From Idea to FDA Clearance: What Nobody Tells Medtech Founders with Darcy Bachert | Ep. 57

In this episode of the Med Device Cyber Podcast, host Christian Espinosa from Blue Goat Cyber is joined by Darcy Bachert, the Founder and CEO of Prolucid. Prolucid is an ISO 13485 certified software development firm based in Toronto, Canada, that specializes in creating software for highly regulated industries, including both MedTech and nuclear. Bachert begins by explaining the origin of his company's name, which is a portmanteau of "Project Clarity." This concept becomes a central theme of the conversation, as both speakers agree that a lack of clarity is a primary cause of failure in software development and business in general. The discussion revolves around the unique and significant challenges that MedTech startups face when bringing a software-driven medical device to market, contrasting it sharply with the development lifecycle of a typical consumer product. The main arguments center on the immense complexity and long-term commitment required for medical device development. Bachert and the hosts emphasize that success isn't just about creating an innovative algorithm or a piece of technology; it's about deeply understanding the end-user's problem and workflow from the very beginning. One of the biggest challenges discussed is achieving product-market fit in an environment where you can't simply iterate and pivot based on user feedback due to stringent regulatory constraints. The speakers point out the sobering statistics for startups in this space, with an average timeline of seven years and an investment of around $35 million to get a product to market. This long and costly journey is fraught with pitfalls, from failing to secure reimbursement strategies to creating a product that, while technologically sound, is too complex or disruptive for clinicians to adopt. It is argued that overlooking these practical considerations in favor of focusing solely on the core science is a common mistake that leads to failure. To mitigate these risks, Bachert stresses the importance of engaging with experienced partners who understand the regulated landscape. He advocates for working with firms that are already certified (e.g., ISO 13485) and follow crucial standards like IEC 62304 for software development. This not only de-risks the process for the startup but also provides confidence to investors. They discuss the false economy of choosing cheaper, less-qualified development teams, which often results in having to redo work to meet FDA standards, leading to significant delays and increased costs. The conversation concludes by reinforcing the idea that building a medical device is a comprehensive lifecycle that extends far beyond the initial product launch, requiring ongoing maintenance, security updates, and a deep, continuous understanding of the clinical environment to ensure long-term success.

The lack of clarity causes the most problems in humanity in anyone's life not just in software development in general. Project clarity starts with the early stages of what are we doing, why are we doing it and then every step of the way making sure we communicate progress, show what we're doing. So at the end what we've built is something that they they actually need that they can use that's going to be successful. What other challenges are pretty common that you encounter? You know really understanding how to do it the right way and how to do it in a way that can be adopted by the end user. I don't know if there's as much awareness about how much different it is to build a medical product than to just create a product. There's so much more that goes into it just from a planning, from a process perspective. Hi, welcome to another episode of the Med device Cyber podcast. Today we have a guest Darcy Bockert, and we're going to be talking about software development and how to do secure software development, a little a little bit about the Canadian Medtech market uh because Darcy's organization Prolucid is based in Canada. So before we uh kind of dive in, uh you might give us a little bit of maybe a little background on yourself Darcy and Prolucid and maybe why the name Prolucid. I I was wondering that earlier, actually. Yeah, absolutely. So first off, thanks Trevor, Christian for having me on. Uh as mentioned, Darcy Bachert founder CEO with Prolucid. We are an ISO 1345 certified software development firm based in Toronto, Canada. Been in business just over 17 years now. We actually do work in both medical and nuclear, so highly regulated industries both with very unique development as well as cyber security type challenges and work with customers really across the world. The bulk of them though would be North America, Western Europe, Australia, uh but others as well. And helping them take an idea all the way through FDA and as as you all know, cyber security is a huge part of that. So that's something that we help support with. Awesome. And where did the name Prolucid come from? So that it it's not what it maybe sounds like. It's actually two different words joined together. So it's project clarity is is where it is. We find, I think one of the most challenging things, in any project is not so much writing the software but really understanding what problem it is they're trying to solve, what they're trying to build. And so that project clarity starts with the early stages of what are we doing? why are we doing it, and then every step of the way, making sure we communicate, progress, show what we're doing. So at the end, what we've built is something that they they actually need that they can use that's going to be successful. So we try and build that into everything that we do, but that's where the name comes from. I like it. I think the lack of clarity causes the most problems in humanity in anyone's life, not just in software development in general. Especially like building a business or going after goal, you have to have clarity. Without clarity, people rarely know what to do. They don't know what steps to take and it makes