Hardware Podcasts

104: Medical Device Certification vs Wellness Device

Product Startup · 1 Dec 2021 · 23m

What this episode covers

Bryon Bhagwandin, a medical device entrepreneur with a PhD from the University of Washington, explains the critical differences between wellness and medical devices, emphasizing that medical clearance allows sales into clinical settings. He details the three pillars of medical certification: safety, efficacy (verification and validation), and manufacturing consistency, noting that hand-built prototypes cannot be certified without statistical proof of uniform production. Bhagwandin advises that while wellness devices are cheaper to launch, starting with a medical device strategy is often superior because it opens higher-margin B2B channels and allows for easier transition to consumer markets. He also suggests that founders can leverage user data from existing wellness products to support the regulatory submission of a redesigned medical version, provided they maintain rigorous quality and avoid feature creep.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Eli Lilly, Mako Design + Invent
Also
FDA, R&D Magazine

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