Your Medical Device Will Fail If You Ignore This | Ep. 67 [Lisa Voronkova]

Описание: Why do so many medical devices fail, not in the lab, but in the real world?

In this episode of Industry Ignited, 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 hard truths about bringing medical devices to market.

With experience building over 200 medical devices, Lisa shares what most founders get wrong and why FDA approval is not the finish line. If you're a medtech founder, physician innovator, engineer, or investor, this conversation could save you years of costly mistakes.

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0:00 Why Most Medical Devices Fail Before Reaching Patients
2:33 From Failed Startup to 200 Plus Devices Built
5:32 From Engineer to CEO: The Hardest Transition
10:24 The Biggest Gap Between Prototype and Market
11:12 Why FDA Approval Is Not the Finish Line
13:43 The 7 Year Reality of Bringing a Device to Market
14:46 When to Outsource R&D vs. Build In House
21:22 Engineering Success but Business Model Failure
30:37 AI in Medical Devices Opportunity and Risk
33:17 The One Question Every Founder Must Ask Before Building

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