Global Opportunities from Starting a Med Device Company in a Pandemic


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    Our guest today is Meow-Ludo. He’s an emerging technology evangelist and Chief Scientific Officer at Moth Diagnostics, a company formed in response to the covid pandemic.

    Meow has a background in solving problems using biotechnology and helped found the biohacker movement in Australia. This culminated in the establishment of BioFoundry, Australia's first open access molecular biology lab, with Moth Dx co-founder Adrian Pearce.

    Meow has also run for federal parliament with the science party and flux party, advocating for data driven policy and technological improvements to democracy. He is perhaps most well known for one of the world's first cyborg law cases, fighting for the right to use an implanted travel card in his hand that gained worldwide attention.

    Lots of takeaways from today’s show. One in particular about having a global mindset. Hope you enjoy.


    World's first cyborg law case

    Music by keldez


    Global Opportunities from Starting a Med Device Company in a Pandemic with Meow-Ludo.



    Robert Fenton: [00:00:21] Hi, everyone. Thanks for joining us on another episode of, From Lab to Launch. I think you'll find today's episode really interesting. Our guest is Meow-Ludo. He's an emerging technology evangelist and Chief Scientific Officer at Moth Diagnostics, a company formed in response to the COVID pandemic.

    Meow has a background in solving problems, using a biotechnology and helped found the biohacker movement down in Australia. This culminated in the establishment of BioFoundry, Australia's first open access molecular biology lab with Moth Diagnostics co-founder Adrian Pierce. Meow has also run for federal parliament with the science party and flux party advocating for data-driven policy and technological improvements to democracy.

    He is perhaps most well-known for one of the world's first cyber law cases, fighting for the right to use an implant travel card in his hand that gained worldwide attention. There are lots of takeaways from today's show one in particular being about the importance and value of having a global mindset when starting in business. I really hope you enjoy.


    I really want, I want to ask you about you and Moth Diagnostics. I mean, I got so many questions may, maybe if it's just okay to kind of kick off, tell us what brought you to this, to this company.

    Meow-Ludo: [00:01:42] So, this is kind of like a thing that's been kicking around for a long time. So just, just a little bit of backstory. I'm sure we'll go through it more. Um, throughout, throughout the podcast, um, Moth Diagnostics is a company that formed in response to the COVID pandemic. And we were able to do like, you know, point of care, low technology diagnostics, all of the, all the technologies in the wet chemistry that sits inside our tests.

    Um, but it's something that we've been trying to commercialize for about six or seven years. So it started off its first incarnation was a point of care STI detection test for people who wanted to see that, you know, sexual health status. And it was it commercially just did not make sense. Um, and this was one of the first big projects that came out of my not-for-profit BioFoundry, which was Australia is Australia's first open access molecular bio lab.

    So, so we took this to a hackathon and we won all these prizes and then we tried to commercialize it and we just got called by everyone. Like there's not enough money in sexual health diagnostics to make it work. And there was also some legislative problems that you can't actually disclose people's status for certain conditions.

    So there's the things like HIV or COVID or chlamydia that are traceable conditions and a pathologist has to give them the results. So they're like point of care is not going to work. Okay. F*** it. We're not going to do that when COVID came out, though, the commercial side make sense. So we pulled it off the shelf and then, um, that was in February, on Valentine's day.

    And it's now like towards the end of the year and we're still going. And one of the biggest stumbling blocks we've had is actually, how do we build a quality management system really quickly.

    Robert Fenton: [00:03:30] This entire thing? Just, just to reframe and reset. This was BioFoundry. And this was one of the ideas just to where you incubating. Right? And COVID happened. And that was the opportunity to, that was the use case you needed I guess.

    Meow-Ludo: [00:03:46] Yeah. That's right. So I was last year in 2019, I was working on a project. So I've basically always got, you know, a startup going, I was working on a product that was a way to, to solve global warming. It was the only proven way to solve global warming.

    And basically that made no money. And I was kind of like wondering after a year of investing in that I've got like $5,000, um, capital and it was going nowhere because there's no money for climate change. I was like, what am I going to do? And then all of a sudden pandemic. I used BioFoundry to do a proof of concept.

    And then we used that to raise, um, raise a little bit of capital. We tried to bootstrap it using exemptions, which was kind of hilarious to think you could like bootstrap a medical diagnostics company because of exemptions. We nearly did it. And then we ended up, um, we decided to raise a seed round kind of money. And we'll just raise the second safe, um, to get us through our, um, TGA application, which is like it like the FDA.

