Personal ECG - Creating a New Product Category
David Albert is a physician, inventor, and serial entrepreneur. He is the Founder and Chief Medical Officer of Alivecor, the leading company in personal ECG technology. He has founded 5 companies, and sold two – one to Arrhythmia Research Technology and one to GE which he joined as Chief Scientist of GE Cardiology. David has 32 issued US patents and has authored or co-authored over 50 scientific abstracts and publications. In this episode David shares what makes ECG such useful tool, how the idea for personalized ECG came about, ECG regulatory strategy, technology development, the importance of robust clinical data, and the challenge of managing massive amounts of data.
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Episode Transcript
This transcript was generated using an automated transcription service and is minimally edited. Please forgive the mistakes contained within it.
Patrick Kothe 00:31
Welcome! The electrocardiogram or ECG is one of the most recognizable and useful tools we have for identifying and tracking cardiac issues. For decades, it was used exclusively in hospitals and clinics, then made its way into the ambulatory setting with Holter monitors, event recorders and then mobile cardiac telemetry. All of these use cases had one thing in common. They were administered and controlled by the physician in 2010. That changed, with patients becoming more involved in ECG testing, and then ownership of the ECG device. Much of the reason for this change is due to the imagination and ingenuity of our guest today, David Albert. David is a physician, inventor and serial entrepreneur. He's a founder and Chief Medical Officer of AliveCor, the leading company and personal ECG technology. He's founded five companies and sold to one to Arrhythmia Research Technology and one to GE, which he joined as chief scientist of GE cardiology. David has 32 issued US patents, and has authored or co authored over 50 Scientific abstracts and publications, principally in the cardiology literature. He earned his undergrad degree from Harvard, and his medical degree from Duke. In our conversation, we discuss what makes ECG such a useful tool, how the idea for personalized ECG came about ECG regulatory strategy, technology development, the importance of robust clinical data, and the challenge of managing massive amounts of data. Here's our conversation. David, welcome to the mastering medical device podcast. So happy to have you join us. Thank
David Albert, MD 02:33
you for inviting me.
Patrick Kothe 02:36
Dave, we're we're gonna have a really fun conversation about all things ECG and your journey and in building a very successful company and kind of changing things within the industry. But I want to start off someplace different. I've seen you on convention floor drop in put out sets of push ups before telling you about your, your, your relationship with exercise, and how it's, it's been instrumental in your life.
David Albert, MD 03:06
Well, exercise and fitness have been integral in my life for a long time. As a small guy, I'm five, five 132 pounds, a BMI of 22. It's a good one at age almost 68. I was a two time high school all American wrestler. And then I was a four year division one wrestler, and I went to the US Olympic trials in 1976. So maintaining weight, working out lifting weights, exercise, were just a part of my life from about age 10. There's a period in my life where school and work would intervene, but always, you know, whether it's in medical school, or afterwards or in my business life, my medical career, exercise was an escape. And I knew, and today we know even much more than I knew 40 or 50 years ago, about the benefits of exercise. It is the easiest to do drug you can have whether it's walking, and you don't have to, you don't have to do 65 Push ups on my 65th birthday that I did. You don't have to do 20 Pull Ups, you don't have to do any of the things I do. But you need to stay active. You know, there was a story recently about a study that said, if you can stand on one leg for 10 seconds, you aren't at a very significant risk of dying, whatever your age is over the next year or two. And that's just means, you know, people who become frail, as they age, we all lose our testosterone goes down and we lose muscle mass. It is a struggle to maintain that well that means mobility and if you don't have mobility, you are frail, and we've seen lots of people and so the notion Is I can't stop aging, there's only one way to stop aging and that is to die. So what I do is I fight it. And and I practice what I preach. And I preach health and fitness. I preach controlling your weight, your blood pressure, your blood glucose, your serum lipids, and so I have to live that myself. It's just part of my life. So that's where fitness and exercise fits in. For me, it is simply part of my life. And it's, it's, it helps me deal with all the other stresses of life.
Patrick Kothe 05:37
It's a fantastic thing that a lot of us would like to do, but have not been as diligent as you have, like you. I was a college athlete, I played football. But my weight has gone up and down throughout the years. My my passion for exercise has gone up and down throughout the years. I've never been able to do it consistently. What is it about it, that you've been able to be so consistent?
