Redefining Non-Invasive Wireless Patient Monitoring with Jeff Pompeo, President and CEO at Caretaker Medical: Audio automatically transcribed by Sonix

Redefining Non-Invasive Wireless Patient Monitoring with Jeff Pompeo, President and CEO at Caretaker Medical: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

Paul Grand:
Hey everyone, thanks for tuning in again. This is Paul Grand for the Outcomes Rocket MedTech Podcast. I’m excited to have you back with us for another great episode featuring industry leaders from across the medtech space. If you haven’t heard of me before, I’m the CEO and founder of MedTech Innovator, the world’s largest accelerator for medical technology. You can find more out about us at medtechinnovator.org. Look in the Show notes for a link to our website. In this podcast series, I’ll be interviewing experts, leaders in the medical technology industry, stakeholders who are working to improve outcomes. There’ll be a link in the show notes also to a post about this particular episode on LinkedIn. I invite you to join the conversation by following that link. Share your thoughts. Love to hear your thoughts on our company today and any ideas you might have. We’d love to hear from you, so look for us on LinkedIn. Now my guest for today is Jeff Pompeo. Jeff is a serial entrepreneur and investor, a board advisor with a proven track record leading, growing, and monetizing technology-driven companies across the full lifecycle of inception and funding to product and exit, product launch and exit. He has 30 years of success building world-class organizations and executing ideas to implementation hyper-growth strategies for FDA-regulated med techs, universities, spin-outs, tech company turnarounds, IoT businesses, and disruptive technology innovations. Jeff, as an undergraduate degree in computer information systems from James Madison University and an MBA from Virginia Tech, he’s on the board of directors for the Virginia Biotechnology Association and a board member for the James Madison University Center for Entrepreneurship. Wow, that’s a lot, Jeff. Had a great career.

Jeff Pompeo:
That’s a mouthful. Glad to be here. Thank you for having me.

Paul Grand:
Thank you. Welcome to Outcomes Rocket MedTech. We’ve got a lot to talk about, Jeff, especially, I want to make sure everyone knows you’re here in particular because you have made it to the finals for MedTech innovators, annual competition, and for those of you who aren’t familiar with it, we had over 1100 companies apply, 50 incredible companies that we selected for our overall program, including 25 who are part of our accelerator. And Jeff was part of that group, which means he was eligible for the finals and he made it to the finals. He’s one of five companies. Congratulations on that. So we’re going to use this time today to learn more about Caretaker and all the great work you’re doing, Jeff. Thanks so welcome.

Jeff Pompeo:
We’re excited and humbled at the same time. What a tough group to get through, so we’re happy to be here.

Paul Grand:
We’re happy to have you here. So let’s get into it. I want to start off just by going back and understanding a little bit about you personally. What inspires your work in the medtech industry?

Jeff Pompeo:
Great question. It was kind of a two-step process for me to get here. I was a big company guy. I was an executive at GE, so back in the Jack Welch era, some of your listeners may not even know who Jack Welch was, but a stalwart in the industry. So I grew up in big companies. I was the CIO of one of the industrial business units, before I got to med-tech, I had to get my first taste of entrepreneurship. And I was lucky enough to be in the right circumstances. I was the president of a joint venture between GE and Cisco Systems that push technology and IP-based standards into industrial environments. And that was my first taste of entrepreneurism. You know, instead of being siloed inside a big company launching a new initiative, but with the underpinnings of GE, and I just fell in love with entrepreneurship and the risk-reward, the autonomy, the idea that every day was a fresh, clean whiteboard to innovate new ideas. And so I left GE 20 years ago, twenty-two years ago, and I’ve just done a series of startups since then. First in the telecommunications field, then in the electronics design field, and the last decade in med devices. So it was kind of a two-step process for me to get here and what really makes me love this space, it’s the confluence of the three things I’m most interested in, which is electronics and software-based devices, very large markets and telecommunications and kind of riding the commoditization and pricing curve that cellphone-based technology has brought to bear, but bringing into heavy, cost-burdened and anti-change medical kind of industries to really drive quintessential change and change that really affects people in a meaningful way across the full continuum. That’s what really gets me up in the morning.

Paul Grand:
That’s great. It’s pretty much what gets me up in the morning too, Jeff. That’s really great. that’s something your personal drive. Let’s talk about Caretakers. So tell us the founding story at Caretaker.

