54 short answers from Lisa Voronkova, PhD, medical device development expert and CEO of OVA Solutions, taken from her podcasts and interviews between 2024 and 2026. The answers are her own words, with filler words removed; each one links to the full transcript of the conversation it comes from.
Topics: Cost, hours and timelines · Validating the problem and who pays · From prototype to market · FDA and regulatory strategy · Wearables, sensors and orthopedics · AI and where medtech is going · Working with an engineering partner · Advice for founders
Cost, hours and timelines
What happens between having an idea and having a device?
So, the output is a device that fully meets the functional requirements that we built during the discovery stage, plus samples that you can put in front of some people. And on large programs, there are several prototypes between design and a finish line, each with its own verification with the own validation, maybe some gates like requirements go no go after the key points. And the client only enters the expansive phases once the cheap ones have confirmed the assumption. So, you wouldn't overspend for unnecessary polishing of something that is not working initially. So that is the main tool for controlling the budget risk.
From Global Medical Device Podcast, September 2026.
Why does OVA commit to a firm budget and timeline?
However, once you have a decent plan in the beginning, you can commit to the timeline. You can commit to the budget. So, the budget is firm. The timeline is firm. So right now, we are completing several, like I would say middle sized projects in half a year, which is extremely fast. And maybe something bigger in one year, but we can commit to this timeline. And we can put it in the contract that it would be like the highest amount of money spent, highest amount of time. And that's because of the planning in the beginning.
From Global Medical Device Podcast, September 2026.
How many engineering hours does a medical device take?
Another category would be like five to six thousand engineering hours. So, it's like mechanics, electronics firmware all working together. So, like drug delivery or diagnostics, also about a year with the team fully loaded for 12 months. And bigger projects are 2 million, and more is 10 to 30,000 engineering hours. On the bigger products like surgical robotics, medical ventilator that I mentioned, glucose monitors, because that's a very complex product. So, it's like twelve to sixteen months and more with testing with clinical regulatory on top. So, for context, median path for a new Class II device from concept to 510(k) is around three million and thirty-one months according to the statistic that I see in the market.
From Global Medical Device Podcast, September 2026.
What do engineering hours cost?
So yes, full cycle firms this year. They typically bill 175 to 275 blended, and premium engineering groups are billing 350 per hour. So, there are sometimes companies charging 75 per hour, it's more like offshore with I would say enormous quality variance. So, the saving usually comes back to you as iterations here and more than 250. As either a premium firm or expert consultants rate for an hour of a conversation. So, our rates is 100 to 150. I would say average in 125. We have engineering in Ukraine, but American delivery standard because all our clients are targets in US market. So, the client gets US firm output at roughly half the blended rate.
From Global Medical Device Podcast, September 2026.
What did the continuous glucose monitor program take?
And then third prototype was clinical ready. So, this one that goes into the study. Then it was clinical completed on our site. Around 2000 engineering hours, around 30 devices. So, we covered here software, protocol, support, analysis of the results. And then we made it first the last prototype, prototype number four. Updated based on the clinical findings. So, total for eight phases it was 11,600 engineering hours and one and a half year for the development.
From Global Medical Device Podcast, September 2026.
Why does design for manufacturing take so many hours?
So here what you're doing, like you're planning for assembly sequence, right? Cycle time, you do panelization, test points, like some probe strategy, you do tool and design support, you do supplier management, you finalize the BOM. Shall I list all of that? Like it's a lot of different things like preparation to kick of the production and most importantly to see what is the exact capacity different production partner has. So, we would adjust to their equipment. We do like bill of material industrialization, like second sourcing. We typically look for at least three different suppliers just in case. So not to be dependent heavily of just one supplier.
From Global Medical Device Podcast, September 2026.
Validating the problem and who pays
What is the first step in developing a medical device?
I hear this question a lot and I think my answer always surprise people because your first step probably is not to build anything not to build a prototype not to do a sketch it's something your first step is to deeply understand the clinical problem. So it's like step number one. You go and you talk to your end users which are surgeons, nurses, patients, hospital administrations and so on. You can ask and sit on the procedures if you can. You have to understand the existing workflow because the tricky part is that most first time founders they just fall in love with their solution too much before they truly understand the problem itself.
