Physician Advisors

Kush R Desai, MD

Interventional Radiologist, Physician Leader in Value Analysis/Supply Chain 

  • Associate Professor of Radiology, Surgery, and Medicine at Northwestern University Feinberg School of Medicine
  • Director of Deep Venous Interventions as well as Systemwide Medical Director of Supply Chain/Value Analysis at Northwestern Memorial HealthCare
  • National and Global Principal Investigator of numerous device trials
  • Associate Editor of the Journal of Vascular and Interventional Radiology (JVIR)
  • Over 150 peer-reviewed manuscripts and book chapters

Michael Lichtenberg, MD

European-based Angiologist; Physician Leader in Advising Medical Device Innovation

  • Chief Medical Officer, Angiology Clinic and Vascular Centre Arnsberg and Chief Medical Officer, German Venous Centre Arnsberg
  • Chief Executive Officer Vascular Scientific Department Arnsberg
  • President of the German Angiology Society (DGA)
  • Numerous peer-reviewed manuscripts and book chapters

Mahmood Razavi, MD

Interventional Radiologist with Extensive Experience in New Device Development and Commercialization

  • Director of Clinical trials at the St. Joseph Heart & Vascular Center
  • Founder or Co-Founder of 6 medical device companies including Trivascular, Mitral Interventions, Neuravi, DeVoro Medical, R3 Vascular, and Razmodics with an exit value of over $800 million to date
  • Past Chief Medical Officer of 4 early stage companies focused on development and commercialization of medical devices
  • National or Global Principal Investigator of 15 sponsored clinical trials
  • Author of over 300 peer reviewed manuscripts, abstracts, and book chapters

Eric Secemsky, MD

Interventional Cardiovascular Specialist and Healthcare Analytics Expert

  • Director of Vascular Intervention Beth Israel Deaconess Medical Center, Boston, MA
  • Section Head of Interventional Cardiology and Vascular Research: Richard A and Susan F Smith Center for Outcomes Research with prolific real world big data evaluations and international expertise in clinical trial design and implementation
  • Over 200 peer reviewed publications 
  • Chair of the National Pulmonary Embolism Consortium Research Committee

Patrick Troy, MD

Pulmonary and Critical Care Leader with a Focus on Value Analysis

  • Assistant Professor of Clinical Medicine at the University of Connecticut School of Medicine
  • Division Director of Pulmonary, Critical Care and Sleep Medicine, Hartford Hospital in Hartford, Connecticut
  • Leader in healthcare team dynamics
  • Active Advisor/Consultant for large medical technology companies and venture-backed start-up companies

Healthcare Economics Advisors

Peter Markell

Health System Senior Executive and Finance Leader

  • Executive Vice President and Chief Financial Officer for Lifespan
  • Former Vice President of Administration and Finance, Chief Financial Officer and Treasurer, Mass General Brigham for 22 years.
  • Audit Partner, Ernst and Young
  • Certified Public Accountant
  • Extensive insight into healthcare administration, technology, supply chain management, physician interaction, and finance.

Regulatory & Engineering Advisors

Dorothy Abel, BSBME

Regulatory Specialist

  • Retired senior regulatory review scientist with over 30 years’ experience as the FDA expert in vascular and endovascular devices.  
  • Former FDA primary liaison to various medical professional societies to develop least burdensome clinical evaluations for vascular and endovascular grafts. 
  • Co-founder of the Early Feasibility Study Program and participant in additional CDRH initiatives to promote innovation in medical devices.  
  • Convener or project leader for the ISO Vascular Prostheses Committee for over 25 years, co-leading the development of standards for vascular grafts, endovascular grafts, and vascular stents, with participation in the standardization of vena cava filters.
  • American Institute for Medical and Biomedical Engineering (AIMBE) Fellow.
  • Focus areas include device evaluation strategy development, clinical evaluation strategic planning, FDA submission planning, drafting or review of FDA submissions, and FDA meeting support.

Marjorie Shulman, MBA, RAC

Regulatory Specialist Instrumental in the 510(k) Pathway Development

  • Retired senior regulatory review expert with over 37 years’ experience at FDA
  • Former Assistant Director of the Premarket Notification Program (510(k)), De Novo, 513(g), Device Determination and Custom Devices Lifecyle Team 
  • Oversight and coordination of regulatory, scientific, and administrative review of premarket notifications (510(k), De Novo, 513(g), Custom Device, device determination, classification, and reclassification submissions
  • Developed appropriate guidance, guidelines, and educational materials for 510(k) and classification and reclassification activities for the Agency and the Medical Device Industry. Led and supervised the 510(k)/De Novo/513(g) staff
  • Provided training to FDA Panel Members and attendees regarding appropriate classification and reclassification of medical devices

Ben Wolf

Mechanical Engineering Consultant

  • Mechanical Engineer with 20+ years of industry experience
  • R&D, design controls, product development of cardiovascular implants and ancillary devices
  • Development of in vivo boundary conditions for use in device development, computational analysis, and non-clinical testing
  • Test method development expertise for devices, including aortic, peripheral vascular, and heart valve devices
  • Cardiovascular implant durability testing and computational modelling methods and strategies
  • Extensive experience in root cause analysis for bench and clinical device failures