Jeff Pompeo:
Yeah, it’s a great story, actually. I had just sold my previous startup, which was a handheld point-of-care ultrasound device, and did the obligatory one year of indentured servitude that comes along with an exit and was really looking for another chance to grow something from scratch and serendipity played a role. You know, I stumbled on to a few guys who had got a government grant to build wireless ‘is the soldier dead or alive’ detector type of technology, A DOD grant. And they had cobbled together a functional prototype, and I met with them and I met with them and said, well, why don’t we move this from, you know, a government grant driven innovation company into a real commercial company? And so we formed a new company around this, funded it, and then launched this technology to create an FDA reviewable with design history files following the model and not just trying to engineer to a grant, but engineer to a commercial initiative. And again, what got me juiced about it was, you know, I have what I call the mom test, right? If this is something that I think my mom would benefit from. If she gets up in years and has some health issues, then it’s something that really grabs my interest. And you know, the idea that noninvasively, we can monitor the health in real-time without inhibiting mobility and movement and be able to get early indications when things are going wrong before they happen. Well, you know, that checks all the boxes on the mom test for me in terms of where I want to invest my time.

Paul Grand:
You know, it’s really interesting because, you know, it’s a classic story of like that university or kind of early technology where, you know, it’s got a very focused particular thing that someone was thinking about in this case, you know, is the soldier dead or alive and then being able to go, OK, but this could also keep my mom, keep all of us healthy and really transform lives in such a bigger way. And that’s where they need, you know, the business leader to come in and help people think about that larger opportunity so I’m glad you got involved and that you found Caretaker. So let’s get a little more specific than on Caretaker and what particular unmet need does the product or your service address and what does the product do?

Jeff Pompeo:
Yeah, great question. So in its largest form, it’s a wireless, non-invasive vital signs monitor, right? But that’s a crowded space. There are lots of vital sign monitors. I mean, a Fitbit kind of does it. Really the secret sauce for us is we measure continuous beat-by-beat blood pressure. That is to say, we measure blood pressure every time your ventricle ejects blood. Why is that important? If you think about vital signs, almost all vital signs are measured in real-time, except one thing blood pressure. It’s still relegated to the seventy-five-year-old upper arm cup spot check. And the interesting thing about blood pressure, Paul is it’s changing all the time. If you were to stand up right now, your blood pressure would change in some cases dramatically or if you take a deep breath. And so to think that you can take one single measurement a couple of times a day and know that your blood pressure is healthy is a bit naive. Right? And if your blood pressure isn’t changing constantly, by the way, that means your arteries are like steel with no plasticity at all and you’re in some trouble. And so the chance to bring the one vital sign that isn’t monitored in real-time out of the spot check where there are blind spots in between readings where you don’t know what’s going on with the patient and make that real-time along with everything, all the other vital signs, that was compelling. And when I started talking to industry experts and KOL’s and some of the big global patient monitoring companies, they all told me the same thing. You know, continuous non-invasive blood pressure is the holy grail, but no one’s really figured it out yet. If you figured it out, everybody will want it. And that, to me, was the first sign that there is probably something really special here.

Paul Grand:
You know, it’s interesting because we’ve seen a whole bunch of companies working in this space, and I think there’s been kind of this ongoing discussion about like, yes, as you said, kind of hypothetically be great to be getting continuous blood pressure monitoring. And then the question is kind of what do you do with it and how does that change care? So let’s talk about value proposition specifically. Give us your version of the primary value proposition. Sum it up for us.

Jeff Pompeo:
There are really two main value propositions. One in critical care and one in acute care. In critical care, when you’re in the ICU or the PACU or surgery, clinicians know that not checking your blood pressure for five or 10 minutes, it’s a problem. I mean, there’s an old joke that said hypertension, high blood pressure, it might kill you eventually, but low blood pressure is going to kill you right now. If your blood pressure drops, there’s no blood. You’re going to be dead in a minute, right? And so in those high acuity settings, they already measure continuous blood pressure, and they do it with a gold standard called an A-line. They put an invasive catheter into your artery and then they measure continuous beat by beat blood pressure through that catheter. So it’s costly. It’s invasive. Sometimes you have to do a cut-down, which can be prone to infection risk, you have to take it out every two days and put another one in, and so the value proposition in those settings is we do that same thing, including the waveforms non-invasively, literally in 30 seconds, you put a finger sensor on the finger and push go and you’re measuring that same continuous beat by beat blood pressure without any invasive catheter. That value proposition is very clear. You know, it hits all four of the range. It’s better for the clinician in terms of simplicity, ease of use, get it up and running quickly. Better for the patient, obviously. No invasive catheter, way lower cost, and far fewer complications, which implies better outcomes. In acute care, it’s a different value proposition there, and it’s about not being misled by a spot check but to get, I think, the future of blood pressure, Paul is going to be kind of like an ECG where the clinician will say, go get me a strip of blood pressure. In other words, go give me one or two minutes of continuous blood pressure so I can get a baseline of some changes instead of a single point in time measurement, which may or may not be accurate. I think that’s the future outside the hospital.

