Hands-on leader with extensive entrepreneurial background having initiated 3 start-up healthcare technology companies, two of which were successfully taken public (IPO), and the third sold to a leading public healthcare products company. Solid accomplishments in fund raising (i.e.$50 million), negotiation of high-level partnerships, corporate contracts and distribution agreements, (e.g., Stryker Medical, Amsco, Lumex, Allergan, Wyeth Pharmaceutical, Select Medical). Extensive experience in regulatory matters with FDA and CMS (Medicare) reimbursement. Personally secured 510-K clearance and directed counsel in a successful effort to mount an official appeal and ultimate reversal of a “final” non-substantially equivalent determination by the FDA.