Hardware Podcasts

#449: 7 Pitfalls of International MedTech Expansion

Global Medical Device Podcast · 2 Mar 2026 · 48m · Episode 449

What this episode covers

Mike Drues, President of Vascular Sciences, joins host Etienne Nichols to discuss the regulatory pitfalls international medical device companies face when expanding into the U.S. market. Drues challenges the assumption that a CE Mark guarantees FDA clearance, explaining that different labeling or claims technically create different devices, which complicates Quality Management Systems and post-market surveillance. He outlines seven key mistakes, including assuming U.S. standards match international ones, failing to synchronize regulatory and reimbursement strategies early, and unnecessarily repeating clinical trials when outside-the-U.S. data can be leveraged.

Most relevant to

companies scaling up

Topics

Mentioned

Companies
Vascular Sciences, Greenlight Guru, FDA, CDRH
Also
ISO 10993-1, ChatGPT

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