Lisa Voronkova, PhD, medical device development expert and CEO of OVA Solutions, talks with Lucas Pianegonda, founder of Gradical, on MedTech Sustainability by Design about turning a medical device idea into a product that sells: validating the problem and the buyer first, the six phases of development, early user feedback, life after FDA clearance, manufacturing and sustainability.

Show	MedTech Sustainability by Design (Gradical)
Host	Lucas Pianegonda
Episode	How to Build a Medical Device That Actually Sells with Lisa Voronkova, CEO of OVA Solutions
Date	March 18, 2026
Length	45:44 (video), 46:34 (audio)
Listen	Spotify
Episode page	Buzzsprout
Watch	YouTube

Facts as of October 2026: 62 engineers, 220 devices developed, $125 per hour.

Key answers

Why did you write Hardware Bible?

Lisa Voronkova: 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.

What is the first step in developing a medical device?

Who pays for the device, and why does it matter early?

Lisa Voronkova: 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.

Do the development phases run one after another?

Lisa Voronkova: 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.

How early should you put a prototype in users' hands?

Lisa Voronkova: 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.

What does FDA clearance actually give you?

Lisa Voronkova: 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.

How do you design for manufacturing before the design freeze?

Lisa Voronkova: 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.

What is your one piece of advice for medtech founders?

Full transcript

How do you turn a medical device idea into a sellable product?

Lucas Pianegonda: How do I turn my medical device idea into a sellable product? To explore this question, I invited Lisa Voronkova. Lisa is a serial entrepreneur and the CEO and co-founder of OVA Solutions, an R&D shop that specializes in designing and manufacturing medical devices from scratch. Lisa also recently wrote a book, The Hardware Bible: Build a Medical Device from Scratch. In this episode, you're going to learn what the most founders get thing wrong when developing their first medical device, why developing a device is more than just engineering a prototype, and what the most common misconceptions are when developing a new medical device, and how to avoid them. My name is Lucas Pianegonda, and we have helped over 30 medtech companies to be more sustainable with plastics. Here's our discussion. Hi, Lisa. And welcome to the podcast.

Lisa Voronkova: Hi Lucas, thank you for having me.

Why did Lisa write Hardware Bible?

Lucas Pianegonda: Yes. Yes. It's a pleasure. So you recently wrote the book The Hardware Bible: Building a Medical Device from Scratch. To begin with that, what motivated you to write the book about medical device development and what problems did you try to address with it?

Lisa Voronkova: A great question. Thank you so much. And I think the honest answer is frustration. So over 9 years my team and I have developed over 200 different medical devices. So like everything from orthopedic implants to surgical robotics to like wearable diagnostics and so on. And I kept seeing the same pattern over and over again which is brand [?] founders with real clinical insights. They're making the same expensive mistakes again and again and again. So, I'm talking about spending 200K on a prototype that can [?] be manufactured, for example, or building a device that surgeons love but hospitals won't buy because nobody thought about how sterilization workflow would happen or running out of money like 6 months before FDA clearance because they underestimated the regulatory timeline and timeline of the project in general. So the resources that existed that I saw they were either too academic like written by people who studied the process but they don't live through it or too surface level like you know advice is like okay be happy how do I be happy you know 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. That ultimately I wrote it for founder just sitting in their garage at midnight and trying to figure out how to get from idea to FDA clearance or from idea to market without losing everything in the meantime.

What is the first step: the problem or the solution?

Lucas Pianegonda: That was very interesting. I think when I had Spencer Johnson on the podcast, he said like either you have this brilliant clinical person who's very good at like their clinical job but has no idea what it takes to get a device to market or the other way around. You have a brilliant engineer who knows how to design for manufacturing and all that stuff and then has no idea what actually is needed in the clinic. So they're having a tech and they try to figure out how to make that tech solve a problem because they just have their solution and which is looking for a problem. But thinking of this problem, I am now a founder of a medtech startup or like a new project and I want to figure out how do I develop this medical device? I have a brilliant clinical idea. How do I do it? Walk us through the first steps and how the process will look like.