it very challenging. Yeah and I think you know you you're the same. when we're talking to people, they they need help. They don't have all the answers. They're looking for that. And so you you're not just there to solve cyber security or to solve software development. You're there to share advice where you can, give input where you can, ask good questions because collectively that's what we're all trying to find is that clarity on what we're building, how we're going to build it, do it the right way and that's where we create the best successes. So Awesome. And what's the weather like today in Toronto? We, so I have to do the conversion, it's it's almost 10 degrees. We've been dealing with blizzards and and nonsense and a very very long winter that's already started but we have a bit of a thaw that we're we're dealing with right now, so I can't complain too much. I think it's probably low low 50s almost here. Guys, I'm in Arizona. It's like 55 today. That's like pretty cold for during the day in Arizona 55 uh Fahrenheit, obviously, otherwise it would be super hot. And Trevor's in San Francisco. He just moved to California not too long ago and uh he's dealing with foggy weather and chilly weather typically. Trevor: The sun has finally broken out today. It's nice to see. Hopefully it'll hopefully the sun stays out for the JP Morgan week next week, but uh yeah, it's been rainy, foggy, earthquakey, fiery, just every bad thing that can happen seems to happen to San Francisco. Host: I'm guessing you're quite glad you moved there then is what you're saying. Trevor: Exactly, yeah. No, I was actually in uh Toronto for the first time a couple weeks ago and I don't think I've felt cold like that in a long time. That was incredible. Guest: Yeah we've the polar vortex hit and it's not just cold it's like a a wet cold it really you feel it a lot more I think so. But welcome anyways in you know I guess in behind after the fact. Host: Yeah, we'll I'll see each other uh, I guess in JP Morgan in San Francisco, so hopefully the weather a holds out there and is nice. Trevor: Fingers crossed. Host: Yeah, so what are some of the primary challenges you deal with with Prolucid deals with with companies that want to have you help them with software for their device? I know you talk about clarity a little bit and trying to drive that clarity because from a software development perspective, obviously you need to know what the actual requirements are. And I know that's a challenge with people. But what other challenges are pretty common that you encounter? Guest: There there's quite a few. We we tend to find that that first when we've already talked about it's the biggest one. You know when they they they have an idea of what what what it is they're trying to build. You know they have an indication of use, they have an understanding of the therapy or the treatment or the diagnosis that they're building, but you know really understanding how to do it the right way, and how to do it in a way that can be adopted by the end user. There's a lot of, you know, a lot of very innovative ideas that if when it's built does not make the end user's life easier, it just will not get adopted and so we'll do a lot of great things together but not see the success that we want. So it's clarity on requirements. It's really understanding that that environment, the end user and how they're going to use it and how it can make their lives easier and better and improve patient's lives. how they can get reimbursed, how they can get funded. It's I'm not saying software is the easy part of it but you know a lot of the the problems and challenges that we definitely have to work through are all those things around it, you know, including just clarity around things like regulatory and cyber security and making sure that when they do get to the FDA that they're going to be approved and not rejected and sent back and have delays that go with it. So it is a lot of those surrounding parts that we tend to find some of the biggest challenges or for the companies that we we help support. Host: And Toronto seems to be like the the Mecca in Canada for Medtech. Is that uh is that true? I mean, that's what it seems like from outside of Canada. I mean, you're there, so might be different. Guest: It's it's definitely the largest hub for Medtech, especially if you expanded into the, you know, Kitchener-Waterloo region. Uh there's the most I guess the largest number of companies would be here. Montreal does also have a really strong Medtech startup scene. They do quite a lot of work in AI there as well. It's a bit of a hub, not just for Medtech AI, but AI in general. And then as you get beyond that, there are smaller regions, Vancouver, Calgary, some on the East Coast, but this would be I think you consider it the largest hub for Medtech in Canada. Host: And I know Trevor and I have talked a lot about IEC 62304, which is the standard for secure software development for medical devices, uh, and I know your organization follows that. When when one of the things we we try to educate Medtech innovators on, when they're trying to find a software development partner, that they should choose one that actually has experienced in regulated industries like you do, like Prolucid. And follow IC 62304. Do you find that that is a a factor when people like choose you over someone else that they are looking at those things or is that more something you have to educate them on? Guest: We we find it's actually a pretty important thing to have before we had it, you know going back a decade before we were certified ISO certified, we did follow 62304, but we found that most of the companies we worked with were local and that they were fine with us not having everything. But as we got our full 60 or 1345, so the quality management system and more track record of taking companies successfully with 62304 through FDA, through CE mark, through other regulatory approvals, that's really launched the international side of our business where now the expertise level that we bring on these sides is