During a lively roundtable discussion at the MD&M East trade show in May, renowned inventor and entrepreneur Dean Kamen didn’t hold back on the subject of current threats to medical device innovation, nor was he shy about ascribing blame—though not just to the usual suspects. While FDA isn’t completely innocent in the whodunit surrounding the killing of medtech innovation, according to Kamen, the real villains in this ongoing drama are partisan politics and the sensationalist media that are skewing public perception.
“We live in a culture that somehow seems to forget that if we want [medical miracles] to happen, we have to be prepared for both reasonable cost and reasonable risks,” Kamen opined. “[The public needs to] stop looking for simple one-line solutions to the healthcare problem and stop listening to the two extremes in our political system, neither of which is offering a realistic assessment of the situation. Medical innovation is going to require serious investment and will have associated serious costs. And, like every other human endeavor, sometimes it doesn't come out perfect. But we have to get back to a reasonable balance.”
Unrealistic expectations for medical devices, according to Kamen, are set for the public by an overzealous media that often focuses on the scandalous or negative stories and the current climate of extreme partisan politics in which leaders are quick to publicly condemn any and all missteps. “If you listen to what a lot of our political leaders say, they believe that industry is a bunch of people that get together every morning and say: ‘What new innovation can we make that is more expensive, less effective, and maybe can kill babies just gratuitously?’” Kamen half-joked. “I've never met anyone in this industry that set out to make a more-expensive, less-effective, potentially dangerous product. It's not in their best business interest, and these are people that have devoted their life to trying to do the right thing. I similarly believe that people in FDA are also trying to do the right thing.”
But FDA is essentially caught between a rock and a hard place and has had to bow to public and political pressure, Kamen said. He noted that the tendency to castigate the agency at the drop of a hat while rarely recognizing achievement has created a system of “perverse incentives” for FDA employees to be overly cautious and somewhat counterproductive.
But while medical device manufacturers are often quick to point fingers at FDA and an increasingly stringent regulatory environment for stifling medtech innovation, the biggest barrier to change could just be the industry itself. That’s because the unrealistic expectations being set are not being adequately challenged and corrected by the medical device industry, Kamen said. If the biggest threat to medical innovation is an uninformed public whose opinions are being shaped by media hype and political rhetoric, then the onus is on the medical device industry to properly educate the public and initiate change, he added.
And he has a point. Whether or not you agree with Kamen’s accused parties in the blame game, you have to admit that the medical device industry could be doing a better job of connecting with the public and trying to change the conversation. Public opinion is a powerful and influential factor in shaping policy and political leadership. Efforts to educate the public about the realistic risks and potential rewards associated with innovative medical device technologies could pay off in spades.
“There's a bigger risk to the public—to the future—from a lack of action than making a mistake: You make a mistake, you move quickly, you fix it; that's called progress,” Kamen said. “But the public is not going to know how much they're missing out on relative to the rest of the world unless they're told. And that's not a story that's been told. It's not easy to tell and, frankly, it's not a simple story.” --Shana Leonard
Watch the two-part chat with Kamen and medtech pioneer Thomas Fogarty and vote in our poll below.
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