Paul Grand:
Yeah, I think that makes a lot of sense. Does this technology also have a place outside the hospital in the home? You know, where else might we find it?

Jeff Pompeo:
Yeah. Right now we’re trying to focus on high acuity critical care. And in fact, we’re one of the very few FDA-cleared, beat-by-beat blood pressure monitors. But we require a prescription so you won’t pick us up at the local drugstore for thirty-nine dollars like you might some other upper arm cuff. We require a prescription because we’re trying to go after the people who are really ill and can benefit from beat-by-beat blood pressure. A guy like you, Paul, you look athletic, you look very healthy. An upper arm spot-check once a week is probably sufficient for you. It’s the people who are fighting comorbidities or undergoing a therapeutic, where a dramatic change in blood pressure might mean a change in the therapy or it may be taking intervention sooner rather than later. That’s the population where the beat by beat continuous monitoring really, really applies,

Paul Grand:
And it makes a huge amount of sense from a perspective of someone who is going to have, as you said, you know, I’m in pretty good shape, you know, I’m not going to wear this, you know, the cuff and the device on my wrist every single day the same way, maybe that I’m wearing my watch right now or something else. But having a spot check that gives you a period of time makes a ton of sense. I know the device is pretty comfortable to wear as well, too, so that that certainly makes a big difference. And again, the idea that you can do this in both high and low acuity environments, I think that’s really exciting and I think that’s something that is going to add a lot of value. And maybe most importantly, when we’ve looked at other technologies like this, the thing that people always tell us is, Oh, it’s got to be as good as the A-line. As you mentioned before. You know that existing standard of care, it’s got to be as good as that. Is this technology, as good as the standard of care?

Jeff Pompeo:
Well, the truthful answer is almost our correlations are in the low 90 percent, which is fantastic. I mean, we’re measuring a non-invasive low pressure outside the finger with a catheter. You know, the gold standard is a catheter inside the artery connected to the artery wall. So you know, the KOLs will tell you any kind of correlation in kind of the eighties and up is pretty good because the patient populations that are going to benefit for us are the populations where there is concerning hemodynamic change going on. So sleep disorders during a sleep study. A dialysis intervention. Infusion oncology drips where you’re manipulating the hemodynamics of the body and you need to know in fairly real-time, am I in trouble or am I OK? We’re not the worried well and the Fitbit users, that’s not our population. So you’re not necessarily looking for empirical values. Whether your blood pressure is 150 over 90 or 153 over 92. There’s no difference. It doesn’t matter. It’s the directional trending that matters. Is my BP trending towards a hypertensive event where I’m going to need a vasopressor or an isotope or something like this, some sort of intervention? Or am I relatively stable to my baseline? Remembering also that everyone’s baseline is different. Not everybody is 120 over 80. So what I want to know is how am I doing in real-time relative to when I started with my baseline? That’s what matters in clinical settings.

Paul Grand:
That makes a ton of sense because again, it doesn’t have to be, as you said, exactly the same as the invasive technology. As long as you’re able to pick up those same trends, see it over time. You know, that’s what I think the correlation is what we’re all looking for. So that’s great. Thanks for letting us know about that. I know you’ve been developing this technology for a while. It’s not always something that just goes completely smoothly and everything works perfectly. There are always setbacks along the way. There’s always something that took a little longer or was a surprise or something that didn’t work. Is there something you can share with us, a setback that happened along the way, what you learned from it, and how you adjusted to it?

Jeff Pompeo:
Yeah. Well, I guess the easy answer is, you know, this entrepreneur thing number one, it always takes more money than you think, number one. Number two, it always takes more time than you think, but specifically for Caretakers. So our whole strategy was to be super-efficient in our use of capital and bring a minimally viable product to market as fast as we possibly can so that we could learn and validate our assumptions. And so that’s what we did. And so the thing that really pushed us to the edge was the design of the finger sensor. We grossly underestimated the difficulty of that. Fingers come in many different sizes and shapes, and some look like a cone. Some look like a pyramid. So we spent a better part of a year doing nothing but working through designs for what ultimately became our one-size-fits-all finger sensor, so the amount of engineering time and money it took to get this done is I’m almost embarrassed to tell you what the number was. But you know, we spent all of our time on the algorithms, the artificial intelligence algorithms, the circuitry, the software and thought that the finger sensor would be the easiest piece. And it turned out the opposite was true.

