In this episode of the Med Device Cyber podcast, hosts Trevor Slattery and Christian Espinosa welcome Marc Zemel, the CEO of Retia Medical, to discuss the critical intersection of medical device innovation and cybersecurity, especially from the perspective of a MedTech startup. The conversation centers on the journey of developing a life-saving medical device while navigating the increasingly stringent cybersecurity requirements mandated by regulatory bodies like the FDA. Marc shares the foundational story of Retia Medical, a company born out of the principle that 'necessity is the mother of invention.' He explains how his company developed advanced algorithms to monitor a patient's cardiovascular status in real-time, providing proactive alerts to clinicians. This technology, embodied in their Argos Infinity monitor, can detect severe problems like internal bleeding seconds or even minutes before traditional vital signs, such as blood pressure, begin to drop. This early warning capability is often the difference between life and death in high-risk environments like the operating room or ICU.
The main argument of the episode revolves around the non-negotiable importance of robust cybersecurity for such critical devices. Marc Zemel emphasizes that when a device's data is used to make life-or-death decisions, its integrity is paramount. He recounts real-world scenarios where their monitor detected severe blood loss before surgeons could visually identify it, allowing for a timely mass transfusion protocol that saved the patient's life. This underscores the catastrophic potential of a security breach; a hacker could manipulate the data, leading clinicians to make tragically incorrect decisions. The hosts reinforce this point by stating that cybersecurity deficiencies are now the number one reason medical device submissions are rejected by the FDA. The discussion concludes that for MedTech innovators, embedding cybersecurity into the core design and culture of the company from the very beginning is essential not only for patient safety but also for the survival and reputation of the business itself.
Key Takeaways
01Retia Medical's technology provides proactive cardiovascular monitoring, detecting life-threatening issues like blood loss before traditional vital signs like blood pressure change.
02For MedTech devices that provide data for life-or-death decisions, cybersecurity is a fundamental requirement, not an optional feature.
03A single cybersecurity breach that compromises data integrity can be fatal for patients and can irrevocably destroy a medical device company's reputation.
04Proactive monitoring with advanced algorithms gives clinicians an early warning system, allowing them to intervene and save lives in critical situations where seconds matter.
05Cybersecurity is the number one reason medical device submissions are rejected by the FDA, making it a critical hurdle for innovators and startups.
06The evolution from cumbersome, multi-lead ECGs to simple, app-based monitors with a single lead highlights the rapid and patient-focused innovation occurring in the MedTech space.
07Building a culture of security from the ground up is more effective and essential than treating it as an afterthought, especially in the highly regulated and high-stakes medical device industry.
Frequently Asked Questions
Quick answers drawn from this episode.
In this episode of the Med Device Cyber podcast, hosts Trevor Slattery and Christian Espinosa welcome Marc Zemel, the CEO of Retia Medical, to discuss the critical intersection of medical device innovation and cybersecurity, especially from the perspective of a MedTech startup.
Retia Medical's technology provides proactive cardiovascular monitoring, detecting life-threatening issues like blood loss before traditional vital signs like blood pressure change. For MedTech devices that provide data for life-or-death decisions, cybersecurity is a fundamental requirement, not an optional feature. A single cybersecurity breach that...
Marc shares the foundational story of Retia Medical, a company born out of the principle that 'necessity is the mother of invention.' He explains how his company developed advanced algorithms to monitor a patient's cardiovascular status in real-time, providing proactive alerts to clinicians. It's most useful for medical device...
Retia Medical's technology provides proactive cardiovascular monitoring, detecting life-threatening issues like blood loss before traditional vital signs like blood pressure change.
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Pre-fills with: "Retia Medical's technology provides proactive cardiovascular monitoring, detecting life-threatening issues like blood loss before traditional vital signs like blood pressure change."
