Lisa Voronkova, PhD, medical device development expert and CEO of OVA Solutions, talks with Alex Koshykov on Digital Health Interviews by BeKey about the journey of a medical device from idea to market: what accelerators taught her, why a prototype is not ready for production, where founders fail, pilots with innovative health systems, trends, and the one job no founder can outsource.
| Show | Digital Health Interviews (Health2Tech by BeKey) |
|---|---|
| Host | Alex Koshykov |
| Episode | Insights on Medical Device Development. Digital Health Interviews: Lisa Voronkova |
| Date | June 26, 2024 |
| Length | 21:15 |
| Watch | YouTube |
| Written version | BeKey blog |
Key answers
What did an accelerator teach you about medical startups?
Lisa Voronkova: 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.
Why collect customer feedback at the earliest stage?
Lisa Voronkova: 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.
Why is a prototype not ready for production?
Lisa Voronkova: 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.
Where do most founders fail?
Lisa Voronkova: 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.
What is the one job no one can do for a founder?
Lisa Voronkova: 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.
What trends do you see in medical devices?
Lisa Voronkova: 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.
Should you run a pilot outside the US first?
Lisa Voronkova: 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.
What is your advice to medtech founders?
Lisa Voronkova: 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.
Full transcript
Who is Lisa Voronkova?
Alex Koshykov: Hi! Welcome to our newest episode of Digital Health Interviews. Today is a very special episode, since for the first time on my show we have a Ukrainian founder, well, besides me, of course. Hello, […] Today we have Lisa Voronkova. How are you doing?
Lisa Voronkova: Great. I mean, kind of hot outside, but great.
Alex Koshykov: That's true. Both Lisa and I, we dedicate a lot of time spreading truthful word about the war in Ukraine and all the horrible crimes Russia is doing in our country. So I highly encourage everyone to continue stand with Ukraine until the victory. But also please subscribe to our channel if you enjoy this video, like it and share with everyone who's interested in medical device space and digital health overall. So let's start with your intro. Please tell us a bit about yourself.
Lisa Voronkova: I'm a bioengineer [?]. I have 10 years of experience in the fields of medical devices, of wellness devices in general, and I run an R&D shop for medical and wellness devices called OVA Solutions. We are based here in New York, but part of our team is based still in Ukraine, so I can completely relate what's going on.
Did Lisa plan to become an entrepreneur?
Alex Koshykov: I was curious, when you started your school, being an engineer, did you envision a future where you would become an entrepreneur and start developing and building medical devices and wellness devices around the whole world, including the United States?
Lisa Voronkova: Absolutely not. I actually had absolutely different vision. So when I started the school, I was more interested in digital security. However, along my way in university I figured out that I want to know more about human body and also about capturing the signals from the human body and making educated decisions on how to proceed with your life based on the signals your body produce. I was also curious in capturing myography, to be more specific, myography signals from the hand, and then understanding the gestures in the space. So it was like 2014, I guess, something like that, and was a big thing back then. That leaded me to my first startup called Force, where me and my other colleagues from the university started company together. We were pretty cool, though. We went through Alchemist Accelerator with this company, and it was amazing, exciting experience.
How do accelerator programs help founders?
Alex Koshykov: Yeah, actually I was going to ask. I know that you've been part of two accelerator programs. Tell us a bit more about it, and how accelerators can assist startup founders in their journey, and what are the main benefits?
Lisa Voronkova: So I've been through Alchemist and through Techstars recently. Alchemist in 2017 and Techstars in 2023. 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. So back then the head of Alchemist was Ravi Belani [?], and I think he affected my life a lot. So he showed me absolutely different world. But I assume that's not the same experience for each startup founder in each accelerator. It's so personal for each one of them.
What is the most valuable lesson from an accelerator?
Alex Koshykov: And what do you think is still, like, the most valuable lesson and outcome you gained from one of those two programs?
Lisa Voronkova: 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.
Which device was the most exciting to work on?
Alex Koshykov: All right. Throughout your career you've developed a bunch of devices already. Which one was the most exciting for you to work on?
