The wrist has been called the beachfront property of the body. For physiological monitoring, the wrist is a particularly good site because (1) it does not get fat, which obscures cardiovascular signals and (2) because people are used to wearing wristwatches. The objective behind the Wriskwatch™ from Emergency Medical Technologies was to add to a wrist watch a stand alone physiological monitor that provides heart rate, breathing rate, blood pressure, and many other parameters which are available from a simple, comfortable sensor placed at the radial pulse. The watch recently completed clinical trials at the Cleveland Clinic where it showed great promise as a life monitoring device.
By placing the monitor in such an unobtrusive location, the Wriskwatch has the potential to address a group easy to forget about when analyzing the mobile health ecosystem – those with little interest in living a healthier lifestyle. The “acknowledged unhealthy” – more concerned with protecting against the worst case scenario than proactively living healthier lifestyles – might find the Wriskwatch to be the perfect solution.
Continue to read the story behind the Wriskwatch from the company’s founder and CEO Bernard Klocman, who has 30+ years experience in the life monitoring space.
(editors note:The following interview has been edited)
BTE: Tell me about your business, where did the idea for the Wriskwatch™ come from?
BK: Let’s see, I was in the monitoring space, lets say it was thirty years ago, and I was working for HP at the time and then I started out my own company and got the distribution rights for Spacelabs ambulatory product line. I ended up getting a call from a good buddy of mine Lou Catius, who had invented a cool technology called Event Recording, which was a t-shirt with built in sensors. He and I originally met when he wanted to start his own company because he had a few investors so I helped him put together that company, finding their medical directors and other things. Eventually through a series of mergers and acquisitions this company ended up becoming LifeWatch. Lou didn’t get that much out of the deal, but he and I got together and started our own company and we actually started manufacturing our own life monitor with his Event Recording t-shirt and grew this into a strong company called Clinical Technologies.
Well, I was invited to present the Event Recording technology at IBM and afterward one of the high-level executives takes me to the side and says, “Bernie, the t-shirt isn’t going to work, people won’t want to wear it 24/7”, so I started to ask people what they would like to see and they said, “if you can put it in a watch that would be phenomenal”. So I found a group of scientists that had developed a little device that tracked the pulse of a rat. They used the technology to show the increase in the rats heart rate when they smoked cigarettes. I said to myself, if they can do it on a rat, they can definitely do it on a human pulse.
BTE: Did you license the technology in the Wriskwatch?
BK: We licensed the technology from a group of researchers in Charlottesville, VA called Empirical Technologies. They gave us exclusive licensing rights to four separate patents and we will give them royalties once we get to market.
BTE: So is your business model to sub-license the device to third-parties or build your own?
BK: Actually, we found a manufacturer called Welltronics and they are going to build it for us in their FDA approved facility. They are doing some really cool technology development, such as blood pressure monitoring without a cuff. We are currently raising funds of about $2M to begin manufacturing the device.
BTE: Have you completed or begun the FDA approval process yet?
BK: No, we have not yet begun the process of applying for FDA approval but we have spoken with consultants in the past and virtually all of them ensured us it would only be a 3-6 month time frame from submission of the application to ultimate approval.
BTE: At what stage of the product development cycle are you currently?
BK: We actually just finished our clinical trials at the Cleveland Clinic, where we literally put the watch on patients in a clinical setting in four different phases. The first was walking around the clinic to ensure patients don’t experience false positive. The second, what we did was take a subset of about ten patients and we actually blew up the blood pressure cuff and you saw the pulse go down to zero. In the third use case, we wanted to see how it behaved when a patient goes into Atrial Fibrillation (A Fib). In the final, and most impressive study, our wristwatch was used in patients receiving AED implants who are intentionally induced into cardiac arrest in a controlled environment, and on all ten patients we watched the pulse go to zero.
BTE: What was the most unexpected finding of your clinical trials?
BK: What we have found in our studies at the Cleveland Clinic is that patients presenting with bronchitis for instance are not given monitoring beds because monitoring beds are very expensive.
What we propose is that when every patient is admitted to the hospital they are given a wristwatch rather than the standard hospital bracelet, which can be used as an inexpensive life monitor. This would make every bed a monitoring bed without the excessive costs for the patient and the hospital.
BTE: I am picturing my grandma going into cardiac arrest and her house literally screaming at her neighbors to come help.
