How to Reduce Healthcare Associated Infections by 65%
Chris Hermann is the CEO of Clean Hands – Safe Hands, a company dedicated to reducing healthcare associated infections through better hand hygiene. In this episode Chris shares what his company is tackling, and the road they have taken from idea, to development, to clinical study to sales. He discusses his take on the customer discovery process and what he refers to as Clinician Centered Innovation, and how what he learned led to changes in the product, along some of the mistakes they made along the way. Also, we discuss their regulatory pathway, and disclose wether their device is a medical device or not.
Links from this episode:
Mastering Medical Device:
Episode Transcript
This transcript was generated using an automated transcription service and is minimally edited. Please forgive the mistakes contained within it.
Patrick Kothe 00:31
Welcome, thanks for joining today, we've got a great guest. And we'll be covering some interesting ground. Chris Herman is CEO of clean hands safe hands, a company dedicated to reducing healthcare associated infections through better hand hygiene. What I think you'll find interesting is what his company is actually tackling. And also his take on the customer discovery process. And what he refers to as clinician centered innovation. He'll share what he learned, and how that led to changes in the product, and some of the mistakes they made along the way. Also, we have a discussion on his regulatory pathway. I think you'll find this particularly interesting because we don't always know what our regulatory path will be when we're attacking a problem. Because we don't know what what the solution is yet, or what claims we're going to be going after. So startups often face these questions, and Chris shares the answer to the question he faced. Is that a medical device or not a medical device? As you're listening, see if you know the answer, Chris has a unique educational background. He earned a BS in biomedical engineering, master's in mechanical engineering, both from Georgia Tech. Then he participated in a joint MD Ph. D. program and earned a PhD in bio engineering from Georgia Tech, while at the same time earning an MD from Emory School of Medicine. Here's our conversation. Chris, thanks for being with us today.
Chris Hermann MD, PhD 02:16
It's my pleasure. Thanks for having me on, Patrick.
Patrick Kothe 02:18
So Chris, you've got quite an educational background. Can you tell us about it?
Chris Hermann MD, PhD 02:23
Sure. I do. I certainly spent more than my fair share of time in school. So my background is I started out my post high school training in biomedical engineering through Georgia Tech. So I was one of the first people to go through their program. And the focus for me all along was to go off and become a surgeon, orthopedic surgeon, actually. So I had a lot of exposure to those two orthopedic surgeons in high school due to a knee injury and problem of mine that I had over the years. And really gravitated to the field. Because it was using technology. It was using medicine to help people in the very hands on way, I always enjoyed the sciences and physics and chemistry and biology. And the biomedical engineering was a really good way to kind of blend all those together. And I thought it was going to be a very interesting and good foundation to go on into a field that does as much engineering as any is orthopedics. It's very much the mechanical engineers of the body and the carpenters of the body. I went through that program very focused on going on to the medical school thinking I was going to go off to be a normal surgeon. And then after graduation started medical school at Emory, through most of my first probably my first year I was focused on the surgery. And the summer after my first year medical school, I worked down at Grady, which is the big Trauma Center here in Atlanta, in the orthopedic trauma group doing research and got the kind of bit by the research bug at that point. And really, at that point in time thought I wanted to go down an academic track for my career, Chris was that research was a clinical researcher, was it biological research, what kind of research this feature was, was purely clinical. So we were doing, we looked at spinal injuries and in one project, and then infections and HIV patients and another project. But this was a purely clinical research track, but it got it got me interested, more interested in research in ways that I didn't experience going through Georgia Tech. I did do some research, but it was really, really basic research. And just at that point, again, as an undergraduate research assistant, you don't get to do a whole lot. And that just didn't really resonate with me. But really, once I get to sink my teeth in and have more ownership of larger projects, I really enjoyed that. That started me thinking about Alright, if I was going to go on and have a career in research, what did I want to do with that? And what what would be my niche so to speak in that field, and what has been really a passion of mine and the thing that I've always enjoyed most is that bridge between engineering and medicine and it's awesome. Especially in the medical field, that bridge can span a chasm. And there are many times there are a huge disconnect between what the engineers do and what the surgeons do for people who could understand both sides of the fence so to speak. It's it's maddeningly frustrating at times. I think I was, it was when I was an undergraduate. pretty early on in my career, I was working with a surgeon who was pioneering a new knee replacement technique as a minimally invasive surgery. And the surgery was going well, but they had to move one of the components in the instrument that was designed to take that component out of the body wouldn't fit through the incision. And I vividly remember the surgeon picking something up this instrument up in his hand, he said, What do I do won't fit in the hole, like it's no matter what I do, like, forget attaching it, I can't put it through this minimally invasive incision. And I remember and I was involved with the back and forth, it took me probably 18 months to figure out a new version of this that wouldn't break or wouldn't snapper wouldn't shoot plastic parts over to the curtain to the anesthesiologist. And that's really what has stuck with me all throughout. So after my first year of medical school, I applied into a dual degree program that Georgia Tech and Emory has so as medical degree from Emory, a PhD from Georgia Tech. In my particular case, it was in bioengineering and mechanical engineering, and then went through a fairly traditional PhD, engineering Ph. D. program, I worked on a pediatric cranial facial bone project, and then went back to finish medical school and had a pretty normal third year. And then what should have been my last six months of, of medical school took me about four and a half years to finish. So by the end of it, I was the longest continuously enrolled student at Emory, which was a very much an infamous title. I was I was fortunate to have the support of the Dean's in the School of Medicine, all my crazy side detours, which I think we're gonna talk about here in a second, but it was quite the journey to finally finish up.
Patrick Kothe 06:58
While so how many years of college how many years of post
Chris Hermann MD, PhD 07:03
education, it was 18. He were at least on paper, I was enrolled as a full time student for 18 continuous years.
Patrick Kothe 07:12
Amazing. So what did you learn about yourself?
