Medsider: Learn from Medtech and Healthtech Founders and CEOs - Managing a Clinical Trial with a Small Team and Lessons Learned Raising Money for an Early Stage Medtech Startup: Interview with Dr. Marie Johnson, Founder of AUM Cardiovascular

Episode Date: February 1, 2017

More than a decade ago, AUM Cardiovascular founder Dr. Marie Johnson was a doctoral student when tragedy struck her and her family. Her husband, Rob, passed away suddenly at the age of 41. He had blockages in his coronary arteries including a ruptured plaque in the left anterior descending artery supplying a large part of...[read more]Related StoriesWhy Intersect ENT is an Example of Hope for the Medtech IndustryAre Medical Device Models the Key to Building a Lean Medtech Startup?Substantial and Sustainable – 2 Words That Medtech Companies Should Get Used To 

Welcome to Medsider, where you can learn from experienced medical device and med tech experts through uncut and unedited interviews. Now, here's your host, Scott Nelson. Hey there, ladies and gents. Welcome to another edition of MedSider Radio, brought you from the WCG Studios here in Minneapolis. If you're new to the program, MedSider Radio is where we learn from MedTech and other healthcare thought leaders through uncut and unedited. interviews. Just a few quick messages before we get started. First, I send out a free email newsletter about once per month highlighting my favorite med tech and or healthcare related stories, the ones that I personally get a lot of value from. I don't send the newsletter out very often, but when I do, I really try to make sure it's valuable. So if you're interested,

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tragedy struck her and her family. Her husband, Rob, passed away suddenly at the age of 41. He had blockages in his coronary arteries, including a ruptured plaque in the left interior descending artery, supplying a large part of the heart muscle. At that time, Dr. Johnson had been working on a prototype device to listen to heart sounds as part of her doctoral degree. Her husband's coronary artery disease had been present, but silent and undetected. Inspired and motivated by her loss, Dr. Johnson decided to apply the principles of frequency analysis to create an acoustic device to identify obstructive coronary artery disease, which is now called the cadence system. Marie has a PhD in biomedical and is the founder of OMCardivascular. She's successfully raised over $10 million

in angel investment from individual investors, small funds, and physicians. Before becoming CEO of Om cardiovascular, Dr. Johnson designed and launched the University of Minnesota Medical Devices Innovation Fellowship Program. Here's a few things we're going to learn in this interview with her. The time when Dr. Johnson realized she had a winner on her hands with the cadence system. The origin story for the device itself. How Dr. Johnson went from initial idea to prototype to eventual production. What she's learned raising money from a wide variety of investors. In an era of consumer-centric wearables, how Dr. Johnson landed on a business model for the cadence system, her approach to managing clinical trials with a small team, Dr. Johnson's favorite business book, the CEO that most inspires her and the advice

she'd give to her 25-year-old self. Of course, there's a lot more that we're going to cover in this interview, but without further ado, let's dig in. Dr. Johnson, welcome to the program. I appreciate you coming on. Thanks, Scott. All right, let's dive in. Let's start with sort of the accolades that you and your team at Ome have won over the past several years. I'm going to list them, but I want to ask you a couple questions about these. So, you know, you've won, you know, as I mentioned several awards, for the invention of your device, more specifically, the top cardiovascular innovation award in 2015. You've been named a top 10 MedTech innovator, I think, in 2014, one of the top 100 creative people in business. The list goes on and on. So if we keep that in mind and sort of rewind the clock just a little bit,

was there a point in time when you look at the OMS story when you think, wow, this device, I think we've got it here. It's not perfect, but I think we've got something that can really make an impact. Thanks for asking that question and I'm really embarrassed and I just humbled that you would have looked up these things about the company and about me. I am embarrassed. So, yes, I think that once we got the product into the handheld device and we were deploying to clinical trial centers, we knew that we had something commercializable. We knew the technology was going to work from the beginning, but just reducing that into a form factor that would be easy for clinicians to use, I think was a pretty important part. of the product development process. Got it. Okay, so it was really at that clinical trial standpoint

