Metyos & the Future of Wearable Medical Devices

Today we are joined by Paul Durand-Estèbe, Lead Electronic Developer at Metyos. He and zach have a fascinating conversation about how Metyos is contributing to the future of wearable medical devices. They focus on Metyos's groundbreaking wearable glucose monitoring tech, the medical field's emergent wearables trend, and much more.

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Show Highlights:

• Intro
• Intro to Paul and Metyos
• A Lesser Invasive Glucose Monitoring Device
• Better Monitoring Faster
• Bad Glucose Monitoring Leads to Disastrous Results
• Potential Chronic Health Monitoring Systems
• Why Start with Kidney Disease?
• From Monitoring to Administering Medication?
• 18:01 Scaling Challenges (Cutout a minute before this)
• 22:36 Proving the Effectiveness of the Device
• 26:54 What Does the Manufacturing Look Like?
• 31:37 Initial Response to Metyos
• 35:56 Doctors Receiving Real-time Data

Transcript:

Zach Peterson:

If you go and look on the company website, I noticed that there were some images of people with what looked like a prototype that you just showed us on screen attached to the arm, putting this on the arm and just having it passively detect. How is that different from the conventional method for testing someone's glucose levels? Do they have to normally do a blood draw?

Paul Durand-Estèbe:

First, you have the data continuously available. So for a kidney disease, those are quite long-term disease, it's chronical disease and that can suddenly evolve quite rapidly and quite dramatically. With only blood sample, you may miss the critical points. And it's less intrusive, you don't have to think about it, it's just in your arm. And you don't lose any data points.

Zach Peterson:

Hello everyone and welcome to the Altium OnTrack podcast. I'm your host, Zach Peterson. Today we're talking with Paul Durand-Estèbe, lead electronics developer at Metyos. If you've paid attention to Altium's social media recently, you know that they are part of the startup program called Launchpad and I'm very excited to talk to them today about their technology. Paul, thank you so much for joining us.

Paul Durand-Estèbe:

Yeah, hi Zach.

Zach Peterson:

So it's always nice to have startups on because you guys are always working on something interesting. So just so that our audience gets to know you better, maybe tell us about yourself and what Metyos is doing and what products you're currently working on.

Paul Durand-Estèbe:

Yeah, sure. First, thank you very much for the invitation on the podcast. So at Metyos what we do, so the company was created two years and a half year on March, 2021, and the main goal of the company is to develop devices to help prevent chronic diseases and to help patients and doctors manage and improve treatment by better monitoring. So we're developing a solution on a wearable patch that is capable of real-time measurements of biomarkers.

So it's quite similar with what we have for diabetes, the continuous glucose monitor, so the small round patch that you can see on the arm of people wearing them. But the CGM are monitoring only glucose. We aim, our device can send several molecules and biomarkers to address all the disease in the diabetes obviously. So I have a small prototype here of our device. That's our first prototype.

Zach Peterson:

So for anyone that's listening on audio, we've got a small red box. It looks like maybe an inch by an inch.

Paul Durand-Estèbe:

Yeah, that's it. It's a bit more three centimeter by three centimeter, I don't exactly know an inch, but a bit more than two millimeters I think. So our first use case or what this prototype aims at monitoring is biomarkers needed for kidney disease monitoring. So namely for molecules, glucose, creatinine, potassium, and sodium. How we achieve this is by having microneedles on the bottom of the patch, microneedles about one to two millimeter long, that will sense the interstitial fluid. So the microneedles access is done in your body just under the dead cells of the skin. So we're not sensing in the blood, it's like the CGM.

The CGM are not sensing glucose in the blood but in the, and the point is to be the least invasive possible, we call it microinvasive microneedles. So yeah, like this we can sense our molecules, then we send them through Bluetooth and through the patient phone to the cloud. It's an gateway of our system. And after treatment, the data can come back to the smartphone of the patient so it can have a real-time vision of this constant measurement, and also sent to a doctor or whoever is needed in the treatment to have real-time access to the patient data.

Zach Peterson:

So if you go and look on the company website, I noticed that there were some images of people with what looked like a prototype that you just showed us on screen attached to the arm, and I'm not familiar with glucose monitoring or biomarker monitoring, but putting this on the arm and just having it passively detect, how is that different from the conventional method for testing someone's glucose levels? Do they have to normally do a blood draw?