Chris Hermann MD, PhD 07:19
Well, I think I think honestly, there's a had there been a few screws loose over the years. Um, but the biggest thing that I have learned over this period of time is they really enjoy identifying and solving problems. And, and, and certainly, through my training in graduate school and beyond, I've ended up biting off some pretty big problems and kind of working through all of the ins and outs and ups and downs to try and solve, solve those. I really enjoy the big complex, hairy problems that usually don't have very good answers when you start out and working through that process to understand and identify the solution.
Patrick Kothe 07:58
Because you you were involved in to really world class dense institutions. I mean, Georgia Tech is known for engineering programs, all kinds of engineering and greater biomedical and embraces a top notch, top notch school, you took a less traditional approach. So what was that like? I mean, were there mentors there that could help us navigate that
Chris Hermann MD, PhD 08:24
there were, and in particular, Emory, in the School of Medicine, they are very supportive of those non traditional approaches. And that's a bit unique to medical schools, because most medical schools, it's a four year and you're done kind of a program, that Emory really encourages you to expand and go on to additional degrees while you're in school. And they actually are very, very supportive of that the majority of those students typically will do a one year detour, unlike mine, that end up being about eight. So that a one year goal offering an additional degree or for a little side project, is probably the right way to go for most people going into the medical field. You can't train doctors fast enough with the detours that I went through. Because of Emory and the CDC ties. The majority of those students who add a year do a master's in public health and go on, typically epidemiology or a similar field. They have a new Master's in clinical research program that had that existed at the time I went through, I might have actually gone down that road. And then there were a handful of people who will go off kind of like I did to do master's degrees in engineering or business. There's a growing group of MD MBA students that I think makes a lot of sense for many, many reasons. And then there's about 10% of the medical school class who does the MD PhD, most of them stay at Emory in the traditional basic sciences, but about 10% of that 10% will then cross over the connector to do engineering over at Georgia Tech.
Patrick Kothe 10:00
So the majority of medical students go in and they come out and practice practice medicine. Yes. And but different schools have different percentages that are coming out with, you know, doing other things research or other things. Are you saying that Emory is as a higher percentage than most schools,
Chris Hermann MD, PhD 10:17
they do, they do have a much higher percentage. And that's and that being a kind of tier one research institution, it's part of why you go to Emory is to have access to those, whether it's basic science or clinical research faculty and programs and departments, they have a higher percentage of people who go there. And that's probably just a natural selection at the application stage, if you if you want to go off and be a I don't mean this anyway, disparagingly, or negatively. But if you want to go off and be an internal medicine doctor, or primary care physician or pediatrician, and have no interest in researcher or any of those things, Emory is probably not the right school for you. Part of that is the costs associated with it. But some of the state school routes are much, much more affordable, it's just a better fit for those pure primary care specialties where Emory really does set you up to be, whether it's a researcher or a kind of sub specialist, that's really what the the Emory programs do very, very well.
Patrick Kothe 11:14
So as a parent, you know, I had a daughter who went to medical school and practicing at this point. And parents are very proud, you know, Hey, Mike, my child is gonna be a doctor, my child can be a lawyer. What did your parents say? When you when you kind of switched?
Chris Hermann MD, PhD 11:30
Um, yeah, it was an interesting and interesting series of conversations. I think they were very supportive of the decision to go back into the PhD. They were very skeptical when I went down the entrepreneur route, and rightfully so right? The statistics of successful entrepreneurs are pretty abysmal. And on paper, I shouldn't have been successful. And then eventually, it was the conversations you have to do. Are you ever going to finish? You know, you've got it sorted out in six months? And then four months, three months, and one month left? Are you ever just gonna get the diploma? Like we've given up on you ever being like a real doctor to actually be able to help take care of the family? But are you just gonna get the diploma on the wall on it? It took a while, but we finally got it across the line.
Patrick Kothe 12:12
So how did you handle the finances part of medical school.
Chris Hermann MD, PhD 12:17
So um, so for the first two years of medical school, I was in the traditional pathway to being a doctor, which is student loans is the way you fund those. If you are crazy enough to sign up to do a dual degree program, so an MD and a PhD, the federal government actually takes pity on you, if you're crazy enough to go down that route. So most institutions and Emory is one of them, you actually they receive funding through the typically the NIH is the main funder. And so in the dual degree program, you actually get a full scholarship for tuition, plus a stipend, throughout your basic your PhD years, and your medical school, I was on and off the federal government payroll over those years. So you don't, you don't make much and you're certainly not saving for retirement or living high on the hog. But you're at least not going into debt, which is which is was the the only way you really can do it.
Patrick Kothe 13:14
You have these ideas. And let's let's talk about that, that five years or period of time or, you know, it took you to get that last year, what was going on in that in that period of time,
Chris Hermann MD, PhD 13:26
I was at that point starting, starting and building, the company that I now run, which is quite hand safe hands. And so our technology is developing the leading solution to reduce the spread of infections through getting the healthcare providers to wash their hands. And fundamentally, it's it's that simple. But the realities got much more complex when I really got into it. And so this started out as a little tiny side project for me in graduate school. And we scrounged around build these big ugly prototypes that didn't work most of the time. But we were able to get state and federal funding. And this started for me early in graduate school where I was fortunate to be in an institution like Georgia Tech, in an environment where I had mentors and advisors who would, I would say entertain my side projects. I had a variety of them all throughout graduate school, where we come up with these crazy ideas. Most of them didn't go anywhere, actually three or four of them. Still in theory are dope chugging along, we started applying for funding and working very closely with clinical clinical collaborators. We developed everything through the way the Georgia Tech or Emory in their affiliated institutions. What took me five years to graduate is because I took time off and took a leave of absence from full time clinical work and rotations to initially test and launch the company. But then as we grew, continue to write
Patrick Kothe 14:50
code, can we go back for a second because you said that you had a number of different ideas Where did the spark for this idea come from?