Lisa Voronkova: Of course I want to say that it was a mammography device or something related to cancer, because we created a pre-screening device for mammography. However, I want to say that the most fun I got from creation of wellness devices, or some sex-related devices, because when you, I can explain, so there like very niche experience here, listen. When you go to production line, and most of this, like, sex toys are finished with soft touch, so it's very specific type of plastic, they produce it like in small grains, and so you have like a huge bag of these grains, and like, I think it's one of the best experiences in the world, like, to dig your hand inside this plastic. It feels just so good. So yeah, this I like. In general in my career I like seeing the sketch or the idea from the founder and then deliver this device in half a year or in one year. So it probably may be related to experience that you have when you have your baby, like you hold a baby in your hands, and that's basically the same. So you're feeling really excited about it. I love this feeling.
What is the journey of a medical device from idea to market?
Alex Koshykov: Cool, very cool. Okay, so my next question is not even a question, it's like a broad topic, and I'm sure you can talk for hours about it, but can you try briefly guide us through this journey of medical device from the initial idea to market, market entrance?
Lisa Voronkova: Of course. So not all the startups are coming to us as subcontractors with idea only. They sometimes come in with the printed board and some proof of concept, so we call it. But stages are in general like: you're coming up with an idea, you're trying to understand if it's actually physically possible to make it happen. Once you're done, it's called proof of concept, right? Once you have a proof of concept, you need to build a prototype and get this prototype ready for manufacturing. So there are like two different things. 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. A real case: so we used to work with a client who had, like, in previous experience this issue. When they went to the production, they figure out they cannot use the plastic they were using in some certain countries. It was not for United States, but anyway. So they had to redesign all the molds for the production, and like, again, it takes like up to 3 months in the best case scenario to redo them. So once you have your design for manufacturing ready, you should find a decent contractor, preferably ask them, like, if they comply with FDA rules, with all the regulation rules. You may want to figure out how to build a quality management system, because it's also important if you're working with a medical device. And then that's it: logistics and support. That's it. That's pretty much it.
Alex Koshykov: Yeah, like, that's easy. Easy.
Lisa Voronkova: I actually have more. Like, I recently put together a short guide for startups, and you guys can reach out in my LinkedIn to receive one sample for free.
Where do most founders fail?
Alex Koshykov: Very cool. From your experience, where do you feel like most of the startup founders fail on the journey? At which stage?
Lisa Voronkova: 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. And another thing that I would be doing as a startup founder is calculating the money of the payer that they going to save as a result of me solving the problem I'm trying to solve. Because I hate to say that, but improving overall quality of life of the person is not an outcome. So you may want to see some value in money for each person, for each patient, to understand: does it worth [?] to spend another 7 to 10 years of your life dedicating to the startup you're trying to build?
Are there problems at the mass production stage?
Alex Koshykov: Okay, so solving technically the problem you can do by outsourcing to companies that have a lot of experience in building both software and hardware. What about mass production? Are there any problems on that side?
Lisa Voronkova: Haven't seen much. And it also matters how you put together the documents you signed with your subcontractor, because you can make them responsible. If you have all put together documentation for production line, I don't see why it might be an issue. And you may want to share your responsibility with your subcontractor, 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.
Should you start pilots with innovative health systems?
Alex Koshykov: So if I understand correctly, your recommendation would be to go to a pilot with some, let's say, pro-innovative health systems, instead of just knocking all the doors to any health system, right?
Lisa Voronkova: I mean, give it a try. You would never know what going to work. And it's also depending on the context [?], right, depending on what you're building. So this advice [?] is very broad, like general.
How long does it take to bring a medical device to market?
Alex Koshykov: Okay. And I know that the usual startup, sometimes from the prototype and MVP version to a real product, it might take like fairly, fairly fast, like, I know, from 3 to 6 months. But with medical device it's still, because of the regulations and all that stuff, it's definitely a longer journey, right?
Lisa Voronkova: So according to [?] takes seven years from the idea to hit in the market for medical devices. If you going to that space, be ready for a long journey.
What inspires Lisa to work in this field?
Alex Koshykov: We've talked about some challenges. What about inspirations? What inspired you personally to go into the space and work for a long time and continue doing so?