just really de-risk working with the company that has those uh accreditation just de-risks it from a execution point of view. the the companies that are funding them they like it because they know they're working with a trusted partner. The amount of expertise and knowledge that you bring around all these different best practices just it really changes things. And so, you know, before you have it, you're not really sure what the impact is, but after having it and having that track record that goes with it, it really makes a huge difference, not just on initial conversations, but again, the amount of value that that company like that can bring to a startup who has so many things that they need to figure out and this is one where we can just bring it, educate them and help take them end to end uh as part of it. So it's it's it's really important and for any startup company that is looking at working externally, you know, whether it's us or someone else, you know, making sure they've got that you know, got the quality management system, understand the processes and have the track record of of doing it, I think that's a pretty huge requirement or consideration. Cool. Yeah. What are some of those things that are on that subject? Trevor: Yeah, you said something that really stuck with me, Darcy, and that's about derisking this process. So any of these compliance areas, like even how you mentioned, Christian, we don't technically have to comply to ISO 1345. Our quality system is compliant. We don't hold that certification. That's something that we're currently pursuing. But building out that quality system was such a valuable exercise for us to solidify the processes that we had internally. Even though nothing really changes as much on the execution, the proven consistency, all of the traceability and artifacts working their way back have been tremendously helpful for us to make sure that we're providing a very consistent and a very good product. Um and then I think, you know, providing evidence of that to any of our clients, it just it really does bring that risk down in their submission. When they see that we're following best practices, you know, general good documentation practices, we have a formal quality system, we have a quality manual, procedures, plans, backup, recovery, disaster restoring and recovery procedures for anything that can go wrong there. It does provide a lot of assurance that we are doing things the right way. So, I think it's very important to make sure that we are referencing standards such as that even if it is a voluntary a voluntary standard for a company like ours. Guest: I would agree that I think sometimes quality management systems are looked at as this thing that you have to have in place to get a piece of paper, you get your certificate and and away you go. But how you actually do things within that and and doing it the right way is way more important than just the piece of paper with the form around it. And I think one of the things that's probably a bit different for for us than you is a lot of our customers when we start working with them especially startups, they often times don't even have ISO 1345 themselves. And so what we're able to do is do all the development design controls documentation under our QMS and then as soon as they have theirs, we can take that entire design history file and transfer it over. So it it really does unblock them on that early stage while they get it because it it does take time to get a quality management system in place and and if they had to wait for that to get going that'd be a pretty big delay. So but I I do agree with you that how you actually do things how you document having a really strong process that's also efficient. That's where the value is as opposed to just the piece of paper that that that says you have a QMS. Trevor: Definitely. Yeah, I think exactly like that. The certification itself isn't as worth as much as the process behind it. It's, you know, it's a good way to just show you have that process behind it. But yeah, it's even just trying to bridge that gap from ISO 97 or 9001, which is just general quality system practices into the medical specific quality practices. ISO 9001 still has a lot of coverage on what you need to do, how to have good general practices within your documentation and within your quality system, but taking that step up into a safety critical industry such as healthcare, or, you know, you mentioned that you're in nuclear, obviously that's not quite as much our area of expertise, but I'm sure it's very similar, making sure that you have these processes very strongly formalized in place. Um, but yeah, it's a great way to make sure that we have this consistency there and I think it's it is correct for any companies that we would be reaching out to or that are reaching out to us or, you know, companies that you're working with, they should want to see these artifacts of compliance. They should want to see that we're handling things in a proper and a safe way. Host: Well that's uh I think one of the challenges we have from a sales perspective. a lot of to set all these things up and to be very niche and regulated uh and have all the procedures means we're going to cost more than some fly by night company. But I know in software development and in cybersecurity we have the same challenge. It seems like a lot of prospects are doing some comparison between us and somebody else and they don't understand what they should be looking for. So they'll they'll choose someone But then they have to redo everything because it wasn't done to the right level of scrutiny that the FDA wants for example. uh it wasn't done for a regulated industry. So like part of our mission is to try to raise that awareness so they make the right decision and you know, we're trying to do in cyber security, we also try to do it for software development since they're closely tied together. Have you found that to be a challenge uh Darcy like you know, you have a prospect on a call and then they they're going to somebody else that doesn't