Building a medical device rarely follows the smooth, predictable trajectory presented in investor pitch decks. While regulatory consultants often default to "it depends," medical device teams require concrete figures regarding engineering hours, calendar timelines, and budget allocations to bring a concept to market safely and effectively.
Lisa Voronkova, co-founder of OVA Solutions, draws on a dataset from developing over 200 medical devices to pull back the curtain on hardware engineering realities. She outlines the four structured phases of engineering—Discovery, Proof of Concept, Design, and Development—explaining how disciplined phase-gate management mitigates costly late-stage redesigns and protects capital.
The conversation dives into transparent, real-world case studies ranging from short pre-production hardware tracks to complex, multi-year continuous glucose monitor (CGM) developments. Lisa and host Etienne Nichols explore the true financial scope of Design for Manufacturability (DFM), realistic blended hourly rates across global markets, and why shortcuts in early contextual validation often lead to catastrophic manufacturing overhead.
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What it is: The engineering phase where a prototype is redesigned to ensure it can be mass-produced efficiently, consistently, and cost-effectively without sacrificing safety or performance.
Analogy: Imagine hand-crafting a single custom wood table in your garage. It looks great, but making 1,000 identical units a day requires specialized factory machines, specific assembly steps, standardized screws, and precise quality checks. DFM is the process of translating that single garage model into a blueprint for automated, high-volume factory production.
"The mistake is getting more and more expensive the closer you are to manufacturing. The biggest mistake is diving into manufacturing before the function is proven." — Lisa Voronkova
"Investors want to feel the product. They want to understand that you already spent time, money, and effort into building something—not just looking at a render or an AI-generated picture." — Lisa Voronkova
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This episode is brought to you by Greenlight Guru.
Navigating the transition from early prototype discovery to commercial manufacturing requires flawless documentation and continuous quality management. Greenlight Guru provides the only cloud-based software platform designed specifically for MedTech companies, seamlessly integrating both Quality Management System (QMS) and Electronic Data Capture (EDC) solutions.
Whether you are consolidating your Design History File (DHF) during initial engineering phases or managing clinical trial data prior to regulatory submission, Greenlight Guru helps medical device teams accelerate development while remaining fully compliant. Learn more at www.greenlight.guru.
Etienne Nichols: Hey everyone, welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. And today I want to talk about what it actually takes to build a medical device, which not the polished version you hear in the pitch deck. You know, there's a lot of generic answers out there, especially in the regulatory world, that they'll say it depends. And it does depend, but I want to talk about the real numbers. How many engineering hours does it take to go from an idea to something you can actually put in investors' hands and talk through and have that regulatory strategy from?
Where do projects actually lose time? What does engineering actually cost? Why does one device take six months while another one takes six years? And as a project manager with a PMP, I was very interested in that. Had my Microsoft projects and we talked about flow critical path. Today I want to talk a little bit behind the curtain and pull that curtain back so we can see that. Our guest today has a data set that most people in MedTech probably don't have or haven't heard about.
And over the past decade, her team has developed more than 200 medical devices. They've tracked what's happened along the way, the phases, the engineering hours, the delays, the iterations, and ultimately how long it really took to get from concept to market. So that means we're going to have a rare look into medical device development. We'll kind of get away from just generic numbers. We're going to try to talk about where the money goes, why verification can eat your schedule, how fast teams can actually move.
And so on. I'm getting way ahead of myself. So let me introduce Lisa Voronkova. She's the co-founder of OVA Solutions. and I apologize, Lisa. Is it OVA or OVA?
Lisa Voronkova: It doesn't matter, you can say whatever. So, let's do OVA. And the name is actually interesting because we decided to do a questionnaire to vote for the name of the company. And then we decided that nobody cares what is the name of the engineering group, so we called it after three of my kids, which are Olga, Valentine and Amalia, so OVA.
Etienne Nichols: I love that. Well, that's that I mean, I think that story in and of itself is important. So, I mean, Lisa, so let me just kind of go through a little bit of what you've come been through. Lisa leads a team of 62 engineers that has developed, as I said, more than 200 medical devices across categories like wearables, drug delivery, very near and dear to my heart, portable ventilators, surgical robots, and orthopedic implants.