From MedTech Sustainability by Design, March 2026.
Who pays for the device, and why does it matter early?
And there's a second layer that also I see most founders miss sometimes entirely is a business model. So you have to answer the question who is paying for this product and why they're paying. And this answer you should understand really early because if a surgeon is already doing I don't know five procedures a day and the bottleneck is or availability not the procedure time your faster device doesn't actually increase. You know throughput. So it's no economic value and no purchase order.
From MedTech Sustainability by Design, March 2026.
Why does the value question come before hardware?
We often see founders who see just the value for patients, but not the strategic value for a hospital, operational value, or economical value of what they’re building. It’s very important to figure that out early before you even start investing time and money into hardware development. After all it’s about identifying the value and how big the problem is, and also how much this innovation would affect the care pathway in general. Sometimes we’ve seen innovations which are brilliant and extremely complex, but the cost of implementation would make it irrelevant for a hospital to adopt. These are business answers that have to be addressed before moving forward with a startup.
From Grant Engine roundtable, July 2025.
How do you reduce the risk of building something nobody adopts?
Rather than doing what founders tend to like, talking to patients or designing the device itself, this prep work has to be done upfront. Even though you can’t predict everything from the beginning, in Dan’s example, that founder could never have imagined what would happen with the Red Cross, there are two things we advise founders. First: go to a hospital and just observe all the processes. Even in-depth interviews, doctors and nurses sometimes don’t mention processes that are so routine to them. Second: find someone who tried to build a similar device or startup in your space and failed, and ask them to be your mentor. They would be fairly open to sharing their mistakes.
From Grant Engine roundtable, July 2025.
How do you map the value of a medical device?
We have our own tool we call the Value Matrix, we created it a couple of years ago. The device I want to talk about was a fall prevention device in a hospital. It had different types of value: the hospital has to purchase the device, nurses have to use it, patients should benefit, insurance should save money, and you have to receive reimbursement from Medicare. You also have to consider workflow changes, not only from the immediate use of the device, but all the follow-up steps affected. We give this matrix to founders, I also put it in the book, just to know what you don’t know about the process, what you haven’t considered.
From Grant Engine roundtable, July 2025.
Why validate the clinical need before development?
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.
From ABRAIDI interview, August 2026.
What is the most common mistake in medical device development?
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.
From ABRAIDI interview, August 2026.
What is the one question every founder must ask before building?
Well, I think everything that we discussed would just summarize into one question to understand who will pay for this device and why they're going to pay it. Not will the device work, not is the technology cool enough because those are engineering questions and they are extremely easy. Extremely easy compared to one real question. Who is going to pay for it? Is it a hospital? Then why is it a patient? Is it an insurance I don't know a value based care program. So each of those has completely different requirements for what they'll pay for and how much and what would be the reasoning why they pay.
From Industry Ignited, February 2026.
Why collect customer feedback at the earliest stage?
About Alchemist, they teached how to build a customer advisory board. So Alchemist is focused on B2B startups, and I think it's extremely useful for startup to collect this feedback from the customer at the earliest stage possible, to understand the pure value of something you're trying to build. And this is again a mistake I see a lot in medical device startups, that they are not completely aware of value they're providing to the customers. Thus it might be good to receive more proof of this value.
From Digital Health Interviews, June 2024.
What did an accelerator teach you about medical startups?
I want to tell more about Alchemist, if you don't mind, because this was really life-changing experience for me. I was pretty young back then and I made the mistake that I see some people making from my industry with my background. I thought that if I going to build amazing technology, I'm going to succeed, and it's wrong. So they helped me to understand that it's not only a technology side, it's not only about the innovation, but about fitting this innovation into the care pathway. So this is basically what all medical startups are about.
From Digital Health Interviews, June 2024.
From prototype to market
Do the development phases run one after another?
I should say that the critical thing here is that these phases are not sequential. They're not like going one after another. They usually in real life they overlap. So you should be thinking about manufacturing in a phase two. So you should be thinking about regulatory approach in the phase one and the teams that think about upcoming stages are usually faster and more successful.
