Stuart Portnoy, MD
Prism Medical Device Consulting

Principal Consultant
stuartportnoy at PrismMD dot com
5151 10th Rd. N
Arlington, VA 22205

Expert at gaining approval for new medical devices across a wide range of therapies. Five years consulting experience for start-ups and well-established companies. Eight years at FDA reviewing or supervising review of hundreds of cardiac device applications along multiple pathways: IDEs, PMAs, and 510(k)s. Extensive experience in developing successful regulatory strategies and negotiating regulatory, clinical, and technical issues with FDA.

Medical Device Consultant Washington, DC 2002-Present
Prism Medical Device Consulting


Biologics Consulting Group




Advise medical device makers on regulatory strategy, clinical trial design, and technical issues to gain FDA market-approval for new products.
Food and Drug Administration Rockville, MD 1994-2002
Acting Deputy Director, Division of Cardiovascular Devices


Assisted Director in managing 70-person cardiac device review division.

Managed high-profile projects, clinical and scientific personnel, administrative staff, and made decisions for approval of cardiac devices.
Branch Chief, Interventional Cardiology Devices Branch


Managed a team of engineering and medical reviewers. Assigned manufacturers’ submissions to team members. Reviewed, edited, and signed-off on team’s work.

Negotiated clinical trial design and FDA approval requirements with device manufacturers.

Developed approach to regulating combination products, especially drug-eluting stents.
Medical Officer


Reviewed and approved or disapproved wide range of cardiac devices.

Negotiated with medical device manufacturers on FDA requirements for clinical trial design, product labeling, post-approval studies, and device recalls.
Biomedical Engineering Research Experience
VA Medical Center Washington, DC 2001-2002

Researched underlying mechanisms of arrhythmias that result in sudden cardiac death and published research results in Journal of American College of Cardiology (JACC).
Weizmann Institute of Science Rehovot, Israel 1985-1986

Optimized a technique for growing human cells on industrial-grade synthetic fabrics.

Harvested tissue plasminogen activator for use in treating heart attack patients.
MIT - Lab of Dr. Robert Langer Cambridge, Massachusetts 1984-1985

Designed/performed experiments investigating techniques for controlled drug delivery.
Organization / Event / Publication Role Year
Stanford University Biodesign Fellowship Program Project Team Advisor 07-17
ASEAN -- Medical Device Global Harmonization Regulatory Workshops COUNTRIES

  •  Funded by US Department of Commerce and USAID

Vietnam 2015

  •  Joined other Highly Knowledgeable Medical Device Regulatory Experts

Malaysia 2014

  •  Trained Asia-Pacific Regulator/Life-Scientists

Singapore 2013

  •  Sessions included Clinical Evidence and Clinical Study Design

Regulatory Affairs Professionals Society (RAPS) Conferences ROLE

  •  Drug Delivery Systems for Biologic Therapeutics / Annual Meeting

Speaker 2011

  •  FDA Regulation of Nanotechnology / RAPS Horizons West Coast Conf.

Speaker 2009

  •  Conference Planning Leadership

• Committee Member


• Track Chair


• Conference Chair

Planning for a Successful Pre-IDE Meeting -- ComplianceOnline Webinar Speaker 2010
Seton Hall Law School -- Advertising & Promotion of Medical Devices Lecturer 04-09
International Vulnerable Plaque Meeting Speaker 2007
Center for Business Intelligence (CBI) -- Combination Products Conference Conference Chair 2005
Advertising & Promotion of Medical Devices - Journal of Health Law Publication 2006
Combination Products - Regulatory Strategy for Preclinical & Drug Testing Medical Device & Diagnostic Industry Magazine, Co-author: Steve Koepke Publication 2005
Medical Device EMI: FDA Analysis of Incident Reports, and Recent Concerns for Security Systems and Wireless Medical Telemetry D. Witters, S. Portnoy, J. Casamento, H. Bassen; IEEE International Symposium Publication 2001
Electrocardiographic Indexes of Dispersion of Ventricular Repolarization - JACC Publication 1995
George Washington University Hospital, Internship in Internal Medicine 1992
George Washington University School of Medicine, MD 1991
University of Pennsylvania, MS in Bioengineering 1989
Tufts University, BS in Chemical Engineering, Cum Laude 1985
Licensed to Practice Medicine in Virginia Licensed since 1992
Heart Rhythm Society Member since 2002