Is the sky falling? Device makers keep saying so

By MARK McCARTY

Medical Device Daily Washington Editor

FDA's Center for Devices and Radiological Health is certainly on a regulatory tear of late, and industry is understandably rattled by some of the developments. After all, CDRH only recently managed to shed a couple of obvious malcontents in the persons of Robert Smith, MD, and Julian Nichols, MD, who both worked at the Office of Device Evaluation at CDRH and were not exactly happy to get their walking papers. My impression is that you have to be either really obnoxious, noticeably incompetent, or both to lose a job with Uncle Sam, so it's difficult to avoid the conclusion that these two had some serious baggage and went out of their way to make trouble.

Even without the aforementioned renegades, industry has a lot of gripes about how things are done at CDRH, which is notoriously underfunded and unable to keep pace with everything that lands in its lap. Still, industry has a bad habit of declaring small device makers an endangered species. This didn't seem entirely speculative in early 2009, when the economy tottered on the verge of collapse. Back then, changes were on the horizon at FDA, venture capital looked nervous, and the U.S. Patent and Trademark Office was bogged down with roughly three quarters of a million patent applications with an average pendency of 36 months.

Things have stabilized since then, but the doomsday talk hasn't abated. For instance, I recently interviewed the principal of a small device firm who said industry was carefully watching the fate of his company's application and that a failure by FDA to approve the application would have “dire” consequences for the entire industry.

To some extent, a reworking of the approval and clearance processes at CDRH was needed, although some of the proposals put forth by the agency seem a bit off the charts. All the same, this business of saying in more or less veiled terms that the sky is falling is just absurd. When you look at per-capita income in the U.S. and the sheer amounts spent on healthcare here, the concept that device makers will utterly abandon the U.S. is just silly. And claiming industry will bail out is dishonest, because we all know better.

Just for the record, I don't go to church – not routinely anyway – and haven't since the age of 15, so I can't say for certain I'd know the Crack of Doom if I heard it. All the same, I'm not deaf, and I know that even in the face of Euro-flight, device makers will still want and need the U.S. market for at least as long as any of us are alive. After all, who can say no to a market measured in the trillions of dollars?

So please industry, no more apocalyptic forecasts. It's getting old. Not interesting, just old.