factors and Usability Engineering to Medical Devices”.
This is a much more formal approach to usability than what we see in consumer or most industrial sectors. For the higher risk devices this culminates in a large cohort of users engaging in unprompted simulated use studies. At the core of this is the shift from labelling the issues as a user error to a use error, with the latter placing the responsibility for mitigation of use risk with the manufacturer. This rigor on usability wasn’t always the case in the medical device industry. IEC 62366 was introduced to address the usability deficit in the medical device industry. This wasn’t published until 2007, so the industry has been playing catch up. For example, when I worked at LG Electronics from 1999-2002, we’d run observational usability sessions with a cross section of European consumers on products as basic as microwave ovens. This however was driven not by risk but by the need to differentiate in a fast-moving competitive market. Another key difference is that more so than in other sectors the role of the designer can be easily underestimated in the medical device industry due to the understandable focus on quality, science and technology. We make the case that the function of design is to control the reaction of people, whether it’s how the device looks or how it’s used during pressurised situations. We see the function of engineering as one that controls technology, i.e. the medical procedure, the device function and reliability or the process by which it is manufactured.
SW: What are the commonalities with other design sectors?
MC: Aside from risk, regulatory and quality focus, and associated documentation the key building blocks of a good design process is essentially common across medical, industrial and consumer sectors. Observation-based research to gain user insights, defining user needs, idea generation to solve those needs, iterative prototyping, user testing and functional testing are still critical in the development of successful medical products.
SW: What do you see as the key trends in the medical sector?
MC: From a design point of view, it’s encouraging to see an increase in the awareness of putting human factors at the core of every device, this shift has been helped in part by the standards, but also by increased competition driving differentiation which brings with it an increased awareness of the importance of how devices are perceived. We are also seeing a trend towards personalised healthcare in the home environment, whether these are early diagnosis via sophisticated monitoring or the management of medication compliance. The goal being to keep people healthier for longer and away from overloaded acute hospital care. As populations age in the developed world, this approach will be essential in preventing our health services from being overwhelmed. This personal and home-based healthcare has the effect of blurring the lines between consumer and medical products. As the expectations and sophistication of healthcare consumers increases so too does the user centred demands on the traditional medical device manufacturers. This has also opened a door to new competition from outside of the industry. This is currently most evident in the IOMT (Internet of Medical Things) space e.g. Apple but it’s influencing all types of medical products.