    Robert Fenton: [00:04:41] That's, that's impressive. Just to maybe for people listening safe or simple agreement for future equity is a really simple agreement that takes the place of more expensive, cumbersome investment documentation, which when speed is of the essence, right, everything you can do to streamline that, that is important. Uh, you spoke about spinning up the QMS really quickly, and I want to get back to in a moment, some of that that acceleration you had to go through, right, almost instantaneously from, okay this proof of concept to now we're, we're a company. Before that though I mean, you just spoke about, you were looking at like big problems to solve. How did you get into just as biospace like, what's the narrative, what's the story?

    Meow-Ludo: [00:05:26] I actually, I often get paid to speak at universities about alternate pathways. So I had a really long undergraduate degree. I took lots of time off and went and worked commercially did independent research. And, um, basically I was like, I was working in it. I wasn't really enjoying myself. I was doing like help desking app support at this time and stuff. I mean my whole family, uh, programmers. My, you know, my dad started programming on f***ing punch cards. So I was like in my blood. Um, and I just, it was very unfulfilling for me.

    Um, it's like, I like to do as a hobby, but not as a main thing. So I like it. Um, I was partying a lot and I had like, I guess in the West coast of America, you'd call it maybe a burning man.

    Um, I was, uh, halfway through this experience and I was just like, had this awakening and I'm like, f***, I want to be a scientist. I don't want to work in it. So I, I finished off my weekend and I enrolled in a mature age entry university the next day. And it's funny cause my first ever job I wanted was just after watching Jurassic Park, I'm like, dad, how do I, how do I go and make dinosaurs? And he's like, you have to become a genetic engineer. So I went back to my roots and I'm like, f*** it. I'm going to become a genetic engineer. So, uh, went back to university, um, enrolled in genetics. And then throughout that time, I realized that research wasn't really for me because of the way that universities are structured.

    And then, realized that it was very difficult to get a job commercially because in Australia, biotech and genetics, aren't industries that have lots of money. So I looked around at what other people were doing and I re you know, I was participating in hackathons and came from a strong background of hacking in, um, in IT.

    So I went off, f*** it. I'm gonna just do what these few other people around the world are doing and set up a biohack space. And then I guess that's like, kind of takes me through to where I am now.

    Robert Fenton: [00:07:19] You made it sound very much like that montage of didn't have a plan, decided on a path and it just, it just happened, but maybe, maybe walk through what were some of the blockers, some of the obstacles, like, cause that's a lot of, it's a lot of behind the scenes I would imagine.

    And what you said, but just, just tons of respect for getting going. I mean, what were some of the big blockers or challenges you had to get through?

    Meow-Ludo: [00:07:43] Yeah, so it's, it's um, I think like one of the things I really like to be first. So often when I see things that people haven't done before I rise to the challenge.

    There was in the very beginning, the there wasn't really that many people around the world to speak to. So there's this kind of broad idea, we take, you know, a maker space and we make a biotech, but no one really had a guide. There wasn't many people to speak to. It was something you had to quite imagine on your own.

    So, so I got in contact with the people who had done it around the world and ask them for some advice. One of the things that's different about a buyer hack space than a normal hack space is that it's hyperlocalized with respect to regulation and that that's the biggest blocker. So I decided I started, Hey, f***, let's have a meeting with some people that are interested.

    Um, you know, Facebook hadn't been around for a crazy amount of time. I put, I put, um, uh, an event up instead of, you know, let's get together with all the people who are interested. So we formed a very, very, um, early community and we've got like, we like 50 people turn up, which was awesome. And then the second meeting we had like 10, a lot of people that wasn't for them.

    Yeah. After we had that second meeting, we got a letter from the government saying we're watching you.

    Robert Fenton: [00:08:54] Interesting. Yeah.

    Meow-Ludo: [00:08:58] We realized that this was going to be like, we couldn't kind of just fly by the seat of our pants. We needed to be on board with government, very different to America. You know, you have a country founded on like, um, libertarian values in Australia it's quite authoritarian. So we have some of the strictest biotech laws in the world. So we said, f***it. Let's sit down for coffee. And we invited them to Sydney. And I went and had a coffee with them, and now I've got them on speed dial and we've worked with them to make sure that, um, the, the legal and regulatory side of what we were doing was at the heart of our company.

    Robert Fenton: [00:09:34] How did those lessons learned to apply to Moth Diagnostics, because you said it was Valentine's day. So February 14th, 2020. Things were, I guess there were signs. Right. And how did you take that and, and spin up the company. I'm and I'm assuming here, you might correct me that, you know, Moth Diagnostics, itself wasn't really a company yet. It was more proof of concept.