or really sort of being, you know, really begin to resonate for you and your team. That's great. And I certainly want to dig into that more because, you know, the word disruptive gets thrown around a lot, but your technology is truly disruptive. And I want to kind of go back further in time to learn a little bit more about how you went from initial idea to, you know, eventual commercialization. But let's sort of level set everything for the audience that's listening. Can you provide a high level overview of your technology? Cadence, I think, is how you pronounce it. So what it does, you know, who it treats. And then there's a couple of follow-up questions I want to ask you about clinical data and, you know, corresponding regulatory approvals as well. Sure, absolutely. So cadence is a non-invasive, handheld, non-intrusive, fast way to rule out

coronary artery obstruction in patients with chest pain and two or more risk factors. Got it. Okay. And so what is it, is it displacing a current sort of treatment algorithm for health care providers now? It sure is. So we have just finished a 1,000 patient clinical study proving that we're not inferior to a nuclear stress test in terms of rolling out obstructive disease. What's important about that comparison is that a nuclear stress test can take between three and five hours up to two days, whereas cadence requires only eight minutes to collect the data and the result to return back within 12 minutes. It takes basically the patient has to lie on their back, breathe normally. The room has to be quiet, but that's all. it takes to perform the cadence exam. Whereas with a nuclear stress test, it requires between a quarter and a half of one's lifetime exposure to radiation, requires exercise or pharmaceutical inducing agents. It requires technicians, special facilities. Cadence is very easy to use. We provide a system where it can be performed anywhere. A cell phone tower can be accessed where there's a room, whereas nuclear stress tests in a lot of places around the country and around the world don't even

and have access to that kind of technology. Sure. And I think for most people that are listening, they've been inside a, you know, a hospital with sort of that nuclear, nuclear testing department, if you will. Maybe I'm not describing it accurately, but I've certainly walked by a fair number myself. And so this technology, this device, the cadence system, that sort of displaces that situation where the patient would have to go to the nuclear, you know, testing department to get that sort of, I don't want to call an invasive, but certainly there's a lot more investment needed on the patient's behalf, right? Not just a patient, I guess, but the entire

health care system, really. And so you sort of bypass all of that. Your testing can get the same thing basically accomplished in eight minutes. Sort of paraphrasing, but is that sort of true from a high level perspective? It is. I mean, it's eight minutes to collect the date and then another 12 minutes to get the results back. But yeah, that's exactly what we're doing. And that's in terms of rolling out disease. So just consider going to the emergency department with chest pain. You're going to spend at least six hours there. And a lot of times they'll even keep you overnight. And with cadence, they can release you within a couple of hours. In primary care doctors, family practice doctor practices, same thing. A lot of times they will perform a lot of tests on a patient to

determine what's causing their chest pain. Maybe they're not in an acute kind of setting, but cadence can be used really quickly to roll out coronary disease. And just, you already know this. Most people that are in the United States would know this, but heart disease is really the number killer among Americans, one in three people will suffer from some type of heart disease. Yeah, that's very cool. And you mentioned that you just finished enrolling, what was it, a thousand, you just finished up at 1,000 patient clinical trial as well? We have, so we have tested a total of 1,350 patients to date in five clinical studies. We just recently finished about 1,000 patient study comparing ourselves to a nuclear stress test

in patients that were indicated for nuclear stress test. So this is important because it's actually in the patient population where cadence will be used, and we proved that we were not inferior to the nuclear stress test. We don't want to scoop our clinical partners, but essentially what we can say, and I can't say publicly, is that nine out of ten times if a patient is normal, we can tell the doctor that that patient is normal. Wow, that's impressive. And do you have regulatory approval? I guess where do you stand from a regulatory approval standpoint? Yeah, great question. So we have our CE mark and we are able to sell in any place in the world where C.E. Mark is accepted. We do have to have registration in those countries, of course, but we also have approval in Canada, Australia,

the Philippines, and are cleared to sell in a number of other European countries right now. We are being used commercially in Germany and the Netherlands. Great. And I presume the FDA clearance is on the horizon at some point. Is there a anticipated date for that? So there is. We think that we will have our first clearance in Q2 of 2017 and then our second clearance at Q4 of 2017. And God, this is the first time I've ever said this publicly. But we have added ECG to our cadence system. Oh, wow. Yeah.