even do regular software development, but then later on they maybe come back to you to fix what they was developed, what was, you know, quote developed. Guest: It it does happen. I think there there's some companies we talk to that really understand. I think companies that have outsourced before, either in their you know, current capacity or previous roles, they understand the value of a partner that has the right qualifications, that's got the track record of doing it successfully. And because time is money and redoing things can be what sinks the company. So most of who we talk to do understand that value of it. And in those cases, you know, they're looking for a partner. So now we're we're you know competing against other companies with similar infrastructure and track record and and in that case, we can be very competitive. There's always going to be the ones that look at that low cost option or try and do it internally. We've seen some companies do things internally and they do a great job because they've got the expertise and and they can and that's great and that's if that's the case. you know, if you ever have questions or you want a bit of extra horsepower to throw it a throw at a project, we we're there to help. But we have seen some where they've gone with that low cost option. often times it's maybe more local or just or even offshore and we've had to come in and fix it. And by time that happens, they're now looking at months of delays and I know you've I know you see the same. It's months of delays. the burn that's associated with that is way higher uh both in time and money than if they had to just you know came to someone that can do it right the first time. And and often times, you know, a lot of what was done is just not usable because it wasn't done the right way. So we're we're not going to sell to everyone. There's going to be some as mentioned they can do it themselves or they have that track record but the ones that really get it, that's where you know, having everything line up and ready to go can be a really strong partnership. So we really try and focus there and and and fail fast and some of the other ones. Trevor: I think in the medical space, I just I don't know if there's as much awareness about how much different it is to build a medical product than to just make a product. There's so much more that goes into it just from a planning, from a process perspective. And I think it can catch a lot of people off guard, even how long it takes to create a product. When you tell a lot of people trying to break into the medical startup space that you're probably not even going to see your product on the market for close to 7 years on average. That's a surprising figure to a lot of people is seeing wow it really does take that long to create something like this. In the in the cyber security industry, we always have a term for kind of these quick shops that are just trying to turn out test results as fast as possible. They're called pen test puppy mills and it's basically running an automated scanner or something just trying to throw all the output of that into a report template and then give it away and do it as cheap and as fast as possible. And we have seen in the past a couple of companies reach out to us, ask for assistance with the cyber security process. We say, you know, this is what it takes for us to do it from a, you know, manual intensive process. And they say, well, you know, this guy over here can do it for this much lower price. And then they'll use those results and the FDA is going to reject it for lack of sufficient testing. They don't see that it's done against patient harm as a primary metric. They don't see complete coverage of the system. They don't see that it included the depth of testing that is required for a medical device. They don't see the right documentation around it. And so it really is then, you know, coming back to the drawing board from the ground up. And so I think the the saying buy once, cry once really does apply well here. Guest: Absolutely. I think he mentioned seven years and I'm not sure if the stat, it's probably worse now, but I think seven years and 35 million is roughly what it takes on average to bring a device to market. And we do find especially companies where they're coming from consumer or you know, very an industry where you can just throw something out and it you still have to you know, make sure the product works and so on. for those to to really understand the medical side is a bigger challenge. Some of the startups that you know, are doing this for the first time and don't have that bias are a bit easier to kind of communicate, but it's it's a long path and there's a lot of steps along the way and I think just like you mentioned, that knowledge of what it takes for success, for FDA, for cybersecurity, for success for, you know, the software development side of things, for for FDA, and also user adoption, reimbur there's these layers of value that you know, yourselves and us bring to an engagement that you don't get from the um the pen test puppy mill or you know, the the offshore development that has no experience in the industry. So I think, you know, just we do our best to to really message that value and the ones that understand that we end up having great partnerships with, but not everyone will and often times we'll fix it in a year or two down the road. Host: I think that stat is uh, pretty sobering for people that don't don't think about the industry too much that 7 years and 35 million, you said that's average. Uh and it's very different to throwing something up on the cloud like a a SAS platform and trying to make revenue while you're still building it basically. It's a very different model. and it's very different from a software development perspective and a cybersecurity perspective. And we run across that challenge quite a bit. People don't understand like we can't just test this in five minutes and and say it's good to go. We have to provide a level of diligence to this because, you know, if your device is hacked, it