PRINCIPAL REGULATORY SPECIALIST
Joined: August 20, 2026
Over 15 years I have taken 9 devices building them from ideas on a whiteboard through FDA and CE clearance, and now work on 510(k), De Novo, and pre-sub strategy for AI SaMD at Innolitics. I have helped clients raise $22mn in grants and $25mn in seed capital. On an engagement I own product, regulatory, and reimbursement together: I set the claims, design the validation study, run the pre-sub, and carry the 510(k) or De Novo through FDA questions with CMS coverage in view from day one. I developed the firmware and co-authored the 510(k) for a bedside device data platform cleared in 2011/2013 and deployed to 5,000 beds across 12 health systems, led product for the 2008T BlueStar hemodialysis machine cleared in 2018, and won FDA agreement on validation designs for five AI imaging devices, saving one client over $400K. At Innolitics I work on 510(k)s for CT coronary calcium and body composition AI, a De Novo for an AI guided exercise therapy SaMD, and AI/ML pre-sub strategy for a teleradiology group. I hold an MS in Electrical Engineering from the University of Pennsylvania, five global patents, and a Stanford AI in Healthcare certificate, and I judge for MedTech Innovator and the CES Innovation Awards.
Over 15 years I have taken 9 devices through FDA and CE clearance, and now work on 510(k), De Novo, and pre-sub strategy for AI SaMD at Innolitics. On an engagement I own product, regulatory, and reimbursement together: I set the claims, design the validation study, run the pre-sub, and carry the 510(k) or De Novo through FDA questions with CMS coverage in view from day one. I co-authored the 510(k) for a bedside device data platform cleared in 2013 and later deployed to 5,000 beds across 12 health systems, led product for the 2008T BlueStar hemodialysis machine cleared in 2018, and won FDA agreement on validation designs for five AI imaging devices, saving one client over $400K. At Innolitics I work on 510(k)s for CT coronary calcium and body composition AI, a De Novo for an AI guided exercise therapy SaMD, and AI/ML pre-sub strategy for a teleradiology group. I hold an MS in Electrical Engineering from the University of Pennsylvania, five US patents, and a Stanford AI in Healthcare certificate, and I judge for MedTech Innovator and the CES Innovation Awards.
🥾Backpacking, 🛶 Canoeing