Inventing the first ever FDA-approved Pulse Oximetry

Chris

Lyon is a serial entrepreneur, inventor, speaker and mentor within digital health. He invented the world's first FDA-cleared, risk sensor pulse oximetry monitor. He has seven US patents, 40 Worldwide patents, was CEO and founder of a highly successful med-tech and digital health company, Oxitone medical, one of the healthcare transformers with StartUp Health and now advises founders, startups and established companies. Today, we're going to talk about the past, present and future of medical devices, advice for digital health entrepreneurs. And not only around business but around how to think about business. Leon, welcome to the pod. We got to know each other over the summer when we were on a learning mission on our side. For chronic disease management and medical devices and wearables. Lucky for us, you responded to random LinkedIn reach out for us to be able to learn more, and you dropped so many insights in our conversation that we knew we had to have you on the pod right away. So thank you for coming. Maybe Leon, if you could briefly tell us about oxitone and anything else you're currently working on?

Leon

First of all, I'm really really glad to, to be here and to talk to you guys. Thank you, Chris, for invitation to participate in your amazing, amazing podcast. It looks like it is a second time I'm here, right? We did it before once.

Chris

Yeah Yeah. Not in the podcast format, but definitely in the interview format.

Leon

Yeah, I remember I remember it was an extremely nice experience. So about myself. I have I'm living in Israel today. And I did my Ph.D. in physics, in quantum optics, quantum electronics, quantum mechanics, quantum computing, in Weizmann Institute of Science, and then I did my PhD in laser cooling. And then I decided to join startups in Israel like engineer. So I was working in many startups, I helped to develop. And it happened that most of my job was dedicated for development of medical devices and digital health. So this way, I was introduced into the medical device industry, that really was amazing. And I found a lot of opportunities there. A lot of things we have to do, because this industry was here in transition mode. From very also, it's interesting because together, it survived very old approach. You still have very old devices, you know, famous. At the same time, people started to use a totally new device, and there is a huge vision for the future. So in 2010, I decided to launch my own company after I got a lot of experience in this area. And it was based on my invention of the workflows that get clear with pulse oximetry monitor, it became possible was world’s first after seven years after invention, but I started to develop unique device, all people wear visible heart rate monitor for wellness, and I was dedicated to develop something that is beyond just heart rate. It's a pulse oximetry, and to give people capabilities to have the very comfortable measurements without any fingertip probe that is really bulky, disturbing and most important, we have to do it on a medical-grade level. That's very difficult. That's first time in our world, it happened. And I invented a totally new technology. It's not totally new based on the old approach, but new placement, new configuration, new measurements, it means we try to use all the ball on the wrist like very unique place where you can measure in a high accuracy level patient vital signs much better accuracy than any other place and cure including fingertip. And you can compare accuracy with forehead for example. So the main issue that bone enables to clean and to guide the signal, optical signal in the way that we have very good signal and steel. This technology opens huge probability capabilities with respect to a relative to conventional technology that wellness devices are using. And by the way, today only three medical devices received FDA for pulse oximetry. And it looks like today oxitone is only wrist worn device on the market that you can buy and use.

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Chris

Right. Thank you for that, Leon. And yeah, I'm curious as to when you were inventing oxitone? What were the design goals that you had in mind? So for example, you mentioned something that is wearable on the wrist, so maybe perhaps people will actually wear it. I'm just curious when you were going in, what were you thinking about, as in this medical device is going to be better adhered to or it's going to be just better than what's on the market? And what you're looking for?

Leon

Amazing question because this question just follows all our development, sales, development and company development in understanding of the market and what we have to deliver. So definitely, in the beginning, we thought we wasn't so much equipped with knowledge and experience. So we thought, okay, while doing something new, we eliminate bulky things, we deliver something very comfortable, people will start to use it immediately. No, it didn't happen. So we had to think about. So we told that you will do something between wellness and medical. So it looks like wellness, but it's medical. It will work, when? No, it didn't. So we will talk about it later. But we didn't. I personally did all possible mistake that is possible to do. That's why I took about seven years, eight years to develop this innovation and commercialize it. And still, we have a lot of feedback. And we're working on totally new device that incorporates all what we were learning during our adventure. But actually, you're right. So it was very difficult. And we'll learn a lot during design and even I went to Harvard business school to learn design thinking specifically to understand fundamentals of design, and bringing product to the market.

