Hardware Podcasts

#411: Unlocking U.S. MedTech Market Access: State-Specific Compliance Pitfalls Medical Device Companies Miss

Global Medical Device Podcast · 16 Jun 2025 · 48m · Episode 411

What this episode covers

Adam Steadman, CEO of MDD Options, explains the complex web of state-level compliance pitfalls that medical device companies face after FDA clearance, often called the 'second valley of death.' He details how definitions of medical devices, sales tax nexus, and income tax requirements vary drastically across the 50 states, creating significant barriers for both domestic startups and international entrants. Steadman warns against the risks of long-term exclusive distribution contracts that can stall growth and advises on the hidden costs of logistics and warehousing infrastructure that acquirers do not want. He proposes a hybrid go-to-market model where manufacturers retain control of sales while outsourcing regulatory, tax, and logistics compliance to specialized partners.

Most relevant to

companies scaling up

Topics

Mentioned

Companies
MDD Options, Greenlight Guru, Edwards, Endotronics, Stryker, Medtronic, Kaiser, Johns Hopkins, Cleveland Clinic, Veterans Health Administration
Also
FDA, 510(k), PMA

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