The Tip of the Spear: A Review of "The Bleeding Edge" and What's Waiting Behind Door #2


I should not have been as surprised as I was. But then the anger set in, then fear, then a few tears as the reality of the current state of our medical device industry hit me like a ton of bricks.

I'm not a surgeon or scientist. I've never been to an FDA meeting or gone through a 510K process. But I've handled more medical devices in my short career than 90% of the folks in the brand new Netflix documentary "The Bleeding Edge", so this conversation is real for me -- and if you're reading this, I'm sure it's just as real for you.

So, first for the review:


Disagreements:


1) There is a fundamental assumption in this film that regulation = safety. The film makers spend a large portion of their time focusing on how easy it is to get a medical device to market through the 510K process and predicate device "loophole" (as they call it). And as far as that goes, I'll grant that there are all kinds of holes in that process. What they failed to prove (and why I call it an assumption) is that the FDA or any governmental body can have the insight or wherewithal to properly, consistently, and 'without undue influence' regulate an industry like this. Obviously, that's not going to stop them from trying -- but I think if we learned anything about the failure of FDA regulation and regulators from this film, it's that they deserve less power not more. If there is a system, it's going to be "gamed," if there's money to be made, it's going to be made. Regulation is not the silver-bullet.