This week I am talking to James Mault, MD, CEO of BioIntelliSense (@BioIntelliSense), who started out as a Cardiopulmonary technician and found his path and career by way of a mentor, Bob Bartlett with the father of ECMO to become a Cardiothoracic surgeon. His early experiences drove his desire for more complete monitoring, closer to the experience he had in the Operating room with constant flow of patient data that drove decision making based on this wealth of data, but something that was lacking in the home care setting. An early pioneer in cloud based electronic health management and storage but ultimately bringing everything together to create innovation in the remote patient monitoring (RPM) where with BioIntellisense he has expanded the world of wearables and in home monitoring with medical grade sensors.
This culminated in foundation of BioIntellisense who offer effortless passive monitoring medical grade wearable and how they achieved this status to obtain FDA approval for a medical grade wearable (The BioButton and BioSticker) which is designed to be worn effortless to remote data capture for up to 30 days of continuous vital sign monitoring that includes respiratory rate, heart rate, skin temperature, body position, activity levels, and sleep status
Listen in to hear the journey to creation of these FDA approved sensors and learn how they approach the fundamental requirements to make the user experience effortless for the patient to capture data that is delivered in useable form to the medical team
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Raw Transcript
Nick van Terheyden
and today I’m delighted to be joined by Dr. James Mault. He is the CEO of bio IntelliSense. Jim, thanks for joining me today.
James Mault
Nick, thanks so much. It’s a pleasure, always been a pleasure.
Nick van Terheyden
So you’re an interesting guy, as many of the folks on my show are, but you’ve got a pretty incredible background with lots of experience that is highly relevant to the topic today. If you would just give us a brief insight into your journey, and some of the sort of key places that you’ve been and the things that you’ve done.
James Mault
Well, it’s been, it’s been, as you said, a journey and it’s, it’s been a dream come true for me. I started very early as a technician actually cardiopulmonary technician, working at the bedside, in the intensive care unit, had the benefit of an incredible mentor by the name of Bob Bartlett, who is well known as the father of of ECMO. So he inspired me to, to have crazy ideas and innovate. And so at a very young age, as an undergraduate students started building new contraptions for making measurements at the bedside in the intensive care unit, was fortunate to be able to, to go to medical school and and live out my dream of becoming a cardiothoracic surgeon, went to medical school at Michigan and then trained in general surgery, trauma, critical care, cardiac surgery, and then thoracic transplant and thoracic oncology at Duke University under another great mentor by the name of David Sampson. And that really was a foundation to come out to University of Colorado on the faculty where I practiced thoracic general thoracic surgery, thoracic oncology, ran the intensive care unit and the ECMO program and also did heart and lung transplants and, and along the way, you know, started a kind of a consistent clinical experience where, especially when you’re doing transplants, and you’d send people home from the hospital, in the, in the Colorado, arena, patients could be 500 miles away after their transplant, and the predicament of, of not having any information to to rely upon objective measurements, after sending those patients home really forced us to to keep patients in the inpatient setting for longer durations, you know, because there is no practical means of, of, of monitoring them. So this whole notion of remote patient monitoring, started driving my my interest and passions. Now more than 20 years ago, and I, I, at that time, decided to start a company that was the beginning of this whole journey of of building out platforms that can enable various technologies and data capture for remote patient monitoring outside of the hospital. One of those companies ended up going public and and then I found myself the CEO of a publicly traded company, made a little difficult to to keep operating and and doing transplants. So I went on what I thought was going to be a sabbatical from my clinical practice ended up being now a 20 year sabbatical. But that led me into another system that we developed, called the health buddy and the health buddy became, I think, one of the early prototypes for this new model of, of exception based remote patient monitoring. It was adopted by the VA system and then we launched a commercial program to be able to To buy literally a device online and, and have it delivered to your loved one, and then a nurse monitoring service that could track and monitor your loved one with various chronic conditions. That led into a an opportunity with Microsoft, where I had the the honor and privilege of being one of the principals in the creation of health fault. And, and 2006 2007 this notion of cloud based electronic medical records was, was actually something very new. Both Google Health and and Microsoft health fault. We’re, we’re very much the pioneers of, of this, this crazy notion of, of storing your your medical information. In this, this internet system, which there was a lot of kicking and screaming a lot of reluctance on the part of health systems to, to participating in something like that it was, it was in and of itself a tremendous learning experience that we can chat about. Ultimately, we, we succeeded and, and started another company. That was, again, a next evolution of this thinking for care coordination and remote patient monitoring called healthy circles, that ultimately was acquired by Qualcomm in 2013. And once again, found myself inside of one of the tech giants helping create a medical focus for, in that case, the wireless connectivity to the medical device industry. So this has been a kind of a, a looking back on it a curriculum of sorts that has ultimately brought us to where we are today with bio IntelliSense. And I think, kind of the, what seems to be the grand finale of all The scars and bruises and learnings along the way. And bio IntelliSense, I think is is it in an opportunity to, to be able to finally make or help make remote patient monitoring something that is ubiquitous, and I mean, truly ubiquitous in the sense that the simplicity, the the cost effectiveness, and the beneficial outcomes, can can finally be realized. And I’ll stop there.
