Lisa Voronkova, PhD, medical device development expert and CEO of OVA Solutions, joins Dr. Leeanne Aguilar on Industry Ignited (episode 67) to talk about why medical devices that work still fail to sell: the gap between prototype and market, life after FDA clearance, when to outsource R&D, reimbursement and the one question every founder must answer before building.
| Show | Industry Ignited |
|---|---|
| Host | Dr. Leeanne Aguilar |
| Episode | Your Device Works… So Why Won't Anyone Buy It? | Ep. 67 [Lisa Voronkova] |
| Date | February 12, 2026 |
| Length | 36:26 |
| Episode page | Buzzsprout |
| Watch | YouTube |
Facts as of October 2026: 62 engineers, 220 devices developed, $125 per hour.
Key answers
Why did OVA become an external R&D team for other founders?
Lisa Voronkova: 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.
Where do founders underestimate the path from prototype to market?
Lisa Voronkova: 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.
What has to happen after FDA clearance for doctors to adopt a device?
Lisa Voronkova: 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.
When does outsourcing R&D make sense?
Lisa Voronkova: 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.
Why do devices that work still fail to sell?
Lisa Voronkova: 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.
How did one company prove the value of a rehabilitation device?
Lisa Voronkova: 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?
Where is the real opportunity for AI in medical devices?
Lisa Voronkova: 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.
What is the one question every founder must ask before building?
Lisa Voronkova: 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.
Full transcript
Why do medical devices fail before they reach patients?
Leeanne Aguilar: Why do so many medical devices fail? Not in the lab, but in the real world long before they ever reach patients. Welcome to Industry Ignited, the podcast where we explore the leaders, decisions, and innovation shaping the future of industry. I'm your host, Dr. Leeanne Aguilar and today I'm joined by Lisa Voronkova, CEO of OVA Solutions and author of Hardware Bible: Build a Medical Device from Scratch. Lisa, welcome to the show.
Lisa Voronkova: Hi. Very happy to be here.
Why did Lisa go from founder to an external R&D team?
Leeanne Aguilar: I'm excited for our conversation today. Thank you for being here. Now, you started as a medtech founder yourself before building OVA Solutions. What problem did you experience firsthand that ultimately led you to create an external R&D team for other founders?
Lisa Voronkova: Oh, that's that's a great question and actually we started as a typical founder story. So we built the company around the technology we invented. So it was in 2016 2017. So we developed an sensor for health monitoring which was more accurate that optical sensor that were on the market back then. So some optical sensors were not performing on a darker skin or tattooed skin or hairy skin and so we designed this technology and we were super excited about it but then [laughter] we hit a wall that nobody talks about in medtech. 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. And it was like 9 years ago almost 10 years ago. And so now when I see startups coming to me with sensors or technology in general, I immediately know what would be the problem. And I think that helps me to speed up the product development and product go to market based on our mistakes. Yeah. Because both me and my co-founders, they were on the founders seat, right? So, we know what it feels like.
Leeanne Aguilar: Absolutely. And I've heard that over and over and over from other founders and CEOs as well that failure is the best teacher and we learn best from our mistakes and then are motivated at that point to succeed and we understand we have a really deep understanding at that point of what it you know means to fail and then what it what you need to succeed as well. So it's a great learn or you learn so much from failure basically.
Lisa Voronkova: You see if we already wasted our life on doing something our founders are like our clients can not repeat this mistake. So it would make sense if we can like cut corners somewhere where it's possible.
How do you build trust in a distributed engineering team?
Leeanne Aguilar: Yeah. Absolutely. So those other founders don't have to reinvent the wheel. They don't have to learn from mistakes that have already been made. They can leverage themselves with your knowledge and experience. And so that's I think extremely valuable. Yeah. Now your company operates globally with engineering teams in Ukraine and business leadership in New York. How did you build trust, quality and scalability in a distributed model, especially in a highly regulated industry?