David Albert, MD 06:06
Well, you have to put it into your lifestyle, you know, changing your lifestyle on a long term basis extremely hard. My eldest son is a doctor named Dr. Michael Albert, and he's a very well known obesity expert trained at Cedars was on the staff there. And as he said, You know, when people go on a diet, what they understand is that diet is very short term. You know, there's no such thing, you have to change your life, if you change the way you eat the way you approach life. And that's the same thing for exercise. There are examples of people who change their lives, but they're also examples of the Biggest Loser where they can go through an amazing process with a coach and everything. And look at him three years later, they're back where they started. And that's because it's very, very hard. There's a lot of psychology in it. It's very hard to do that. And so, you know, today we've got some very exciting new developments. Manjaro is this latest drug from Eli Lilly would go he was the one from Novo Nordisk these two drugs are amazing, in that they were developed to treat diabetes, type two diabetes. What's the problem? Well, they had a major side effect, they helped you lose 20% of your body weight. So your lipids went down, your blood pressure went down, and oh, by the way, your diabetes got better. And this new, the new one Manjaro. I mean, I heard my old college classmate, Jim Cramer say this is this could be a $50 billion drug, it's an injection, but people lost 20% of their body weight. That's the kind of sustained weight loss that only comes from bariatric surgery. And so you know, the cost of these medicines is very high. So there's a barrier for them right now. But that's going to help people because it impacts the brain, the brain is what controls you know, I want to go out and do a walk or I want to go do some calisthenics, or I want to go lift weights, or I want to go on the treadmill. Well, what's keeping you from doing that as your brain is your mind. And so I want to eat these cookies. No, I don't want to eat these cookies, I'm gonna eat this apple, that's also in the brain, or I want to, you know, I'm good with the small plate of food, I have a say at tea is, is again in the brain. And so these, these medicines are going to be revolutionary. And I think they're going to help more people because we have an epidemic, you know, we've had a global pandemic for two and a half years. But we have an ongoing epidemic of obesity, which leads to heart disease, and we can talk about EKGs and electrocardiograms. And it leads to diabetes. And it leads to all kinds of other problems. And ultimately, as people get older leads to frailty, and what I call early mortality, because we're all going to die. My goal in life has been to help people not die before their time. And that's, you know, in the era of cardiovascular medicine, we have a lot of tools today, to try to help people not died before their time, the one we were probably least effective at is changing their lifestyle and getting them to live healthier, but it's the one we need to put a whole lot more focus on as a country as a world. I try to lead by example.
Patrick Kothe 09:33
Let's have a fantastic way to start this conversation. But let's get into something else that's been consistent in your life, and that's ECG. So ECG is something that you've devoted a great deal of your career to. And to get get this kicked off. I'd like to talk a little bit about what ECG does for us what it is and what it does for us because all of us know about it, but we don't know the interest The intricacies of exactly what it what it's doing and what it's able to measure and assess. So can you give us that that broad version of what ECG is all about?
David Albert, MD 10:11
Yeah, certainly, you know, everybody who watches, TV medical shows or movies, sees the patient in the intensive care unit with the, the waveforms and the beep, beep beep going on, as as their family or friends are watching over them. The electrocardiogram is simply a body surface measurement of the electrical activity that controls the pumping of the heart. Your heart is an amazing organ, in that it works. We're mostly unaware of its effort. From the day you're born, actually, before you're born when you're in utero. To the day you die. Your heart is pumping in the background without taking much of a rest. It rests every beat, but it doesn't stop for 10 minutes and take a siesta. And so the electrical activity of that pump is manifested on the body surface as the electrocardiogram and over the last 100 So years. The Dutch physician inventor Dr. Vilhelm, Eindhoven in 1924, won the Nobel Prize for Medicine and physiology for the first practical electrocardiograph, and people have seen the picture of, of this huge gizmo look like a Rube Goldberg thing with a man sitting there with his two arms and left leg in buckets of saltwater. Those were his electric conductive electrodes. So what we've learned over this last 100 years, what we know now in great detail, is by monitoring by measuring this surface electrical activity, we can know a lot about the functioning of the heart, its performance, its status, and your health. And what we all know is, is if that heart does take a rest for five minutes, well, you're dead. So it can't, and, and it works like a metronome, very regular beat, beat, beep that beep you heard on TV. And if that cadence, that rhythm changes, it can signify something very bad, or something not so bad. And so today, you watch TV, you see ads for drugs like Xarelto Eliquis. For atrial fibrillation not caused by a heart valve abnormality. You might even see an ad for cardio. And what that is, is atrial fibrillation is an abnormality, the most common abnormality of the heart rhythm. And, and it can have some very serious consequences, including it's a significant cause of of a major stroke. And so, you know, Xarelto Eliquis are what we call what people call blood thinners. They're anticoagulants so that the clots that cause stroke don't occur when atrial fibrillation can potentially cause them. But we live for sell our cardio devices to monitor and allow people at their home anywhere in their car at dinner, to record their electrocardiogram. And if they want to send it directly to their physician or another cardiologist to have them assess it if they think there's a problem. And so this notion of a personal ECG now, we know that companies like Apple and Fitbit, Google and Samsung, you know, I have to say I'm fairly proud followed by lead, you know, the person electrocardiogram is now a common thing, and available from a number of vendors and we live where we're simply the pioneers. We've continued to innovate. But, you know, basically, the ECG is our ability to look into the functioning of a heart to look into that electricity that controls the pump, and you know if the electricity goes or if the pump goes wrong, so that's it in in a nutshell,
Patrick Kothe 14:08
and you're looking at you talked about metronomic. Yes and no, it is very regular, but you wouldn't want it to be exactly the same at every beat, every beat is going to be a little bit different because the heart needs to have the ability to compensate and to make changes and well
David Albert, MD 14:25
you're absolutely right. So we there's something called heart rate variability. There are a lot of devices and uses for heart rate variability that have to do with by the way fitness and exercise, relaxation, heart rate variability is that variability from beat to beat in the timing of the of the beating of the heart, and it can change with exercise with fitness. It can change you know, today, many many serious athletes, professional athletes monitor their heart rate variability using a whoop band or or some other kind of device. Because we now know that if you train too much, your heart rate variability is gonna go down. Okay, it's going to be reduced. And that means you need to, you know, rest, you need to recover. And so it's it's your right body is a system of, of compensation. It has the yin and the yang, the sympathetic and the parasympathetic nervous systems that both work in concert to speed it up, when you need the heart to speed up, like you're running up the stairs, or you're doing something vigorous, or to slow it down, when you get in bed, and you want to go to sleep, and so that Ying and Yang are manifested by this heart rate variability. And you're right. You don't want it to be exactly like a metronome.
