Lisa Voronkova, PhD, medical device development expert and CEO of OVA Solutions, talks on podcasts and in interviews about how medical devices get built and why they succeed or fail on the market. Each page below has a short summary, Lisa’s key answers and the full transcript, with links to the original episode.
Short on time? 54 of Lisa’s answers grouped by topic: cost, validation, FDA, wearables, choosing a partner.
Global Medical Device Podcast #470: The Real Cost of MedTech Innovation
September 22, 2026. Host: Etienne Nichols, Greenlight Guru. Podcast and video, 40 minutes.
What it really takes to get from an idea to a pre-production device: the four development phases, real engineering hours and costs, and design for manufacturing. Key answers and full transcript. Original: Greenlight Guru, YouTube.
ABRAIDI interview: The Challenge Is Getting the Device to Market
August 13, 2026. Host: José Luchetti, ABRAIDI (Brazil). Written interview, Lisa's original English answers.
Hardware Bible, the most common mistakes, validating the clinical need, market access, clinical studies in Brazil for the US market and AI in regulatory work. Key answers and full transcript. Original: ABRAIDI (Portuguese).
BoneChat #131: Lessons Learned Building Wearables for Orthopedics
June 18, 2026. Host: Tiger Buford. Live discussion, 60 minutes.
Why recovery data lives at home, the move from the wrist to the patch to the bone, smart implants and the engineering that decides whether a wearable ships. Key answers and full transcript. Original: YouTube.
MedTech Sustainability by Design: How to Build a Medical Device That Actually Sells
March 18, 2026. Host: Lucas Pianegonda, Gradical. Podcast and video, 46 minutes.
Validating the problem and the buyer first, the six phases of development, design freeze, life after FDA clearance, manufacturing and sustainability. Key answers and full transcript. Original: Spotify, YouTube.
Industry Ignited Ep. 67: Why Devices That Work Still Fail to Sell
February 12, 2026. Host: Dr. Leeanne Aguilar. Podcast and video, 36 minutes.
The gap between prototype and market, life after FDA clearance, when to outsource R&D, reimbursement and the one question to answer before building. Key answers and full transcript. Original: Buzzsprout, YouTube.
Grant Engine roundtable: Navigating the Risks of Medical Device Product Success
July 25, 2025. Host: Sam Tetlow, Grant Engine. Video roundtable with Dan Burnett, MD (Theranova).
The risks that sink medical device products: payment and reimbursement, stakeholder mapping, FDA engagement and design for manufacturing. Key answers and full transcript. Original: Grant Engine, YouTube.
Digital Health Interviews: Insights on Medical Device Development
June 26, 2024. Host: Alex Koshykov, Health2Tech by BeKey. Video interview, 21 minutes.
Accelerators, the journey from idea to market, why a prototype is not ready for production, where founders fail and pilots in the US. Key answers and full transcript. Original: YouTube, BeKey blog.
Magic or Medtech: How to Balance Innovation and Limitations
June 4, 2024. Host: Clark Teeple. Podcast, 30 minutes.
How to balance innovation and limitations in medtech. Transcript coming later. Original: Magic or Medtech.
Press and media
Columns in MD+DI
Lisa writes a regular column for Medical Device and Diagnostic Industry (MD+DI).
- 95% vs. 53%: The Sleep Metric That Launched Oura Into Court, September 2026
- How to Position Yourself as the Engineer Every Medical Device Company Needs, August 2026
- When Closed Medical Device Systems Create Single Points of Failure, July 2026
- Why Building a Cortisol Sensor Is So Much Harder, June 2026
- CGM Market Hits $15B in 2026, But Are These Devices Built for Older Patients?, June 2026
- Closing the Loop: Inside the Race to Build Radiation Therapy's Missing Sensor, June 2026
- Why Makary's Exit Changes Nothing for Device Companies Drowning in Delays, May 2026
- U.S. Hospital Dependence on China Poses Security Risk, May 2026
- The Impact of FDA's Workforce Reduction on Regulatory Timelines for Medical Device Companies, April 2026
All columns: Lisa Voronkova on MD+DI.
Talks and teaching
- MEDevice Silicon Valley 2026, California: speaker.
- TecMed Brasil 2026, the first Brazilian congress of medical technology: speaker.
- Aquillius Medical Device and Diagnostics Symposium, September 2026: roundtable host.
- CBEXS Futuro, Brazilian College of Healthcare Executives, September 2026: international mentor session.
- The Wond'ry, Vanderbilt University: mentor and judge at the NSF Regional I-Corps demo day, September 2026.
Book: Hardware Bible
Hardware Bible: Build a Medical Device from Scratch is a practical guide for medtech founders, clinicians and engineers: the whole path from idea to a device on the market, with realistic costs and timelines. ISBN 9798285270478. Hardware Bible on Amazon.
Invite Lisa
To invite Lisa to a podcast, a panel or an interview, or to ask for a comment, see about Lisa Voronkova. More from OVA: what medical device development costs, how to choose a development firm, our quality system.
Updated on October 8, 2026.