Lisa Voronkova: To be very honest, I didn't build it from scratch, right? I didn't have to build it from the very beginning. It was not always like that. The team was not distributed at the beginning. So I'm in New York for just three years almost four years and before that I was in Ukraine for the entire time. We were building team on the ground. We were working next to the engineers. So the core team is still the same for all this year. So we know each other for a long time. So we were going through a lot of projects together. We were dealing with manufacturing problems together. And when I talk to clients now, I'm not just saying well that there's a distance team elsewhere, you know, that I manage remotely because it's not the case. And also three other co-founders, there are four co-founders in the company and three other co-founders are in Ukraine. So they're also managing the team locally. Yeah. But I think what really builds trust with new clients is our track record because when we are mentioning that we've built over 200 by now different devices and most of them are in clinical trials or in the market well it proves that we already executed with someone else.
Leeanne Aguilar: Yeah. Wow. So you've been together for nine years you said already
Lisa Voronkova: And with some a bit more.
Leeanne Aguilar: Okay. All right. And then you've worked on over 200 devices so far.
Lisa Voronkova: Yes, that's correct.
What was the hardest part of going from engineer to CEO?
Leeanne Aguilar: Yeah. Yeah. So that is a solid track record there. And so right I think that in itself you know builds trust with clients. Now looking back what was the most difficult transa transition for you personally from founder to CEO of a fast scaling engineering organization?
Lisa Voronkova: To be very honest, it might sound a bit cocky, but the hardest part was accepting that I was wrong about something I believe deeply in the very beginning because as I believe most engineers, I thought that managers were useless, that sales people were useless and I think most engineers think that by the way so especially talented ones, they don't think like well they would help to sell my work. They think like why do we need all these project managers? Why do we need all these coordinators? They don't actually build anything, right? And then I became one of those useless people, right? So [laughter] this transition forced me to see that building great products and building great company are completely different skills. So before I could design a device, I could do simulation by myself, I could review code. But now the task is different like I was questioning myself and I was educating myself again and I in fact realized that okay I know nothing in this space. So I need to read more business literature to understand how can I help 60 engineers work together effectively? How do I identify who is about to get a burnout before they quit for example and can I spot what is off with the client relationship and so on. So I had to learn all that.
Leeanne Aguilar: All the people skills is what I'm I'm hearing I would say.
Lisa Voronkova: So yes and also how to build a sales team for example was also challenging for us because I always had this mindset before before running this company that I would just hire someone and they would execute for us but in fact you can hire someone after you did your homework and well I also learned it hardly.
What did building a sales team teach Lisa?
Leeanne Aguilar: Yeah. So what did you learn when it comes to like building a sales team then? What was your biggest takeaway there?
Lisa Voronkova: Be very very specific about who is your client and how to reach out to them in a way that they would not discard it right away as a sales pitch because at some point if you were in the conferences and you know how sales people approach in most cases you feel them like a white noise. You seen their card, you see that they're a sales team and they're like okay so probably our approach is to build friendship and build connection with the client. That is why for example for most potential clients and for most people who are reaching out to us even though they are not directly our clients we are providing free hardware consulting cuz oh okay after well this it's a bit deeper story maybe a bit negative but after war started in Ukraine we realize that we don't want to live in vain and we want just to help other people to build great products. With or without us. So that's like a mission that we have for last four years in the company. We charge for our engineering expertise when we do something but we don't charge for advice and I've been very transparent when for example I work as a mentor in Vanderbilt University. I've been very transparent about the FDA pathway about the reimbursement pathway. I'm not trying to make it sound more complicated than it is as people sometimes do when they're trying to sell you something. I'm just trying to share whatever I know on the subject and being like very open to say that well I don't know something about this topic so this you should figure out by yourself or something like that.
Leeanne Aguilar: Yeah. All right. So, I'm hearing like you really became a an advocate for your clients really and empowering them by sharing your knowledge and giving them advice, but then not making them completely dependent on you, but also letting them know where you can help and where you are there for them, but being willing to help them even if it's not something you're charging for.
