Senior Advisors | Health Care Inroads

Physician Advisors

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

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

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

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

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

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.

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

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.

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

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