Lisa Voronkova, PhD, is a medical device development expert, CEO of OVA Solutions and author of Hardware Bible: Build a Medical Device from Scratch.
Lisa runs OVA Solutions, a New York engineering group of 62 engineers that has developed 220 devices. She has built medical and wellness hardware for more than 10 years: wearables, patient monitoring devices, neurotechnology, orthopedic and rehabilitation devices, and the electronics, firmware and mechanics inside them. She holds a PhD in applied mathematics. She writes for MD+DI, mentors founders at the Wond’ry, Vanderbilt University’s innovation center, and publishes the newsletter No Mercy MedTech.
What Lisa works on
- Taking a device from a working prototype to a design that can be manufactured, tested and documented.
- Wearable and remote monitoring devices: sensors, power, connectivity and measurement accuracy.
- Planning the cost and schedule of a Class II device before the money is spent.
- What breaks between prototype and production, and how to see it early.
- Moving a stalled hardware project to a new engineering team.
Facts
| Role | CEO, OVA Solutions |
|---|---|
| Location | New York |
| Experience | More than 10 years in medical and wellness hardware |
| Team | 62 engineers |
| Track record | 220 devices developed at OVA Solutions |
| Education | PhD in applied mathematics |
| Book | Hardware Bible: Build a Medical Device from Scratch, 2025 |
| Quality system | OVA Solutions works under an ISO 13485:2016 certified quality management system. Details are on the quality page. |
| Public rate | $125 per hour of engineering time. Details are on the cost page. |
Book: Hardware Bible
Hardware Bible: Build a Medical Device from Scratch is a practical guide for medtech founders, clinicians and engineers who need a clear, realistic picture of how medical devices are built. It covers the full path: early feasibility, risk analysis, prototyping, design for manufacturing, supply chain, verification and validation, and regulatory strategy.
It is written in plain language and based on real projects. The subtitle explains why it exists: the book I wish I had before my first device.
ISBN 9798285270478. Buy Hardware Bible on Amazon.
Articles in 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 articles are on Lisa’s MD+DI author page.
Podcasts and interviews
Each page has Lisa’s key answers and the full transcript, with a link to the original episode. All in one place: podcasts and interviews with Lisa Voronkova.
- Global Medical Device Podcast by Greenlight Guru: The Real Cost of MedTech Innovation: From Idea to Pre-Production, September 2026
- ABRAIDI, Brazil: The challenge is getting the device to market, August 2026 (Portuguese original)
- BoneChat #131: Lessons learned building wearables for orthopedics, June 2026
- MedTech Sustainability by Design: How to Build a Medical Device That Actually Sells, March 2026
- Industry Ignited, episode 67: Why devices that work still fail to sell, February 2026
- Grant Engine roundtable: Navigating the risks of medical device product success, July 2025
- Digital Health Interviews by BeKey: Insights on medical device development, June 2024
- Magic or Medtech: How to balance innovation and limitations, June 2024
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, “From working prototype to production: where medtech hardware programs stall”.
- CBEXS Futuro, Brazilian College of Healthcare Executives, September 2026: international mentor session.
- The Wond’ry, Vanderbilt University: mentor in the mentorship program and judge at the NSF Regional I-Corps demo day, September 2026.
Newsletter
No Mercy MedTech is a newsletter about medical device hardware development by Lisa Voronkova. It goes out every two weeks to more than 2,200 readers. You can subscribe from the form at the bottom of this site.
Work with Lisa
If you are a physician with a device idea, or a founder with a prototype that has to become a product, the first step is a 30-minute call. Bring what you have: a sketch, a prototype, a requirements list or a failed test report. We will tell you what we see as the main technical risks and what a first phase of work would look like.
Engineering at OVA Solutions is billed at $125 per hour. Book a 30-minute call with Lisa, or write to lisa@ovasolutions.com.
Invite Lisa to speak or comment
Lisa speaks at conferences and comments for journalists on medical device hardware. Topics she covers:
- What it costs to develop a medical device, stage by stage.
- From prototype to production: why hardware programs stall and how to restart them.
- The first steps for a physician with a device idea.
- Wearable medical devices: accuracy, power, and claims the data can support.
- How FDA timelines and supply chain risk change engineering decisions.
For speaking and media requests write to lisa@ovasolutions.com.
Short bio for programs and bylines
Lisa Voronkova, PhD, is a medical device development expert and CEO of OVA Solutions, a New York engineering group of 62 engineers that has developed 220 devices. She has built medical and wellness hardware for more than 10 years, holds a PhD in applied mathematics and wrote Hardware Bible: Build a Medical Device from Scratch.
Profiles
Updated on October 8, 2026.