Medical innovation requires reasonable risk

Philadelphia, PA. The U.S. medical device community leads the world in innovation. But maintaining that leadership role will require improved communication among the industry, the public, and government officials—with the public accepting and government officials permitting reasonable risk.

That's the conclusion of Dean Kamen and Thomas Fogarty at a panel discussion at MD&M East May 23. In response to questions from panel moderator Maria Fontanazza, managing editor at MDDI, Fogarty admonished attendees not to be discouraged: “Keep the faith,” he said, adding, “Continue to be leaders…we ain't dead.”

For his part, Kamen offered a more optimistic picture than “not dead,” although he did say the industry faces unnecessary regulatory burdens. Politicians like to take shots at the industry, he said, but he emphasized that there are no medical miracles without reasonable costs and reasonable risks. “Everything that's valuable people pay for,” he said, adding, “Medical innovation requires serious investment.”

Kamen noted that every human endeavor entails risk. We could eliminate automobile accidents, he said: impose a speed limit of 3 mph and make everyone drive bumper cars. But despite 40,000 auto accident fatalities per year, we have not chosen to shut down the highway system. He suggested that if we are willing to accept such risk to continue driving, why should we not accept one bad outcome related to a medical innovation that otherwise saves 10,000 lives. The problem, he said, is that political leaders use that one bad outcome to grandstand.

When asked by Fontanazza what he would do if he were FDA Commissioner, Fogarty said the commissioner is seriously compromised in what he can do, with major decisions made by his reports in a bottom-up, not top-down, process. Kamen said he does not necessarily blame the worker bees in the FDA but added it's likely that perverse incentives are driving perverse outcomes. The FDA's incentive is to make sure nothing bad happens—and the way to do that, Kamen said, is don't let anything happen.

Fogarty also took issue with the press for focusing on bad outcomes and ignoring the benefits of the medical device industry. A downside of the industry being treated as evil and nasty, he said, is that young people will have no one in the industry to emulate and no incentive to enter the industry. He also commented on medical schools, saying they are good at science (producing papers that are outdated in one year) but not necessarily so good at technology. “We don't help many humans by operating on mice,” he said. And as for practicing physicians, he said that surgeons don’t like to adopt medical innovations that might put them out of business.

As for advice, Fogarty said, “Never give up.” Projects take longer than you think, he said, adding that your viewpoint should be, “I'm going to make this work no matter what.”

Kamen noted that the industry is full of people of incredible passion who are adopting technologies such as high-speed processing for medical applications. He said that the U.S. public needs to be educated to encourage politicians to provide the FDA with the right incentives. “The public must understand that if we are to raise the bar on humanity we must take some reasonable risk,” he said, concluding, “We are all busy, but unless this industry has the voice to discuss alternatives, then shame on us.”