FDA to Medical Device Companies: Forget Global Warming, it's About to Get Really Cold

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Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Geologists, archeologists and the like usually examine things in terms of hundreds of thousands of years: Think the Paleolithic Era which they measure from the introduction of stone tools by pre-humans or hominids such as Homo Habilis about 2.6 million years ago, to the introduction of agriculture around 12,000 years ago. That’s nearly the whole time folks like us have been walking around the planet on two legs.

But for us FDA watchers, those trends tend to be a bit shorter in duration. For example, just as Earth goes in and out of ice ages into relative warm periods and back to colder climates, it looks like we’re coming out of a 20-30 year period of relatively light FDA regulation into something new and, for medical device companies, a little scary.

Device makers, pharmaceutical companies and even food manufacturers “got used to a certain regulatory treatment from the FDA in the past twenty to thirty years,” notes industry expert and Creo Quality LLC Principal Jon Speer.  Translation: The FDA generally went a little easier on the industries it regulates.

But that sound you hear might be the ice freezing up again.  As spelled out recently in an excellent Minneapolis Star Tribune commentary by Arne Carlson about possible FDA alterations to the way it regulates medical devices, “changes should accelerate innovation, not hamstring it. Medical device companies, physicians and venture capitalists are investing time and money on new devices, agreeing to clinical study rules the agency outlines at the start. But in too many recent cases, the FDA has delayed its feedback to the companies, then determined in the end that the company needs to meet new milestones before the agency will consider clearing the device. That isn’t right.”

And earlier this week at an FDA “Town Hall” meeting that’s part of a three-city listening tour many speakers lamented a lack of predictability in the FDA approval process, which they say chokes funding for start-up companies. Device makers detailed what they criticize as bloated timelines and an unprepared, unresponsive agency staff that is often hostile to industry input.

Is it time for medical device companies to panic? Yes and no.

“At present I do not believe there are any new rules affecting device innovation; there is however a fear of new rules to come,” says Sheppard Mullin Partner at Peter Reichertz. “In addition, there is a new attitude at FDA resulting from fear of Congressional oversight as well as newer less experienced employees who tend to be stricter and more conservative in their review of premarket notifications,” he adds.

But Reichertz sees this going further, “FDA seems bent on making changes to the 510(k) process that would make it more difficult to either develop improvements in currently marketed devices by their current manufacturers, as well as to allow for the development of products that improve on existing products due to fear of what they refer to as ‘device creep’. While changes in these rules are not yet known, all of the industry assumes that it will make it more difficult to innovate, and companies may already be deciding not to proceed with innovation because they are not sure what the new scheme will require.”

“I can see both sides of the equation,” notes Speer. He points out that the FDA is charged with protecting consumers while medical device companies are under investor pressure to get their products to market. Get more of his insight by following his Twitter postings.

But potential FDA moves are making it “extremely challenging for start-ups,” Speer notes. He works regularly with medical device companies to help negotiate the increasingly treacherous FDA regulatory minefield.  He cites anecdotal examples of companies that recently waited 267 days for FDA clearance, and another that even had a predicate product already in the market, yet still waited almost 100 days for agency approval.

“In the last 18 months medical device companies have come under tremendous additional regulatory scrutiny,” suggests Jerry Chase, CEO with Lantronix (NASDAQ:LTRX), a provider of equipment that network-enables medical devices (both embedded and external to the human body). He’s worked with a lot of medical device companies that produce infusion pumps and glucose meters, and seen them cowering over potential FDA rules they fear will stifle their innovations.

Stressing that he shares the FDA’s goals to protect patients, Chase called on the FDA to listen carefully to the concerns of the medical device industry. “The FDA needs to understand that what it seems to be proposing now is too broad” and is more likely to ill-serve consumers by slowing valuable medical devices rather than protect the public. He remains optimistic, though. “Obstacles can be opportunity,” Jerry says.  For more, check out Jerry’s blog.

Meantime, if you are a medical device company, it might be time to hone your arguments for a healthy debate with the FDA. And don’t forget to bring a really warm coat.

Showing 3 comments
  • Reply

    We’ve just completed some fairly tricky 510(k)s, and are now using the 513g with new devices where the indication is expanding or there is the possibility of “device creep” – that way the company (and investors) can get a nailed-down pre-submission requirements list. And we are getting increasingly concerned that this process is going to bog down because so many others have the same concerns and are using the same approach. I can tell you that VC investment in medical device startups is dramatically lower this last 9 months, and it is *not* the economy – the bias used to be for 510(k) path investment, now it is strongly against it precisely because the agency has been changing the level of scrutiny in the middle of submissions.

  • Reply

    Thanks Scott for that interesting, if sobering, feedback. I wonder how far the pendulum is going to swing this time? Reminds be a bit of how the FDA overdid it with 21 CFR Part 11 restrictions before realizing they were thwarting what they had intended to encourage. Thanks again for your input here. Michael

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