Food and Drug Act polymer restrictions (medical devices)

When we come to material selection, another externality, particularly in medical materials, is in the early 1970s Congress passed the law enacting the Food and Drug Act, and they said we will grandfather any material that's already been used as an implant in the human body, but if you're going to bring in a new material, since we're dealing with humans here, we're going to make you qualify it. Since then, to my knowledge there has never been another material qualified for use in the human body, other than the materials that existed before the 1970s. Because no one wants to spend the hundreds of millions of dollars in all the dog studies and then a human study.

The reason is the Food and Drug Act of 1972 grandfathered in a bunch of polymers that had been used, like polylactic acid. You can imagine — polylactic acid, it degrades into milk, or something that's in milk. Polyethylene had been used in the body before, and it's basically like paraffin wax. Surgeons have been putting paraffin wax on wounds and stuff for years. But there's been a lot of advances in polymer science, and a lot of things that probably are a lot better. You can't use them in the human body unless you certify them to the 1972 Food and Drug Act. Well, guess what — the regulations with that act are so onerous that no one wants to spend the hundred or two hundred million dollars, or billion dollars, that it would cost to qualify a new polymer. So everyone designs with 40-year-old polymers. It has stifled a certain type of innovation because no one wants to take a chance.