PASSIVE HEALTH MONITORING: COLLECTING PATIENT DATA AT HOME
Nick Conn of Heart Health Intelligence and Jean-Philippe Couderc of VPG Medical’s join Trial Better for an expanded discussion of new passive health monitoring technologies, including how new devices can pass regulatory scrutiny and the impact they’ll have on patients in clinical trials.
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What is the Heart Seat and what does it do? [01:38]
The Heart Seat is a cardiovascular monitoring system integrated into a toilet seat. This allows you to monitor a comprehensive set of measurements in the home without requiring patients to change their behavior at all. The Heart Seat automatically starts downloading data when the user sits down; that data is then uploaded to the cloud. It can measure over nine clinically relevant cardiac parameters including blood pressure and cardiac output.
What is the user experience of the Heart Seat like?[03:22]
The seat has the same standard hinge mounting as a regular toilet seat. It’s as simple as popping off the old toilet seat and replacing it with the Heart Seat, which is completely battery powered. The version coming to market will have full cellular and WiFi capabilities built into it.
What’s the timeline and process for bringing the Heart Seat to market?[04:22]
Right now, Heart Health Intelligence is working through the required regulatory processes to bring the Heart Seat to market. They anticipate finishing development and submitting for final FDA approval by 2021, and are targeting the end of 2021 for the initial product launch.
Is there anything different that needs to be done to achieve regulatory approval for passive monitoring devices versus achieving approval for new drug therapies? [05:00]
Companies seeking approval for passive monitoring devices must prove that high quality data can be collected using the device. So far, nobody has gotten approval from the FDA for these types of devices. While the FDA is interested in understanding the impact the device and passive acquiring procedures can have on data, they also want to ensure passive monitoring devices can produce robust data.
How can the introduction of passive health monitoring devices impact clinical trials? [06:47]
Integrating passive monitoring into clinical trials will make participating in trials less burdensome for patients. One would expect that this type of technology will not only lead to more data but will also increase patient compliance and enrollment in clinical trials. Passive health monitoring can also be looked at as a trigger for virtual clinical trials.
Besides regulatory approval, what other challenges might passive health monitoring devices like Heart Seat face? [09:23]
One of the big challenges with adopting any in-home monitoring technology is how it ends up being used in clinical practice. Passive health monitoring devices put massive amounts of data in the hands of providers and study teams that are already extremely busy. Producers of passive health monitoring devices are also digital services companies that have a responsibility to figure out how to reduce this burden in order to achieve widespread adoption.
How can we ensure patients are compliant with these devices?[11:57]
These devices require much less effort from the patient in order to achieve compliance. The point of these devices is that patients don’t need to change their behavior in order to provide the data that sponsors need.
Do you have any final thoughts on the future of passive health monitoring?[13:07]
One of the most exciting things about these technologies is that we don’t know what we’ll discover when we capture data at such a high frequency and with such high levels of adherence. It may enable us to develop better, safer medications and make improvements in the quality of care. There are also opportunities for advancements through machine learning. These devices and the data that they capture can be used for other purposes and applications that we can’t yet imagine.
[Intro]: Welcome back to Trial Better a podcast series where experts discuss clinical trial best practices and take a deep dive into the latest industry trends. Today we’re exploring more on passive health monitoring in particular, the smart toilet seat or better known as the heart seat. On this episode, we’ll discuss how the smart toilet seat works. The challenges of adopting home monitoring technology and regulatory approval. Leading this conversation is our host Jason Eger and returning guest Jean-Philippe Couderc, we’re also welcoming to the show Nicholas Conn, the founder and CEO of heart health intelligence. We’ve got a great discussion lined up. So let’s jump into this edition of Trial Better.
Jason Eger: Hi everyone. Welcome to Trial Better ERT’s clinical trial podcast series. I’m your host, Jason Eger and today I’m joined by not one but two great guests. Nicholas Conn, founder and CEO of Heart Health Intelligence and podcast veteran, JP Couderc, CEO, and co-founder of VPG medical. Both of you, welcome back to the podcast.
Nicholas Conn: Thank you, Jason.
