About Me

Innovation in medical technology requires more than a great idea - it requires the ability to make sound decisions in an increasingly complex regulatory environment.

For more than 20 years, I've worked at the intersection of innovation and regulation, helping medical device companies navigate complex regulatory challenges while bringing new technologies to patients. My experience spans a broad range of medical technologies, including software as a medical device (SaMD), ophthalmology, orthopedics, sports medicine, trauma, wound management, craniomaxillofacial (CMF), patient-specific devices, oncology, and digitally enabled manufacturing workflows. Throughout my career, I've developed regulatory strategies supporting both US FDA and European regulatory pathways, working with cross-functional teams from early product development through commercialization.

Today, I work independently with founders, investors, and growing medical technology companies to bring practical, business-focused regulatory insight to critical decisions. Rather than viewing regulatory as a hurdle, I help organizations use it as a strategic advantage—identifying risks early, aligning development plans with regulatory expectations, and supporting decisions that stand up to investor diligence and future growth.

My approach is grounded in a simple philosophy: good regulatory strategy should enable innovation, not slow it down. The best regulatory decisions are made early, are informed by both science and business objectives, and create a foundation for successful product development and long-term value.

Whether supporting an early-stage startup defining its first regulatory pathway or helping investors evaluate regulatory risk in a potential investment, my goal is the same: provide clear, practical guidance that helps teams make informed decisions with confidence.