Archives for April 2018

Why 2018 will be the Year You Embrace Continuous Connectivity

18 min reading time

Nersi Nazari, 10x for Design and Manufacturing keynote speaker and CEO of VitalConnect, bet the fate of his company on the widespread adoption of continuous patient monitoring.

Sounds like a reasonable bet to me.

In his 40-minute keynote at 10x for Design and Manufacturing, Nersi said patients and consumers are accepting the technology and clinical evidence supports its efficacy. After all, the continuous monitoring of vital signs is not new. In critical care, life depends on it.

So how to make continuous monitoring portable, inexpensive, and effective?

Mr. Nazari answers that question and many more in this enlightening talk. Watch below and click through for the slides and transcript.

Nersi Nazari: There’s basically, to go through quickly, it has to be novel and non-obvious. And non-obvious is some ordinary people skilled in the art. Imagine a fresh biomedical engineering graduate with a library card, but not inventive.

Would it be obvious that all of the elements that make up that patent are obvious to him?

What I’d like to also present tonight is that besides the challenges of the healthcare system, there are three other things that are at play which makes 2018 a very exciting year for this sort of technology.
• One is acceptance by patients and consumers.
• Second, the technology is here.
• But the third, and the most important thing that is unique to 2018, is the clinical evidence.

We’re now starting to have clinical evidence and as we speak, I know a number of a prestigious journals that are viewing this type of data for publication. And leading institutions are starting to use these products in their hospitals and healthcare systems.

We all know that nobody wants to be the first to use new technology.

But, as a chief medical officer reminds me, nobody wants to be the last. So, the trend is there, the clinical evidence is here, and with all those other underpinnings of the cost of healthcare, the technology and also the need that is seen by the patient community, I think this is going to be an exciting year for all of us.

So, I’m going to start with the first of the concepts that I talked about is that really the acceptance is there by everyone to be continuously connected. So, as we know, socially, everybody is connected and if you have a teenager, you know they’re more than connected – they’re always connected. On finances, banking, on purchasing stocks, and all of those type of activities, payments, again, everybody’s continuously connected.

And then, even parenting, you know, having virtual boundaries for your children, looking after them and so forth. So, this concept is becoming widely used and accepted. And I could also extend to alerts for remote control of your house and lights and all of those types of conveniences. Then moving to the temperature of your house, energy-saving, that sort of activities, plus monitoring your house by utility companies it’s all there. Nobody seems to be upset about these anymore. And at the same time, they are enjoying the convenience and the cost savings.

In the healthcare market, also the wellness, the unregulated part, the health and wellness part has also enjoyed and a number of acceptances in the market.

So, for example in fitness, how many steps you took, your exercise and calorie burn, a whole bunch of applications in that area.

On the consumption of food, and as you know, there are some that even try to estimate the number of calories you’re consuming by taking a picture of what you’re eating, so again, more health and wellness applications.

And if you live in California, and maybe on the east coast as well, there are also applications for your pets. So, for example, you want to make sure your dog took the appropriate number of steps and walked the right amount of time, and if you’re not the one who’s walking the dog, you want to make sure the person who did, walks a certain number of miles or steps for your dog.

So, that’s sort of a starting with the fact that everybody wants to this sort of monitoring. Again, moving it to the healthcare side, statistics are also revealing on both on the wearable and for the medical apps. And again, that’s an area that you see almost a tripling in a matter of just a few years.

So, we are accepting these types of monitoring and moving it to healthcare, first, to their wellness area where we’ve seen rapid growth. So, I want to now expand out to the medical side, which is what we’re concerned with in this audience.

What do we do right now?

The continuous monitoring of vital signs has been around for a few decades. And we know if anybody’s in ICU, essentially their life depends on it. So, it has been done. But obviously that is a type of technology that you cannot extend because of costs. And, not just cost, the complexity of device. It has to be operated by very skilled technicians and it has to be interpreted by doctors.

Then, as far as the monitoring is concerned, when a patient is a released to the general ward, again, these types of equipment are too expensive to move.

So, what do we do? We do a spot check. But when we do a spot check a good number of times 96-97 percent of the time, the patient is not monitored.

So, if there is a technology that can do that, obviously, the hospitals will look at it favorably because they know if somebody was sick, they want to do a hundred percent of the time, if somebody was really sick.

As you know, when patients get discharged, they essentially get a phone call and that’s about as much as most people get. They ask you to come for a check-up in a week. So, this is what we are dealing with right now. But again, if the technology is ICU grade but is inexpensive, convenient to use, obviously for a good portion of patients, we could have extended to general ward and, also, to home use after discharge. And obviously, from the price point of view, the first is super expensive, takes a lot of time for nurses to visit in their rooms, and the phone calls are very inexpensive but also very ineffective.

