How to Build and Fund Your Home Healthcare Product

The healthcare industry often approaches home diagnostics by taking technology designed for a clinic, making it smaller, and expecting consumers to adopt it.

Anywhere Dx began with a different question: What would a parent actually want to use?

In this episode of LifeSci Continuum, I welcome my clients Nathalya Mamane and Dr. Michael Mina, Co-founders of Anywhere Dx  to share their real-world experiences building, funding, and commercializing healthcare and life science innovation. These conversations are designed to give founders, product leaders, and commercial teams a clearer view of what it actually takes to move from idea to adoption, and where smart teams often get stuck along the way.

If you are just starting your journey, or you are feeling stuck somewhere between strategy, product development, commercialization, and growth, contact me today. I’d be happy to help you find the clearest path forward. https://www.linkedin.com/in/founderandcdo/

Nathalya Mamane: https://www.linkedin.com/in/nathalya-mamane/ 
Dr. Michael Mina: https://www.linkedin.com/in/michael-mina-md-phd-711918113/ 
Anywhere Dx Website: https://www.anywhere.health/ 

00:00 How to Build a Healthcare Product People Actually Want
02:20 How Anywhere Dx Identified a Real Healthcare Problem
06:45 How to Find the Right Healthcare Startup Co-Founder
10:19 Why Healthcare Startups Should Solve Problems, Not Build Technology
15:45 Medical Device Design: Building Products Patients Will Actually Use
20:29 Healthcare Startup Challenges: Investors, FDA, and Market Adoption
31:43 Why Simple Medical Devices Win Over Complex Technology
38:00 Medical Device Engineering: Making Complex Technology Simple
45:14 Healthcare Startup Funding and Product-Market Validation
50:18 Healthcare Startup Advice: Find the Problem Before Building the Product

Nathalya Mamane was not a diagnostic scientist. She was a mother who was tired of losing an entire day every time one of her children needed a strep test.

The healthcare industry often approaches home diagnostics by shrinking technology designed for the clinic and expecting consumers to adapt. Anywhere Dx started somewhere smarter: with the question, what would a parent actually want to use?

In this episode, Nathalya Mamane and Dr. Michael Mina share how Anywhere Dx is working to create an affordable, saliva-based molecular strep test that families can use at home, and why successful healthcare innovation starts with a real user problem, not a technology looking for a market.

A simple user experience is not simple to build.

This conversation explores what it takes to turn a clear consumer need into a regulated healthcare product, from defining the right requirements early to navigating funding, technical complexity, and the realities of bringing a new diagnostic to market.

If you are just starting your journey, or you are feeling stuck somewhere between strategy, product development, commercialization, and growth, contact me today. I’d be happy to help you find the clearest path forward. https://www.linkedin.com/in/founderandcdo/


#LifeSciences #HealthcareInnovation #ProductMarketing

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Most founders think that the hard part is building the product. The hard part is often proving the problem is real, earning trust in skeptical market, and staying focused when investors, experts and incumbents all have opinions that include what can't be done. As a mother, I feel the pain of having to drag my kids to the physician's office. It is time consuming. It is hard to get an appointment. She wasn't coming into this with all the baggage that healthcare professionals with them. It was very much what you see drive the most successful companies. In this episode LifeSci Continuum, and back to the world sit down with Nathalya Mamane and Dr. Michael Mina, the co-founders of AnywhereDx, a company working to make high-quality diagnostics affordable, accessible and usable wherever people are. Nathalya brings more than 20 years of experience building and scaling along with a kind of founder passion you just don't see every day. Her path into diagnostics didn't start with a lab breakthrough. It started as a parent dealing with a very real pain of trying to get a sick child tested, treated and back to the world without blowing up her entire As a parent, I felt that there was this unmet need and this gap in the market for tools that would make my life as a parent simpler. Michael brings the other side of the equation: deep scientific, clinical and public health expertise. He's a globally recognized immunologist and epidemiologist, formerly of Harvard, Brigham and Women's Hospital, and the Broad Institute He became one of the leading voices of testing strategy during the COVID 19 pandemic. How do we allow somebody to be able to read out a molecular diagnostic tool just on their own with their own two eyes. That usually requires like an instrument and a camera that reads photons and all this stuff and we don't actually need that we just need the eyeballs. Nathalya and Michael pull back the curtain on what it really takes to build in healthcare. We want these to be in the nurse's office of every single school system in the country, if not in the world. And so having a teacher say that and validating what we always envisioned is really great for us. We get into founder passion, market friction, public health, regulatory realities, and why the best campanies often start with a painfully simple problem, not a complicated technology looking for a market. Full disclosure, AnywhereDx is a client of mine. All right. Let's go. Alright, well Michael and Nathalya, thanks for joining me today. Thank you for having us. Thank you. Getting right into it. Nathalya, why don't you do a quick introduction to AnywhereDx. What is it? Why have you put it together? So AnywhereDx is building very simply a diagnostic solution for at-home testing. And that is in plain terms. As a mother, I feel the pain of having to drag my kids to the physician's office when they are sick. Something that is, according to me, completely unnecessary. They use very simple things. It is time consuming. It is hard to get an appointment. And as a parent, I felt that there was this. unmet need and this gap in the market for tools that would make my life as a parent simpler. And so we decided to build this product with very strong pillars ~ that would allow for just a more streamlined process to get our kids tested and treated when we need it. And the first disease or the first indication that we are going for is for strep throat because it is way time for us to be able to have an at home strep test whenever we need it, anywhere we need it. Michael, from your perspective, what is really interesting about AnywhereDx for you? The most interesting aspect and the reason we really wanted to start AnywhereDx is that we've not created a system in healthcare that is accessible to the average consumer and the average parent individual who needs healthcare they need it. We still live in a system that was built over the last century and ~ it evolved organically and every now and again there really needs to be a step change in ~ how the healthcare system works. I'm not somebody who's ever wanted to sit idly by and say, well, this is how things are done. So we'll just make incremental changes. And I think that this approach that Nathalya and I are