Chris Hermann MD, PhD 14:58
So this this actually came completely by accident, my main graduate work was funded by Children's Healthcare of Atlanta. It was the pediatric craniofacial project. And we were sitting around a conference table one day with some of the physicians of their critical care unit. And we got talking at the end of the meetings that I love what you guys are doing. But we've got this big problem around hand hygiene, do you think you can help us? And my response was, and we talked a little bit, my response was? Sure, that seems simple enough, let's give it a shot. And that's, that's where it started.
Patrick Kothe 15:30
And so what was what was the problem? What was their problem,
Chris Hermann MD, PhD 15:33
their problem was, is that they had tried everything they could possibly think of, to encourage the staff to wash their hands. And what we thought we were going to doing at that point is to develop a, we thought it was going to be a very simple technology solution, to provide a reminder to them to perform hand hygiene. And that's where it started, initially came up with a little sensor that would beep in the alarm and buzz at the staff. But they said, I like the approach. But that's not going to work. Because everything in my ICU beeps and buzzes and flashes at me in that and I ignore all of them, but the ventilator, and I had no idea what she was talking about. And I asked, Can you explain that you said, Yeah, I learned that if I know that ventilator beep something really bad is gonna happen to one of my kids, everything else. it beeps and flashes and buzzes, I ignore it. And that was what she was describing at that point in time was not well known. It's now very widely known as alarm fatigue across healthcare. And so we went back and got rid of the alarm and came back with a voice reminder. She's like, all right, I like it. Let's see how it works. Sure enough, that very simple switch from a being a flashing, blinking light or buzzer beeper alarm to a person's voice that would say, Please, in that case, it was foam up, which was their hand hygiene slogan. That was the aha moment for us is we found that that and are doing first clinical trial, just turning that voice reminder on tripled the staffing and hygiene rates over a period of about six weeks. And if we fast forward to what we know now, and we've gone through big randomized control trials with Emory and the CDC, and we've got over 50 hospitals that have used the voice across the country at this point. With more coming on, that's the single biggest driver is that real time feedback that we give the staff as soon as they forget to go into a patient's room and forget to perform hand hygiene. We give them that, please. And then the reminder. And that's the single biggest driver. So you're you're encouraging hand hygiene.
Patrick Kothe 17:30
What is the downside to poor hand hygiene, what is the problem?
Chris Hermann MD, PhD 17:36
So the problem and this is why everybody cares about hand hygiene is that if you don't perform it, infection spread. It is that simple. And so you hear it with a call that's going on in the last year, you've seen people talking about it, you've seen billboards, you've seen I actually saw a DMV sign, ironically, driving down the highway about there's about 10 months ago. So right as things are getting bad. And I saw I was driving down the connector in Atlanta, which is the big Interstate, and I saw a four signs DMV sign encouraging me hiking, which I don't think has ever happened in the history of the world. And so really, what it is, is your hands are what spread infections. So in the healthcare environment, you have primarily the healthcare providers, the doctors and nurses, but there are other people who work. And what happened is they touch one patient or their environment, what's typically bacteria in the healthcare environment gets on their hands. And then when you go room to room, you touch the patient or other things in their environment, that bacteria is transmitted in much the same way that that the COVID is a virus. But it's the same way. If you have COVID particles, and you go into a restaurant and touch something in your hands, and then you touch your mouth, nose, face, etc. Without cleaning your hands, you can get those virus particles or bacteria in your body. The stakes in healthcare are much, much higher because you have people who are sick. And you also have people that have invasive medical devices that go through their skin, so it acts like a little highway for bacteria. So things like catheters. So urinary catheters is one type. You have other ones that are basically like supersized IVs that go in other parts of your body that can allow bacteria to get into your bloodstream or other parts of your body directly and cause pretty significant infections.
Patrick Kothe 19:20
As you stepped into this problem, what was the rate of infection at a typical hospital.
Chris Hermann MD, PhD 19:27
So sadly, the rate of infection was in his for most hospitals largely the same. So it is it is about 5% of all people who are entered into a hospital get in an AGI. So one in 20 patients walk into a hospital without an infection. And they basically catch one of these infections while they're admitted. That is unfortunately much higher for ICU patients. But it's a shockingly high number. When you look at across the country,
19:55
AGI being what
Chris Hermann MD, PhD 19:56
is sorry, it's healthcare associated infection. So the infections that are typically spread with by hand hygiene in the hospitals it's this it's a very specific type of infection and the criteria to be diagnosed with one of those is that you have to develop the signs of the infection and be diagnosed 48 hours after you bring them to the hospital so this is not something where i stepped on a stick and got an infection to my foot and then went in this was i came in for knee surgery or a heart attack or a stroke and i developed an infection that i didn't have on the outside while i'm in the hospital
Patrick Kothe 20:33
can you divide it out what is what is hand related and what is other types of infection related
Chris Hermann MD, PhD 20:40
you can sort of and the the challenge with these infections is is they are multifactorial hand hygiene and everybody sort of says this with it quite frankly without a ton of data in most cases to back it up hand hygiene is the single biggest factor because that's what spreads the infection and if you can cut down on infections or bacteria going from patient to patient you will cut down on infection and then you get into the other factors that are more related to healthcare providers some of these are the techniques that you use to put these certain lines or devices in some of these are patient factors and if they're immune suppressed or elderly or diabetic eager you're at higher risk for infections but the the single biggest factor that we see and is widely accepted is hand hygiene and the reason why we say that is hospitals that have used our technology and we've got a systematic way that we improve hand hygiene as long as hospitals follow that on average we see them reduce their infections by over 65% and so we very comfortably say that at least half of that infection transmission equation is hand hygiene and that's largely widely accepted and the challenge though is it's a very simple concept is oh yes we all agree and most people in the infectious disease or hospital quality fields well now is it yes hand hygiene important in theory we know what's the biggest driver but when you take large health systems that will have in some cases 10s of 1000s of employees across multiple hospitals some across multiple states going in and consistently changing their practices for things that they're supposed to be doing sometimes couple 100 times a day or shift is very complex and that's something that largely everybody's known in healthcare for about the last 150 years but nobody's really been able to solve it better than meaningful way and large scale
