An AgeTech Collaborative™ startup participant, Wellvii has developed a noninvasive, clinically validated blood pressure monitoring device that people can use with ease at home, without having to fumble with traditional arm cuffs. Also offering a device that measures nine vital signs with similar ease, Wellvii makes it easy for users to obtain and track personal health data to make more informed health decisions.
We caught up with Mark Khachaturian, CEO of Wellvii, who explained the importance of accurately monitoring blood pressure, why relying on readings at a doctor’s office can be suboptimal, and insights for getting medical devices through the FDA approval process.
This interview has been edited for clarity and length.
--
Tell us a little about Wellvii.
Wellvi is a disruptor in the hypertension monitoring space. We build a device called BP Go, a finger cuff that measures your blood pressure by squeezing your finger the same way a traditional arm cuff squeezes your arm, and with the same accuracy. Those arm cuffs are cumbersome, hard to position correctly and some people find them painful, but BP Go gives you the same results using just your finger.
BP Go has a display so you can see your results, and it also has Internet of Things connectivity, so we can send the data via Bluetooth or cellular. We have a cloud that stores all your data, and you can share it on your terms with family, friends and care providers. Some configurations of the device have a fingerprint reader so you can use it for multiple people and still know which readings belong to who. It’s small, so it’s easy to use BP Go … “on the go.”
It sounds very simple and convenient.
It also means you don’t have to go to the doctor’s office. A significant percentage of people get what’s called white coat syndrome — they see a doctor and immediately become anxious because, for example, there may be a lot riding on the results of that visit. Or maybe they’re aggravated because they got stuck in traffic on the way! These kinds of factors very often yield misleading blood pressure results.
Blood pressure is one of the most important parameters that we can measure for our health. Cardiac disease is the biggest killer worldwide, and hypertension affects more than 1.2 billion people. The most important way to monitor hypertension and improve your heart health is to lower your blood pressure. But first you need accurate measurements, which people generally do only once or twice a year when they go to the doctor, under less than ideal circumstances.
That speaks to another advantage of BP Go: Our app takes your readings and trends that data over time, so you can get an accurate picture of your true average blood pressure. Being able to monitor your blood pressure easily and having access to that data is how you get to know your body. Wellvii is all about getting to know yourself through your vital signs: We have other products, including a device that has the blood pressure finger cuff, but it also measures heart rate, SvO2 levels, respiration rate, temperature and more, giving you an overall assessment of your health.
How did you get started with Wellvii?
When I was 16, I had an MRI for my back and when I saw it, I thought, “How can they look inside my body without opening it up?” It was incredible. I decided then that I wanted to go into medical technology. Fast forward, and I was consulting with the founders of Wellvii on a different product when they told me they wanted to develop a way to take blood pressure from the finger, and I said, “Well, I have to try that.” So I started with Wellvii in 2017 and became CEO a few years later.
It’s been quite a process, because in healthcare, it’s not just about having a good idea. Investors often see medical devices as risky, and you have to build the device and get it through the FDA. This is the fifth device I’ve put through the FDA, and that’s tough.
Can you say more about your experience with the FDA? It seems that people sometimes perceive it as adversarial.
The FDA is definitely not an adversary; really, they’re not for you or against you. They're a legal organization set up by the Code of Federal Regulations, and their job is to interpret the law. They're unbiased — but you have to really understand how to interpret their role relative to your particular medical devices.
Because it’s very field-specific, you need someone to help you get through the FDA in the specific field you’re in — someone that has walked your path and understands how the FDA looks at your particular technology. For example, I now know how to get a medical imaging system through the FDA, but I have no clue how to get a pharmaceutical through.
There are a lot of people who leave the FDA and then consult with companies, and you can’t do the process without them. You just can’t. They know the kind of testing you need to do and how to present the information you need to present. They may even tell you that you’re just not ready to submit to the FDA yet. While that might be hard to hear, it will save you a lot of money in the long run.
Your company is fairly new to the AgeTech Collaborative. Are there other companies in the ecosystem you’re hoping to connect with?
I’d love for anyone who’s involved in remote monitoring or hypertension monitoring to get in touch with us. Our solution empowers people to engage their health, get meaningful data about it and help prevent negative outcomes. If anyone is interested in working with us — especially in doing a pilot — we’d love to hear from them.
Want to learn more or connect with startups like Wellvii? If you’re already in the AgeTech Collaborative, log in to explore the ATC Directory and start a conversation. If not, apply to join us today and tap into the power of purpose-driven innovation in AgeTech.
#StartupSpotlight