Patrick Kothe 15:46
So you mentioned when I'd joven did the original work 100 years ago, there's been evolution of ECG, but most of that up until about 2010 was in the office. Most of it was done in the hospital, in physician's office in a controlled, controlled environment. 2010 something really interesting hit, there was a very interesting video that that came out, walk us through your what was going on in 2010.
David Albert, MD 16:24
The story actually starts in 1995 1995, I had started a company called data critical. And ultimately, we went public in 1999, and 2001, GE Healthcare acquired data critical, but in 1995, I had an idea. It was the early days of portable computing, Palm Pilots, HP palm tops, and the earliest days of wireless data communication. We didn't have 3g, we didn't have anything, you had these dial up modems and an analog cellular, it was very early. But I had this idea that since the shortest distance between two points is a straight line. And the ECG is critical biometric information that can that can be used to save a person's life, that if a patient could record their ECG anywhere, and send it directly to a cardiologist, that that would be a good thing. And so actually built a prototype using all these various different devices, cell phones, CO, P CMCA. Cars, that's something you haven't heard in a long time.
Patrick Kothe 17:28
They come with a floppy foam
David Albert, MD 17:30
top, a palmtop, computers, etc. built something actually got a 510 K actually got a patent issue. And we call it rhythm stat XL, however, it never was commercialized, because literally, it was a Rube Goldberg. It had cables and a cell phone. And it was an idea for which the technology was not ready. And in Silicon Valley, there's an adage to be earliest to be wrong. So that never got commercialized 2007. The famous Well, one more thing is, as Steve Jobs walks off, and comes back in and says, you know, we had Apple, we're working on internet, communicator and email, device and a phone. And then he introduces the iPhone, we couldn't do anything, then there was no app store. There's no development. But 18 months later, there was an app store, you could write apps for this new device. And so together with a couple of partners of mine, we built a case for an iPhone that had electrodes on it that could record your ECG. And on December 14 2010, which happens to be my birthday, I received a box with about 15 prototype cases from a manufacturer in Hong Kong that we visited. And then on December 30, by the way, I was headed off to my daughter's college graduation from Harvard, she was graduating in December. And so we hit it off. But then on December 30, I went into my office, and I was going to make a video and send it to about five people because the next week was the Consumer Electronics Show. And I had this cool new device. And I wanted to show it to a bunch of people. But there were four or five companies that weren't going to be there. GE was one of them, were going to be there. And I had shown them a prototype in March of 2010. And they said, Well, you know, they that's kind of a toy. It's nearly not a medical device. No patient is going to pay $99 out of pocket, no Medicare age patient. No doctor is going to interpret that ECG without getting reimbursed and you don't have a CPT code. So I shook my head up and down. Okay. Uh, by the way, they just took a board seat made a major investment in a lot court. They said you were right, Dave. You're right. You don't skate to the puck, skate to where the puck is going, you know, and at least I had that. So on December 30. I walk into my office with this prototype, and I'm bringing up my kid Camera. And my nine year old son, who himself is graduating in December from Harvard, taught me how to do a YouTube video and uploaded because he did Nerf gun videos, modifications, Nerf guns, you know, extra power and stuff. There's crazy. And so I did it. And as I was, I'd finished this video unscripted, doing a demonstration. And as I was getting ready to upload it, there was a button that said, Send a link to your LinkedIn connections. Well, I had maybe I don't think I was even on Twitter. And, you know, Facebook was my family. But I had two or 300 LinkedIn connections at the time because they were business people and medical devices, G HP people I'd known Medtronic, etc. And so I don't know why I did. But I clicked that button. I hit Upload, and uploaded. I went home. The next day was New Year's Eve had a date with my wife, I remember it very well. And I get home New Year's Eve, and my partners who are in Australia, they'd already had their New Years of it. Also, at about one o'clock in the morning, I get a phone call. And I go, Bruce, mate. What did you do? I go, What do you mean, what did I do? He said, You uploaded the video? I said yeah, I'm going to CES was that this was Saturday, the next day Sunday. He says with 250,000 views of that video. I said what?