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Chris

Okay, yeah, I think you're right , Leon, I do want to unpack that oxitone journey and those learnings quite a bit later, understand what made you understand that you needed to go back to school and study something new, like, for example, design thinking from Harvard. But maybe so people can understand that journey more, we can back up and talk about a little bit, just defining what medical devices are. Now you are the inventor of the world's first FDA-cleared pulse oximetry monitor on the wrist. And so we were thinking, Who is the best person to ask questions about medical devices and the past, present and future? And also, what's needed to bring them to market for example, FDA clearance? So my first question for the audience, and for me is, what is a medical device? And what are the different types of medical devices?

Leon

It's a very tough question. And today there is no such a pure line between medical and wellness and wellness devices like it was 10 years ago, for example. Thanks for Apple and so but actually medical device, it is not what received FDA, like all people think that okay, you have a FDA, your medical device now? No, it's not. Medical device from physician's point of view, it's not device that has only has of FDA, So it's not enough. You have to prove that your medical device is accurate, is, you can trust the data. And it's, it has a very good repeatability. So you have to qualify any medical device, even if this device has FDA because of they check for safety. But if you want to deliver accuracy and all the stuff around, it's important to go to the field to the hospital to make pilots and to prove through incredible number of pilots and articles to prove that specifically, these device is good for specific content of interest for healthcare, and this is most important, and some physicians think even okay, I can use apple. It's not medical device. But row 1000s of validation. It works Okay. So I can use it, why not? That's why I said there is no clear line between medical device and wellness. But even more, even more will have, because I was dedicated to build medical device. And suddenly I found myself in competition with wellness devices, even among physicians. Interesting, So what happened? You remember I said in the beginning, I thought if I make design like wellness, and I will use it like medical, I will win from both parts. No, you have to focus on your specific area. And what happened, all these big wellness companies, Corporation moved specific medical device into specific niche, it's a big niche, but niche of chronic diseases and high-risk chronic diseases. Where we met holter monitor, for example, who is for 50 years there, in this niche never get out of these. Now, all these medical devices like Oxitone were just moved, squeezed into these niche. That's why we decided on our new generation of devices to remove for example, screen, who needs screen? It's a medical device with screening. They don't have to watch on device, people very sick, they don't need. So this is what is a trend today. I will say.

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Chris

Yeah, no. And I'm hoping you can comment on the difference in perhaps rigor between wearables and medical devices. So I recently got my first wearable Garmin watch. And it was amazing up until the point I worked out for the first time, and I hit the treadmill hard practically out of breath, heart racing, and yet my heart rate is still showing 95 beats per minute, which absolutely defeated the purpose for me knowing that I'm in that orange zone of 140 to 150 beats per minute, for my age, and which by taking my pulse I was actually over. And frankly, I don't know if that bodes well for the pulse ox that is also on the same watch. But yeah, I was wondering if you have any comment on these popular off-the-shelf wearables, and whether they have the rigor, accuracy to really be used for disease management.

Leon

This is exactly the issue that what you mentioned now, because they don't care about accuracy. They don't care about it, you decide whether you want to use it or you don't have to use it because it doesn't influence on your health. And by the way, wellness devices for healthy people. So I am healthy,  Why do I need pulse oximeter? because my oximetry doesn't change, never change, even change, I have to go to the hospital and I will receive medical device like oxitone. But okay, I am healthy, I wanna prove myself every day, that I am healthy, good. And you decide if you are good with this accuracy or not good. So you have some bias to these devices. Okay, I accept it not so accurate. But to give me some understanding that I'm healthy and happy to understand that I'm healthy, I have a lot of a lot of dopamine because I'm healthy, great. Go, And in medical device, we cannot afford to give you  non-accurate data. So what we do, we eliminate any measurements if patient is moving, we cannot give you a wrong data. So we gather data for patient who is not moving. And we are using for patient who is not moving. So we have our accelerator at some point, just switch off all measurements, if patients is moving, because we cannot rely on whether device decide to give us good data or not good data, we have to eliminate any risk. And by the way, our patients are not moving so much because it's very sick patients. So these, the difference again, the difference between medical device and wellness is that it's specifically dedicated for very sick patients and very focused on specific measurements. For example, if I have COPD patients or sleep apnea patients or CHF patients, it has very specific approach how to measure and we claimed it for FDA.