taking with AnywhereDx is really it's a step change that that we feel really needs to be made in the healthcare industry to push it along, to to make a declarative statement that the average individual shouldn't be beholden to these very rigid structures that are generally holding healthcare back, but should have accessible health care on their terms in a way that really fits the modern person, the modern family. Nathalya, can you recount for us the impetus? How did you come up with the idea? the idea or what drove you to start. this business. What was kind of the the the initiator for you. The initiator for me was just pain for me as a parent. I just felt that I just couldn't take it anymore. Like I remember during COVID when all the doctors were closed and I had to fight my way to urgent cares and my daughter was sick and we knew it was in COVID, but we didn't know what it was. And they would come in completely like hazmatted and they went to the my car door and they would like s swab her throat through the car window and I'm like This does not make any sense. Like we have not evolved. We literally have not evolved in the past, I mean, Michael, what would you say? Like 50, 60 years? Like I remember when somebody told me about the fact that they went from they went from a throat culture to rapid antigen test way back when it was, I don't know, 60 years ago or 50 years ago. And then the big innovation was instead of doing two swabs one after the other and swabbing the kid twice. they would just put two swabs at a time in somebody's throat. And so that was a big innovation that is so old, it just doesn't make sense anymore. And so when this happened to me ~ during the pandemic, I just went on this rampage and figured like we gotta do something. I somebody someone's gonna have to do something about it. And it was so happened that I was in the process of doing my MBA and I just kind of like decided to kind of run with it. through my MBA journey and and here we are. So I don't come from a scientific background at all. I mean, I'm learning things as I go. And I just took it I just took this as this sort of like mission that something needs to be changed. I don't know. I think I was crazy at the time. I think we all feel like that at at some level when we're when we're getting things going. Michael, how did you get connected with Nathalya? It was actually that process of her tracking me down in the middle of the I was, you know, at the time, I was advising the White House, governors across the country, Congress, Senate, international governments around the COVID nineteen response, working with companies like Abbott and Becton Dickinson and Quidel and And all sorts of testing companies to support them in various ways.~ was running the US home test to treat program. And and I'm pretty sure I I probably got a couple of emails from Nathalya that I that probably went into my into my trash can or something in my email.~ but you know, I can't recall the the exact moment she might ~ but somehow she did pique my interest at some point. And you know what the moment I I met her,~ it was very clear that this was a woman Who to hell or high water was going to build a successful company. And that drove ~ that drove me to want to get to know Nathalya. And she ~ was very passionate about bringing home diagnostics for strep throat into the home, you know, in a in a s in a fashion that made sense to me. It was everything that I was standing for in a very public fashion. Everything that I was advising about was around access. The US program that I was running for the Biden administration was ~ specifically towards enabling access to care and ~ and treatment through the through enabling access to to home diagnostics and linking those to telehealth was which is exactly what Nathalya wanted to do and exactly what we're doing. And ~ and so we really started talking at that point and then ~ over the years decided to to build a company around this idea that she was so passionate about and I was so passionate about. She brings expertise that I don't have and I bring expertise that she doesn't. So we made a we made a great duo to to get this thing started. Nathalya, do you want to add anything to that? Well, I remember how I met a it was during the pandemic and he was on a webinar and at the time I would just not go to any of the webinars. I was like, enough with the Zoom. If it's not in person, I'm not attending. And for some reason, this one I attended and Michael came on and he started talking and I'm like, I'm going to meet this guy and I'm going to talk to him. And so I found out he was gonna be at this conference. I don't remember which conference in Texas. And I went all the way to Texas and I finagled my way to a meeting with him. And he had no idea who I was because yes, he did not receive any of my emails. And then we spoke. And then he was coming through Boston and I said, I'm not gonna let him leave him alone until we meet one on one. And we did. And I basically said, Look, I I need you on my team and I can't afford you. You gotta come and help me and you gotta help me do this. And he said yes. Michael, what do you think it was that convinced you to say yes? I mean, I imagine in your position you must not get emails from a lot of people and they want they want your time and attention and they want you to to participate and you you just can't, you know, be involved in everything. So what what was ~ that made you say yes? Yeah. Yeah, I think there were a couple things. One, I I love that Nathalya doesn't come from diagnostics. She wasn't coming into this with all the baggage that healthcare professionals with them, that diagnostic companies carry with them. You know, it was very much ~ it was very much in the vein of what you see ~ drives the most successful companies. Somebody naive coming into a new space with a certain skill set who says I don't care about those rules that exist.~ I we're gonna make our own rules. We're gonna plow our own pathway. And that was at at the time that resonated and to this day to be clear, you know, resonated very, very strongly with me. I've never been one to sit by and follow the rules that are kind of laid out in society about how things are.~ I like to build the new rules about how how we think that they should be and envision the future and I think Nathalya shared that same passion. She she didn't share it. She exuded that same passion and to to build and and you know, create a new healthcare system and a new ecosystem,~ starting with something really simple. And and that was where I think the for me, I was at the time watching a lot of companies try to build the next super sexy thing. That was going to be too expensive for consumers to buy and out of reach at the end of the day, despite all the best aspirations in the world going into And Nathalya came came into this with a very different position. She said she wasn't coming in from a tech heavy position or or anything like that. She was just saying people need to be able to test their kids and themselves for strep throat. And it and she had a very clear vision of what that looked like. It was not sexy, it was very straightforward, affordable. And something that the average person could actually buy on a whim when they it, online or at a CVS or Walgreens. And that was exactly what the world was needing at the time for tackling the pandemic. it's what I've stood for and all sorts of ecosystems