Lisa Voronkova, PhD, medical device development expert and CEO of OVA Solutions, answered questions from journalist José Luchetti for ABRAIDI, the Brazilian association of importers and distributors of health products, after her talk at TecMed Brasil 2026: why she wrote Hardware Bible, the most common mistakes, validating the clinical need, market access, running clinical studies in Brazil on the way to the US market, and AI in regulatory work. The interview was published in Portuguese; below are Lisa's original answers in English.
| Publication | ABRAIDI (Associação Brasileira de Importadores e Distribuidores de Produtos para Saúde) |
|---|---|
| Interviewer | José Luchetti, DOC PRESS |
| Title | O desafio não é criar o dispositivo. É fazê-lo chegar ao mercado. |
| Date | August 13, 2026 |
| Format | Written interview after TecMed Brasil 2026; published in Portuguese |
| Read | ABRAIDI (Portuguese) |
| Related article | Medicina S/A (Portuguese) |
Facts as of October 2026: 62 engineers, 220 devices developed, $125 per hour.
Key answers
Why did you write Hardware Bible?
Lisa Voronkova: I wanted a reference book, the kind where you open the table of contents and immediately see what's coming for you. By the end you at least know what you don't know, which sounds like a modest achievement until you've met a founder who doesn't know what he doesn't know. My favorite critics like to point out that the book doesn't go deep into any single discipline, and they're right. That was never the goal. You read it and realize: this part I know, the FDA review I'm prepared for, and these next three steps I've never heard of.
What is the most common mistake in medical device development?
Lisa Voronkova: The most common mistake is not understanding how the innovation fits into the patient pathway and how it will actually reach the market. It's a broad topic, but the short version: define the value, define who will pay for the device, and define who wins from having it on the market, and by how much. "By how much" is measured in money. If your product prevents complications of a procedure or an intervention, that prevention has to be priced in economic terms. People find this cynical. I find it cheaper than learning it after the Series A.
Why validate the clinical need before development?
Lisa Voronkova: If you don't understand the clinical need from the start, you won't sell the device to anyone, and your investment becomes investment for its own sake. In my talk I walked through cases where companies poured hundreds of millions into innovations that, in the end, nobody needed. So it depends on the goal. If the goal is to stay busy for five to seven years and spend a budget, validation is optional; the industry has proven this repeatedly. If the goal is to make money, validate the clinical need before going to market, before development starts, before a single line of code is written.
What kind of moment kills a medical device?
Lisa Voronkova: One case from our practice: a client brought us a device to rework after another engineering team. I'll stay deliberately vague, but picture something like a pen with a screen, made for the operating room. It was tested beautifully, validated; everything looked great. Then surgeons stopped using it during rollout. The reason turned out to be simple: the lighting in an operating room is extremely bright, and under it the screen was unreadable. All the testing had been done under normal laboratory light. The device worked perfectly everywhere except the one room it was built for.
Can clinical data from Brazil support a US submission?
Lisa Voronkova: Brazil can be a very convenient place to run clinical studies on the way to the US market. Many FDA consultants in the States will tell you that clinical data must come only from US soil. That's not true, and mostly it's a way to inflate fees. FDA itself wrote down how it accepts foreign data: 21 CFR 812.28 covers studies conducted outside the US that support an IDE, 510(k), De Novo or PMA, and the requirements are the things any serious sponsor does anyway: good study design, GCP compliance, documented ethics approval and informed consent, and records FDA can validate through inspection. Some consultants apparently haven't read that far.
Will AI replace regulatory professionals?
Lisa Voronkova: What I see right now is an enormous simplification of the work. AI finds standards and the right documents fast, it assembles things like design controls in no time, and it searches for predicates very quickly. I can't speak to Anvisa's internal processes; I don't know them well enough, but overall the productivity gain is colossal. It is still unambiguously a tool. It makes a knowledgeable person faster; it doesn't make an unknowledgeable person right.
What skills will regulatory professionals need?
Lisa Voronkova: The obvious answer, and the honest one: learn to use AI properly. Everyone says it, but it really is a colossal jump in speed, and sometimes in quality, because a human gets tired and a model doesn't. Used correctly, with well-formulated queries, it turns you into a super-strong professional. And it genuinely saddens me to see people still using these tools as a slightly chattier Google. That's like buying a car and using it as a place to sit.
Full interview
Why did Lisa write Hardware Bible?
José Luchetti (ABRAIDI): Your book, Hardware Bible: Build a Medical Device from Scratch, has become a key reference for professionals in the medical device industry. What inspired you to write it, and what gap were you aiming to fill?
