Real-time analytics will be revolutionary for preventative care and remote monitoring.
In this episode, Andrew Malcolmson, president, CEO, and board member of Fifth Eye, explains their groundbreaking technology, which predicts patient deterioration based on heart rate variability. This software-only solution integrates seamlessly with existing ecosystems and partnerships to avoid additional complexity. Andrew highlights the benefits of early detection and interventions, especially in predicting rapid response events, and talks about how Fifth Eye’s adaptability and ease of deployment make it a valuable addition to the healthcare landscape. He foresees a transformative shift toward hospital-at-home care, accelerated by COVID-19, and discusses the potential of their technology in revolutionizing cancer treatment monitoring.
With over 20 years in MedTech, Andrew brings extensive expertise in medical devices and software to his role as President and CEO of Fifth Eye, an Ann Arbor, Michigan-based company that develops intuitive, real-time clinical analytics based on physiologic waveforms to improve outcomes and reduce costs.
His leadership experience includes large public companies such as Covidien/Medtronic and Danaher, as well as start-up and private equity-owned organizations. Prior to joining Fifth Eye, Malcolmson was the General Manager of the Intra Oral Scanning (IOS) business unit at Carestream Dental, where he led the $600M carve-out and sale of the business to Envista Holdings Corp.
His diverse background spans R&D, sales and marketing, and strategic business development. He started one of the first remote monitoring and clinical decision support software platforms and today is guiding Fifth Eye to become the industry source to bring intelligent data to inform clinical decision-making with its AHI System. AHI is the only FDA-cleared clinical decision support software that continuously predicts the risk of hemodynamic instability earlier than vital signs, giving clinicians an unprecedented picture of emerging patient shock.
Download the “Outcomes Rocket_ Andrew Malcolmson audio file directly.
Outcomes Rocket_ Andrew Malcolmson: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.
Saul Marquez:
Hey everybody! Saul Marquez with the Outcomes Rocket. So excited to be with you again today, and thank you for tuning in to the podcast. Today, I’ve got the privilege of having Andrew Malcolmson on the podcast. He’s the President and CEO, and board member of Fifth Eye. With over 20 years in MedTech, Andrew brings extensive expertise in medical device and software to his role as president and CEO of Fifth Eye. They’re an Ann Arbor, Michigan-based company that develops intuitive real-time clinical analytics based on physiologic waveforms to improve outcomes and reduce costs. If you’re talking about catching patient deterioration way before it’s a thing, you’re going to want to listen to this episode. Look, his leadership experience includes large companies like Covidien, Medtronic. Actually, I had the privilege of working with Andrew directly while he was heading our vital sync portfolio at Medtronic. So great to be with you here again, Andrew, and a little bit more, so he also has experience with private equity-owned organizations. So prior to Fifth Eye, he was the general manager of intra-oral scanning. It’s a business unit at Carestream Dental, where he led a $600 million carve out and sale of the business to Envista Holdings Corporation. Just big, you know, and love that he’s got this diverse background because healthcare is connected, whether it’s oral health, mental health, overall health, spiritual health, it’s all part of it, and he exemplifies what leadership across the different continuums of care are. And so, with that introduction, Andrew, I want to welcome you to the podcast. Thanks for being with me.
Andrew Malcolmson:
Hey, thanks, Saul, great to see you again. And yeah, like I said, we certainly spent a lot of time together in the past. It’s nice to have the opportunity to spend some more time with you here today.
Saul Marquez:
Absolutely. And look, you guys are doing some fascinating work at Fifth Eye, we’re going to touch on that, and folks, you’re going to want to hear the really interesting work that they’re up to there. Before we do, though, I’d love, Andrew, if you just kind of share a little bit about what inspires your work in healthcare.
Andrew Malcolmson:
Sure. So I’m an engineer by training or an ex-engineer by training, recovering engineer, depending on how you want to name it. So I really started my career more in analytical instrumentation, building really high-end analyzers, more for chemical or material science purposes. When we transitioned into infectious disease, right, using a lot of those same technologies now, rather than to characterize materials that characterize blood, to look for infections, you know, you just realized it was like light bulb moment for me, how much opportunity there was to use technology, to use science, to use analytics to deepen and improve healthcare. So really, it was at that point I made the transition over and have never looked back. You know, the last 20-plus years in my career now, I’ve been dedicated to primary location monitoring, primarily med.
