If you want to make your medical devices more sustainable, let's talk—: https://calendly.com/lucas-pianegonda-gradical/discovery-call-gradical

Most MedTech founders build the wrong device because they skip the steps that actually matter before the engineering starts.

Lisa Voronkova is CEO of OVA Solutions, an R&D shop that has developed over 200 medical devices from scratch, and author of Hardware Bible. In this episode, she breaks down exactly where founders go wrong, what the development process actually looks like from clinical need to commercialization, and why FDA clearance is really just your entry ticket into the real competition.

We also get into how lean startup thinking translates (and doesn't translate) to MedTech, why manufacturing decisions belong in phase two, how to document without losing your mind, and where sustainability has a real seat at the design table.

Lisa's number one piece of advice: don't build anything until you've validated the problem. The most expensive mistake in MedTech is building the wrong device.

🔗 CONNECT WITH LISA VORONKOVA:

OVA Solutions: https://ovasolutions.com/

LinkedIn: https://www.linkedin.com/in/lisa-voronkova/

Hardware Bible: https://www.amazon.com/Hardware-Bible-Medical-Device-Scratch/dp/B0FB4XL71K

🔗 CONNECT WITH US:

🎧 Apple Podcasts – https://podcasts.apple.com/us/podcast/gradical-podcast-the-podcast-about-plastics-in/id1773569554

🟢 Spotify – https://open.spotify.com/show/4vNQ6rPE2CQUGgQtEY3sYq

📺 YouTube – https://www.youtube.com/@GradicalGmbH

🌍 Gradical: https://gradical.ch/

📩 Work with us: lucas.pianegonda@gradical.ch

#GradicalPodcast #MedTech #MedicalDevices #MedicalDeviceDevelopment #RegulatoryAffairs #MedTechStartup #FDA #HardwareDevelopment

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If you are a Medtech company struggling to make your devices more sustainable, let’s talk—BOOK A CALL HERE.