How do we get this thing outside the ICU?

Let me show some statistics really quick. You’re all familiar with that? We have a lot of hospitals. The average stay is about five days and staying in a hospital is like a super expensive hotel.

So, these are the stats that we’re familiar with and, obviously, we want to do something about them. But, I pass through these quickly to get to the part that I think is a more exciting part. Again, a lot of expenses in readmissions and also in Medicare cost, which has ramification in public policy, taxes that need to pay for those and so forth.

The economic part, as I said, has been well known and I want to spend more time on why, this year, all of those have been around. The clinical evidence that helps us move along, too, solves some of these problems.

Essentially, what we’re trying to do is to keep the patients out of the hospital.

I will show you some data on a leading hospital system that has gone beyond monitoring their patients after the ICU or the surgical procedure. They’re trying to actually admit some of the patients, right off the bat, to their homes. It has very, very promising results, for that institution.

Obviously, we want to keep the patients healthy at home. How do we know they’re healthy if we do not take measurements? Obviously, the continuous monitoring is helpful for that.

The patient deterioration is the cause of all these readmissions, and possibly worse. If we could know that the patient is deteriorating, we could do what is possible to avoid it. Obviously, we want to have a more preventive healthcare system.

Finally, under clerical burden, once the data is continuous and electronic, you can always find the interface to put it in your EMR or EHR, so, that’s also an additional advantage.

So, let’s see how we can do to that. Again, I go through these very quickly, you know, the costs are extremely high, population is aging, and continuous monitoring is the solution that we’re going to deploy to look after these costly situations.

Now, what are the statistics? Has the continuous monitoring been shown to be useful? Before we had the technologies that are a cost effective, people have done quite a bit of analysis on the patients, and how they could be helped. For example, the number of people who have preventable adverse events annually, in just the United States, is over 400,000.

So obviously, if these patients were monitored, since these are preventable adverse events, they could have been helped and this is not just costs, obviously saving lives.

Other statistics, their Medicare expenses, 50 percent are for readmits that are preventable. And again, to help that, we want to be monitoring patients, so we can prevent it.

Right now, patients that have cardiac situations are usually identified, on average, 15 minutes before. So, if you have systems that can predict that, it would be, obviously, a huge, not only cost-saving, but more importantly, life-saving. I will show some clinical data later that this can be done.

Again, in the hospital, as much as it’s a burden for the nurses, an inconvenience for their patients, at the same time, 96 percent of the time, there is no one in the room to take a look at the patient. So, a lot of bad things can happen.

So, obviously, early warning signs can be extremely useful for a number of these conditions and I could go on and on. I just want us to give this as a motivation that this sort of monitoring is extremely useful for both saving lives and expenses.

Another condition that is extremely sensitive to monitoring is sepsis. Sepsis is huge in terms of the damage that it does to the patients, to the costs and to the healthcare system. And this is one of those conditions that early detection is extremely important. Even every hour is important.

If we could have these technologies in hospitals so they can administer the right medicine and treatment in just a few hours, it can make a big difference. And on a regular spot check, that could be every four, six or eight hours depending on the hospital system and the protocol. This makes a huge difference.

So, when you talk to hospitals, if you say you have a solution that can help in any way with Sepsis, you get immediate attention. One, that this early detection is extremely sensitive.

How can you monitor the two – there are three, really, things to look at – the subtle changes in heart rate and breathing rate is an indication of an infection, which sepsis really is.

So, if you have every heartbeat and every breath looked at very carefully and with accuracy, you can make those detections. The other measurement is temperature, which is also useful.

So, this deterioration or preventable, why haven’t changed? And again, that goes to the thesis, that, obviously, we need the technology and the clinical every day. The things that we have up to now and some of those clinical studies that I showed you, they were done with bulky, expensive devices, they were done for research purposes and this was not a solution-oriented study.

But what is the condition that needs to be done? Now, that’s where we need to develop medical grade devices that we’ve been able to do now, and it’s not just my company. There are a number of companies that are developing extremely accurate, yet small and affordable devices.

But, it has been hard and part of that is not just a medical device development. You have to have the infrastructure, the Bluetooth, low energy, Internet, also ability to do the cloud computing, analytics and so forth, that I have touched on.

Let me also go back to show another aspect of these devices that is often overlooked. The intensive care unit, which is accurate, it’s not just cost of this that we’re trying to avoid when we go to the general ward, but also inconvenient and uncomfortable.

Now, that inconvenience and discomfort also cause patients to rest less. And again, there has been a lot of studies that if a patient rests better, they recover faster.

