Medical Device Makers Express Optimism About Future – But QA Worries About US Regulatory Burden
Crystal may be clear, but crystal balls, at least metaphorically, are certainly not. The late, great political columnist David Broder with 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% of more than 5,000 medical device makers and 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 medical device makers feel better about their prospects than do counterparts in the EU – and this was before Greece really started to tank.
Casting eyes around the globe, it turns out device makers in Asia were even more optimistic than those in America. Still, confidence among Asian device makers fell to 77% in 2015, from 83% 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 U.S., smaller companies actually felt a bit more optimistic than their big brothers and sisters. But mid-size 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 QA/RA professionals for their thoughts on current and prospective regulatory trends. Just over one-third of American 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% think the regulatory process is getting easier, though I’ve personally never found or spoken to any of those people!
Not surprisingly, the QA/RA professionals in the U.S. 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 when FDA’s Center for Devices and Radiological Health Jeffrey Shuren noted 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.