Saul Marquez:
That’s awesome. And it’s about finding that variability, right, and doing it in a scalable, automated way that helps us figure out things to improve care, right?
Andrew Malcolmson:
Yeah, and it’s hard, right? I mean, it takes a lot of understanding of how do you actually get these technologies being on the discovery you don’t need approval, but into deployment clinically, right? I mean, I think that’s sort of the stage of where it was before. You know, we have all of our approvals, we have technologies ready to go, but, you know, getting it adopted is the next challenge that we have.
Saul Marquez:
For sure. So let’s talk about Fifth Eye. What is it that the company does to add value to the healthcare ecosystem, providers, health systems?
Andrew Malcolmson:
So, you know, there’s sort of two parts. There’s what we do, and then there’s how we do it, and I think both are really important, and both are worth highlighting here, which we’ll cover today. So what we do, we really are the first to bring a real-time indication of compensatory drive and a prediction of decompensation or shock to the market that’s based on clinical heart rate variability analysis. It’s been around it’s been studied for 60-plus years since the advent of high-precision ECG, but it’s never been available or utilizable in vivo non-invasively in real-time, and so we’re really the first to bring that in. And the power there is, we can understand a patient’s, again, compensatory drive, how hard they’re fighting something off, be it an infection like sepsis, be it a clot with a DVT, be it a blood loss undiagnosed, or postpartum, or CRS oncology patients. So understanding that in a …, before any other vital sign has any indication that the patient is fighting for something, fighting for homeostasis, fighting for their life is really important. So again, we’re the first to do that and excited about that. The how we’re doing it is, as I mentioned, equally as important because we’re a software-only solution, so we don’t have additional sensors you need to buy it to use it, you use any ECG sensor or any wearable patch that has an FDA-approved EKG. So we’re not adding burden or adding complexity to the hospital’s lives or their supply chain issues or any of those sorts of issues or any sort of pieces because they have EKGs galore inside the hospital. So … suddenly worry about that. Additionally, we have our own user interface. We have our own screen, so if people want to use our solution, our what’s called, RGV analytic hemodynamic instability as a …, it’s no problem, but we don’t think that’s going to commonly be the case. Most people don’t want another screen, they don’t want something else to learn, they don’t want something else to keep track of. So again, being a pure software solution, cloud-based, HIPAA compliant, high trust, we can push the results in near real-time in milliseconds into whatever screen you’re looking at already. So whether that is someone else’s central station monitoring, whether it’s just the EMR, whether that’s at the bedside on a tablet, or even in somebody’s bedside monitoring, that’s where we are ultimately deploying this solution. So we want to make sure that it’s right next to SpO2, right next to respiratory rate, right next to all the other physiologic indications that you need as a clinician to make an informed care decision.
Saul Marquez:
That’s great. So really, you’re taking ECG, pulling from it some very early indicators of deterioration as a result of sort of like the compensatory responses of the body to these things. So even before you’re hearing a monitor alarm, you’re seeing that something’s about to happen here, and it doesn’t take any additional sensors or capital. You literally just lay your AHI System, as you guys call it, to really give clinicians the insights to know what’s happening.
Andrew Malcolmson:
Yeah, absolutely right. And as I said, we’re not pushing the boundary of clinical science here. We’re actually laying on top of mounds and hundreds, if not a thousand clinical publications that testified to this being a viable, valid clinical approach to measuring, again, autonomic nervous system, compensatory drive, so that’s not the issue. The hard part was the four and a half years of clinically supervised machine learning, product development, training the model at the University of Michigan, where this was all … that got us to this place in the first place. So yeah, absolutely. It’s really easy to use. It’s really intuitive how it can be used, and the clinical outcomes are compelling. I’ll just share one sort of paper that we have available today and a manuscript that’s under development. We saw at the University of Michigan in their ICUs and in their stepdown unit, so telemetry in the PACU, over seven months we looked at every single rapid response event that occurred in those care areas where they had ECG on them because, obviously, they need ECG. And we saw and predicted the 111 patients that did have a rapid response call over 90% of the time by more than 24 hours in advance. So again, it gives you tremendous head start on understanding what interventions, if any, are necessary for these patients, because they’re at the earliest stages, again, of sepsis, of some type of circulatory issue of CRS. So it gives you time to do managed measured interventions or simply increase the level of vigilance on them using traditional vital signs. It’s really up to the hospital what protocols they want to deploy.
