FDA Approval, Pandemic Drum Up Demand For Device
Vitals 360 collects heart rate
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As a subscriber you can listen to articles at work, in the car, or while you work out. Subscribe NowIt could be called a cell phone. Or a portable medical device. VoCare President and Chief Executive Officer Dr. Ben Park calls it both. While you likely won’t text Uncle Joe on the Vitals 360 handheld device, it functions “like a cell phone on steroids,” says Park. Only slightly bulkier than a smartphone, Vitals 360 measures five key vital signs; put it on your head to take your temperature, stick your finger inside it to determine oxygen level, and place your thumbs on either side for an ECG heart rhythm. Boosted by recent U.S. Food and Drug Administration approval and hundreds of units already sold, Park believes the Zionsville-based startup is “a billion-dollar company waiting to happen.”
VoCare says 5,000 units will be arriving in a matter of days, and a good portion of them are already sold. Park says Toronto-based Constellation Software has already purchased 800 of the devices in advance. While the pandemic sparked a fortuitous flurry of demand for the mobile device, success came after the startup’s first attempt failed, mostly because it was ahead of its time.
VoCare’s original technology was a tablet for telehealth applications, with attached devices to measure vitals, but this was even before iPads. The startup not only developed the tablet, but also had to create the operating system and write the interfaces for the attached devices.
“It was a pretty darn heavy lift,” says Park. “It was expensive and a little difficult to use. [VoCare] sold 4,000 then shelfed it, because it just wasn’t going to be successful.”
VoCare founder Steven Peabody realized the market needed a smaller, more portable device; Android phones had arrived on the market, so the team selected that operating system and developed a device “which, really, was still ahead of its time,” says Park. While the startup was gaining significant traction in the years that followed, Park says the pandemic sparked an explosion in demand and “really proved the value of the product that we have.”
VoCare gained even more momentum when it recently earned FDA approval for all five key vital readings that Vitals 360 collects: heart rate, blood pressure, blood oxygen saturation, ECG heart rhythms and temperature.
“That really separates us from the crowd; so many of the other devices out there aren’t FDA cleared,” says Park. “It is an arduous process going through [FDA approval]. It’s a big deal. It shows we’re a quality organization with a quality product.”
VoCare says the device, which can immediately send the data to any third-party cloud, has multiple applications. By collecting all of the traditional vitals that a hospital, emergency room or physician’s office would capture, Vitals 360 can remotely monitor patients with chronic conditions that need oversight, such as hypertension, diabetes, COPD or congestive heart failure. The startup says the device can detect early deterioration in any of the vitals and potentially prevent an unnecessary hospital visit.
The pandemic highlighted the device’s ability to monitor patients who are acutely ill, which describes a condition with an abrupt onset and typically short course. Additionally, patients who had Covid and stayed home often fared well, but would then “deteriorate rapidly, in about a 6-hour period of time,” says Park, who is a medical doctor.
“As a physician, you often feel uncomfortable sending people home, because you’re worried about them,” says Park. “[Vitals 360] takes some of the worry factor out, because you know you’re going to be notified if things are going in the wrong direction. So you feel a lot more comfortable monitoring them at home, which is really the safest place for them to be.”
The explosion in telehealth is drumming up business for VoCare. Before joining the startup’s executive team in the summer, Park was president and CEO of Indiana-based American Health Network/Optum. He says the healthcare organization was doing about 500 telehealth visits per month before the pandemic, but that number exploded to 1,500 telehealth visits per day just two months into the pandemic.
“What was dramatically different is that we were caring for people with chronic illness using telehealth, and that had never really been done before,” says Park. “We’re able to start…treating a variety of illnesses, because we have a good set of vital signs. So telehealth was dramatically expanded, and it’s a lot easier to do it if you have all the vitals you’d have in the office.”
Next generation devices are already in the pipeline; Park says a future iteration will enable video conferencing, so patients can use Vitals 360 to complete an entire telehealth visit. With trial devices soon to be doled out, Park says VoCare has “definitive orders” for about 15,000 additional units.
“I really do think VoCare is a billion-dollar company waiting to happen. We’ve done all of this development, and really, we got kind of lucky. It was the right device at the right time,” says Park. “Now it’s just a matter of raising funds for commercialization of the product, and that’s exciting. All of a sudden, we’re not just developing [a device]. We’ve got it, and now we need to get it out there.”
Park says the pieces are in place for the company to surpass its first year sales goal.
Park says an additional application for Vitals 360 is the ability to automate the process of collecting a patient’s vitals in the hospital, ER or clinic.