Congratulations. Thank you so much. Yeah. It's really a great addition to the product because it doesn't require leads or electrodes. and we can provide equivalent of a six-lead ECG wirelessly. And the clinician takes the data and then they return the data. We return that within 12 minutes too. And then it not only provides that ECG information to the clinician, but then it also

allows us to be even more accurate in terms of our assessment of turbulence in coronary vessels because we can't split out distally from diastole. And so it's that lub dub, lub, so we can separate those sections of the cardiac cycle. And it just is really terrific because it allows us even more powerful assessment of that data. Nice, nice. I know MedSider, for those listening that are familiar with, you know, with the interviews or the program, I should say, it's not typically don't break news here. We usually dive deep, you know, stories behind, you know, medical devices and founders and how, you know, how these technologies came to fruition. But nonetheless, congratulations on that edition. It's very cool news. And so you're

currently, CEMAR clearance is on the horizon. That's great news. Let's use that as an opportunity to really kind of dive into how this technology came about and how you got to where you are today with film. So if we had the chance to rewind the clock even further, can you, I think most people that are familiar with your background have maybe heard the story before, but can you provide an overview of how the cadence system came to be, the idea or the concept for it? Sure, absolutely. Fourteen years ago, I was working with the 3M. Lintman Company. I was a fellow in the program and I was doing some research work at the University of Minnesota, computerizing an electronic stethoscope and we were our goal was to automatically detect heart valves pathology

and I am not a clinician I'm an engineer and so I used my husband as a test subject I collected lots of data from him and he was 41 years old 6 foot 2 180 pounds an excellent condition he swam three days a week and nine months after I started my my PhD he died from a sudden cardiac event he had a vulnerable plaque rupture in a widowmaker coronary artery that's the left anterior descending coronary artery it was a complete surprise I had a four-year-old and a six-week-old baby at the time and I always say this and I'll say it again that you could have listed a million things that would have happened to me next in my life and that was not one of them at that time I decided this was not

by accident and so I decided to dedicate my life to taking attack out of heart attack. So I started the project and then I moved my kids to Italy and did some work on more science, the hemodynamics and arterial elasticity of blood flow through the vessels. I discovered a lot of literature about times and places where this similar phenomena had been described in that phenomena as using acoustic to detect coroner disease. There was a guy back in 1967, his name was Doc, DOCK and he described a case study of a guy who had come in to a Brooklyn VA and was suffering from severe hypertension. They did a physical exam on him and discovered he had a really unusual loud sound and they didn't quite know what it was from. He came in, the same patient came in two

weeks later and unfortunately died at the hospital and they did an autopsy and discovered that he had a widow maker, vulnerable plaque rupture in that LAD vessel. And when I really dug in, I found that there were doctors that had described this a lot and engineers too. And ultimately, the clinicians came to the conclusion that they didn't hear the sound all of the time and so they couldn't trust it clinically. In addition to that, this sounds really quiet. And so it's just really not, you can't pick it out. Sure.

And then I went to Italy and then I was out at Stanford for a while. I studied under some pretty successful med tech entrepreneurs and innovators and learned a lot about how to translate an idea into. to a business. Yeah, makes a lot of sense. But if I go back to that time period, I mean, your husband passes away, you know, completely unexpectedly, you've got two young children and you move to Italy. So what was kind of going through your head at the time, if you don't mind me asking? And we'll certainly move on to kind of how you brought this technology, you know, into life, you know, through the kind of the prototyping stage and whatnot. But I'm just

curious. I've always been intrigued by, you know, by MedTech founders and, you know, sort of where they, you know, what drives their passion. And clearly there's a personal story here. but I got to think that a lot of people wouldn't have made those types of efforts, you know, with two young kids and then, you know, move to Italy, study the, you know, go really, really deep in terms of the technology. So what do you think that comes from, that drive, that passion? Sure. I 100% agree with you that, well, people thought I lost my mind. So they did. I mean, because why would a widow take two little kids to Italy? I didn't even speak Italian. But I felt that God was calling me to solve this problem. And that's why, through the hard times, easy to keep moving forward when you feel that

you've got something ordained on your life. Yeah. I wouldn't have expected you to answer in that fashion, but certainly I can completely appreciate that. And so how long were you over in Italy then before you came back to the States? Yep. I was there for half a year. Half a year, okay. Got it. This may be a little bit more of a personal question, but your kids now are, are they teenagers now? If I kind of do the math correctly in my head? Yes. My daughter is 18 and my son is 14. And their whole lives, basically, they've been a part of this, this whole quest, and have grown up around it. And they're just excellent human beings and beautiful kids. They're seeing, you know, entrepreneurism, you know, lived out right before them.

