Mid-year Reflections from the Biodesign Fellows: Part 1 of 2
The 2014-15 fellowship has passed the halfway mark and the three fellowship teams are deep into concept refinement and testing. This year’s cohort comprises six physicians and six engineers with a mix of clinical, business, and research backgrounds. Each of the twelve fellows arrived at Biodesign with some prior work in medical devices and each carried certain expectations about the process. In this post, six fellows discuss their prior expectations, the surprises they encountered, and how their expectations have shifted during the year.
SBAA asked these six fellows to answer the following question:
What’s the most surprising thing you’ve learned about the medtech innovation process since you started the fellowship?
Their responses are below.
The most surprising thing about medtech innovation for me has been the process of striking just the right balance between various aspects of bringing a product to market. In selecting a need/concept pair, the tradeoffs between technical risks, market size, clinical/regulatory timelines, reimbursement, and the delivery care models can seem overwhelming. Each need ends up developing a unique signature and ultimately figuring out where to draw the line – making efficient decisions with available information and in a team with four unique perspectives – has been one of my most valuable learnings.
These past 6 months in Biodesign, there are of course many lessons I’ve learned about the process of medtech innovation. I will share with you three lessons that surprised me the most. First is how the medtech world is such a small community, everyone seems to know each other and for the most part it really is a collegial atmosphere with people willing to give advice and lend a hand. Second lesson is about the current changes in medtech innovation, which leads to an exciting opportunity, but with it uncertainty – there really is a large shift in medical devices to emphasis on cost savings and also we are a new intersection of medical devices and technology. Third, the process is really messy, not a simple linear process that can easily be described in a textbook.
One of the most surprising things I have learned has been how challenging it is to identify compelling, unique, and insightful clinical needs. I have discovered that these insights come from intense questioning and true immersion into a clinical need. I did not anticipate that this experience would give me a new perspective, would challenge my medical knowledge, allow me to question my assumptions, and ultimately would change how I practice medicine. This was unexpected but has been one of the most rewarding aspects of the fellowship for me.
As a young entrepreneur coming into Biodesign, I was eager to glean advice from as many prolific innovators as I could. I didn’t expect that that advice would be so divergent – big versus small projects, the long game versus quick wins, traditional medtech versus digital health. For me, this underscores the importance of understanding my own goals and values and that success can be found in many different ways.
I always sensed that creating a new medical device would be challenging – I anticipated a number of technical hurdles along the way. What I did not anticipate was the powerful forces of regulatory and reimbursement and how these forces can constrain the development process. Most young entrepreneurs, myself included, operate with a certain idealism; if I build a great medical device that solved a problem, it would become a commercial success. This year has taught me about all the other, non-technical challenges we face – the power of a phrase like “a new CPT code” and “a PMA device” that can cripple an idealistic development path. I think that understanding these challenges and weighing them against technical hurdles has been a great learning experience during my fellowship year.
One of the most surprising thing I’ve learned about the medtech innovation process is how little patents actually really matter. Patents seems to be necessary to play in the medtech space, and that it’s expected that you have them, but in reality it doesn’t do much in terms of protection. Our group had a first hand experience in this, where we found an existing granted patent that in spirit was doing exactly what we are planning to do. However, the clinicians on our team found a “technicality” where the key difference between the granted patent and our proposed solution was that the granted patent claimed to predict an outcome, whereas our team is planning on detecting the early symptoms of the future outcome. We ran this by one of our industry mentor and another patent attorney who both agreed we still had the freedom to operate. Turning this lesson into a more positive light, it takes a lot of skill to write a bulletproof patent that prevents others from working around it.
Stay tuned for the second part in this series where we’ll ask a different question to the other half of this year’s fellowship class.