and public health ~ efforts that I've been involved with or have led over the years. And it was it was very refreshing to see somebody taking a different approach and not trying to win a Nobel Prize with this, but trying to say, This is going to change healthcare and it's going to be accessible. And the reason is that it's going to be simple. That has so many advantages. It has an advantage of enabling easier clearance through the FDA and faster clearance and enables us to build it on more of a shoestring budget. ~ and it's just the right type of product for people to be able to have access to. So all of it made sense. And she came into it from a very business. mindset first, not wedded to any particular technology. I think you're making a great point. And this is something that I see some of my clients struggle with in that they have this brilliant idea, but often it's over ~ engineered. It's overly reliant on a specific technology or you know, frame of mind. And it is refreshing to have somebody come in with fresh and start with solving a real problem as opposed to I made a thing, now let me go find a market for and I like I like that Nathalya, do you want to add anything to that? Well, I'm like so honored by everything that Michael's saying, but you know, there's such so much mutual respect between him and I. That's why we make such a great team. You know, I struggled a lot with being taken seriously because I didn't come in I didn't come in with the scientific background. I didn't come in with a startup background either. Like I hadn't started a company before and exited one. So like for a very long time I was sort of like seen as like, this is a pet project for this mom, right? I was just a mom starting this thing and it's never gonna take off. And I, you know, I w I was really struggled with that. So for a long time I had to kind of like I couldn't say I I started I had this idea because I am a mom, because then it would it would sort of like blur things into like, are you just a mom or like what what is it are what are you exactly? But I did come at this with a very clear vision. And whether some people took it seriously or not, it it didn't matter to me. In fact, I'm one to never really care what people think. So it I just I just came at this with like this is as a person, as a consumer, whether I'm a mom or a sick person, this is what I would want for me. And I know that if I want this for me, I would want this. A lot of people would want the same thing. And I had to come at this with a lot of market research and I had to talk to a lot of people because I needed somehow to get credibility into what I was saying. And that was very hard. It was very hard. So the fact that I was able to kind of get Michael's attention and have him to have him listen and say, Look, I can buy into this idea. And then, you know, it took time. Like he bought into it and then we kind of talked a lot and you advised me a lot and like and then we became co-founders, I had to build myself up as an entrepreneur because not what I was before. So it definitely was part of the journey. It's definitely part of the growing up part of taking this role. It just wasn't that it wasn't that easy. I wanna come back to that in a minute. You know, the the types of conversations ~ and the value, you know, that having having Michael on board brings.~ what I'd like to understand though is what was your earliest vision of what the product and how has your journey changed that over time, if at all? So that's the one thing that has not changed ever since day one. So when I came up with this idea, and and I have to admit this, I came up with this idea during my MBA. I moonshot it. I was like, I didn't know anything about anything, but I was like, if I had the ideal solution for an at home strep test, it would have to be on the shelves of the pharmacy. So not just online. And that has to have a certain price range, price price point. What is that price point? I just guesstimated an average price of a copay, which could vary between, you know, a copay is between zero and fifty dollars, seventy-five dollars. So somewhere in there. Market research told me and Michael validated that the price point needs to be under twenty five. For that to happen, we need to create something that is really inexpensive to to create, right? To do to to manufacture. Under five dollars, which is It's very hard. Like it's not that easy to make. Right. So that was one. It had to be on the shelves. That means it had to be inexpensive and accessible. The other thing is it needed to be super simple to use. I wanted something that worked like a pregnancy test, where if you can pee on a stick and get your results, you y technically you can spit it to something and get a result. Okay, it's not that simple, but that's how simple I wanted this to look like from the very beginning. So I wanted to use saliva because I wouldn't want to s I wouldn't want to swab my kids. Who would want to swab their kids? So no swabs. Has to be saliva. I had no idea if those things were even possible. Cause again, I had no background. But I was like, I want saliva, I want cheap, I want like a pregnancy test. I want a simple readout. So like, you know, everybody understands a one line, two line result. I f I figured that was probably the least expensive, least technical, you know thing to to to develop. And so I had these crazy ideas, but I had these, right, Michael? We're it's exactly what we're building. We're building this saliva based test that is going to be under five dollars to manufacture so it could sell at retail for twenty or twenty five dollars. And it has a very simple readout. So here you go. So you started with basically the requirements and the restrictions and your your arrow shot is to get to the product. You didn't start with a very concrete, you know, physical idea for the product. It was really more around what it had to do and what it couldn't. Right. The one the one thing that you know, and Michael and I totally agree on this is the one thing we didn't want is we didn't want like a device we didn't want to be associated to a device. So whether it's plugged into a wall with a you know, with a cord or whether it needs an instrument for it to heat it or to read it or and it needed to work completely like it had to be self contained. I mean, at some point we threw around, you know, using your phone and plugging something into the phone and then having the readout out there. Like I was like, you know, these things change everything. I I we want to be completely fully integrated. So it doesn't depend on any other instrument. Will that be exactly what we end up with as a first product to get to market? Maybe, maybe not. But that is really where we're going. We want to get something. And again, you know, I I talk about the pregnancy test a lot a lot because, you know, the the pregnancy test kind of evolved over my lifetime. Right. When my mom first got pregnant with my brother, she went to the doctor. When she got pregnant with my sister, she went to the pharmacy to get tested. And then when she got pregnant with my baby sister, she did it on her own. Like in the span of What the diff what the difference is what, 18 years? Everything changed for my mom. Right. And today, no who goes to the doctor to get tested and pee in a cup or to the pharmacy. Like, we're just buying these pregnancy tests by the case. So, like, I that's what I