Later on, when I show you the clinical study for patients that are admitted at home, one of the leading reasons that they recovered faster was because they could rest. There were not all these noises, the machines, the lights and so forth. So that’s a very important aspect. And that’s why I wanted to show this in a picture for you.

The other part in the hospitals, obviously, you want to be visited by technicians so you’re not out there. But the other thing that some of you, I’m sure know, from visiting loved ones, in hospitals, that it seems like they’re often coming at the wrong time, when somebody is studying, sleeping, or resting. And again, going back to my previous thesis that, when you rest, you recover faster.

And then the other point is that with the devices that are out there, the telemetry devices and so forth, not only are they bulky, you can look at the data there, so it’s been very useful for the nurses and technicians to warn doctors or nurses to help the patient, but at the same time that data is almost temporary. You can look at it in the screen, but they have not been well documented into a EHR or EMR system that’s almost disconnected. Most of these devices have like 96 hours of memory, not well connected to internet or other systems for post-analysis.

Why can we make these changes now?

And again, obviously, the technology is the solution and the ecosystem that now we’re enjoying. And as I started, the culture has evolved, and people do not mind to being monitored.

And, if fact, what we have seen is people have legitimate concerns about privacy. But, when you talk to the patient population, they’re still concerned about their privacy. But, a lot more than that, they’re concerned about getting their data to the doctors as soon as possible. So, they do not deteriorate or if help needs to be sent, it is sent immediately.

How has this technology evolved?

We have four components I touched on. A one is obviously cloud analytics. We can get this data and not run one computer on it, but as many as you essentially need, if you’re on, as you know, in IBM Watson or Amazon AWS, essentially you can get as much a computing system as you need as you pay for it. And no one wants to sort of short-change you when you are analyzing healthcare data.

Connectivity, very important, one of the things that we are trying to do, and other people, that this is not just in hospital, so when the patient is discharged, this continuum of care continues. So obviously, good cellular connections, LTE and whatnot.

The third one, one of the things that we make in our company, we make these biosensors. I’m holding one and I’d be glad to show you later on. They’re very small, very flexible, but at the same time they’re as accurate as devices that are the size of a table, for measuring your breathing rate, heart rate, ECG, and so forth in the hospital. These devices enjoy the same standard of FDA and regulatory clearances and obviously can be relied on to make medical determinations.

Last but not least, obviously, artificial intelligence and more analyzing of these data, which is very, very important for some of the conditions that I talk about in a few minutes, such as heart failure, and a very, very subtle changes that need to be calculated and looked at.

How has Culture Evolved?

Again, under culture, I go a little faster. We all have busy lifestyles, but at the same time we’re very happy to be using mobile devices. But, the change that we really are seeing now, this last year in 2018, the hospital is not viewed as the best place to be. A lot of people in healthcare, a lot of us knew that the hospital, in a way, is a dangerous place. That other than proximity to doctors and great caregivers, which is great, when you’re sick, there is also opportunity to catch other diseases. You don’t rest well, you don’t sleep well and so forth.

And that is becoming more widely known. And in fact, patients that a clinical study, I will talk to you about later on, in the random study, most of the people that wanted to be on the home side, rather than the hospital side for the clinical study have meaningful comparison.

Continuous Monitoring – One Patient Story

Let me just talk a little bit of a clinical studies that we did.

And again, this is showing one of the things that is only can be done by continuous monitoring. When we developed

our products, we wanted to make sure people can use these things easily at home, that you don’t need a doctor or a nurse to help you out. So, we did a study of two months, so we have 50-60 volunteers and they took these home, a showered with them, you know, did whatever they usually do.

And, we collected all that data for an FDA submission.

But one of the interesting things that happened was that one of the patients actually had a heart rhythm issue. If you see the bottom graph, some missing heart rate pulses. And if you do get the data, that happens very, very infrequently.

So, obviously, our chief medical officer sent that patient to a cardiologist, and it turned out that she just needed a simple a pacemaker to resolve her condition. Again, coming back to the case that you really need continuous monitoring to come up with some of these diagnoses.

Continuous Monitoring – HF Patients

But, let me talk a little bit more detail about one of the other clinical studies that was done with our device with a third party, analytics company called physIQ in Chicago. They did a very large study at the VA. The paper was published, was based only on 100 patients, but that’s, obviously, still statistically significant.

This paper was published in the American College of Cardiology and showing very, very promising results for the heart failure patients. This is the sort of study that I was talking about that they’re coming out with and they going to be the catalyst for wide acceptance of these devices.