Lisa Voronkova: 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. 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. So step one is a clinical need validation and step two which are like two steps of a first step is to understand the reimbursement landscape and who is an actual buyer and only then you should start thinking about the engineering and that sequence save you years and maybe like thousands millions of dollars

Why fall in love with the problem, not the solution?

Lucas Pianegonda: That really tracks that really tracks with the following things is I always say like engineers tend to be like a person with a hammer and they run around looking for stuff that looks like a nail. The image is like how founders work. They have cool tech and they want to just fall in love there with their solution. But my advice is like fall in love with the problem instead like what clinical problem are you obsessed with solving and then like take care of the solution later. And the first thing that you mentioned is like go and see for yourself. That's actually a very I'd say lean principle because that comes from genchi genbutsu is a Japanese principle in lean manufacturing or Toyota system which is like go real thing real place it means goes go and see for yourself get your boots dirty and go and watch the problem watch the procedure because only like this you will learn and we had Dr. Axel Bersie [?] which is like very similar to you on the podcast and he's an engineer but he has the rare property that he also works in a clinic and in a innovation setting. So he was looking at this surgeon performing a procedure and he was like weirdly bent over and he just asked him like why the hell are you doing it like this? Because like your back must hurt and then he said yeah like the device doesn't let me turn like this so I can't make it work without bending over like this. And he's like I'm an engineer. I can make a hinge here. That's like problem solved. So that's very very interesting that you say that. Good. And then what is the next step? I have figured out what my problem is and then I have figured out who's going to pay for it. So how do I like start building stuff?

What are the six phases of medical device development?

Lisa Voronkova: Oh okay. So here I would say there are like six steps maybe like five and I tell you up front most people might underestimate the first ones. So like the first step is the discovery. So that's your clinical need validation. That's your market research. That's understanding the competition and also here in the first stage you have to define the regulatory pathway. So that's where you have to make a decision is it worth [?] to go after this idea or not because according to data from the FDA it takes seven years in average to bring a medical device to market. So it's a seven-year commitment and you want to figure out earlier do you want to commit for seven years or not. Now second step would be to build the concept and test feasibility. So you have to understand if it's physically possible to build something that you envision in this world. Can this be actually built or not? And what are the physics constraints? What material would work and so on. Then once you're sure it's working, you go into phase three which is design and development. So that's probably the longest stage. You're doing this like detailed engineering. You're doing design for manufacturing, building the device, testing functional prototypes. You run a lots of tests here also developing your quality management system here in the same time. Then you do verification and validation. So basically proving the device meets its specification which is doing exactly what you thought it would do. So all this like testing to be sure it's safe like electrical safety testing usability studies and so on. And if we're talking about higher risk devices it's also clinical trials in this stage. Then phase five would be regulatory submission like 510(k), De Novo, premarket approval like depending on your device classification and final step is a phase six, amount of fingers here [?], six is a commercialization so you scale up the manufacturing you handle supply chain you handle distribution like doing a post production support and so on 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.

Where do lean startup methods work in medtech?

Lucas Pianegonda: I mean that is a very good keyword or faster and more successful. You said estimation is that it takes you 7 years to get the device to market. Like I am obsessed with innovation and I would say also like sustainable innovation in medtech. And the problem that I see is that it just takes forever to get something to market. And there are certain reasons for doing so because of course you need to make sure that everything is safe and effective and sometimes even regulatory bodies take longer to review what you have I'd say submitted to them. But like what is your take on I'd say lean startup methods in medical technology? Because like the lean startup method is like built, measure, learn. You try to figure out what your solution should look like with it's a very iterative and fastly iterative approach. So you build a prototype, you get it into the hands of a surgeon and you let him tell you everything that is wrong with it and then you go fix it and then you do it again until he has nothing left to tell you that is wrong about it. So it's probably a good solution to his physical or clinical needs. And the second thing is like if I just if I go do discovery now and in seven years my device comes to market like maybe the problem doesn't even exist anymore. So that's a very high probability that like the landscape has shifted a little. Some things will stay the same but in seven years there can be a lot going on. So what's your take on this?

