Medsider: Learn from Medtech and Healthtech Founders and CEOs - The Incredible Story of How Dr. David Albert Brought the AliveCor ECG iPhone App to Market

Episode Date: October 22, 2020

This interview is a throwback to several years ago when I chatted with Dr. David Albert about his incredible journey in bringing the AliveCor ECG app to market. Here are a few things we covered:The amazing story of how AliveCor’s iPhone app helped save a man’s life while on an airplane!The roller coaster ride Dr. Albert experienced in his pursuits to develop the ECG app.Five key lessons you can learn from Dr. Albert’s experiences. And his timeliness advice for ambitious doers, which includes the following: believe in your ideas don’t be afraid to swim against the stream.Click here to learn more.

Welcome to Medsider, where you can learn from a mix of experienced medical device and med tech experts through uncut and unedited interviews. Now, here's your host, Scott Nelson. Close your eyes and imagine the scene with me. You're at Grandma Betty's house for a family gathering. Suddenly, Grandma Betty begins to experience chest pain. She's had some issues with her heart in the past. But could this be it? Could Grandma Betty really be having a heart attack?

You know what reaction would be to call 911. right? Not this time. Instead, you simply pull out your iPhone and use a LiveCore's ECG app to detect Grandma's heart rhythm. And thankfully, her heart appears to be normal this time. No, this isn't a science fiction story. The iPhone ECG app is real and very close to FDA approval. In this interview with Dr. David Albert, we learned more about his incredible journey in bringing the ECG app to market. Here's a few things we're going to learn in this interview with Dr. Albert. The amazing story of how LiveCorp's iPhone ECG app helps save a man's life while on an airplane.

Two disruptive features of the iPhone ECG app, cloud and cost. The roller coaster ride Dr. Albert experienced in his pursuits to develop the ECG app. Five key lessons you can learn from Dr. Albert's experiences. One, be stubborn.

Two, use sounding boards. Three, protect your IP. Four, stay patient. And five, make a freaking demo. Dr. Albert's advice for ambitious doers. Believe in your ideas and don't be afraid to swim against the stream. Of course, there's a lot more valuable info we're going to uncover in this interview. But before we dig in, you need to listen to these brief messages from our sponsors.

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edition of MedSider. This is the site where you can get your personal, free, med tech or medical device MBA. It's a show where I bring on dynamic and interesting medical device, med tech stakeholders so we can all learn a few things. Hopefully there's some entertainment value along the way. And today's guest is Dr. David Albert. He is the founder of Alivecore and is infamous amongst other things for the iPhone ECG app. that was, I think we're coming up here on the one-year anniversary of the, what I think was dubbed as the unofficial hit of the CES 2011, the Consumer Electronics Show 2011.

So without further ado, welcome to the call, Dr. Albert. Appreciate you coming on. Thank you very much, sir. My pleasure. And so let's start off. I mentioned the iPhone ECG app. Why don't you briefly tell the story about Dr. Eric Topol and his experience when using your app on a recent flight with the person who was experiencing the heart attack?

Well, it's an anecdote. So Eric, who is a world-renowned physician scientist, would tell you that this is not a clinical study, but it was an anecdote and a good Samaritan use of our technology. Dr. Topol had been at the Bethesda at a conference at the National Institutes of Health, This was about two months ago and was left from Dulles Airport headed back to his home of San Diego and the Scripps Institute. When 30 minutes into that flight, they came on the overhead PA and said, is there a doctor on board? We have a passenger who's in distress. And Dr. Topal had several other physicians with him from Scripps, but they were all surgeons.

So they said, Topal, this is your gig. ago, he got up and went to where the passenger was. And the passenger was a gentleman who will remain hippocomplying anonymous, who had several years before had a stent place for coronary order obstruction. And at the time in the air, the patient had chest discomfort and was sweating. And so, you know, they were trying to figure out as this serious, what do we need to do. And so Dr. Topol, after talking to the patient, observing his distress, took out his live core ECG for the iPhone and opened up the gentleman's shirt and placed it on his anterior chest.

