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 the past 15 years I took 9 medtech products from concept to clearance to product-market fit with deep involvement in product, regulatory and reimbursement.
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.
My regulatory and reimbursement work focuses on building an evidence layer within companies to give them the best shot at securing capital and customers.In the last three years I secured FDA agreement on validation study designs for five AI-enabled imaging devices spanning chest X-ray, lung CT, retinal OCT, brain MRI, and ultrasound, saving clients $400K+. On a wearable monitor, resolving skin-tone performance disparities let FDA cut the validation cohort by 75%. On another program, replacing an invasive reference method with a non-invasive one cut study cost by $800K and timeline by six months. Those wins move the business too — a $13M Series A closed, and $22M in non-dilutive NSF, NIH, and DoD funding secured for clients.My first two 510(k)s came at Nuvon, now part of Philips, 15 years ago. I helped build the platform — architected so that adding a new device driver was a letter to file rather than a new submission — cleared it with FDA, and scaled the deployment from 20 beds to over 5,000. At Fresenius Medical Care I led the launch of the 2008T BlueStar and brought the 5008x hemodiafiltration system — a new ESRD therapy — to North America, delivering two 510(k) clearances in 18 months for a complex therapeutic system.In 2021, I founded Anooka, a company that built exer-games using webcam based motion tracking for rehab, named as 2022 NASDAQ Milestone Maker. Building Anooka is where I got into Remote Therapeutic Monitoring policy, working on RTM and RPM reimbursement — work I still carry into client filings as CMS moves from TCET and NTAP toward RAPID.
I hold 5 global patents in wearables and therapeutics. I judge the CES Innovation Awards and MedTech Innovator, and peer review for BMJ Digital Health and AI. I hold an MS in Electrical Engineering from the University of Pennsylvania and a certificate in AI in Healthcare from Stanford.
🥾Backpacking, 🛶 Canoeing