Lisa Voronkova: Oh, maybe the answer would be a bit unusual, but I feel power. I don't know how to explain that. Power over human body, like power to change something for better, so for real. So something that would affect humans' life, or will speed up their recovery process, or help them to prevent some conditions, or help them to understand what's going on with their body in general. Because I think it's the biggest value in life to have a healthy, nice life as long as possible.
What are the current trends in medical devices?
Alex Koshykov: Very true. What do you expect in the space of medical devices, in this industry, in the, I don't know, next couple of years?
Lisa Voronkova: Are we talking about, like, regulations or general trends?
Alex Koshykov: General trends.
Lisa Voronkova: 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. Another issue is the metabolism control and trying to fight the obesity in general, trying to understand how to balance your diet and so on based on your specific case. And as the next step for this is wearable devices, but not wearable like smart watches, because I think everyone played with it some time ago, but wearables that can help you to understand your glucose level, your ketones level, lactation [?] processes, whatsoever.
Will Lisa focus on services or a new startup?
Alex Koshykov: Looking ahead, are you going to focus on a service business for now, or you have some cool ideas of a new medical device to start working on as well?
Lisa Voronkova: I would love to focus on the service part, because I feel like at this point this is the place for me, and that's the place where I can be the most beneficial to a lot of people who have their idea in mind and their vision of the product. I just don't want them to make common mistakes, and I want them to achieve the results as soon as possible. Thus I think I have a perfect fit for this place, for service provider for medical device startups.
When should founders reach out to OVA?
Alex Koshykov: At which stage is the best time for a startup founder to reach out to you? Right when they have the idea, or maybe later on?
Lisa Voronkova: I mean, it depends. Like, we are working with startups at any stages. Some recent example: so one friend of mine reached out to me and told me that he has an idea of medical device, but he's not sure how to proceed. Like, should he do it as at-home diagnostic, or should he collect the sample and then send it to the laboratory? So we have an FDA expert in our team, and we can arrange a free call with them. So that's exactly what I done to a friend of mine. He had a free conversation at the idea stage with an FDA expert to see pros and cons of each path, to understand what would be the best scenario for him and how he should proceed in general. So depending on the stage, you may want to, it actually, it's a specific for medical devices, you may want to keep an eye on all the regulations and to understand what would be like in some steps ahead. It's actually pretty similar to how we play in chess. Do you play chess?
Alex Koshykov: Yes, I do.
Lisa Voronkova: So it's super similar. Like, you need to think, like, some steps ahead in medical device space, because you may want to figure out all the risks in the very beginning and the potential risk management.
Should you run a pilot outside the US first?
Alex Koshykov: What would be your recommendation in terms of geographical pilots? Like, for example, if you're a startup founder outside of the US, but you definitely want to come to the US market at some point, do you think it makes sense to do a pilot somewhere else, where it's potentially cheaper, you get some valuable clinical data, and then move to the US? Or it doesn't really matter?
Lisa Voronkova: 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.
What is Lisa's advice to medtech founders?
Alex Koshykov: Okay, I think that's very important. Last piece of advice for startup founders in medical device space.
Lisa Voronkova: 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.
Alex Koshykov: Because what if they're your competitors? It's hard to think of a decent example for me. I can give you my example. I have my medical device, and I have a few competitors who went the same path as I did, but I'm not sure they would want to share any knowledge or expertise.
Lisa Voronkova: Then see how they are, like, how they are doing. Let's say, if they're like on the market for 10 years and they still have like zero revenue, well, you can assume that they are stupid, but it's unlikely. So maybe something is off with the space, and that's something that I would check in the very beginning. It's how I chose working in the hardware space, like, as an outsource provider. I had to look at other companies. They're doing pretty well. I was like, okay, there is some chance that I'll be doing well also. But if no one in the industry is succeeding, of course there can be chance that there's like not the right time for that, that they are like not truly educated or don't have such a good network as you have, or whatsoever. But there also a chance that this just not going to work. And well, the only thing to figure it out is just to try, I guess. However, if you're going to succeed, it would be so inspiring for you to go one day to the hospital and see your device in use for all these people, and you would, I guarantee you would feel so proud of yourself, you would feel achievement, and I think it's literally the best feeling in the world.
Alex Koshykov: Awesome. Thank you very much, Lisa.
Lisa Voronkova: Thank you so much for having me.
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.