Dr. Kevin Soucy is a Principal Consultant at CardioMed Device Consultants and former FDA Senior Lead Reviewer with seven years of FDA experience and involvement in more than 500 regulatory submissions. He helps medical device manufacturers navigate complex regulatory requirements and develop effective preclinical testing strategies, specializing in Class II and Class III cardiovascular devices, including transcatheter heart valves, structural heart interventions, and mechanical circulatory support systems.
Experience
Dr. Soucy spent seven years at the U.S. Food and Drug Administration (FDA), serving as a Senior Lead Reviewer on the Heart Valve Device Team within the Office of Cardiovascular Devices. He contributed to more than 500 regulatory submissions, including FDA Pre-Submissions, Breakthrough Device Designation requests, Investigational Device Exemptions (IDEs), 510(k)s, Premarket Approval (PMA) applications, and postmarket reviews.
His FDA expertise includes preclinical verification and validation, simulated-use testing, particulate and coating integrity assessments, clinical study design, and risk mitigation for transcatheter heart valve replacement and repair technologies. He also participated in AAMI and ISO standards development, including work on cardiovascular transcatheter delivery systems.
Prior to joining the FDA, Dr. Soucy conducted cardiovascular device research at the University of Louisville’s Cardiovascular Innovation Institute, developing mechanical circulatory support technologies and investigating therapies for heart failure. His experience includes computational modeling, hemodynamic analysis, benchtop testing, and large-animal GLP studies. He maintains an adjunct faculty appointment in the University of Louisville’s Department of Bioengineering.
At CardioMed, Dr. Soucy advises manufacturers on FDA regulatory strategy, preclinical testing programs, device performance evaluation, risk management, and regulatory submissions, combining firsthand FDA review experience with practical engineering and product development expertise.