Patrick Kothe 21:30
Viral before viral was a thing
David Albert, MD 21:32
I had not looked I had no idea. You know, again, a viral video viruses to me were bad things I have this. And you know, I was later called by the producer of Good Morning America, Fox and Friends. Everybody wanted me on their show from Las Vegas. And I had hundreds I got GE called me a fruit company out of Cupertino called me everybody wanted to come and see this thing. There were people on YouTube, hundreds of 1000s of views and people saying this is fake. This is not real. And my nine year old walks up to me as I walk in the front week goes Dad, you've made it. What do you mean, I've made it? He said, You know you've made it when you have YouTube haters. And I had YouTube haters. So you said you know you've made it dad, when when the haters come out. And then you know, three weeks later, Eric Topol calls me and he says, Dave, I gotta have one of these things. And I go, Eric, nice to meet you. I didn't know Eric, at the time, we're now good friends, he takes the thing and diagnosis a heart attack on an aeroplane and puts us in his first book, and then puts us in all his books. He's a vision guy, and he saw the potential to empower patients, the patient will see you now, deep medicine. You know, these are his books, the democratization of medicine. These are all themes that he's been a huge supporter of. And in that way, he's been a huge supporter of a live course. So, you know, after that, to be honest with you, venture capitalists came to me, I didn't have to go to them. And a live course started and, you know, for for a number of years in 2012. Really good friend of mine, who also has been an early supporter, Dr. Leslie Saxon, who was the Chief of Cardiology at USC Medical Center as a close personal friend. She invited me to the heart failure Society of America, and I got up to speak about this new personal ECG technology. And for those who know, the chair of that session was this guy named Dr. Eugene brown Wald, and I was smart enough to bring my heart disease books, which he autographed. He was sitting right next to me. And after my talk, there were questions this one guy raises his hand stands up goes, Dr. Albert, that's just one lead. That's not a 12 lead ECG. What value is that? And I have to say, that I had prepared. This was like John Kerry saying, I knew Jack Kennedy, Jack Kennedy. Kennedy, you know, he he had that one ready, when Dan Quayle. And I had it ready. I said, You're right, sir. But how many leads does an automatic external defibrillator or an implantable defibrillator need to decide is going to save your life and I pointed at him, and he just sat right back down. Because of one lead ECG is not a 12 lead ECG, but it has a tremendous amount of valuable information. It can tell you if you're an AFib or BT, or SVT or bradycardia. It can tell you lots of very valuable things. It's not the same. It's not going to diagnose a heart attack in most instances, but it still has an awful lot of value. ABL information. And so we became a pioneer. And we pushed and pushed and pushed this idea of personal empowerment, patient empowerment. I had adoption and had papers published an industry kind of gadfly, John Nasta comes up with Albert's rule. What's Albert's rule lead with clinical validation. So today live where we have almost 200 peer reviewed publications validating a live core technology in every major cardiovascular journal. Over the last three weeks, I think we've had six abstracts presented, HR X meeting and San Diego, European Society of Cardiology meeting. You know, we continue to push science and push validation and push our technology. But we were a little company. You know, people believed my chairman of my board is very famous venture capitalist, Vinod Khosla, big believer helped continue to fund our growth. And then in September of 2018, something happened. The world's biggest company introduced ECG into their wearable. And on that day, I figured my company just got shot in the head and we were dead. My CEO at the time, he felt the same way. And Vinod Khosla calls us up and says, This is the best thing that ever happened to you. And he was absolutely right, our sales more than doubled 260% The next year. And of course, then when the pandemic hit, they doubled again. And you know, today we have a company with way more than $50 million in revenue selling a product for 80 bucks, we must sell a lot of, yeah, we do a lot of them. And we've done, you know, again, whether you're Mayo Clinic, full disclosure, they're an investor, my company, but every major health system around the world, uses cardio devices and have patients that use them. Lots of clinical applications and validation. And, you know, I feel very proud that here we are, four years after the world's biggest company became my competitor, as well as Google, as well as Samsung. And our business continues to grow and thrive. We push our technology, we push our clinic, we're the experts, you know, as much as chagrin for them, we're the experts they aren't. We're the people with more clinical validation and better signals and better algorithms. And that's been proven independently. And so, you know, I'm very proud that we can face the world's strongest companies and still thrive. And we did it because of John Austen's Albert's rule, lead with validation, lead with the science.
Patrick Kothe 27:52
It's always about what's behind the idea. And what's been the knowledge of, of the deep knowledge of the technology, that that's what's going to win the day, it always comes back to that you can have in the next shiny object, but unless you've got the deep donate domain knowledge to continue to build off of that initial entry, you're not going to take it very far.
David Albert, MD 28:19
I read my first ECGs taught by one of the late Dr. GALEN Wagner, who was one of the world's expert preeminent experts on electric Cardiography. In 1978, it on microfilm at Duke Medical Center. Okay. So as you said, I've been in ECG, a long time, and ECG for about 45 years, and my mentors. And by the way, I know I'm old because my mentors are all dead now. But my mentors were world experts. And you know, when we just announced a big partnership with GE, which is the world's leader in hospital ECG, another validation of of the fact that we are the leader in personal ECG and personal cardiac monitoring. It's built on that deep knowledge you talk about, I personally, unfortunately, have have over read hundreds of 1000s of cardio ECGs that knowledge and that feedback enables us to provide to our customers the best solution we can and so that that's, as you said, it's based on on that knowledge in that feedback. We don't produce a consumer device, we produce a medical device, we just happen to sell it directly to consumers. And there's a big distinction there.
Patrick Kothe 29:45
Well, I want to focus on the evolution of the product because a lot has had to change since 2010. Till today, a lot of the environment as well, but I want to come back to Something that you said earlier, and it's a one lead versus a 12. Lead. So for the general audience here, a one lead, you can get rate and rhythm. 12 lead is something that you're going to have the stress test, you can be able to look at different parts of the heart different directions of how that electrical signal is propagating around the heart, you can be able to look at areas of ischemia, you can do a lot of other things with that 12 lead. So you're not competing in that area. That's, that's 12 lead that's in hospital stuff. What we're talking about is raid and
David Albert, MD 30:39
not yet. Okay,
Patrick Kothe 30:41
I take that back. But at this point, it's it's rate and rate and rhythm.