Nick van Terheyden
So, you know, long storied career, obviously starting out in a very intense area of medicine that you know, demands a lot of data, but actually doesn’t get a lot from the patient that’s not on the table, when you’re on the table, you suddenly get this continuous, you know, available and see of data clearly sort of guided your process. Before we sort of talk about the background, tell us a little bit about bio intelli sense and what it is and what it does.
James Mault
Sure, great. So bio intelligence as I, as you nicely pointed out where we’re, as a cardiac surgeon, you’re spoiled by all the monitors and sensors we have not only in the operating room, but in the intensive care unit. And, you know, that affords us the ability to make life and death decisions on a minute to minute basis. We literally have the, the cumulative data stream from, from just 10 different monitors in the intensive care unit are generating about a million pieces of data per hour per patient. So that, that gives you the ability to, to, to be able to see what’s happening and to recognize, you know, trends and and problems and to be able to take action. Without information. It’s hard to take action. And so, you know, all of these circumstances is not just an issue surgery, but in the practice of medicine in general, is there’s a paucity of, of actionable data unless that individual is inside the four walls of the hospital or sitting in front of you, in your clinic. And so to bio IntelliSense, what, what these 20 years of, of scars and bruises I referred to, you know, there’s, there’s five fundamental learnings that have taken place along the way. One is, if you want to collect data from a patient, outside of the hospital or clinical setting, sending them home with a big box of equipment, is not likely to be fruitful. They, they didn’t go to medical school, to expect them to hook this stuff up, and tell them, we now want you to, to make these measurements on yourself, we want your family to figure out how to, to be the nurse even though they didn’t go to nursing school or medical school and make these measurements, it’s just not likely to happen. The complexity, the cost, the traditional remote patient monitoring systems were were just not scalable. And it wasn’t practical to, to be able to apply that concept universally. Because of the just the, the, the the lack of compliance and the the sheer complexity of it. So the starting point is bio intelligence set out to change that by making the user experience on the part of the patient. effortless. And and, and that’s not a, you know, an overstated claim if, if the patient is expected to make active measurements of themselves, that’s a burden that you’re placing that’s a reliance on on an effort that you may or may not be able to count on, especially if that patient is higher and higher acuity. So what we’re talking about now is, is something that I think was a big epiphany for, for all of us over the past decade. With the introduction of the wearables craze, you could finally put on a little device on your wrist, and without you having to do anything, it would start to measure how many steps you took. And you know, that was a curiosity. Everybody bought one, everybody started to learn how many steps do I normally take in a day. But we also recognized in healthcare that that wasn’t, that wasn’t going to cut it for what we need in order to actually take care of patients from a medical sense. So that brings us to the next dimension of what we’re doing about IntelliSense, which is effortless passive monitoring, using a new category of what’s now being described as a medical grade wearable. So now we’re talking about taking what we’ve learned from the fitness and an exercise wearables and upping the ante to say, we need, we need wearables that are passive and effortless on the part of patients. But they need to be able to measure in in medical grade terms, on par with the level of clinical accuracy and reliability that that we that we need to make life and death decisions. In other words, in the intensive care unit, we have to know that what were the numbers that we’re looking at are plus or minus at least better than 5%, which is what most medical devices are plugged in minus 3% is even better. And so and when we start talking about Remote Patient, monitoring Think of it in these terms in at least in the intensive care unit in the hospital, if the numbers aren’t making sense, you have the benefit of looking at the patient and examining them putting your hands on them, and saying, okay, you know, the the monitor says you have no blood pressure. But you’re sitting here talking to me and I can feel a pulse in your wrist. So you can you can apply some some pragmatic common sense. When you start talking about home monitoring, now, you’re not going to have the benefit of being able to physically examine them. So the burden of reliability and clinical accuracy is actually higher.
Nick van Terheyden
So for those of you just joining, I’m Dr. Nick the incrementalist today I’m talking to Dr. James mold, he is the CEO of bio IntelliSense, we were just talking about the technology, wearables, in fact, medical grade wearables, you touched on one of the points, you know, that pervades throughout the medical profession, but even came about when it came to stats, because as you were talking about that, I thought immediately of the 10,000 steps, this arbitrary number that was important. And the reality is for congestive heart failure patient that can barely walk in their home, getting 500 steps would be you know, a major positive whereas you know, for somebody that superfit 10,000, is probably just a walk in the park. So I think that gets to the point of, you know, the value of this constant availability of data is now it becomes reconcilable with the individual. And it becomes a reference point that we can refer back to say, oh, for this individual, these are the relevant numbers. And importantly, I think, you know, highlighting the issue of this medical grade element, and I think a great point, the fact that you can’t see the patient, this is somebody that’s outside of the hospital, so there isn’t that oversight. Tell us a little bit about the process of guessing to medical grade capabilities, because it’s not just our here we have a medical grade device, off you go, there’s more to it, right?