    Meow-Ludo: [00:09:54] Yeah. So we've incorporated about five or six months ago. Um, and it was a non incorporated, something, you know, an idea or a proof of concept for, you know, four or five months before that. Um, the thing is that the gym control laws in Australia, are actually built on ISO 17025.

    I think it is, which is the micro microbiological lab standard. So, so to even get our space certified, to meet the basic levels of biosafety, we had to get everyone in Australia who was a hacker who was interested in creating these spaces to go through those, um, th those standard documents together and make sure that we either met, approached or had a good, a really good f***ing reason for not meeting every single item in the standard. So that was a collaborative effort amongst hackers. Um, we still have that document that we refer to, which is a custom standard. And our dream as hackers in Australia is to make the regs easier to follow.

    In different parts of the world when I talked, when I talked before about hyper localization, um, you know, in countries like Indonesia, Yeah, their main focus is making sure that, um, their community is safe when it comes to things like drinking water. When we speak to, um, hackers in Nepal, it's a combination of like making sure they have access to medications, but also enabling commercialization of good ideas. In Australia it's about being able to do community science and commercialize ideas for not going to jail for breaking the ranks.

    Robert Fenton: [00:11:28] Interesting.

    Meow-Ludo: [00:11:30] Yeah. Our goal in Australia is basically to write our own biohacker standard that could be used around the world.

    Robert Fenton: [00:11:36] And maybe I, I I'll try not to go down that rabbit hole because I think we could spend hours kind of digging into some of that. I think it's a fascinating space. Just to, just to pull back a bit and let's look at the last, you know, eight months, right? Since you started really working on, on Moth Diagnostics and moving forward with it. Yeah. It's not like somebody who just gets going right. Just gets going and tries to figure it out as you go and bring in people. I think that's a good lesson learned for people about, you know, people always wait for the right time, but sometimes you just, just got to get going and see how it goes. Right?

    What were some of the lessons learned in the past eight months? Because that sounds like the first time you really started to look at why commercial operation and maybe some of the complexities, some of the detail around the regulatory challenges. I'm curious what you learned so far this year.

    Meow-Ludo: [00:12:24] Yeah. So I, I, I think my, um, I'd always been interested in the medical diagnostics space, but I hadn't, um, ever had a startup, which went as quick and, and became, had so much interest as this one.

    Um, previously in biotech, I'd been doing things like food and animal, uh, animals stuff. We'll just say broadly a whole bunch of agricultural things, but none of them have the same regulation as a medical device. And in fact, the thing that I learned was, this was something that I kind of put off and I wish I hadn't.

    Um, I learned that there's not a whole heap of innovation going on in this space. You know, like our only competitor to this service was something that had been around for like 30, 40 years and was substandard.

    Robert Fenton: [00:13:09] Still the same.

    Meow-Ludo: [00:13:11] Yeah. Um, come a long way, but you know, it was like, it was kind of like using Google Wave or something like that, you know, and every time I was using,

    Robert Fenton: [00:13:21] Everyone know what that is?

    Meow-Ludo: [00:13:23] I love Google Wave, but no one uses it. People still maintain it which is crazy. And like, it got started in the Syndey Google office. So I've got this, like, you know, kind of patriotic allegiance to it. now, um, Oh, by the way, I dunno, know what, what temperature is over there? It's like, You just like 35 degrees in my car at the moment, which is like, you know, 105 hundred and 110 degrees. So like that.

    Robert Fenton: [00:13:49] Yeah. It, it, it's absolutely absolutely fine here, I guess just, I think, uh, in the Bay Area right now, looking out the window, it's probably in Celsius I would imagine 13 to 15 degrees.

    Meow-Ludo: [00:14:03] Um, the vaccine comes, I'll have to fly over and come in and see the office.

    Robert Fenton: [00:14:10] Hey, you're welcome over here and anytime. We'll give you, give you a tour around the city. I would love that. But I think to anchor, you said something about that's important that the competitor was 30, 40 years old, and we come across this all the time. And the way we talk about this, I'm curious to get your thoughts as some of the fundamental problems we have in healthcare and if we, if we accept the assumption that there's a wave happening right now, where you got a democratizing access to creating healthcare products, right. And I think it's you do it with a finance. I think we're going to be at the point where people are going through hackerspaces and almost getting into commercialization.

    That's really exciting, but there's, there's a question here, which I always ask and I struggle with, which is why can't medical products move with the sand velocity. Yeah, uh, as a consumer products, because oftentimes the consumer product doesn't really matter to the world. You know, it's just a, it's a thing for a want.

    It's not often for as a core need, but the medical products actually make a positive dent on the universe. Right. If you're successful yet we have this molasses that just holds them back. And if we look at Qualio and just like, that's that's, if we can make a difference, I'm curious how you look at that.