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Chris

Yeah, got that and then I think what's interesting about wearables though is that it's getting people like me to actually wear a device more or less at all times. And it's almost like this flipped classroom where before, clinicians will request that a particular patient with a particular disease adhere to an advice, or sorry, a device. But now, there's a little bit of this counter flow of patients that are bringing in their Apple watches and Fitbits, etc, and hoping that they have some medical use for the clinician. But maybe to expand on the difference if you can walk us back through medical devices, and really the past and the present, and just how they arose. And then also for that first flow of being pushed out by programs from, let's say, clinicians, how are they adopted? And who pays for them?

Leon

Oh, very interesting. But before I would like to just record very interesting meeting with Google five, five years ago, they were working on their own watch. You know, it didn't happen. But they were working. And I had a meeting with guys from Google variety. And they said, We have medical device, this one that we're using in our clinical trials. I said okay, Does this has had of the clearance now. So why is medical device you said, Oh, it's medical device because we're using for medical use, for clinical trials. Okay, I was very surprised about such approach. And finally they both fit. Okay, this is the story , about your question. I don't know if many people know that the first medical, Device first watch first wearable, wearable medical device happening to be design in , in 1695. In 1695, It's a 300 , 400 years ago. Yeah, something like these 300 years ago. So this is what happened. And seal John for Oh, in 1707, if I remember, just released the first essay about how it works. So they create a so called pulse watch. It's really a stopwatch. And they developed counting called today, BPM beats per minute they developed and who realized that it was engineer associate of Newton. His name was Samuel Watson, Samuel Watson. And he realized his watch. And they started to sell to physicians and users. So it's a stopwatch that enable using two hands to to count the beat per minute, at wrist. Interesting, right. And just in two years, 200 years, it became widespread. And by the way, these guys also created all these devices were using in sports, stop watches alarms all these stuff, they created this. But in our, in our time, the first wearable device was Jeff holter. Holter monitor, the first Holter monitor was commercialized in 1962. And people started to use it everywhere. And this was the only wearable device this was the first wearable. And first wearable was medical. And in 90s, if you remember Garmin in 1990s, released the first device with ECG here. Not medical wellness, with ECG plotted here in something like this. And just so I think Apple was the last not least, but last who developed ECG monitor on the wrist. And so it's interesting first it was medical devices wearables, then became wellness wearables. And then today it back to medical wearables but for specific niche we were talking about before. So this is the interesting history and how it will continue. I think wearables a very important in some applications. But it looks like all the trend year ago, I told that the trend is to implantables. But now I understand that people don't want to use implantables. It's a point of trust. It's a point of security. So it looks like it's very, will be very difficult to penetrate into the market. So I think the future in noncontact measurements for the camera, like, is really company amazing company, binah AI, they develop technology that may enable to measure all vital signs that any wearable device even beyond these, from the camera, or the smart smartphone. So I think this is the future today, from the cameras, some sensors under the mattress. This is how this is a trend for the measurements of patients' vital signs today, and it's mostly wearable should be wearable device. It's not wearable should be medical devices. Well, so most the cases.

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Chris

Right. Yeah, that makes sense. So more of a ambient monitoring. And I think like along the lines of I guess we'll find out more of when you were theorizing that something on the wrist would have better adherence than something that is more intrusive. The Holy Grail of this sounds like you don't have to wear anything at all, it's not a wearable, but it's just a part of your environment. That is monitoring. And I think everyone that's in the industry of devices, patient engagement, has understood that the challenge is not just creating a device that is accurate and very useful for disease. But then the counter part of that is actually making sure that patients will use it. And patients themselves, right, they don't wake up wanting to be engaged, they don't want another thing to put on I went with Garmin, because I knew I could charge it once every 10 days instead of once a night. And so with Apple, and I knew I would never do that. So I think that level of friction for adherence is what you're touching upon, or else people aren't going to be able to adopt it. Eventually, like today, I didn't sleep with my Garmin watch, because I didn't find it useful for exercising. But yeah, is that what you're talking around is that it's all of the points of this remote physiological monitoring. It only matters that people are actually being monitored, they're actually engaging in using the thing. So if you don't put any steps in front of people to be able to use it, you set it up around them, then hopefully that is this ideal future state.

