Dorothy Abel

Vice President, Regulatory Strategy

Dorothy Abel had a highly accomplished career with the U.S. Food and Drug Administration (FDA) in the Center for Devices and Radiological Health (CDRH), leading the evaluation of vascular and endovascular surgical devices for over 30 years. Joining Syntactx in January 2020, Dorothy provides expert assistance in developing and communicating evaluation strategies, helping clients achieve regulatory approvals and product adoption worldwide.

During her time at FDA, Dorothy pioneered approaches for the evaluation of vascular and endovascular surgical devices in collaboration with FDA colleagues and members of professional surgical societies and international voluntary standards committees. Examples of her efforts included leading the organization and execution of two FDA workshops on the preclinical testing of endovascular prostheses which incentivized the later Greenberg Stent Summits, and working with surgical societies and device manufacturing representatives to develop least burdensome clinical study designs for abdominal and thoracic endovascular prostheses. Several of these approaches are now reflected in FDA programs and initiatives such as the documentation of a device evaluation strategy for early feasibility study applications, the use of real-world evidence to develop performance goals, and applying the appropriate balance of pre- and post-market clinical evaluation. Additionally, Dorothy has led the development of several international standards for vascular devices, including surgical vascular grafts, endovascular grafts, vascular stents and vena cava filters.

Dorothy holds a Bachelor of Science in Biomedical Engineering from the University of Iowa and is a fellow of the American Institute for Medical and Biological Engineering. Dorothy has co-authored over 50 scientific articles, co-initiated the Greenberg Stent Summit, and is the recipient of several honors including the 2006 FDA Civil Service Civil Engineer of the Year and the 2017 CDRH Group Recognition Award for the Endovascular Devices Standards Team.

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