Uncertainty on both sides of the Atlantic
Governments on both sides of the Atlantic are creating an uncertain business environment for medical device companies.
A year ago, it seemed that the Trump administration and Trump’s FDA commissioner appointee, Dr. Scott Gottlieb, would make FDA even more industry friendly. But amid increased media scrutiny of industry problems, FDA has started to take actions to ensure medical device safety, from 510(k) clearance modernization plans to post-market medical device oversight improvements.
Odds are good that there will be calls for more reforms, not to mention investigations into industry practices, now that Democrats control the U.S. House.
Meanwhile, medical device companies are scrambling to comply by mid-2020 with the significant regulatory tightening embodied in the European Union’s new Medical Device Regulation (MDR).
“Patients and providers now have a clearer picture of the weaknesses of the flawed FDA approval process, and a better understanding of potential long-term side effects of under-regulation. This will bring about global change in 2019,” Madris Tomes, a former FDA analyst and CEO of software company Device Events, recently told MDO.
The flip side of 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,” Eric Geismar of EPG Consulting said during DeviceTalks West in December.
Beyond regulations, governments are also creating a host of other uncertainties. There’s supply chain disruption from the U.S.-China trade war. There’s the ongoing U.S. government shutdown, which is disrupting the ability of FDA and other agencies to deliver services. Over in Europe, there’s a great deal of uncertainty about what will happen with Brexit.
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