Principal Consultant
CurrentProvide executive level consulting for start-ups and mid-stage medical device, diagnostics, imaging, companion diagnostics and biotech companies for US and international markets. Emphasis is on providing key strategies supporting market access, reimbursement, coding and valuation, pricing, product/service line development, contracting, health policy and economics, and government affairs activities. This also includes assisting with regulatory filings specific to Breakthrough Device designation, submitting applications for new technology add on payment (NTAP) and transitional pass-through (TPT), and managing commercial launches for devices awarded NTPA and TPT status. Strategies are aligned with an organization’s Research & Development, Clinical, Marketing, and Sales objectives for purposes of effective market product placement. Portfolio of clients include companies in Gastroenterology, Cardiology, Surgery, Imaging, Ear/Nose/Throat, and Oncology, including respective AI applications.