Lisa Voronkova: The book grew out of my mentoring work at Vanderbilt University. I kept meeting students and entrepreneurs with no medtech background who all asked the same questions and carried the same misconceptions, and I had nowhere to send them.
I went looking for a resource that walks through the entire path, from idea to a device on the market, and found nothing; nobody had written down how this actually happens. So I did.
I wanted a reference book, the kind where you open the table of contents and immediately see what's coming for you. By the end you at least know what you don't know, which sounds like a modest achievement until you've met a founder who doesn't know what he doesn't know. My favorite critics like to point out that the book doesn't go deep into any single discipline, and they're right. That was never the goal. You read it and realize: this part I know, the FDA review I'm prepared for, and these next three steps I've never heard of. I also tried to give the most realistic numbers I could on what a device actually costs to build, in money and in time, because the optimistic version of those numbers is how people end up surprised.
What are the most common mistakes in medical device development?
José Luchetti (ABRAIDI): Based on your experience in developing medical devices, what are the most common mistakes made by startups and innovative companies during the product development process? How can they avoid them?
Lisa Voronkova: This is exactly what my conference talk was about. The most common mistake is not understanding how the innovation fits into the patient pathway and how it will actually reach the market. It's a broad topic, but the short version: define the value, define who will pay for the device, and define who wins from having it on the market, and by how much. "By how much" is measured in money. If your product prevents complications of a procedure or an intervention, that prevention has to be priced in economic terms. People find this cynical. I find it cheaper than learning it after the Series A.
Why validate the clinical need before development?
José Luchetti (ABRAIDI): In your book, you emphasize the importance of validating the clinical need before beginning technology development. Why is this step so critical to the success of a medical device, and how can companies carry it out effectively?
Lisa Voronkova: The answer is almost self-evident. If you don't understand the clinical need from the start, you won't sell the device to anyone, and your investment becomes investment for its own sake. In my talk I walked through cases where companies poured hundreds of millions into innovations that, in the end, nobody needed. So it depends on the goal. If the goal is to stay busy for five to seven years and spend a budget, validation is optional; the industry has proven this repeatedly. If the goal is to make money, validate the clinical need before going to market, before development starts, before a single line of code is written.
Which stage do companies underestimate most?
José Luchetti (ABRAIDI): Developing a medical device involves technical, regulatory, quality, and market access challenges. In your opinion, which of these stages is most often underestimated by companies, and why?
Lisa Voronkova: I'd flip the question, because what companies usually overestimate is the technical part. I say this from experience: our engineering team can execute almost any technically feasible task, and we've been proving that for eleven years across more than 200 clients, including projects that looked impossible at first. So if you're stuck on a technical challenge, come talk to me. That part is solvable.
What gets underestimated is market access: finding product-market fit and spotting the bottlenecks in implementation. Products drown at non-obvious points. Sometimes the entire failure mode is "the nurses don't use it." One case from our practice: a client brought us a device to rework after another engineering team. I'll stay deliberately vague, but picture something like a pen with a screen, made for the operating room. It was tested beautifully, validated; everything looked great. Then surgeons stopped using it during rollout. The reason turned out to be simple: the lighting in an operating room is extremely bright, and under it the screen was unreadable. All the testing had been done under normal laboratory light. The device worked perfectly everywhere except the one room it was built for. If a project manager had sat through a single actual surgery, they'd have looked up and noticed the giant lamps. Nobody did, so the screen had to be redesigned. That's the kind of moment that kills products, and no amount of engineering talent protects you from it.
Why can Brazil be a good place for clinical studies on the way to the US?
José Luchetti (ABRAIDI): Brazil has been strengthening its healthcare innovation ecosystem and expanding its capacity to develop medical technologies. What advice would you give to Brazilian entrepreneurs, manufacturers, and companies seeking to transform innovative ideas into internationally competitive medical devices?
Lisa Voronkova: I'll share one specific observation. From what I've seen, Brazil can be a very convenient place to run clinical studies on the way to the US market. Many FDA consultants in the States will tell you that clinical data must come only from US soil. That's not true, and mostly it's a way to inflate fees. FDA itself wrote down how it accepts foreign data: 21 CFR 812.28 covers studies conducted outside the US that support an IDE, 510(k), De Novo or PMA, and the requirements are the things any serious sponsor does anyway: good study design, GCP compliance, documented ethics approval and informed consent, and records FDA can validate through inspection. Some consultants apparently haven't read that far.