    Meow-Ludo: [00:15:25] I'm wading through them. I'm wading for the molasses right now. So, you know, I'm sure like it's, we, we had a working product months ago, but quality like legislatively quality has to be at the core of your medical diagnostics company. If you are even thinking about starting a medical diagnostics company, and you're listening to this podcast, like you should start with quality. It's such a difficult thing, but like you're, you might not know this, like your R and D has to be, it has to be in your quality management system.

    So that means that if you go and do all this, like hacking and do all this, um, you know, basically use a hacking process to get a product you are going to double your workload. You have to go back through and then rewrite all your R and D rewrite all your results. Um, you know, Work out ways to show that you are hacking or even like, you know, um, lean processes are actually quality processes. Cause lean processes are quality, but unless you have documented this, it is going to be a massive pain in the ass. And we're going through that right now. And we're paying a fortune for it. You know, we paying quality consultants and all these problems can be solved with money. But if you think about quality while you're doing your hacking. And you think about quality, um, as a response, as, as a process to solve your problem, you can make your life so much easier. And the thing is medical devices aren't standardized around the world. We've got like, um, the medical device, single authority, um, take off, which is f***ing cool. Right. But the thing is, if you have quality at the heart of your company, your medical device company, you don't have to worry about s***.

    Every step every country, their medical device, uh, Authorization program FDA section 80, whichever it is, you know, TGA in Australia, all of these are based around the same standards. So we're having them at the company you don't have to worry about getting the AUT if it passes in one country and should pass in another country.

    The thing is that that doesn't lend itself well to a hacking mentality or lean startup kind of mentality of like, okay, how do you get an MVP without getting the quality stuff done? And the way you do it is you do it during a f***ing pandemic when there's exemptions everywhere and they just care that it works. And that's why our company formed and why we've been able to get traction.

    Robert Fenton: [00:17:46] I wish that was a lesson that was more repeatable across at cross timescales and companies, but I'm just going to anchor kind of what you, what you said is that this is really difficult and there was an obvious unintended side effect, which is, there are things which don't exist in the world right now that could exist that would make positive impact. Right. And, and, and how we solve that? So I think that's, it's useful to hear from your eyes as somebody who is inside the tornado right now, trying to try to make this happen and work. Yeah.

    Meow-Ludo: [00:18:17] Just one, one thing though, going back, you said, you know, you wish it was more repeatable.

    The pandemic is increasing. The pandemics are increasing in frequency. This isn't the last pandemic we'll see in our lifetime. But there are elements that are repeatable, that people listening should really have a think about. Which is how do you exploit the things that the pandemic highlighted to accelerate your business?

    So, you know, we're looking at one of our target markets to commercialize in is India. And it's because it has a more relaxed regulatory framework. So if it wasn't for the pandemic, I might not have looked at commercializing in India, but there are lessons to be learned that we can, we can look around and say, okay, well, that was really cool. So where does just that? And can we do that there? So is there a country it's easier, um, to get things manufactured? Is there a country it's easy to do clinical trials in, and these are things that if I go into another startup in medical devices are different take advantage of those even without the pandemic.

    So like you can hack your way to the same benefits the pandemic gave you by being more globally minded.

    Robert Fenton: [00:19:21] Just kind of applying a hacking mentality right. To this as well. So just to repeat some of the lessons here, I think are important, the, the quality has to be to at the center of what you do or else it creates a ton of pain later. Try and get it right if you can at the beginning.

    Number two, no matter what's going on the world, you're saying that there's always going to be stuff going on good or bad. And that always means there are opportunities that get created, right? If you're creative, if your eyes are open to them, is that a fair summary?

    Meow-Ludo: [00:19:50] 100%. And the thing is important quality doesn't change anywhere in the world. And after running a startup, I ran a startup in San Francisco once upon a time I'm in the food, food, biotech space, and a lot of the investors and the people I was surrounded by were very, you know, um, um, American centric. And like, I can see why that is.

    But also at the same time, there are huge opportunities available around the world. That if you take the time to go and speak to some people outside the country, speak to some investors outside the country, find mentors that can broaden your horizon. You are going to be able to take advantage of things that will give you an edge over other startups.

      uh, I really enjoyed this, just this chat today. I've learned a ton as super interesting story.

    I'm really excited that we were able to support you as the quality owner. I will be reaching out separately just to get some time to dig in there in a bit more detail.

    Thank you very much. Stay safe, stay healthy. And thank you for sharing some of your journey today.

    Thank you very much for your time. And, um, please follow along with us and our journey and, uh, looking forward to working more with Qualio going forward.



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