Spotlight Speaker: Clinical Design & Endpoints — Dr. Mylea Charvat & Maital Rasmussen
Spotlight Speaker: Clinical Design & Endpoints — Dr. Mylea Charvat & Maital Rasmussen
Dr. Mylea Charvat and Maital Shemesh-Rasmussen from GLX Analytics reveal why brilliant science alone won’t generate revenue—and what neurotech and diagnostic founders must master to reach paid adoption. If you’re building medical devices or diagnostics, this masterclass is your roadmap from FDA clearance to sustainable reimbursement.
Learn how to navigate the three FDA pathways (510(k), de novo, and PMA), decode substantial equivalence and predicate strategy, and use pre-submission meetings to de-risk your raise. Discover why analytical and clinical validity are only the entry ticket: lasting reimbursement depends on clinical utility—changing behavior, improving outcomes, and lowering cost.
This session matters because most founders design trials for regulators, not payers—then wonder why coverage stalls. You’ll distinguish FDA pathways by risk class and timeline, define substantial equivalence and build predicate comparison tables, use pre-submission meetings strategically to lower investor risk, separate the ACCE diagnostic-evidence tiers, map the fragmented U.S. stakeholder landscape, and navigate reimbursement mechanics—CPT vs. PLA codes, crosswalk vs. gapfill pricing, and why coverage ≠ payment. Walk away ready to design commercialization strategy from day one, not bolt it on after approval.
Learning Objective
Distinguish the three FDA pathways — 510(k), de novo, and PMA — by risk class, evidence burden, timeline, and cost, and explain when a predicate makes the 510(k) the fastest path to revenue.
Define substantial equivalence (same intended use; same or different-but-safe technology that raises no new questions) and build predicate comparison tables.
Use FDA pre-submission meetings strategically to lower “FDA risk” for investors, and understand why documenting agency sign-off protects you when reviewers change.
Separate the diagnostic-evidence tiers — analytical validity, clinical validity, and clinical utility (the ACCE framework) — and recognize that utility (changing behavior, improving outcomes, lowering cost) is what payers reimburse.
Map the fragmented U.S. stakeholder landscape (patients, providers, for-profit payers, CMS, pharma) and design endpoints, evidence, and messaging tailored to each.
Navigate reimbursement mechanics — CPT vs. PLA codes, crosswalk vs. gapfill pricing, medical policy vs. contract, and why coverage ≠ a code ≠ payment — plus the role of guidelines and real-world evidence.
Resources
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