BK: Exactly. If the user simply presses two buttons on the watch it can be used as a traditional “I have fallen and I can’t get up” monitor. The cool thing being we have taken the operator out of the process. Until now, life monitoring devices have all directed users to an operator who then goes ahead and starts calling everyone one at a time, having one way conversations with each person on that user’s emergency contact list. What we have done is design a solution that literally delivers a message to up to 300 people simultaneously, each of whom can then simply press 7 on their phone to join a conference call with the user and all other people responding to the message on one open conference line. So your grandma could be in Seattle, for example, and when she goes into cardiac arrest the system will automatically notify the neighbors and everyone on your grandma’s list, which can include you in Chicago, so you can say, “hey grandma, how you feeling?”
BTE: Do you plan to release a mobile app that interacts with the watch?
BK: Yes, as a matter of fact, one of the things we will be releasing in the near future for the iPhone and Android will be the capability for individuals to see on their phone the location of the nearest AED device. Our sister company Attris has set up a registry at the Sudden Cardiac Arrest Association. We decided since there are two separate markets we are focused on, one being the patients who are wearing the Wriskwatch, the other being the people who witness an event and call 9-1-1. These individuals will instantly be able to see on their phone the location of the nearest AED device. In fact, the city I live in Westin, Florida, was the first town to make it mandatory to register an AED device, due to the fact that a few years ago at a local Democratic Party meeting someone went into heart failure and nobody could find the AED device so the individual died. Westin actually made it mandatory for any public venue with greater than 200 people to have an AED device on-site and registered. So through the Attris group we literally have a registry at the national Sudden Cardiac Arrest Association where individuals can go to register their device.
BTE: Will the device itself be connected to the Internet?
BK: Originally we will utilize a Bluetooth connection to the users Smartphone, but we have been talking to some that say people don’t like having to carry their cell phones everywhere. So Qualcomm has just recently developed a phone that is a chip literally the size of a quarter and you can just put that on the watch. We are in the process of talking to them now about integrating the chip into our product.
BTE: In my opinion, wrist-worn devices like yours could be the key to bringing mobile health to the mainstream because so many people wear watches and its not a stretch to think people will adopt these devices without much resistance. What feedback have you received from the users in the clinical trials?
BK: Well, we have spent a lot of time talking to people about what they think of the device and one thing that came up again and again is how to deal with a false positive. The solution we have come up with is when the device indicates loss of pulse it vibrates, and if the user is alive and not experiencing an event they can simply shake their hand and the device will know not to automatically alert the National Guard. Another thing we have found is that people do not like having an AED device in their living room because it signifies death and heart attacks so they don’t want to identify with it. So what we have done is found a way to put the AED device in the closet so nobody can see it or has to be reminded its there, but when the call goes out that an individual is in cardiac arrest the system tells everyone it contacts where in the home to find the AED device. This allows people to take the AED device out of view, which to this point nobody has been able to do because there was no system to alert respondents where to find the device and therefore it had to be in view.
BTE: How big do you think the market is for your device?
BK: Our marketing studies showed a large number of what we call the “worried well”, which are individuals who are not exercising or losing weight like they should be, but are still looking for peace of mind that were something to happen they would be okay. Our device gives these people the peace of mind that even if something were to happen they will be able to get help and have a better chance at survival.
BTE: So you are targeting the acknowledged at-risk, or the acknowledged unhealthy, who know they aren’t taking great care of themselves and want a backup?
BK: Exactly.
When we were originally selling the LifeWatch “I have fallen but I can’t get up” solution we were targeting strictly 70 or 80 year olds, but what we realized was that there is a whole market of people in their 40’s, 50’s and 60’s who are totally untapped. This technology would work well for them, the 88 million who suffer cardiovascular disease.
That is the market we are going after; if you are in your 40’s, 50’s or 60’s and you have cardiovascular disease we offer you a layer of protection for about $1/day, which seems to be the magic number.
BTE: How much will the device cost?
BK: The device itself will cost $99, and then the base monthly service costs will be $30/month. We plan on making the device really inexpensive for hospital clients because they will essentially be redistributing it for us to patients. A patient who received a Wriskwatch upon checking into a hospital, can keep it after leaving the hospital and we will give them a free trial of about 14 days and then they will have to pay the monthly fee. We designed the device to be basically disposable, so if the user doesn’t pay the fee we can just turn it off.
