3. Trouble with valuation amid an uncertain regulatory environment
[Image from Unsplash]
Media reports including the International Consortium of Investigative Journalists’ “Implant Files” articles and the Netflix documentary “Bleeding Edge” have increased public scrutiny of FDA’s 510(k) clearance process. There’s now a push at FDA to move away from using predicate devices over 10 years old, as well as creating a new alternative 510(k) pathway based on objective safety and performance criteria.
“There’s certainly been a lot of criticism in media and elsewhere about whether or not the 510(k) process indeed is a safety review as we understand it to be or just a substantial equivalence stamp as some have been arguing, and what does that mean. It has impact on what I do, litigation, but it has even more of an impact in terms of what companies are doing and how easy or challenging it is to get that clearance through a process that will continue to change as FDA considers the proposals for evolution of the 510(k) pathway,” said Ginger Pigott, a litigation attorney at Greenberg Traurig.
In Europe, scrutiny of medical devices is also increasing as the new Medical Device Regulation (MDR) goes into effect.
In Europe, scrutiny of medical devices is also increasing as the new Medical Device Regulation (MDR) goes into effect. “Previously, a U.S.-based medical device company could get an approval and start selling products in Europe much faster than in the U.S. – which provided additional funding – but it’s going to take longer to get to the market in Europe as well,” Fayerberg said.
The situation means that the cost is going up for medical device companies to achieve regulatory approval or clearance for a product.
“The conundrum is that the [regulatory] path is getting harder, but companies want to see an approval before they invest,” Geismar said.