How do you get user feedback early without losing regulatory control?

Lisa Voronkova: So well first of all I'm a huge believer in this principle that in medical devices this gap between what engineers think is good in design and what actually works in clinical settings this gap is enormous. And we also we were not doing it from the very beginning but we started it probably four years ago in our company and we are trying to incorporate user feedback at every stage. But this method of how you approach that it would change depending on where you are and early concepts we do observation like we see the context. We watch surgeons working. We watch nurses. We watch technicians in their actual environment without pitching them what we're building. Just trying to understand what is happening. And we also try not to interview them because sometimes when you ask questions to a doctor, they might not even mention something that is critical for you, but it's just a routine for them. So they might forget some step here. So that's why you should watch them. You know, not in the conference room, but in actual action in the operation room, in the clinic, because you learn things that you could never discover from a requirement document, how they for example hold instruments, what is frustrating about the current tools, what is their actual workflow when it's under time pressure and so on. That's the first stage. 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. And if we're talking about later stages, you know, like formal usability testing becomes part of your regulatory submission. So they increasingly requires human factor validation. So you need to prove that your device can be used safely and effectively by intended users in realistic conditions. But I think the key insight is don't wait until you have a polished prototype. The earlier you get feedback, the cheaper and faster is to incorporate these changes.

When do you move from iteration to a design freeze?

Lucas Pianegonda: Yeah. Because like the first and people think they're good engineers or I think very good engineers think that their first prototype is always going to like hit the mark and I think excellent engineers knows that this can never be the case. And yeah, so the faster you get the prototype into the hands of someone who can actually judge and use it, like maybe they'll tell you it's good, but it's like they're it's clunky or they're slower or whatever. And what you also will see is like sometimes, and this is also what I've heard from people who have extensive experience with like the watching and interviewing doctors interact with your device, is that sometimes they'll tell you what they think they're supposed to tell you or how it's theoretically done. And not how they actually do it. So it's like the procedure in their head is or it's like in the book is that they will recite what is in like let's say the textbook and not how they actually do it because it's like they haven't even verbalized this. It's because it's just like a motor pattern that they're using. So that is very that is very very interesting and that is I'd say a key principle in coming up with a let's say good concept for the device but at some stage if you have iterated enough and you're happy with the device enough you'll have to somewhat transition to waterfall in order to get the regulatory done because like at some point you need to say okay now this is the device this is version one design freeze and we can iterate on it like behind the doors, but if we want to get this to market, it needs to stop to change now and then like we'll go through the next phase. So, walk us a little through how would we do design verification at the point that we have the design freeze and how do we get from I'd say design freeze to like approve product.

Why is FDA clearance just an entry ticket?

Lisa Voronkova: And this is something that almost every first time founder is struggling with because they are typically like spending years to get to FDA clearance. They celebrate and then they realize that the real work is just beginning because everyone see the FDA submission as final step while it's just the beginning because getting the clearance that means that FDA says well your device is safe and effective to be marketed that's it. 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. And you need a postmarket surveillance to track how your device perform in the real world. And so postmarket complaints is a huge part of it. So like if something goes wrong after the clearance and you already had a design freeze and everything you need a huge system to identify the issue, investigate the root causes and submit reports to FDA. So you should also think of it and allocate some part of investments into this process because otherwise your product might be recalled which can either destroy a brand or just bring you a lot of negative emotions to say. So I think the biggest take here is that you have to budget twice as much money and twice as much time for what happens after clearance that you think you will need because FDA is like just your license that you are allowed in the competition. It's not like a trophy. It's just you know entry ticket.

How do you get from design freeze to clearance?

Lucas Pianegonda: If you are a medical device company and you're looking to make your devices more sustainable, there's a link in the description for you. So it's the FDA clearance is your I'd say starting line and not not the finish line. But let's pull it back a little. So like okay we have this concept. So we have done the discovery. We understand the problem. We have figured out our business model and who's going to pay for it. We iteratively developed the product and now we have a design freeze. We want to get to clearance and of course like then in the end commercialization reimburse postmarket surveillance and manufacturing complaints challenges are there but we have the gap. How do we get to the design freeze from the design freeze to the approval process or the FDA clearance. How do we get there? Because that is what people also are very much interested in like they think this is like the ultimate goal. Of course it is not. But how do we get to this like intermediate starting position?

