In this article we speak with W. Drew Palin, MD, Medical Innovation Officer at Preventice, about their recent FDA 510(k) clearance for the BodyGuardian Remote Monitoring System™, which was developed in collaboration with Mayo Clinic and STMicroelectronics. Read more about this new technology here.
Tell us about the development of the BodyGuardian Remote Monitoring System.
Three cardiologists and one engineer, Dr. Paul Friedman, Dr. Charles Bruce, Dr. Virend Somers, and Kevin Bennet, MBA, had been working on a remote cardiac sensor for a number of years. About two and a half years ago, Preventice was introduced to them through some people at Mayo Clinic, and learned about what they had been working on, which was the medical and technical aspects of acquiring a quality signal. Preventice, in collaboration with STMicroelectronics, was working on how once the signal was acquired, how to communicate that via Bluetooth to a cellular phone and take that data from the cloud and display it on a web portal or iPad. This effort soon became a three-way collaboration between expert clinicians at Mayo Clinic, STMicroelectronics with their computer chip and technology, and Preventice with our integrated platform for communication, data display, security and mobile phone expertise.
Describe the components of the BodyGuardian Remote Monitoring System.
There are three primary components: the BodyGuardian device, which is a body-worn sensor; a mobile phone; and the Preventice Care Platform™. The BodyGuardian device uses a small adhesive called a SnapStrip to adhere to the patient’s skin. Inside the BodyGuardian device there is a microprocessor, memory, and a Bluetooth chip. Once the signals are acquired, the BodyGuardian device pairs with a dedicated cell phone, and the ECG, heart rate, respiratory rate and activity levels are transmitted via mobile phone through a cellular network and, ultimately, to the cloud. The third component is the Preventice Care Platform, which allows all the ECG, heart rate, respiratory rate and activity data to be displayed for physician evaluation, either on a web portal or an iPad app that is dedicated to this purpose.
What types of arrhythmias can it detect?
Our indication for use is for non-lethal arrhythmias in an ambulatory setting, so a typical arrhythmia would be atrial fibrillation.
Describe how information is transmitted.
This is a fundamentally important aspect, and we have built the system so we don’t miss data or acquire erroneous data. There are several ways we deal with this. First, with the device itself, we can set parameters if the heart rate exceeds a certain number of beats per minute or drops below a certain number of beats per minute, the BodyGuardian RMS will capture that data. If it changes more than X number of beats per minute, it will capture that as well. So there is some intelligence on board that helps capture various events. Secondly, on the BodyGuardian RMS itself, we can store up to 24 hours of data in memory, so even if a patient is out of the cellular network, we can still acquire and store a signal. If the cell phone is within Bluetooth range, we can upload that data into the phone and store days (up to approximately a week) of data. Then, when the phone gets within range of a cellular network, that data will be sent by the cellular connection to the cloud, where all that data is stored for later review by medical staff. So there is redundancy designed in the different layers of the system to make sure data is still stored, even if connections are not working.
Discuss some of the ways the BodyGuardian RMS benefits patients.
One of the driving requirements from the primary inventors was that their device be unobtrusive, because if the patient had to do anything or if it was annoying to the patient, the utility and compliance goes way down. I’ve been fortunate to have worn this device a lot in our testing, and within 5–10 minutes of putting the device on, I didn’t even know I had it on. The patient does not have to push any buttons — the data is uploaded automatically — so in that sense, it’s very easy to use.
How does that provide value to patients?
Well, certainly for arrhythmia detection. Also, as these devices become smaller and have a longer battery life, it is easy to imagine putting a simple adhesive strip on your body that is monitoring your heart, glucose, and blood pressure — it’s like a physiological dashboard. This can be useful for monitoring chronic diseases, but you can also establish healthy baselines and then intermittently put it on and make sure you’re functioning properly. So the initial intent is to monitor people with chronic disease to preemptively manage them better and intervene earlier, but over time as the sensors become more prevalent and less expensive, it could be used in many wellness applications as well.
How is the BodyGuardian RMS unique from other remote monitoring systems available on the market today?
There is both a clinical component to that question and a business component. From a clinical perspective, there are several things that make this device very useful. First, the quality of the ECG signal and the consistency of the ECG morphology are remarkable. Second, because this measures activity, respiratory rate, and ECG, you can combine those elements to create useful, clinically logical algorithms that can acquire relevant data. Third, if you have an iPad and Internet access, you can look at the data very quickly wherever you are, so the ease of access for the medical community is very good, too. On the business side, I think what we’re driving toward is an integrated platform that connects patients and engages physicians, and in that sense, you can imagine if a patient has an iPad or a mobile phone and we see they have been inactive for a number of days or have had increased heart rates when at rest, we would send them a message. If we know they are a congestive heart failure patient, we’ll ask if they have had too much salt or if they are properly taking their medications. You can imagine over time that when you integrate data from physiological sensors with smart clinical logic and multiple channel communications, whether by text, email, or even video content, that you can send relevant messages to end users to help them be aware of how to better manage their health. Therefore, the integration of data with a personal care plan and content is one of the ways we’re trying to bring more value to patients and providers.
When will it be commercially available?
It will be commercially available the first quarter of 2013.
Tell us about other initiatives or technology Preventice is working on.
My personal goal as a physician is to change the paradigm of personal health care, because as we know, access is a problem, and we have pending physician shortages. So my mission is to use the Preventice platform to change the health care paradigm from 1-to-1, which is the physician-to-patient relationship, to a 1-to-many, so one physician can effectively manage multiple, even thousands of patients at once using an intelligent platform. From a company perspective, what we really want to be is an agnostic platform for physiological sensors. We want to be able to integrate data from multiple sensors or sensor types, and provide intelligence underneath those sensors to turn that data into useful information for physicians. Frankly, the biggest hurdle to overcome in this technology is how this data fits into their workflow — physicians are not used to getting this amount of data on this regular of a basis, and they’re already very busy. So there is the issue of availability of physicians and how workflow is managed. Another challenge apart from physician workflow is reimbursement, because there are some CPT codes that cover some of the kinds of things we’re doing, but as we envision this being more of a proactive, preemptive platform, the reimbursement codes don’t yet exist for that.
Once we acquire that data and intelligently sort it, we also want to provide that channel to encourage and support the patient users and physician users (e.g., what this data means, what message should be sent, who needs to send it, can it come from family members, is this a problem that the nurse should look into or is this a problem that a physician should pay attention to). There is a lot of complexity in that.
Is there anything else you’d like to add?
I think this type of platform, which can unobtrusively monitor patients with an intelligent engine underneath, can really help both digitize and globalize medicine. As we well know, the major problem in medicine is access, so if you can think about a platform like this being a way to deliver good health globally on a 1-to-many basis, that is extremely exciting. We’re initiating clinical trials here in the U.S. and soon in Europe, because there are still a lot more questions than answers in this field and it’s going to take a lot of work, but we’re committed to do that.
Disclosure: Dr. Palin discloses that he is both employed and has stock/stock options with Preventice.To see another article in the November 2012 issue of EP Lab Digest®, please visit: http://eplabdigest.com/articles/Community-Memorial-Hospital