Paul Grand:
Funny, right? You should always, always plan for things that you thought were going to be easy to be hard. That’s probably a good takeaway from everyone is listening to this, that little thing. And you’re like, Oh, yeah, that’s not that big a deal. We’ll put that in. That’s going to be easy. We’ll come tripping you up. So that’s good. That’s good for us to hear about Jeff. But I know you’re also working on your second-generation device and getting closer to the FDA approval for that. I’m excited to hear about that. Please tell us about the second-gen device and FDA in that process and anything else that’s exciting to you today.

Jeff Pompeo:
Oh yeah, thanks for the opportunity. We are so excited. And I guess, Paul, this is a scoop, right? So I’m announcing for the first time publicly, we actually have received, you know, just in the last couple of weeks, FDA clearance, 510k clearance of our next-gen hemodynamic monitor, which we’re calling Vital Stream. So the Vital Stream uses the same core technologies and AI algorithm sets, but it’s in a much smaller, easier-to-use form factor that is up and running much faster. In 30 seconds now, put the finger sensor on and you’re up and running and measuring, sending data either to our cloud or to another monitoring platform. So we’ll be announcing that in a press release next week. The general availability of it, and we’ve got some expanded claims too in addition to continuous beat by beat blood pressure, which was cleared. It’s also cleared for advanced hemodynamics. So those are things like cardiac output, stroke volume, left ventricular ejection time. Again, things that the consumer market is not going to be interested in, but the hospital-to-home market or the COVID sequestered monitoring or the PACU step down, the E.R., ambulatory transport, very much interested in those advanced hemodynamics so that they can inform fluids and resuscitation and other really quick emergency kinds of decisions.

Paul Grand:
Yeah, that is exciting. So you’ve heard it here first, folks. We got the scoop on the FDA clearance. Thanks, Jeff, for giving us the scoop. I always like that. But more importantly, you know, the idea that you’ve taken the learnings from the first-gen, you’ve put into the second-gen, you’ve got that one also approved. Now that’s a big deal. And also is this device disposable, the second generation device? Is this something that people take home or use in whatever setting? And then that’s it. You don’t have to sterilize it and reuse it, or there’s a big CAPEX component. Tell us about that.

Jeff Pompeo:
Yeah, great question. So the wrist-worn device that has the touch screen and the radios and the electronics that send it to the sky or the cloud, that’s cleanable. So aseptic wipe recharge it. Get it ready for the new patient. The finger sensor is disposable, so, you know, put it on the patient. They can wear it, you know, one minute or one day or one week. But it’s really about infection control. So rechargeable, reusable electronics piece and then consumable disposable finger sensor. Again, getting back to how difficult that finger sensor was to design so that it was low cost and disposable.

Paul Grand:
Yeah, now that is a big deal that those economics I know are very important, especially if it’s something that people can be using a lot in the health care settings. We’ve got to make sure that these devices can be easily reused if they’re reusable and if they’re disposable, that, you know, the economics all make sense. So that’s great. So thanks for sharing that. So we’ve had a chance to go through a lot of the story here, Jeff, and hear quite a bit about the product, how it’s going to be used, how it’s going to be different than what’s out there. Before we conclude and wrap up, I’d love to hear any closing thoughts you might have in general, something you want us to leave thinking about when we think about caretaker, what should we be thinking, and then also let us know where the Outcomes Rocket listeners can get in touch you with? Whether that’s LinkedIn or what’s the best way to find you if we’re interested in learning more?

Jeff Pompeo:
Yeah, great. So you know the vital stream. What I want everyone to know is right. We’ve been known as caretaker, and that’s the name of our company caretaker medical but the product now is taking a divergence name. And so the product is called Vital Stream, mainly because we think it’s a much better at-a-glance illustration of what the device is doing. It’s streaming continuous beat-by-beat vital signs. So that’s the thought behind the term Vital Stream. And so there are a number of products out there that claim that they’re wearable that measures blood pressure. I’d encourage clinicians to read the FDA’s IFU and find out really very, very few of them are FDA-cleared for continuous beat-by-beat hemodynamic measurements. That’s where our secret sauce is. That’s where our pulse decomposition analysis technology and AI algorithms are different than anyone else. That is ICU grade and which allowed us to get that FDA clearance when so many others have struggled and had to settle for spot check blood pressure. So we’re about wireless, we’re about continuous and really finally, we’re about taking that ICU-level quality of care and moving it across the full care continuum. It doesn’t matter whether you’re in the ICU or the O.R. or the E.R., if you’re ill, spot check blood pressure monitoring leaves blind spots where the clinician has to guess what’s going on or not know, and that’s because it’s been so difficult and elusive to get Now any bed can be a telemetry, any patient can be a telemetry patient. Any patient can put this vital stream on and get beat by beat measurements and hemodynamics from the point of trauma through the ambulance ride to the E.R. and triage to O.R. step down and then remote patient monitoring at home after discharge, all with the same workflow, the same tools and a familiarity that the patient has with the same device at all points of care. So that’s what we’re super proud of. We’ve got big plans. We’re not done here. We’ve got a whole nother set of hemodynamic parameters that we’re building on top that will launch, I hope, next year again. So so don’t blink or you’ll miss something. www.caretakermedical.net is our website. I’m happy to speak to anybody on LinkedIn or email me at jeff@caretakermedical.net. I’d love to talk with you.

