From Bench to Bedside: Navigating MedTech Product Development with NAMSA

Building a medical device or diagnostic company means navigating preclinical testing, clinical trials, regulatory review, reimbursement, and fundraising, often all at once. In this half-day, interactive session, NAMSA's regulatory, preclinical, and entrepreneurship consultants join CED to work directly with founders on the real challenges facing their companies right now.

This session moves past general overviews and into the specifics: what to test, when to engage consultants, how to fund each stage, and how to navigate regulatory and reimbursement pathways. The day closes with 1:1 breakout mentoring, so each company gets dedicated time with every speaker.

📅 Thursday, August 6, 2026
⏰ 8:00 – 12:00 p.m.
📍 523 Davis Dr #523, Suite 200, Morrisville, NC 27560

 We'll Cover

• Where to Start: The Total Product Life Cycle, starting with the end in mind, and the three legged stool of success
• Consulting When, Why, and How: building a living regulatory strategy and positioning around funding milestones and valuation inflection points
• Funding Your Company: dilutive vs non-dilutive capital, angel through Series A/B/C, strategic investors, and building your money slide
• Lab and Preclinical Testing: biocompatibility, sterilization, non-GLP and GLP studies, and supporting your IDE application
• Clinical Studies: EFS/FIH vs pivotal studies, US vs OUS data, and the role of human factors
• Postmarket Studies: PMCF, 522s, PAS, and real world evidence for claims expansion
• 1:1 Breakout Mentoring: a dedicated 10 minute session with each NAMSA speaker

You'll Walk Away With

• A clear framework for sequencing preclinical and clinical testing against your product's regulatory pathway
• A sharper understanding of when and how to engage outside consultants without wasting time or capital
• Direct, personalized feedback on your pitch deck and your toughest open questions from NAMSA's consultants
• A practical view of funding mechanisms and how to position your company for each stage of investment

Come Prepared
Bring a pitch deck you're comfortable sharing with the room and two or three critical questions you want NAMSA's consultants to answer during your 1:1 session.

Facilitators:

NAMSA

Adam Saltman

Adam E. Saltman, M.D., Ph.D., is Chief Medical Officer at NAMSA and at HyperSpectral.ai, bringing a rare combination of clinical, regulatory, and industry expertise to medical device product development. He trained in cardiothoracic surgery at Harvard before joining the FDA's Center for Devices and Radiological Health, where he led cross-cutting policy revisions on benefit-risk and corrections and removals. A fellow of the American College of Surgeons and the American College of Cardiology, he has published more than 100 peer-reviewed articles and holds board certifications in surgery, thoracic surgery, and clinical informatics.

NAMSA

Michael Frie

Michael Frie is Associate Vice President of Business Development at NAMSA, where he supports medical device innovators across laboratory testing, biological safety consulting, and preclinical development services. With more than two decades of MedTech experience, he brings deep expertise in GLP and non-GLP preclinical study design, animal model selection, and regulatory submission support, backed by scientific and operational roles at Boston Scientific and American Preclinical Services spanning vascular, neurovascular, transcatheter valve, and cardiac mapping programs. He holds a bachelor's degree in biology from the University of Minnesota.

NAMSA

John Pigott

John Pigott MD is a Vascular Surgeon with a longstanding interest in medical device commercialization. He also served as the Chief Innovation Officer at a healthcare system in Northwest Ohio where he and his team assisted in the advancement and funding of early stage medical technologies. He remains involved in healthcare entrepreneurship and investing and has founded two medical device companies in the cardiovascular space.