envisioned. Like, in my in my in my the world that I'm dreaming is that is that we don't need to we can just get these by the case as we need them. So thinking about that, the the vision for the end product has kind of you know, it's come into focus along your journey. Have have you received any pushback from anybody, whether it's been a partner or, you know, maybe there's a a representative group or a manufacturer or I mean really anyone. Have you have you gotten pushback on this? You wanna start, Michael? Yeah, I would say I don't know that we've we don't get pushback on the idea that the average person should have a home strep test available to them. I think that's broadly agreed upon. Mm-hmm. The big pushback though does come in with people saying, Well, we have urgent care, so is it that important? Like the reality is yes. It it's just like a lack of foresight to say, Well, if of course, once this is out there, nobody's gonna be saying, Hey, urgent care was good enough. The biggest pushback I would say we get is probably the market and investors trying to understand whether they want to invest in early stage companies. It's not really pushback. It's more just this is early stage technology. Are you really going to get through the FDA? Is the FDA really going to be okay with this for home tests? We know, because we've spoken to the agency that yes, they are they are supportive. And in fact, they've been pretty emphatic about trying to improve home tools and That's a big departure from when I was yelling about it to the FDA in 2020 that people needed home tools for COVID and and then for flu. And and now they've actually quite embraced the idea. And inside I don't think they're I think this is actually generally accepted. Like, wow, great idea. A a question that comes up is like, well, what's wrong with what we got? Why not just bring the tests that are dot done at a doctor's office into the home? The reality is that those require throat swabs. And they're not particularly sensitive. And so they're regulatory roadblocks to that. And so that's actually part of how Nathalya went about first envisioning this product was it has to be simple, it has to be something people will use, and it can't be a throat swab. We know that the agency doesn't want a throat swab. They want saliva or something really simple. So we're going after a saliva ~ collection process to to measure strep throat. And that ~ of course, you know, that's the answer to. sort of s any of the pushback we do get, like why not just use what's out there? Well, because what's out there just it's not really appropriate for the average home and and the average user who is completely uneducated about diagnostics. And it's not particularly sensitive. And so we've we're we're making a highly sensitive device that is extremely easy to use and affordable. So I've received a lot of pushback prior to getting Michael. I've had everything from in in certain terms push aside, like move aside, ~ you don't know what you're doing, to what are you doing? Are you a doctor? Like what what are you what are you doing? do you know what you're doing to ~ you will never get funded because you don't have any track record? To I mean I've heard it all. Tell us the story though. What's one that kind of sticks with you as you go about your journey? There's one that I remember, and I don't want to say g give you any names, but there was somebody also in diagnostics. There were two actually who basically said the same thing. And I was just sort of like doing my research and telling them, you know, like I was like, look, I have this idea, you know, can we can we talk about it? And they were working on some they b both of them were working on it was two different meetings, but they were both working on some diagnostic product, which I didn't think we were at all competitive with. And they basically told me. Listen, you're wasting your time. We're gonna get to market before you. And all of the work or money you're investing is gonna be wasted. So move aside and let us pave the way for what we're doing. Twice. I got that. Twice. Once over a Zoom and once over lunch. And both times I said to myself, F them. We'll see who stays standing at the end. I didn't know that it was gonna be me at the end. And I don't still don't know that it's that it's gonna be, you know, anywhere DX, but I certainly weren't gonna let them sort of like beat me down. So I've heard I've heard it, I've heard it all. If I let those kind of things or pushbacks sort of like affect me, then I you know, what would I be doing today? You know, like I I'm way too passionate. And I knew that what they were doing was not answering the idea or the meat that. we had in mind. Like I I knew that we were not competitors. So I knew the problem wasn't me, it was them. And you know, you can't change them. So it is what it is. Like you're gonna get pushback as an entrepreneur all the time. You know, what we're experiencing now that we have anywhere DX, you're right. You know, we don't have pushback as much as we are truly trying to mount a very steep mountain. Very steep mountain. And so What you would call pushback, we just call sort of like, you know, it's a consequence of an environment that is stacked against us. And not because we don't have the right product and not because it's not the right time, because we are in an environment that is risk averse and you know, still, you know, still licking their wounds from too many failures in the industry, both of which were these companies, by the way. Both of which were the ones who pushed back. before ~ push me back. And so that's what we're dealing with now. So now it's no longer push back. Now we're just trying to kind of like climb this very steep hill and you know, it's just one step at a time and then you repeat and that's what we're doing. So I want to dig into that for a second. Without revealing, you know, who these two companies were,~ can you share kind of your insight as to why you think they missed the mark? What specifically you're very solution focused. You're trying to solve a problem. You know, some of some of the, you know, the requirements that you've set in place drive that, but you're not married to a technology. You're not married to much beyond the ease of use and the accessibility and the form factor. So what what do you think they got wrong? When I kind of came up with this idea and not, you know, and I hadn't started developing the company yet, a lot of people came to me and said, Nathalya, have you seen Cue Health?