Paul Grand:
Hey, thanks, Jeff. So fantastic way to wrap all this up. I can tell you everybody that we’ve looked at a lot of these kinds of technologies, and this is special. You know, what you’re going to see with Vital Stream is different. It’s special. This is the kind of technology that has the profile that would allow it to do exactly what Jeff is saying to be there for the whole journey, for the patient. From the time that you’re in an ambulance or you’re admitted to the time that you go home and you’re recovering, you could have that vital stream streaming your vitals the whole time. And I think that’s what gets everybody excited when we think about Caretaker and Vital Stream. It’s that you really have a device now that can follow the patient all the way through that journey and make then an impact on their care, get them out sooner, monitor them more efficiently. You know, that’s what we’re all looking for. And as you said, you know, where is the spot check might be good for me, for someone who’s critically ill, you know, there’s no room for spot-checking. We need to have these things continuously measured. So very exciting technology. It’s going to add a huge amount of value. And I’m just so happy that we had a chance to come across each other and for you to be accepted to medtech innovator and of course, to have made it to the finals. So good luck with that and thanks for being such just a great part of our ecosystem and a great innovator. So thanks for that, Jeff.

Jeff Pompeo:
Thank you, Paul. I’m so grateful to be included and I’ve got to say props to you. I was a little suspect of the accelerator being completely virtual, I must say in this day and age of COVID. But I don’t think you’ve missed a beat. I mean, the value we’ve received from the webinars and the people, the experts you’ve brought to bear, everything from reimbursement to strategy to partnering is just been unbelievable. So I really appreciate the opportunity to participate and we couldn’t be more excited than ever to be in the finals.

Paul Grand:
Well, it’s very nice of you to say. I appreciate the feedback. As you know, Jeff, we take it to heart and we want to make sure we’re delivering the best experience we possibly can. I’m thrilled that we’re going to have an in-person capper on our virtual program this year and get to have you in the finals live there in Minneapolis. That’s going to be really terrific at the MedTech Conference by Adva Med. So that’s going to be great, as you said, you know. It’s tough to do these things virtually and do them well. And, you know, we work really hard at that so I really appreciate those kind words. So. Thank you, Jeff. All right, so that’s our interview today with Jeff Pompeo, a really inspiring guy, someone who again, I want to make sure you knew how to reach out to him because he’s someone you want to know. From the first time I talked to Jeff, he said, Hey, you know, you got all these great companies. I love sitting on boards. I’d love to advise people. I love helping out other entrepreneurs, and he’s really walked that walk. I’ve watched him do it during our program. He’s been great in terms of providing resources and advice for other entrepreneurs. So I encourage you. Look Jeff up on LinkedIn, find him. You know, he really is as I said, he’s walking that walk, not just talking the talk. So that’s our interview for today. Let me wrap up here by saying that again, Paul Grand here on the Outcomes Rocket MedTech podcast. We’re doing these episodes as often as we can, sometimes at least once or twice a week so please keep tuning back in to the Outcomes Rocket. You’re also going to get to learn about other areas of the medical industry. So we’ve got a show on the nursing industry, so you’ll learn a lot about nursing innovation. We have a show on the pharmaceutical industry, can learn what’s happening the latest in pharma. Health tech, we have a dedicated show related to health tech and of course Saul Marquez’s Classic Outcomes Rocket looking at all of just the general innovation that’s happening again to improve outcomes in health care. So I encourage you to tune in. I encourage you to keep coming back. Make sure you look for us on LinkedIn so we can join in the conversation together. Just look up Outcomes Rocket. You’ll find the company listing and you can look at the activity and join in the conversation. That’s it for today. Hope you join us again next week and hope you have a great time today and whatever else you’ve got on your schedule for today or tonight, whatever’s left. I hope you have a great day. Take care of everyone.

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