In this episode of the Med Device Cyber podcast, hosts Trevor Slattery and Christian Espinosa welcome Marc Zemel, the CEO of Retia Medical, to discuss the critical intersection of medical device innovation and cybersecurity, especially from the perspective of a MedTech startup. The conversation centers on the journey of developing a life-saving medical device while navigating the increasingly stringent cybersecurity requirements mandated by regulatory bodies like the FDA. Marc shares the foundational story of Retia Medical, a company born out of the principle that 'necessity is the mother of invention.' He explains how his company developed advanced algorithms to monitor a patient's cardiovascular status in real-time, providing proactive alerts to clinicians. This technology, embodied in their Argos Infinity monitor, can detect severe problems like internal bleeding seconds or even minutes before traditional vital signs, such as blood pressure, begin to drop. This early warning capability is often the difference between life and death in high-risk environments like the operating room or ICU.
The main argument of the episode revolves around the non-negotiable importance of robust cybersecurity for such critical devices. Marc Zemel emphasizes that when a device's data is used to make life-or-death decisions, its integrity is paramount. He recounts real-world scenarios where their monitor detected severe blood loss before surgeons could visually identify it, allowing for a timely mass transfusion protocol that saved the patient's life. This underscores the catastrophic potential of a security breach; a hacker could manipulate the data, leading clinicians to make tragically incorrect decisions. The hosts reinforce this point by stating that cybersecurity deficiencies are now the number one reason medical device submissions are rejected by the FDA. The discussion concludes that for MedTech innovators, embedding cybersecurity into the core design and culture of the company from the very beginning is essential not only for patient safety but also for the survival and reputation of the business itself.
I remember being nine or 10 years old I think with all of these ECG leads running all over the place connected to me 24/7, even for months after surgery. And now we've had some companies come through our door where it's just a little app you get on your phone and then one tiny ECG lead and that's it. That sounds like you guys are a key example of that.
It's sort of the old story of necessity is the mother of invention.
We develop algorithms for detecting changes in cardiovascular status. And we deploy them in standalone monitors, our new product called Argos Infinity. Often we will detect problems before the blood pressure drop. We took a long look at this protections that we needed to ensure that we had proper cyber security because there's no going back. I've had scenarios where people were in the OR and we saw change before they saw blood pooling in the surgical field where seconds mattered and they had to initiate mass transfusion protocol to bring the person back to life, frankly. And if somebody is getting in there and they're monkeying with your system and then giving you the wrong information because they found a back door or whatever, your reputation is gone.
Cyber security is the number one reason that medical devices are getting kicked back.
Hello there and welcome back to another episode of the Med Device Cyber podcast. Your usual hosts, myself Trevor Slattery and Christian Espinosa are here as well as a very special guest that we have today, Marc Zemel. What we're going to talk about are some of the challenges that MedTech innovators and startups and manufacturers may face while moving into their cyber security journey and moving towards their submission pathway. Before we dive in too deep, I'll check in with everyone and see how everyone's doing today. I'll start with you Christian, how are you doing?
I'm doing well. I just got back from Kenya, so about 40 hours of travel, a little bit jet-lagged. Uh, got a little sunburnt at Kenya where I was staying at altitude and I it's about 6,000 ft high. So I hung out at the plunge pool for about 15 minutes and I guess because of the altitude and the the sun bounce off the water I got a little sunburned, plus you're driving around in these little vehicles all day in the wind, looking for the the rhino and all the animals. So that was, it was fun.
Well, a sunburn in December is never a bad thing.
Yeah, and plus I got, I I still wear these glasses. I don't like the way they look on on video though, but I've got used to wearing these like blue blocker glasses or whatever, even though they don't look so cool.
There you go. And how about yourself, how are you doing today Marc?
I'm doing great. We just uh almost done wrapping up 2025, way ahead of plan which was awesome, and looking forward to kicking off 2026 and continued growth for our uh Retia Medical.
Awesome. And where are you calling in from today?
Yeah, uh we're based in White Plains, New York, just north of New York City.
Trevor was just up in the area recently, weren't you, Trevor?
Yeah, just uh was out in New York for a couple of days and then up in Toronto. I actually just got back I think day before yesterday.
Nice. Nice. Well, let me know when you're in town.
How far from Lake Placid is that? I did the Lake Placid Ironman.
Lake Placid is all the way north.
Oh, okay.
Several hours, like four or five hours north of us.
Oh, wow. Okay.
Yeah.
I feel like New York's a bigger state than a lot of people realize. You kind of, if you're not from New York, you think about the city and then everything is just upstate until you get to Lake Ontario.