~ Cue Health has millions of dollars funded and they're 10 years ahead of you. So I'm like, let me find out again. I was green, like I didn't know anything. So I look up Cue Health and they have this beautiful little machine that sits on your counter and then you have these disposables. And then when you kind of go deep, you realize they sat on this technology for, I don't know, about 10 years until they found the pink elephant called COVID nineteen, where you know people were gonna buy these, they were so desperate for testing that they had the number one solution for molecular testing. Like it was like the best innovation. And everybody, and by the way, when I say everybody, large companies bought these these sort of like devices for all their employees because they other employees to stay healthy and and they would give them this this this instrument and they would give them, you know, dozens of disposables to use in the instrument so that they n they knew that their employees would stay healthy and they would come to work and they were negative and they would test every single day. And they made millions, right? Michael, they did so well. I think they went public and they were valued at four billion dollars. But they sat on this technology for 10 years. But I remember when I first spoke to Michael, and I had first met him, and and I said, you know, Cue Health, they're not gonna make it. And he said, You're probably right. And I said, because I would never buy it. These instruments were like $300 and every disposable was, I don't know, 80 bucks or something. And I'm like, I would never buy this. Never. And he says nobody would. And the only reason they did so well is because they all these big companies, we're talking about the Googles and the Metas and the and the Microsofts of the world, bought them for their employees, and they were thousands and thousands of employees. So they did very well during the pandemic. So what went wrong with them? Well, the market would never want to own a device and a disposable. So I call this a razor razor razor blade model, right? It works for the razor. But it doesn't really work for something that you use once and once a a year, twice a year, right? There's no reason to do that. And so what I think happened, or what I knew we know happened, we know now, is that a lot of companies sort of like piggybacked on that model, the Cue Health model, which is the razor and blade model, and created other ones similar and their, you know, value proposition was we're cheaper. So if the Cue Health model but were cheaper. So they went from fifty dollars for ~ for a instrument to twenty five dollars for an instrument. Those are great prices, but you know what? Consumers didn't want it. And I would bet that even if I were to give consumers the instrument, they still wouldn't want it because nobody wants to keep it. And I talk as a consumer, because I don't know for those who have kids but and who are listening here is when you're looking for a thermometer And you need it, what are the chances it it's not broken or lost? Who wants to maintain an instrument? No one. And so when Michael and I really came to sort of like identify the, you know, the the true final you know vision of this, we're like it needs to feel and cost like a pregnancy test. And people were familiar, like. They were very happy with the with the COVID tests that are it that were to them at the pharmacy. They just want to take something that they can test and throw away. And so all these companies who tried very hard to bring solutions to market followed this razor razor blade model and it didn't work. No matter what price point, it just didn't work. It did not answer to the needs of the consumer. Whereas what we are doing is we are looking at the consumer and said, What would the consumer buy? And like you said, we're not looking at the technology. We don't care about the technology. We just need to answer to the needs of the consumer. And if the technology turns out that it's purple and green and that's what the consumers will buy, that's what we will create. There's an interesting psychology behind a lot of this that I'm sure that~ people have formally evaluated this in other sectors.~ but there's there's sort of a a weight on your shoulders or a baggage that comes along with i if you either buy or even just get in receipt for free of of a of a box that looks shiny and nice, you have the now this burden. You don't want to throw it away because it must have some inherent value. But you also don't want to be wedded to buying the things that just go with it, especially for something like strep throat or some infectious disease diagnostic. You want people want to retain choice and opportunity.~ you know, unless it's something like if you're a ~ in the Apple ecosystem, you know, that's a real investment you've now made. And and Apple has done a great job to keep people in that ecosystem. But in these kinds of disposable infectious disease diagnostics, people don't want to be wedded to And ecosystem. They just want whatever is going to be next, whatever's cheapest and best, and it's going to be useful. And they don't want to overthink it. And the burden that actually is like weirdly placed, even if you get in receipt of one of these boxes, like a Cue health box for free, it actually places a psychological burden on a on an individual to kind of keep it and and hold hold it in, you know, safe and and and then ideally like they have to feel out like they have to go out of their way to spend more potentially to get the next. cartridge that will go with it versus the thing. It's a sunk cost that nobody really wants to have that burden of. And so we've just really, you know, and there's from a technology and build perspective, I totally get why Cue Health and others would build it. They're coming at it from the position of, well, a doctor's office definitely wants that kind of thing for a lot of things. If they can spend an upfront amount here, but then have thousands of tests that they run in the future be 50% less because it's just the cartridge, great. They'll they'll oftentimes go with that. Or the technology is something that as a interesting technological innovator,~ you might say, This is really cool. We can link this to the internet, we can link it to people's EHRs, we can do all kinds of fancy stuff. Turns out the average mom, the average dad, the average person really like not only wouldn't pay for it, but actually is actively almost disincentivized to like be part of that in a lot of ways. And so we've just really embraced that. And there are so many benefits in terms of where we're going with our technology. As soon as we really took this position of saying, we're not going to build fancy and and for lack of a better word, at the moment, we're not going to build durable. We want this to be a one-use thing. All of a sudden, it opens up a world of opportunity to get your cost of manufacturing down way lower than others. Because now you don't really have to worry about. Is this gonna last for 18 cycles or for, you know, a thousand uses or something? You just have to say, is this gonna last and be highly reliable for one? And once you take that approach, the materials you can use get different. The approach you can take gets easier. So there's really, really nice ~ advantages as a company and as building a marketable product that people can actually afford and buy in the future that comes with this just sort of clarifying mindset of we wanna keep it. Simple and accessible and Silicon Valley might not always love a lack of sexy, but you know what? We talk to a lot of investors and in general we've gotten feedback. People are tired of the the fancy diagnostic efforts for home. A lot of them got burned on it and they're saying, Look, we love what you're doing. Like that's makes so much sense. Don't build a tech first program, build a use case first program and then find the tech. And even how we're connecting into telemedicine and treatment, low tech, like not gonna be it's gonna be something that is based around a QR code and and really, really simple and easy and essentially free for the consumer. Say, like this is what ~ Michael was able to bring, you know, to to my understanding, or he to bring this because when I came up with this idea, it was just a strep test and