Bleeding Edge Hero

Netflix Documentary takes on the medical device industry

Posted on April 30, 2018 by Medtech[y] Staff


Billions in sales. Millions of U.S. patients at risk. An industry that goes largely unregulated and unchecked — until now.

That's how the website for the new Netflix documentary, The Bleeding Edge, describes the medical device industry.

For many of workers in the $400 billion medical device industry, hearing that first sentence will be hard to swallow, especially considering employees in the industry deeply care about the products they are developing, marketing and selling.

There's bad apples though, and the documentary appears to hit hard at them and paints a disturbing picture of the medical device indsutry.

While the documentary doesn't come out until this summer, the film premiered at the Tribeca Film Festival and reviews of the film have started to drop. There's also a website and heavy social media campaign going on to market the film.

According to reviews, the 510(k) exemption will be one of the targets of the film. For those unfamiliar, the 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device.

While there are numerous examples of safe and effective medical devices cleared through a 510(k), the documentary focuses on some of the devices that have been 510(k) cleared by comparing them to recalled products that were unsafe. Not a great look at all.

Some of the devices discussed in the film were transvaginal mesh implants, metal-on-metal hips, the da Vinci surgical robot and Essure birth control, a product in which the FDA just restricted the sale and distribution of.

Most employees in the medical device industry are good people and extremely proud of the high tech devices that are developed. These devices are part of what makes America's healthcare system the most technologically advanced in the world.

We will review the film once it releases this summer.

Our hope is that some of these bad apples do not force the general public to overlook all the great, life-saving, technologies the medical device industry brings to market.