What makes Lisa particularly interesting for this conversation is it's not necessarily the 200 devices, but the fact that they've been tracking that, and they know some of the some so what the projects actually cost engineering hours, dollars, times, c calendar times. So today let's talk about that a little bit. I'll also mention we didn't really, I didn't really put this too much in the intro, but that you wrote the Hardware Bible, a book that kind of details a little bit more about some of your experiences in and in medical device and what to expect if you're developing a medical device.
So, I think that's worth throwing out there. If you're interested in learning more about her book, I'll put a link in the show notes so that people can look at that as well. So, Lisa, thank you so much for coming out on the show. You built more than 200 devices before we get into the numbers, can you talk me through a little bit about what goes what happens between I have an idea and I have a device. What that's a big gap. Talk to me a little bit about that journey.
Lisa Voronkova: Absolutely. So let me just talk about engineering part of it, because there are also other parts like IT and FD clearance and so on. But I want to talk about engineering only here. So, we typically work in four phases, which are discovery, proof of concept, design, and development. So, in discovery, shall I start again?
Etienne Nichols: Sure, yeah, it's fine.
Lisa Voronkova: So, we typically work in four phases, which are discovery, proof of concept, design, and development. In discovery, we break the idea down into hypotheses. What has to work, what are the risks about this idea, what technologies we would need, and the client received a plan, like a functional requirements list, which they don't usually have. For example, if we're talking about the batch for seniors, okay.
So usually, a client comes in with an idea and they say we want a patch for seniors, but without specific like how this patch would be used, should it be waterproof, how long the battery would last, what would be the ideal size of the patch, what would be the connection, and so on. So that's something that we would do during the discovery. Then goes proof of concept. So, we call it functional validation, basically to prove that.
It's possible to build something like that in this physical universe. So, we test this hypothesis in hardware. So, the output on this phase is a working mock-up that proves the core function. For example, we were working on a colonoscopy device, and the idea was to build a caterpillar structure that would self-navigate inside the colon. So, we constructed it in a two-week size. We made colon environment.
So, it would be wet, it would be like hard to move in. And we were trying to understand would it be possible to move with this device as it was seen by a by a founder by a client. Then if we have proof of concept, it's all well, we go into design. So that's where we do the full engineering, like electronics, mechanics, firmware, and the output is engineering prototype. Then it goes into development.
So, we take it to so called golden sample and then run design for manufacturing and certification preparation in parallel. So, the output is a device that fully meets the functional requirements that we built during the discovery stage, plus samples that you can put in front of some people.
And on large programs, there are several prototypes between design and a finish line, each with its own verification with the own validation, maybe some gates like requirements go no go after the key points. And the client only enters the expansive phases once the cheap ones have confirmed the assumption. So, you wouldn't overspend for unnecessary polishing of something that is not working initially. So that is the main tool for controlling the budget risk.
Etienne Nichols: Okay. So, I love that you lay out the phases. it makes sense. You make an interesting distinction between because when I was thinking about those design and development, sometimes people kind of push that together into almost one thing. You know, design and development is just an iterative process. So, can you talk to me a little bit about some of the distinction between those two phases? So maybe some of the things that people get wrong with each phase.
Because I can see each one of these being, you know, there's some pitfalls along the way. If you don't really, I'll use a really kind of poor ex this might be a poor example, I don't know, but there are some games that you play where you move to the next level whether you like it or not. If you didn't do everything you needed to do in that level, you're gonna be not ready for the next level.
And I think that's sometimes the way it is when we move from phase to phase. If you don't really accomplish everything that you're supposed to accomplish in that phase, are there things that you see commonly done or not done completely, where people move to the next phase and then you know they're gonna have to go back to that previous phase to to really move through this next one.
Lisa Voronkova: I would say first of all, the mistake is getting more and more expensive the closer you are to manufacturing. And I would say the biggest mistake is diving into manufacturing before the function is proven. That's why we have a structure like this. So, let's say you're making molds, you cut expensive steel, and then you have a design change. So, like let's look into the prices. The prototype mold is like one point one point half to 8,000, and a production multi-cavity mode is 25 to 150 grams and more.
