After three decades of working in the medical device space, with stints at leading healthcare companies like Lilly and Medtronic, John Mastrototaro is now setting his sights on digital health and bringing medical-grade technologies to consumers in the form of wearable devices.
There’s a need to collect and leverage data from people remotely and in their homes — a need that is especially useful for patients with chronic conditions, like type 2 diabetes or hypertension.
Data collected from consumer devices give insight into a patient’s health and can identify when someone may need intervention.
That’s where Movano comes in.
John joined Movano in April 2021, knowing he could use his decades of experience in the diabetes and cardiovascular medical device arena to help propel the company’s technology forward.
Movano expects to launch its foundational product, the Movano Ring, in the third quarter of 2022, pending FDA clearance. The smart ring and accompanying app, which are targeted toward women, measures the wearer’s heart rate, heart rate variability (HRV), sleep, respiration rate, temperature, blood oxygen saturation (SpO2), steps, and calories.
With its wearables portfolio, Movano distills health data and insights down for users.
“We want to show people the cause and effect. We want to help them understand how their activities of daily living affect their health metrics, and maybe show how those are improving over time,” John says.
In this episode of Medsider, John explains how digital health technologies can help consumers understand more about their health, give doctors and researchers insight into real-world health data, and how companies can convince payers that the technology is worth the expense.
John Mastrototaro, Ph.D., has more than 30 years’ worth of experience in the medical device industry and was part of the MiniMed team that helped develop the world’s first ambulatory continuous glucose monitoring system and sensor-augmented insulin pump. After MiniMed was acquired by Medtronic, John went on to hold a number of positions in Medtronic’s Diabetes Division. John is now CEO and Director of Movano, a health technology company that makes smart, personalized devices that can provide vital health information to users.
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Key Learnings from John’s Experiences
- Don’t discount the real world. Clinical trials are essential, but when a device’s data also comes with applications beyond user intent, payers and investors will pay attention. Part of the appeal of Movano’s model is that the device provides valuable health metrics for users while also providing doctors and researchers with usable health data, creating a win-win for multiple parties.
- Aesthetics matter. The Movano Ring design was a direct result of listening to customers. Yes, a wearable device needs to function, but it also needs to appeal to the user. If customers don’t want to wear it, they won’t. At the end of the day it’s about form and function.
- Building an experientially diverse team leads to innovative solutions. Think outside of the box when hiring. Look to experts in other areas beyond the medical device space who can offer broad knowledge and insight.
Demonstrate the Value of Your Technology
Medical-grade digital health technologies like the Movano Ring can be used across settings and by multiple stakeholders, including researchers, consumers, and payers.
Wearables could play a key role in helping pharmaceutical, biotech, and medical device companies gather data on their products in clinical trials and the post-market setting. Data from digital health technologies could also help healthcare plans gain insight into their members’ health and well-being which then can be used to help members make healthier lifestyle choices.
“I think this has a number of applications where it could be phased in, and in a way that's so much more affordable than anything that's ever been accessible in the past,” John says.
John advises medtech companies to focus on demonstrating value in two key areas when presenting their products to payers:
- Show the value of your product in a controlled environment, such as in a clinical trial.
- Show that the clinical work translates to real-world use of the technology. Make sure people continue to benefit from the therapy the same way they did in the clinical trial.
You have to show payers that the money saved by using the technology is more than the cost of the technology. The more expensive a core technology is, the more you need to show a big benefit to offset those costs, John says.
Companies can access long-term data from users to see whether the data have evolved over time and translate that into benefit, John says.
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Focus on User-Friendly Cost and Design
Always do right by users and think about them when considering cost and design, John says. Listening to and understanding your audience is key to creating a successful product.
The technology’s function should be commensurate with what a doctor would want to see, but at the end of the day, the consumer should want to actually wear and use the product. If users don’t keep wearing your product, you won’t be able to demonstrate value and benefit over time.
That user-first philosophy is what led Movano to design the Movano Ring, which is specifically targeted toward women.
When Movano looked at the wearables landscape, the company noticed women seemed to be an afterthought, especially when it came to design and user experience. At the end of 2021, the company announced the Movano Ring, which uses medical-grade technology, but is also aesthetically appealing and looks more like jewelry.
Movano also is considering offering its product through a subscription model where users get the device free of charge and pay for the service.
Like Movano, a lot of big companies are trying to figure out how they can bring affordable healthcare to underserved, underrepresented groups across the United States, John says.
John suggests medtech companies weigh the costs and benefits of their technology against the cost of regular doctor’s office or lab visits.
For example, a subscription service for a wearable might cost the user a couple of hundred dollars a year and provide a year’s worth of health data and metrics. Patients would typically pay more than that for a single doctor’s office visit to get blood work done, John explains.
The more accessible your technology is, the bigger your customer base will be. And you can make up for a lower-cost product with a higher volume of users.
Think Outside the Box To Grow Your Company
Nothing is more important than the people on your team, John says. They're the ones that make the product work.
It’s important to think big — go beyond the traditional avenues and recruit people from across industries who can bring different knowledge and expertise to your team.
“Other industries are often more evolved than the medical device industry in certain areas. Taking someone who's coming from that more evolved space and bringing them into your organization is important,” John says.
John offered up four other key lessons for medtech entrepreneurs and companies just starting out:
1. Operate as a medical device company (from day one).
Movano set itself up as a medical device company right out of the gate. Movano has a quality management system and design control process in place, just like what would be used for a traditional medical device seeking FDA clearance. The product will even be made in a medical device manufacturing facility.
Every part of the Movano Ring development process, from the clinical trials to the accuracy of the metrics, will be looked at through the lens of a medical device company, which will better position the company to meet FDA standards.
2. Have a regulatory expert on hand.
John recommends medtech companies retain a regulatory expert to help guide them through FDA process.
The FDA has already published standards for how devices should collect certain metrics, like heart rate, SpO2, and respiration rate. A regulatory expert can help companies understand what they need to do to meet FDA standards and get clearance from the agency.
3. Contract out certain tasks.
John’s philosophy is that it’s important to keep the “secret-sauce” internal, while contracting out other day-to-day tasks. For example, Movano outsources customer payments and credit card transactions to a third-party company.
Thinking strategically about what to outsource and what to keep in-house allows medical device founders to protect their intellectual property while still running a tight ship.
4. Don’t be afraid to fail.
There are going to be a lot of speed bumps along the way, but John advises to stay true to your work and always keep the end goal in sight. All the hard work will pay off at the end of the day.
“Always keep your chin up, keep the mission in mind, and keep marching forward toward the end goal,” John says.
Big Sky Biomedical is a medtech incubator co-founded by Scott Nelson and a team of serial entrepreneurs and proven operators with a stellar track record of success.
One of their first companies, FastWave Medical, closed on an investment plus milestone-based acquisition agreement within 6 months of forming the entity. Supposedly, that breaks some type of record within the medical device space.
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