So I imagine those skill sets will come in handy for sure down the road. So it's such a good story. I would encourage everyone to, you know, if they want to hear Dr. Johnson, you know, touch on a little more detail in regards to the background. You know, there's a great TED talk that she gave while back. There's a couple other stories that are on their website, which we'll link to in a show. notes for this particular interview, but definitely that TED Talk is one to watch for sure. So it's transition and talk a little bit more about Om and how you kind of went from studying the technology

over in Italy, moving to the West Coast and learning, you know, I think you were part of the Stanford Biodesign program, correct? Yes, I was. Yep, great. So you've got this technology, but yet, you know, now it's a very sleek device based on sort of the images and the videos that I've seen online. So first, how do you go about raising money when you don't have deep connections with venture capitalists? So can you talk a little bit about that part of the OM story? Yeah, absolutely. But can I step back just a little bit? Sure. I was at the University of Minnesota when I came up with this idea and disclosed it to the university.

They filed patents on it, and they put it on their website to try to entice entrepreneurs to take the product commercial. And you know what was kind of funny? I could never understand why over years nobody saw the potential of the device. And you know what, Scott, it was because it was math. Interesting. I mean, to me, it was so obvious. Well, I went out to the Stanford Biodesign program, not even expecting to do anything with my invention. It didn't even occur to me.

I went and did this as a postdoc. I thought it would be a really terrific program. While I was at Stanford and in the Biodesign program, I contacted the University of Minnesota and asked them to waive the technology back to me. And so that just means I could take it forward and start a company. Sure. And I came back and here's where I started. I don't know if you remember years of the United States.

there were some stimulus grants available. They called them the qualifying therapeutic delivery project grants. And basically, they were grants or tax breaks, I think. I took the grants. I don't know what the deal was on the other side, but they were $250,000 and it didn't require much work. I was at the University of Minnesota. They had recruited me to come and develop and lead a program similar to that at Femford, the one that I had just the biodeign program. Anyway, I applied for this grant. We applied for the money in July, And then they awarded the money in October, and then we had to spend it by December. So here I was. I won the grant, and I had all of this money.

And I thought, well, I won't be able to carefully take care of this money. And so I ended up leaving the university to start the company. And so I remember I went to the bank, and I had to open a bank account to actually receive this money from the government. And the banker asked me if I wanted to get checks and a credit card. And I looked at him and I thought, when I got the credit card in the mail, I thought, well, I have a business. I actually, you know, have this vehicle to make money. So anyway, that's how I started the company. And after that, I started to raise money and I reached out to angel groups.

And I should also just let you know that stand for biodesign. They do a great job in networking, the fellows. And so I had been introduced to a number of venture capitalist groups. They train you on how to put together strong pitches. They teach you a variety of topics that intersect with translating the technology. So insurance reimbursement, FJ regulatory or OUS kind of regulatory things, business models, putting teams together. So I had this background and I had learned from these just incredible entrepreneurs and innovators.

So that's what I did. I started putting together my overview and cold called the last group got on some ancient groups. I got onto their radar, made some presentations. And then I always say that the first, I guess, $200,000 was the hardest. Everything else was pretty easy after that, but it's just getting someone to listen to you so that you can describe exactly what you're thinking. And I'll tell you, I worked with this woman who had been a metronic and she helped me put my business plan together. And that was pretty pivotal too, because I had it in my head, but writing it down on paper, I think, was really the next step. And once you get it into that format, it's easier to, you're going to

to start working from that and massaging it and get it into this PowerPoint format so that you can start pitching your ideas. Sure. Yeah. And I could completely understand where you're coming from. I mean, there's this notion, I think, in Silicon Valley right now, at least in the tech vertical that business plans anymore are irrelevant. It's all about iterating every, you know, eight to 12 weeks. But the reality is that writing a, you know, a more formal plan and getting those into slides and telling that story with data. I mean, that helps to sort of like really fosters this, you know, kind of this foundation for the company moving forward. So I think that that's great. So those first few months after the grant then, once you got the credit card and the check writing ability, you spent most of that

time at least early on trying to raise additional financing. Is that correct? I did. And the first thing I did with my cash was I, and this sounds kind of crazy. I knew that getting it into a form, you know, like the hand towel and kind of taking the math and putting it into the actual device would be pretty straightforward once I had enough money. But what I knew sort of intuitively upfront is that we needed to lay out a plan for how we would prove it clinically. And so I hired someone who had a lot of stats background and did clinical research and worked hard on putting that plan together. And once we had an idea of how we were going to prove it, then raising money was pretty straightforward. So I just started cold calling and made appointments. I did. I mean, yeah. Funny. A lot of people think