So, you probably want to change the first one and validate it well and move closer to manufacturing later. So that's probably the biggest mistake. Another one, but it goes not that much into engineering, but into maybe a value of the device and understanding how the device would be used. That's one of my I would say favorite examples. So, we worked with the client. we redesigned the device after another engineering group, but the main issue there was that well not to go into details, imagine a pan with a display that should be used in an operation room.
And they built the first batch of the device, then they noticed that surgeons are not using this device because it wasn't tested in the operation room and the display is not bright enough. So, they tested it elsewhere, they tested it in a laboratory where the light is normal, so you can see what is on the display. And then when they started using it in the operation room, they realized that it's just physically impossible to read what is on the display.
So, we have to redesign the entire device to change the display to make it brighter and also change the battery and also change the casing to fit everything in. So that was an expensive redesign that could have been avoided if let's say project manager would go and see the procedure in their own eyes and then make a decent requirements to the device because that is something that surgeons, for example, they wouldn't tell in the interview because it just so obvious to them about the light, for example.
They're just used to it. They wouldn't even mention this part of the procedure because they just take it as given. So that is something that engineering team should see, and that's something that we practice from time to time. Going into the production facility, if we're redesigning some part of the production process or going into the hospital to see.
The entire flow because sometimes it's just not enough to conduct a customer development interview for these reasons.
Etienne Nichols: Yeah, that makes sense. And you know you mentioned what it’s kind of in the previous like when we were talking about this episode and getting into this, some of the your team and being in Ukraine and I know you work with some other countries and so on and did your PhD in Moscow. And I just got off another just episode with a company that develops out of Israel. And there's interesting cultural dynamics and differences.
And do you think there's any and not to get into that necessarily, but I just look at some American-based companies and how versus let's just use a German-based company that I've worked with as well, where there's a difference in how they plan and there's a difference in how they execute against that plan. And I don't know exactly what the different you know, why that is. but for example, I I've just used that that German company. They very, very spend a lot of time in the planning phase, a whole lot more time than I've seen an American company spend.
American company may throw their plan together and then iterate all along the way and can keep iterating very loosely, whereas that German plan takes forever and they finally lock that in and that's done. And they work that plan regardless. And it almost feels like you have a different way of approaching this, even from both of those. You know, it's and I don't know if you have anything to say about that's okay. We can get on to the D FM, which I'm very interested in your talking about as well. If you have a comment, that's fine. If not, it's okay.
Lisa Voronkova: I would say we're more a German approach because also another expensive part is you know certification. If you certify a version that is going to change, you're gonna spend way more money. So, first of all, something that we incorporated in our I would say structure of our team is that once we give an estimate, it's almost like a fixed price contract. Because my experience working with companies who are not planning ahead well is that they give you more optimistic approach and then you reconnect in one year and you see that not much was completed. So, it's another way of upselling more hours than something comes up.
However, once you have a decent plan in the beginning, you can commit to the timeline. You can commit to the budget. So, the budget is firm. The timeline is firm. So right now, we are completing several, like I would say middle sized projects in half a year, which is extremely fast. And maybe something bigger in one year, but we can commit to this timeline. And we can put it in the contract that it would be like the highest amount of money spent, highest amount of time. And that's because of the planning in the beginning.
Etienne Nichols: So how do you how do you determine that number? Because we talked a little bit about in in the intro, coming up with those numbers. I know it's going to vary from project to project, but how can someone have that idea in their mind of this is real? So, I mean, l say I'm a founder, I have an idea, I come to this firm, I come to that firm, I get wildly different numbers.
How do I know what's real and how do you come up with that number? Can you can you get walk me through a little bit of how what the thinking is?
Lisa Voronkova: Experience. Yeah. I mean, sorry to sound boring. So usually, like I would say there are three main categories, and I can even like give rough numbers about it. So, first one would be small one, for two to three thousand engineering hours. So, it's a product with the clear architecture builds on proven technologies, it's like about a year maximum here, like two to three engineering hours, more often half a year right now, because with the I you can move just way faster with that.
