The vast majority of today’s medical-grade monitors being used in hospitals are large, clunky devices that patients hate wearing—and hospitals probably hate having to use. Werner Vorster, Founder of Vitls, wanted to offer a better solution. Something that patients barely even notice that they are wearing and that hospitals can easily get rid of. But the ramifications for a device like this can go far beyond just hospital use. Think continuous monitoring for chronic disease patients. Or the ability for patients to participate in clinical studies from their home. Or just the value in the data that is collected. PM360 spoke with Werner about the potential for Vitls to impact all of those areas and his ultimate hopes for the company.
PM360: Why did you decide to start Vitls?
Werner Vorster: I have three boys and one of them suffered from febrile seizures, which is basically a seizure brought on by a high-, or fast rising temperature. When he was younger, any time he had a fever, my wife and I needed to sleep next to him at night so we could constantly check his temperature to try and avoid these seizures, because we couldn’t find anything that could monitor him remotely and alert us. The theory is that if you can keep the temperature low, or at least slow the rise of the temperature, you could avoid these seizures from occurring. So, we started talking about something that could monitor him and alert us when he had a fever. We tried a few things but couldn’t find something that worked properly, and that’s when we started doing more research on wearables.
Can you describe the technology behind this monitor you developed?
Yes, we developed a small and flexible wearable that has a six-day battery life and is disposable. The monitor is encapsulated in a foam material that is very light, which also makes it unobtrusive—that was a big goal for us. We wanted to build something that could accurately and continuously monitor people while they go on with their lives without being cumbered by something, which is what’s currently happening with most of the hospital monitors available.
What type of vitals can you monitor through this wearable?
We can monitor body temperature, pulse, heart rate variability, respiration rate, pulse ox (SpO2), sleep, and movement. We are able to monitor continuously for six days, but as soon as we start playing around with the intervals of monitoring we are able to increase the battery life. We then collect the data and send it to our HIPAA-compliant database. From there we can send it to wherever the patient or the care provider want us to send it—be it a patient’s medical record or even directly to a physician’s phone.
Our goal is to make continuous monitoring, outside of the ICU, the standard of care in hospitals. Yes, there are many other use cases for our device, but we’re starting with hospitals. Our secondary goal is to build a big data set, because currently continuous vital sign data sets on patients outside of ICU do not exist. We see a lot of value in being able to collect that data, analyzing it, and picking up warning signs of deterioration before that deterioration happens—that’s the big advantage of continuous monitoring.
Do you know how valuable this can be? Have you seen any results from your early trials?
Unfortunately, it is just too early. We’re just starting pilots now with a few providers in Houston, Philadelphia, and New York. While a lot of studies have been done around the impact of early monitoring, until we operate in the hospital and we’re able to show huge sets of data, we don’t know what the true value is.
Besides hospitals, have you also gotten interest from pharma or medical device companies in either the data you collect or the potential to use your device during something like clinical trials?
Pharma companies have expressed interest, early on, in the data we could collect, but since we don’t have any clinical data yet, they’re sort of waiting in the wings. But we have also heard from pharma companies that want to use devices like ours to monitor the effect of a medicine on a patient. For example, monitoring a patient’s body temperature and pulse before the meds, on the meds, and after the meds.
Also, outside of pharma, we have heard from organizations that conduct sleep apnea studies. The big challenge with these studies is getting someone to come into a facility and then being able to host them for up to three days while they sleep there—it’s a big cost on both the organization and even in terms of the time commitment for the participant. But with us, you could essentially send our device in the mail and the patient can participate in the study from the comfort of their home, so there’s no time off for them. So this device certainly has a lot of implications.
How far along is your product in development?
We’re finishing off testing now and preparing for a study, so it’s not commercially available yet. We still have to take it through the regulatory process, as we are preparing for FDA submission. For now, we’re preparing for our studies and looking for more study opportunities. We have an Institutional Review Board (IRB) approved study with Texas Children’s Hospital. You have to go through an approval process with an IRB before you’re allowed to pilot on patients. Once we complete that phase, clinical evaluations will be next.
Thinking more long term, what are your goals for after the product hits the market?
Right now, I just want to see the product on the market. Over the past two years during the development process, we talked with a lot of people who expressed a real need for this product. So we would love to make a difference, especially when it comes to kids. For example, the ability to lighten the load of kids with chronic illnesses who require continuous monitoring and don’t want to have to lug around big machines. After that, I don’t know. If someone is interested in the company, it would be great. But, for now we’re focused on getting through regulatory certifications and then we’ll go from there.