could kill a patient or harm a patient. It's it's much more risky than somebody stealing a credit card number for instance. Guest: Yeah, and and it doesn't just, I mean, that that's seven years. Obviously there's a lot of steps there. There's there's trials that are built into that. There's validation gathering data all the way to approval. But I think also people sometimes forget what happens after your products on market. and both with software development and cyber security, your your journey does not end there. You you have to make sure it stays secure. You have to make sure it's updated. There's going to be new features that are required. So it's it's not like you just, you know, throw the app out, start getting generate revenue, build as you go, test as you go, there's very clear steps you have to follow. And then once it's on market, you have to make sure it's secure. You have to make sure it's updated. Uh so that that's something that we also have to message to companies that are that they're looking to build a device. It's this is not just a a one and done. This is a whole product life cycle that includes potentially 5 years, maybe 10 years of ongoing maintenance while it's out in the field being used. and and again, I think when you think about that, it's a bigger challenge. I'm not trying to talk people out of building medical devices because we need them, but it's they're probably our easier things to do. Trevor: Yeah, I think especially you know, especially even being here in the Bay Area and seeing what the startup ecosystem looks like outside of this space. There's very much I think even recently with the huge prevalence of AI development tools, try to get something out as fast as possible. and just keep throwing stuff against the wall until something sticks. And that that practice is common with both founders currently and even with investors and venture capitalists. You'll see a lot of the VCs in the area just trying to throw money, a little bit of money at everyone because they think that one of them is going to go, you know, 10,000 X and become the next the next open AI or whatever it might be. But I do think there's a very big trend of just trying to make something super fast, see if you get a little bit of user adoption and then maybe take it off from there. And it's so hard to do that in the medical space. Since then, you're probably already four and a half, five years into development, fighting through regulatory approval, you've sunk millions of dollars into this project. and if you realize at that point that you don't have market fit, then you're in really difficult situation. You can't just make a hard pivot and go, ah, we tried to make a pacemaker but now we're going to make an oxygen pump. You have to stick with the pacemaker. You've already built it. And so it's a lot different of a mindset. And I do think you kind of mentioned like people getting into this for the first time, they aren't stuck in that mindset of trying to make something and iterate it. They're a little bit more new and willing to see exposure to a different way of doing things, which I think is a really big benefit that, um, you know, isn't really talked about too much. Guest: Yeah that there's not a bias going into it so much and you mentioned something product market fit. This is, you know, despite the fact that you have all these restrictions around what you can do, we do find that as an area that we we have to challenge on quite a lot is there's you know people are so focused on the core research or the core science or proving their algorithm does what it needs to do, but they don't spend enough time talking to the clinicians, the nurses, the doctors, the end users and really understanding not just what this technology can do but how they would use it, how it integrates with their workflow because product market fit is when you've got a solution to a real problem that is easy to use, that integrates well that they, you know, they can't wait. They're wondering when they can get it. And so there is there are it is still critical. It's harder to do in medical than when you just throw an app out, like you mentioned, you just throw it out, you see what hits. If not, you you pivot and you do something different. You can't pivot the same, but you still can talk to people. And and there are things, you know, the formative and the sub and and other types of steps that are supposed to support with that to a certain level, but we do find it as an area where sometimes we we will say to people, you need to go talk to your your end users because do you know what they want yet? And if you don't know what they want, we're going to spend a lot of time building something that they can't use. So, so you still again another challenge of that tech that maybe doesn't exist is getting product market fit without being able to put a product in front of them or, you know, demo device. It's it's tricky to do, but they still have to find a way to do it. Host: Yeah, we've been talking a little bit about de-risking like choosing uh like software development that understands the industry regulated industry and And then we'll see or cyber security. Um I know some investors that have changed how they invest and they're they only invest in alumni or people in the Mettech innovator program as an example or some sort of accelerator program because they have much higher success rates because in the past I've talked to investors and they've said one out of 10 of their investments actually succeed, which you have to get a very high return on an investment to make it worth your while if those are your odds. But on the contrast, if someone goes through this program, like Mettech innovator, which I know you support. uh the odds are like 90% of them or something like 85% succeed. So it's very different. I know like I said investors are just now saying I'm going to only going to invest in people that go through some sort of accelerated program. What is uh your perspective on that, Darcy and I'll turn over to you Trevor. Guest: Yeah, absolutely. So I think that the stat that you mentioned, so one in 10 startups and this could be slightly changed by now. 1 in 10 startups survives, 1 in 10 of those will make it to 5 million in revenue. So if you think about the odds of that, 1 and 100 companies making it to 5 million. one and 10 actually that's exist, but only one and 10 of those will make it to 5 million maximum revenue what you're saying. 