For this study, they again, had to measure every beat, every day to come up with these subtle changes. And, what they essentially found out is that you could predict heart failure condition, that the patient is in the wrong trajectory about six days in advance.

And for those of you who are practicing medicine or know more about heart failure, when it’s six days in advance, sometimes it’s just a change of diet, and moving patient, walking more, or things of that nature, diet and so forth that can help you prevent this type of things. You don’t need to be admitted to the hospital.

So, this was a very, very big a study for both VA and also for our partner because it had indisputable evidence that if you can have accurate measurements, but it has to be continuous, and over time, you can make this sort of a prediction.

Why Continuous Monitoring?

Again, I’ll go through this quickly because I think I talked about it enough, you have to have the continuous time to tell the whole story. And also, the fact that you have the continuous monitoring of your vital signs in presence of activity that is also very, very important in terms of the analytics. So, now it is viable to have these types of solutions.

State-of-the-Art Hospitals

Let me move to hospitals. I have two cases are of using these sorts of devices in hospitals. The first case, let me just show you the chart. This is probably better. Essentially, the data goes from the biosensor to a relay, which we make something that is very dedicated for hospital use. And the data goes through the nurse but also goes to the cloud for aggregating this data, analyzing it, and a command center, so somebody out the hospital or team can watch the entire hospital systems. So, that’s sort of the architecture.

Continuous Care Systems

But let me just jump to the, and this is sort of how it looks, the upper right picture is looking at the single patient, and the bottom right is when you’re looking at a whole bunch of patients, and it has all these analytics to see which patient to look at, which one has an alert, and that sort of stuff. All of this has to be FDA cleared, go to quality system, and so on and so forth. But let me just rush this through in interest of time, to talk about their results.

A patient experience, obviously, for the cardiac patients is so different with the halter monitor is something that we have here for a sleep analysis. Again, the same type of thing, once you have all this data, you can do analytics to do Sleep Analysis, as good as, Capnography and the picture on the left.

Again, the one of the two studies that I wanted to emphasize more, this was on at Brigham & Women’s Hospital in Boston. Dr. Levine, has a video on YouTube if you want to look at it, is a professor of medicine at Harvard Medical School, but also is the leader in this hospital-to-home type of program that they’re doing.

In this case, this is the published result, there’s a much bigger study with hundreds of patients that is going to be published later, but this is what I can share with you. And, again, on this, when they did the biosensor and randomly admitted some patients to home for mid-acuity, they saw enormous saving in costs, but more than that, they also saw fewer readmission for the patients who went home, they recovered faster, and they’re all, obviously, did not ever catch some other infection or anything like that.

They were more active. They were happier. Some payers, the measure of satisfaction of payer has influence on how much the hospital gets paid. So that’s obviously something that was appreciated by them. And since we measure activity, we could also see that they are more often… and so forth.

Mercy Virtual

So, let me go to another hospital system that we had the privilege to work with, and that’s the Mercy Hospital system in St Louis. They are so committed to this sort of technology, they built that building on the upper right, which is a Mercy Virtual. That’s a hospital with no patients in it. But, they have ability to look at thousands of patients with the technology that they have, and we have this small part of giving them the biosensors, to look at their entire hospital, thousands of people that are in the hospitals and monitor them continuously and they have shown better care at a lower cost. And I let their officers give, maybe, the presentation, at the next opportunity.

Hospitals as the “Hub & Spoke”

One other thing that we see is that the heart hospitals are also becoming very expensive themselves to build. Cost of a hospital bed is becoming one to one and a half million dollars to build. So, what do you want to do is that you want to have the hospital as the sort of the center of the care, but, push the care outside. And that’s what they’ve done in Boston. Their activities similar to that in California by leading teaching hospitals. So, that way we can essentially have hospitals that kind of move out and be able to give a patient care outside the hospital. And again, this sort of technology is required to get the data from the patient, but analytics experts, doctors and so forth or in the hospital. Which brings us back to those numbers that I’d talked about.

Tomorrow’s Standard of Care

This sort of technology, not only saved the patients, maybe the number of hospitals over time goes down, and the length of stay, and the significant cost associated with that. Same thing for the admissions for the patients in Medicare and so on and so forth. So, this technology really has the capability, now that we have clear medical evidence by leading institutions and very carefully published results, that I’m very optimistic that this gets picked up by more and more hospitals for 2018.

Continuous Connectivity

We are sort of a year for the tipping point on this technology, more than anything else, it would save lives, improve patient experience. When we were looking for volunteers in hospitals there were usually more people who wanted to be on the biosensor than the ones who did not want to be monitored. Because as you know, you have to have two groups to do the clinical comparison.

