The medical device development ecosystem: Current regulatory state and challenges for future development: A review

Background/Purpose: There has been increasing emphasis on the development of new technology to mitigate unmet clinical needs in cardiovascular disease. This emphasis results in part from recognition that many devices, although being initially developed in the United States, were studied, and then eventually approved abroad before being returned to the U.S. for clinical application. The FDA (Food and Drug Administration) guidance document on Early Feasibility Studies (EFS) and then the 21st Century Cures Act from 2013 to 2016 focused on these issues. Materials/Methods: There are multiple components of medical device translational pathways to be considered in continuing to reach the goal of providing early access to safe and effective products to the U.S. population. This review article documents the various stages from early idea innovation to device design and iteration to clinical testing and then potential approval and application in the wide clinical practice of cardiovascular health care. Results: The CDRH (Centers for Devices and Radiological Health) has focused on key components including EFS, Breakthrough Devices Program, Total Product Life Cycle, the Unique Device Identification Program, the establishment of a Digital Health Center of Excellence, and leveraging Collaborative Communities. Each of these initiatives focuses on improving the Medical Device Development Ecosystem. Conclusions: Major changes in device translational research have improved the device research climate in the United States. Goals remain including increased training and education for constituencies aspiring to work in the field of device development and regulation as part of a continuous health care learning system.