Panel examined burdens and benefits of FDA regulations on medical technology, explored solutions.


Medical devices have improved and saved countless lives and are a driving economic force in the nation's, and Minnesota's, economy. However, with a regulatory process stewed in a set of nearly 40-year-old parameters, are the Food and Drug Administration's (FDA) regulations on medical technology a benefit to the public or a burden to innovation and commerce?

That was the question an illustrious panel of experts sought to answer at an event hosted at the Carlson School by the University of Minnesota Center for Business Education and Research (CIBER) and the Medical Industry Leadership Institute (MILI).

"This is a complex industry with a lot of different actors," says Professor Stephen Parente, director, MILI. "What we tried to do is bring those actors together to talk about what the challenges are and also the solutions, and that there are solutions. But the solutions are ones that are specific and require having a broad representation but not too broad."

The event, attended by scores of industry representatives, began with an address by Susan Alpert, a former FDA official and most recently senior vice president for Global Regulatory Affairs at Medtronic. Alpert provided a history of how the FDA has struggled to keep pace with advancements in the industry and shared the inherent conflict the FDA faces with a mission of both protecting public safety and spurring innovation in a marketplace that extends beyond the nation's borders.

In a subsequent panel discussion, Alpert was joined by Simon Stevens (UnitedHealth Group), Richard Manning (Merck & Co.), University of Minnesota law professor Ralph Hall, and representing the financial services community, Thomas Gunderson (Piper Jaffray & Co.) and John Alexander (Twin Cities Angels).

According to Gunderson, the uncertainty of FDA timing and approvals in recent years has resulted in Wall Street paying less attention to medical device stocks than before.

"We're looking at the present value for future profits. Those future profits come from future revenues, and those future revenues come from new products and new technology," says Gunderson. "Over the past several years, the timeline for when those new technologies come out has shifted--it's longer now. The difficulty for Wall Street, and for industry for that matter, is that we don't know how much longer."

Alexander agreed, adding that the current environment is also inhibiting private capital flow to small companies that create new innovation--something that could significantly limit the development of new products and technology.

Agreeing that the current system is lagging, the group discussed a range of options, including starting afresh, but did not reach a consensus solution in its short time together. Nonetheless, Alpert found the discussion healthy and believed it was the ideal forum to develop strategies and policy decisions that can be taken to Congress and the FDA.

"I think places like the University, like the Carlson School and the MILI program provide those environments where it's not about a given company, it's not about one technology, but it's about the environment in which we're trying to advance the U.S. healthcare environment, the U.S. industry, and clearly the Minnesota industry," she adds.

Parente agrees with Alpert's assessment that Washington could use the CIBER/MILI event as a model to find a solution for this significant issue.

"It was just six panelists and some fairly concrete things were suggested to kind of move things forward," notes Parente. "I think a member of Congress should hear that. They have the ability to do that; they can try to structure something with a hearing that is just as focused as this if not even more pragmatic.

This is an industry that has a lot of challenges in front of it. It's already slowing down, it's facing regulatory burdens, not many people were negative towards the notion of blowing up the current process, mostly because the process was sort of stewed in a set of parameters that are more than 30- or 40-years-old and are not serving a 21st century healthcare system as well as they need to be."