And what he told me, this is what Dr. Topal said, is Dave, he had four or five millimeters of ST elevation. Well, I can just tell you that's absolutely diagnostic that the guy was having acute heart attack. And so he said immediately he said, you got to tell the captain, we've got to land this plane ASAPE. This man's having a heart attack and no telling, you know, what's going to happen to him. So they did. And they landed somewhere, as Eric said, somewhere near Cincinnati. I don't think it was at the Cincinnati International Airport, which, for those who knows, is actually in Kentucky. They landed at some other airport, and the gentleman was removed by the MTs and taken and actually had another step placed, and Eric told me it's doing well.

So that's good news. Happy ending. The maybe not so happy ending part of it was that the plane they landed. which was probably a 760 set up on some larger kind of aircraft going cross country could not take off with all the people on board from that airport they landed at so dr tople they had to bring other planes and to shuttle people up he didn't get to san diego for 13 more hours in the middle of the night the plane had taken off in the morning early in the morning so he said i don't think they're very happy with me but he said you know we did uh you know the patient's alive and well so all all ends well uh

with that story. Right. You know, it's a great story. And I think, you know, we don't claim that our device should be used to diagnose heart attacks. That's not really what it was designed for. But in that kind of situation, it was an appropriate use. And certainly, you know, when Dr. Topol saw what he saw, there's no questions to what the

diagnosis is. So it's not a replacement for a 12 lead ECG when you get in your doctor's office or a hospital where it took the electrodes on you. But in this case, it was all you needed to know that this man needed urgent there. That's a happy ending. Yeah, no doubt. So the passengers on the plane were like that amazing, you know, on one end they were like that amazing app, ECG app. And then on the other, on the flip side, they were like, that damn iPhone app.

It's cost you. It's costing us an extra 13 hours. We're all slaves to time. That's right. And so, you know, a lot of people had their schedules messed up by that. You know, I look at it this way. Dr. Topal's done this many times. I've been involved in a number of these things.

You know, the fact is if that was you were somebody you love, you want that plain land. Absolutely. So, you know, we're, it worked out fine. And that, by the way, it's in addition to the fact that we've completed three actual clinical studies of our technology now. one at the University of Southern California with Dr. Leslie Saxon, Chief of Cardiology at USC, and two, here at the University of Oklahoma, Dr. Dwight Reynolds, Chief of Cardiology and former president of the Heartrhythm Society.

And, you know, between Dr. Topal, Dr. Sachs, and Dr. Reynolds, these are really world-renowned cardiologists. And the three studies have all resulted in abstracts that we haven't heard about but have been submitted, and we're very happy with results of that. data which which is used for our medical device CE mark so that we can sell in Europe and and it's being used for our FDA 5 K applications which requires some some clinical efficacy data and so you know we've actually done studies now and and I'm happy to say they turn out really well gotcha very cool I want to come

back and ask you a little bit about that kind of that that regulatory and reimbursement aspect of your device but before we get there people in the audience are, I got to imagine thinking, wait, wait a second. Okay, so what I'm getting out of that story is, okay, so Dr. Albert's developed an app that can actually read a heart rhythm. And yeah, I mean, this is what we're talking about. And I'll definitely link up to the YouTube, you know, your famous YouTube video when I post this interview on MedSider. But yeah, I mean, patients that you're used to seeing that you mentioned the 12 lead ECG, yeah, with the, you know, the electrodes and the cables. Yeah, you basically transform that sort of technology in a sense.

you know I'm somewhat exaggerating this a little bit but in essence you're transformed that technology into an app on the on the iPhone and so why don't you just give give the audience give myself a brief intro into what the iPhone ECG is sure and today we also have it working on Android although it's nearly as well-developed as our iOS product currently we have a case which is designed to fit the iPhone 4 and the iPhone 4A's, 4F. That case is like a case you'd buy in the Apple store or Verizon AT&T, wherever you buy your iPhone cases to protect your beautiful loved iPhone.