Lisa Voronkova: That's true. So there's just one thing that we are focusing on and one thing we are charging for is a hardware development but we're not trying to also take money for consultancy or for building an FDA pathway or building a reimbursement strategy but still we can give at least preliminary advice on that.
Leeanne Aguilar: Mhm.
Lisa Voronkova: If we already had experience in this field with other clients.
What is the biggest gap between prototype and market?
Leeanne Aguilar: Yeah. Now you've worked with class one, two, and three devices from wearables to OR equipment. Where do founders most underestimate the complexity of taking a device from prototype to market?
Lisa Voronkova: 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 business point of view the biggest mistake is to think that well FDA approval is the final step and I also heard that a lot. So I would say that FDA approval is just the beginning and the final step or rather a milestone because then there would be like more steps is to understand how to bring the device to hospital or to someone who going to pay for it because I hear this really often when founders are saying well we're going to just sell to a hospital without being very specific and that's the trickiest part probably for any product
Why is FDA clearance not the finish line?
Leeanne Aguilar: Right. Yeah. You mentioned that before like the most startups believe FDA clearance is the finish line, but that's actually a dangerous mindset. So what comes after clearance that catches the teams off guard?
Lisa Voronkova: Reimbursement strategy and making doctors use the device because it also like should play a bit with their ego. And by the way, you also talked to a lot of early stage founders, right? And what from your opinion, what would be like the thing that makes you think like, oh, they have no idea what they're for?
How long does it really take to bring a device to market?
Leeanne Aguilar: Well, I mean, I think most of them are are learning. I mean, I'm hearing like like you mentioned at the beginning, starting with the problem. Starting with the problem is super important. And then but I do see that a lot of them expect to just get bought out right after they create something. I think the end goal is just to get acquired quickly. Danger. I've heard a lot of them is that it takes longer than it they think it will, you know, that acquisition or they might run out of money or also when it comes to funding for FDA, you know, when they're trials like the trials. So once they reach clinical trials too, that can take a long time and running out of money is a huge concern. So not being prepared for the clinical trials or yeah, I think it's just expectations overall are not always well established from the beginning. That's what I hear a lot of
Lisa Voronkova: That is that is true because even in FDA website there is a statistic that it would take seven years to bring a medical device from idea to market in average like seven years that's like half of your life and some first- time founders or first- time founders in medtech they think like oh just a couple of years like for consumer electronics we just build it and advertise and that's it but also yeah I completely agree with you also another thing is clinical adoption 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.
When does outsourcing R&D make more sense than building in-house?
Leeanne Aguilar: So, yes, that's true. I've heard that too. Yeah, it's scary because a first adoption Yeah. I mean, there's that that risk, you know, for first adopters. And so, you're right. A lot of times people hesitate because of the risks or potential liabilities that come with using something new and different. So, they are comfortable and experienced using what they have. So, like you said, they have to be educated and convinced and willing to give it a new device a shot. So, that can be I can see daunting and right expensive and take a long time as well. Yeah. So, OVA acts as a full external engineering team. When does outsourcing R&D make more sense than building in-house and when does it not for a company?
Lisa Voronkova: Okay. So let me give you frameworks I actually use when founder asked me this because it's not just a simple answer in my opinion and in my understanding 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. Second scenario when you need like really specialized expertise and you would only use this expertise for a short period of time. So for example we have people experience in orthopedic implants like very specific expertise I should say working with speak [?] working with titanium or we have people specialized in optics in our team it's really hard to find this people and maybe engage them in a project for small amount of hours and with us it's possible. And third category would be when speeds matters more than building you know knowledge inside of the company. So if you need to speed up the process well as I mentioned in the beginning we've built over 200 different devices very likely we already built something similar so it might help us to speed up the project development have experience if that makes sense.
