Clincal Data from the Home
This week I am talking to Arvind Thiagaraja, founder and CEO of HD Medical (@HDMedicalGroup) that is saving patient lives through early diagnosis. Arvind’s journey into healthcare started from a young age when he was diagnosed with a heart murmur and he and his family went through an extended period waiting to find for investigation to determine if he needed surgery. Thankfully h did not but the experience made him want to enter the healthcare profession. He was lucky to have A. P. J. Abdul Kalam, the former president of India as a mentor who said to him
If you’re a doctor, you can help thousands of patients. But if you’re a doctor’s doctor, solving their problems with technology, you can not only help thousands of doctors, but through them reach millions of patients
With an early start through support from the Singapore government that funded their work to record heart sounds to screen early stage heart disease and allow for earlier life saving interventions started a journey to the development of the HD Steth. A Stethoscope with 3-lead ECG that combines the output synchronized to an associated app for display and diagnosis. The device was cleared for use by the FDA in July 2020 as COVID19 was emerging.
With the pandemic raging across the world they expanded their focus to see what capture systems they could get into the home that anyone could use. The result was the HealthyU which was recently announced – an all in one home health monitoring solution. The device is interesting as it contains monitoring capability for multiple clinical inputs that includes:
- Wireless 7-lead EKG
- Heart Sounds with Murmur Analysis
- Lung Sounds
- Heart Rate
- Blood oxygen saturation (Pulse Oximetry (SpO2))
- Temperature
- Respiratory Rate
- Cuff-less Blood Pressure Trend
And it fits in your pocket and anyone can use it. Currently it is undergoing IRB approved trials and they are hoping to have FDA clearance in the latter part of the year. Listen into hear about the capabilities, the excitement in the healthcare industry and where the incredible expansion they expect to add in the future. Dr McCoy would be impressed – this feels as close like Star Trek Tricorder technology
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Raw Transcript
Nick van Terheyden
and today I’m delighted to be joined by Arvind Thea gorazde. He is the founder and CEO of HDX medical. Ivan, thanks for joining me today.
Arvind Thiagaraja
Thank you so much, Dr. Make Very nice to meet you and talk to you. Thank you.
Nick van Terheyden
Um, so as I do always on the show, I like people to know a little bit about the background of folks that join me. Tell us a little bit about your background and how you arrived, where you are now, founding this company, HD medical?
Arvind Thiagaraja
Sure, I’ll share a little story of how I got into this field. When I was a child, 13 years old, I was detected with a heart murmur and went through a lot of stress and anxiety as a child determining whether I needed a heart surgery or not. Long story short, I didn’t need a heart surgery and seeing the stress and anxiety my parents went through wanting to become a doctor in life. And various reasons. Despite scoring 99% ended up reluctantly in an engineering college, even though a very prestigious one. But I was a little disappointed. I couldn’t become a doctor. But fortunately, I met my mentor who was none other than the former President of India. His name was Dr. Abdul Kalam, he was himself a very eminent scientist, he was the man behind the space research and Nuclear Research Program of India. But he told me these golden words which changed my life. He said, Arvind, if you’re a doctor, you can help 1000s of patients. But if you’re a doctor’s doctor, solving their problems with technology, you can not only help 1000s of doctors, but through them reach millions of patients. So with those golden words of inspiration is how I started working in this field of early detection of cardiac device, diseases, defects, and, and did some background work in Asia, before I moved to the US, eventually, in 2012, and then started HD medical here.
Nick van Terheyden
You know, it’s fascinating, you tell that story, because that really sort of amplifies a point that I often make about my own career. Even though I did practice medicine, one of the reasons that I stepped out into the technology field is is precisely for that the capacity to reach and bring positive impact and many, many more people because you’re touching it through others and sort of facilitating so fascinating to hear that I think, you know, we could do a whole show on your mentor. That’s, that’s kind of cool to know, that didn’t know that.
