About Lisa Voronkova, PhD
Lisa Voronkova, PhD, is the CEO of OVA Solutions and the author of Hardware Bible: Build a Medical Device from Scratch. She leads a powerhouse R&D team specializing in taking medical and wellness devices from early concept to real, manufacturable hardware.
With more than 10 years in engineering and over 200 completed hardware projects, Lisa focuses on helping founders build devices that can pass FDA/CE requirements, scale in production, and deliver real clinical or commercial value — not just prototypes or pretty renders.
About the book — “Hardware Bible: Build a Medical Device from Scratch”
Hardware Bible is a practical guide for MedTech founders, clinicians, and engineers who need a clear, realistic understanding of how medical devices are actually built. The book covers the full journey: early feasibility, risk analysis, prototyping, design for manufacturing, supply chain, verification/validation, and regulatory strategy.
It’s written in plain, direct language and based on real projects — the book Lisa wishes she had before her first device.
Where to buy
👉 Buy on Amazon
Connect with Lisa
• LinkedIn: https://www.linkedin.com/in/lisa-voronkova
• OVA Solutions: https://ovasolutions.com