Upstate's a pretty, pretty far away though it sounds like.
If you live in Manhattan, then where I am, which is Westchester County is considered upstate, but it's really more like New York metro area. We're about half an hour into Upper West Side, so it's pretty funny.
The strictest definition I ever heard is anything past 125th Street is upstate.
That sounds about right.
All right. Well, why don't you start by telling us a little bit about yourself and a little bit about what Retia does?
Sure. so, uh, I'm the co-founder and CEO of Retia Medical. Uh, I actually uh trained as a mechanical engineer. Uh, I got my master's from MIT and then worked in the uh semiconductor capital equipment industry for about a decade. Uh, and then I decided to move into MedTech, so I went back, got an MBA, uh, at Yale, worked at Becton Dickinson for a few years, and then decided to start my own company, which I've been running now. In May it'll be 15 years, Retia Medical. Uh, I joke that we were two guys with slides, so uh, licensed the technology, raised the capital, built the team, took us through FDA, CE mark, and now we are sold in 18 countries, uh in the US uh we're sold by Medtronic, we're in 75 hospitals. Uh it's been quite a ride and, you know, a lot more to do.
We develop algorithms for detecting changes in cardiovascular status, that's the fundamentally what we do, and then we deploy them either in standalone monitors, which is our historical product, and now what what we'll probably talk a lot more about is our new product called Argos Infinity that will be rolling out in Q1 of uh 2026 pending FDA clearance. Um so in the middle of that process right now.
When when you're talking about cardiovascular, because I I uh had blood clots, would that help detect something like blood clots or is it mainly like the heart muscle?
Yeah, so I say cardiovascular is sort of the broadest term. We particularly uh assess cardiac and circulatory function.
Okay.
So we're we're monitoring um blood flow and the resistance of your arterial system, the amount of blood ejected with each heartbeat. When you think about what people typically will measure, they'll measure blood pressure. That's the easiest thing to measure. But blood flow is what carries the oxygen to your, keep your vital organs alive. So, historically, uh, the way to measure this was by threading a catheter through your heart into the pulmonary artery, that's called the pulmonary artery catheter, and that would be the way that they would measure, they would measure flow by by injecting cold saline and then measuring the change in temperature and that would be the way they would infer the flow rate, which is it's like a I call it a science experiment at the bedside.
So, what we do is we take that blood pressure signal that people get from an invasive arterial catheter, and then we run an algorithm using a sophisticated model of the circulation to calculate the blood flow, the vascular resistance and all these other parameters that then are used by anesthesiologists, intensivists, critical care nurses to manage their patients more precisely, to diagnose what's wrong with the patient and and obviously to detect, you know, patient deterioration. Often, we will detect problems before the blood pressure drops. So it's an early warning system for your body, for your cardiovascular system.
So the blood pressure is less important than the blood flow, or then but they're sort of related but not not enough to to make a prediction, is that correct?
Yeah, I mean, look, blood pressure is a vital sign, if your mean blood pressure drops below 65 millimeters of mercury, you know, every alarm, every bedside monitor will go off. Right? That's an emergency. Um so but typically that's a sign that already something was going wrong beforehand, and that's what we're picking up that earlier, the technical term would be loss of perfusion. The perfusion is what's delivering that oxygen to your vital organs. You know, typically like, let's let's take an example where somebody's bleeding. And if you bleed and you're a relatively healthy person, you will squeeze your vessels down to maintain that pressure in your trunk at the expense of your, you know, peripheral limbs. Right? And so, um, you might maintain your blood pressure for quite a while until you kind of fall off a cliff. Meanwhile, your your blood flows going down the whole time because it's not obviously coming back to your heart, it's leaking out. So we detect that change before the pressure drops.
Yeah, that's uh that's awesome. Uh It's interesting to me because I think when well, both Trevor and I have had, I guess cardiac or blood issues. so, you know, to me it's interesting to to hear about these kind of uh this kind of technology. What, what was it your heart, it was beating too fast? Is that the deal, Trevor?
Yeah, yeah. So I have uh Wolff-Parkinson-White syndrome and that led to quite a few complications when I was around eight or nine.