Another category would be like five to six thousand engineering hours. So, it's like mechanics, electronics firmware all working together. So, like drug delivery or diagnostics, also about a year with the team fully loaded for 12 months. And bigger projects are 2 million, and more is 10 to 30,000 engineering hours. on the bigger products like surgical robotics, medical ventilator that I mentioned, glucose monitors, because that's a very complex product. So, it's like twelve to sixteen months and more with testing with clinical regulatory on top. So, for context, median path for a new Class II device from concept to 510(k) is around three million and thirty-one months according to the statistic that I see in the market. So, our numbers I believe look pretty competitive. It's because we can use the knowledge from a previous project to accelerate something and cut some corners.
Etienne Nichols: Yeah. Now a lot of companies don't want to talk about how much stuff costs. Are you willing to talk about that? Like the actual dollar amounts of the hours and so on?
Lisa Voronkova: In fact, I prepared two cases for you. Okay, so I can just be…
Etienne Nichols: Well to hear it. Yeah, no I'm excited.
Lisa Voronkova: Transparent about it. So, there is a case of a short project and the one of a bigger one. So shorter project, it's we were built on electronics and firmware for I would call it a rehabilitation chair. It can be also like a smart hospital but imagine something like this.
Sure. Mobility system. Okay. So, the client does the mechanics themselves, and we take the entire electronics and software track firmware of the device. We built two boards, the control box itself and control panel on the board, and also remote. we worked under the standards, it was firmware under class B.
And full documentation package for 510(k) submission. So final deliverable here was five pre-production prototypes plus a complete design history file. So that was four phases, I would say, was discovery around 280 hours. Then first prototype was 720 hours, testing and iteration 500 hours and compliance.
Etienne Nichols: Adding on. So, two hundred and whatever number hours for the discovery and then you add on another five hundred for the or what was the number for the prototype?
Lisa Voronkova: Total was two thousand one hundred or sixteen weeks. Yes.
Etienne Nichols: Okay. Okay.
Lisa Voronkova: Sixteen weeks. So, it was the compliance and project management and CTO engagement.
Etienne Nichols: Okay. Awesome. Okay. So, and then what about how much are each one of those hours, if I might ask?
Lisa Voronkova: So, the price for this project was two hundred sixty thousand of engineering, and then client walks away with this five pre-production units and submission ready design history file as I said, talking about the price per hour. I know the average on the market, and I can tell you about it. Sure. So yes, full cycle firms this year.
They typically bill 175 to 275 blended, and premium engineering groups are billing 350 per hour. So, there are sometimes companies charging 75 per hour, it's more like offshore with I would say enormous quality variance. So, the saving usually comes back to you as iterations here and more than 250.
As either a premium firm or expert consultants rate for an hour of a conversation. So, our rates is 100 to 150. I would say average in 125. We have engineering in Ukraine, but American delivery standard because all our clients are targets in US market. So, the client gets US firm output at roughly half the blended rate. So, the spread comes down to three things. Who's actually doing the work?
Where team sits and what is included in this hour. Like is it a PM, is it a quality design for manufacturability, like or just engineering and science sometimes?
Etienne Nichols: Yeah. Okay, you said you had another you had two projects that you wanted to share with us. Correct.
Lisa Voronkova: Yeah. Second one is like more scary. So, it's glucose. Yeah. surprisingly, like at first we when we took a first look into this project, we gave a smaller estimate internally, of course, not to the client, but then we dig into details and actually we matched this estimate because we completed this product already. So, pharma company ordered a proprietary continuous glucose monitoring patch. Okay.
So, skin worn single use electrochemical CGM patch, needle sensor, proprietary, and chemistry also. The target was wear it for two weeks. Bluetooth connection. So, market for these devices is huge, and as you know, two players hold about 85% of revenue in this market. So, there's the reason that it's hard to enter because most of them are using a proprietary needle and proprietary processors in this type of devices.
So, here we gave an estimate into eight phases to a clinically validated prototype. It's now in clinical trials. So, certification designed for manufacturability, manufacturing come after and get priced separately based on clinical results. So, the phases were discovery, proof of concept, design.
