Dr. Kevin Soucy

Kevin Soucy is a Principal Consultant with CardioMed Device Consultants, bringing extensive expertise in medical device development and regulatory strategy. Prior to joining CardioMed, Dr. Soucy was a Senior Lead Reviewer with biomedical engineering expertise at the U.S. Food and Drug Administration (FDA) for 7 years.

Dr. Soucy joined FDA, Office of Cardiovascular Devices, Heart Valve Device Team in 2018. His primary role was premarket medical device review, including pre-clinical testing and clinical study design, to support the advancement of projects toward market approval. His areas of expertise includes pre-clinical verification and validation testing, simulated use testing, particulate and coating integrity test criteria, and risk-mitigation approaches for transcatheter heart valve replacement systems and novel heart valve repair devices. During his time at the FDA, Dr. Soucy contributed to over 500 regulatory submissions, including Pre-submissions, Breakthrough requests, IDEs, 510(k)s, PMAs, and post-market compliance and surveillance reviews. He reviewed adverse event MDRs for several Class II and Class III device product codes. In addition, he actively participated in AAMI, ISO, and other recognized consensus standards activities, representing the FDA’s perspective, including a task group to develop recommendations for cardiovascular transcatheter delivery systems.

Dr. Soucy earned his B.S. in mechanical engineering from the University of New Hampshire in 2003. He then completed both a Master’s and Ph.D. degrees in biomedical engineering at Johns Hopkins University in 2010, with a research focus on vascular function in response to aging and ionizing radiation.

Dr. Soucy then joined the Cardiovascular Innovation Institute of the University of Louisville where he developed mechanical circulatory support devices. As faculty in both the Departments of Cardiovascular & Thoracic Surgery and Bioengineering, his research focused on the feasibility and efficacy of left ventricular assist devices in delivering pulsatile flow as well as mechanical-biological synergistic therapies for heart failure patients. Through this experience, Dr. Soucy gained hands-on experience with computational modeling, benchtop simulated use testing, hemodynamic data acquisition and analysis, large-animal GLP studies, and NIH SBIR grant writing. Dr. Soucy maintains an adjunct faculty position in the University of Louisville Bioengineering Department.