The practical conditions are simple to state and hard to fake. The device you study in Brazil has to be identical to the one you submit in the US, or every difference has to be explained and justified. And the study has to be run as an FDA-inspection-ready study from day one, not as a local study you plan to translate later. The Brazilian side has become friendlier too: under ANVISA's RDC 837/2023, only studies meant to support Brazilian registration of Class III and IV devices need a prior submission to ANVISA, with up to 90 days for a position, while Class I and II studies need ethics approval but no ANVISA clinical-investigation submission.
The economics help as well: industry estimates put Brazilian per-patient trial costs roughly 25 to 35 percent lower than comparable US trials.
People in the United States are the same as people in Brazil, and they need these devices just the same. Validating a device and running clinical studies in Brazil, then transferring to the US market, is a sound strategy, and companies already do exactly that. My advice: design it as a global study from the first protocol draft, and don't let anyone charge you extra for geography.
How was TecMed Brasil 2026?
José Luchetti (ABRAIDI): How would you evaluate your participation in TecMed Brasil 2026? What were your impressions of the event?
Lisa Voronkova: It exceeded all my expectations. I enjoyed the other talks, and the organization was flawless. I publish a newsletter called No Mercy MedTech, so finding problems is basically my job description, and I still couldn't find one. The topics were strong, it was fascinating to hear how the Brazilian system works from the inside, and I was struck by the growth of interest in orthopedics, which happens to be one of our key areas of expertise, from implants to instruments for orthopedic surgeons. It was also a pleasure to talk with so many people who don't just import but manufacture their own products in Brazil. I'd be delighted to take part again. Honestly, it beat a vacation (on vacation I bring my kids, and here nobody asked me "mom, what's for dinner?" even once).
How will AI change regulatory affairs work?
José Luchetti (ABRAIDI): Artificial intelligence is increasingly being incorporated into different stages of medical device development and regulatory assessment. In your view, how will AI transform the work of Regulatory Affairs professionals? Do you see it replacing part of their role, or will it primarily serve as a tool to enhance human expertise and decision-making?
Lisa Voronkova: What I see right now is an enormous simplification of the work. AI finds standards and the right documents fast, it assembles things like design controls in no time, and it searches for predicates very quickly. I can't speak to Anvisa's internal processes; I don't know them well enough, but overall the productivity gain is colossal. It is still unambiguously a tool. It makes a knowledgeable person faster; it doesn't make an unknowledgeable person right.
We see the same effect in our own company. With AI built into our development process, we can take a device from zero to design for manufacturability in six months, or twelve if it's a genuinely complex device that requires proprietary development. Six months for a from-scratch build to requirements would've been unthinkable two years ago.
What skills will regulatory professionals need?
José Luchetti (ABRAIDI): As technology continues to evolve rapidly, what skills and competencies will be essential for Regulatory Affairs professionals in the years ahead? What knowledge and capabilities should they develop to continue creating value for companies and for the medical device ecosystem?
Lisa Voronkova: The obvious answer, and the honest one: learn to use AI properly. Everyone says it, but it really is a colossal jump in speed, and sometimes in quality, because a human gets tired and a model doesn't. Used correctly, with well-formulated queries, it turns you into a super-strong professional. And it genuinely saddens me to see people still using these tools as a slightly chattier Google. That's like buying a car and using it as a place to sit.
"Properly" in regulatory work means controlled workflows: every AI output traces back to a primary source, and a human signs off on the result. Use it for regulatory intelligence, literature screening, predicate research, first drafts, and for mapping the gaps in your own knowledge. And learn the rules being written around it. FDA has already laid out a total-product-lifecycle approach for AI-enabled devices and finalized guidance on predetermined change control plans for adaptive algorithms, RAPS now lists AI capability next to data analysis, strategic thinking and ethical judgment, and in Europe the AI Act keeps medical technologies in the high-risk regime on top of MDR.
So the professional who wins in the coming years isn't the one who can prompt. It's the one who can decide where automation is reliable, prove that it's controlled, and defend the final regulatory position in front of an auditor. The tools will keep getting better at writing. Somebody still has to be right.
What OVA does here, and where our responsibility ends
OVA Solutions is a medical device engineering group working under an ISO 13485:2016 certified quality system: 62 engineers, 220 devices developed, $125 per hour, offices in New York, Florida, the United Kingdom, Estonia and Ukraine. We design electronics, firmware and mechanics and take a device from concept to design for manufacturing. We are not a regulatory consultancy and not a contract manufacturer: the regulatory strategy and the submission stay with you or your regulatory consultant.
More from Lisa and OVA: about Lisa Voronkova, what medical device development costs, how to choose a development firm, our quality system, all podcasts and interviews with Lisa.
Updated on October 8, 2026.