Oh, wow.
Some very rare, very rare side effects. Luckily nothing has emerged too quickly from there, but I know even, you know, us being so involved with the cybersecurity and with the FDA process for medical devices, we get exposure to a lot of devices that are even intended to treat symptoms of Wolff-Parkinson's White or manage it a little bit better instead of uh I remember being whatever it was, nine or 10 years old, I think with all of these ECG leads running all over the place connected to me 24/7, even for months after surgery. And now we've had some companies come through our door where it's just a little app you get on your phone and then one tiny ECG lead and that's it. So it's cool to see how these things can evolve as time goes on, for sure. And it sounds like you guys are a key example of that taking something that used to be a little bit of a complicated, a very invasive and a very difficult process and finding some ways to look at it a little bit more precisely and a little bit less uh science experiment.
Yeah, I mean, if you think from the ECG world, think of that as uh measuring your electrical system where you're, you know, you're saying to your heart, beat, beat, beat, beat, however frequently you fire, right? And then we are telling you how much blood actually came out after your electrical system said, do something. So they're very complimentary.
So earlier you were mentioning that your initial strategy was to have a monitor that you were producing and having this algorithm go within the monitor. Um and then you said that you were leading that you're bringing this algorithm into some other technologies. I'd be curious to hear a little bit about what drove that shift for you and then what you're seeing in some of the variations between those two different models that you had.
Yeah, it's sort of uh the old story of uh necessity is the mother of invention. Um, we came out with a box, right? And we're trying to get it into the hospital. First we tried with, you know, some local distributors, then we tried selling direct, uh, and then, you know, we were able to get enough traction to then get Medtronic interested, which is wonderful. But selling the boxes for us meant you roll the ball all the way up the hill. And all the stakeholders in the um, hospital system, right? And and you're going to do, you know, the amount of effort to sell two or four or six or 10 boxes is a very, very significant, uh, a long sales cycle, and very um, difficult to get capital, you know, budget. And on the other hand, when we would go and show the monitor, um, let's take like a 16 bed ICU, right? Well, they, in a CVICU, every one of them has an A-line, but they wouldn't be able to afford putting, uh, one of our monitors at every bed to start. So they'd buy three or four and then they'd buy another four. It'd take them five years to get the proper bed coverage. So I'm looking here and I'm saying they need it on every bed, but they can't get there right away because of capital constraints.
And then you have all the problems, the complaints about, well, you know, I don't want another screen at the bedside, right? And there's always, you know, you walk into like a one of these uh, you know, very, very complicated, you know, ORs with robots and lots of, you know, anesthesia machine. There's like not a lot of room. Then you walk into a neuro ICU and, you know, you don't even know where the patient is because there's so many different things. You know, like I counted one that had 15 screens, not to mention all the pumps, you know, and other uh, equipment there. So I was like, what if we could get the data that they want, right? at their fingertips, whatever screen they had, you know, if it's on their phone, tablet, laptop, wherever. And and could we then cover every bed in the hospital? And so the beauty of that is a couple things. One is it's meeting the clinical need that much more quickly. Number two, it's a bigger deal, right? So, it's, I mean, my expectation is that this is not going to be five times the effort. It's going to be more effort because IT gets more involved, but a lot of it was the clinical adoption and the trials and all the other things and the navigating the budgeting, that's all the same. But the bang for that is that we now cover 100 beds at a time, or 500 beds at a time. So we piloted this project, we called it Argos Infinity, through their Tel ICU, where they already had the infrastructure to monitor a lot of patients. So we're right now we're live on 400 beds and in Q1 we'll be at 500 beds. Right? And and it's like, okay, now we're maximizing the possibilities of this algorithm to get it and make it available on every single clinician's hand. So that that piece was sort of like a a natural evolution of our understanding of the channel difficulties, right, which by the way, includes the fact that the big companies in this space, they don't sell just a hemodynamic monitor, they sell a cerebral oximeter or they sell a pulsox oximeter or they sell depth of anesthesia or they sell, you know, any number of other products and then you know, they they have that portfolio that they bring to the hospital. And we're like, you know, we'll go and they'll be like, we love your product, but I need these three other things that you don't have. So we're going with this other company. What happens all the time? Well, this is its own category.
