Hardware Podcasts

#461: Why Manufacturing is Part of Product Development with Mike Dolphin

Global Medical Device Podcast · 22 Jun 2026 · 47m · Episode 461

What this episode covers

Mike Dolphin, CEO of GuideStar Medical Devices, explains why manufacturing process development must be integrated into product design rather than treated as a post-development step. He details the engineering of a closed-loop epidural safety device, emphasizing early decisions on injection molding and radiation sterilization to ensure scalability. Dolphin highlights the financial and timeline risks of using contract manufacturers for iterative development, advocating for in-house manufacturing to reduce costs and accelerate FDA 510(k) clearance.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
GuideStar Medical Devices, JPL, SpaceX
Also
FDA, 510(k)

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