then go see a doctor, right? And it's Michael's sort of like experience in in having worked with all these different companies who was able to really give me the clarity of the importance of making something simple, single-use. Not that that's not what I wanted, but it kind of validated. that that is really the only way to go. And then when you add this this telehealth component to it, I remember when I first came up with this idea, I was talking to friends and they were like,~ and can and then can it connect to your doctor? And I'm like, no, I I don't know how to do that. And then Michael was like, wait a second. No, it has to, and this is how we're gonna do it. And so now I know it's Paul it's part of the full, you know, it's a full circle solution. And and that's what makes it so exciting because when you talk about streamlining people's experience, it really is from soup to nuts. Like end to end streamlined. Why take a kid out of the house, out of their bed, ~ to go see a doctor for any reason when you can do it all from home. You know, I see this a lot and it's it's a little bit of a red flag sometimes where you see a company that their story is we're going to take this big technology out of the hospital, we're gonna take it out of the doctor's office and we're gonna bring it into the home.~ and we've had a we've had a handful of clients that have done that successfully, but in a lot of cases, you know, the patient doesn't want that hospital experience in their home. They wanna solve whatever their particular problem is, they wanna identify. you know what the issue is or they want what they want whatever level of care they can get, but they don't want to bring that experience in their home. So when they're starting with the idea of big tech and make it small and bring it home, that doesn't always solve the patient problem. Well you had mentioned something in the middle of that that some things, That you know, in making this happen, you know, you you focus on making it easy, but we all know when we're trying to make an easy experience, a lot of complicated thinking and building has to go into that to make it happen because that's just how it works everywhere. So you know, without getting into too much of the IP, what are some of the things that have been, you know, challenging along the way that maybe were surprising? So I you know, again, I'm gonna say about what I thought my vision was and then Michael could tell you about all the hard things into that vision. First using saliva, ~ was very important. Then it was running a molecular test, which is a highly sensitive it really is taking a big machine and putting it into the small little thing.~ and I was like, no big deal, we're just gonna do it. And then ~ and then having a very simple readout. And when I compared to all the other companies, nobody had a simple readout. So I like, I don't know, I just want a simple readout. And then when you think about all these steps, Michael could tell you how challenging they are. I think the for us, you know, making something very, very simple, you're absolutely right. It is hard. It's easy to make something complex because if you can just keep bolting together, you can get it to where it needs to be and that's fine.~ I think there's a couple of things. One, my view is it takes really deep expertise to figure out how to make something that should be complex simple.~ I'm not to harp on Apple again, but obviously Apple has made one of the most complex technologies into something that a a first grader could use, you know, in in the iPhone or or preschool, you know, for that matter. ~ and ~ and that took deep, deep expertise. I think that's something ~ that we have ~ at anywhere, we have ~ real experience and one of those areas is certainly on like the the actual readout how we do it, how we allow somebody to be able to read out a molecular diagnostic tool just on their own with their own two eyes. That's usually requires like an instrument and a and a a camera that reads photons and all this stuff. And and and we don't we don't actually need that. We just need the eyeballs. And so that takes a little bit of knowledge around molecular engineering and molecular biology that maybe isn't always ~ the first place that somebody building this test would look. but also one of the really simple things that's completely overlooked ~ is how you prepare the sample up front. It's actually really hard to take a saliva sample, a get it out of the person, and then be able to run what's called a LAMP test, which is like a PCR. ~ it's a molecular amplification test ~ on saliva. That's actually a really hard thing to do. And to be able to do it so that somebody with n who's never seen a diagnostic tool in their life can run it on their baby at home,~ or on their kid at home, whatever that ~ whatever the case might be, is is even more challenging. And so that's where having ~ a a clear head about what you want the end product to be is probably the most important starting point. We know that we don't want it to get clunky, we don't want it to get complicated. And when we stick to those rules, it forces us to find the right people, to find the right approaches. And when we also say we want to stick to inexpensive ~ for manufacturing costs, it also pushes us in a certain mindset to start thinking about, okay, how do we actually do this? And it and frankly, it's taken some real research and development effort to to find the right approaches. And that's kind of where our real special sauce is for this device. And it's the least interesting part of the device for a lot of people because n very few people think about the sample prep up front. but to be able to make this into something that truly can be under five bucks to build and have it be highly sensitive and highly specific and highly user friendly is taking a lot of R&D. And that's something that I think we're really proud of building and ~ and it's a unique aspect. It's where the IP lives. And what's what's also very interesting Not the question asked, but this this component of it doesn't have to be locked into just our device. If we want, we can go sell this IP, you know, to other manufacturers that can really boost their sensitivity for their own assays or their own tests. So I we're also looking at it from more business perspective. What what IP can we build that's hard to build, that makes something easy to use,~ that might actually give us a diversified revenue stream in the in the kind of dovetails really nicely into ~ where where is the business at today? What you know, what milestones have you reached and you know, what's the future look like? I'll let Nathalya come in in a moment. I think we've been in a real research development and now we have an de-risking phase. That is some of the technology, some of the really core technology of this, actually we're saying we don't even want to touch that. Like we we want to buy it off the shelf. Because to improve upon what's off the shelf would cost hundreds of millions of dollars. Like we don't want to do that. And that's actually the mistake that some companies have made in this space, like thinking that these small incremental gains would somehow give them a better market share. Like, no, that is not worth the investment. So there's the nice thing is we're starting with an already de-risked kind of core module, which is the LAMP technology. And now we're in a phase where we have de-risked all the other parts, the end product and the sample prep product. And we're building these into a a prototype. This will be the second prototype that we've brought forward. we learned a lot with the first prototype. We actually made some changes.