Three different prototypes where in first prototype we covered electronics firmware enclosure, produced a batch of 100 units, bench testing, accuracy management. then second prototype was optimization, the applicator for the device, and also tissue testing and model testing. And also in this phase, we were doing like a small trials to see what would be the optimal solution not to cause irritation on the skin.
After long wearing of the device. And then third prototype was clinical ready. So, this one that goes into the study. Then it was clinical completed on our site. Around 2000 engineering hours, around 30 devices. So, we covered here software, protocol, support, analysis of the results. And then we made it first the l the last prototype, prototype number four.
Updated based on the clinical findings. So, total for eight phases it was 11,600 engineering hours and one and a half year for the development. And then it goes like certification design for manufacturability manufacturing, which would be following.
Etienne Nichols: Yeah. So that that would be added on a little bit later. Yeah. Okay.
Lisa Voronkova: Correct. So, the price of the pro this type of project would be million and a half…
Etienne Nichols: Okay.
Lisa Voronkova: For engineering efforts and materials on top roughly twenty thousand, forty thousand, like standards, lap equipment, materials for samples and so on, study itself also can be external host for certification fees and manufacturing.
Etienne Nichols: Do you have any idea about the pricing on something like that? Because I mean, so we've got the design or we've got the discovery and all of the design that goes into that. design for manufacturing a little bit different. that's you said another cost or it comes after that, after the prototype. And I guess part of the w way this is broken out is so that you can present this to an investor and get additional funds at the each one of these milestones, I would assume. any other reasons you would break it out this way?
Lisa Voronkova: So, depends on a client because this one was for a corporate client and yes, there was a similar procedure like as in a startup. So, they still needed this so-called golden sample. What we call the golden sample is this pre-certification device that fully meets the functional requirements. So, it's like the reference of what you want in the production.
So, what you can do, you can show it to investors, you can take it to a trade show, you can give samples to your partners, collect user feedback as we did, right?
Run early research without clearance and then after all kick off design for manufacturability. Of course, in the state you cannot sell it as a medical device or make any clinical claims, but it's enough to understand do you want to invest more on that or not really. But for startups, this is the most useful artifact to open the next round. Right. So, we will also see that investors want to call the product, want to feel it, want to understand that you already spent some time, money, efforts into building something, not just looking the render or some AI generated picture.
Etienne Nichols: So, this is this is pretty impressive to me that you're able to do that for that amount of money. And then you get to the design and manufacturing. Can you tell me a little bit about how much the DFM phase costs and what else is entailed after that? So, w what else are we expecting to have to come up with money to pay for after we get to this point?
Lisa Voronkova: So, after we're done with the prototyping design for manufacturability would probably be the most expensive part. And here not only we build the final engineering part, but we also start negotiating with manufacturing facilities. So, we can produce up to 200 devices ourselves in our office. But if we're talking about the bigger batches, we have to negotiate with different factories, different manufacturing facilities. Sometimes there are certain requirements.
For example, some devices have to be produced in the US, some devices can be produced elsewhere. We have partners in Europe, in Asia, in the United States. So, we would adjust to the needs of the client. And then goes the post-production support. So, we have a client, I cannot name it. That wellness device, it's not a medical device. And they are producing like two thousand, two and a half thousand devices a day. So, they are pretty popular. So, we are still working with them even though they do not need like more design engineering.
Etienne Nichols: Yeah.
Lisa Voronkova: We're just doing a post-production support for them.
Etienne Nichols: Yeah. I think people don't d people forget about that post-production support, the manufacturing engineering, even after things are off the ground. So that's important as well. How much time would you say is required for that post-production support?
Lisa Voronkova: Once it starts producing the devices like forever, I would say. sometimes we're working with companies. Well yeah.
Etienne Nichols: Well, I mean just like engineering hours per year. Did do you have a thought there? No.
Lisa Voronkova: Yeah, it's it varies. So sometimes it's like not as much. we spent depends. It's like related to a discovery phase. Like usually it's two to four hundred hours a year only. it's not something that we do often though. but sometimes let's imagine let's imagine there is a company that's been around for 20 years, like I don't know, insulin pen, for example.
