The regulatory maze behind health tech vaporware
Every year at CES, you’ll see a lot of fascinating health tech concepts and prototypes — at-home urinary scanners, smartwatches that can noninvasively monitor blood sugar, and a wearable patch to prevent sexual dysfunction. And then, nothing ever seems to make it to market. Or if it does, it only happens years later, and often, the final product isn’t nearly as capable as the initial pitch.
There are three letters why: FDA.
The Food and Drug Administration is meant to protect public health. One of the many ways it does that is by regulating medical devices. This is a good thing. When human health is on the line, you want medical technology to be accurate, safe, and reliable. You want these devices to have gone through the appropriate...