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Let’s Talk Medtech

Movano Wants to Put a Ring on It

Movano CEO talking about the company's first wearables product.png
The startup's CEO joins Let's Talk Medtech to chat about wearables trends and why Movano's first product is specifically designed for women.

It's hard to believe it's been more than 10 years ago since FitBit pioneered the fitness wearables market. As the technology has advanced, the lines between what is a consumer wellness device and what is a medical-grade wearable have begun to blur, with a number of companies sitting at the intersection of consumer wellness and medical-grade wearables. One such company is Movano.

John Mastrototaro, CEO at Movano, joins the latest episode of Let's Talk Medtech to discuss that intersection of consumer and medical-grade wearables, and why he joined Movano. The Pleasanton, CA-based company is creating consumer products designed to deliver medical-grade data. Founded in 2018, the company recently announced that its first product will be a fitness ring designed specifically for women that measures heart rate, heart rate variability, sleep, respiration, temperature, blood oxygen, steps, and calories.

Movano is currently conducting clinical trials with its radio frequency-enabled technology and developing algorithms to add medical data, including non-invasive glucose monitoring and cuffless blood pressure, to its core product in the future. The company plans to execute accuracy studies to pursue FDA clearances on its vital signs monitoring capabilities including heart rate, SpO2, and respiration rate.

The Movano Ring is expected to be available through a beta release in the second half of 2022.

Image courtesy of MovanoMovano_Rings medical-grade wearables

Episode 42 transcripts:

Amanda Pedersen:

I'm Amanda Pedersen, senior editor at MD+DI, and this is Let’s Talk Medtech. Our guest today is John Mastrototaro, a veteran in the medical device industry who recently joined Movano, a company that is developing consumer wearables designed to deliver medical-grade data.

Now, John you've had a long career in the industry, and worked at Medtronic where you were heavily involved in product and development for the diabetes business there, and more recently you worked at OrthoSensor, which was acquired by Stryker early last year. So, tell us why you wanted to join Movano.

John Mastrototaro:

Coming to Movano is really allowing me the opportunity to maybe even go one step further, you know, to not only develop a solution that will help people who have certain chronic conditions managed through those at home, but also potentially help people who just want to try to maybe modify their behaviors or live their life slightly differently to avoid ever getting chronic conditions like diabetes or hypertension. And so I'm really excited about having the opportunity to help a very broad cross section of people who just want to live a healthier, happier life.

Amanda Pedersen:

It's really interesting how just knowing that your steps, for instance, are being tracked or being counted can really change a person's behavior. I know I myself, I wouldn't consider myself a fitness nut by any stretch of the imagination, but just knowing that my steps are being tracked every day does kind of motivate me to want to get those extra steps in. Even my dog wears a step counter in his collar, and so not only am I checking at the end of the day to make sure I got my steps in, I'm checking the app that coordinates with my dog’s collar to see if he got the activity that he needs on a daily basis.

John Mastrototaro:

Yeah, it's interesting. And I would say that you know the same holds for if you're monitoring your sleep as well as activity, you want to see, ‘did I get a good night's sleep last night?’ And then of course when we start to add a lot of the actual measures like heart rate heart rate variability and respiration temperature blood oxygen you know, etc. One of our goals is to translate those measures into what it means about your overall health. We don't want to, you know, bombard people with data … we actually want to distill it all down to insights for people that help them understand how activities of daily living and their lifestyle affect their overall health.

Amanda Pedersen:

John, I'm curious to hear your thoughts about the trends in the wearables space. It seems like, you know, 10 years ago when the first FitBit came out – or, a little bit more than 10 years ago now – they were truly wellness devices. They were not tracking medical-grade vital signs like heart monitoring and Afib and things like that which some of the newer devices have capabilities of now, like with the Apple Watch. So, it seems like we're seeing more and more of the lines between consumer wellness wearables and medical-grade wearables sort of blurring. What are your thoughts on that trend and where do you see it headed?

John Mastrototaro:

Well, you know, first off, I think the wearables started as stop counters and were very, very far removed from medical devices. And I think what you've seen over the last 5-10 years is this convergence. They're starting to, you know, come closer to one another as a lot of the wearables start to monitor things like heart rate, and heart rate variability, and some of the more traditional medical metrics you're starting to see, ‘Okay, well how is this data used, and is it medical grade or not?’ So, I think, you know, there's a lot of maybe questions from folks about that. I certainly believe in general that this convergence is something that needs to happen. I think there's an expectation from consumers that we make medical devices more consumer-like, I also think that driving a lot of the healthcare to the home is important for users, and obviously through COVID was a necessity to do that. The approach that we've taken as a company at Movano is to set ourselves up as a medical device company right out the gates. So we have a quality management system we’re developing our product using a process called design control, these are all stipulated as part of the FDA guidance documents that we use. So, that's how we're setting up right out the gate, and even to the point of our manufacturer of our product will be done at a medical device manufacturing facility. We want to do that, and we also want to conduct clinical trials on a lot of the metrics and seek FDA clearance for a number of different measures that we’ll be making with our solution, because we want people to be able to trust the data that we're providing to them, and know that it's going to be reliable and have high quality, etc. Now, at the same time we also want our solution to be what people expect from the consumer device in terms of usability … the look and feel …And so we're trying to bring the best of both worlds together, and so, we consider ourselves to be a little bit at the intersection of the two, but fundamentally be a medical device company.