From MedTech Sustainability by Design, March 2026.
How early should you put a prototype in users' hands?
Then if we're talking about the prototyping, we are trying to put physical models in user hands as early as possible, even just mockups because we want to see how they interact with this form factor, how they interact with controls, the interface. And we had a project where surgeons love the technical specs of the device, but the handle was wrong for how they naturally, you know, grip the instruments during like 4-hour procedure. So that's something you can only learn by watching someone use it.
From MedTech Sustainability by Design, March 2026.
Why is a prototype not ready for production?
I've heard this mistake from first-time founders, that they're thinking that once they have a prototype would be the same in the production. It's absolutely wrong, because you have to build a design for manufacturing. And here in this stage it's very important to keep an eye on all the regulatory issues, because you may not want to go to the production and figure out that you have to replace some type of plastic, and then you have to replace all the molds, because you can't just like pour another plastic in the same molds because of all the properties of the materials, and you may lose up to half a year, a year actually.
From Digital Health Interviews, June 2024.
Why build a golden sample before the next round?
Of course, in the state you cannot sell it as a medical device or make any clinical claims, but it's enough to understand do you want to invest more on that or not really. But for startups, this is the most useful artifact to open the next round. Right. So, we will also see that investors want to hold [?] the product, want to feel it, want to understand that you already spent some time, money, efforts into building something, not just looking the render or some AI generated picture.
From Global Medical Device Podcast, September 2026.
How do you design for manufacturing before the design freeze?
So what we are doing we are trying to engage our contract manufacturer early. So not after design freeze because a good manufacturer will look at your design and tell well I don't know there are certain features that would add you don't know 10 bucks per unit and 6 weeks to your timeline does it really worth it or not maybe you can change it a bit and this conversation at early months would save you from a crisis later on.
From MedTech Sustainability by Design, March 2026.
Where do founders underestimate the path from prototype to market?
I would say one of the biggest gap at least from our perspective from engineering's perspective is to understand that manufacturing is not just scaling the prototype. Design for manufacturability is usually different process than just producing 20 or 50 prototypes because you have to optimize for a specific production line. You have to be aware of what components are out there, what is their delivery time to your factory, how you going to certify these products, how you going to deal with maybe some production mistakes and so on. And I would say from engineering point of view that's the biggest mistake.
From Industry Ignited, February 2026.
What has to happen after FDA clearance for doctors to adopt a device?
Because doctors don't just start using your device because FDA said so. They need training. They need clinical evidence, not just your preliminary data, but real world outcomes. So, it's really hard to find this first advocates. They need to see other doctors using it successfully and it will take years and it would take a lot of money and efforts to bring it there.
From Industry Ignited, February 2026.
Why do devices that work still fail to sell?
Couple of years ago we worked on a surgical instrument that was objectively better than existing standard of care. So they were doing like a faster procedure to short the procedure time. They had better outcomes and so on and then they were not able to sell it like to scale sales because they haven't figured out training and adoption of hospitals of surgeons in the hospital right because they needed like three cases to become proficient with this new technique and hospitals won't give you three cases when existing instrument works fine and surgeons are already trained on it so they miscalculated the cost of adoption. How expensive it would be to train the staff to use the product.
From Industry Ignited, February 2026.
What kind of moment kills a medical device?
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.
From ABRAIDI interview, August 2026.
How did one company prove the value of a rehabilitation device?
They took a look at all the negative outcomes that might appear as a result of people not using their device and calculated how much is the loss for every outcome and how likely this loss going to happen. And then their reasoning was different. The reasoning was okay, you're losing that much money now because of not using our device and we were willing to save you half of it or 95% of it. Like let's risk and do pilot together and figure out how much we're actually saving because some outcomes can appear in one year after the surgery for example. So it's like very long study, right?
From Industry Ignited, February 2026.
FDA and regulatory strategy
What does FDA clearance actually give you?
