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. They also discuss when outsourcing R&D makes sense, where AI is creating meaningful opportunity in medtech, and the single most important question every founder must answer before building anything: Who will pay and why?

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Lisa Voronkova
https://www.linkedin.com/in/lisa-voronkova/
https://www.linkedin.com/company/ova-solutions/

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