Paul Durand-Estèbe:

Yeah, for glucose, before patches, you had to pinch a finger to get a drop of blood and put it in a small machine, which was I think already a big improvement from the blood sample regular test. But still having the glucose monitored or whatever molecules monitored in real time is a clear improvement from a blood sample in regard with several points. First you have the data continuously available. So for a kidney disease, those are quite long-term disease, chronical diseases, and that can suddenly evolved quite rapidly and quite dramatically.

So with only blood sample you may miss the critical point or do the blood sample a bit too late. And also the delay between a blood draw and the results can be a few days or maybe weeks, maybe depending on where you live. And so you can do it only... I don't have not impacted by this disease, but I guess you cannot do this more than a twice a week or something like this. So you have a better monitoring and it's less intrusive. You don't have to think about it, it's just on your arm and you don't lose any data point.

One of the issue for kidney disease, some medication can dramatically damage your kidney, and so when you are prescribed this medicine, you have to do a blood sample in one week or two weeks to see how it went. But some people just forget or do it a bit too late and it has dramatic consequences. So yeah, with one of these device you have the medicine at the same time the monitoring device, you monitor your kidney health and it is a way better comfort and way better monitoring.

Zach Peterson:

So with regard to kidney health monitoring, has this resulted in, you could say degradation in the patient's quality of life or possibly even death if they miss these spikes in glucose or any other biomarkers?

Paul Durand-Estèbe:

Yeah, totally. So we need the glucose for kidney disease even if it's not for, but yeah, it can lead to deaths or at least very acute health issue. I'm not a doctor so I hope I don't go too far from my field, but kidney disease is rarely the first cause of death or very important symptoms, but it'll damage other things. The first being the heart, with kidney diseases you often have then heart issues, and that will be a failure in the heart or something like this that will eventually.

But the root cause was the kidney disease. So yeah, that's why it's very important to monitor it continuously. And again, it's a point with chronical diseases and that's why also Metyos want to address and monitor chronical diseases is that for a long time it's quite quiet, nothing evolves, you're okay. And because you went under stress can be it's suddenly very hot, which is quite more and more often these days. And so you are under the dehydration and your kidney will have to work more than usually, but as you have a disease, they will start to fail.

And it can go very quick in matter of days, you will have symptoms or you're not that well and all, so you can then consult a doctor. But it'll take few days, then blood sample's few days more, then the result few days more. And so yeah, you just lost two weeks just because you were dehydrated for a short period of time because it was too hot outside. So the continuous monitoring is very important in chronical diseases.

Zach Peterson:

So the bigger question as far as where this technology with microneedle sensing directly through the skin is going is, is what's the longer term vision for leveraging this? You've mentioned two conditions, you mentioned diabetes and kidney disease, but are there other chronic health conditions that could be monitored with this approach but maybe not this specific device?

Paul Durand-Estèbe:

Yeah, totally. So kidney disease is our first application, but we have a broad roadmap including different pathologies in cardiovascular health directly, women's cells, metabolism issues and others. The thing is it depends on the biomarkers. If you manage to find biomarkers or several because the point of our device is to monitor several biomarkers at the same time that are characteristic with your disease, you can then adapt the sensor. We see our sensor as a platform for chronical disease monitoring. So the electronics, and the mechanical parts also down to the needle, is quite easily reusable for whatever biomarkers you want.

So that's more the chemistry of the electrodes. So you have these microneedles and of course you have to functionalize those microneedles to be able to detect and measure the concentration of the molecular interest. So yeah, kidney disease is very good thought for this application because there's a high burden on people suffering these diseases. In term of market, that's a big market but also a lot of people to help, but then it can be declined to other chronical diseases. As long as we can monitor, we can find the biomarkers relevant and then find the chemistry to properly functionalize the electrodes to then send them.

Zach Peterson:

You brought up another point that I was going to ask, which is why are you targeting this market first? It sounds like a couple of reasons. One, it sounds like it's a high value market, so it makes sense from a business perspective. But then from the technology perspective, it sounds like this is a good way to prove out the concept for what you're trying to do. And possibly, again I'm not a doctor either, but it sounds like kidney disease is really a symptom of other chronic diseases that would require monitoring. Are those points fair?

