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A medical device consulting company working with medical device manufacturers around the world |
5523 Research Park Drive, Suite 360, Baltimore, MD 410.674.2060 |
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CardioMed Device Consultants, LLC |
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Home | About Us | Services | News | Publications | Useful Links | Contact Us | Find Us | Site Map |
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Consultant - Stephen L. Hilbert, Ph.D., M.D. |
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MEET OUR STAFF |
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PRESIDENT AND FOUNDER
HONORARY VP, ENGINEERING
PRINCIPAL CONSULTANTS
AFFILIATE CONSULTANTS |
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Dr. Hilbert has over thirty years of experience working in the area of cardiovascular medical device development and evaluation, conducting safety and performance and explant pathology studies. Prior to joining CardioMed, Dr. Hilbert worked in FDA’s Office of Science and Technology (OST) within the Center for Devices and Radiological Health (CDRH), where he conducted peer-reviewed, replacement heart valve, explant pathology studies in collaboration with the Pathology Branch of NIH's National Heart, Lung, and Blood Institute (NHLBI). He also held positions as a senior reviewer in the Division of Cardiovascular Devices, Office of Device Evaluation (ODE/CDRH), 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). In addition to his work with CardioMed, Dr. Hilbert continues his scientific and advisory activities. He is currently 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, and serves as an Independent US Expert on the International Standards Organization's Cardiac Valve Working Group (ISO 5840) and as an Associate Editor for Cardiovascular Engineering and Technology. With his research laboratory affiliation, he is capable of offering clients cardiovascular device explant pathology studies, complaint with FDA's Good Laboratory Practices (GLPs). Dr. Hilbert earned his Bachelor of Science (Pharmacy), Master of Science, and doctoral (Ph.D., Experimental Pathology) degrees from the University of Maryland and his medical degree from Georgetown University. Click [here] to review a list of selected publications. |
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CONTACT DR. HILBERT |
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Office: (410) 674-2060 Fax: (410) 674-2133 Email: shilbert@cardiomedllc.com |
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Home | About Us | Services | News | Publications | Useful Links | Contact Us | Find Us | Site Map |
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Copyright (c) 2011 CardioMed Device Consultants, LLC. All rights reserved.
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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 cardiovascular medical devices, particularly pediatric cardiac surgical and cardiac circulatory support devices. Dr. Hilbert offers extensive scientific expertise to assist at every step of the device development process from early animal testing to clinical trial planning to after-market analysis and regulatory submission strategy.