Leeanne Aguilar: Yeah. So your clients are they are you finding that most of them have tried internally and then they come to you because they get you know at a point where they're stuck or do they come to you at the beginning of the process when they have a new idea that they haven't built out. I mean what's what do you find more of and what's ideal?
Lisa Voronkova: We can work with both for us it's not a big difference. So sometimes they're coming with proof of concept. So they already figured out that it's like physically possible in this world to build something that they have in mind. Mhm. Or sometime they have just an idea. For example, we had a client. It was a startup inside of the pharma company. So it was a corporate client but more like a startup. So there's just a group of people was trying to solve problem on how to address drug delivery and they had just a list of requirements. So they didn't knew what the device would be, how it would be addressed. They just knew what they want to receive in the end of our cooperation. So we can also work with the clients like that. It's also an interesting way of cooperation when we're not only charging for hours but also taking a small equity in the project and that way we not only execute on what they gave us as a technical task but also trying to make it the best in the market basically.
Where can OVA contribute the most?
Leeanne Aguilar: Oh, interesting. Yeah. And I mean are there times where you take an idea that a client has and partner with them because you see another way to innovate that's even further beyond what they've conceived.
Lisa Voronkova: We have three favorite categories where we have experts in house who already worked with at least 20 projects in the space and these three most interesting categories for us would be anything related to orthopedics starting with an implant ending with at home rehabilitation any sort of wearable devices all the electrodes and how to get a signal from an electrode if you're wearing the device for eight hours for 10 hours because skin could become greasy or sweaty, the signal is not as pure as it was in the beginning. And third category would be any equipment that goes inside of the operation room. So if it's not a biotech for example and it's a device that falls into the three categories, very likely we can contribute more than other R&D shops.
Why did Lisa write Hardware Bible?
Leeanne Aguilar: Okay, that's good to know. Yeah, interesting. So you're those are your areas of expertise. So tell me about your book. I know you have a book, Hardware Bible, that is positioned as a book that could save a medtech startup. What knowledge gap did you repeatedly see that convinced you that this book needed to exist?
Lisa Voronkova: When I started my mentorship in Vanderbilt University, I was expecting to receive more technical questions based on my position or experience and I realized that gap in the knowledge was not technical was more like strategic. So something that we already discussed, founders think that well FDA is just the last step for their project development and in some meetings I heard people say well we just need to get to FDA clearance then we'll figure out sales later without being specific and I think in my opinion you have to figure out the value of the products in medtech really really early to understand what to build and why to build if the market is big enough and what is how to calculate the real market size and so on. So I've put together this book in a way that it would be beneficial just to take a look at the names of the chapters to understand what to expect and where you have the knowledge gap because well I mean I know that I run an R&D shop so it also benefits me to say well the technical execution is not a big deal or it's not the main thing but it in fact is not a big deal like we would likely be able to build something that you have in mind but will you be able to sell it that's another question and I try to put it in the reason [?] in the book that's why I wrote it right
Why do devices that work still fail commercially?
Leeanne Aguilar: Yeah like you said it's not just about engineering it covers reimbursement hospital adoption training and commercialization why do non-technical factors often determine whether a device succeeds or fails
Lisa Voronkova: I think the biggest mistake I see is They un like lack of understanding that patients are not using medical devices but health care system do use medical devices. So you can build the sleekest, the nicest, the most elegant, I don't know, clinically superior device in the world and nobody going to use it if you don't understand how hospitals are making this purchasing decisions. How insurance going to pay for it, how they're going to reimburse for it and how doctors would integrate this device into the care pathway. Right? 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. And another pattern I see all the time is reimbursement as I said. So if you have an FDA clearance, but there is no CPT code for your procedure or [laughter] because that was a massive failure. We've worked in a project for at home rehabilitation and they applied for their own reimbursement [?] […] Was zero under this code. So great success. I mean was useless this scary story all the day.
Leeanne Aguilar: And why why was the reimbursement zero?