~ and and so this will be the second one that we feel very good about. It's it's almost certainly not going to be the prototype that the consumer ends up getting. That's just how diagnostics go. We'll probably learn here. But this will be probably the most important. step for us in terms of getting a product that we can actually start trialing in real users' hands rather than sort of the benchtop testing that has really dominated our efforts thus far. So we're excited to be moving into this phase. We've gotten ~ non-dilutive funding from the NSF and the NIH. we have good relationships with those entities. We actually just had the NIH come back to us and and effectively say can we give you more money? And so we're very excited about the interest from, you know, third parties, third party funders in the government that see the value here. And we're taking that those funds and we're taking the WeFunder campaign and we're gonna be starting a new campaign ~ and fundraise to really get these products built in a way that we can start really doing some some robust clinical trials and testing as we gear up ~ to ~ bring this into FDA trials. Nathalya? So, you know, where I stand, I think and where the business is so on on the R&D and and the development, you know, Michael gave you a great ~ description of what's going on. On the business side w where I'm seeing the most the things that are~ most exciting to us is the fact that now people are listening and there's the conversations are a lot more meaningful. And we can see that they will actually convert into significant impact for us. So getting, you know, the NSF and the NIH to listen, not only to listen, but to say, okay, now, you know, what's what's next with us? Like let's not end this here. Or, you know, conversations with investors who are saying, okay, look, this is great. Let's be in touch in a couple months. These are all very validating to us and very exciting to us because we can actually see this. moving in the right direction for a long time. It was just completely flat. And we just couldn't get these conversations to to go anywhere. The WeFunder campaign helped us a great deal because instead of going to institutional investors, our philosophy or our ~ our strategy was, you know, let's prove product product market fit before we even have a product. And so going out there into the you know, into the world and saying, how much would you love this? And if you would, why don't you be part of it and take get a piece of it? And it's actually happening. And people are responding. And by responding, then we can go back to these institutional investors and say, look, if you're afraid of the market, we already have it proven. This is happening. People want this more than ever. So there's a lot more movement. There's a lot more the water's getting hot. And it's very exciting to see. And I think that everything that happened in the past five or six years that created such scar tissue with investors when it came to diagnostics, I think it's starting to kind of calm down. And we're trying we're starting to see a little bit more interest in this space. So we're very excited about what's going on.~ you know, there's there's never any guarantee on where companies is gonna go, if it's gonna succeed or not, but We're definitely putting all the pieces of the puzzles down so that we can actually see this through. You mentioned We Funder. Can you just give us kind of a quick overview of what that campaign is? ~ and and how it's working for you. It's a crowdfunding campaign. It's allowing the everyday person to invest as little as a hundred and fifty dollars into a company as an investor. So every time they every dollar they invest, it will be a little piece of the company when that company actually ~ moves into a larger round. It's similar to like a, you know, a GoFundMe, but it's not donation, it's investment. So you're not donating into a company, but you're actually investing into a company, which is great because ~ any amount of money will actually turn into sh into a piece of it later on. And so what we are seeing is a lot more people who have never been investors, who have never even thought about being investors, it actually opens a door to them about of like what is investing look like. So it not only allows us to get capital, but it also opens the door to people that would have never thought of investing to actually make their first investment. So it's a perfect marriage of educating the population, right? The regular lay person to invest and and us to sensitize the, you know, the ecosystem as to what we're doing and getting them to be involved with us. So we we just find this to be such a great marriage for us and it's a it's it's bringing it's actually creating more than we thought. And it's going well. We were raising, we were looking to raise very small round of three hundred thousand dollars. We're, you know, we're at what two hundred and almost two hundred and forty thousand dollars ~ in and you know it's every single day we get these, you know, we get these small checks. Sometimes we get big checks, sometimes we get small checks. But what's very exciting is, you know, the comments that we see like One woman ~ that I've never met before. I don't know how she heard about us.~ she put in very small amount and she basically said, I'm a teacher and I could have sold a hundred of these last year alone. So that is so validating to us and so exciting to us because schools have always been a market that we wanted to tap into. We want these to be in the, you know, nurse's office of every single school system in the country, if not in the world. And so having a teacher say that and validating what ~ what we always is really great for us. And it it it's something that we can bring back to us when we go in for institutional funding. Michael, have you been through this kind of experience before? And what are three things that you would say to your peers if they were considering starting their own startup in any space, not necessarily this specific space, but looking at kind of the business side of things?