Let’s
Nick van Terheyden
start with a little bit of, you know, the course that you’ve taken, so you obviously got into engineering, you were focused on healthcare, and indeed, specifically around cardiac disease. Tell us a little bit about that journey. Sure, yeah. So
Arvind Thiagaraja
I was actually fortunate to get funded by the Singapore government fund, they gave me a million dollars right out of college, and did some early clinical work in Asia. And during the time was involved in recording the heart sounds and waveforms of so many children, some of them newborns and so on, and found that there are so many of them who go through these congenital heart defects. And they have these murmurs. And it’s very important to screen them and detect them at an early stage. So they can be given the follow up care, or intervene with a surgery and so on. So that’s where we got the inspiration for developing our very first device here in the us when we started this company, called HD stat. And what HD stat does is that it actually is the world’s first intelligent stethoscope with integrated ECG leads, and cleared by FDA with three product codes, where we actually can not only record the heart sounds, but can also see the ECG waveforms in real time. And then the AI algorithms provide intelligent visualization that helps the doctors in diagnostic better, and even the healthcare workers can actually use this information to come up with a quick screening and referring the patients for a follow up care. Right. So that’s where this device today has been used in the last couple of years for screening over 50,000 children in India and so other parts of the world like Fiji, or Sri Lanka, Nigeria, and several other countries like Malaysia, and even in the US. And we’ve actually detected a few 100 cases of murmurs confirm them without rasaan echocardiograms. And then with the help of some nonprofit organizations and government support, we have provided free surgeries to save the lives of more than 35 children. And that is actually a very rewarding thing for any technologist or an entrepreneur that you can actually save lives with your technology, even though not directly, but by early screening, they can be intervene early, and their lives can be saved. So that is very satisfying journey. And we want to build on top of that. And then also, this device can be used for both adults as well as children equally well. So it can be used for screening a lot of other conditions and triage in some acute conditions also.
Nick van Terheyden
So, before we get to the next innovation, I want to understand this a little bit better, because it sounds like I mean, if I simplify this, down to the basics here, it’s a stethoscope. But what you’ve added is an ECG that then synchronizes to the cardiac sounds, is that a reasonable sort of estimate of it?
And
Nick van Terheyden
what helped me understand how that’s used. So I mean, I understand how a stethoscope to use but I’m trying to imagine the sort of the bringing together of those signals in a presentation. So that you start to get to that early diagnosis.
Arvind Thiagaraja
Yes, absolutely. So what we’ve done is on the stethoscope itself, we have integrated three electrodes, gold plated ECG electrodes, so without connecting any wires or gel, you just have to place the stethoscope on the patient’s body. And then it picks up the heart sounds, lung sounds, as well as the ECG waveforms. And it connects to a smartphone or a tab through a Bluetooth ble. And we have a app that is available for free download. On the app, you can see it pairs immediately. And then in real time, we can see the ECG waveforms, the heart sounds, and also any high frequency aspects and so on. And then the AI provides intelligent visualization that actually helps in detecting these cardiac defects at a much earlier stage. And we’ve also done a clinical study in India, comparing with ultrasonic who has a gold standard for detecting murmurs for about 1200. Just under 1200 cases, we’ve shown a sensitivity of 91% and specificity of normals, 99%, which is much much accurate, higher accuracy than what you can get out of a traditional acoustic stethoscope or even for that matter, a basic electronic stethoscope, which just amplifies the sound, but it’s it’s more than amplification that is required, you need to have intelligent visualization. And the ECG gives you the timing. So you know, whether it’s a systolic or diastolic murmur, all of those aspects become very important.
Nick van Terheyden
You know, it’s really interesting in the context of certainly some quotes that I’ve heard from, you know, some pretty substantial cardiologists in the field who said, the stethoscope is dead, we don’t need it. We’ve got ultrasound. And, you know, I’m hearing very clearly that this is absolutely a functional solution. And it sounds like because you’re gathering the additional signal integrating that in an intelligent way. My sense is that you can start to apply some analysis to that as well. Is that going on?
