MDIC In the News: MedTech Strategist

The Early Feasibility Studies (EFS) Program, spearheaded by the FDA, has been a game-changer for the medical device industry, bringing clinical trials back to the U.S. and offering earlier patient access to cutting-edge technologies. Originally, the lengthy approval processes drove companies to conduct trials abroad, but with recent regulatory improvements, the EFS Program now allows U.S. device manufacturers to work closely with the FDA throughout the clinical trial process. This collaboration enhances the FDA’s understanding of new technologies, enabling a more streamlined approval pathway. As regulatory challenges in Europe mount, the U.S. emerges as an increasingly viable and attractive destination for early-stage medtech research, particularly under the EFS framework supported by the Medical Device Innovation Consortium (MDIC).

Read the full article to learn more about how the EFS Program is transforming the landscape for medical device innovation.