Payers Don't Care what FDA Considers Safe and Effective, with Erik Harris

Getting FDA clearance is not a business goal. It is a milestone on the way to one. The goal is revenue in year one, year two, year three — and if a startup's pitch deck doesn't show how reimbursement dynamics support that revenue, sophisticated investors will notice before founders do.In this episode, Erik Harris, founder of Market Access Solved, joins Dan Mazzucco to demystify the market access and reimbursement landscape for early-stage medtech companies. They discuss the three pillars of reimbursement — coding, coverage, and payment — and when a product can legitimately fly under the radar of payer scrutiny, why payers don't care what the FDA considers safe and effective and what they actually care about instead, how coverage policies are really non-coverage policies in disguise, why label language drafted without a market access expert can be used against a company by payers, and how to design clinical trials that serve both FDA requirements and payer evidence standards without losing focus.This conversation is for medtech founders, executives, and investors who know reimbursement matters but haven't yet figured out when to start — and how much it affects everything else they're building.Erik Harris is the founder of Market Access Solved, a strategic and tactical market access and reimbursement consultancy specializing in U.S. and international medical device markets. With over 30 years of experience spanning device manufacturers including Zimmer, Wright Medical Technology, BioMimetic Therapeutics, and Moximed, as well as provider and payer organizations, Erik brings a rare 360-degree perspective to reimbursement strategy. He provides due diligence support to venture capital and private equity firms on M&A and investment activities, advises startups on pricing strategy within reimbursement, and conducts commercial payer coverage landscape assessments. He is a presenter and CEO mentor at ZeroTo510 Medical Device Accelerator, the 8400 Health Network's U.S. Market Access Symposium, and Peak Spirit Academy in the DACH region.Theme Music: Prelude, composed andperformed by Benjamin Mazzucco, © 2026. Used with permission.