#408: What MedTech Startups Miss: Design Mistakes, Risk Testing & the Myth of the Quick Exit

Global Medical Device Podcast · 26 May 2025 · 9m · Episode 408

What this episode covers

Justin Bushko, author of Medical Device Fireside Chats, explains why early-stage MedTech startups fail by ignoring critical engineering details like tolerance stack-up analysis and human factors testing. He highlights the risk of field failures, such as cranial fixation devices breaking under surgeon torque, and emphasizes the need to validate designs with a broad group of Key Opinion Leaders (KOLs) rather than just a few. Bushko advises founders to build sustainable companies with longevity rather than chasing quick licensing deals or acquisitions, noting that acquirers can detect an exit-first mindset.

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