Lisa Voronkova: Because they didn't manage to prove the value of the device. So they complied with the procedure but it happens sometimes some reimbursement codes are zero or really low so it doesn't make any financial sense to proceed with the product even though it's good and beneficial for the patients but still like what the system has is good enough and this good enough is biggest barrier of entrance. So in my opinion or at least from what I see most medical device failures are not engineering failures at all. They are business model failures because device probably works but nobody from founders figured out how to actually get it into hands of people who need it and how to get paid for it.
Can you know in advance whether a device will be reimbursed?
Leeanne Aguilar: Yeah. Exactly. So marketing I think is a big part of it. Training like you said and just calculating the cost of all of that into the overall project and making sure it's worth it. Like you said, is there a way to figure out if it's reimburseable beforehand?
Lisa Voronkova: Good question. Well, I think it's possible to answer this question when we would look at the specific case because it's just too too broad of a question. But I think the best way to understand is to see let's say if we are talking about the device for rehabilitation the one I mentioned they after all managed to integrate the device into a care pathway how 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?
What will the newsletter give founders?
Leeanne Aguilar: So they finally demonstrated the long-term savings and the total cost savings ultimately. So you're also launching a newsletter for medtech founders. Tell me a little bit about about that. Like what do you what kind of insights are you hoping to deliver that founders aren't getting from accelerators or investors?
Lisa Voronkova: So as I mentioned earlier today, we now have this belief that information should be open because it's already hard enough. I'm already confident that we have this experience and knowledge that if we would tell to someone what to do, it's very likely they would still hire us because we know how to do this. Exactly. You know, so building medical device is already hard enough without people, you know, gatekeeping knowledge behind expensive consulting fees or telling you to, you know, trust the process without explaining what the process actually is. Because I also noticed that some founders recently were complaining to me that they hired independent consultant and their advices were not very specific. So it's like you know when you go to a psychologist and they're not coaching you, they're asking you questions like what do you think would be you know the best approach in your case. So it means that it's not no specific advice on how to do certain things even though it's not a big deal to just share how to get things done. So advice is like oh just you know be happy they're not specific enough and you're basically taking all the responsibility yourself as a founder. So I try to put some tips on this newsletter to make it easier to maybe be a bit more clear about certain processes or once again like to understand what is the process in general and where is the knowledge gap. I'm writing for engineers for founders for investors who need to understand the technology and I'm writing every other week. So every other Tuesday.
Why are established medtech companies outsourcing innovation?
Leeanne Aguilar: Okay. Every other Tuesday. I was going to ask how often you're releasing it. Okay. Great. And I know you're shifting focus from early stage startups to more established medical companies as well. What does that say about where the medtech industry is headed?
Lisa Voronkova: From what I see, the early stage market got saturated. So too many startups are chasing the same problems with similar technology and that means that funding for them became a bit harder. Also like critically regulatory commercialization complexity didn't go away. They just got worse. So you have a lot of early stage company just stuck in the valley of death between FDA clearance and actual revenue. Meanwhile established medical device companies the one with revenue with hospital relationship in place with regulatory infrastructure they have different problems. Mhm. Because they need innovation but they can't build it fast internally because their R&D teams are maintaining existing product lines right so they already have regulatory burden public companies so they can't take huge technical risks and we see this like as an opportunity for us like this shift where established companies are essentially outsourcing their innovation And for us, it's just maybe a bit odd.
Leeanne Aguilar: Yeah, that makes sense. It's more sustainable and probably working with higher level problems as well or problems that are more complex that you're are more fun to solve perhaps or like cuz you said that a lot of them in the early startups those are problems that you've already seen that other people are already solving and so those in the mid mid level are bringing on new challenges. Perhaps
Lisa Voronkova: I should say that there's classic garage startup story, it works the best in software where you have just two founders and you can code something and then execute on it. But in medtech to go through all the stages and to last for at least seven years, you need capital, you need regulatory expertise, you need decent relationship with manufacturing and understanding the reimbursement in general. So established companies they have most of that they just need the engineering execution and maybe some specialized expertise which is exactly what we are doing.
