More Medical Devices, Less Red Tape

The FDA recently announced that they have reached a tentative user fee deal with the $105.8 billion U.S. medical device industry. The deal allows the FDA to collect around $500 million from the various companies over the next five years. In return, for this near doubling of fees, companies - and in turn patients - will benefit from a faster and more transparent review process.

While this might not seem like front-page news to most people, it is to us. The U.S. medical device market is the world’s largest. As a country, we spend $339 per person, per year on medical devices. America is home to 7 out of 10 of the world’s largest manufacturers including Johnson & Johnson, General Electric, Baxter, Covidien and Medtronic. A faster and more streamlined approval process means more medical devices getting a green light for production.

At Keats, we specialize in the kind of small metal stampings, wireforms, and assemblies that are crucial to making exacting medical devices.  We recently designed and built over 3,000,000 wire links for a leading medical device maker.   The Florida-based medical device maker came to Keats because they needed their medical device parts to be durable, consistent, and exacting. It’s not the kind of component you want made by just anyone. You might even say it’s a matter a life and death.

Many of these devices play critical roles in keeping people alive and well. Because of this, the quality control experts at Keats go to extraordinary length to make sure that nothing leaves our facilities before it is subjected to rigorous inspection and testing.   

Over the next few months, we’ll do our best to keep you informed about how the FDA’s faster review process will directly affect our industry and most importantly, you and your loved ones.