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Michael Causey

FDA Compliance

Medical Device Makers Express Optimism About the Future...

... but the U.S. regulatory burden is worrisome

Published: Thursday, July 23, 2015 - 16:36

Crystal may be clear, but crystal balls, at least metaphorically, are certainly not. The late, great political columnist David Broder of The Washington Post used to run a column at the end of the year tallying up where he had guessed correctly—and where he’d missed the mark. Not many columnists have the guts to do that.

A survey taken earlier this year found that some 75 percent of more than 5,000 medical device professionals felt “very or somewhat positive” about business prospects for 2015. Those numbers are pretty much in line with the findings of the 2014 survey, conducted by our friends at The Emergo Group.

Taking a closer look at the 2015 numbers, it’s clear that domestic device makers feel better about their prospects than do counterparts in the European Union—and this was before Greece really started to tank.

Casting eyes around the globe, it turns out that device makers in Asia were even more optimistic than those in the United States. Still, confidence among Asian device makers fell to 77 percent in 2015, down from 83 percent in 2014. It’s interesting to note that, even then, concerns about a slowing Chinese economy don’t reflect an increasing edginess about the state of things in the world’s most populous nation.

In the United States, smaller companies actually felt a bit more optimistic than their big brothers and sisters. But midsize and big shops were a little less thrilled about the future, likely due to “regulatory and pricing pressures,” Emergo notes.

The study burrowed down to quiz more than 2,000 quality assurance and regulatory affairs (QA/RA) professionals for their thoughts on current and prospective regulatory trends. A bit more than one-third of U.S. respondents said they expect the process of gaining regulatory approval will be tougher than it was a year ago. The study says about 3.5 percent think the regulatory process is getting easier, though I’ve personally never found or spoken to any of those people!

Not surprising, the QA/RA pros in the United States said their country was one of the toughest when it comes to regulatory approval. Even the FDA sometimes acknowledges that, as we noted in an earlier blog in which Jeffrey Shuren, the director of the FDA’s Center for Devices and Radiological Health, noted that the agency is sensitive to this and trying to make some pro-industry changes.

We’ll check back with Emergo—and Shuren—later in the year. Let’s see if we can find some of that Broder confidence where folks circle back and reassess their predictions.

First published June 30, 2015, on the AssurX blog.

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About The Author

Michael Causey’s picture

Michael Causey

James Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past 10+ years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers. Causey is the editor and publisher of eDataIntegrityReport.com and is a contributing writer on the AssurXblog.