Saul Marquez:
Yeah, and look, there’s people behind these numbers, folks. 90% of all the results were caught 24 hours before. That’s your mom, that’s your son, or your daughter, and I mean, that’s your patient or your patient population. Think about catching things 24 hours before, and the impact that could have to the care journey of a patient could be really big, and the impact to their families, the impact to the economy, it’s all tied together. So it’s obvious, Andrew, that this technology is different. Why hasn’t it been leveraged before if it’s that good?
Andrew Malcolmson:
There’s a …, the science, and the sort of the clinical foundation has been long established. The, you know, I liken it to SpO2, in many ways, it’s a business you and I know very well, Saul, you know, and people who knew the value of measuring arterial saturation 100 years ago, forever ago, right, they all they’ve known, and there were ways to do it invasively or offline, right? Taking sample … It really was the advent of the theory and the principles of pulse oximetry, where you now had a methodology to non-invasively measure that. Well, it still took technology time to catch up to make that theory become a deployable medical device, and as it did, the rest is history, and now pulse oximetry is ubiquitous; it’s used everywhere in the hospital. We’re largely the same, as I mentioned. So people have been studying ECG heart rate variability, not just the delta T between peaks, literally, waveform analysis associated with ECG variability for 60 years, 70 years or so, and again have had the ability to do post hoc offline analysis, scrubbing through and cleaning up mountains of ECG data to say, in retrospect, this is what we saw. But it’s never been utilizable, as I mentioned, in real-time, and it’s really the advent of cloud computing, of data science, of our machine learning techniques, our signal processing techniques that transform this, this dream sort of measure into something that is actually utilizable on the clinical frontline.
Saul Marquez:
That’s fantastic. Well, look, we talk about things here on the podcast, there’s always a way for you to dig deeper, and in the show notes, we’re going to leave links to the paper that Andrew is talking to us about, as well as a link to Fifth Eye, so you can learn more, because it’s fascinating technology, folks, definitely worth taking a look at. You’re an entrepreneur, Andrew, and one of the fun things we get to do here on the podcast is talk about the ups and downs. So talk to us about biggest setback and what a key learning that came from that has been thus far.
Andrew Malcolmson:
Yeah, sure. So where does one begin to answer this question?
Saul Marquez:
… every day?
Andrew Malcolmson:
So, you know, quite honestly, I’ve been at Fifth Eye now for about nine months, and thank goodness, no major setbacks here so far. But I will talk about one that’s analogous, and, you know, you know well, you know, going back to, again, some of the stuff that we worked on back at Medtronic, right? I mean, we built an amazing team, built an amazing product that had remote monitoring capabilities, clinical decision support capabilities, all those sorts of things, and it was a great product then, it was a great product now. But what I really learned in that stage of my career and building that business and starting a business from scratch, was that the ecosystem is king in the end. I mean, the days of buying one product to solve one problem are over in healthcare. Everything is integrated, everything has to play nice together. Nobody goes it alone, especially on the digital side. So it’s one of the things that we’ve made a real priority, here, at Fifth Eye, is making sure that we did have the ability, as I described, to do a stand-alone, single-only shift, only deployment. But the reality is it’s much more powerful when it’s used in combination with the other systems that are already out there. So, in the end of the day, if no one ever sees our logo and no one ever knows what Fifth Eye is, but they’re using AHI on their central stations or in association with their ECG or their patch solutions to save lives and improve outcomes, but I’m fine with that. So I think that is it, it’s understanding that you need to play nice; you need to understand that it’s all about the partnerships and the ecosystem and making sure that everybody wins, and I think that’s what we’ve done here. So by following this approach, obviously, we win because we’re not really competing with anybody. We’re augmenting everybody. So our partners win, you know, the ECG vendors, the remote monitoring, Central Station … vendors win because now they have a very easy way to add more compelling feature functionality to their systems that they already have installed. We just literally can turn it on, so that’s advantageous to them, and obviously, both financially and from a value prop standpoint, clinicians win because they don’t need to learn something brand new. They now have this embedded in their systems, their protocols, their procedures they already have in place, and most importantly, patients who are …, because now, we have an additional insight in their caregivers, have an additional insight that can improve the quality of the outcome, reduce the risk of having some type of adverse event while they’re in the hospital. So that was my biggest lesson is, make it fit and make sure everything is seamless, frictionless, as cliché as that is, because if you’re not, you have, it’s a tough route.