Leon

Yeah, this is, You are right. So all this stuff is all about data. It doesn't matter how you generate these data, it could be wearable, it could be ambient. Everything that you want, it could be implantable. But most important how you generate the data. And data became with development of such devices, became this very complicated. It's became multi dimensional data by the way, oxitone delivery of multi-dimensional data more than 10 dimensions 10 vital signs, and how to manage all these multi dimensional data, how to build algorithms that enable to identify and even predict based on historical data, what happened to the patient and how to avoid any complication. So here, we're talking about, again, that the difference between wellness and medical devices, wellness device is good for, for preventing disease and chronic disease. Medical Device is for preventing complications. So these two different domains of patient management, and there is a clear understanding of these difference. So we're talking about in both cases, we're talking about data. We're talking about events. So medical device, very good like holder for screening, and screening gives you understanding about some events that happen to patient. But again, here is very important, how assessment we're talking about endpoint, assessment of endpoints that you're waiting for a patient outcome and how to how to qualify these specific device for the specific endpoint, because for example, all medical devices, were working in the hospital, now you take it same vital signs and move it to the home. You know, when you are coming to the clinics and we get measurements of blood pressure, my blood pressure goes up to, I don't know, 60 points. People immediately try to put me into the hospital immediately and I said, I'm okay. I'm okay. It's because I'm in clinics, I want to run out from here and I will be okay. And this is what happens with how to understand what's the difference from point of healthcare context, what we're going to measure how to qualify a device, and if for example, but in our case, we have we're in wearables who are in the much better situation because we have many vital signs multi-dimensional and we can find correlation and this correlation gives us more trust and more accuracy. Accuracy of what? Not vital  signs itself. Assessment of the end point based on the correlation on the pattern on this patient so we have the pattern and pattern is much more reach that taking one seperate vital signs and measure blood pressure or measure blood oxygen saturation. So if you have the pattern and you apply algorithm, you apply machine learning. You have much rich data ,much complicated data but much accurate data to deliver final resolution and understand and qualify this product for specific end point.

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Chris

Right yeah that makes sense and  just to break into oxitone for a second. It goes much beyond SPO2 but, can infer or correlate things like sleep tracking, fall detection, respiratory rates, and more. Is that what you’re talking about that you’ve been able to do with Oxitone is correlate data that  was invented for with these other things that would be very useful for and that people like me are interested in which is more accurate sleep tracking, For example,  more accurate heart rates.  Yeah I  guess just a little bit of how you approach that at Oxitone.

Leon

Yeah because we identified that this technology enables much more than we were thinking in the beginning you know here is very interesting. You know that any invention become invention. when you recognize this idea,so if you design or devise idea this coming out of the context if you recognize the idea within the context, this idea has a huge chance for success so we recognized this idea, we took this idea from the context, and we developed technology that finally enabled to measure today blood pressure for example even more we decided to focus today on prenatal care because our technology we call it trans-illumination all-in-one technology, and applicable to any bone in our body enables to measure stauts, heart rate and heart rate variability. And we are starting pilot about it. And this is a huge breakthrough. It's a revolution. Because today for the last thirty, thirty years, it wasn't a big advance in prenatal monitoring, There are clinics, women go there. But pregnancy monitoring at home is not advanced at all. There are some devices, very non accurate. Home ultrasound devices, for example, very not accurate, or some big things that women should like big belts to do it. But now we come from the wrist and we have fetus, fetus, heart rate, monitor heart rate, blood pressure, heart rate variability, that is stress, and sleep position,  position of the woman is to understand which position is the best and which position is worse for the baby. A lot, of its revolution. And this is our direction today and all because we have very clean and very unique signal from our technology. And these comes from the single, single sensor.