It doesn't mean hospitals will buy it. It doesn't mean that surgeons will adopt it. It doesn't mean that insurance will reimburse it. It means nothing. It just means it's safe. You're not going to hurt someone with it. So after the clearance, you have to scale manufacturing and maintain the quality. You have to build the supply chain that is reliable [?]. Train your sales teams who can articulate the clinical economic value of the device. Also, you have to figure out how the hospital procurement committees work, which by the way can take like 6 to 12 months on their own.
From MedTech Sustainability by Design, March 2026.
How should founders approach the FDA today?
It’s a shift from paperwork to real-world proof. Companies need to invest early in evidence generation and value delivery. On the other hand, there are alternative approaches emerging where you don’t even have to run a clinical trial, people are trying to simulate data to create more evidence. I would say it’s obviously important to consider regulatory early in the product development lifecycle, but don’t focus on it too much. Engage early, but with a strategy. You don’t need a full regulatory pathway locked in day one, but you do need alignment on claims, endpoints, and value proposition. Same for payers, don’t assume reimbursement will fix a weak business model.
From Grant Engine roundtable, July 2025.
Why check the device classification early?
And also a lot of FDA experts offer free one-hour consultations. I would encourage founders to take that, at least to understand the device classification. We’ve seen examples where a product is about to start mass production and they realize they’re receiving a different classification, they have to change the plastic, but you can’t just change the plastic and pour it in the same mold. You have to redesign the mold. More redesign, more time, more money. It’s critical for a startup because every month counts, it’s a burn rate.
From Grant Engine roundtable, July 2025.
Can clinical data from Brazil support a US submission?
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.
From ABRAIDI interview, August 2026.
Should you run a pilot outside the US first?
I mean, if you want to waste your time, you may want to do this. However, my recommendation would be, like, just to go to US, because medical system here is so different from European or from Asian countries, and also values are different here. So when you're trying to understand the value of your startup in the US, in any, let's say, Asian country, like in Singapore, it would be so different. So if you want to do the same work from zero, then yes, start with another country, then go to US. But if your target market is in the US, you should be here doing everything here from the very beginning. It's a must.
From Digital Health Interviews, June 2024.
Will AI replace regulatory professionals?
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.
From ABRAIDI interview, August 2026.
What skills will regulatory professionals need?
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.
From ABRAIDI interview, August 2026.
Wearables, sensors and orthopedics
Why does real recovery data come from home, not the clinic?
So this there are like 168 hours in a week and if your patient is doing well you might see them for one of those hours maybe less. So think about what that means. In the clinic you get a snapshot like a single frame. The patient walks in they're nervous. They're on their best behavior and you measure them for a couple of minutes. But the real recovery doesn't happen in this frame. So it happens in the other 167 hours at home when no one is watching. And that is where the swelling goes up or down. And that is where the muscle either wakes up or stays asleep.
From BoneChat, June 2026.
Why is the next wearable form factor a patch?
And what we observed over the last five years that the electronics did not just get better, they got small enough to vanish on the body. And once that happens, the ring and the watch are not the final shape. We think that the next shape is a patch. So think of something like a band-aid like thin sticker you put right on the spot you care about and after the patch maybe as a next step the sensor goes one step further it goes inside like into the implant into the bone itself. So that move from the wrist to the patch to the bone is the line of what we see like the market is moving towards.
From BoneChat, June 2026.
How can a patch catch infection after surgery?
So instead of waiting for the patient to feel bad and come in you get early signal days before visit. So you see the problem while it's still small. So let's imagine I don't know day four the patient is at home and he feels fine but the patch sees the temperature goes up and stays up. So then you see the flag on your dashboard. You bring them in early and you catch the infection while it's still small and cheap to treat instead of like 3 days later when they already notice that it's off and come to the emergency room. So that single catch can pay for the whole device here
From BoneChat, June 2026.
How can wearables catch a bad recovery earlier?
And this is where wearables change the game because the motion data from a simple sensor, the way the person actually walks lines up well with the standard clinical scores that you already trust and you already implement. It can show a bad recovery starting earlier than the next scheduled visit you have with this patient. So you can see the problems sooner. And when you see it sooner, you can step in sooner. And that's the whole difference between a patient who recovers and the patient who joins this like one in five statistic.
From BoneChat, June 2026.