5 million revenue. Yes. So it really like there's a lot of companies that exist in, you know, in the US alone, you know, probably in the 8 to 10 there's a lot of startups. So you know, as an investor you're looking at where you're going to put your money, where's the best bet. And you know, the Mench innovator program you mentioned, we're we're also partners as you are. Fantastic program, the a lot of it comes out of their selection process, you know, having 1500 applicants and from that selecting, you know, around 150, 200 to pitch. and then of that around 40 that actually get into the program on an annual basis and so they are really challenging all those things as part of the program, not just what is the core technology, but they're looking at the team. How good is this team, how open to feedback are they are? How strong of a product market fit do they have? Do they understandment? Do they understand?tory? So they really challenge everything to get selected in and then when they do get selected in, they go through a pretty intensive mentoring process, pitch competitions and coming out of that, you know, these are the companies that you know, there's others that haven't went through the program that have been highly successful, but the ones that do go through it, the stats. I think it's over 90% of them and over 10 years of history uh are still either been acquired, went public or in business. And so you know, as an investor looking at companies to to really target, I think that's a great a great checkbox for just the quality of companies in that that alumni cohort that exists. Trevor: Yeah, I think playing playing a little bit of the other side of the conversation is how many of these do you think are companies or products that were already bound to succeed? You mentioned looking at companies where they have a mature regulatory process, they understand how to go through this process with determining reimbursement, understanding this product market fit and they have a genuinely good product before going in. And so I think that accelerator programs like Medtech innovator, you know, even going back to things such as Y Combinator for more general startups, it's a great way and the proven success metrics from these are just the numbers are just there. These companies do better. They succeed more, they get more money, they last longer and they have bigger outcomes. Um, I do think that there's a lot of it where you aren't going to see some nobody's inventing a product and then trying to find a solution and then getting into Mettech innovator. They're looking at companies that do have a good fit that are actually solving a real problem and they're doing it in a good way to make sure that they are giving those companies a leg up. Um, but yeah, anything to try to avoid. I think from a uh from an investor perspective, it makes perfect sense to try to look for these companies which historically are proven to be much more effective and much better companies than the scrappy ones where they're inventing a problem and then trying to invent the solution. Guest: Yeah, because at the end of the day, you know, it's one thing to get a product to market, but I I still believe the biggest challenge for Met startups will be when they have to sell. You know it's they're getting to market or getting to FDA approval is hard enough but now you have to sell. So getting to that 5 million in revenue or beyond is incredibly we see a lot of companies get to market and the sales are not there. And and that's one of the things that the Metator program really does challenge as well. Trevor as you said, it's not a solution looking for a problem. They they have a problem identified that they're solving and they really look at things like reimbursement, market adoption, you know, do you have the KOs on board because if all those signs exist, all those things are checked off, the process of selling into the market's going to be a lot better and a lot of higher likelihood of success. So it's yeah it's so many different things that factor into it but you know, as a program, uh pretty fantastic one to be part of. Host: You mentioned uh you do software development for nuclear as well. Is that right? Which nuclear or Mettech, which one is uh more stringent would you say? Guest: So the we have 9001 is as a quality management system which is the base. so 1345 for medical is definitely more involved. There's a lot more that has to be done for Mettech especially with the FDA and CE mark and everything else. The nuclear side of things is a step above that again. the quality designation we have allows us to write software that controls reactors. We're not actually writing software that controls reactors right now, we're primarily working on inspection and maintenance of them. But the quality management system there is extremely prescriptive and even more so than 1345 written from the point of view of building a physical reactor as opposed to writing software for. There's a lot of a lot of misunderstanding of what software is and how it's built. Uh so that that doesn't make it a bit more challenging, but I think from a public perspective to know that the quality management system on the nuclear side is even more stringent is probably a good thing because if something goes wrong in a reactor, it's not ideal and it so yeah, it is more challenging. Host: Yeah, I guess uh you also had things like Sxnet, which I guess is not really a typical nuclear facility, but it was similar right. so that was a took advantage of a vulnerability also. Guest: Yeah, you know there's there's been a few a few accidents that that have happened. If you overall look at the