Patrick Kothe 22:37
so in many instances people say in startups that you need to fall in love with the problem before you start start developing a solution and you were trained in biomedical engineering and probably the front end of product development as well so how did you fall in love with the problem what how did you how did you learn what the real problem was
Chris Hermann MD, PhD 22:59
yeah it's a great question so i and i think where what i fell in love with is the the ability to apply engineering to help solve problems in healthcare if you'd rewound me or my career and told me that i'd be doing what i would have done now when i started out the string out of left edge and specifically my absolute my lowest grades through an engineering and medical school were in the field of circuits and microbiology and infectious diseases they are the absolute lowest grades and like on standardized tests the absolute lowest i did but i what i fell in love with was with applying engineering to helping save people's lives and that's something that really resonates with me and our team all the way through to today
Patrick Kothe 23:50
so let's talk about the company how did it come together at what point did you go from researching the problem to forming a company
Chris Hermann MD, PhD 24:02
for me that was my my third year medical school which was about six or seven years ago and three things happened all about the same time which is where why we decided to to go from a research consortium to to the beginnings of a very early stage startup the first was that we basically got about as far as we could in the research organizations in particular the the engineering programs at georgia tech they're very good at making one or maybe a couple of things what they can't necessarily do and that's not their focus is to go manufacture hundreds or 1000s of whatever widget or technology gadget you have so we were doing more and more clinical trials that were larger and larger and we just couldn't keep i mean we just couldn't do it it's just not sustainable with with what they have set up the second was is that we had some really really compelling data out of our first clinical trial that showed the importance of the voice in changing people's behavior. And that was something that at that point in time, we thought we could patent. Turns out, we were right. And we've been in that. So that's a patented piece of our technology that we've got a pretty strong foothold in the third piece. And this is what we thought was going to be we were going to be the next unicorn and be a billion dollar company in the next 12 months, which clearly did not happen, the Affordable Care Act changed. And, specifically, as it relates to infections, there were some major changes to how infections were reimbursed and how hospitals got paid. So in the past, pretty affordable care act, if you want to do a hospital, and you got an infection, the hospital made more money, you stay longer, you get antibiotics, you saw different doctors, etc, etc. And it was a fee for service. So the more services they did, and quite frankly, the sicker they made you. Again, nobody's doing it intentionally. But that was the result, the more profitable they became, in the Affordable Care Act, it changed. And that was a hospitals are paid based on the quality of care that they deliver, and the efficiency in terms of of that care. And so starting three years ago, and even through to today, if you go into a hospital and get an infection, the hospital doesn't get paid for the treating of that infection. And we said, okay, this is going to be the thing that unlocks this industry, it's always been the patient safety need. But now it's a big financial driver for the organizations. And we thought that, Oh, this is a no brainer, the CFOs are gonna love it, we, we can come in and save them 10 times what it costs with our technology, blah, blah, blah, though it's a no brainer, we're going to go sign up 30% of the hospitals the next year. Turns out, at least our third assumption there was was wrong, it was a lot more complicated than than that. But those are the things that we said, All right, we've got market movement, we've got some very compelling technology about why we should, this is not just gonna be a widget, but we can actually build a company around it. And then we, we just need to kind of take that step for the next evolution in in company growth.
Patrick Kothe 27:06
So you have clinical data. At what point did you develop that clinical data?
Chris Hermann MD, PhD 27:12
So for us, our very first aha moment was, this was back when we were doing our first clinical trial, using the ICU at Children's Healthcare of Atlanta. It was a relatively simple study. And what we were doing is testing the impact of the voice reminder head. And our assumption was that Oh, yeah, we may see some improvement over time. And then we can basically turn the voice on, change people's behavior, and we may be able to turn things off. And once we give them the reminder, they're going to learn the patterns, and they're going to stick and stay. And so we were both right and wrong with our initial hypotheses, it turns out that the voice reminder worked, and it did change people's behavior. It actually did it better than we're far better than we expected. However, though, and this is what was the surprise, and quite frankly, only reason why we can actually build a business around this phenomenon is that that voice, that the feedback from the voice only worked as long as the voice played. And so we tripled there in hydrates with the voice, but then within two weeks of us turning the voice off, they fell back to where they started, that was the aha moment for me to say, Okay, this is not just a little widget that we can throw at a wall. But this is going to require sensors through an entire organization, you can't just move them around. And we can actually build a scalable business around this. And it turns out, at least in that aspect of it, we were right. And that continues to be our biggest driver of improving hand hygiene and reducing infections and as a result,
Patrick Kothe 28:43
so you've iterated the product, as as you've got more learning in here. So what is the product today?
Chris Hermann MD, PhD 28:50
So our product is a combination of physical sensors. So we have a latest buzzword to describe what we do is an IoT or connected device network. So these are low power sensors that we put throughout the patient care environment. And they specifically typically will go on the soap or hand sanitizers. There is a data analytics platform that takes in the the information that the sensors generates. And fundamentally, most of the time we calculate is the percentage of time the staff are washing their hands. And then we have a platform that uses that data to drive a behavior change or performance management. We call it pathway but it's just a series of phase interventions that are supported by the sensors, the data and this this process that we use to help very efficiently change people's behavior.
Patrick Kothe 29:40
If a sensor on the on the dispenser and then you have a sensor on each individual,
Chris Hermann MD, PhD 29:44
correct, you can think of it as something that's functionally equivalent to a Fitbit. Instead of on the wrist, we put them in their their their badge reels because all healthcare providers have to wear photo ID so we put something that's basically replace something they already were so small, lightweight, and they forget They have it on. And then we put sensors on the dispensers that identify when people go by, did they clean their hands? And they also provide that voice reminder. So the sensor on the wall will say, please sanitizer, please clean your hands.