Leeanne Aguilar: Yeah. But your book is it focused more towards beginning startups startups who who haven't been through the process before?
Lisa Voronkova: It's geared more towards that audience.
Leeanne Aguilar: Okay. All right. So it's like once they've been through it a couple of times and then they can come to you and you'll be better or they'll be better equipped to man or get your help to go through the process I would say.
Lisa Voronkova: So yes
Where are the opportunities and risks for AI in medical devices?
Leeanne Aguilar: Yeah okay let's see so with wearables predictive diagnostics and AI-driven devices advancing quickly where do you see the biggest opportunity and biggest risks in the next 5 years?
Lisa Voronkova: Well, everyone now is talking about AI for the last couple of years and of course it's extremely powerful but in medical devices I think the opportunity isn't in building some general purpose diagnostic AI in my understanding just my opinion here 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. So there's opportunity now in the market because regulatory pathway is getting more clear and the FDA now have this predetermined change control plan this framework so you can build devices that improve over time with new data and just year ago it wasn't possible so there are almost a thousand of AI enabled devices on the market already and it's not like future or it's not theoretical anymore
Leeanne Aguilar: Yeah. Wow. And so how have you integrated AI in your R&D process?
Lisa Voronkova: Oh, we work with it a lot and we work mostly with AI implemented in the device. So we don't do software typically and we integrate it in their devices. We have a lot of experience with obstacle recognition and visual systems in general and there's in fact a huge opportunity for us because established medical device manufacturers they don't have AI expertise in house they have mechanical engineers they have regulatory people like quality systems but they don't have ML engineers who understand both the algorithm and medical device regulatory requirements so we position to be that bridge because we have understand of both.
What is the one question every founder must ask before building?
Leeanne Aguilar: Okay. So more value that you bring to potential clients in the AI understanding and integration and awesome. So Lisa, finally for a founder or physician with a brilliant idea but no road map, what is the single most important question they should ask before building anything?
Lisa Voronkova: 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. Does it save money? Does it improve outcomes enough to justify the cost of the device? Does it reduce admissions? Does it fit into an existing reimbursement code? And if he asks why would you replace the existing solution or do you need to create a new reimbursement code and then why? So I think yeah that's the most important question cuz I've seen a lot of devices that work perfectly. They solve real clinical problems. They have FDA clearance and they failed because nobody figured out who would pay for them and why they're going to pay for them.
Where can listeners find Lisa?
Leeanne Aguilar: Right. Yeah. That's brilliant insight. I know. I have not heard anybody talk about that before that I can think of, but you're right. You want to think of I mean, it's not only if the device works and who it's going to help. It's Yeah. Who's going to pay for it and is it is it reimburseable is because if it's especially if it's an expensive medical device, the customer the client the patient themselves may not be able to afford it. And so at that point, they would expect insurance to come in and pay for it. But if it's not reimburseable, then it might not be marketable or patient. I might not be able to purchase it. Wow. So, Lisa, thank you for sharing your insight and for demystifying what it really takes to bring medical devices to market. For listeners who want to learn more about your work, your book, or your newsletter, where can they find out more?
Lisa Voronkova: On my LinkedIn page or my book is on Amazon. So, yeah.
Leeanne Aguilar: All right. And again, it's it's the hardware Hardware Bible. And what's the entire name of the book?
Lisa Voronkova: Hardware Bible builds a medical device from scratch by Lisa.
Leeanne Aguilar: There you go. So for listeners please check out Lisa's book. And is it available in just in print or do you have it audio as well?
Lisa Voronkova: I don't have audio yet request so often. We still haven't done that. But I should say that I think for digital versions should be for free. And there's also a physical copy of the book.
Leeanne Aguilar: Okay, great. And so for those listening, if you enjoyed this episode, be sure to subscribe and share it with those in your network. Until next time, stay bold, stay curious, and keep igniting industry.
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.