They're selling pretty well, and at some point, they just need to redesign the device because some components are outdated. Or another request last year we got a bunch of clients who came back to us who wanted to relocate the production from China to Europe or from China to the United States because of the tariffs. So that's where you would invest more into post-production support. But typically, it's not that big of a number.
Etienne Nichols: Yeah. That makes sense. Okay. So got the hours sort of from discovery, design. DFM is still feels a little bit like a black box to me. So, you mentioned that's probably the most expensive part after that production or that that initial prototype that you could put in investors' hands. Talk to me about DFM a little bit and give me some do you have any thoughts or numbers that you can associate with that phase?
Lisa Voronkova: Let me get back to this because monitor device. So, for this type of product, I say it we spent eleven and a half thousand engineering hours on everything before design for manufacturability. I would say it would be probably another five to seven thousand engineering hours to prepare design for manufacturability.
So here what you're doing, like you're planning for assembly sequence, right? cycle time, you do penalization, test points, like some probe strategy, you do tool and design support, you do supplier management, you finalize the boom. Shall I list all of that? Like it's a a lot of different things like preparation to kick of the production and most importantly to see what is the exact capacity different production partner has.
So, we would adjust to their equipment. We do like bill of material industrialization, like second sourcing. We typically look for at least three different suppliers just in case. So not to be dependent heavily of just one supplier. So, we would always have a backup plan.
We do end-of-line test fixture plus test of software plus the firmware, documentation of manufacturing, some work instructions, assembly instructions. So, everything would be fixed, there would be no tech and salts on how to produce and assemble the device. Then another amount of hours would go into this like pilot build support.
We produce a first batch, then we do a first inspection, we do analysis if everything's working well or not and then goes like process validation.
Etienne Nichols: The IQLQPQ. Yeah. Yes.
Lisa Voronkova: Correct.
Etienne Nichols: Yeah. So yeah, yeah.
Lisa Voronkova: Course.
Etienne Nichols: If anyone's ever wondering about why would DFM cost so much? You already have the device in your hand. Well, a lot of that there's a strategy in so maybe you have a device in your hand that costs $25 to make, and you're only going to sell it for $10. And so, you've got to drive that cost of goods sold. Or what I mean, those are pretty astronomical di num differences in numbers, but say your 3D print the housing and then you buy a custom-made needle.
And maybe what you plan to do is you're gonna do a 12-cavity mold, injection molding. And then you also plan to make the needles yourself. So, you're gonna cut you're gonna pay pennies on the dollar where you might have bought those custom things. So, there's a lot of ways to drive that down. But in the initial phase you're trying to just get there to where you have something that you show it works. And then that DFM is very you really dive down deep. And so, yes, it's a valuable which yeah, obviously it's costly, but it's valuable and it's it it's important, something I think a lot of founders don't necessarily consider.
Lisa Voronkova: So, for average product, DFM would be somewhat between two and a half to four thousand engineering hours. I gave you an example for a complex product as a glucose monitor, but for average one wouldn't be like that expensive. But then you'll be ready to produce as again one of our clients, two and a half devices a day.
Etienne Nichols: Hm. Yeah.
Lisa Voronkova: And they would all look the same.
Etienne Nichols: Right. Consistent, safe and effective. no worries about maybe findings later on. And then the that's one thing I didn't mention about the manufacturing hours, cause someone may be wondering four hundred manufacturing hours, why is it not just consistent?
Why would we need to re resign that much? But anytime you have customer feedback, you say, Well, there's a sharp edge here. Well, you need to maybe change the radius here. It's just so it doesn't when they're holding it, there's not that irritation or whatever the case may be. It's maybe mild changes, but those are there's a lot to that that could go into that.
Lisa Voronkova: We're trying to avoid that. Right. That is why we are making the prototype that would look exactly like the device you would receive from a manufacturing facility, and we'll try to eliminate all the subtle differences after this pilot run on the production, just to be like very sure that we tested everything before because that like you're saying a sharp edge that might cost a lot. It might end up in redesigning the entire mold, which I said is like one of the most expensive parts of the production.