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Chris

Got it? Yeah, that's incredible. And as you're designing for prenatal, I'm going to be curious as to how much different characteristics for example, form factors start to matter or not. And I bring that up because another entrepreneur we met named Chalisa she invented a wearables company. But one of her big learnings was with women, how much style and customization mattered to her target user base, and became ultimately the selling point. So I'm really curious as you go into this, if there is, you know, these completely Non medical considerations that go into your thought around the design of the device. So not about convenience, necessarily not about what it does, although, of course, those are first and foremost. But how does it look? And can I personalize it for me, and then when people understand that I'm wearing this thing that I am pregnant, and, you know, but I'm almost sort of representing some part of myself with a form of fashion. So not to be I don't know if you've even thought about it.

Leon

Yeah, pregnancy is quite easy, because everybody see that she's pregnant, so she doesn't have to hide anything. Alright, so it's much easier, definitely, we have to think about colors, we have to think about design. But it's much easier than we were elderly, for growing up of chronic patients. We told in the beginning that some community of elderly patients, elderly people ,chronic disease people, so it's a great market for us. And what happened when we came to this kind of convenience and try to sell people said. People 80 years old even 90 years old in community,  in community, they create networks, they create, even they have laugh with each other. They don't want to look old, with some crazy medical device on the wrist. And they said, Now we don't buy it, because we're going to do support because we have some we have girls here also 80-90s old, we're going to look young by going to look healthy. And you want me to wear this medical device? No, it doesn't have one of our mistake, by the way market definition. So yeah, what we, what we check with pregnant women, they are really interested because they conscious more about baby and their health than about how they look like.

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Chris

Okay, got it? Yes. And so getting back to the practice or business side of medical devices. So one is the business side. So for devices that are recommended as part of a treatment care plan to a patient, who ultimately is paying for that. And what are the different business models if I'm creating a medical device startup?

Leon

Yeah, medical device, mostly b2b In a consumer device. Wellness devices, people buy it, in medical b2b, you know, in Germany, for example, people going to die, but not not to pay by themselves. So this is what happens. So people get used to ,so our society just make people get used to somebody pay for their disease management. And this is, this complicates and increase the cost of the whole healthcare. That's why it's very difficult to change something, because too many shareholder,  stock, stakeholders in this market, and try to do something you know what alone in the business, what really works is only one step decision, you think you don't have to think about five steps ahead. Because you create a lot of uncertainties, you have to think about one step ahead. And that's why I designed something called backward that I teach my, my students, enterpreneurs, about backward planning. Because this gives the opportunity to see yourself in the future. But it doesn't eliminate, but it eliminates complexity. Because if you think about several steps ahead, you create a lot of complexity in your, in your thinking, and in implementation as well. So it's very important to think one step ahead, and then to to recognize what happens and to  re-evaluate. So you know how it works , you take background data, you think about this data and extract what is important, then you evaluate what is important, and then you decide, make conclusions. This is the line of thinking that is important for entreprenuer your to succeed. A lot of techniques we can talk about for days, but this is one of the main techniques how to think.

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Chris

Got it,Yeah, and I do want to unpack that quite a bit more later. Yes, but so for medical devices, you mentioned most of them are b2b, as opposed to me going to buy a Garmin or someone going to buy an Apple, right? That is direct to consumer. But for b2b, who is, who can be the B , right? And what are they buying it for? So for example, distinguishing between payers or health systems. And in particular, for someone who knows they could create a device but needs to get it off the ground with an actual pilot customer. Who could that be?