James Mault
Oh, very much. So. It’s, it’s not for the faint of heart. No pun intended relative to heart failure, but, you know, it it is a a very stark distinction. And, and mindful prospective decision
Nick van Terheyden
to,
James Mault
to build a company and a technology platform, that is in FDA terms, medical grade. And so you, you know, actually from a from a business point of view, as I, as I kind of culminated all of these these learnings over the past two decades and, and had a clear vision for what I wanted to accomplish with bio IntelliSense, I actually sought out and found a team of engineers and an actually data scientist who had been together working in the wearable space for the for the past decade. So there’s a tremendous body of knowledge and, and, and, and engineering know how I took that team and said, Okay, now, instead of consumer wearables for fitness and exercise, we’re going to pursue a medical grade wearable to to take care of and monitor sick people. And, and it really is a complete, you know, wholesales shift in culture. In discipline, you have to implement what are called quality management systems, you have to now document everything prospectively, specifications of what you’re going to build, then you have to build it according to that specification. And then you have to test and verify that what you build actually meets the specification. And this is all table stakes of what it requires to be an FDA registered medical device company. And and I’ve been building these companies serially over the past 20 years. And it’s been interesting The the evolution of, of, of, I would say, sheer sheer challenge and, and barriers to entry. In other words, if for good reason, it’s become harder and harder to, to, to get FDA clearance on new technologies and new devices and new medications, you know, because the FDA is ultimate responsibility is the safety and the and the outcomes, the beneficial outcomes of these devices and drugs. So you now find yourself having to do a host of things that cost a lot more money. So as a startup company, you have to have more capital than a consumer products company, in order to, to do the clinical trials to validate the accuracy of your of your device or the safety of your system, you have to do shock testing and heat testing and crash testing. And, you know, it’s it’s, it’s, it’s a, it’s an appropriate level of, of documentation and testing and verification and, and safety. But at the same time, you know, I think what, what you’ll see is on the other side of this, and what we achieved with our bio sticker, and now our bio button, medical grade wearables is, first of a kind, multi parameter, continuous vital signs monitors that are measuring minute to minute, heart rate, respiratory rate, temperature, 3d motion, sleep, body position, gait analysis, a host of parameters, all streaming out of a simple wearable device that’s about the size of a quarter, and being able to do so continuously for 30 days, on a single charge. So that the, the simplicity and the you know, that effortless nature, this is truly stick it on and forget it. And this is a bit of a holy grail, frankly, that that is about to, to open the doors to be able to send somebody home with a simple sticker, and be able to just continue monitoring them. In fact, now, there’s not a reason to, to hold them hostage in the hospital for an extra day or so. Because you’re, you’re uncertain about whether they’re ready to go home, you know, you’ll feel more comfortable sending somebody home, because of the fact that is so easy to keep monitoring them. And now this is the other dimension is the data science is you don’t want all this new data overwhelming clinical practice. So the other key aspect of this is to be able to have all this rich data now streaming to a cloud based analytics engine that can apply, what you just described earlier is is individualized parameters, and alerts and notifications that that are custom to that person’s baseline physiology that can then watch for meaningful deviations and negative trends or a deterioration and serve that up to the clinician, or the nurse case manager on a silver platter.
Nick van Terheyden
So all in all exciting times. Now suddenly, we’ve got continuous data that’s available in a simple to use format. And I think you can’t underestimate the challenge of getting people to, you know, connect up technology make it work. I’d love to know, you know what superpower you had in terms of solving the power problem to make it 30 days, that’s very impressive. You know, I set it and forget it for 30 days. That’s a whole host of data. And, you know, importantly you talk about it. I often say this, it’s never a data problem. It’s a filter problem. It sounds like there’s an accompanying cloud based distillation of that to sort of identify those elements that can now come out. And I think you went through that FDA approval process. So those are FDA approved devices, medical grades, so now available, and opportunities and to really start monitoring and get that Oh, our level type data continuous stream but also filter it in a way that’s really valuable. Exciting times, I think, you know, this is the next frontier and, you know, credit to 20 years of scars and pain and agony that you’ve obviously had through this, but to get to this point, so very exciting, you know, looking forward to seeing what kind of data comes out of it. Unfortunately, as usual, we’ve run out of time, but you know, appreciate you taking the time to talk with us today and share some of the journey in the learnings along the way. So, Jim, thanks for joining me today.
James Mault
Dr. Nick, always a pleasure. Thank you for having me. Very much. enjoyed it.
