The FDA is revamping their medical device clearance process after a week of none-too-flattering press coverage related to med device issues. The current process for med device approval can be accelerated if companies demonstrate their product is substantially equivalent to already approved products. Trouble is that technology evolves every once in a while (in infographic form here), so the new process puts a ten-year limit on using a reference product. The agency is pursuing these changes after stories like this which allege that medical devices have caused 80,000+ deaths since 2008. Other stories included ‘export-only’ devices made in the US without FDA approval causing injuries abroad, and Health Canada changing their clearance process after similar criticisms. Looks like a change is gonna come. Here are 2018’s 10 most innovative medical devices.
Stop me if you’ve heard this one before. As the US waits to see who President Trump will select as the next FDA commissioner, there seems to be a push-me, pull-me between faster approval timelines and the rigorous, gold-standard process the FDA has had in place since 1962 (think thalidomide). On the surface, faster drug approvals should benefit the pharma industry, right? But what happens if long-term distrust of new medicines grows because faster approval times lead to ineffective or unsafe products? Wall Street hates uncertainty and the past few months have not been kind to pharma. See this chart for proof. So, buckle up and hold on.