Leon

A lot of companies in wearable area started from pharma because pharma pay directly. And they need using medical devices for assessment of the end point for their drug and therapeutic development. So this is the most important market, for example, one of the greatest company by foreigners, Unicore, they started from the pharrm. And a lot of companies started on the pharma, because again, no complexity, you know, who pay you'll sell them. That's all. When you come to health care area, it's much more complicated. You can get payment from durable equipment agency, you can get payment directly from hospital, it depends, during the pandemic, for example, it happened many times when hospital make purchasing within the three days. You know, usually you go through the Badgett assessment, all the stuff it takes about a year to sell, it depends when you start to sell, but it takes about a year or two, to sell to the hospital. And during pandemic, they bought this for three days. That's amazing. So this is what happened. It doesn't happen anymore today. So it's, it's  really very, very difficult to estimate, for example, we sell to a lot of, a lot we sell to and collaborate with research, universities who need some research. So we receive grant and they pay directly and very quickly, and they use our product for their research. And we'll customize sometimes what kind of data they're going to receive specifically for their patient. It could be CHF, it could be sleep apnea. Another another business is sleep apnea clinics, so they pay immediately as well. But they don't need a lot of ,a lot of items. So it's quite not so good. Hospitals are the best. But it's quite complicated to enter into this into this. So again, we try to mostly try to sell and also we're using distributors. And we're planning to close, big agreement with one of the biggest distributor in healthcare in the United States. And we think this will accelerate sales, because distributor has access to all clinics, and we don't have to look for some champion there and spend time on sales on structuring the sales there.

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Chris

Right. Yeah. And you're mentioning some of the complexities of going direct to the health system is that what you were talking about is the complexity of navigating and defining your internal champion and then getting a pilot signed off on and just the length of time and grit that it takes to actually get to use something in a clinical setting. Are there other types of complexities? That you are talking about?

Leon

It's a multi dimensional complexity ,when talking about when you have to start to talk to them because they close their Badgett maybe in September. So if you come to sell to the hospital in October, they say, Okay, you're late , come in April. Come to us in April. So sometimes it happens. Another complexity is even on the personal level. Just imagine you're working like manager of Promotion Department, and some company came to you and say, Okay, I have something I went through innovation department, by the way innovation department specifically designed to, to filter companies hospital not to fai,l to filter out companies this way. And yeah, and so you come to the purchasing department, and say, Okay, take it and personally  what you think I am here, I have very good salary, I gonna grow here. And if I will buy and they will disappear as a small startup, I will lose. Okay, I did something wrong, I bought something that doesn't exist. So it will have a huge impact on my career. I don't want to talk to these companies, even they bring incredible device. Or some once it was an amazing experience. So I was working with one physician in one of the biggest medical system in the United States. And I came to another department or this medical system to another physician and said, Look, I was working with this physician, he tried our product he like if he bought it, I think you need it as well. And he answered, who am I  working with, I don't want to hear about this guy. I will never buy something what he is using. So everything happens even so you go for a whole level from Badgett level from personal understanding person, mind of people. So this comes to entrepreneurship. What is it entrepreneurship, you have to understand all these complexities, and manage it and control it, and how to control this is what we have to learn.

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Chris

Right, yeah, it's super interesting because in the technology space for many SaaS products, so let's just call them, let's say, Slack, figma, github, a very viable strategy is to go in with the end user, that may not be the CIO of the company that  makes those decisions, but get early adoption and a lot of usage and a lot of internal evangelism from a small user base. And then the next thing you know, six months later, you have 500 licenses on Slack. So it is very much that grassroots, bottom up adoption that can work. And what I'm hearing is, you know, there's a whole lot of risk for someone, there's no risk to start using slack for a project and decide you like or don't like it. But within our health system, when we're talking about people's lives and a bunch of different roles and investments in the company, probably there's a big blast radius. Now, one of my observations is that, gosh, there's this graveyard of companies that did create medical devices or wearables, and at the end of the day, they're gone, because no one would ever actually use those devices. So what we've spoken to many entrepreneurs who are kind of flipping that grassroots Adoption Model, which is hey, let's get the consumer to adopt the device, adopt the program, maybe their caregiver, and they're going to drive the demand at the end of the day, back towards the health systems, who probably still will be a big part of the business model. Yeah, I'm wondering what your thoughts are on that of these different styles of Yeah, go ahead.

Leon

Yeah, some people go to consumer market, but there is another side of this coin. And that is you have to invest a lot in consumer market. And you were talking about medical device, you know, you have to train people even to measure blood pressure, they have to be trained and the whole by what pressure people who are not technically savvy, they're elderly people, and you have to train so how, what kind of team you have to keep to train each each person separately, you can. So, the consumer market for medical device is very complicated. It requires a lot of money   did you  pay attention that how how much money any company consumer market raised, take or take other companies without money, I cannot do anything and create demand from this market. It's almost, almost impossible. So it's like lottery. So probability is less then you have to win lottery.

