What sets the FDA apart on medtech innovation?

UCLA Biodesign executive director Dr. Jennifer McCaney shares insights on a recent research project with BCG examining the global regulatory landscape, and discusses what excites her about the industry's future.

The global regulatory landscape for innovative medical technologies has changed drastically over the last decade with the digital transformation of healthcare, changing tides in global regulatory policy in the United States and Europe, increased capital investment in digital health, and the introduction of innovative program policies and programs by regulatory agencies to support transformational medical devices and products. We interviewed more than 100 CEOs and regulatory executives to understand their experiences developing and bringing innovative medical devices to market, with a specific lens on their experience with regulatory bodies. From these interviews, we discovered that medtech innovators are prioritizing the U.S. as their first go-to-market most notably because the FDA has responded more favorably to advancements in medical and digital innovation over the last decade than its global counterparts, medical device regulation is creating uncertainty and complicating patient access to innovative devices by raising requirements for CE Marking in Europe, and the U.S. now offers a more innovation-centric and digitally friendly ecosystem for regulation, capital investment and market potential.