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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. 𝐈𝐧𝐝𝐮𝐬𝐭𝐫𝐲 𝐈𝐠𝐧𝐢𝐭𝐞𝐝 https://industryignited.com/ 𝐈𝐧𝐬𝐭𝐚𝐠𝐫𝐚𝐦 / industryignited 𝐅𝐚𝐜𝐞𝐛𝐨𝐨𝐤 / industryignited 𝐋𝐢𝐧𝐤𝐞𝐝𝐈𝐧 / industry-ignited 𝐒𝐩𝐨𝐭𝐢𝐟𝐲 https://open.spotify.com/show/3TX1L5L... 𝐀𝐩𝐩𝐥𝐞 𝐏𝐨𝐝𝐜𝐚𝐬𝐭 https://podcasts.apple.com/us/podcast... 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 #podcasts #podcasts #podcastshorts #podcastinterview #podcastlife #businessgrowth #industryignited #drleeanneaguilar #lisavoronkova #medicaldevices #medicine #innovation #leadership