Clinicians also very happy. This is not the type of technology they look at as they’re replacing doctors or nurses, they say, essentially, helping doctors and nurses to do what they like to do, which is givingcare to patients rather than measuring the pulses or looking at their ECG or things of that nature.

So, we essentially think that with this sort of technology, not only you can do that in hospitals, but you can monitor patients anytime, anywhere which leads to post discharge and, obviously, extending the hospitals to the neighboring communities. So, thank you very much and thank you for your attention.

Joe Hage: Nersi, I’m really, really pleased that you’re here with us today. As I said in my introduction, I can’t think of anything more contemporary and on trend in medical devices right now then this combination of IOT in miniature and immediate feedback. A|s I understand it, there is no standard yet. You have a number of competitors, if I’m not mistaken, how do you compare and are we going to look at a Sony versus Beta situation where one of the formulations is going to win versus the other? Is there a risk there for someone to bet on you, for example, versus another standard?

Nersi Nazari: There’s not as much of a standard point, between one and two things, because everybody, really, is going to provide an end-to-end solution. Like we provide the cloud, the biosensor, the connectivity, and so forth. And other people are probably going to be doing the same. So, this is gonna be like Medtronic versus Boston Si versus St. Jude. You know, it’s who has better overall technology. We are a long way from a day that you buy the biosensor from this company and the cloud from the other company and so forth. And on top of that, the regulatory regime, right now, it is that you have to submit the entire system to get approval.

Joe Hage: So, is it rare that a hospital will be your customer, but rather you have a strategic that you work with and you helped them bundle their product offering, is that more likely the way it works for your business?

Nersi Nazari: Yes, yes, that is one of the business models.

Joe Hage: I know there are a couple of questions in the audience.

Walt Maclay: Hi, I’m Walt Maclay. I’ve got an interest in wearable devices. I’m curious what challenges you had in developing the wearable device and what was the main challenge in how long it took to develop?

Nersi Nazari: Thank you for the question. It took us five years to develop this device and one of the challenges that… one of the speakers this afternoon, our friends at 3M, adhesive is always a challenge to get it exactly right. But, accuracy is probably the most important challenge. These devices are small. And we had also a speaker about the dangers of miniaturization. The tolerances have to be higher, the algorithms have to have more accuracy. But, I think those were the two, being accurate and yet small and adhesion and all of those issues that you have with the device that is on or in your chest.

Hitesh Mehta: Hi, I am Hitesh Mehta. Great talk. I was just wondering, you have the system for the hospital? So, could I buy for my parents and monitor them and see… “Oh, you live 6,000 miles away so I can know what’s going on and say, OK, you got to go to the doctor because something is not right and help them out. Is that a possibility?”

Nersi Nazari: Technologically, it’s possible. When you have a patient wearing one of these. If fact, we’ve had cases that the consulting expert is somebody that is at Cambridge University, but as far as putting medical devices outside the country and so forth, there are regulatory and other restrictions.

Del Lawson: It’s a great talk. And just a quick question. The data seems to be potentially overwhelming, if you have to keep all the data for liability or other reasons. And, how much human interaction is required? Or can the algorithms spot the anomalies so that the nurse or someone doesn’t have to look at all the data?

Nersi Nazari: Thank you. Very, very good question. What we have done is that we really looked at these things from the current standard of care, the telemetry machines. So, we have simple thresholdings for various measurements which the nurse or the doctor orders that. Some of those are very subtle things, like that heart failure prediction and so forth. Those were done essentially by experts. And those were done in clinical study. They have not been done on live patients yet because we need to get regulatory approval for prediction more than the algorithms.

Joe Hage: Nersi, this kind of dovetails on Hitesh’s question. It sounds as though almost everything you’re focusing on now, at least from a strategic, all the things you could be working on, prospective is the hospital level of monitoring. And there are so many consumer level risks and body suits and other things. Do you think that sensor technology, the kind that you specialize in, we’ll find a consumer application or is that strategically off-plan for you?

Nersi Nazari: You know, it could, one day. But, right now, we almost even speak different languages. Because, you know, you’re measuring the number of steps. I measured the number of steps, like a versus some of the consumer products. But the standard quality system is so different. We have to worry about a patient that is sick and is walking like this, which means a lot more testing and so forth. Whereas, for a pedometer, that is for a healthy people, they want to know if they do the 10,000 steps or not. So, even the simple things like number of steps, the approach is so different that the emphasis on accuracy is so important. And, I also find it that if somebody is perfectly healthy, like we wear it for our own studying and so forth, we don’t find this much useful, to be honest with you on a perfectly good engineer. We just gathered the data for analysis, but they’d rather use the Fitbit for the jogging in the morning anyways.

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