John joined MCRA from the U.S. Food and Drug Administration (FDA), where he was chief of the Interventional Cardiology Devices Branch. In his position, John supervised and provided leadership for a multi-disciplinary team of scientists and healthcare professionals on the regulation of interventional cardiovascular Class II and Class III medical devices. As Branch chief, John reviewed and edited scientific memoranda from staff relating to all regulatory decisions on PMA, IDE, and 510(k) medical device submissions pertaining to coronary interventional products. He also functioned as a focal point for industry representatives, Advisory Panel members, scientific experts and cardiovascular thought leaders in discussing the regulation of products in the rapidly evolving interventional cardiovascular device arena.
David Lown, MCRA's general manager said, "Beginning in 2004 MCRA has led the medical device model of deep industry specialization and service integration to assist industry in bringing innovation to patients. Michael is a recognized expert with an extensive background in cardiovascular device regulation and physiology, and his appointment reflects MCRA's strong commitment to providing first-rate regulatory services to the cardiovascular community. We are honored Michael has joined MCRA. He will make a tremendous impact."
John has extensive knowledge of medical device regulations and regulatory pathways to drive a device from conception to market. Prior to becoming Branch chief, John was an animal testing reviewer and lead reviewer in the Division of Cardiovascular Devices at FDA. Before joining FDA, John conducted cardiovascular research at The Massachusetts General Hospital in Boston, where he specialized in cardiovascular pathology and histology, and performed countless stent implantation procedures in animal models.
John said, "It is a privilege to join the team at MCRA at such an exciting time in the history of cardiovascular innovation. MCRA has a long track record of success in the device arena and has established a strong foundation for growth into the cardiovascular field. I look forward to leading the MCRA Cardio team to bring the next wave of innovative cardiovascular products and solutions to patients in need."
Founded in 2004, MCRA is a clinical research organization and advisory firm. MCRA's value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance and quality assurance. MCRA's integrated approach of these key value creating initiatives provides unparalleled expertise for its clients. MCRA has offices in Washington, D.C.; Manchester, Conn.; and New York, N.Y.; and serves nearly 500 clients globally. MCRA has a history of driving success in all areas of the medical device industry including spine, orthopedics, cardiovascular, diagnostic imaging, ophthalmics, drug delivery, wound care, dental, general healthcare, neurology, in-vitro diagnostic (IVD) devices, combination products and biologics.