Rochelle, Virginia (September 26, 2016) – NDA Partners Chairman Carl Peck, MD, announced today that Mitchell Shein, former Deputy Director of the US Food & Drug Administration (FDA), Division of Cardiovascular Devices, Center for Devices & Radiological Health (CDRH), has joined the company as an Expert Consultant. Mr. Shein is a Biomedical Engineer with an extensive career at the FDA. Prior to his role as Deputy Director, he was Branch Chief and Supervisory Electrical Engineer in the Implantable Electrophysiological Devices Branch (formerly the Pacing Defibrillator and Leads Devices Branch), and an Expert Scientific Reviewer and Electronics Engineer. In his early career, Mr. Shein was a Patent Examiner with the US Patent & Trademark Office, responsible for reviewing devices that applied electricity to the body for therapeutic purposes.
Mr. Shein is an expert in premarket regulatory pathways for medical devices with specialized expertise in cardiovascular implantable electronic devices (CIEDs). His expertise extends to related areas including cardiac electrophysiology, electromagnetic compatibility and electromagnetic interference (EMI) of active implantable devices, the clinical impact of exposing patients with active implantable devices to the electromagnetic environment specific to magnetic resonance (MR) imaging, and clinical trial design for electrical stimulation therapies to treat cardiac dysrhythmia and heart failure.
According to David Feigal, MD, MPH, head of the NDA Partners’ Medical Device Practice area, “Mr. Shein brings a deep base of knowledge and expertise for working with our medical device clients, not only in cardiovascular implantable electronic devices, but across the board in medical device development and regulation”. “We are delighted that he has joined the NDA Partners team.”
Mr. Shein earned a BS in Biomedical Engineering from Duke University and a MS in Physiology from Georgetown University. He is a registered US Patent Agent and a member of several professional societies, including the Association for the Advancement of Medical Instrumentation; Heart Failure Society of America; and a Fellow of the Heart Rhythm Society.
About NDA Partners
NDA Partners is a strategy consulting firm specializing in expert product development and regulatory advice to the medical products industry and associated service industries such as law firms, investment funds and government research agencies. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and virtual product development teams.
Earle Martin, Chief Executive Officer