The Regulatory Foundation: Getting It Right Before You Build
For early-stage MedTech founders, regulatory strategy isn’t a late-stage checkbox, it’s a foundational decision that shapes everything downstream, from your FDA pathway to your funding story to how you eventually get paid.
In this fireside conversation, former FDA reviewer Sam Murray walks through the decisions that matter most before you build. We’ll cover how your intended use and your own claims define your regulatory reality, how to read your risk class and map the right pathway (510(k), De Novo, or PMA), the low-cost early moves that get you FDA’s read before you’re locked in, and what SBIR/STTR reviewers actually want to see in your commercialization plan. We’ll close with why regulatory and reimbursement timing should be planned together and how getting it right early is the cheapest course-correction there is.
Bring your questions for a live audience Q&A to wrap.
About the Speakers
Sam Murray, Head of Regulatory & Quality, PRIA Healthcare
Sam leads PRIA’s regulatory affairs and quality division, providing strategic leadership to life sciences and medical device companies navigating complex regulatory pathways and quality system challenges. He advises executive leadership teams, investors and diligence teams, product development organizations, and regulatory and quality leaders on regulatory strategy, global product approvals, and scalable quality system design across the full product lifecycle.
Sam’s background spans medical devices, diagnostics, combination products, and software-enabled technologies. His primary areas of expertise include U.S. regulatory strategy, global regulatory submissions including European MDR and IVDR implementation, quality system development and remediation, design controls, risk management, and regulatory authority engagement. He has led and supported regulatory programs that enabled global marketing authorizations and reduced time to commercialization. In addition to founding and leading an independent regulatory and quality consultancy supporting medical device manufacturers globally, Sam has also held senior leadership roles at Advanced Instruments and Formlabs, where he built and scaled global regulatory and quality organizations, established multi-site quality systems, and led acquisition due diligence, assessing regulatory risk, quality system maturity, and post-close integration needs. Sam previously served as a medical device investigator with the U.S. Food and Drug Administration, conducting domestic and international inspections and driving compliance and enforcement actions.
Suzy Engwall, Senior Director, Global Business Development and Strategic Growth, PRIA Healthcare
Suzy is a healthcare innovation and commercialization executive, who has spent nearly two decades helping MedTech companies navigate the complex journey from product development to market adoption. She has extensive experience across the MedTech ecosystem, spanning startups, accelerators, health systems, GPOs, and international markets, connecting clients with strategic guidance and expertise they need to successfully commercialize their technologies.
Before joining PRIA, Suzy founded and led HealthTech Strategies, a consulting firm specializing in U.S. market entry strategy, GPO contracting, and commercialization. She previously served as VP of Early MedTech Development at Alira Health, advising emerging MedTech companies on clinical and commercial strategy. As National Director of the Innovation Lab at the Innovation Institute, she managed a multi hospital innovation program that brought 21 products to market, including licensing agreements with CVS and OrthoPediatrics. She designed and facilitated accelerator-style programming, including hackathons, innovation sprints, and pitch showcases, and guided participants through the process of refining, patenting, and launching their inventions.
A recognized thought leader and speaker across the MedTech ecosystem, Suzy has served as director and mentor for the Founder Institute HealthTech program, was on advisory boards for ASU’s Edson College of Nursing and Health Innovation, the UC Riverside Design Thinking Program, and currently serves on multiple startup advisory boards, including the Board of Directors of Actuated Medical.
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