Industry Ignited Podcast · 2026-02-12 · 36 min
In this episode of Industry Ignited , host Dr. Leeanne Aguilar sits down with Lisa Voronkova , CEO of Ova Solutions and author of Hardware Bible: Build a Medical Device from Scratch , to unpack the real reasons medical devices fail, not in the lab, but in the real world. Lisa shares hard-earned lessons from her own founder journey, including the classic trap of building around “cool tech” instead of solving a real clinical and commercial problem. Together, they explore what founders consistently underestimate: manufacturing realities, clinical adoption, reimbursement strategy and what truly happens after FDA clearance. This conversation dives into why FDA approval is a milestone, not the finish line and how many startups get stuck in the “valley of death” between prototype and real revenue. Lisa explains the difference between building a prototype and designing for manufacturability, why hospital purchasing decisions are more complex than most founders realize, and how reimbursement can determine whether a breakthrough device ever reaches patients.
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