How can data from the body protect the surgeon?
So part of what looks like a bad recovery is not the surgeon, it's usually the patient. So they skip rehabilitation. They behave horribly like the moment that doesn't doesn't hurt anymore. Like they just don't care. They don't follow the procedure. They skip rehabilitation. They overload the joints and for a first time the data inserted to the body can show that objectively. So it takes the blame of the doctor also and that might be an interesting way to communicate this to the doctors.
From BoneChat, June 2026.
What is the hard part of building a medical wearable?
Making that thing actually work in real body for years cheap enough and getting it clear. That's the hard part and that's the whole game. So I have six six things that actually decided that's what we've seen in the space here. So first one like signal not sensor. So the sensor is a cheap part. The hard part is getting a clean signal from the body. So you have like sweat different types of skin you have different medication person is using the motion whether the patch even stays stuck to the body. So the sensor with not clean signal is worthless and clean signal is the real product.
From BoneChat, June 2026.
Can an implanted sensor power itself?
And I've seen a technology in the market that turns that pressure straight into electricity with no battery, no wire. So they use the piezoelectric and triboelectric sensors and then they make power from motion from movement of the leg and recent work shows that walking loads in the knee can produce a few microwatts of power. Well it's small but it's enough because modern low power electronics are built to run on exactly that just a few microwatts. So the picture is this. The joint moves, the movement makes the power. The power runs the sensor and the sensor measure the joint. So this entire construction feeds itself from the very thing it's measuring.
From BoneChat, June 2026.
AI and where medtech is going
Where is the real opportunity for AI in medical devices?
The opportunity is in using AI to make existing devices better better cheaper or possible at all so I personally see real value in AI that compensates for hardware limitation. For example, you can build the simpler like cheaper sensor with fewer sens fewer sensor fewer channels and then use AI to reconstruct the full signal. It's for example like talking about wearable devices like Apple watch can detect like arrhythmia with a single-lead ECG instead of a 12 lead like a standard one.
From Industry Ignited, February 2026.
What trends do you see in medical devices?
Well, I see just two trends now. Again, it's just my perception of things, it may be different from general industry. But I see a lot of opioid control intake devices, which can be done like in a different way. So it can be either some tools to deliver medications or some tools to reduce the pain. But this is a huge problem and it's growing market, so I see more and more startups trying to address the same problem but in different ways.
From Digital Health Interviews, June 2024.
Working with an engineering partner
Why did OVA become an external R&D team for other founders?
So our sensor was not integrated into care pathway properly. So we were building the company starting from the technology not from the problem and I think it's the most typical mistake first time founder can make at the same time friend of mine had an engineering team in Ukraine and they were going through exact same thing so they stopped working on their product development and instead of dissolving both teams we merged these companies and shifted our entire business model. So we stopped trying to build our own product and started helping other founders to build their products.
From Industry Ignited, February 2026.
When does outsourcing R&D make sense?
Outsourcing makes sense when you're pre-revenue and capital constraint because if you're a founder if you have like half a million in seed funding you just cannot afford to hire a full in-house engineering team because good medical device engineer in US like 200k fully loaded and you probably don't need that and you need a mechanical engineer, electrical engineer, you need someone to build the firmware, maybe a regulatory person. So it's around 800K a year and before they even design something, right? So with us with our team you get access to this entire multi disciplinary team and we charge a fixed price per hour. So basically you use people once you need them. It's like first scenario.
From Industry Ignited, February 2026.
What does OVA do for a founder with an idea?
We have two different types of clients. The first is a startup or doctor who has an idea for a medical device, either a prototype or just a vision. They come to us and we handle everything related to hardware from idea to production setup. For example, we’re working on a project now, a tube that separates blood and air. It was just a founder’s vision. We created 10 different digital prototypes, ran simulations, selected the top three, built them as physical prototypes, and are now doing tests with pig’s blood to select the best one. This type of client is where we handle everything from zero to setting up production.
From Grant Engine roundtable, July 2025.
What does OVA want to be known for?