David Albert, MD 30:50
That's right. And rate and rhythm are very important. But you know, a single lead ECG gives you one view of a three dimensional system. Okay. And so what we've done is, first of all, we've evolved our single lead ECG. So I said the first manifestation was a case. But at that time, Apple had one iPhone model. Okay, androids weren't big yet. But soon, Apple began producing multiple models, multiple sizes, androids became very popular in many different manifestations and sizes. And so the notion of a case, we soon wanted to get out of the case business, because we didn't want to be a consumer product manufacturer, we wanted to manufacture our product. So at that point, we developed what in essence became cardio mobile, which is sold today. And it's a wonderful design looks like a slightly large piece of of chewing gum. That is small fits in your pocket, and works with any smartphone, any tablet. And that device has been a staple. You see it in ads on TV, until this last year, when we brought out our latest version of the single lead ECG, and that's our cardio mobile card, which is literally the size of a credit card. And is revolutionary took five years to develop this device. It has a three year battery life and can literally fit in your wallet like a credit card. And that that is a just simply to make it more convenient, easier to carry more available. And so that that was the evolution of the single lead at the same time, we'll hang on to him was not lost on me. So his iron Tobin's triangle and the ability to generate what we call the limb leads. Half of the 12 lead ECG or the six limb leads back in 2014 shows you how long ago it was, we developed a prototype of a six lead ECG which used three electrodes, left arm right arm left leg just like iron Tobin's original ECG, and in 2019, that was FDA cleared and brought out as the cardio mobile six cell. Today we have way more than 15 million recordings and that's becoming far more popular. And physicians are recommending their patients get that GE is going to be distributing that to hospitals for for their patients. Why? Because now gives you six views of that heart. It's not a 12 lead ECG yet, but I can derive I can a be more accurate. And we have several published papers, comparing our six lead to single lead ECGs it's more accurate for diagnosing a fib. And Alia allows you to look at things like cardiac access to look at at atrial flutter to look at heart block of various kinds. It's it gives you a more complete view. Still very convenient, you know, available for less than $200 but gives you more information. So we go from one lead, principally lead one left arm minus right arm to six leads, leads one, two and three AVR AVL aVF. I remember that cardiologists that the heart failure Society of America Yeah, but it's just one lead. It's not a 12 lead. Yeah, but looking at our evolution. Where do you think we're going next? I can tell you wherever we go next. It will be revolutionary. It will be easy to use and and completely intuitive because that's been our hallmark is to make devices where you don't need instructions, where my two year old granddaughter and I have a great video can use the device and she can't read but she can use As cardio, so you know, will will continue to evolve our technology continue to evolve our AI, and continue to bring more and more capability to that empowered patient and deliver really valuable insights to their physicians. So that we, you know, realize my goal, keep you from dying before your time.
Patrick Kothe 35:26
So, David, let's go back to 2010. And talk about the regulatory situation. And what was possible at that time, what claims you could make about a product who you could sell a product to? And what, you know, what, what the concerns were of the regulatory bodies about putting ECG of?
David Albert, MD 35:49
Well, first of all, let me just tell you, I'm walking on the show floor at CES, people coming up to me, it was crazy. And I get a phone call cell phone. And it was a gentleman at the FDA, who happened to be a very long term friend of mine. He's now retired from the FDA. I won't use his name, but he had been a student of mine. When I was in grad school in Biomedical Engineering at Duke, he was an undergrad biomedical engineer. He said, Dave, what are you doing? I said, You got to understand, I had no idea that this thing would go viral. You guys at the FDA are gonna have to just deal with this. This whole social media, I had no idea. I was going to show this to five people. Okay, this video. And now millions of people have seen it. And by that time, it had been on TV, and they didn't scream at me. Our first 510 K, which was 14 or 15 months, laters. sometime. Yeah, how long it took to get that first 510 K 70 days? Statutory 90, but nobody tells you they got a 90. I got it in 70 days. Now, it wasn't over the counter yet. But it was it was prescription only but 70 days. Why did they give that to me in 70 days? By the way, I submitted an abstract we'd already presented hrs Wait, because I think they viewed us as a pilot as a test. Is this going to work? Was this crazy? What's going to happen here? Probably the risks are very low. We'd said, You know what? Somebody's going to run into their doctor and say, what's, what's the show, we had no algorithms at the time, told you your heart rate. That's it. And of course, we then went in and said, well, we'll connect you to a cardiologist. But if we do that, and we spend that money to do that, allow us to sell this on amazon.com. And directly. And they gave us that opportunity. And so then, you know, for several years, you can still buy our product from amazon.com. It's, you know, our website, whatever. But we first century ECG and had it sent and reviewed by a cardiologist and board certified cardiologist so that you had somebody you could send it to even if you didn't have a doctor, and who would review or you know, in case you had something bad, you know, your urine, urine.