Arvind Thiagaraja
Absolutely. Absolutely. That’s where See, I mean, there is a school of thought that with ultrasound, echocardiogram is being in place. Why do we even bother about auscultation. But there are two challenges, actually 311 challenges the cost of the ultrasonic algorithms that is prohibitive. second most important is the training required for both acquiring the quality images as well as interpreting them. And that’s always a challenge in developing countries. And the third challenge, particularly in India, and other countries like that. There are certain government regulations. For example, in India, there’s an act called pmdd Act, which prevents a physician from using an ultrasound on the field. Because that has been shown to have a predetermination of the sex of the babies and sometimes the girl child’s are terminated. So a doctor can get arrested for using ultrasound on the field. Right. So that’s where traditionally people have to rely on acoustics at its core electronics of its scope. And the healthcare workers. They don’t have those skill sets to ask, rotate and differentiate between a murmur or innocent murmur, pathological armor and things like that. And that’s where our device can really help in bridging this gap and addressing to the needs you know,
Nick van Terheyden
it’s fascinating how you say that I understanding I mean, obviously It’s a tragic sort of concept. But you know, we recognize the realities that we live in. But, you know, the other two are remained entirely valid, obviously cost and, you know, I think probably most people can look up and see what the cost of those, you know, bedside ultrasound devices are nice to have. And, you know, you only have to actually operate one of those things one time to know. That’s why we don’t all fly in flying aircrafts, if they were available. It’s three dimensional thinking, which we’re not very good at, we’re not very good at two dimensional on roads, it is so, you know, fascinating. So, you know, some great innovation. And I think, you know, I’m excited to hear the stethoscope is still part of, you know, the the medical future, I think it was always something that, you know, you felt was part of that, that medicine, and that interaction with the patient. But you’ve taken things a step further, right. So, you announced some really exciting news with a new innovation. Tell us a little bit about that, and what’s going on there? Sure. So
Arvind Thiagaraja
we first of all, got FDA clearance for the HD state device, last year in July, and, and then we were right in the middle of the pandemic, in 2020. July, and we were actually feeling like, Hey, you know, we should really do something even more to actually get this device at the home level. And, and then we started looking at the requirements. And we spoke to some of our advisors, and they said, they can’t even meet a patient for several weeks and months. And some of them, they don’t even know how to use zoom meetings. So they allow, go through a phone call for checking their heart condition. Now, how difficult is that, right? So we thought we should have a very easy device that even a grandma at home can use, that can help her or any patient from home level connect to a physician. And apart from just having a video conferencing or audio conversation, if the physician can have access to real time diagnostic grade parameters, both, you know, the the vital parameters, as well as the cardiac aspects like like heart sounds, ECG waveforms, and all of that. So that’s where we actually came up and really accelerated this innovation. And we announced it at CES. It’s called us healthy u, which is the world’s first intelligent, all in one remote patient monitoring device, where we have integrated 10 parameters into one small little device that can literally fit into your pocket. And it’s very, very easy to use, no wires, no carbs, no gel, nothing required. So it can do to start with the stethoscope, which will have heart sounds, lung sounds and murmur detection, then it can do seven lead ECG, which is a game changer, because nobody in industry has seven lead ECG today. So it can do lead one, literally three AVR, Revell aVF, and also one vector lead at a time which you can theoretically move to all the six vector leads. So you can sequentially get to a lead also if you want, but simultaneously can get seven leads. And then it can do temperature, pulse ox, we didn’t have plans for temperature before. But because of COVID, we wanted to introduce temperature, pulse ox, which is again a very important parameter, respiration rate, blood pressure, okay. All of that integrated into one single device. So imagine having an ICU grade monitor at your home, literally in your pocket, and that with your stethoscope, and suddenly, these are the functionalities. So we believe this could be a game changer. And we have early versions available right now being clinically evaluated under IRB protocol, and we’re hoping to have FDA clearance pretty soon by q3 this year.
Nick van Terheyden
So for those of you just joining, I’m Dr. Nick the incrementalist and today I’m talking to Arvind Thea garagem is the founder and CEO of HDX. Medical, we were just talking about the healthy you device that you announced. You know the sort of next innovation beyond your stethoscope device that was already synchronizing leads with the audio signal. And I think from a clinical standpoint, the idea that you’ve got 10 parameters in this sort of pocket based device, and a seven lead EKG or ECG depending on what country you come from. Just terribly exciting. I’ve got to ask, how do you do that? I mean, that just sounds like an impossible task. I feel like you’re Dr. McCoy. from Star Trek, and you’ve finally got this tricorder.