We are not consultants or advisors. We are engineers who are ready to take full responsibility. We know that if you come to us, your device will work, period. But if you want to build it yourself, the information is very open. I recently posted an article about how to build a robotic surgeon, step by step, because I tried to Google it and couldn’t find it. We’re trying to be really open about the knowledge we’ve acquired over the last 10 years. That’s also another reason I wrote the book, it’s free in digital form, at least in the United States. Just look at the chapter names and you’ll understand what a founder is missing.
From Grant Engine roundtable, July 2025.
What does OVA Solutions work on?
I would say that we have three main areas of expertise which are orthopedics and everything related to orthopedics bone drilling equipment implants itself at home rehabilitation sensor and so on. So second biggest category would be any type of wearable devices. So we have we have 16 ongoing projects in our company right now and I would say 30% of them are wearable devices in different form factors. And third category would be whatever equipment that goes inside of the operation room like medical ventilators. We have one very big project which is a robotic surgeon that we're working on right now or another equipment that goes inside of the operation room.
From BoneChat, June 2026.
What is the one job no one can do for a founder?
But there is one job that no one can do for you, which is networking. Okay, doing all your homework with the payers and trying to get as much early stage customers as you can. And by customers I mean either insurance companies, and trying to set up a pilot with them, or hospitals who would really believe in you. Some hospitals which are ideally tied with an insurance company, like Kaiser Permanente in California, the ones that are truly innovative and want to bring innovations in their hospital and just give it a try, you know, and support you.
From Digital Health Interviews, June 2024.
Where do most founders fail?
I don't want to sound cliche, but I think the most important is to keep focus on what matters, and what matters, big surprise, it's not the product. So that's why, if I were a startup founder, I would completely outsource my hardware development and software development, and what I would focus on is working with payers [?], working with hospitals and the clients to understand how my solution going to affect humans' lives and bring them value.
From Digital Health Interviews, June 2024.
Advice for founders
What do first-time founders get wrong?
But it's very important in the beginning to understand what is the value of this medical device and how to feed it into the pathway of care, how it how it would affect like next steps of care, for example. Because sometimes you need to also educate the nurses about the care related to this device. Maybe you can do some extra screening, which is needed now because you just changed the process completely and so on. So that is something that I see like a biggest mistake.
From Global Medical Device Podcast, September 2026.
What is your one piece of advice for medtech founders?
If I can narrow it down to just one advice I'll try to think not as an engineer but as a salesperson like as a business person in general I would say don't build anything. Don't waste money before you validate the problem because the most expensive mistake in medtech is building the wrong device. You need to validate the clinical needs. You have to validate the business model and regulatory pathway before you commit any serious capital to development.
From MedTech Sustainability by Design, March 2026.
What is your advice to medtech founders?
You should be truly passionate about what you're doing, and you should understand that once you start a medical device company, that's your destiny for like next 10 years. Don't have this illusion that, oh, I going to hit the market in one year, in three years I going to be a billionaire. Unlikely. I mean, I think the best thing to do is, once you have some idea in mind, trying to see if someone else already executed to a similar idea, approach them and try to get them as your mentor.
From Digital Health Interviews, June 2024.
Why did you write Hardware Bible?
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.
From ABRAIDI interview, August 2026.
What gap does Hardware Bible fill?
So I wanted to write a book I wished I had when I started back then not theoretical one not maybe too optimistic but just rather a practical tactical I would say knowledge from someone who still actively develops devices you know every day. So that's what makes it different because these are real applicable actions written there. And I'm happy to figure out that the book ended up becoming an Amazon bestseller in bioengineering and now it's been in use in one Canadian university which I'm really proud of.
From MedTech Sustainability by Design, March 2026.
Reference pages
- FDA medical device user fees for FY2027
- 510(k) review times in 2026
- De Novo review time, grant rate and fees
- FDA QMSR in 2026: what changed from the QSR
- FDA cybersecurity requirements for medical devices (Section 524B)
- EU MDR transition deadlines
- SBIR and STTR grants for medical devices in 2026
- Medical device engineering firms compared
- Alternatives to large medical device design firms
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: all podcasts and interviews with Lisa, about Lisa Voronkova, what medical device development costs, how to choose a development firm.
Updated on October 8, 2026.