Jean-Philippe Couderc: Thank you, Jason.
Jason Eger: So we want everyone to know. I mean, we dove into the topics early in some of our earlier podcasts and you spoke to us about passive health monitoring, JP. We felt it was really so innovative and informational for everyone. We had such great feedback. We wanted to dive into the topic a little further. So with that, Nick let’s get started with the smart toilet seat. Can you tell us a little bit more about it? What does it do? What is it? Tell the listeners, I think they’ll all find it to be very innovative.
Nicholas Conn: Definitely. So my company, Heart Health Intelligence is working to commercialize what we call the Heart Seat. It is a cardiovascular monitoring system integrated into a toilet seat and we’re excited because it allows you to monitor a really comprehensive set of measurements in the home without requiring patients to change their behaviors at all. They just go to the bathroom as normal, it automatically starts recording when they sit down and then uploads to the cloud for analysis when they get up and with this device, we’re able to measure over nine clinically relevant parameters, including blood pressure and cardiac output and also a single lead electrocardiogram. The exciting things about this with blood pressure, without a cuff, it has many benefits as well because you don’t have to rely on putting a cuff on. But cardiac output is a really unique capability that we have where we’re actually measuring how much blood is being pumped out of the heart for a minute as you’re sitting on the seat and I get asked all the time how that works, and there’s one instrument that we’ve integrated into the seat called a ballistic cardiogram, so BCG, and this instrument is measuring the mechanical forces of contraction.
So the heart begins to contract, it’s building up pressure and when it ejects blood is forcibly pushed upward, which will actually push the body down slightly and I’m simplifying the physics a little bit here, but we’re measuring the slight apparent changes in your body weight due to ejection and the cardiac cycle, and then able to accurately measure those forces to calculate things like blood pressure and cardiac output.
Jason Eger: Nick, can you describe for everyone? I mean, literally, is it just a toilet seat with the software and hardware inside it? I mean, when someone brings it home, is it they’re unscrewing their old toilet seat and putting this one on?
Nicholas Conn: Right. So it uses the same standard hinge mounting that the seats that you would buy in the stores have, and it’s as simple as popping off your old toilet seat and popping on the new one. Our seat, the heart seat is completely self-contained, battery powered, passive cloud connected. So the version we’ll be bringing to market will have both cellular and Wi-Fi built into it. The goal there is that with cellular, you don’t even need to have set up that’s the homeowner require local WiFi if there’s sufficient cell signal and that minimizes the efforts that the patients and users have forgetting the seats set up in the home. So it’s very straightforward and simple and looks just like a regular toilet seat just electrical on the surface.
Jason Eger: That’s incredible. How is it that you get this to market? What’s the timeline for the smart toilet seat.
Nicholas Conn: So right now we’re working through the required processes for regulatory approval and we anticipate finishing development under the quality controls and running our studies and submitting to the FDA. By 2021, with the goal and target for product launch and FDA approval towards the end of 2021 which is when we anticipate our widespread launch for heart failure, which will be our initial focus.
Jason Eger: JP, I think, welcome back to the podcast, by the way, and I think for both of you, is there anything different that needs to be done in both the technologies in health cam or a smart toilet seat? Do you need to do anything differently than say a drug development company in getting the medical device or the drug approved by the regulatory authority? Is it collecting the data, proving the data prove that it’s the highest quality?
Jean-Philippe Couderc: Yes, it is. Jason, and in a sense because we are acquiring this data where nobody has done it so far, obviously when you go to the FDA and you present the technologies we are talking about today the day of the FDA has no experience in this kind of technologies and they want to see raw base data. They want to see how the patients or individual are interacting with these devices and because these devices are at home, it’s not like in a hospital where a nurse is putting a cuff on a patient or any kind of sensor on the finger of a patient, here we have actually sensors that are in everyday life objects, hence the patients or the subject may use it without any control without any kind of review or procedure, they just use it the way they use it every day. So these create actually a new context for the acquisition of the data and the FDA is obviously very interested in understanding what is the impact on the quality of the data on the measurement that these acquiring procedures are completely free of any kind of training or any kind of recommendation to the patients using the technology.