Patrick Kothe 38:16
How did you deal with the licensing of that? Well,
David Albert, MD 38:19
we dealt with a company that actually did multistate reviews of ECGs for prisons. And I knew the company and I knew the doctors who had licenses and now we have cardiologists in all 50 states. So we can in our app, you can get a a cardiologist overread that is from a cardiologist that's licensed in your state. And we you know, that as you know, those Byzantine rules, were kind of excused during COVID Because telemedicine, it was just Yeah, we had to deal with things and telemedicine went up dramatically because people were scared legitimately So, but at the time, you know, we found a company that had that capability. I think the FDA saw we didn't have any complaints. We didn't have anybody come in and say, oh my god, I just spent $50,000 needlessly because this thing, this cardio thing, no, they didn't. The our fears or their fears at the FDA turned out to not be real. And so you know, Apple comes out selling watches, 10s of millions of watches a year and Fitbit and Samsung and cardio. We've sold millions of devices. Will somebody have a false alarm? Yes. You get a false alarm you you can false blood pressure alarm, false temperature alarm, you feel a headache, you think you're having a stroke. That's just reality. And what we've all come to do is deal with the E hypochondriac that was a concern. That was a concern of Eric totals. But none of those fears have turned out to be real. And doctors began to accept At this patient generated data, these digital health solutions, we just happen to be one of the pioneers. And today, it's just common, right? You take your blood pressure at home, scale at home, do your COVID test at home, take your ECG at home. Digital Health is simply becoming health.
Patrick Kothe 40:21
Remind me but my memory of that 2010 era was, you could sell it to a consumer, it could not have any interpretation of it. You couldn't even display the full waveform, you had to have a cartoon of the waveform right at that point couldn't
David Albert, MD 40:41
display you could record an ECG poll or chest straps or an ECG that gave you your heart rate for for running. You couldn't display an ECG. But we went to them and had a prescription device. So our first year, doctors had to send us a prescription for us to sell a patient a device, okay, they were still self pay, there was no insurance, you know, ultimate today, you know, we're FSA eligible, you can go to the FSA store and buy with your pre tax dollars a cardio. And since it's only $79, pretty inexpensive, and we sell around the world. So you're right. They had rules, because they had fear. You know, what is the FDA regulate safety and efficacy? They were afraid of both because it was unknown. It was new. And I think they used a live corps of test. And as a trial, and it worked. It didn't create major problems. And so today, it's common. But we were the pioneers. And unfortunately, you know, the definition of a Pioneer is somebody with arrows in their backs. So I don't take my shirt off anymore, because the scars are ugly. But, you know, the FDA has has a whole digital health group and that, you know, a cool Patel just left to become the head of Google Health. You know, the point is, they've evolved, they realized that this is real. The head of the FDA today is a 42 year friend of mine, Dr. Rob Kaleb, he was the second author on my first paper on EKGs, by the way I do. So I've known Rob for for decades, just like his predecessor, who we saw a lot on TV, Scott Gottlieb, they're innovative, guys. And they brought an innovative perspective to the FDA. And so I think we're going to see what I would say is good regulation. Like you said, I think the FDA has a very valuable role to play. But they're going to adapt to the world to a situation where as Eric Topol says, Doctor, the patient will see you now.
Patrick Kothe 42:49
David, let's talk about some of those arrows because we're sitting 12 years post when you made that video, and the company did not grow. From day one. It wasn't a linear growth. That early phase of the company, when you had several things that you need needed to put together. One was the development of the technology. And you kind of describe some of the some of the innovations that you've made in the technology. There was a development of the regulatory strategy and some changes that the agency would have to make from an OTC standpoint as well as as a prescription device, and how that rolls in. But there's, there's also a business model strategy that you guys had to come up with, is it going to be a prescription? Is it going to be going through the doctor's office? Is it direct to the patient? So you had a whole bunch of things that you are trying to wrestle with, in that early phase of your company? So tell me tell me a little bit about how you guys approached the business side of managing this this company? Well, first of all,
David Albert, MD 44:07
I had a little bit of an insight. So for the first year, the first year of operation of the live core, we had a million dollars in revenue. How do we do that? Didn't have FDA clearance. We sold it to veterinarians. So there's still a vet app out there that's like 12 years old. And so we could sell it around the world of veterinarians. There have been a dozen papers published on use in dogs, cats, horses, racetrack horses all over the world race, racing horses, get a fib. And so Cornell vet school. Veterinary cardiologist became a huge advocate, used it in dogs and cats. You know, very quick assessment. You wouldn't have to hook up electrodes and needles and things that they do for animals and then veterinarians, and now we've had, you know, grizzly bears, dolphins monitor lizards, you cannot imagine every kind of animal, you know, there's a great, the Cincinnati Zoo had a great story about a year or two ago of one of their gorillas. And that gorilla had an arrhythmia. And they trained the gorilla to come over. And they would put, they had a cardio device and a tablet. And the gorilla would put its two fingers out and measure its ECG. And that was in the Cincinnati newspaper and went out that the grill would come on, get a banana and put his fingers out and measures