Lisa Voronkova: So like following the steps that I mentioned earlier, the one on like prototyping and so on. But what also might help here is to identify your manufacturing method before you finalize the design. So like how you going to build the device? Would it be injection molding? Would it be stamping? I don't know. Like each approach here has different design constraints. And when you're thinking of a product of building a product, you have to design to those constraints from the start. So I can advise I mean it's more applicable things that usually we are doing as an external engineering team. 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. Another thing that is I think critical to consider would be a supply chain issues because single source components it's just it's not only not reliable it's just a time bomb because for example we had a client whose entire production was held up for almost half a year like 5 months because they were relying on one specialized sensor And the specialized sensor had a supply disruption. So design should be built with the like alternate sourcing in mind. Oh and maybe like one more thing when you build your design history file you should build it with manufacturing validation in mind. So like process validation, IQ, OQ, PQ protocols, they also should be considered early on because they are part of your product development plan.

Why plan manufacturing and the supply chain from day one?

Lucas Pianegonda: Yeah. Yeah. I think that is what we see a lot. So you made a bunch of good points like one is like manufacturing having manufacturing in mind when you design. The second is like the supply chain that you're going to use later because like the materials, the components that you put in your device and that you design into your device, you're gonna have to procure those and you to manufacture those and that they can be a lot of headaches if you get it wrong. I think 80% of the cost that you have in the device is determined in the design phase. That's also by the way true for the environmental footprint. So design is the most important part for manufacturability for your supply chain for your cost environmental footprint whatsoever. And this very much tracks with what we hear from contract manufacturers. So when we talk to them it's like yeah we have this engineering team and their whole purpose is to get flaws out of products that we would have been stuck with for the next 10 years because the devices are going to be like 10 15 years lifetime at least and if we have a bad OEE so bad manufacturability or manufacturing output then we're stuck with it. So we have a lot of scrap. We have a lot of issues. We have a lot of stuck tools. So we try to get this out as early as possible. And that means if you just go design a device and go to your manufacturer and says please manufacture this, they're going to tell you also what is wrong with it. So not only incorporate your I'd say final customers, your clinical customers, but also like everybody let's say along your value chain. So for example your CDMO is one of them but also probably raw material manufacturers because they'll have to understand that this and here we come to like the second sourcing that this has to be available in a certain quantity. It has to have certain properties. Those properties should stay the same. So we're coming to the let's say topic of medical grade because if you choose a plastic that is just like yeah this is like any old plastic and you do not have a change control on it's like yeah that can affect your biocompatibility by a lot. So I like having let's say industrialization components during a phase where you actually also have design freedom. So that really tracks with like overlapping project phases or development phases. Good. So the last thing you mentioned and probably I'll play it back to you then is documenting. So what I see good engineers do usually is like okay they they iterate they develop a cool product and then like oh after the fact oh we should do documentation by the way because now we need to submit to the FDA and this was like a year of development that needs to be documented like in hindsight and you'll miss stuff. I don't know what I ate for breakfast yesterday. So that is really a challenge. So what do you advise on how to document without like spending all of your time documenting instead of developing?

How do you document without spending all your time on it?

Lisa Voronkova: To be very honest, this is just a process [?] like in our company, we have this system. I would say it's a unique management system that we have now that allows us to build this documentation from the very beginning. It's just we are working with the variety of projects and of course we have to document everything because some people in the team might change for example at some point and you should always be able to even use these documents internally and diversify the risk of you as a company. So we are trying to document it from well not day one but once we have a proof of concept should be documented properly we're not exceeding documentation because we also had one experience I would say rather negative it was a corporate client and they kind of forced us to document too much so there were like 80% of engineering time in documentation efforts and 20 like development. It was a bit extra but keeping up with documentation is important part of the process because as you say it correctly like you can you might forget something when you submit all the documentation about your products and you'll just create more problems for yourself in the future.