amount of accidents related to oil and gas as opposed to nuclear and a per capita basis, it's it's non-existent. The nuclear side is extremely safe. But you know, when you had Fukushima and Chernobyl and the other things which were gross either gross human error or natural events that are pretty hard to plan for. Obviously it gets a lot of attention, but as an industry, it's over the last few years it has really taken off again and there's a lot of new builds going in and all these AI data centers that are extremely power hungry getting in across across the world right now we just don't have the power for them and so nuclear SMRs in particular are a big investment that's happening to help with that side of things. Host: I didn't I didn't really think about that perspective because I thought nuclear there was a push to like move away from nuclear and have solar and wind farms, but it sounds like with all the data centers, we need more energy than solar or wind farms or anything else can provide. so we're back to building more nuclear facilities it sounds like. Guest: Yeah, it is and right now, I mean, they're they're building gas and oil and coal plants to to support them and it's really challenging the grid and there's a lot of actually states in the US now that are pushing back on data centers because they just don't have the infrastructure to power them and a lot of money going into it. So uh the nuclear side was kind of a downward industry from, you know, for the last 20 years up until 2022 and some geopolitical events kind of changed the view on that. The challenge with solar and wind is it, you know, it's not always the sun's not always shining, the winds's not always blowing. and so you need a lot of storage to be able to level it out whereas nuclear can be a very sustainable baseline energy source. there's no carbon emissions during generation. So it's one of the cleanest forms of energy and it's extremely scalable. So a lot of a lot of tailwinds pushing that industry along right now which is great as opposed to previously where it was for public perception kind of a lot of push back. Host: So I think just the physical footprint too of nuclear is a big factor to consider. I know that compared to like a solar or wind farm or something. Trevor: Yeah, exactly. So out a little ways past Oakland when you're driving out from here to Nevada on the 80, there's these massive solar farms covering both sides of the highway and it takes up so much land. Especially in a place like California where we have these huge concentrations of data centers and huge concentrations of AI companies. Land is extremely, extremely expensive here. And so for when you have, you know, a square mile of land of solar farm comparing that to a square mile of nuclear, you're getting an exponentially higher amount of energy out of that nuclear plant. So you're able to create so much more with so much less space. I'm personally a huge I love nuclear. I wish that there was a stronger push for it across the board, especially with all these huge problems that we're facing now in the data space, but it's just such a more efficient way to produce this energy. Host: Yeah, where I grew up in Arkansas was next to a nuclear facility and I tore that facility a number of times. The only thing that was environmental that and I was naive back in high school was they had to to cool, you know they had that big tower to where they dropped the water that was hot. So and it it ran into like a river so the river for a while was hot. I think that's the only really environmental thing unless there's a leak or something, right? Guest: Yeah, you need you need a source of water for cooling, but you know all these big data centers have the exact same thing they need a lot of they're very water intensive. So there are only certain, you know, places. Lakes are a great example. We have a lot of great lakes in the region here and so there's a lot of nuclear that's built right against some. So you do need that centers the water. So the data centers need water also? Trevor: From a cooling perspective. you know, most of those data centers are they're pretty um pretty intensive on that side as well. They they're usually built along that they'll need sources of water to go with it and along with the power for cooling and and heating and everything else. Host: I'm excited for the push for launching the data centers into space and dealing with the cooling problem through that means, I think still a little ways off but I do think it's actually closer than we might even think and I think that's going to be a big push in the future. Guest: Do you think so? Have me to transmit the data back to the US quickly or to the to the earth. Trevor: Well, that's probably going to be the big constraint is you don't do it quickly, but you can store a massive amount of it for far cheaper. And so I even think at the current cost of storing and processing a lot of data, it's going to become a little bit more cost effective quickly as long as you don't need the rapid retrieval. And so then I think that's going to be that's going to be the next thing to figure out is that rapid retrieval side of things. But I know even like in the Shenzen Bay in China and I think they're trying to get a little bit here in the San Francisco Bay, but they're also just sinking these data centers into the ocean to try to benefit a little bit from that cooling. Host: Do they actually have any operational ones in the ocean right now? Trevor: There are a few in China and I believe there are a couple on the Oakland side in the bay here as well. Host: It seems like that would disturb the ocean and the the fish should heat up the ocean. Trevor: Yeah, everything disturbs the ocean in the bay. We're we're not supposed to eat anything that comes out of the ocean here. You'll get mercury poisoning, lead poisoning, you'll grow a third eye. It's crazy. Host: Yeah, there's uh so much heavy metal poisoning in the ocean here. Trevor: They leave them like that and then eventually they convert them to apartments and so I'm