his his rhythm. So that's how the first year of our business, we had a million dollars in revenue, then we had our 510 K, ready to take prescriptions. That was a huge pain, okay, it did not make for easy commerce. And that's when we had to come up with the idea of this using a cardiologist connection to allow us to sell the ECG directly. And then we had to come up with the notion of what people really want is they want an assessment. So we came out with our atrial fibrillation algorithm and normal sinus rhythm algorithms and got those through the FDA, through the same mechanism of the cardiologist will validate that that's an accurate diagnosis. And so these LED, I can tell you, you know, it was not a linear path. And we put a lot of effort in to grow the business to, you know, something less than $10 million in revenue. And then the world's biggest company, exploded our business. And then the pandemic exploded our business again. And we continue to grow. And we at the same time, we were evolving our products, making it so any smartphone doesn't matter android iphone, we expanded our product line, we expanded our distribution to Europe. So now the NHS, we have nice guidance, they can you can you know, a GP in England, can basically prescribe a cardio for a patient who has a fib, the VA, we have our cardio mobile card, a va cardiologist can prescribe that means they get it for free just in England or a veteran. So we've expanded, we have the ability with our six lead device to monitor the Qt segment. So we have drug companies that are having to monitor we have patients all over the world, patients getting methadone patients getting TB medications, patients on psychiatric medications all over the world, now have the ability to be kept safe to be monitored for safety, anywhere, anytime. And so we've grown our business through multiple, you know, geographic and product line expansions. But it was it was never linear. We're continuing to look for adjacent innovations. I'm not dead yet. I'm still doing push ups. And so I'm still looking at at at ways we can we can benefit and in the meantime, you know, our persistence, our commitment to clinical validation. Want us some wonderful partners. From the beginning we had Qualcomm who appreciated the elegance of our technology, they've been a partner since 2011. Then we got to Omron the world's biggest consumer medical product company, you go into any, any drugstore and he Best Buy the blood pressure cuff is on Ron, they're a big corporate partner. And today we have General Electric healthcare, which will be a standalone company come January 4, you know, a major cardiology supplier. And so from whether it's technology, consumer healthcare, or actually top of the line, medical care, hospital care, we've won supporters. And I'm very proud of that because it means we've done something right to get that varied group of of, of companies, experts believing we're a horse to ride. Again, John nostos Alvarez rule that clinical validation god is their innovation enabled clinical validation. And today we were reaping the benefits.
Patrick Kothe 49:22
So when we say ECG, ECG covers a lot of ground, so the category that you're in and want to not talk about the future, but talk about today the categories you're in because I know that you've got plans in the future. But right now we've got an in hospital in doctors, offices, 12, lead full workup, monitoring of patients in ICU, those that that's kind of one segment we'll, we'll talk about with with ECG. There's another segment, continuous monitoring, or event monitoring something that you would like to Holter monitors something that you'd have to patch, you
David Albert, MD 50:03
know, I read them, you know, by Hotel, which is now a Philips company prevent us, which is now a Boston Scientific company Holter monitoring, you know, continuous ambulatory monitoring, started with Dr. Holter. And then you know, basically was for the last 30 years was 24, then 48 and seven days and then Uday Kumar. And I rhythm came up with this patch idea of a single lead up to two week, continuous recording and proved that it yielded higher diagnostic capabilities than a 24 hour 48 hour Holter. And so that capability, there was a company called cardio net started by a guy named Jim Sweeney, that today became biotechs. And today as part of Philips, and they did what's called Mobile cardiac telemetry, where for up to 30 days, they monitored, you are being monitored from a central station, it will add a continuous cellular connection. And so those types of devices were principally diagnostic devices, the doctor is prescribing you that putting that on you, and using it to diagnose whatever your symptoms or potential arrhythmia is, I call our area, personally CG. And that means and in that category are all the smartwatches with ECG capability as well as cardio is, and that means a consumer a patient. And by the way, not every consumer is a patient. But every patient is a consumer. So having that notion of the customer first has been vitally important to our success. And these other companies that are in this area. You know, this is patient recorded ECG snippets, segments. And while that can be used for diagnosis, and a lot of papers published on that the apple Heart Study the Fitbit Heart Study, it's principally used for monitoring and managing a patient. You've had a cardiac ablation where we burn or freeze tissue in your heart to try to stop your a fib or your VT or your svt, all your arrhythmias, you go out, well guess what, in some not insignificant percentage of people that arrhythmia comes back. And so you want to monitor these people longterm. Traditionally, we did that by doing one of those holsters or Zio patches every six months or one year. But oh, by the way, that a reason you can come back two weeks later, three weeks or four days or six months, it doesn't matter. It can come back anytime. And so the notion that when you feel something, you're able to send that ECG to your doctor or feet realize, Oh, those are ectopic beats, that's not my afib. It's very valuable for managing both from the patient's perspective, as well as the physicians perspective, that cardiac disease, that's the area we're in is personal ECG monitoring.