Paul Durand-Estèbe:

Yeah, totally. The symptoms are the root cause for other disease or issue. But the kidney disease case is also, that's a major chronic disease that requires frequent biology monitoring. There are some people with dialysis that have to go to dialysis center several times a week to properly filter blood, and a device like ours can also improve, or what we think, to give more data to probably set up the machine or you also have dialysis at home that maybe can be improved by continuous or at least by the availability of more data. So kidney disease by itself is still a very big market and a very interesting market to address.

And that I'm myself, but that's a root for all the disease like cardiovascular that can be... The thing is that apparently from when you are about 30, you start to have kidney malfunction or at least the kidney start to functioning less than it was before. So you have several stage of kidney health would say, I don't exactly remember the scale, but from 30 you are at already at stage two, everything is normal, but it is bit less action than before. It's only a problematic at later stage. But the thing is that it's not as good as before, quite early in life. So with very widely available sensing device, you can detect all those disease quite early. And as we all know, treating a disease early is always one of the best thing to do.

Zach Peterson:

Yeah, of course. The other thing I'm wondering is if this technology could be leveraged away from just monitoring and then to possibly administering topical medications?

Paul Durand-Estèbe:

Yeah, totally. At least at Metyos for the moment, we're not planning any step in that direction, but that's totally devices that are in development today continuously delivering drugs to the patient or adapting the treatment and in real-life time. But that's not the step that we are going to. But for diabetes, that's already what is happening. At least I saw some... I'm not sure if it's on the market now, I think that there are. But the same thing of the glucose continuously on one side and it's connected to insulin pump that will adjust in real time the insulin level for the patient. So you start to have an organ replacement at this point, but.

Zach Peterson:

Yeah, that's really interesting. Organ replacement, but you just hook it onto your arm and you don't have to go into surgery to get that done.

Paul Durand-Estèbe:

Yeah, totally. It's by an external device that monitors and pump the right treatment.

Zach Peterson:

So I'm sure in order to get to high volume there are quite a bit of challenges and it's going to be challenging to scale out this product to the point where everyone has access to it, doctors are aware of it and recommending it to their patients. What are some of those challenges that might be preventing scaling of this type of product?

Paul Durand-Estèbe:

Well first, we are developing a medical device and it is a medical device with medical grade or not. We don't aim at all at wellness market.

Zach Peterson:

Like personal monitoring. This would need to be something that's prescribed?

Paul Durand-Estèbe:

Yeah, exactly. Then if you look at CGM, again they are medical device, but you can also buy them for wellness or personal use without medication. If you just want you to eat healthier, you can buy one, it's okay. But same, the first market is medical device. So we are developing a medical device, so we have to go under a clinical trial, at least one clinical trial to prove... A clinical trial has several goals to prove that your device is okay and cannot harm anyone, which for us is quite obvious. It's very microinvasive, just a red spot on your skin, but that's about all.

And of course the main point is to prove that it's useful and that you can compare to standard way of measurement. So yeah, we plan to start our clinical trial in the first semester of 2024, so in a few months now, to demonstrate that we can properly monitor the molecules of interest as well as a blood drug. And then you need to manage to scale up the production of the sensor I would say, so that's not my field, but on the chemistry side, we'll of course have to redevelop methods of functionalizing all our device up to scale and doing so we have to maintain a low cost of our devices.

Our goal is to have an affordable solution for everyone, so it can benefit the most people possible. And of course as its medical device, we have to ensure the best quality possible. The market and the field is highly regulated of course. So we have at least to comply with all the regulation, which is a very high level of quality and control over the entire production process. But that's always thing that you have to keep in mind when you are developing such device and in a high quantity. And so we aim to sell our device on the mass market in 2025, which will one year of developing the certification and mass production.

Zach Peterson:

So because it feels like this is akin to health monitoring devices like maybe optical pulse oximetry or something like this, I would've thought that you wouldn't have to go through the level of clinical trials that maybe another medical device would. Is it just because the device is invasive even if it's just a couple of millimeters below the skin?

