I know we've focused a lot on Food and Drug Administration (FDA) regulations and other innovation concerns in the US in prior blog posts, but this article was too good to pass up.
On November 15, the Consumers Union in the US wrote a letter to the Congress urging them to make medical device approval processes in the country stricter. This is while manufacturers in the US loudly proclaim that the existing FDA process already stifles innovation, clinical trials are incredibly expensive, and the medical device tax imposed as part of the Affordable Care Act will just cause further problems. By contrast, the Consumers Union claims that medical device laws are lax and threaten the safety of patients in the US, pointing to recent problems with metal-on-metal implants and surgical mesh as proof that the safety of medical devices is not adequately investigated. In particular the Consumers Union targets the fact that 90% of new medical devices are cleared in a fast-track process just by proving that they're similar to existing devices. It goes on to suggest that the standards be brought higher, closer to what is expected of new drugs. Oh, how manufacturers would love that.
Of course, there is still plenty of pushback from the other side. One of the more interesting recent articles that mentioned medical device regulation involved a discussion of medical apps an area of increasing focus lately because of the trend toward mobile health. Many medical apps actually fall under medical device regulations despite the fact that their creators might not necessarily realize it. Any regulation will stifle innovation says Simon Wickes of Roke Manor Research.