Leaders in academia, business, and government—who often find themselves at cross–purposes during the innovation process—agreed at an April workshop that they must work together to produce medical devices and bring them to market.
The panelists who spoke at “An Introduction to Device Innovation and Development at Yale” said that despite having different goals and areas of expertise, stakeholders must listen to one another.
“None of us can do this by ourselves,” said Jon Soderstrom, Ph.D., managing director of the Office of Cooperative Research (OCR), which co–sponsored the workshop in Fitkin Amphitheatre together with the School of Medicine.
Several speakers said that the regulatory process in the United States has been a major roadblock to device innovation; however, they praised recent efforts by the Food and Drug Administration (FDA) and National Institutes of Health (NIH) to cut red tape. In the last few years, said Mark Turco, M.D., chief medical officer of Covidien’s Vascular division, a medical device maker, the FDA has done “a tremendous job” in streamlining the regulatory machinery and working to bring innovation back to the United States. Still, he said, on average it takes 54 months to bring a product to bedside in the United States, compared to 11 months in Europe. And it costs on average $94 million to bring a device from concept to approval, Turco said, adding that $75 million of that sum goes to FDA–related activities.
“This is why a lot of the innovation and early device approval moves outside the United States,” Turco said. Regulatory paths are getting more stringent worldwide; but such factors as market forces may still compel a company to develop its concepts overseas, he said. For companies developing stateside, it’s “critical that the agency allows us to fail” during clinical testing. “It is very hard getting the device correct the first time,” he said, and the approval process is slowed further when the FDA then resets the clock and requires repeated preclinical tests. Innovative devices for the future, he said, need to show that they can improve patient care and safety while removing cost.
The NIH has come around to that thinking, said Kurt Marek, Ph.D., deputy director of the Office of Translational Alliances and Coordination of the National Heart, Lung, and Blood Institute. “We think about bench to boardroom,” he said. “And this may seem like an impure thought to many of you who are traditionally funded by NIH.” The agency has a new program that partners device developers with patent experts, angel investors, and regulators. It even coaches businesses on how to make presentations, he said.
Meanwhile, the FDA is equally concerned that novel devices are being developed offshore, said Andrew Farb, M.D., a cardiologist and senior reviewer for the Center for Devices and Radiological Health, a division of the FDA. The agency recognizes that exhaustive clinical testing may add costs with no return, and has consequently developed programs that cut down superfluous studies. But Farb emphasized that the relaxed rules are “not a shortcut.”
Laura Niklason, M.D., Ph.D., professor of anesthesiology and biomedical engineering, learned an important lesson when she formed a company that developed the first artificial blood vessels. Regulators decided—much to her surprise—that the vessels are a biologic, not a device.
Niklason came up with a vessel suitable for clinical testing, but the work took eight years and government funding was sparse‒the NIH prefers to fund basic discoveries. “Just when you’re getting to the point where it might actually be useful, that’s when the NIH closes the door, and you have to find other sources of funding,” she said.
The regulatory hurdles, Niklason said, taught her that “being really, really new is not necessarily a good thing.” Creating the first product of its kind means there are no benchmarks to follow, so “it does make the regulators and investors nervous.”
Niklason’s company, Humacyte, has raised more than $2.4 million in grants and more than $19 million in investments, said Erika Smith, deputy director of the Yale Enterprise Institute. OCR, working with industry, has helped launch 50 faculty startups. “We want to create more Lauras,” Smith said. That’s fine, Niklason said, as long as she’s not in charge of the company. “Expert management is critical,” she cautioned.
That sentiment was echoed by John Martin, M.D., co–director of the Yale–University College London Collaborative and founder of a biotech firm called Ark Technologies. “No professor should ever be a CEO,” he said, adding that he wasn’t cut out to lead the company. “I just didn’t have the right sort of personality.”
Martin said that all sides benefit by collaborating instead of clashing, but stressed that university researchers should take the lead in coming up with ideas. On the other hand, those ideas also need a plan for moving forward. “Academia really has to think more seriously about how it puts together a proper strategy as opposed to just letting things happen,” he said.