Patrick Kothe 53:04
And that can bleed a little bit into the diagnostic and can bleed a little bit into the into the diagnosis can bleed a little bit into the worried well. So there's the primary category that you talk about is the personalized somebody who's it sounds like it's somebody who knows that they have something, and they want to continue to monitor
David Albert, MD 53:29
Yes. And we've done surveys of our customers, and somewhere in the United States north of 55% buyer device, because their doctor recommends that buyer device, okay? Our average age of our customers is over 60. Our biggest decade is 60 to 72nd biggest decades, 70/83 biggest decades, 50 to 60 cardiac disease manifests, it's there, but it manifests itself in the sixth decade, that is when you turn 50. Okay, that's when it begins to manifest and it goes up exponentially from there. And so that's why our customers are in many instances, actually patients. And so again, they may be diagnosed, or they may our device may help with their diagnosis if it's unknown, but But it certainly helps with them dealing with their disease, just like a glucometer is essential for a diabetic to deal with their disease or at home blood pressure cuff is essential for a hypertensive patient. And we now know that that data that's supplied from home, be it blood pressures, rhythm strips, is really valuable and probably far more valuable than that one snapshot you get at a doctor's office, you know, once a year. Everybody's realizing that that's the promise that you know, and now we're dealing with all this new information that doctors are saying, I'm being swamped. Yes. And so you know, at the same time time over the last 10 years that the doctor's lives has been have come to be under the control of the electronic medical record, by the way, where they spend most of their time. We've added all this new information. And so, you know, today, that's a challenge is how you integrate only what's needed in terms of information flow. And from all that avalanche of data. You know, no doctor wants to the six inches of Fitbit activity data or heart rate data, EKG data, they want to see that they need to see the insights, what happened when. And so we've worked with partners like Cleveland Clinic, and mayo and to develop those insights and make them manageable.
Patrick Kothe 55:45
So David, I want you to play Minister Damas for us a little bit, we've had a 90 or 100 year old technology. And the last dozen years a lot has happened, you know, first 90 years, not so much less dozen years a lot has really happened with the democratization as you called it of the ECG. Where is it going not not specific to your company, but ECG in general? Where is it going?
David Albert, MD 56:14
Well, it's going to become more prominent. And we will learn the limits of the information. No matter how good your AI is, whatever it is, you're trying to detect, what we call the positive predictive value of the statistical term, your ability to make sure that when you pick something up, it is what we call a true positive for real problem gets more and more challenging, the lower the prevalence of that problem is in a population. So as we push this personal ECG technology out to hundreds of millions, if not billions, of people, we're going to learn the limits of its value. Because unfortunately, when you take any test of any sensitivity and specificity and put it in a very low prevalence population, what you end up with is a test that generates far more false positives than true positives. And dealing with those, we have a healthcare system that's already under tremendous stress, with doctors and nurses leaving health care burning out, you know, the pandemic was a huge hit to the health care industry in general. And, and so we're going to have, we're going to be challenged to deal with this issue. And I know everybody's aware of it, the FDA is aware of it. Medicare's aware of it, the consumer companies, the large ones are incredibly good at selling huge volumes and scaling businesses. But this is going to represent a challenge. Because when you sell to 25, and 30 year old, ostensibly healthy people, most of what you find will not be actionable. And I just gave a lecture at a meeting call a big cardiology AI meeting called computing in cardiology, and I had two very smart after my talk, which was on the uses, and the limitations of personal ECG. I had two very smart cardiologists get up, and who I know well, and said, you know, Dave, I get these things all the time. And people bring in things that are not actionable, or they're a waste of my time. You know, yeah, they may have a PVC, and they're scared. And I just tell them, Don't worry about it. But this shouldn't have ever, you know, we just wasted a visit, they wasted money. And I said, we're going to have to deal with this. And whether AI helps us, it inevitably has to help us. And as we scale and get, you know, a lot of quarters way more than 100 million ECGs in our cloud way, way more. That's huge data, not just big data, but huge data, it will help us make better AI. But then we're also going to have to just figure out how to deal with this, and educate people that, you know, if you're 30 years old and healthy, there's no reason to have no reason to use this technology. And that's an education process. Because big companies sell, you know, they don't they don't determine who buys their product. They just market it, and then people buy it. So it's not like they can select their customers, at least not in any significant way. So that's going to be a challenge. But what I can tell you is the genie is not going back in the bottle. It's only moving in one direction, kind of like you know which way our deductibles and co pays going for health insurance the United States. They're not going down. And so this is part of the challenge we face in US healthcare, where we have tremendous resources and tremendous assets and tremendous cost Last, we got to figure out how to address that. Whether it's obesity, and all the associated chronic diseases, or whether it's acute care, or whether it's the deluge of consumer data we've got to deal with.
Patrick Kothe 1:00:16
As David said, his journey was not linear, that there were many challenges and issues that a live core needed to navigate to build a business as it stands today. But it all started with David's vision, a few of my takeaways. First, the importance of a commitment to robust clinical data can't be stressed enough for those of us in the business, it's all about the data. It's all about building that clinical story. Not just one study, but a commitment to a series of clinical data to prove that your technology stands apart. The second thing is, you could compete even against the largest company in the world, Apple, alive core is the expert at ECG, not Apple and for ECG. That's where you need to go to, and they position themselves that way. By going back to that first point, that commitment to clinical data, having the experts and having the clinical data to support it. Finally, prepare yourself for questions, you know, are coming. I love that story of David when he he knew that question on 12 lead ECG was coming he had prepared for it and he had a concise answer for it. That immediately silenced the public critic. The question is, have you done the same for yourself? When you know the question is coming? Have you prepared that concise answer? And really to put that issue to bed in the mind of the person that's asking. Thank you for listening. Make sure you get episodes downloaded to your device automatically by liking or subscribing to the mastering medical device podcast wherever you get your podcasts. Also, please spread the word until a friend or two to listen to the mastering medical device podcast as interviews like today's can help you become a more effective medical device leader. Work hard. Be kind