Paul Durand-Estèbe:

No, for pulse oximeters, I think that you still have... It depends on what purpose you want to sell your device. If it's just, I was about to say entertainment, but if it's just, I still call it wellness, you don't have to prove that well. And if people cannot also use it thinking that it's a very accurate monitoring device. Pulse oximetry you cannot... I get that you cannot do much with the value. So you can still sell not that accurate pulse oximeter. And on my smartwatch won't show what run it is, but I don't think that the pulse oximetry is very good.

It often shows me that I'm 92% or 91% oxygen saturation, which normally I should be under a mechanical respiratory machine, something like this. But if you want to sell it as a medical device, then you have to go under clinical trial. And I also talk about it because in my previous company we had at one point a project developing our own oximeter and we approached all the path, we started to get interesting in all the path to get a clinical trial and a certification for our pulse oximeter. And clearly it was supposed to be medical device grade, so we had to go to the clinical trial.

Zach Peterson:

Real quick, when you say medical device grade, this is high enough grade for diagnostics or just for monitoring?

Paul Durand-Estèbe:

Honestly, I'm think that's-

Zach Peterson:

Or there's no distinction?

Paul Durand-Estèbe:

I'm not sure. I think that's helpful diagnosis. I'm not quite sure on on the terminology here, but we still have to... The point is we have to prove the effectiveness of our device and prove that it's effective to be able to be sold and to be prescribed and then probably reimbursed by healthcare insurance. And in order to prove the effectiveness of our device, well we have to do a clinical trial in the good shape to have a solid proof that it's actually working. So yeah, it's not because it's microinvasive it cannot... I'm not even sure how it is considered with respect with invasiveness, but also just for effectivity proof.

Zach Peterson:

Yeah, they want to make sure that your claims are legitimate and that they can be backed up with actual results from the device.

Paul Durand-Estèbe:

Yeah, exactly. To my knowledge, you cannot have a useless device that can be medical greater or medical device approved, both in Europe or in the United States. The FDA or won't be happy with.

Zach Peterson:

So if someone has a great idea for a product that could be considered for personal health monitoring or disease monitoring. It sounds like there are two really big challenges, obviously the regulatory side, which you've been talking about a bit and having to prove out that the technology works from a regulatory aspect.

But then you also brought up the manufacturing end of it, and that's actually something I'm interested in is, because you guys have a functionalized device that relies on some chemical process to achieve that, what does that look like alongside the electronics manufacturing? Do these two things go in parallel in different facilities? Are you going to end up working with one manufacturer who oversees a quality control program for the entire product? What does that look like for you guys as you start to scale?

Paul Durand-Estèbe:

One important thing that I forgot to mention about our device and that will have a big impact on the manufacturing is that what we want to do is a two part device. And actually I showed the device, I will show it again for those who have the video, which we can separate the parts that will have the microneedles and the part with the electronics, and we have small connectors in between.

Zach Peterson:

So you've just popped this device apart from the top. And what we're seeing is in one hand you have the backside that would attach to the patient and then the other side you have it looks like part of the enclosure, but you said it has all the electronics in it, like the Bluetooth chip and some of the other stuff.

Paul Durand-Estèbe:

Yeah, exactly. And so here we don't have the electronic board here to be on this side, but it's a mockup. So exactly, all the sensing and communication electronic port will be reusable and the microneedle part will be disposable and will have to be changed every set days and all. So we are doing it mostly for ecological point of view and cost point of view. We think that eventually it'll be less costly, and also we don't want to throw away every time a board functioning PCBA with everything. So of course it leads to a different challenge with rechargeable battery and wireless charging that you don't have to...

I think all CGM, at least the one I know are entirely disposable. You use them for, I don't know, one week, two weeks and then you throw everything away. We have a slightly more complex electronic, so it would be even more shame to throw everything. But also from a cost point of view, we think that we can achieve lower costs even if it adds some complexity around the connection. So back to the manufacturing, it also allows us to have all the top part with the electronics manufacturer on one side, totally regular electronic manufacturing up to the casing, you put it in the casing.

And the microneedles part with the chemistry happening, that can be entirely done in parallel like you said. And then when you have your two parts, you can then assemble them together or not even assembling them together because it'll be shipped, you also need one reusable part of course as it's reusable. And several disposable parts for the time of your treatment and monitoring, depending on the time you will be using it. And it's also a key point because the microneedle part will have to be sterilized of course. And not having the electronic maybe easier to what is constraint less for manufacturing.