Lucas Pianegonda: Yes. Yes. Yes. And I think then there are also tools who can help you with this. It's like we had also Carl Larson on he runs a company that does a documentation software basically and what their system does instead of you're just writing a let's say report this like an Excel or a word where you document stuff it's like they have like distinct data points I would call them for example requirements test cases results that you have separately from what I would call a report [?]. So if you have to like some component has an ID and that ID changes because yeah you need to do the second source and then you have 17 documents where this like comes up. Okay, I have to change the 17 documents now. I have to check through them. I have to release them. I have to approve them. It's like all painful. However, it's not really necessary because like you could just reference that single ID which is like a data point that you have referenced in several different reports and that speeds up this process of document and by a lot. So I think his estimate was not 80% probably a little extra as you said 80%. But 50% is his is his estimation that 50% of the time of medtech engineers is spent document and you can cut that by half if you use a system that is like a database first approach and do you use something like in this direction or how is your system set up?

Lisa Voronkova: Yes, we had our proprietary system for that but we are also using another European company. So we also have this similar system which does basically what you described and I would say that time for documentation would be like 30% in our case.

Can medtech be fast?

Lucas Pianegonda: Yes, that's I think that's a good KPI. It's like if we can get it down to 20% I'd be like I'd be super happy because like just imagine what an engineer can do when he documents 20% instead of 80%. It's like you just have like four times more time to actually do the engineering and then like how much can we speed up the time to market like of course we have external constraints. So if you build a tool it's going to take you a few months. If you're going to do a regulatory submission like the regulatory submission is going to take time. If you do commercialization you have half a year until you actually get the go [?] from the hospital. But like those constraints who we can control like we need to speed those up because a lot of medtech companies and especially established ones and not the startups are like on the move fast and break stuff that they might break stuff that they later would have needed. So that's their I'd say sin or fault. But the other the other ones, they're just like, "Oh, let's not just move too fast because it's like we will have to adhere to bureaucratic processes that could have gone a lot faster and that they just have like a let's say homemade mindset problem. Medtech can never be fast and I think that is wrong. I think medtech can be fast. We just haven't figured out how to yet." What's your take on this?

Lisa Voronkova: Yeah, I completely agree with you that I think medtech is not fast because it's like highly regulated field but I agree if you can optimize it somehow then there is a chance it would be like 5 years instead of seven years in average

Lucas Pianegonda: And I mean two two years if you do that for like two three generations you're a generation ahead you're a generation ahead on your competition if you can do the five instead of seven years so I mean tell us a little bit about your company, what you do and what devices you work on. I'd say mainly what when what your passion is.

What does OVA Solutions work on?

Lisa Voronkova: We mostly work with class 2, class 3 medical devices, but we also do class one and wellness devices in general. So, we're a team of 62 engineers either with master's degree or PhD in engineering and we're acting as an external engineering team. So very typical approach for us. We work on a time and material basis and I think what is so special about our team is that we can build complex devices fast. So if it's something that we have experience in because as I told you like 200 devices were built […]. From those devices, we can deliver a product sometimes in one year, sometimes in a year and a half, which is extremely fast for products like from tech space in general. If we're talking about areas of expertise, I would say we have the strongest expertise in three categories which are any sort of orthopedic equipment, any sort of wearable equipment like any wearable devices and also whatever equipment that goes inside of the operation room. So like colonoscopy devices or ultrasound machines. We work a lot with cameras in general with AI on the device. So we don't do any software application like we don't do mobile applications or web interface or any external computing but we work a lot with the firmware. So that's another sweet spot for us I should say.

Lucas Pianegonda: So what you like to do the most is like complex devices with I say hardware firmware electronics. So really the I'd call it the cool stuff.

Lisa Voronkova: Yes. Okay. Yes. Well we have half of our teams in mechanical lab. So there are mechanical engineers. We also have electrical lab. We can facilitate animal trials. We can do up to 100 devices in our office which is usually a typical flow for the project that you have to produce 100 devices and then do clinical trials and then step into a manufacturing and we don't do manufacturing but we can help to find the manufacturing and supervise the production.