This is its own uh, break, we hope uh and we'll apply for this breakthrough designation from GPOs, where, you know, there's no such thing as hemodynamic monitoring software. That's not a thing in these categories. So it's like, okay, look, you guys can do what you want, uh, with your specialty boxes and disposables and, let's not forget that our major competitor, their list price for their new box is $100,000. and then $300 every time you use it. Like, that's not sustainable in today's healthcare environment. So it's never going to be at every bed. This is now changing not just the the clinical workflow and making it's reducing the friction for all the users but it's changing the economic model to allow patients then to have data at every bed that not just makes it better for them, but it also leads to those potential improvements in critical care that we set out to do when we started the company. Because if you think about it, you know, once you have all that data, then you can start to collect it and then you can start to develop new algorithms that detect even finer changes and other problems, then you can start to develop care protocols on larger datasets. So think of it as ushering in the era of big data merged with physiology to transform critical care medicine. So this was a sort of a natural evolution and sort of an understanding of the necessity of both the clinical problem and the business problem that led us to go down this path of deploying in a software platform.
What is uh you said you've been doing this for 15 years, I believe you said earlier.
Yeah.
What's your overall like plan? You're looking for 15 more years? You're looking for, you know, like to do something new or like what's what because 15 years is uh it's a fairly fairly a long time frame. I mean you're you're bring something awesome in the market. I was just curious like where you see yourself like you know, five or 10 years from now and and or what the next thing is?
Yeah, you know, it's so funny because when I got in, I was like, oh, I'll do this for five or seven years, I'll sell it and you know, get moving. Yeah, the average MedTech company takes I think somewhere around 14 years for exit. Um, and you know, I have investors. I'd certainly would would like to return money to them, but honestly, companies get bought, not sold. And so, you know, what I think all the time is I'm just going to keep creating value. Keep building the business. And if somebody does something and wants to have a conversation, I always talk to them. Uh but at this point, it's really about two things. One is uh, like I said, building the business. And and the other thing is it's creating value at the clinic. Right? Like we have a, we have a road map of algorithms that we want to roll out beyond just Argos Infinity, which is this, you know, digital algorithm platform for critical care. I'm keep having fun doing that the next several years and and uh there's a lot more we can do in this space. A lot of unmet needs, uh a lot of things we can do not just in sort of a our traditional space, which is high risk OR, and ICU, but we're on our road map, we're working on non-invasive algorithms which allow us to monitor people when they come in through the emergency department, L&D, um, you know, the CCU, maybe they don't have an A-line there, stepdown units, PACU, the medium risk surgeries. We do that right. Then we start to think about, you know, maybe we even go in the pre-hospital, you know, at home market. Again, all about assessing cardiac and circulatory function, which currently not well monitored outside the hospital. Well, you know, you look at these things, and there's only so much you can do with ECG, right? There's some things where it it might be better to look at these things in combination. And we did that and you didn't feel right, you know, in women for example, when they get a heart attack, it might feel like nausea or indigestion, right? And do you you really want to go to the emergency department for six hours or eight hours and before you figure out whether it's one or the other? Or maybe I'd like to hook up some things and have it tell me you're fine or, you know, get in the car or call 911, right? And and I see that as a game changer for um, a lot of people, you know, who really care about their health. And and you're investing in they're today. And the beauty of this is will be validated in the high risk scenarios. So, you know, Cleveland Clinic has 75 of our boxes. They use us all the time, you know, now with the software platform. And if it's good enough for them, right? then why isn't it good enough for your grandma? or your your uncle or whoever, right? If we get there, why wouldn't you put it on there?
Yeah, that's a good point. Oh, I was just talking to Trevor earlier, before we started recording and he has an aura ring. He just got one, I think. I used to have one back in the day. It was like 10 years ago version 1.0 or something. But it uh it measures your pulse. I don't think it measures your flow rate of your blood or anything, but it measures quite a few things that you were concerned about the security of wearables in general in that ring, aren't you Trevor? Like in what aspects?