that like, you know, that's, you know, the world of raising money is there's like a mystique about it, I guess maybe for lack of a better description in reality. It's like it's cold calling. It's kind of sells. You're selling someone on your story and what you're trying to build. I can appreciate that. I remember a presentation here locally in Minneapolis that Stacey Insing Sang gave on raising money because she's now with Lightstone Ventures and it was a really good presentation. I'm hoping to have her on the program, you know, soon we can kind of, you know, go into that a little bit more detail. But yeah, I mean, one of the avenues that she recommended for early stage founders was, you know, was grant money, friends and family, foundation money. It was really good. What it sounds like to me is

you spent your time trying to feel out, you know, who were some low-hanging fruit that I could raise some additional funds. Definitely. And I think in part, the entrepreneur isn't passionate or really that sold out to whatever idea they're pitching. It's easy to pick up on it. But my passion has never waned. And one more thing I should tell you, Scott, when I spend money, I see my investors' faces before me. We are so careful with the way that we spend money. We're very considerate with respect to our stewardship of that money. So I think over the years we've proved ourselves really trustworthy. And so we've raised three rounds. We've raised $10.3 million from individual investors. I don't have any institutional investors in my poll right now. Wow. And so on that note, I want to kind of move on eventually here to

sort of the business model for OM and in the clinical trials and how you went about that. Because, I mean, you know, 1,300 some odd patients. That's no small feat by no means. But on that note regarding financing, I interviewed the founder, Safjan, gosh, this was probably five or six months ago now, that. And they didn't raise, I mean, they didn't have a traditional, you know, venture capital firm lead any of their rounds. It was all through, you know, angels and individual investors. So looking back, is that something that you recommend to other med tech entrepreneurs or would you do it differently the next time around? No, I would 100% do it the same way. When you're interacting with high net worth individuals, they've been successful. So they all bring additional

knowledge. And you grow every time you beat to one of these folks. I would do it exactly the same way. That's good to know. That's great. So you've raised three rounds. and are you currently raising money again or are you follow the philosophy of like you're always sort of you know passively raising money what's your approach to that so I don't I don't always passively raise money because I'm so concentrating on the business but we are raising a convertible round right now great very good and if someone was listening and was interested and possibly investing is the best way to just to reach out to you directly yeah definitely very good okay let's move on let's talk a little bit about the business model and then a little bit more about your clinical trial too I think

mentioned before. I mean, it's not like you just did a small little trial. I mean, it was a significant number of patients. But in regards to the business model, you know, it seems like your device could potentially, you know, kind of play within this consumer world of like Fitbit and, you know, Fitbit, I guess, just acquired Pebble. But, you know, I watch in that whole like consumer-centric realm, but obviously you went down a different path. So explain to us kind of like your take on maybe those two different directions and why you pursued the one that you ended up running down. 100% happy to talk about that. So the American Heart Association, American College of Cardiology guidelines indicate that testing asymptomatic patients is not a good idea. And my ultimate goal is to

test every person over the age of 40. And that's ultimately, you know, getting to the point where we're eliminating that kind of heart attack and sudden cardiac death. But at this point, the medical system is not ready for that type of testing because it can increase costs downstream. And also it's higher risk to patients if you have them undergo additional testing. And so I think it will definitely be a great fit in the consumer market. It's a point of care. It can be performed to anywhere. At this point, though, we are concentrating on patients with chest pain and tumor risk factors. We think it's the best thing that we can do for the patient and for the public. Got it. Okay. So long term, in order to meet those goals and have everyone, you know, tested below the

age of 40, yeah, it would sort of require a little bit more proactive effort, you know, on the consumer behalf, but I can completely understand. I mean, I don't think the healthcare system, nor most people in general, are ready to, you know, to go down that path or that proactive, unless you're talking to a very specific audience, you know, it's sort of that biohacking audience that, you know, are, you know, you probably know that audience that I'm speaking about. Yeah, I mean, they probably love to get their hands on your technology and test themselves, but that makes a ton of sense. So you've gone down this path. It's a little bit more traditional sort of med tech where you're, you eventually sort of want to get societal support. And so would this eventually, you know, once you have FDA clearance here in the

