The recent VdE debate on the Healing Innovation blog forced me to reconsider what drives innovation in medical devices. A reduced pool of money clearly hurts innovation, which is our current situation due to the lack of regulatory visibility and healthcare reimbursement concerns. But, under the same financial constraints, what has a greater impact on innovation, the process or the people?
I have read several entrepreneurial articles that expressly state that anyone can be innovative and it’s more about the opportunity. I question whether these pundits have ever worked with a quality assurance engineer. Seriously, though, it is true that individuals can be taught techniques for innovation, as we can teach school children how to draw or paint. At the end of the day, however, I believe in nature over nurture. For me, it’s more impactful to find the Michelangelos and provide them the resources and clear the obstacles, than offer a recipe for great art.
The problems that have led to the U.S.’s loss of medtech innovation are more about barriers and constraints than the lack of instruction or procedures. ABIA is preaching that there is a process for improving medical device innovation. My experience and intuition is that people are a greater factor in innovation than process. That said, bad processes can clearly sabotage innovation. I would rather have no process than bad process or too much process.
When we look at the tremendous productivity of Silicone Valley, was it due to a process or due to an environment that allowed creative and passionate individuals to make things happen? Some have called the early days of Silicone Valley the Wild West due to an excitement equal to the Gold Rush, where academic credentials are still trumped by ingenuity.
I have repeatedly read articles by the “experts” that state “new ideas are a dime a dozen; the hard part is turning those ideas into successful products.” The truth is that really good ideas are precious. It is also true, however, that a great medical device idea that never gets utilized by a clinician and does not help a patient, is not an innovation.
Obviously, innovation is not just creativity and ingenuity, there’s an equal portion that is execution. But, great ideas don’t come from vapor, innovators are by nature more inquisitive, more rebellious, and exploratory, all key traits tapped to determine user needs and requirements.
Despite my wisecrack about QA engineers, they play a vital role in the commercialization of medical products and Design Control processes are critical to ensuring safe and efficacious medical devices. But, for most leaders creating an innovative medical device company from scratch, the QA engineer would not be the first hire. It would be the most talented creator. Forgive me for using a sports analogy, but I believe that Kobe Bryant has a greater impact on the Lakers than the Triangle Offense.
So, my message to ABIA is that attracting and freeing the innovators is the key. Surround the innovators with the business leadership, complementary personnel, and resources to execute and shield them from bad processes, and innovation will flourish.
