A couple of weeks ago I had the opportunity to interview a company that was undergoing a pivotal trial in the U.S. The company had actually received approval from the FDA to use a second generation device in the trial - because the device was already approved in Europe and had been advanced to its second iteration.
While this has been an issue for a while in the med-tech space - the fact that FDA can sometimes lag behind during the approval process to this degree is a bit troubling. To my mind it hampers innovation in the U.S. It's also a bit of a headscratcher.
Most companies that I speak to now large or small cap - almost always look toward Europe first. The CE mark is perhaps the inaugural approval. Many firms are too terrified (especially if they’re relying on venture capital for funding) to even begin shooting for FDA approval first. The standard goal is typically Europe. I’m not condemning the CE mark, but I’m asking why can’t the FDA work with companies to create a more regulatory friendly environment? Why is this the norm? Why can't FDA approval come first? Why can't the process be ab it easier?
Talk to anyone outside of the space - a spouse, a friend, someone who is removed from the intricacies of FDA and med-tech, and you’re probably going to get a baffled response from them.
Why would a U.S. -based firm try and get approval outside of the country first, and then take the data they garner from trials done in Europe to appeal to FDA to use that data so it can get approval.
That’s like the (insert your favorite team) winning all of its away games, but constantly struggling to win one at home. But I digress. I guess home court advantage just doesn’t exist in med-tech.