the U.S. you'll eventually, this is something that you hope insurance companies will cover and then reimburse for? Yeah, 100%. We hope that they see the worst, and we think we can take a tremendous amount of cost out of the system. Yeah, absolutely. It would seem like that. On that note, that might be the biggest beast to tackle its coverage reimbursement. I recently interviewed Bill Factor, who's the CEO of Eirlands, and he was the CEO of the Clarenet of the Clarenet of the Acclarant through the acquisition by J&J. And we went deep into this whole concept of, you know, coverage and reimbursement and, you know, the lessons he's learned along the way. So that will go live by the time I guess our interview goes live that will probably be up but I encourage anyone

that's interested in learning a little bit more about Bill's thoughts to check that one out so very good let's talk a little bit more about your clinical trial so if I understood you correctly before you have do you have two trials in place one that's around 300 and so 1300 ishundred ish that patient's and then another one that's a thousand patients is that correct no we've tested a total of 1,350 patients 1,000 of them were in our big turbulence study and then we had a few smaller either post-market registry studies or actual in US perspective blinded studies. Okay. Got it. Our FDA study is the turbulence trial. Okay. And so when you went about sort of designing and developing what you wanted this clinical trial to look like, how did you look at that from the beginning and

how did that sort of come to life? Yeah. So originally we wanted to do a pre-angiogram study because that would have allowed us to collect patient data and then automatically have kind of the answer, right? The gold standard associated with our test. And so we would pretty easily be able to match up those two things, right? Our test results and then the angiogram test results, proving that the technology worked. We went to FDA and suggested this study and they required us to debt back, collect the patient data at the point of stress testing. And so that was pre-nuclear stress test, is what we decided was kind of the best place for the company. When we originally started this study, we thought that we would have to collect about 368 pieces of data to be able to calculate

our performance endpoint. What we discovered was in the middle of this process was that what we thought was happening in clinical medicine and what was published wasn't really what we found in practice. So originally we thought there would be about maybe a 40, 60 blitz in terms of disease and normal patients. But what we discovered was that about 15% of all patients who undergo nuclear stress test are positive. And so that made our study just about, yes, three times, almost four times as big as we thought it would originally be. Got it. Just put those numbers out to you. There are about 10 million nuclear stress tests performed every year and about 10% of those. The patients actually have some disease. And so nuclear stress tests are vastly overprescribed for normal

patients. And that's an $11 billion industry. Wow. Wow. Those are some big numbers. I wouldn't have expected that big. Were those numbers specific to the U.S. alone? Or is that worldwide? So specific to the U.S. alone. Got it. Okay. And on that note, your clinical trial, did you enroll patients just here in the U.S. or did you enroll patients in Europe as well? So for our large clinical study, they were 21 clinical trial centers around the United States. We have done post-market registry studies in the Netherlands and also in Germany. Got it. Okay. Very good. With respect to managing the clinical study itself, did you do that

internally or did you work with a CRO? So we did it internally. We did look at Farrows in the beginning, but they're really expensive to do a 1,000 patient study. It's more than a million dollars just to do that. And so we were very careful about understanding, learning, memorizing FDA guidelines with respect to conduct of clinical studies, monitoring requirements, data safety, ways to just ensure that you're getting good data, you're capturing good data.

We ended up using electronic data capture systems, hired really good consultants to help us. But then I had on staff monitors that, you know, kept an eye on the data. And we did lots of monitoring visits all over the country. But we opted not to use a CRO just because it's so expensive. Sure. You know, Dr. Johnson, there's got to be a story there because of the laughter at the beginning. It seems like a beast. I mean, to tackle, especially, you know, managing it internally with the company your size.