What changes between orthopedics, wearables and surgical devices?

Lucas Pianegonda: Okay. So you said you had orthopedics, wearables and any complex device that goes into the operation room. Have you found like between those three areas what would you say are like the key differences in I would say clinical needs or is there like also is there a different mindset because like I have my opinion or what I've heard about orthopedics but do you have like a take on if they differ in any significant way the people that you're selling to

Lisa Voronkova: I would say that in orthopedics the material science is critical and it's unforgiving Because you're putting something inside of the human body that needs to withstand like millions of load cycles, you know, like fatigue testing, this corrosion resistance, biocompatibility. These are areas where you should really pay attention to and the surgical technique matters as much as an implant design also. So if a surgeon can't reliably place your implants the same way every time, outcomes might be difference regardless of how good the engineering is. So you also again have to be aware of the flow in the clinic in general. If we're talking about wearables, I would say they present a different set of challenges because here you're dealing with miniaturization, which is also our sweet spot. I should say we're really good in miniaturization. Like power management also keep the sensor accuracy in a device that also have to survive the daily life you know like sweat any impacts a constant motion that you're taking a shower with this device or you're sleeping with this device and so on the user experience bar is incredibly high because people compare your medical wearable to I don't know like their Apple Watch if it's uncomfortable or the battery dies in 4 hours well compliance drops to zero and your clinical data is worse here. And if we're talking about the complex medical devices like surgical devices, they are mostly designed for high stress time critical environments and you don't want them to fail because it might harm someone. You also have to make them with the sterilization compatibility and it would constrain some of material choices. Ergonomics also must account for surgeons wearing gloves sometimes or working in tight spaces sometimes for hours you know and also you have to consider the integration with existing operation room workflows and it's it's something non-negotiable here because if your device disrupts the surgical team's rate [?] they'll just stop using it no matter how innovative or how valuable the device is but I would say there's The common thread I see across all three categories that you have to deeply understand the use environment. It's something that I spoke about already because lab conditions and real clinical conditions are two different things and sometimes you cannot just foresee something coming.

How do surgeons and clinics see risk and waste?

Lucas Pianegonda: Yeah. It's if you go and see for yourself, you'll see the things that you didn't know you didn't know. And that is why it's so important. I mean I have my take on orthopedics. It's like this was also what I was told by people who are very deeply into orthopedics. And it's like he said I think it was like Jim Sururik [?] he's deeply into commercialization and also orthopedics. And he said, you know, I know surgeons who who told me I'd rather amputate than use something that I don't know if it's safe because like I know people can live without legs, but I know I don't know if he can live with your device. If you have an infection or something goes wrong, like it patient might die. So they have like the highest stake I'd say of a lot of let's say medical disciplines. They put their livelihood, their good name, and the patients life on the line. So, your device better be safe. And there's like no leeway for like any bells and whistles. If it is not necessary to do a better clinical outcome, I don't care. So, that is why they seem to be very conservative. I don't think that they don't want to do good for the patient. But the conservatism comes from a very well-thought through place because yeah some someone might die and it's not very unrealistic. And I think like in wearables what I've seen is like it depends a lot if they're singly used the wearables or if they're like I'm going to wear them for longer time. So if it's like something like an Apple Watch where you would wear it for a longer time and it's reusable or if it's just like an insulin monitoring patch where you just like every week you do a new one because like with these single use devices and single use devices in general I see the trend emerging that hospitals clinics and surgeons in general or health care professionals in general they start to criticize the let's say waste problem because like I work a lot with medical devices device companies and they see sustainability as this CO2 reduction problem but clinics don't don't see it that way they see it as a waste topic and I think if we can like tackle this in a meaningful way there is value to be unlocked what's your take on this

How can medical devices become more sustainable?

