You don’t know what you don’t know before you know it.
For that reason, I’m a real fan of ongoing education throughout one’s career. I’ve learned most of my craft by doing, but realize that every now and then you need to stop “chopping the wood and spend time sharpening the saw”. Fortunately, LUNAR shares this philosophy and encourages professional development for its employees.
My passion is product design for healthcare. Not surprisingly, my career has focused mostly on medical devices and life science equipment. It’s been a great fusion of my background in biomedical sciences and industrial design. Over the years I have gotten to work on some really fun devices and developed an understanding of the healthcare industry as it relates specifically to product design. But I was aware that there is a lot more to medical devices than design and engineering. I knew that I needed to expand my knowledge base to include everything about medical device commercialization that is not product design. I discovered the Biodesign program at Stanford University in Palo Alto. They have created a post-graduate program which teaches an end-to-end MedTech* innovation process (*medical devices and clinical diagnostics). Stanford’s Biodesign is the most highly regarded medical technology innovation course in the world – not surprisingly, since its creators and contributors are part of the most prolific medical technology hub in the world: Silicon Valley, California.
Education in MedTech is a relatively new phenomenon. Up until about a decade ago, formal processes for innovating medical technologies were closely guarded trade secrets created within multinational companies who appreciated the competitive advantage they enabled. Now there are a handful of universities that offer courses in medical technology innovation. The uniqueness of the Stanford program is that it acknowledges that medical technology innovation is a multidisciplinary challenge that is only successful if you’ve identified the right clinical need, have a sound business case and have the wherewithal to solve that need. And so the Biodesign department is a fusion of Schools of Medicine, Business and Engineering.
You can’t run before you can walk
Innovation is all about risk management. As designers, it’s the reason why we first look for unmet needs, iterate designs on paper and prototype before going into production. In Medtech this same philosophy applies, but compared to consumer product innovation the cost of failure increases dramatically as the technology is developed. As such, a much more cautious approach is needed to make sure MedTech programs stay on track. The Biodesign process is structured to maximize the chance of success at each stage of development. Each MedTech program is unique so creating a one size fits all process is unrealistic. However, through years of collective experience, the creators of Biodesign identified trends for success and failure. They created an idealized process for a typical MedTech program. The process is accompanied with case studies of many of the situations you may encounter doing the right thing or the wrong thing.
LUNAR works with plenty of MedTech companies.The Biodesign process gives us an additional tool to enable us to provide higher value services as we permeate more levels of our clients’ business and so provide higher value as consultants. As a product designer, I use awareness of the Biodesign process for things like anticipating clinical or regulatory challenges, which can influence system configurations and inform part design.. It has armed me withrelevant terminology like IRB, 510(k), PMA, double-blinded prospective studies, the difference between morbidity and mortality, disease prevalence, percutaneous access – the list goes on. This is the language of the medical device world. The great thing about the terminology is that it’s easily passed onto others at LUNAR – designers and engineers. As mentioned, a key contributor to success of MedTech firms in Silicon Valley is their access to the local medical device Ecosystem; which includes experts for clinical opinion, regulatory strategy through FDA, health insurance reimbursement strategy, and of course product design. Another unexpected benefit of the Biodesign program is access to this community. It’s easy to appreciate that without this network of support, MedTech commercialization is very difficult.
Since completing Biodesign I have had a number of people contact me interested in finding out more. If you have questions please reach out to me for specific questions; especially if you are a consultant in medical devices product development – matt.durack@lunar.com.