Etienne Nichols: Yeah, that makes sense. I just in my experience, I remember I was working on a certain product and the FDA actually put out a letter about this type of product. And so, as a result, it changed the behavior of the physicians who utilized that product, which our product had been on the market for years and years and years, no problems. I mean, you know, for the most part we had no intention to change the design.
But because the FDA some of our competitors had issues. So, the FTA put out a warning to say, hey guys, when you use this, think about this the way you use it. So, it changed the behavior of the physicians. And as a result, we had to redesign some of the elements of our product. So, it's interesting how it may not be your product that changes. It may be the environment or the way they're being instructed to use from other due to other external factors due to competitors' products even. So, it's something to think about. I'll yeah, so anyway. Other questions.
Lisa Voronkova: Interesting story, yeah. Yeah. I haven't faced that. I we didn't have this type of experience.
Etienne Nichols: Yeah.
Lisa Voronkova: I imagine how people were so annoyed.
Etienne Nichols: Yes. it's it was something. But what about patents? I think people rush to get a patent if they have just the idea of a back of a nap and well okay, the first thing we're gonna do is gonna get our IP and our patents. What are your thoughts there?
Lisa Voronkova: It's very important to patent something that will be useful and give you some advantage here because I let's say if we patent something innovative but doesn't worse patent in. Like I heard the example okay, so like let's imagine a toaster integrated into a chair. So, does it exist? No. Is it useful? Also no. So, I would say that heavy investment into patterns would only make sense if you know that this is something that can be used by competitors because it's just so innovative and so useful has so much value.
Etienne Nichols: Yeah, that makes sense. I'm trying to think if there's any other questions, I want to ask about developing a medical device product, what are some of the things that you see maybe early-stage companies not really getting right? And because they don't have this element, whether it's proper project management or proper discovery, I don't know, if there's something that stands out to you in your mind. I don't mean to lead the witness here by asking those questions necessarily, but anything that really is consistent across projects.
Lisa Voronkova: Hmm, I would say that first time founders not fully understand the value usually of the device that they're building, and they might end up completing all these steps and still end up with the device that they don't know how to sell to the hospital and who exactly is going to pay for it.
So, it's a number of products on the market they were that unfortunately failed. For example, this drug delivery inhalator for insulin. You remember this product? It was probably the biggest engineering failure. I would say not engineering, it was the product was working. So, the product was working, it's just the market was not ready to the device where you inhale insulin rather than making an injection. Like it sounds like a good idea, but then there were no clinical superiority, and device was bigger, and then you had to also compare.
Complete the testing of the lungs while you're using the device. So, people just stopped using this because there were no reason in the device. Or another example, this the pill with the tracker that can give feedback if the pill was swollen. it's also like another project that existed and failed after a huge investment. And also, they were backed by an insurance company. But the idea is that okay.
You give it to a schizophrenic patient. First of all, they don't really like to be tracked. And there's like an extra thing to be tracked. But the thing is, like the engineering part here was excellent. They produced the device. It was on the market. It was all good. But again, no clinical superiority. Like you're paying for this pill with the sensor, 1500, and you're paying for like generic 20 bucks a month.
So, what exactly are you buying for this extra $1,480 a month? Like knowledge that the pill was consumed was clearly not enough to make sense to scale in the market. So, I would say of course it's like it's very fun to gossip about these products once they're failed already and we know why.
But it's very important in the beginning to understand what is the value of this medical device and how to feed it into the pathway of care, how it how it would affect like next steps of care, for example. Because sometimes you need to also educate the nurses about the care related to this device. Maybe you can do some extra screening, which is needed now because you just changed the process completely and so on. So that is something that I see like a biggest mistake. And by mistake, I mean the something that would lead you into losing time and money.
But to be like not so global, not so dramatic, I would say like under budgeting for compliance. that's another mistake I see often.
I would say the ordering the full ISO ten nine three panel, when a device like just needed like a biological evaluation plan. Yeah. Some chemical characterization and all. So
Etienne Nichols: So let me let me ask you make sorry, go ahead. I didn't mean to interrupt.
