The Fogarty Institute for Innovation, a Silicon Valley medtech accelerator, recently wrapped up an unconventional partnership with the Food and Drug Administration: Much like a foreign trade mission, the Institute brought a couple of regulators out to California, and linked them up with medical device startups to discuss the challenges of the innovation and approval process.
The small program – easily duplicable by other accelerators – yielded some interesting results: The Fogarty Institute startups found that the FDA isn’t out to bog startups down with excessive red tape. The FDA, in turn, learned more about how its policy impacts how a startup brings a device to market in the U.S.
“The point of the program was to humanize and demystify the whole relationship between startups and the FDA,” Fogarty Institute Chief Operating Officer Michael Needels told MedCity News. “The regulatory challenge can seem otherwise crippling, if not deadly, to a startup.”
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To remove a conflict of interest, the Fogarty Institute matched the FDA staffers up with device companies that they wouldn’t normally review. From there, the FDA review team would have in-depth discussions with the startups, coaching them on regulatory strategy. In turn, however, the startups shared their process in terms of business plans, marketing plans, funding, board management and team building.
The FDA reviewers, hailing from its Office of Device Evaluation, emphasized to the startups the importance of presubmission meetings and informal interactions, Needels said. On top of that, regulators actually prefer interacting directly with startup personnel, particularly the founders.
“We realized that maybe our startups shouldn’t get so hung up on getting high priced regulatory consultants,” he said. “‘Let’s just talk as collaborators directly,’ the FDA reviewers told me.”
Equally important is constant transparency with regulators, Needels continued – singing the praises of the U.S. regulatory overlords
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“An interesting lesson for myself, as well as for the startups: The FDA is full of inquisitive, technically curious individuals – highly trained people who have taken these jobs because they’re as interested as medical innovators themselves,” he said. “These are not slouches at all. So if startups come off as secretive, because they’re scared, they’ll sense that and wonder why you’re being evasive. It doesn’t necessarily pay to hide things from the FDA.”
After all, FDA regulators are “in it” for the same reason as startups, Needels learned from the experience. The government employees are aiming to serve the public, getting technology approved in an efficient manner – they’re not interested in “overzealous policing.”
Quite the takeaway, given that devices often have a tough time in the U.S. achieving regulatory approval. Thanks, Fogarty Institute.
[IMAGE: Flickr user marco fieber]
