NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Mitchell Shein, MS

Practice Area Focus

  • Medical Devices
  • Regulatory Strategy
  • Development Strategy
  • Clinical Trial Design

Biography

Mitchell Shein joined NDA Partners as an Expert Consultant in 2016. Mr. Shein is an accomplished Biomedical Engineer with an extensive career at the FDA Center for Devices and Radiological Health (CDRH) where he was formerly Deputy Director, Division of Cardiovascular Devices; Branch Chief and Supervisory Electrical Engineer, Implantable Electrophysiological Devices (formerly the Pacing Defibrillator and Leads Devices Branch); Expert Scientific Reviewer and Electronics Engineer, Pacing Defibrillators and Leads Branch. In his early career, Mr. Shein was a Patent Examiner with the US Patent and Trademark Office, responsible for reviewing devices that applied electricity to the body for therapeutic purposes.

Mr. Shein is an expert in cardiovascular implantable electronic devices (CIEDs), with an emphasis on the premarket regulatory pathways for medical devices. His other areas of interest include 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.

Mr. Shein is a registered US Patent Agent. He is also a member of several professional societies including Association for the Advancement of Medical Instrumentation; Heart Failure Society of America; and a Fellow of the Heart Rhythm Society.