Zach Peterson:

So what has been the initial response from shopping this product around? Who have you shown it to and what's been the response? Have you been showing it to doctors, potential patients?

Paul Durand-Estèbe:

Yeah, both. And actually, so we have of course a board of doctor to be able to chat with and exchange with on what they expect of such device, what data is useful for them, and how they can use this data to improve stuff down to how the interface should be when they see this data. And they are very enthusiasts and excited about it. So yeah, because again, data life that you don't have to prescribe a blood draw and analysis so you have it immediately if the patient was already wearing the device in a few days if he has to put it on now. So yeah, they are quite enthusiastic.

And the patient too, because kidney disease apparently, it's not a big... It's a big issue for people suffering from it, but it's not a disease with a lot of money in the research and stuff like this. There are a lot more effort put in cardiovascular research for example, than in kidney, which can even be a shame if we remember that kidney can cause heart issues. So the patient are also very enthusiastic and very excited to have something that can help them. We are in touch with the association of kidney disease patients also, which we discuss with them.

Also for the interface, how you can manipulate it, what is convenient to have, not convenient for the design of the device itself and how you use it and how you live with it. be able to live with it. So we're in touch. And the thing is that sometimes doctor and patients don't want the same thing. That's also true for quite different device or technology in the medical field for example, and I don't judge anybody here of course, but the doctor often can be quite scared to give all the data to the patient and that can be probably totally right because a patient can panic seeing a small bump in the concentration of that molecule or glucose, even if it doesn't mean anything.

But on the other side, allowing the patient to see in real life, in real time, his own constant health can have a reassuring effect. So yeah, we'll have to speak with both to know what they expect, what they want. And we will have to decide on some or probably let the doctor decide if they want to show the data to patient or not. But it is really important to talk with doctor and patient to develop such device to know how they will use it and what they're expecting.

Zach Peterson:

I'm sure patients would probably appreciate another aspect of this, which is the ability for the doctor to give them feedback without them having to actually go into an office. Because the doctor could then give feedback either let's say through the app or just over email or they could call them on the phone, whatever it is, they can get that feedback from the doctor and determine whether that spike they saw is actually meaningful.

Paul Durand-Estèbe:

Yeah, totally. And it's in line with the development of telemedicines to develop medicine not only at the doctor office and you don't have to only take an appointment and see your doctor, but you can wear stuff and he can react in real time again and reassure you or tell you, maybe change your prescription. Or even, I don't know, that's either adding appointment to make bigger check if something is maybe a bit off or on the other side canceling appointment. Apparently everything is okay. And I think that's really where we are going to with different continuous monitoring or at home medicine that is developing with help with the telemedicine and consultation.

At least in France, it's relatively new with the COVID. I don't know how it is in other places, but in France, COVID has been a great accelerator of this, but that you can now have an appointment with your doctor through a webcam and with just your computer. And so if you can add stuff that can also make measurement at home, you go to the local pharmacy or you get also delivered your devices or make your own measurement. So yeah, it participate in this new medicine, or at least at home medicine. I don't know if there is probably a better term than this, but yeah, this new medicine that you can be part of as a patient.

Anyway, I think that's really the future of medicine to be able to grab all this data yourself. That's also the patient is more implicated in his own health. Seeing how. There's been the point with the continuous glucose monitoring, you eat a lot of bad foods, you will see immediately, one hour later you'll see a peak in your glucose and you know that the peak is not very good. You eat a lot healthier, you see that it has an effect and that it's good for you. And so if we can expand it for other molecules, it can only be good, I think.

Zach Peterson:

Yeah, I would agree with you.

Paul Durand-Estèbe:

To be able to participate again and explain what we're doing and our progress.

Zach Peterson:

Absolutely. Thank you so much. To everyone that's out there listening and watching on YouTube, we've been talking with Paul Durand-Estèbe, lead electronics developer at Metyos. If you are watching on YouTube, make sure to hit the subscribe button and hit the like button. You'll be able to keep up with all of our tutorials and podcast episodes as they come out. And finally, don't stop learning, stay on track. And we'll see you next time. Thanks everybody.