Stephen L. Hilbert, PhD, MD

Stephen Hilbert, PhD, MD

Stephen Hilbert is a Principal Consultant at CardioMed Device Consultants. He provides preclinical, clinical, and explant pathology consulting services for the medical device industry, specializing in the area of replacement heart valves. Dr. Hilbert offers extensive scientific expertise to assist at every step of the device development process from early animal testing to clinical trial planning as well as after-market analysis and regulatory submission strategy.

Dr. Hilbert has over thirty years of experience working in the area of cardiovascular medical device development and evaluation, conducting safety and performance as well as first of a kind replacement heart explant pathology studies.

Prior to joining CardioMed, Dr. Hilbert was a member of the FDA’s Office of Science and Technology (OST) staff within the Center for Devices and Radiological Health (CDRH), where he conducted peer-reviewed, replacement heart valve performance and explant pathology studies. He also held positions as a senior reviewer in the Division of Cardiovascular Devices, Office of Device Evaluation (ODE/CDRH), served as the Acting Director of the Division of Mechanics and Materials Science (OST/CDRH), and as the Acting Deputy Office Director of the Office of Cell, Tissue, and Gene Therapies in the Center for Biologics Evaluation and Research (CBER).

Dr. Hilbert has also been active in the area of tissue engineered heart valve translational research while serving as the Deputy Director of the Cardiac Surgery Research Laboratories at the Ward Family Center for Congenital Heart Disease, Children’s Mercy Hospital and Clinics, Kansas City, MO. He has regulatory experience in the area of combination biologic-device product development.

Dr. Hilbert currently serves as an Independent US Expert on the following International Standards Organization’s working groups: Cardiac Valve Prostheses (ISO 5840) and the Cardiac Valve Repair Devices (5910). In addition to his ISO activities, he is an Associate Editor of the Biomedical Engineering Society journal of Cardiovascular Engineering and Technology.

Dr. Hilbert earned his Bachelor of Science (Pharmacy), Master of Science (Pharmacology and Toxicology), Doctor of Philosophy (Experimental Pathology) degrees from the University of Maryland and his medical degree from Georgetown University.

Selected Publications