It has rubbery sides and a hard back, but integrated into the back, the only difference you would notice, it really is no larger than a standard case, is that there are two dull electrodes on the back right underneath where the camera hole is. And those two electrodes are used, are connected to electronics built into the case, to actually measure your electrocardiogram, and you can do that from a number of locations on a body. And it is then combined with the app, which is a standard iPhone app, which receives the wireless data. So the case actually speaks wirelessly. You can actually kick the case off and have it 6 to 12 inches away from the iPhone, and the ECG still shows up on the iPhone.

So it's wireless connectivity, and that's important because in medicine, we have to have something called an isolation barrier. You've got to keep what connects to patients and what connects to potentially AC power, totally separate with a very high isolation barrier. And so we talk wirelessly between our case and the iPhone, and then our app takes that wireless data, turns it back into an electrocardiogram, displays it, processes, stores it,

and then uploads it to our secure cloud server. And so, you know, it is an abbreviated part of a 12-lead electrocardiogram. In fact, when I hold it in my two hands, I'm actually recording what's called lead one, which is left-arm minus right-arm. That's the first lead in a standard 12 lead. And one of our studies we did actually compare the one from a 12 lead to our lead one, and

they're basically identical. Ours is slightly noisier because you're holding it in your hands because it's not as good of connections putting the sticky electrodes on. But otherwise the data is absolutely identical. And so it's a combination of a case and an app. We also have in a preliminary form what we call our iCard, and there's a video on YouTube about that, which is a credit card size, version of the same technology that works with iPhones, Android, iPads.

It's basically a version of it that's not a case. Gotcha. So the exact same technology transmits wireless. So that's the technology. It allows literally 10 seconds after I finish recording. reporting, the ECG can be viewable anywhere in the world securely will have browsed. Wow. And that's another part of the disruptive factor.

It's available to your doctor almost immediately after you report it. Gotcha. I mean, and that's amazing. I mean, that's an amazing part. And I love the... Well, that's a good. Amazing is a good. We have a lot of people saying amazing.

It just came back from CEF 2012 or the M Health Summit or Medica and Dusseldorf in November. and amazing is a, you know, from a lot of people, a lot of companies, even a lot of doctors, they say amazing. And you know what? We've worked very hard on that. And as I mentioned you earlier before this call, this really is an evolution of an idea I had back in the mid-1990s when the technology wasn't able to implement what we have today, but the idea was there. Right.

I love that you, I'm sure you get that a lot. this is amazing, Dr. Albert, this is amazing. Yeah, I'm sure you're, but you use the word disruptive. And that's, I think that's a really good description of the kind of the cloud-based ability to view these ECGs, these heart rhythms anywhere in the world. You know, so if I'm just, you know, from a practical standpoint, if, if my grandma has a pacemaker and she took a trip to California and I wanted to make sure her heart rhythm was okay, and she stuck her iPhone, you know, she used your iPhone app,

and I was able to view that rhythm, you know, wirelessly through the cloud, you know, through the cloud-based browser. It's funny you said that. It's funny you said that because one of our studies at the University of Oklahoma is with pacemakers. In fact, in the last few days I've had some people comment on our LiveCorp Facebook page that, well, how does this work with pacemakers and implantable defibrillators? Well, the fact is we've used it with no cross-execorbiturates. problems with pacemakers, the device is put into airplane mode so the radios are actually turned off,

which is, you know, you're not supposed to walk around with your cell phone right next to your pacemaker, by the way. So we turn the radios off, put it in airplane mode as if you're on an airplane, we're still able to record using our wireless technology. By the way, that's pretty cool. And we've actually, we have a study ongoing, but we've already been an abstract that we're able to, to dispel if the pacemaker is functioning properly. That's really revolutionary, and really the most disruptive part of this, is the fact that the product's only going to cost $100 in retail. So that's the disruption is that this kind of technology,