But obviously, you were able to do it successfully. What are some of the best practices, I guess, or challenges that you encountered and how did you sort of, we don't have a ton of time to go very deep in this. But I mean, anything that you can offer up to other people that are kind of in the same boat are considering, you know, starting a clinical trial and don't know whether to manage it internally or to work with a CRO. 100%. And I'm happy to share this knowledge. And I think we're awfully smart about it within the company. So first of all, let me say my staff was really small. I had at any time about 12 people. And any one of us can train users on how to collect kids. data. I think that's very important. In addition to that, all of us can troubleshoot the systems. And so if we had groups that needed to be trained, it was not just a single clinical person. It could be a clinical person who was reviewing regulations. And then I could have an engineer that would travel along with them to train them on how to use the device. And so we were careful about resources. And then we learned an awful lot about risk-based monitoring. And so I had,

And actually we still work with Susan Alpert, who was one of the senior VPs at Medtronic over-regulatory. She was also chief at CDRH at FDA. And I talked to her at length about monitoring requirements because I think that's really the most difficult aspect of running a clinical study is just going into the centers and checking the data. I had talked to her at length about this. I read the FDA regulations probably more than 10 times and realized that I don't think

was ever really, I don't think that they, the way that we interpret those regulations is really what they meant. And this was, I think, really reiterated by Susan, Timmy, just that doing this 100% monitoring and just the amount of time and money that people spend on this. I just don't think that that's exactly what they meant, right? By the decisions. And I just want to be careful about how I'm saying this because we did not cut corners. We used statistical methods. We did 72 monitoring visits and it's really expensive. So let me tell you something, Scott, that is very eye-opening to me. Clinical monitoring just basically means that you go to the center, you take a look at the data that they've written down, so they write this down on a piece of paper that the research

coordinators do, and then the monitor will go in and just check to make sure the data is correct, right? So they'll look at Box A. Box A is, you know, age 25, and then we'll go into the patient's record is at age 25, and they're just matching up this data, right? A lot of these monitors are making $150 up to $300 an hour and it's a check data. That's really all they're doing. And that is not meant with any level of disrespect. But I had monitors who came to me and said, I make $300,000 a year. And that's to check data.

Wow. I've never actually, this is the first time I don't usually go too deep into this world. But that's really fascinating to know. Wow. There's a lot of money going somewhere there. It's incredible. And so that's what happens. And I think it's really hard to manage these kind of studies just because you have people out all over the country.

And they interact with the cardiologists and with the nursing staff and with the coordinators at the hospitals. But that's where the bulk of the money, I think, goes is just been to monitoring the data. Yeah. Well, in a conversation I had with Duke Rowling, to use acquisition of Fox Hollow, then sold CV ingenuity to Cavidian, et cetera, et cetera. I's now with Spyrocks. When they were doing their clinical trial at Fox Hollow, that they, or was it CV ingenuity, I I can't remember which company may be, but they specifically wanted to manage it internally because of that relationship issue in the field. They really wanted to get to know everyone at their trial sites, not only just physicians, but all of the healthcare providers.

And they think that really helped, you know, increase enrollment in an era where a lot of times clinical trial enrollment is pretty difficult. Yeah. Yeah, I agree. I agree. And we have great relationships there and coming up with ideas to get patients to join clinical studies. I mean, I think you're 100% on for all of those things. I mean, these kind of small nuances, relationships, and getting people excited and motivated to collect data. I think it's a lot of work for the folks at the sites to do a good job and to actually get patients that fit within criteria and within really our patient population.

Sure. And the goals for our, you know, sort of commercial launch. Yep, absolutely. So I know we don't have a ton of time left. But on that note, there's a few other questions that we probably won't be able to get into, unfortunately. But it does seem, you know, just hearing sort of your story, you know, over the past. you know, 45 minutes or so, it seems like you've been able to recruit and build out a team of really solid people, right? I mean, it started with the lady that you got to know at Medtronic,

even just taking on this clinical trial thing. I mean, you were able to obviously build out an internal team to help you manage this. So are there certain things you've learned along the way or how you've been able to track those people and keep them motivated internally to, you know, when they're probably, you know, at times, you know, pretty overwork considering if you're at a startup or you're building out of startup. But can you talk to us a little bit more about that? Sure. So I think the clinical need and the drive to solve this problem is the reason why people stay with the company. I don't, just like you mentioned, it's a lot of work, it's overwork, it's really, we study a lot of the regulations, we know the product, we know the clinical

field inside and out, and I just think you have to be sold out to the patient and dedicated to the patient. In addition to that, I think that they really like to work together. I mean, we have a certain DNA within the company. And once you develop this team, you bring people in that have kind of similar DNA, they want to work together and it's easier to retain that talent. Sure. It sounds like you've got a pretty good culture there, you know, a lot of smart people that are willing to hustle. Oh, we do. And one more thing I would say to other people that would be listening to your show is that needs change. And so I had a lot of clinical people on staff for a while. And I only have one person who does any clinical work and it's just a very small amount. And so it's really keeping people when you