Yeah, so with a lot of the information that it's collecting, when I wake up, I get a little score. It'll send it over to me on my phone and it's collecting all sorts of information while I'm asleep, while I'm active, if I'm exercising, um if I'm not exercising but something else is causing my heart rate to go up. And so I'm not exactly sure what information uh you know, exactly how it's processing all of this. I know it's collecting some information about your pulse rate, your blood oxygen, things like that. And then it's trying to determine like if my pulse rate spikes and I'm not doing anything, I'm not moving, it probably means I'm stressed out about something instead of exercising. But one thing that I do think is unique about some of these wearable technologies is they're in a little bit less of a regulated space than Argos Infinity for an example. That is a regulated algorithm that's something that goes through FDA approval process. Uh something where you have to address any security concerns around it as well. And so I know we were working with your team on the security considerations for the Argos Infinity and helping build out this documentation, all of the testing. But some of these wearable devices don't go through that same process. So I'm concerned about some of the safety uh risks that could potentially be there around the device. I have it on my to-do list for before the end of the year to try to hack into the Aura ring and see what happens. It can't do anything to you though, it's just a monitoring device. It's just a monitoring device, but if I can, you know, it it talks to my phone over Bluetooth. What if I can trick my phone into saying, "Oh, you're not stressed out. You can just keep going with that lifestyle." Or, "Oh, you're super stressed out. You need to change something that you're doing." Uh, you know, it's giving you a score and The fact that it's telling me I'm stressed out when I'm really just sitting here over and over, it would stress me out even more.
That's what it does to me. But it'll give you it'll give you a little suggestions. Like last night I got this Dan, I was going on a walk just to get out of the house for a little bit, and I came back home and it says, "You should keep walking for a little bit longer." And I'm like, oh, that's interesting. It'll try to give you some insight in one way or another. And obviously this is a pretty harmless example. It's a little bit of a gimmick. It's fun to see but you're not really making any decisions off of it. But once you're moving into those decisions, then it's very important to make sure you're covering all your bases with proving these are safe and secure.
Yeah. I think wearables are interesting and I probably I should probably get one because my blood pressure has been high. Every it's it's only high when I go to the doctor. I think it's like one of those things that I know they're going to take my blood pressure. So I try to breathe a certain way, but it probably makes it worse. so it's high. but then I measured it at home all the time it's normal. So it's like this weird thing. Yeah, well, there's there's the white coat effect, white coat hypertension, but also you go into some of these places and uh it's not always measured correctly. You got to do about 11 things correctly. You know, like, make sure you empty your bladder, you got to be in a dark room, no talking, you know, feet on the floor, your arms supported. get in there and the nurses like, you know, you're fine or you're a little eye or whatever. Like, you know, it's it kind of That's a that stuff and it it works me but you know, the reality is if you look a little high, you do what you do, which is you measure every day and you record your readings and they'll make a decision based on that. So I wouldn't get too worried about a one-time measurement on an annual physical or something like that. Um but back to your comment about the um wearables, I just saw something uh where they're looking to update the uhppa which is the, you know, the hippa security and extend it to wearables. Um I I it's funny that you brought this up because I I didn't have time to read the article but it looks like that is going to be an area of increasing concern because these devices, as you say, are collecting a lot of information about people and your location, right? And then it's like a wearable tracker. You know, in the old days like, you know, the spy movies and things they'd plant some bug on somebody's like pin or their shoe and now you're doing it yourself. I have to bug for the bad guys. Right, you're wearing the bug for it right? So, so having some security around that is increasingly important. Um and I think there's a lot of people that, you know, are very mistrusted of of this data and having appropriate control measures to establish trust. I mean, we're dealing it with it in the hospital. You know, there's just a so many layers of review that you have to go through before you can go live. right? It's not like, you know, in the old days we just you know, as a consumer just download free free software and try it. That's not happening. not in the hospital, right? Even now, I'll download an app on my phone, you know, but I rely on Apple to you know, make sure that it's okay. But that kind of trust environment is key, right? And that's why, you know, we we took a long look at this and protections that we needed to ensure that we had proper cyber security, the right architecture, the right penetration testing, you know, because there's no going back. All these news articles about hospitals getting hacked and the data getting sold for ransomware and all that. They're all ultra-sensitive for this. And so now, you know, unfortunately, it's just a cost of doing business. You have to go that way, but but frankly, it's the right way to do things.
