Device Makers Are Bucking Decades-Long Trend Of Launching Products In EU. Here’s Why

Study finds more device makers are bringing new products to the US first

 
• By Shawn M. Schmitt

In this Medtech Insight Q&A, two UCLA-backed study authors argue that the US FDA “has emerged as the global regulatory agency most successful in promoting access to novel medtech products, especially digitally enabled or software-driven ones.”

Interview

Most medical device manufacturers are launching new product in the US first, upending a decades-long tradition of companies going to Europe first for a CE mark.

So says a recent study from UCLA Biodesign – the health care technology innovation hub at the University of California Los Angeles – and Boston Consulting Group, “Interstates and Autobahns: Global Medtech Innovation and Regulation in the Digital Age

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