Lisa Voronkova: No, sorry. I want to say like another mistake that I highlighted already is like not planning properly and starting manufacturing before you prove the function and certifying something that wasn't proven, something that you're going to change. Because it's like the most expensive things and…
Etienne Nichols: You may have just answered the question I was gonna you may have just answered the question I was gonna ask then, and that would be what do you recommend them not spend money? What do you think the biggest waste of money is early on?
Lisa Voronkova: A good question yes like I’m thinking something apart from certification sometimes people really want to document everything because someone told them that everything should be written down and we had one example just one in our portfolio where the client was so concerned that 80 percent of the time we were just putting together the documentation…
Etienne Nichols: Yes.
Lisa Voronkova: But while you're still doing the research it's not that necessary to document every step because you still don't know the outcome. It's like too early. So maybe it would make sense closer to manufacturing stage, but not in the very, very beginning.
Etienne Nichols: I've heard that. Okay.
Yeah. Yeah. Okay. Let me and especially in the age of AI, I actually saw something recently that said, okay, previously we said if it did if it wasn't documented, it didn't happen. That's the way the FDA looked at things. If it didn't doc wasn't documented, it didn't happen. So, documentation is very important. However, now it's so easy to document things. There's almost a question is, okay, I see it's documented, but did it actually happen? Because it's so easy to make documentation now. So…
Lisa Voronkova: Okay.
Etienne Nichols: We're in a new world in a in a way, but anyway, that I'll leave that alone. So, one other question and then we could be done. I know we're coming close to the top of the hour. And if you need you know, if we got a time, I should have asked if you're I got a hard stop, but I want to ask you about the experienced project manager. Let's say we've got a brilliant project manager coming from aerospace, military, automotive, consumer electronics for software, areas where they have figured out project management. I feel like med tech lags a little bit as far as they're not as good at project management, but these areas like automotive aerospace.
The DOD, Department of Defense, they've shipped complex products before. What do you think about med tech is going to trip them up or say make them think, wow, I just don't know what I'm doing anymore? What's is there anything about project management in med tech that's fundamentally different?
Lisa Voronkova: So, some of our project managers have IRSP background. and I would say that in this industry what we notice that like project manager manage what? Like the scope of work, the schedule, the budget, and in medtech there is also this force part which is evidence.
So, you're not just building something, you're building the reason and or like the argument that this thing is safe, efficient, and that it has to be assembled in real time, you know? So yeah. I would say that's the main difference between this industry. basically, managing two products.
Etienne Nichols: They to bring their attorneys. Yeah. They need to get their JD to go along with their PMP. Yeah. Any last piece of advice? I know we're kind of coming up on time. Any last piece of advice to a first-time founder or a physician founder or someone working at a medical device company?
Lisa Voronkova: I would say don't stress too much about creation of the device because you can always hire someone like us or our competitor who would build a device for you. If it's physically possible, I would say we would definitely build it. However, we would not be able to understand the value of what you're building, and we would not be able to sell it for you. So that is something to stress on early. So, imagine you already have all your devices behind you, you know, like how are you gonna sell them?
What you gonna do next? So, this is something this is a question should be answered early. And once this question is answered, it's so easy to raise investment, I believe.
Etienne Nichols: Yeah. Yeah. Great. Well, Lisa, thank you so much for coming on the show. I really appreciate you sharing those numbers. Not everybody's willing to pull the curtain back and really kind of show the raw numbers behind hours and cost of those hours, where the money goes. I think that's very helpful for people. And if those of you listening, if you have additional questions, I know this hour went by super-fast and the part of it's my fault because I had so many questions for her before we even hit record.
But thank you so much for your patience with that too, Lisa. But if you have additional questions out there, those of you listening, let us know. Reach out to Lisa or myself. I think we're both active on LinkedIn. drop us a line. I love seeing those actual listeners give me some feedback and love to hear what you have to say. But until then, everybody, really appreciate you listening. I'll let you get back to the rest of your day but take care.
Lisa Voronkova: Thank you so much for having me.
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