Saul Marquez:
Yeah, it’ll cost you your business.
Andrew Malcolmson:
Yeah, exactly. Yeah, and again, it’s simple. There are many brilliant ideas that have come and gone. There are many brilliant people. There are many great companies that never survived because they couldn’t escape. They couldn’t overcome gravity. In most instances, so that’s really, our goal is it’s about these partnerships, it’s about these relationships. It’s about making sure that we fit into the ecosystem as unobtrusively and with as much value as we possibly can.
Saul Marquez:
Well said, Andrew, and a great lesson for all of us to take note of. It’s kind of like, I mean the analogy that comes to mind is sort of like the iPhone is the hardware, the apps that make the iPhone that much more useful, right, like this is the technology. What technology are you guys building that is going to help customers, health systems, physicians, caregivers, nurses, augment what they currently do. And I see Fifth Eye as a super powerful layer that people could take simple ECG, valuable ECG, and take it to the next level.
Andrew Malcolmson:
Yeah, no, I mean, what it does is it gives you the other side of ECG, right? ECG has always been a tremendously powerful, useful measuring tool to understand cardiac issues. You know, they have and, you know, these other sort of issues associated with cardiac patients. Now we’re transforming it so it does that, and now it does hemodynamics as well, right? So it’s a twofer in many ways. You use one sensor, and you can see sort of both of these macro types of issues that can help, that can hinder patients. But I think it’s all part of the, again, digital health transformation. I know digital health is kind of a throwaway term at this stage because everything is digital, and everyone’s just like AI, am I right? You know, people talk about it, even if you don’t know what it means. I think, though, what, going back to some of the things we’ve already talked about, there’s been a huge amount of technology, and we’re one more piece of that, digital technology that has been developed and deployed into these hospitals. Some good, some great, some not so great, but I think it’s important to understand as that there will be an inevitable concentration on this. There will be a convergence, so a lot of these technologies because, at the end of the day, people will want to have it, just as you described, their applications or their pick list of things that they can do on the primary solution set that they are using, so that’s one of the big things. And we’ve really, you know, tooled and built ourselves so that we will, whoever that ultimate platform winner is, which is again, it’s not something we’re attempting to do. We will never win that game. We will fit in, we will conform, we will be available on whatever those ultimate winners are in this certain digital health race.
Saul Marquez:
Will you be part of the intelligence that shapes healthcare? That is the question for you. And look, Andrew, you’re always inspiring these kinds of thoughts in me and hopefully in the listeners, too, and we’ve been talking a lot about technology, but what would you say is the one healthcare trend or tech that will change healthcare as we know it today?