Patrick Kothe 30:13
Is this for everyone, every employee? Or is this for people who frequently touch patients?
Chris Hermann MD, PhD 30:19
Yeah, it's so it's typically for every employee who has direct patient care. And what that is basically anybody who goes into a patient's room on a regular basis. So doctors and nurses are the obvious ones. You also have people that are patient care technicians, which are also a big piece of it. And then we'll look at people such as therapists, patient transporters, and sometimes Environmental Services staff. If you go down to maybe some of the, let's say the billing, people who do administrative work in the front end of the hospital, they probably don't need a badge. Somehow organizations just say, Hey, this is part of our branding. This is part of our uniform, we're going to give everybody one, but from on a day to day basis. Now it's the people, the people we want to change their behavior are the ones who go in and touch the patient, basically,
Patrick Kothe 31:05
sales reps, or our company people that are in the LR, or they badged as well,
Chris Hermann MD, PhD 31:11
we are starting to do that more and more, what we typically will do is with a health system is we want to focus on the people that directly touch the patients the most, right, that's where the biggest bang for your buck, it's now, six or 12 months down the road, when you've addressed all of your problems with your doctors and nurses and technicians, which again, that's a big undertaking, if you're if you're looking at a pretty big health system. Like take Emory, for example, it's almost 15,000 people. So that's a lot of people to go change a bit, something that occurs 100 times a day, every day, seven days a week. So once they've got that tackled, then they will typically look at some of those other individuals on the operating rooms are a bit unique. Because the hand hygiene practices are different because of the sterile fields that are involved in those environments. But we are we are starting to see hospitals do more and more of those. But it's typically not something they'll do on day one. And that's probably appropriate.
Patrick Kothe 32:08
Chris, you said 100 times a day is that really the number
Chris Hermann MD, PhD 32:11
it is? That really is the number for a your average doctor or nurse, your average healthcare provider, so nurses are probably doing a little bit more than doctors. But on a 12 hour shift a even a non critical care nurse will go in and out of rooms 100 times a day. critical care nurses will sometimes do almost double that over 12 hour shift. And we have some people that will go in other rooms 800 times a week, it's mind boggling that they can do anything with running around that frequently. But that's but that's also part we've seen that that is also part of the challenge with hand hygiene is it's something that they have to do so frequently, there's no way you can think about that behavior. Because it's something you do so frequently that it's the idea and this is this was when we first started it was the seatbelt analogy was very commonly used. Oh, it's like we want to change your behavior. Because certainly with my generation, we never got into a car without seatbelt. When you look at my certainly my grandparents generation seatbelts didn't exist. And my parents when they grew up, they never wear seatbelts. There's not we need to just reinforce them to educate. So you get in a car and put in your seatbelt. Well, that's great for people who get into a car, put their seatbelt on drive to work, get out of the car, go to work, come home, put their seatbelt on your twice a day, that's a behavior you can change. Do that 200 times a day. And specifically, if you look at the delivery drivers, like the UPS drivers and FedEx and Amazon drivers, they don't wear seatbelts. Because they're in and out in and out in and out and forget, sometimes they do. But if it's a quick hop, they probably don't. And so those because it occurs so frequently, those basic education and those things just don't work because it's the behavior is too complex to change with a simple education or posters or things like that.
Patrick Kothe 33:57
So are you guys in the education business? Are you in the compliance, compliance business?
Chris Hermann MD, PhD 34:02
Both? We don't like to say we're on the compliance business because that's a that word has very negative connotations. We actually are very, very careful not to use these words, compliance monitor or hygiene. Because it's a pretty negative piece because nobody likes being monitored. Nobody really likes your compliance being. And how do you think most people like their hygiene compliance being monitored? Yes, and I write, I jokingly say that because we are the leader in an industry called hand hygiene compliance monitoring. But we've taken a different approach. And we and this goes back to our early research days, whereas quite frankly, most of our industry is focused on just monitoring compliance to give them a number. We are very transparent with our hospitals and just I just had a call with an executive team yesterday. And my kind of opening line was guys monitoring hand hygiene. Compliance is a waste of everybody's time, money and energy. And they looked at me like, wait, what, that's what the invite title says, there was like, you're right. If you just wanted to monitor a problem that exists, fine. What we're focused on is improving that problem. In our world that's improving hand hygiene. We just don't want to keep measuring and say, Yep, our hand hygiene, bad, bad, bad, bad. We want to come in improve your hand hygiene, improve your clinical practice to then lead to those better patient outcomes.
Patrick Kothe 35:22
So you mentioned that, that you are in the education business, too. So how are you? And you also said that, when you stop the voice, behavior went back to baseline? So it sounds like, you know, the voice is the most important thing, even if you kept hammering, education, education, education, it's not really going to do much. So how do we balance those two things?
Chris Hermann MD, PhD 35:45
Yeah, it's a great question. So we we do it and we leverage the voice is a way to educate people. And so when we first come into a hospital, and turn the voice on, we actually tell them to, and this is a bit counterintuitive, and we learned this lesson, the hard way is don't do anything with the data. Don't talk about data, don't show anybody numbers. Just Just take a deep breath, let the voice do its thing, it's going to go remind people and just let them react to the voice. And almost everybody figures it out. And they appreciate the reminder. And surprisingly, the overall sentiment from the staff is overwhelmingly very, very positive. But there are some people who, because of just whether it's a lack of education, a misunderstanding of education, or just some unique circumstances that nobody foresaw, they will consistently hear the voice. And a very common example that we see is staff will say, Hey, I hear the voice every time I take my gloves off. And we very politely say, uh huh, yep, that's correct. Because the expectation from the hospital is that when you take your gloves off, that you perform the hygiene before you leave the room. And so the voice will highlight those educational opportunities in what we do, especially early on, and some of those common ones that I see current l healthcare gloves are a common one. And they're probably six or eight different things that we we will see very, very commonly, we use the voice to drive the conversations to allow the people to have those conversations. And we encourage those frontline clinical leaders to talk about the voices and talk about gloves and talk about going between patient rooms and talking about when you just go into check on something very common misperceptions around hand hygiene that we know we're gonna see in almost every case, we want to encourage that discussion. And then what we find that as long as you have the voice on and lead the voice on, you can then subsequently go on to do other interventions that will have an impact, you go and let's say do, we do a lot of competitions, because it's fun, and healthcare providers are a naturally competitive bunch. So we'll go in we'll we'll do a competition, they'll they'll improve their hand hygiene, as long as you leave the voice on, they will sustain that improvement. And we will come back with a series of interventions, over six to 12 months to take them in really lead to very high hand hygiene rates and good clinical outcomes.