hoping I can cash in on the class action when it happens. But um yeah, it's leeches out into the San Francisco Bay and so there're big notices that you're not supposed to eat anything that comes from inside the Golden Gate Bridge. Uh except for Halibut because those only come in temporarily and leave. Host: Oh no. I just bought a bunch of uh sardines and oysters. Hopefully the none of those came from that area. Trevor: There you go. Yeah, I think they're still getting those up in the Humblet Sea and out by Monre. Okay. Host: Yeah you got me uh hooked on the sardines and I kind of migrated to oysters as well. Trevor: Well, I still I've still have some from Portugal from this summer so have to have some when you come out to San Francisco. to Monaco and Trevor ate nothing but sardines and then he slept on top of his boat. and uh what happened Trevor? about the seagull? Trevor: Yeah, so we were go to sleep on top of the boat and we had, you know, some wine and sardines and bread up and we were just eating that and then I fell asleep up there. and I woke up, I felt this little tapping on my chest. and I wake up, I open my eyes and there's a seagull right here, staring right into my face. And you know, I was kind of freaked out for a minute. I sat there and stared, but as soon as he saw I woke up, then the seagull freaked out and was running all over the place. Guest: You you might be one of the few people I know Trevor that has a real passion for sardines. It's not it's not the typical go-to that I hear for people so that's very interesting. Host: You got me hooked on sardines too. but he ate so many that the seagull probably thought he was a big sardine, you know. He's like emulating sardine you know odors and stuff. Trevor: Yeah, but I've got since that trip, I've uh trying to find like the sardines you bought in Portugal are like really good. So I try to find good ones as well. I bought some whole foods yesterday but I don't think they're as good. Guest: Cool. Well we're coming up on time here. So I like to go around the room and ask for last minute words of wisdom. Uh so I'll start with Trevor. I usually start with Trevor and then I'll go to you Darcy next uh for audience like what's some departing words of wisdom. Trevor: Well, I think I have there are two angles that I want to come about this for. The first is don't invent your problem. When you're trying to understand what you're doing with your product, you can't just go through iterations and try to pivot back and forth as fast as you can. like you do traditionally in tech within the medical space. So really drill into your problem statement, what are we trying to solve, collect feedback from physicians, how would you like to use this product, does this make sense, is this effective? I think that another thing that we didn't really get into but comes up as a constant concern for uh Mettech startups is how is a physician going to use this? Uh physicians don't like passwords, they don't like complexity, they don't want to add new steps. They want things to integrate into an existing workflow for it to be easy and efficient for them. So start with these considerations and then work your way back. And then as the second part of it, just be sure that when you're building this, build it with quality. Do not try to just cobble something together and see if it works. Start with the quality artifacts, start with your risk management at the beginning. Don't write any code until you understand what you're going to do in the event of a problem, how are you building this code safely, how are you building this code with security in mind? So those are I guess two closing thoughts. Guest: Those are excellent. I I think the first one I I probably would have said the exact same thing but because you already did, I'll share a couple of others. you know, a lot of what we talked about here are some of the challenges, how how long it takes, how much it costs the chances of success and so I don't want people to be you know, concerned or you know, I shouldn't do this. We we do need these technologies so we there are great resources out there to help make that journey a lot higher a lot better, a lot easier, a higher like a good of success. We talked about the MT program. That's a great example of where you can go to to find a network of advisors and and people that can support you along the way. You know, if you don't have all the expertise that you need internally, find people that have done it before that you can work with. You know blue goat yourself on the cyber uh for us on on the software side of things. There are a lot of great partners out there that can help make that journey a lot easier and and take you from you know, the odds of success being on the lower side into, you know, you've as Trevor mentioned a problem a clear problem you're solving really easy way of integrating the right partners along the way, the right right accelerator along the way, you know, just in taking something and really making an impact make a difference. So I think there's a lot of great resources out there, a lot of great groups that can support so contact them, talk to them, pick their brains, take advantage of it because we're all here to help. Host: And I'll add two things that my wifessa works for the company she used to be a nurse and a couple things she mentioned with Mettech is like the innovator would bring the product to the hospital and they would try it out and they would love it, but then they never saw the product again because they got the buy in from the people that would use it, the users, but they didn't get it designed properly from a cost reimbursement strategy for instance. So she's seen that problem and she's also seen the other side where they got it approved from a reimbursement perspective but nobody wanted to use it because it wasn't easy easily adopted in the in the environment. So you have to consider both those angles. Cool, well we'll uh close here. so thanks for tuning in everyone. Hope you found value in this episode and we hope to see you on the next one.