A Medical Device Roadmap for Startup Founders

A Hands-On Workshop with NAMSA Building a medical device means more than getting a great product to work. You also have to prove it's safe, show it works, and convince regulators, payers, and clinicians along the way. Most founders learn this the hard (and expensive) way. Join NAMSA's experts at Bounce Innovation Hub for an afternoon that walks through the full medical device product life cycle, from early lab testing through clinical studies and postmarket requirements. You'll learn how to build a regulatory strategy that works as your North Star, one that lines up with your funding milestones, drives valuation, and positions you for strategic partnerships. The afternoon ends with something rare: one-on-one mentoring time with speakers, so you leave with advice specific to your company, not just general best practices. The first eight registrants are guaranteed to meet with a NAMSA expert. Additional meeting times may be available. Event Details 📅 Date: Thursday, October 15, 2026 🕧 Time: 12:30 PM – 5:15 PM (networking starts at 12:30; program begins at 1:00) 📍 Location: Bounce Innovation Hub, Akron, OH 🍩 Light Refreshments Provided What We'll Cover • The Total Product Life Cycle: how to plan your development strategy backward from your Instructions for Use (IFU), and the "3-legged stool" every device company needs • When and why to bring in consultants: why regulatory approval is necessary but not enough, and how reimbursement and clinical adoption fit into your plan • Lab testing essentials: analytical chemistry, biocompatibility (ISO 10993), sterilization and microbiology, GLP vs. non-GLP studies, animal studies, and building toward your IDE application • Clinical studies demystified: early feasibility and first-in-human vs. pivotal studies, phased study designs, using data from outside the US, and why human factors matter • Biostatistics: an introduction to the role statistics plays in medical device development, including how early statistical planning can shape study design and strengthen the evidence behind your device • Life after clearance: postmarket studies, PMCF, 522s, post-approval studies, real-world evidence, and planning for indication expansion What You'll Walk Away With • A clear picture of the full path from prototype to market, and what comes after • A framework for building a regulatory strategy that supports fundraising and partnerships • A better sense of which testing and studies you need, when you need them, and how to avoid costly repeat work • Individualized feedback from NAMSA experts in dedicated 1:1 sessions • Connections with fellow founders and medtech professionals How to Prepare To get the most out of your 1:1 mentoring sessions, come ready with: • A short (1–2 minute) overview of your device, its intended use, and your target patient population • Your current stage of development (concept, prototype, testing, clinical, etc.) • Your likely regulatory pathway if you know it (510(k), De Novo, PMA), or questions about it if you don't • Your next major funding milestone and timing • One or two specific questions or challenges you want expert input on