Arvind Thiagaraja
Sure. Now we got that same reaction from several others at CES, we had a tremendous response. There are many countries in the world who haven’t contacted us for partnership opportunities. And we had great coverage from the price. Also, some of the leading publications covered us, including CNET, featuring us as one of the most important health tech of ces 2021. So yeah, so what what we do there is we have obviously retained some of the sensors from earlier stethoscope device for the heart sounds, lung sounds, murmurs, and the three lead ECG. And then we have added additional ECG leads on the front side of the device, which will have the finger electrodes, and then the combination provides a seven lead ECG, and then we have optical sensors. And with those optical sensors, we can get Pulse ox, respiration rate, and also blood pressure without cuff. Right. And also, we have a temperature sensor. So So with that, it makes it possible that you can get ICU grade monitoring at home level without connecting any wires, or calves, or things like that, which can be very cumbersome, especially for all patients, right. So that’s where we want to make it so easy that they can literally hold within their four fingers and put it on the chest. And that’s it, you know, and then it pairs to a laptop or a phone or a tablet, and then connects through Bluetooth again, and then transmits all the information through either our platform, or even a zoom meeting or a Microsoft team’s meeting. It’s so so user friendly, you can share your screen, you can share the audio, so that the other side, the doctor can use our own HD stat device to listen to the heart sound, and make real time asked rotation possible, along with all these parameters. So So we believe this is going to be the future of healthcare, particularly for telehealth, he visits and so on, but during the pandemic, and beyond the pandemic, and a lot of very important use cases for remote cardiac monitoring, and so on. Right, so we are doing a lot of those validations as we speak.
Nick van Terheyden
So I mean, some some clever miniaturization innovation, you’ve clearly, you know, as a corporation, as an individual, you sort of think about costs around this. I listened to that. And I’m thinking, well, this sounds expensive, where is where are you with a cost basis for that.
Arvind Thiagaraja
So it’s very easy to price it for a few 100 bucks of the shelf, but we are we are actually thinking it will serve the patients and the providers and payers better if we have some kind of a subscription model to this. So people can subscribe to the service. And depending on what kind of back end service they add to this, you know, it could have a monthly subscription model, you know, that’s kind of early thoughts, we are validating those thoughts as we speak. We’re also talking in colleges and some major partners, and who obviously will also provide us a lot of those inputs.
Nick van Terheyden
So as you think about all of those inputs, and you know, obviously, the capacity to send that information in a remote setting. So you know, we’re talking in this country across zoom, which is now you know, it’s a verb. Other models, what’s the sort of the need? Or the capacity? Is this something that would work in remote parts where there’s maybe not the same level of connectivity? How are you managing all of that in terms of transfer of information? Sure,
Arvind Thiagaraja
sure. That’s a very good question. So that’s where we’re doing some pilots in settings where the bandwidth is not very conducive for video conferencing. And thanks for that. So there, we are trying to see how we can at least transfer the data. You know, and and we believe there are some interesting ways we can solve this problem. I mean, the last thing we want the patient to do is just to talk over phone, and then the cardiologist assessing their cardiac health based on a phone conversation, right? We just don’t want to let that happen anymore. So definitely, there are ways to transfer these waveforms even in a low bandwidth scenario. Quite honestly, the video conferencing is optional, right? I mean, yes, it’s nice to put a face to the name and the doctor looking at the person making some assessments based on facial expressions and general health aspects and so on. But But tele medicine is really not videoconferencing, right, videoconferencing is a nice to have, but it is what is really must have is all these parameters including tele auscultation. That’s our belief and we believe that requires much lesser bandwidth than videoconferencing.