that this kind of capability, this kind of global connectivity, is going to be affordable for anybody. If you own an iPhone, you'll be able to afford it. Right, right. And I'm going to use the word of, I don't know, how else to describe that, but amazing. You talked about the disrupt nature. the cloud-based ability to view the rhythm,

but that's, you know, that's another disruptive piece is the, is the, the cost. I mean, really, people spend more at Starbucks probably in a month than they would on this thing,

you know, so, um, that's awesome. It costs what a, what a, what a, podometer or,

or, uh, even less than a iPhone-connected blood pressure monitor. Yeah, because I actually, or go ahead, go ahead. Well,

I have the widening's blood pressure monitor, and I have the widening scale. And I, I, I love those devices. They're great. They both cost more than this than our device. And those are, you know, I'll tell you one thing, Scott.

You know, a lot of people use this term M health. And M health is a great term. I'm a firm believer in M health. But the reality is what we're doing and what the live core ECG for I is, is it's an M medical device. M-health devices are, you know, pedometers, scales, blood pressure devices you use, which, by the way, everyone needs to be using to keep yourself healthy. The reality is our device is a device for, unfortunately, the tens of not hundreds of millions of people around the world,

your grandmother with a pacemaker, who have a problem and who need to be monitored. That's, you know, we spend most of the most of the time. Most of our money, we need to spend more money staying healthy, but the reality is we spend most of our money treating our illnesses. So we look at our product as an M medical device, not just an M health device. And that's really what's disruptive is we're going to bring a medical quality, clinical quality device for less than $100 anywhere in the world.

And that to us is exciting in terms of what we're going to do to improve medicine around the world. Yep. Yep. What I was going to say is I think I bought a Garmin watch, you know, that I think it has nav and it's got the ability to, you know, to monitor my heart rate, you know, and I think I paid, you know, some like two or two or two or three hundred dollars for that, you know, which is, you know, two or three times the cost of, uh, of your device. So, um, very, very cool. You mentioned, you know, the idea for this, um, what, you know, was, you came up with the idea in the early 90s. Let's dig into that a little bit. And, and, And let's start with kind of, you know, walk us through, you know, how you came up with this idea and then kind of the story behind, you know, how this, how you began to see this into fruition and kind of the roller coaster ride as it, you know, until, you know, late 2010, I think, when you posted that YouTube video.

Well, it's an interesting story, actually. my previous company was called Beta Critical, and we were a wireless healthcare company and sold in-hospital wireless systems, inevitably went public in 99 and 2001 sold to General Electric Healthcare. And in the mid-90s, I had an idea that wasn't exactly in our main product line and for a handheld V-CG device using a, at the time, state-of-the-art hand-hand-hound. computer, which was a device by a British company called Cion, and it was called a Cion 3C. And that inevitably, we got a patent on that device in 1997 and actually an FDA 510K around the

same time. And that product was called RhythmStat XL. We really never commercialized that device because, as I said, it was really, we got it built, we got it FDA approved, we patented it, but it really wasn't in our business. And so that, product wasn't exciting enough at the time because the technology, you know, the handheld computer of 1997, you can't even compare it. It's like comparing, you know, a concrete wheel to a indie racer. It's just not comparable. So when, you know, in the mid-2000s, around 2005, But an old-time friend of mine from Australia named Bruce Satchwell had developed a Bluetooth ECG device that worked with at the time the state-of-the-art Windows mobile phones. And he was selling them to researchers, although there wasn't really an opportunity.