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Chris

Okay, so I want to ask two more questions on medical devices and then want to move on to say I think I could ask and learn from you all day about the devices but as far as the you know, the that in proved rigor act We have seen safety and medical devices in the FDA clearance process. Can you please outline for our audience a little bit? Like, what are the steps, how long it takes? And what I would tell myself 10 years ago, if I was going to about to embark on this process?

Leon

You know, Again, it's not straightforward. So people think, okay, I do something, I check biocompatibility, I go through a whole checklist from the FDA applied to the FDA, and I'm done. No, It doesn't work this way. Because I think from my experience, 50% of your success in FDA and we did something first and FDA feels device, it's who represent you, in FDA, its very important, how does he write a message to FDA,  how to manage how to he controls conversation with FDA, call consultant and the consultant 50% of success, despite the fact you went through a whole clinical trial successful, everything else is done. Now, these were important. So personality of your consultant. Second who is in FDA you meet with? whom? It could be some I don't know, students five years ago, who didn't even find a job in the FDA? Who doesn't understand how not to recognize the problems? Or is some major guy who is 50-60 years old, who is 40 years in the FDA, and kick you out immediately? Because I understand all the bullshit you're going to apply. So, also, it's some, it's some lack of luck. Depends, okay. So a lot of things happen. So you have to think for whom I will have to work with how you make the claims. Who is ,who is responsible for your file in FDA. When you apply, try to apply to december? Yeah. Okay, check what will happen. So that's why we go to consultant from the beginning, from the first day from the beginning of my company, I asked consultants, how do I have to build the company to go for FDA? First, I had the plan to be the first in FDA . How should I build my company?

Chris

And for clarity, when going through the FDA clearance process, it is I believe, as you've mentioned, for a specific claim. So for example, oxitone, SPO2,  and the first one that's reading that accurately, from the wrist FDA cleared, how about for other things that a device may do? For example, let's just say sleep tracking, fall detection, respiratory rates, which of those are either the same FDA clearance? Or not under FDA at all? And yeah, how do you navigate that?

Leon

Through I don't know. Now, we're preparing all documentation to apply for FDA for respiration rate, and blood pressure in line. And we're working with our consultants very close about how to apply so, all device has FDA clearance. So with that don't have to clear device, we didn't change anything, what we changed, just we added some algorithm on  the FDA cleared a date already, above, that enabled to measure a pulse and other vital signs. So how do we apply like Apple for the algorithms? Or because we have FDA clearance for the whole device we cannot do this we have again apply for all device. So we decided to apply separately for respiration rate, and then we will see what will happen

Chris

Okay, got it. And then for the software components, like for example, let's say there's something that runs that's not on the watch. Or sorry, the wearable, and it is interpreting the data and correlating it with a real medical usage. What are those lines as far as the hardware over here and the software over here that's meant to work with this device that would trigger two different thoughts of FDA clearance or two different pathways, or is it kind of treated as the same now? Like the hardware and the software.

Leon

Yeah, this is the problem with FDA because themselves they don't understand exactly how to deal with this. Because you're right. For example, you have the full platform, you have the index that could give you some data about event with your heart , heart event, you have some index we build this index based on machine learning and other stuff. And you have the clearance for this index. Now, what is the input? Can they use Apple like input or have to use Oxitone like an input? For Oh, so physician decide by himself? What he's going to use to have to have to use this index for his medical goals,outcomes. So it's, it's not clear today, and we are in transitional state, we are transitioning from, not from towards digital health. And it, it requires change, a lot of fundamental basics of the health care approach are the health care measurements. And this is what happens today. So we're living in very interesting time where this transition happens, and it creates a huge opportunities for innovation huge, just you have to follow what happens and not to be in the place and time too early and not into, you know, in the right place. You have to be in the right place in the right time. That's why you have to follow what happens. And watch this ping pong in the market for healthcare devices, medical devices market.

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