Patrick Kothe 38:01
What does a sensor sense?
Chris Hermann MD, PhD 38:03
So it, it senses three things. So the first one is it detects people when they walk by or it's really objects, the way the reason we can detect object is the only objects that move in the hospital are either a person or they're being pushed by a person. So the text is a a person walking by, and then looks to read a signal that's being sent from those batteries. So it's a serial number that we then tie that back to that was that Chris? Or was it Patrick that we saw? And then that senses did they dispense the hand hygiene products? Did they use the hope, the soap or hand sanitizer that are throughout the patient care environments? And the
Patrick Kothe 38:43
sensors? Or the the the dispensers are in common areas where you would you're outside a patient's room? outside? You are outside? outside? Yes.
Chris Hermann MD, PhD 38:53
areas where they make sense? Yeah, so the ones that we typically will interface with are not the ones that you as a visitor will typically see walking through a hospital like the lobby, the elevators, etc, etc. These are the ones that are directly tied to the patient room. In almost every case. When we say hand sanitizers, the alcohol based products, there's typically one outside the patient's room, there's typically one right inside the patient's room. And there's typically a soap dispenser near a sink inside the patient's room. So we will see and sometimes they're more than that, but those are the basic ones that we will see. And so we're looking for, did the healthcare provider use any of those associated dispensers before and after they went into that patient's room?
Patrick Kothe 39:36
Do you get pushback from healthcare providers?
Chris Hermann MD, PhD 39:39
We do sometimes I'm I'm continually surprised how overwhelmingly positive this is all received. I mean, this year, quite frankly, more than ever, we've seen kind of the superheroic actions of healthcare providers and nobody stays in the hospital environment, unless they're really committed to making patients lives better. And they really do see the overworld Ming Li Hime majority of people appreciate the reminder. They appreciate the feedback. They're really intending to do the right thing and they just get busy and forget. And so overwhelmingly, that's what we the feedback that we see. However, the noisiest people in the organization are the people who are the push backers. And there are people who don't like, I mean, they don't like the reminder, they don't think hand hygiene is important. They don't think hand hygiene is the reason why infections are high. I mean, you name it. I mean, we don't like the bads. There's a big brother component. But those are pretty few and far between. And we, we will work with the hospitals to address some of those concerns over time, but it's, again, exceedingly low. I mean, it's less than 1% of the staff who really have issues with and interestingly, when you talk to the their managers, they told me, they could have told us ahead of time where these people weren't gonna like it, because it I mean, they're their constant problems. They don't like that they don't like the other. The other patients, they do things, they just one of the interesting things about healthcare, especially in the hospitals, is they're very resistant to change of any form.
Patrick Kothe 41:08
So we got 5% Hospital infection rates as a baseline. That right, okay, so what is it after someone fully implements your system,
Chris Hermann MD, PhD 41:20
so we will take that infection rate and typically cut it, by our average is over 65%, we've actually had some organizations who will go to zero infections, which is really cool to see now, they're typically not the big hospitals. But we've, we've had small hospitals who've gone I think the longest we've gone is nine consecutive months without a single infection. Now, that's not that's not totally attributed to what we do, we will very proudly say that we're at least half of that factor. And there are other things that they do as well. And so with hand hygiene and some other basic interventions, it's not uncommon for hospitals to have a 90 plus percent reductions of that, compared to that national baseline, or that national
Patrick Kothe 41:58
average. What does that mean in terms of patients that that have don't have infections, number of patients that don't have infections, or dollars saved? Right as it was. So
Chris Hermann MD, PhD 42:08
when you look across the country, there are about 2 million infections per year. And when you look at the mortality rate of the infections, it's about 150,000 people a year who pass away again, we've seen extraordinary high infection death numbers this year, unfortunately. But To put that in perspective, that is more than car accidents, breast cancer and colon cancer a year combined, is a it's actually a leading cause of accidental death in the US. And when you look at the dollars associated with that, it's about a $40 billion a year problem for the US healthcare market. We alluded to this earlier. But these Unfortunately, these it's not like there's a $40 billion budget line item, which is the complexity of the healthcare finance side of things. But it's a $40 billion problem that the hospitals now pay for the insurance companies and Medicare, that melt. These are preventable, you guys are on the receiving end of this tab. But it's been a dirty little secret. I don't think it's a secret any longer that,
Patrick Kothe 43:08
you know, some people go to the hospital get well. And unfortunately, some people go to get sick. Alright, the name of this podcast is mastering medical device. So let's talk about the development and the regulatory pathway, and kind of how that all came together. So let's start off with you know, how did you how did you fund the company? And how do you kind of navigate the early stages? And the regulatory side?