And Windows Mobile was state-of-the-art at the time. You wouldn't want to bring one out at a party today unless it was a party of archaeologist. the fact is that it was hard to use and had lots of issues and it was good for researchers and so in 2007 when the first iPhone came out he and I were excited

we converse often on Skype and we were both doing our own thing and you know we said wow this is cool and when they opened up the app store and opened up the FDK to allow you to develop apps I said great Bruce you need to you need to

port your your Bluetooth device to the iPhone. And the only problem was that Apple, they want to do, made their Bluetooth connectivity very controlled so he could not connect his Bluetooth device to it. And that was very frustrating because, you know, we then saw the 3G and ultimately the 3GF. So at the time the 3GF came out, I thought back to my 1997 product, Burden's Set-E-C-Taccom. I said, well, Bruce, I got an idea. And so I built a prototype tape actually out of a Mofi juice pack air, as an extra battery.

I took it apart, took all their parts out, put a prototype circuit board in it, and I called Bruce up and I said, Bruce, your partner there can write iPhone apps. This is what I need him to do. And he wrote an iPhone app. And it kind of worked. And I say kind of worked because it just kind of worked. This was like 2008, 2009. And so we worked on a little bit and got to the point where I thought I could go show it to people.

Again, it was kind of a handheld prototype. And I had it right now framed that my wife, for Christmas, framed that that original prototype in a frame with the Science of American article from December, where it was named one of the 10 World Changing Ideas by Science for American in the December issue. and they handed those out, by the way, at CES, which is really nice. Signs for the American people right down the way. So I took this around to some of the company I knew like GE. And they said, hey, that's kind of cute, but we've done focus panels. We don't really think people want to look at the recG.

We don't think doctors. You know, they got 12 lead ECGs, and GE is the world leader in that technology. And having left as chief science is GE cardiology in 2004, I fully appreciated that. So I kind of said, I don't have focus groups. I just thought this was kind of a cool idea. And so I went off. And the good news is Chris and I are both very stubborn sons of guns. Okay?

And so while I had people tell me this didn't think it was a good idea, I actually got approached by a company, fast-growing venture-funded company, that invited me to their headquarters in Houston. And they put up a slide showing a picture of my prototype and a concept drawing that looked exactly, like it. And they said, we had somebody to do this. He said, great, mine's spank a light. And so what happened there

was we were able to get a little seed capital from this company that enabled us to go to China and actually have some prototypes built in 2010. So in October 2010, took the seed capital from this company, who by the way, ultimately decided not to go

forward with it. They later changed their mind, but that was too late. Sorry. And so on December 14, 2010, which happened to be my birthday, I received a box from Hong Kong of 15 prototype iPhone 4 cases. And they were really cool. They looked really good, five white ones, ten black ones. And so I was getting ready to go to the consumer electronics show since the medical company had told me they weren't interested. I was going to go meet with consumer companies. and see if they were interested.

I mean, you could use it as a heart rate monitor if nothing else and not even mess with the FDA. And it would be, by the way, incredibly accurate. Oh, yeah. So on December 30th, getting ready to have New Year's Eve last year, I pulled out one of the cases, and I told this story, and you can watch the videos, my today. At the time, my 13-11-year-old sons, really my 11-year-old son,

made YouTube videos as he modified his Nerf Gun. That's the whole cult of Nerf Gun modifiers. And so he knew how to do it. And so I said he went, I had done a couple, but I'd done them poorly. He said, Dad, let me show you how to do it. You've got to talk to the camera. This is how you do it. You want to edit it.

You want it to be short. And so I listed to my 11-year-old. I went to my office. I took one of these cases. And I did a four-minute video, no script, no preparation. And I was sending it to two companies. who weren't going to be at the EF the next week. And I just happened to click the box that said post to LinkedIn.

And at the time, I had about 500 LinkedIn connection. I had about 30 Facebook friends and about 20 Twitter followers. Yeah. Didn't have any. I was at the time a 56-year-old guy, not a very socially connected dude. LinkedIn was my preferred network, business network, had some, you know, what I'd work with. And so I just happened to clip them.

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