Jason Eger: And so you spoke a little bit about the impact of the, it’s great that everybody’s accepting of it and I think as you develop it in both your technologists are incredible. The impact on how patients are treated is it is any different with clinical trials, JP on how passive health monitoring and that data there’s so much data that’s collected. Is there anything different in clinical trials, the impact of the patients there?
Jean-Philippe Couderc: Well impact to the patients? No, I don’t believe so. Actually, there’s less impact to the patients. Obviously the fact that in a clinical trial, you would integrate such type of passive monitoring. You put less burden on the subject. I don’t like this term, but for the subject of this study to actually generate the data for the company for the formal companies or the CRO, really in a sense one would expect that with this type of technology, not only we have more data than what is used today but we have more compliance of the subject in clinical trial because they don’t create any boundaries for these subjects. So in a sense, I think it’s only a win, win situation and it’s exactly why I think HHI and VPG medical are working so hard on developing this type of technology because we are opening new ways of acquiring good data, inpatient, at home and I think we are really triggering what we call virtual clinical trials in a sense, because we have with this kind of technology, the ability to spread out the sensors very easily to a lot of people.
When we see what Apple recently published with the smartwatch, I think the most important results of this study was really about enrollments. I mean, where’s this device, they enroll more than 40,000 people I think in couple of months, it is amazing. I think this is a third aspect of this kind of sensors and passive monitoring technology is really they create opportunity where we can access to more people more easily as well.
Jason Eger: Great, thanks and for our listeners, if you haven’t heard our episode with JP earlier about health care I encourage you to listen to that one because his technology as well is extremely innovative. So we talked a little bit about the regulatory scrutiny. Nick, what other challenges do you see for the adoption of the smart toilet seat as you go towards 2021?
Nicholas Conn: So one of the big challenges with adopting, I think any in home monitoring technology is how it ends up being used in the clinical practice. It’s one thing to have data that you put in the hands of the patient, but fundamentally we want to put the data in the hands of the providers so that they can make it the intervention and keep the patients healthy. But providers are already incredibly busy they’re overburdened as it is and the last thing that many of them want is it was a deluge of data from every single kind of patients are using the bathroom. So part of the challenge is figuring out how to integrate into the clinical practice without it being burdensome. What we’re focusing on is offloading that burden to an operation center, which will either be run internally at HHI or in partnership with home care organizations for basically fielding the alerts as they come in from the measurements and then reaching out to the care provider at the hospital clinic when there’s something that’s been identified as wrong and suggested intervention, so that the provider then just have to make a decision rather than just through this data deal with false alarms, alert fatigue and all the other challenges that come with having this much in home data. So working through that is something that needs to be done correctly so that we do have widespread adoption and it’s a challenge to get it right. But we’re, we’re committing to doing that and we think that that is going to help really add a lot of value to this technology in clinical practice with the seat.
Jason Eger: Great. JP, how about you? Any, any thoughts on?
Jean-Philippe Couderc: Yes, I totally agree with what Nick said and what should not really and it’s true for both, HHI and VPG medical is that we are not only technology companies. We are actually digital service companies. Where with what Nick just said, it’s developing the technology is one thing, but really servicing, I would say healthcare professional the health care and also the CROs in the field of clinical trials require this step of making sure that the substance from the data is provided to these stakeholders and that’s a very important part of it. I think Nick, right, this is one of the important challenge in developing these things.
Jason Eger: Is there any, I know one of the other challenges that we’ve experienced just in clinical trials in general is patient compliance and patient adherence. Is there anything different that you could do and how do we make sure in using both of your technologists and digital services that patients are adhering to what we need them to do? Is there anything that we can do different?
Nicholas Conn: Yeah, so with the smart seat as long as we make sure it’s installed and the patients don’t go through the effort of removing it from their seats, we’re guaranteed to get measurements and I think same with the VPG technology, we’re focused so much on integrating this into the everyday life that we want to make it so they don’t have to change their behavior at all so that we can still get high levels of adherence. The only behavioral change that we can rely on is no behavioral change at all and both of these technologies are focused on that and making it seamless
Jean-Philippe Couderc: Obviously for the toilet seat and the smartphone think about it. I mean, we all use these two devices every day without any doubts. So, that’s it.
