It’s been tough times of late for the medical device industry – and much of it’s being pegged on the inefficiencies at the Food and Drug Administration. Indeed, faster approval times abroad mean business is getting outsourced to Europe – but, according to a new report, there may be a light at the end of the U.S. regulatory maze.
The California Healthcare Institute, along with Boston Consulting Group, conducted a competitiveness and regulation study, which it just released this week. It analyzed FDA product review trends, and its impact on the innovation that goes on in the medical device industry since 2010. It took into account the Medical Device User Fee and Modernization Act that came into effect in 2002, and how despite being a revenue driver, it slowed approval times. But the government’s heart’s in the right place:
One dynamic does seem certain, however. The evidence is overwhelming that leaders at the Agency and, in particular, its Center for Devices and Radiological Health (CDRH) have worked to get processes, internally and with industry, back on track.
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There’s been some improvement in review times for medical device premarket approvals, or PMAs, at least – indicating that there has been some engagement among bureaucrats and businessmen. “That’s a bit of good news,” Gillenwater said. But there’s still a huge difference between European PMA approvals and those in the U.S. – about 3 to 5 years in lag time. See the figure:
“The problem is, while we have begun to see some improvements in the FDA regulatory timelines for PMAs, we still don’t see that bearing out in terms of the lag between the U.S. and Europe,” Gillenwater said.
The FDA is, after all, only a part of the medical device innovation ecosystem, he said. It’s a critical element, but when you add that on top of the overarching regulatory environment and add on top of that some intellectual property and patent law challenges – as well as the Medicare and private payor system – well, Gillenwater puts it nicely:
“You have a stacking of straws on a camel’s back,” he said.
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This is an interesting trend: After staying steady between 2000 and 2006, suddenly the 510K clearance times lengthened substantially – up 60 percent in 2010 from a decade prior. 510Ks of course account for the vast majority of FDA submissions – perhaps only 30 PMA devices receive FDA review versus more than 3,000 510K devices. So there’s another positive – 510K clearance times seem to be speeding up a touch.
“While in the past two years we’ve seen a bit of plateauing in terms of clearance times, the 510K clearance times still remain far above the history average, particularly when compared to the pre-user fee era,” Gillenwater said.
“The data in our report illustrates that Agency leadership has worked to get processes, internally and with industry, back on track,” Gillenwater said. “But there is more work still to be done to ensure device regulatory review processes are best directed towards the Agency’s twin goals: protecting patient safety and promoting patient health through timely approval of and access to innovative medical technologies.”