need them and letting them go when you don't need them. You have to be flexible. You mentioned earlier on that a business plan should change every 12 to 16 weeks. And I would say that the business does change every 12 to 16 weeks and you just have to be agile. And the team has to be comfortable with that kind of quick change. Got it. Yeah. And before we get to kind of the last three rapid fire questions, you know, what's next for, you know, for OM and, you know, if you can highlight maybe, you know, we've talked a little bit about this, but, you know, looking back over the last, you know, 13, 14 years or so, you know, I'd just be curious, you know, would you do anything differently? Or is there something that you think if we could have just done it this way, I think we would have gotten there a lot faster?

Sure. So, yes, absolutely. The answer is that. So probably I would have not only for myself, but for my longer term team members, just kept in mind that it's a marathon and it's not a sprint because we were nonstop for three years. And then you get to the. point where you start getting really tired. So, you know, I think that for me personally, that has never really been an issue because I'm just so motivated. But I think for some of the other folks that have been on staff, it's really exhausting. So that's one thing I would have, I wouldn't have let people work until one in the morning. You know what I'm saying? Go home. Take your vacation. Please have a balanced life. And I think I'm really good at that now in terms of being a leader.

Make sure that people take time off. And then maybe the second thing that I would add on is, I mean, maybe raise a little bit more money up front, just all at once instead of piecemealing it altogether. I may have done it a little differently that way because I think you can move a little bit faster if you have more money. That's probably the second thing. And then our next step is that I'm currently looking for a chief commercial officer and also like a VP sales and marketing that wants to join our team and help us ramp up commercially. We're ready. We've got commercial product ready January 1 and I want to hire someone. that has strong commercialization background and he has a lot of energy and wants to take on a disruptive

product. That's great. Yeah. So anyone listening that their ears just perked up, you know, if you want to just email me directly, I'm sure I could pass along your information to Dr. Johnson here. So with the last few minutes here, I'll just ask a few quick rapid fire questions. They rapid fire, you know, in terms of the nature of the questions, but not necessarily, you know, rapid fire. You don't have to provide rapid fire answers. But I don't, and I don't blame you if I'm putting you on the spot here for this first question because you're running a, you know, fast moving startup. But is there a favorite business book that comes to mind or one that you recall has kind of made an impact over your career? Yes, and my son makes fun of me. It's Dale Carnegie's book, How to Make Friends and Influency.

I swear to you, my son thinks it's hysterical. But yeah, I think it's been very helpful. I love that answer. In fact, it comes up actually quite a bit that it's still a book that a lot of people remember as one that's been the most impactful over their career. So is there a CEO or business leader that you're either kind of following right now or one that's inspired you over the last five years or so? 100% yeah so i have two dennis war is one i think he's an incredible leader and then also bob pulson he's just a terrific motivator and has a great business mind got it and i think not med tech but i think stan hubbard is pretty remarkable too cool love those answers and then lastly you know we've rewound the clock quite a bit in this interview but you know if we had the chance to do it again and we you know

go back to your your 25 year old self is there something that you tell her well you know i was working at General Motors at the time. I was working out at Sandusky, Ohio, and I really never thought that I would do anything but be an engineer in the current industry. And so I would just say, take more chances. Don't be afraid. I mean, you've certainly, you know, taken that advice. I guess maybe it would be, you know, there's going to be opportunities. Don't take your chances. Or take your chances. That's usually, don't turn them down. So very good. I know you've got to get going. I can't think enough for coming on the program. Such a great story. We'll link to your website there in the show notes. Is that probably where you direct the audience for those that I want to learn a little bit

more about you and your company? Yeah, definitely. Very good. Of course, you could always Google Dr. Marie Johnson and OMS, spelled A-U-M, but we'll link to that in the show notes as well. But thanks, Dr. Johnson, for coming on, I'll have you hold on the line here. But for everyone listening to the show, thanks for your attention. And until the next episode of Medsider, everyone, take care. Thanks again, ladies and gents for listening. This episode has been brought to you from the WCG Studios here in Minneapolis. And don't forget to grab your Panoptic stacking blueprint. by visiting reachfiredigital.com

for slash medsider. Again, that's reachfiredigital.com forward slash medsider. Okay, bye for now.