Jason Eger: No, I get it and Nick, great point. Before we wrap up today, from either of you any final thoughts, do you want to share with the audience about the future of passive health monitoring? Nick, do you want to start first?
Nicholas Conn: Sure. You know, I think that one of the things that excites me the most about our technologies together is that we don’t even know what kind of things we’re going to discover when we have data captured at such frequency with such high levels of adherence and even at risk populations. So who knows what we’re going to find when we measure stroke volume and cardiac output and blood pressure every single day. We may be able to develop better medications from that data we may be able to make medication safer from that data and provide all kinds of the improvements in the quality of care and then there’s applications outside of even monitoring heart failure and other types of cardiovascular disease. When we start having this breadth of data machine learning can do amazing things if you provide it with the right inputs and I think we’re getting to the point where these types of data that we’re creating will provide inputs to machine learning algorithms that can provide a ton of value in ways that we’ll never expect today.
Jean-Philippe Couderc: Yes, that’s again, a very good point, Nick and I can share with you a story that happened actually a couple of weeks ago with the health scan app that was used by a heart failure patients. In one of our pilot’s program, with the technology we money toward the daily resting heart rate for a long period in these patients. And suddenly we realize that his resting heart rate is increased by 25 to 30 beats every day for a couple of days. So we basically come back to the person, we try to understand what’s going on and we realized that actually this patient has a device in his body, which is called a cardiac re-synchronization therapy device that actually synchronizes the different parts of the heart to actually optimize the pumping function of the heart. The programming of this device was changed and was erroneously changed and the CRT was not working anymore and the patient left and he went home. Then suddenly on our measurement, we see that his heart rate is going crazy and things are not working and we basically are able to detect with the technology that something some clinically relevant event has occurred and could be detected just by having the person having fun with it.
Jason Eger: Oh, sorry, go ahead. Nick.
Nicholas Conn: It’s just a great story to highlight how passive monitoring can really change lives.
Jason Eger: Yeah. And it seems like your both in any passive health monitoring technology, you’re making it easy for the patient and you’re going to collect so much data. I bet you, we don’t even know all the uses of the data that we’ll get to at this point and what we’ll uncover. So I’m sure to many positive things going forward and hopefully finding cures and making patients’ lives easier. So, gentlemen, I want to thank you both for joining us, I think it was a great conversation. I think you’ve spoken and taught us a lot today. Continued education for us on passive health monitoring. The technologies that both you’ve have smart toilet seats and health cam and we look forward to hearing about your success and your regulatory approvals. So with that, I know we’re all looking forward to seeing these technologies going forward and to our listeners, thank you again for tuning in a Trial Better, and be sure to get in touch with us with any feedback at [email protected] Thanks everyone.
[Outro]: That’s a wrap. Special, thanks to Nick, JP and Jason for today’s discussion on the smart toilet seat and for once again, exploring the benefits and challenges of passive health monitoring. Also thank you for tuning in. Please remember to comment rate and review Trial Better on Apple podcasts or your favorite podcast channel. You can also reach us [email protected] Your feedback helps us deliver the research and technology you want to hear about. So please get in touch again that’s [email protected] Thanks for listening and we’ll see you next time on the Trial Better podcast.
Nicholas Conn is the founder and Chief Executive Officer of Heart Health Intelligence (HHI). Prior to founding HHI, Nick was a Research Scientist at the Rochester Institute of Technology (RIT). He completed his PhD in Microsystems Engineering in 2016 at RIT, where he developed HHI’s technology – a toilet seat-based cardiovascular monitoring system.
Nick’s passion is to bring clinical grade medical devices to the consumer, through revolutionary internet of things (IoT) and wearable technologies. His expertise spans business development, medical devices, ultra-low power systems, physiology, signal processing, algorithm development, and heart failure monitoring.
Also find more information on Heart Seat at Heart Health Intelligence.