~ what are what are some recommendations that you could make to them? I've certainly been in a a lot of fast moving biotech startups, some very successful and ~ others that have kind of muddied along, some that have switched gears, so a little bit of everything, I suppose, particularly in the devices space, in the software and sort of d digital health space as well. And I think one of the most important things, especially for anyone who is thinking about building a device, like a physical thing that somebody is going to hold in their hand, is to have a very good idea before you start doing anything. both of what that's going to look like to actually build it, how long is it really going to take? It's kind of like the diagnostics ecosystem is somewhat famous for people starting a project and saying, we'll be done with this in a year, and telling investors that it that there's, you know, very little to do. The reality is most people have no idea what they're about to get into. bec either because they've never done it before, you know, and that's very common in diagnostics actually, because a lot of like PhD students and postdocs, like everyone's kind of like spent their graduate school like measuring stuff. So they say, I can just go create a company that measures stuff. Not if you're trying to get into the regulated space. So I think having a very, very clear idea early on of exactly what it is you want to do, talking to the right people who actually have done it, who have gone through the FDA, who have really understood what it takes to build a regulated device is just absolutely essential, not just for the development process, but also to ensure that you're telling your investors the the right thing and the truth about what it's going to take. because the investor community is much more savvy than most of the startups They actually know their shit and they and when they don't, they know to go and ask. And that's because they're about to put one or two million dollars into or $10 million or more. or a few hundred thousand. Either way, whatever their base is, they're putting something substantial to them relative to their to their own abilities. And ~ and so they're gonna do their diligence. The other thing is like it takes tenacity. And Nathalya embodies tenacity. And it's why I wanted to co-found a company specifically with her. I'm very much ~ while while I'm very tenacious about biology, about science, about changing the face of public health, Nathalya brings this tenacity in the business sector, in the fundraising sector. And you have to have both. So if you don't have the right co-founder, you know, I I I feel very firmly that these kinds of companies can't be built with one person. You need the right complements. And and I think that it's extraordinarily important. And if you come up with an idea, you have to be ready to give up equity to find that right co-founder.~ and recognize that, you know, giving up equity is going to make a more successful company in the long run and is ultimately going to be more successful overall for everyone's, you know, everyone's reasons for doing it.~ and th those are some of the biggest things that I that I look at and and think about. I talk to so many people who try to do all of it. They try to go it all alone. Can you imagine for a moment? what it would have been like for you if if you had been bitten by this bug and you said, well, I can do all of this and also my, you know, my full time gig. What would that have can you even imagine that? I mean, I wouldn't have gotten the email account started, right? Like I just I I think it would different people bring different skill Mine is not one to like do the administrative pushing and, you know, and things like that. I can't really imagine it because I wouldn't have done it. You know, that's that's the I I guess in in that sense I can imagine it. I've and I've thought about starting a company like this for a long time and I just hadn't yet hadn't found the right person who I wanted to do it with, who I trusted, who I felt would be the right compliment. I can go and p partner up with any number of scientists or professors or whatever in the world, but they wouldn't bring that same interesting Nathalya brings. And ~ I had I tried to go it alone, hundred percent it would have failed ~ a year ago. I don't know about that. And Nathalya, how about you? What are three things that you would share or, you know, tips for somebody who maybe has less of the, you know, the bio or the you know, the technical aspect of this and more of the vision and the drive? What would you what would you recommend to them when starting something like this. it's interesting you asked me that because I've been asked that question~ before by people who said, you know, I I don't know that I want to keep staying my job. I I wanna I wanna start something. And I'm like, okay, what do you want to start? And they're like, Well, we don't I don't know. I'm just kind of like thinking about different ideas. So I always give this advice. My advice is go work. Go go work. Go in your lives. And if you're a dentist, go work as a dentist. If you're an accountant, go work as an accountant. And then go find the things that hurts the most. Go find those gaps. The pain has to you have to feel the pain in your gut. And that's what it was for me. Like I felt this pain in my gut. And it wasn't just pain for me. It was, I remember like when I when I was feeling this need of fixing this problem, which was completely insane. Like I was an event planner before. Like it was completely insane that I would go into this industry like out of completely being green. I had no idea what I was doing, but I felt the pain in my gut. And then I remember going to like a Starbucks or Dunkin' Donuts or the supermarket and thinking, you know, all of these mothers, like, if they don't come to work, they're not getting paid. And I remember when I would used to take all day, it would take me a whole day to take my daughter to s to to or my son to the doctors for a a strep test. And you know, and and and it you have to kind of feel that pain and that strong desire to fix it. Because then if that passion is not there, it's not gonna go anywhere. So I tell people all the time, I'm like, go work. Go do what you know how to do and then find the things that bother you the most. And then find out if that is a problem that is that is reasonable to solve. And then if you have if you have that passion to f solve it, then solve it. Go and solve it. And so that is my biggest piece of advice is I became, you know, like people ask me, are you know, how does it feel to be an entrepreneur? I said, I don't know what it means to be an entrepreneur. I the only thing I understand is that. I'm not gonna stop. This nothing is gonna stop me. I know there's a chance we'll fail. In fact, Michael told me when we first met, he says, you know, this can fail. I'm like, I know it can fail, but we ha still have to try it, right? So, you know, you have to be ready to fail and you have to have the passion. And without these two, then, you know, it it it would be very hard for you to to really get it off the ground in a meaningful way. You can get things off the ground, but it's never gonna be like something that is for the long run. And and then you have to think about ~ dedicating a whole bunch of yourself, right? It it y there's sacr there's extreme sacrifice associated to that and you have to be ready for it. I know I've sacrificed a lot, you know, I I'm still a mom of four,~ yes, or older and, you know, potentially like being a grandmother very soon and I have to think about that and I have an enormous amount of support on my end. Like my whole family supports me and I have a great co founder and I think that Michael make it made a great point. You can't do this alone. I tr I tried and eventually I it ended with getting a you know, finding a a the perfect co founder for us. And so these are the kind of things that you have to just really feel it and you have to just be ready to fight for it. Cause if you don't have that, it just not gonna go anywhere. Thank you both. You were great today and you know, I look forward to speaking with you again. Thank you so much, and thanks for having us. Yeah, thank you. It's a lot of fun. If you made it here, thank you. If you haven't already, like, share, and subscribe to the channel. If you want to learn more about this topic, I expand on it below, as well as in my LinkedIn newsletter. That's all for now. More soon.