Lisa Voronkova: Yeah I mean I agree with you it's it's not only a question that patient safety is non-negotiable and for example you can't use a recycled material if it hasn't been validated for biocompatibility. You can't reduce packaging if it's compromised. Sterility and safety always comes first. But there is in my opinion enormous room to improve within those constraints like start with material selection. They're increasingly biocompatible materials that are also more sustainable like bio-based polymers, recyclable metals and so on. The key is to evaluate sustainability as a design criterion alongside performance cost and regulatory requirements ideally from the very beginning and not like later on. Also, packaging is another huge opportunity. So like the amount of single-use plastics and medical device packaging it's enormous. You can often redesign packaging to use less material, use more recyclable materials or reduce overall volume which also cuts shipping costs and carbon footprint and so on.

Lucas Pianegonda: What I've also say is that if you just add this as an additional aware [?] requirement because it's like the problem usually is like it has never been taken to into account. It's like it was never on the table. So even if you just say okay performance and cost come first then optimize for sustainability you can already do a lot with just this hierarchy performance first cost second then environmental footprint because you can do so much with it. So I've seen a lot of interesting approaches as you said if it's just nobody cares about how big your packaging is if you don't optimize it. It has never been looked at and we have always done it like this and then it will never change. So I think design is the right space to go look at it. And what I also find very interesting and this would be like the last point is something like a hybrid use device because we do not only have a lot of single use plastic but we also have complex medical waste. So if I have like a single use I'd say powered device something like that in a home setting I will be using that for years like a drilling machine or whatever electronics displays whatever and that is just a single use device it's very complex e-waste after that no way in hell I can ever recycle that so what I've seen as a concept is this hybrid use approach where the thing that comes into contact with a patient that is going to be single use and the whole electronics the will display the intelligence. If you have artificial intelligence in there, you probably also have a lot of computing power and rare earth and whatnot in there that will be multi-use and with that you can cut waste cost and probably also a lot of environmental footprint. So what's your take on this hybrid use concept?

Lisa Voronkova: Well, I should say that I know your company works specifically on making plastics more sustainable in medtech. So I think this is an area where collaboration between device developers and material experts is really critical because neither side can solve it alone and well it's also like another way of approaching it would be a manufacturing process optimization in general. So to reduce like energy consumption, minimizing material waste and all choosing manufacturing partners with strong environmental practices.

What is Lisa's one piece of advice for medtech founders?

Lucas Pianegonda: It's a triangle. It's always the process, the material and the design. And if you get those right, which is difficult, then you have something that really works. Cool. Good. So Lisa, I always ask my guests to give our listeners some some piece of advice. And in your case it would be how do I or what advice would you like to give to startups or medtech projects to really develop a device the right way?

Lisa Voronkova: 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. And honestly if you want a practical road map that goes deep on all this that's exactly why I wrote my book because it covers the full journey with real examples from real projects. So it would help to understand how much money you have to allocate, what is the realistic timeline when you have to hire regulatory experts and so on. So it help you to first of all think of the process realistically and budget realistically as well.

Lucas Pianegonda: That is very solid advice. Thank you very much. Lisa, do you have any last words?

Lisa Voronkova: Look, as well [?] again, thank you so much for having me. That was really great conversation and I can tell you that I really enjoyed it and I see that you care deeply about making this industry better which I appreciate a lot and I leave your listeners with this like that's I think that well medical device development is generally one of the hardest things that you can do in technology. It's expensive. It takes a lot of time and roughly like 80% of startups don't make it if not more. I'm not going to sugarcoat that. But the thing here is that the patients who need better medical devices, they don't care about your excuses because they need people who are stubborn enough and smart enough to navigate this complexity and deliver solution that actually work cuz well every device that makes it through the process had the potential to improve or save lives and I think it's extremely important that worth every challenge. Another thing I want to mention that if anyone listening is working on a medical device and wants to connect, you can find me on LinkedIn, you can check out my newsletter. It's called No Mercy MedTech where I share some news in the industry and some tactical insights for medical device engineers and founders every other week. So, thank you Lucas again and thanks everyone for listening.

Lucas Pianegonda: Yeah, thank you very much too, Lisa.

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.

Updated on October 8, 2026.

Lisa Voronkova on MedTech Sustainability by Design: How to Build a Medical Device That Actually Sells