And I don't think too many of our too many of our prospects uh think the same way you do. A lot of people come to us when they get rejected by the FDA. and they're like, oh, maybe we should have thought about this before, but now we got to redo everything. So it's it's uh refreshing here a little bit of proactive approach but also an approach that you realize this is also directly related to patient safety.
Yeah, I mean, look, our whole brand is about being proactive and and patient safety, so you know, it's a very mutually uh reinforcing what we try to do. Um, but you know, like we knew this was a regulation, like why go back and do it after the fact? You're just going to waste a lot of time.
Yeah, and we'll see a lot of times like Christian was saying companies will come to us and say, hey, we just got, you know, kicked back by the FDA. Um, often times we'll see letters come back from the FDA just saying, make sure you address cyber security concerns. They keep it that high level since there's so much that gets mishandled.
Wow.
Right now, cyber security is the number one reason that medical devices are getting kicked back. And so when we're seeing a lot of companies that not exactly sure what the source the most common source would be, but we do see a mix of just not being aware of the exact regulations, not being aware of how important this can be. And then I think we're also seeing a little bit of a blend of uh people that are are aware of this being a problem manufacturers that are aware, but they don't know how severe it's going to be and they don't know how seriously the regulators take it. They think they can prepare a couple of quick documents, say, you know, hey we ran through, we ran this through a static checker when we were developing it in our development pipeline. Should be good to go. Here's the outcome of that. Here a couple pages describing it. And then the FDA says, we were looking for a little something a little closer to and then they provide the list of documentation which for us is generally 150 to 600 pages of documentation that goes into it. So this isn't a small effort. And I do wish that a lot of me more manufacturers would just have an understanding of how important it is to address this early since you don't want to have to write 600 pages of documentation at the 11th hour and run the risk of some problem coming up in that process.
Yeah, I mean, the other thing here is, you know, we face this in Medtech all the time that, you know, the the war for talent. Like yes, you know, we're not paying, you know, $100 million salaries like, you know, Meta and some of these companies over that, you know, AI expert. We're we're competing in a different space. Similarly, the people in hospital IT. You know, there's some really great people but they the expectations and the demands on their time are such that you've got to make this as reliable and easy for them to implement as possible. Every IT department I've talked to, they have nine months or 12 months worth of projects. And and if your thing is not locked down and right and tight for you, you know, okay, we'll get to you later, right? Sorry, I I have other things to do. You know, come back when you're ready for prime time.
Yeah, there's something you said earlier, I just wanted to kind of uh rewind to. You said it sort of in passing. I think you said companies should be built to be bought, not built to be sold or something along those lines. I I know what you mean as an entrepreneur, but maybe should expand upon that just for our audience to understand it because I think it was very well spoken.
When we started, the idea was get to FDA, and 15 years ago, FDA was, you know, the milestone and you can get acquired on that. And now, I think with the consolidation in MedTech that, particularly in monitoring, you know, it's not about, you know, a clinical result because there's no therapy here, it's information. It's about traction and so, you know, how much is enough traction, you know, is it repeat customers? Can you show that, you know, in a particular area that the same people, uh, come back and continue to buy from you and you get that recurring revenue and expansion in the hospital? Sure, you know, is there an absolute revenue number that they like to see? Sure. You know, at some point these companies have gotten so large that there's a thinking, well, what moves a needle for us, right? Is it is it 10 million? Is it 20 million? Is it 50 million? Like is the bar standard of care, right? Like it it's a very kind of uh loose definition. And and I've thought about this a lot. And, you know, sure, we're going to continue to drive the the adoption of our technology and we're going to continue to make it better and and more indispensable in the hospital. I think about in tech when people talk about making products that were insanely great and products that that just worked. That's to me is what will drive the sale. you know, or the, you know, quote unquote exit. that that people can't live without it. That's so ingrained. But, you know, can you control that when somebody recognizes that, you know, I control this side of the table. So, I figured we just keep building things that, you know, people hug our monitors. Right? Nurses they get so passionate about taking care of their patients a lot better. They get very emotional about it. Um that tells me we're on to something.