Nick van Terheyden
Right. So I think if I hear you correctly, you know, there’s the capacity to sort of issue or capture information and store and forward so this can be a sort of correct disconnected activity. You could you know, capture the information To me, people can do it quickly and easily. Maybe with some video guidance locally, not sure but and then it can be reviewed, and then perhaps review it together doesn’t even have to be on video. And I agree with you. I mean, that is it is nice to have, but it’s a significant bandwidth suck. So you’re in trials, obviously don’t want to sort of overstep the boundaries, but you know, understanding where you are, and how things are going, but whatever you’re able to share, and some view of where you think this is going to go.
Arvind Thiagaraja
Sure, yeah. So we believe we can get clearance for this. These are some of the initial use cases by q3 this year. And based on that, we want to launch it both in the US market, as well as in some of the international markets, too. We are in some very interesting conversations with some major partners and potential distributors, and so on. And as I mentioned before, we are looking at a subscription kind of model for this. And that makes it easier from an option point of view. We are also evaluating the reimbursement codes landscape for Medicare and MediCal reimbursement in this country. So yeah, that provides some very interesting opportunities. And right now it’s on demand monitoring on a daily basis, the patients can evaluate themselves, but in future, there could also be additional use cases for continuous monitoring and things like that. So So yeah, there are a lot of potential and you are right, I mean, this whole healthcare space needs a lot of very intelligent miniaturization and digitization aspects. to really take it to the next level, I mean, enough of those big old equipments bulky ones, and, and we want to really bring it at the home level. That’s where the wires are so messy and cumbersome. Even in a doctor’s office, very, very few doctors do it themselves, they usually have their nurses and physician assistants. Doing these ecgs is just too cumbersome, adding all those 12 barriers and so on. Now, we don’t want to claim, of course, that this is going to replace a conventional 12 lead ECG, or any of those patient monitoring devices, it would never, but at least it brings them the access at the home level, so that you have more information and evidence based diagnosis that is possible.
Nick van Terheyden
Right. So as you look back, any insights that you got through that process to get all of that in there. I mean, you’ve obviously brought together this blend of, you know, healthcare focus and Technology, Engineering focus, I don’t think that you look back and say, Wow, that was really helpful in terms of your trajectory to get you to this point, the, you know, strikes you
Arvind Thiagaraja
sure, I mean, the pandemic certainly was a catalyst for everything, I mean, who would have thought people would rush to buy a pulse ox device at home, right. And that, really the pandemic daughters, and, and more and more devices are getting to the home. I mean, there are already a lot of blood pressure monitoring services, where they provide your device and you can monitor at home. temperature has always been there. And then now asked rotation ECG mean lot of my single lead ECG devices, including the watches, and so on, so they are all trying to revolutionize the healthcare space. I mean, it’s it’s it’s all good stuff. But we want to make a distinction between a lifestyle device versus a medical device.
Nick van Terheyden
Right. So in the last couple of minutes that we’ve got left, where do you see this going? what’s what’s what’s next. I mean, it sounds like you’ve really sort of pushed the boat out. And you know, I’m expecting Captain Kirk to contact you shortly. I’m just gonna say.
Arvind Thiagaraja
So we just announced our first 10 parameters. And already, we have a wish list for another 10 more parameters. So
Nick van Terheyden
Wow,
Arvind Thiagaraja
we are working on that. So we want to keep innovating. We want to keep improving the state of the art both for, you know, the payers, and physicians at one side and also for the patients to actually benefit from this technology revolution. So we believe this is just the starting and we want to really take it much further. Yeah,
Nick van Terheyden
that’s fantastic gossip, that blows me away as much as the sort of innovation that I’m hearing about an additional 10 parameters that, you know, you can start to push out into the home that really sort of makes for this medical home that you know, can truly be engaged. Unfortunately, as usual, we’ve run out of time, it just remains for me to thank you for joining me I think fascinating progress, amazing innovation, I love when these sort of engineering insights, you know, development of a device that was already providing value. Now you know, moves to even more value and more miniaturization and continuous you know, potentially continuous access or capture of data in the home. I think this is exciting stuff. So thanks for sharing your story. And thanks for joining me today.
Thank you so
Arvind Thiagaraja
much. It was great to be here and thanks for all your wonderful questions and look forward to further conversations. Thank you so much.