Chris Hermann MD, PhD 43:33
Yeah, we were very fortunate, we were able to leverage both direct research funding through the universities. And because we grew out of the university system, some additional follow on funding. So all of our first funding and first research dollars were were non diluted grants, which is the only reason we could we could we could do this from the ground up. I mean, when you rewind back to that point in time, when you start talking about low power wireless devices. This was before the iPhone existed. This was before, Bluetooth, not even low energy Bluetooth existed. And we actually use the very first Bluetooth chip that got released, about midway through one of our our development projects. The technology wasn't where it needed to be. But we did the best we could with what we had. I'll speak to the regulatory piece because interestingly, our very first grant came from the FDA, and it was a pediatric device grant. And through that process, nobody really knew where we were certainly have device is a physical device in the healthcare industry. But there was lots of ambiguity around do we qualify as a medical device or not? And we actually because we received funding through the FDA, we had a little bit of not quite backdoored. But we had were able to go directly to the people that made these decisions and went through a series of questions. And they ended up deciding, you know, this is this is not a medical device. So we are regulated from a regulatory standpoint. We work the same way as you fitbit or apple watch to us it's an fcc so it's a wireless regulatory pathway which is compared to what most medical devices go through it's an afternoon worth of work you pay a couple 1000 bucks and you get your fcc stamp and you go on your way it's a very much simpler pathway from that standpoint was that
Patrick Kothe 45:16
a was that a good or a bad piece of information when you got it
Chris Hermann MD, PhD 45:20
at that point in time it was good because especially as an early well our initial reaction was aha this is great when our medical device our funding is going to be dramatically different trajectories and medical device companies but we didn't realize is that because of that we were in the kind of a from a funding perspective a little bit of a no man's land is there's a very well established funding route for medical devices and you typically get bigger dollars because you get more regulatory burdens and you can be valued and go through people who are used in the medical field and then at that point in time anything with sensors or iot people were scared of and so then you look at the traditional technology company funding sources and they were a little skittish of healthcare and they're really skittish to the devices and healthcare and so we really struggled early on to find the right funding source when you look at today and especially this year if we could wave a magic wand and plop ourselves into this funding environment it'd be great because iot and sensors are white hot anything digital health is even hotter and so like if we were to go and raise our series a round of funding now totally different environment and trajectory and valuation but early on it was it was tough to get off the ground so to speak
Patrick Kothe 46:35
really interesting because you come in to solve a clinical problem you're told you're not a medical device but you need clinical data to support use of your product so the definition of a medical device is pretty pretty clear with that on what it is but you still have to do a lot of the things that any other medical device would do correct so it's really you're really in an interesting spot
Chris Hermann MD, PhD 47:03
yeah yeah you're stuck between a rock and a hard place for sure
Patrick Kothe 47:07
thanks for kind of explaining that because yeah as we said you know we're we're mastering medical device but this is one we're going into it you really wouldn't know you wouldn't you wouldn't you wouldn't know which direction you're going in and i think a lot of startups are kind of in that spot is you need to go validate that that regulatory pathway as quickly as you can because it just said it it affects funding and affects your activities that that you need to have in the systems that you're building but um so i'm assuming you're still doing a lot of the same things you still have quality systems you still you still need to do those those things like a medical device company
Chris Hermann MD, PhD 47:44
would do as well yes very much so
Patrick Kothe 47:47
one of the things that that i found pretty interesting is you use the use the term when i was talking with you earlier called clinician centered innovation could you explain that a little bit absolutely
Chris Hermann MD, PhD 47:59
this goes back to our early days and we were very fortunate to have the clinical collaborators collaborators that we did and in particular we would have staff who would give us very very honest feedback we come in and we test something with a mic alright i like a b and c but these other things are garbage go try again okay you got that one figured out but now that one you made worse let's go back and try these other things we didn't know what we were doing at the time but what we were fundamentally doing is applying lean principles to innovation and specifically to healthcare technology innovation and each industry has their own kind of slogan or branding of this these lean principles but they're all fundamentally the same is where you are trying to rapidly identify solutions that work on minimizing waste and so in the manufacturing world this is pioneered probably probably best and it's most widely known by the toyota company with lean manufacturing and healthcare you have the six sigma in the technology world it's agile methodologies but really what it is you will have a series of things that you believe are true and in our case almost all of them are wrong and if you spend a bunch of time money energy doing things that are wrong you're going to eventually go out of business it's super critical for early stage companies but we'll apply even for big companies as well is you need to be as efficient to reduce waste and as possible and so for a technology company what that is is we need to very quickly test things that we think are going to work and then in our mantra is you want to fail quickly and it's not about being right or wrong it's about learning what the right answer is what we did early on and this was just a product of who we worked with is we we put those clinicians at the center of our innovation process and this is something we even still do today is we will we will develop our technology with what works best for that frontline clinician that's our kind of northern light so to speak is everything we do will is driven to improve the experience of that frontline staff and so if we run into whether they be physical forks or proverbial forks or just a decision point we ask ourselves a question what's best for that for that clinician and it's specifically the person who's at the bedside that means at times we have to make a more complex technology solution sometimes that's a little bit more expensive for us to build sometimes it's maybe not the most efficient from an electronic standpoint and sometimes those decisions may conflict with what the senior leaders of the hospital want for example well we still put the clinician first and we we push back and in my role i'm the one who has to come and explain to a ceo or chief nursing officer why we don't why we won't do what you want us to do because that's going to disrupt the that frontline commission and our goal with that clinician centered innovation is to do that quickly without wasting a bunch of time money and energy on things that aren't going to work and so we will run little teeny experiments learn from that develop a little bit more learn from that develop a little bit more and so we have we have this formula where we actually have hypotheses and run experiments and look at data and then revise things it's really about testing things quickly when we talk about this we've at this point we have been doing this long enough to know that we will almost always be wrong we will go into down a pathway and we're going to be wrong and by assuming you're going to be wrong you end up finding the right answers and if you could figure out how to build a business where you're always wrong you eventually become successful and because you learn what works and that's the piece that my engineering background in particular really prepared me for i didn't know understand these principles as and certainly never had a class about lean methodologies in school i wish i did that iterative problem solving the kind of analytical approach that engineers take to where you have assumptions need to test the assumptions and refine your design or whatever problem you're working on that's really what this all is about people rebranded for different industries but it's all the same fundamental piece of trying to learn what works and what doesn't work as efficiently as possible