The nurses actually like hugged the monitor? I have photos of them hugging the monitor.
That's pretty. That's like the best testimonial you can have, really. Right? I mean, who does that? Right? Like Right? So, so to me, that piece is what I I, you know, keep in that pocket where I'm like, okay, this when I need to be cheered up, like I keep that in that pocket. Um to to remember that. That and obviously when we've helped, you know, catch patients in trouble, right? those are the two things you hold on to. Uh, but we keep building the business, keep making, you know, improvements in care through, you know, the information that we provide and I know good things will happen.
I like it. It's a great model. Uh well we're coming up on time here. I'll ask I usually ask for last minute words of advice or wisdom and Trevor has been smiling. I think he went to the dentist. Maybe that's why you're not smiling. Is that right Trevor? Is your mouth hurt or something today? I just got a new permanent retainer attached on my teeth.
A what?
A new permanent retainer. My old one snapped like three weeks ago. I just got Oh, I was wondering why your face looked a little bit different today. I thought, oh, he went to the dentist, so now it makes sense.
Yeah, it feels weird so I keep messing with it and so I'm like kind of but, yeah.
So what's your uh quarters words of wisdom, Trevor.
Well, I think more so than my typical where it's around some statement. I think this is going to be what I want to see and what I expect to see coming up is that we're going to see shifts in the way that wearables are handled. I know we had a little segway into the conversation around wearables but it definitely did get me thinking about how loosely regulated these are, how loosely controlled they are. There's no I'm not even sure what information I'm supposed to get from these, honestly. And so I think we're going to be seeing a pretty big shift for some very impressive, very uh useful use cases for them. And as such, I hope that the safety and the regulations around it are soon to follow.
Yeah, I couldn't agree more on that. And then especially as these things become closer to what I would call clinical grade, right? And they're no longer wellness devices and people go to their doctors and they say, "Look, I've been wearing this, I've been watching it. People want to start to make decisions. Well, where is that data going and how are we protecting it?" And how are we validating that that data is any good? Right? What are the standards? They have to be updated. A lot of these uh, cup blood pressure devices, you know, they make a lot of uh aggressive claims, shall we say that are not supported by the data.
Yeah, and along the same theme theme, one of my concerns is I have a scale that puts stuff on an app, I have a blood pressure thing I do put stuff on an app. It's like at some point when I want to get a new life insurance policy, are they going to ask for all this data from these providers and then give me a health rating based on my own choice of using certain applications to measure my health. I just figure it's going to be used against me in some in some capacity at some point.
Well, I'll tell you what they're going to do. They're not going to ask for it. They're going to ask, they're going to say, well, if you volunteer it, right, then we'll give you a discount. Like I got this from my car insurer, they said they want to put a tracker on my car and they'd give me an extra 5 or 10% off and they were tracking, you know, how hard did I break and how far did I travel and where was I? And then they were, you know, optimizing my insurance rates from that. So I definitely already have on my car. It's already happening.
I have the same one the same thing. is tracking how hard I accelerate, break and all that stuff. And it has a terrible understanding of how steep the hills are here and how fast you need to accelerate to get up them.
Yeah, but these things get better and better, you know. So they didn't care. They're like, let's collect all the data and then we're going to compare you to the other, you know, thousand people in your neighborhood who are going up that same hill every day. And then they're going to be like, okay, this guy takes it faster, this guy takes it slower. Right? Like this massive super computer is going to like completely like understand who you are.
Sounds like Skynet. It all comes back to Skynet.
I was with somebody at speed Vegas and they have a track there you can drive cars as fast as you want and they had on their phone that 360 tracking app and their friend got an alert on the phone saying they were recklessly driving in an erratic manner. So their friend calls like, what's going on? They're like, I'm at a race track, you know, driving them the instructor, you know.
Yeah, there you go.
Yeah, it's kind of crazy.
It's impressive.
Awesome. Well, thanks so much uh Mark for joining us here. It's been a pleasure and uh thanks as always Trevor. Hope your mouth feels better. I know we have another recording later.
Yeah, thank you for having me. It was a pleasure.