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

Andrew Holden, MBChB, FRANZCR, EBIR, ONZM

New Zealand-based Interventional Radiologist with Extensive Experience in Medical Device Development and Early Human Trials

  • Director of Northern Region Interventional Radiology Service and Professor of Radiology at the University of Auckland. Co-Director of the Vascular Intervention Research Unit at Auckland Hospital.  
  • Co-Director of the Charing Cross Symposium in London.
  • Has been involved in over 100 medical device trials, often as Principal Investigator, including many “first in human” trials .
  • Author of over 150 articles in peer reviewed journals and five book chapters. He has presented over 700 times at major scientific meetings.
  • Past-President of the Asia-Pacific Society of Cardiovascular and Interventional Radiology (APSCVIR). 
  • Awarded an Officer of the New Zealand Order of Merit (ONZM) medal for his contribution to vascular and endovascular interventions.

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 at the Richard A and Susan F Smith Center for Outcomes Research
  • Prolific researcher with extensive real world big data evaluations and international expertise in clinical trial design and implementation. His research involves utilizing real-world data to perform comparative effectiveness and outcomes research, with a focus on the treatment of peripheral vascular disorders. 
  • 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, CPA

Health System Senior Executive and Finance Leader

  • Executive Vice President and Chief Financial Officer, Brown University Health
  • 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.

Paul Rudolf, MD, Esq

Reimbursement Specialist

  • Physician and lawyer widely recognized for his ability to assist clients in navigating the Medicare regulatory environment.  
  • Extensive experience serving as a Medicare Part A/B Contractor Medical Director as well as leading the development of hospital, physician, and clinical laboratory payment policies at the Centers for Medicare & Medicaid Services (CMS). 
  • Represented CMS at the Current Procedural Terminology (CPT) Editorial Panel and the AMA/Specialty Society Relative Value Update Committee 
  • After leaving the government, was a partner at the law firm Arnold & Porter for 15 years.  
  • Currently advises a wide range of clients on Medicare coding, coverage, and reimbursement issues.  
  • Works at the intersection of FDA and CMS regulations to help clients develop product development strategies that are most likely to result in Medicare coverage and payment. 
  • Regularly meets with CMS staff and political appointees on a wide variety of issues related to coverage and payment.
  • Clients range from large publicly traded manufacturers, to venture funded mid-stage companies, to early-stage angel funded start-ups, and include physicians, clinical laboratories, independent diagnostic testing facilities, medical device companies, and developers of remote monitoring equipment, software and artificial intelligence

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.

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