Amanda Pedersen:

Okay, so tell us about your first product.

John Mastrototaro:

So, our first product is going to be a ring designed specifically for women. And that's really important to us for a couple of reasons. You know, as we look at the landscape today of the wearables market, it looks like a lot of the products were initially designed maybe for men. They're thicker, they're a little bulkier, they’re monochrome in color, and so we're trying to develop a ring, which looks like jewelry at some level, and is something that a woman would want to wear for those aesthetic reasons, separate from all the value that they'll get from it, from you know, the perspective of what it's doing as a medical device. And so, that's the first thing. The next piece of it is the app experience. So as we're collecting data from sensors that are embedded within the ring, which again revolve around heart rate, heart rate variability, sleep, respiration rate, temperature, blood oxygen, steps, calories and other women-centric features with the product, you know, we want to have the app experience where all that sensor data is going to the app, and that app experience is something that resonates with women. And so, we don't want to show graphs and charts of data that people really don't have a good understanding of what to do with it, and we don't want to burden people with that. We want to go ahead and take that data, and we want to distill it down to the insights that are relevant for the person, and personalized to the person based on their goals and objectives with wearing the product. It may be age dependent, maybe where they are currently in terms of child rearing or beyond, and so we want to make sure that we're providing them information that they see as very useful to them in living their life. And we also recognize that, you know, people are busy, right? They've got jobs and children and families and other things in their lifestyle and we don't want to add additional burden. What we want to do is provide them some insights periodically that are very meaningful to them and allow them to live their life to its fullest.

Amanda Pedersen:

You know, it seems like for a long time there wasn't a lot of clarity from FDA about how these types of wellness devices that were tracking steps and things like that were regulated, and how they were differentiated from a regulatory perspective from the more medical-grade wearables. So, how has that changed over the years? What are your views of the regulatory landscape for wearables today?

John Mastrototaro:

Look, I think the FDA has done a great job of, you know, coming up with guidance for this and certainly there is some clarity now about what is a wearable that's a non-medical device, you know, and even the language that a company that develops a wearable that may report heart rate or other metrics, what language that they need to provide to users about … the fact that they can't use that data for medical applications, for example. So, that's very clear now. Obviously you can pursue an FDA clearance for various analytes that you're measuring, and certainly that's what we're going to be doing, and I would envision over the next you know two, three, four years we may have five to seven or eight different measures that we're making that we will have sought FDA clearance for. So, things like the heart rate and the SpO2 and respiration, there's diagnosis of a couple of conditions, and of course we have a proprietary RF technology that we've been developing to measure glucose noninvasively, and blood pressure without a cuff. And certainly those are huge opportunities out there, and we're very excited about the progress that we've made there both in terms of miniaturizing the RF technology down to a very small chip that we can put into any form factor, and we've spent a few years and tens of millions of dollars really miniaturizing that technology, and it's unique at the frequencies that we're using for the measurement, getting it down to that size, and then conducting clinical studies on blood pressure and glucose to obtain data that's helping us develop machine learning algorithms that will be able to predict someone's blood pressure from that cuffless sensor, or their glucose from the noninvasive … so you know we've got that happening as well in parallel with the development of our first product, which would have kind of the core things I mentioned earlier, but you know we're looking at adding other analytes overtime to the measures that are all relevant to women.

Amanda Pedersen:

So, you've talked a lot about your first product, which is designed specifically for women, and that's awesome. But what are you looking to do in the future with your future products?

John Mastrototaro:

You know, in the future we will do two things: number one, we will provide additional form factors, you know, so if a woman likes her fingers for other rings – we hope that ours will be one of them and we're certainly making the look and the feel something that you would want to wear – but to the extent that they want to have it, you know, on a wrist-worn device or other location, we are looking at that long term. And as we provide more analytes and more measures, we will also have a solution for everybody, including men, you know not just women. But we thought it was really important to come out with the first product that, from our estimation, it was addressing an unmet need in the marketplace and that was a product specifically for women.

Amanda Pedersen:

That's it for this episode of Let's Talk Medtech. Thanks again to our guest, John Mastrototaro, CEO at Movano, you can find him on LinkedIn. And visit us at www.mddionline.com for all of your medtech news. Make sure to rate, review, and subscribe to us on Apple Podcasts, or wherever you get your podcasts.

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