Andrew Malcolmson:
So I think it’s partly that digital health piece, but I think the other thing that’s really going to be transformational, and we’re hearing this more and more as we’re on more discussions with hospitals and clinicians, is the move to hospital-at-home. I mean, nobody really wants to be in the hospital. I mean, it’s been a necessity. And so now as, the more and more these digital tool sets are available and deployed in the right way with the right clinical backup and the right level of monitoring, vigilance, and personalization, then more and more patient care will be done at the home. I think COVID accelerated that dramatically and there’s no going back, but now I think as more companies lean into that and deploy these types of approaches, then who wouldn’t rather be at home with their family when they have issues or who wouldn’t rather have some type of early, early notice of some type of potential future adverse event and walk into their primary care physician to have it assessed rather than call an ambulance and have you take you to the hospital? So I think that’s really going to change over time. We’re doing a lot of work now and just starting with oncology, and there’s a lot of these absolutely incredible immunological approaches that frankly I’m only learning about in the last couple of months. CAR T-cell therapy, T-cell engagers, these are all unbelievably, incredibly powerful for a wide range of cancer and will change cancer treatment as we know it in the not-too-distant future, 5 to 10 years. But again, all of those patients have certain risks of CRS or cytokine storm or sepsis, or other sorts of issues, so they have two choices right now. Number one, you can sit around in a hospital feeling fine in the event, you know, for a week or longer, just in case that happens so you can respond quickly, or you can go home and be with your family, have a wearable patch, have some of our technology continuously monitoring, but give you ample time that should you start to use a bit signs of that at the earliest stages, again, you can drive yourself to visit your oncologist and have additional work done to understand exactly what’s going on. So that’s the future of healthcare right there, and I think it’s probably coming faster than most people believe.
Saul Marquez:
Love it. Thanks for highlighting that. And definitely an entire chapter, another entire podcast in itself on hospital-at-home, so maybe we do a part two, Andrew, really appreciate that. Look, thank you for jumping on with us today. The opportunity to, look, do you guys want ECG to be more than ECG? do you want it to be cardiac output? Do you want insights? These are the show notes you got to click on. So don’t just listen, click below. But look, Andrew, give us a closing thought. Let us know the best place listeners could get ahold of you, follow you, and the work that you and Fifth Eye are up to.
Andrew Malcolmson:
Sure, yeah. So we’re obviously, FifthEye.com is, you know, you can get all the updates on us. We’re pretty busy on LinkedIn, and on Twitter, reach out to me directly, happy to have any conversation with anyone on this topic. I have a lot of passion around it and have been working on this for a lot longer than I’ve been here. And we’ll be, we’re actually going to start hitting some of the shows in the fall, so we’ll be at HLTH in Vegas in October, I believe, so yeah, come by, and another option, show notes are out there. So we’re headquartered in Ann Arbor, just a stone’s throw from Michigan medicine, where all these, our products are developed, and we have actually have a great solutions lab in our office. So if you want to come in, you’re in the Ann Arbor area, you’re at Michigan, then come on by, we’ll show you, because there we have demonstrations set up of, you know, … as a standalone as well as with running with some of our wearables, … partners, as well as some of our central station vendor partners. So you can sort of see it in all a number of its embodiments live and running real-time, and we’ll even put some patches on if you want so you can see it on yourself. So yeah, we’re there, we’re always keen to have visitors come by, so that’s always another option.
Saul Marquez:
Thanks, Andrew. And hey, by the way, if somebody wants like a demonstration at their hospital, could you do that?
Andrew Malcolmson:
Oh, absolutely. So we can do, given that it is a software solution, we can do demonstrations on Zoom. We can do demonstrations virtually. But obviously, if you want us to come by and have additional conversations, let us know. Also, given that it is a shopper-only solution, in many instances, we can run pilots on really short notice with almost no infrastructure adjustments or no from the hospital standpoint. So if you just want to kick the tires on this for 30, 60 days and you already have an ICU set up, we’ll just turn it on, and off you go. So again, it’s a really easy thing to deploy most of the time, right? If you have ECG already soaked up, if you don’t have ECG, and you need to put patches on the floor in the ED, other areas we’re looking at, then it’s a little more involved, but again, in critical care, in step down, in tele, it’s really straightforward …
Saul Marquez:
Well, thank you, Andrew. Then there you go, folks, like call Andrew, give him a shout, get him to set it up, he’ll have somebody on his team set you up. And if you’re in Michigan, stop by. But the truth is, they could do wherever you’re at. So Andrew can’t thank you enough for the opportunity today. Just appreciate the work that you do and how eloquent you are in speaking about it. So appreciate you visiting with us.
Andrew Malcolmson:
Oh, anytime, Saul, it’s great to see you again. And yeah, let us know when we can do this again.
Saul Marquez:
Sounds good.
Andrew Malcolmson:
Okay, take care.
Saul Marquez:
You too.
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