Patrick Kothe 52:14
those end up on your customer needs
Chris Hermann MD, PhD 52:16
exactly exactly
Patrick Kothe 52:17
yeah so i think it's really interesting because you're focused on the clinician but look clinician isn't the only customer so the customer being you know everybody else that you described the ceo and everything else so what are you doing for them to do customer discovery with with that group
Chris Hermann MD, PhD 52:38
yeah that's a great question because early on we didn't understand that very very important difference in our world and this is more of a technology stereotype the clinicians are users our customers are different people yes they do all wear the same uniform but they have very different wants needs and desires have we done this over again we would have spent much more time doing customer discovery with the customers and not the users right this is the the the analogy that people most widely use and i'm literally like this analogy but it articulates the point is everybody knows facebook and you and i are probably facebook users the people who go around and post pictures and comment on things etc etc but their customers are advertisers and so we have that that similar phenomenon the way we have balanced that is it's a bit unique to what we do is because what the customer in our world wants which is the executives and especially for the senior most executives and these are typically ceo cfo ceos what they want to solve is reduce infections and then you kind of go to their clinical leaders the chief medical chief nursing to quality officers their solution their goal is to reduce infections by improving hand hygiene this is where the alignment comes is the the c level executives don't necessarily care about the technology or how it works or how we do certain things what they really want is in fact hygiene to go up infection to go down and their staff not to revolt right and and this is why we why we continue to focus on that clinician centered dimension is we want the experience to be as smooth and efficient as possible for those frontline staff and then we can then roll up to meet the executive schools but that is a very very complicated discussion we could go on for hours and hours about that piece but that is that is a very very important distinction that we need to understand and walk that road very carefully
Patrick Kothe 54:36
i think you know you could you could do product development two ways you can take the top down approach and say i'm going to i'm going to build it for the ceo of the hospital in the c suite people and then we'll jam it down the organization right we know that that doesn't work it doesn't work but we also know that just building something that makes the clinicians life better with without figuring out the financial implications of that All right, it's not gonna work either, right? So I like your idea of having clinician centered because it that has to be there. But the other piece has to be there too. Right? We all we always have to keep an eye on who, who the user is and who the customer is.
Chris Hermann MD, PhD 55:15
Absolutely. Those really good words.
Patrick Kothe 55:18
So, Chris, thank you so much for spending time with us today. A lot of good stuff. So you, we started this off with your unique pathway to industry. So if you were advising somebody that was kind of in your same position, what have you learned? What would you tell someone that's, that's going to cross over from a clinical focus to a business focus?
Chris Hermann MD, PhD 55:44
Yeah, is I think the, in this and this applies whether your focus is going on clinical or business or whatever career path, right, because it certainly with my, as you go out on any of my potential career paths, they're all very long, they're all very arduous in the light at the end of the tunnel is pretty far away when you start. And the most important thing is to love what you do. And that's whether you want to go off to be a scientist, a physician, an engineer, some combination of both, or entrepreneur, all of those pathways involve a lot of early blood, sweat, tears, hard work to get to the end goal. But it's not about the money. It's not about what what very little glory and things you get from any of those careers is almost non existent. But you just got to love what you do. And for me, that's, that's solving those engineering challenges in the medical field. And that's what keeps you getting out of bed. At the end of the day. We're very proud of the fact and after all this hard work, we save a person's life every day. And that's, that's what keeps us coming in. And working as hard as we do. It's about saving people's lives for me and our team. I mean, it's been a 15 year journey of beating our head against a pretty significant wall for most of that time. But we're finally seeing things work, we're finally seeing the results we needed. And I just got an email this morning from a CEO thanking us for what we do. He's thanking us for partnering with them. And he's thanking us for allowing them to be our customer, which is which is really, really cool. And that puts the the hard work in perspective, but it's a long road no matter what you do. But the important thing is just love what you do. And it's all of
Patrick Kothe 57:19
what an interesting guy and product, a few my takeaways, first medical device or not a medical device? Well, regulatory bodies spell out the definition of a medical device. And it's really pretty clear. But sometimes we have the ability to influence our own category, by the claims we make or don't make about our product. So when we do this, we really need to be deliberate about these decisions, because they have repercussions. On the plus side, your timelines may be shorter, less money is generally needed to fund the company. And we're quicker to revenue. But Chris talked about the difficulty in obtaining funding that he had when when it was decided was not a medical device, then we have some other things that we need to factor in here. Do you need clinical data to sell. And by getting that clinical data? Is it just as easy to go ahead and be a medical device, sales and marketing. So claims, when you make a product claim, very often that's very beneficial. But if you're not able to make a product claim, it makes the sales that much more difficult. And then finally, the barrier to entry. If you're not a medical device will then other people in your category will also not be medical devices. And the barrier to entry is is much lower. So sometimes there are strategic decisions, why you would want to be a medical device and also why you might want to be a 510 k A de novo or you want to go full PMA. So those are regulatory strategic decisions that you can make as well. Second, Chris discussed this concept of clinician centered innovation, he called it their North Star. So I think it's really a great concept to design for the clinician, because adoption is always impacted by how effective the product is, and how easy it is to use it at the clinician level or at the clinical level. I think it's really important that we design products that are easy for clinicians to use. But as Chris also said, the clinician isn't the only customer, they may be the user but they may not they may not be making the buying decision and may be making the using decision. So just as important in this customer discovery process is you need to make sure that all of your customers are covered. And that includes the non clinical people as well, because that's where adoption may be very easy to get, but sales may be much more difficult to get. So you're really need to keep an eye on all your customer types during that during that product development phase. Finally, just wash your hands and do it often. It will save lives and one of those may be your own. Thank you for listening. Please spread the word and tell a friend or two to listen to the mastering medical device podcast. As interviews like today's can help you become a more effective medical device leader. Work hard. Be kind
