Welcome to the Medsider interview series, a regular feature at MassDevice. All interviews are conducted by Scott Nelson, Founder of Medsider and Group Director for WCG. We hope you enjoy them!
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 the heart muscle.
At that time, Dr. Johnson had been working on a prototype device to listen to heart sounds as a 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 Ph.D. in Biomedical Engineering and as the Founder of AUM Cardiovascular, she’s successfully raised over $10 million in angel investment from individual investors, small funds and physicians. Before becoming CEO of AUM, Dr. Johnson designed and launched the University of Minnesota Medical Devices Innovation Fellowship Program.
Here are some of the topics we’ll cover in this interview with Marie:
The time when Dr. Johnson realized she had a “winner” on her hands with the CADense System.
The origin story of the CADense System.
How Dr. Johnson went from initial idea, to prototype, to eventual production.
What she has 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 CADense System.
Her approach to managing clinical trials with a small team.
The biggest lessons Dr. Johnson has learned through the process of building AUM Cardiovascular form scratch.
Johnson’s favorite business book, the CEO that most inspires her, and the advice she’d give to her 25-year old self.
The following is based on an audio interview with Scott Nelson and Dr. Marie Johnson. It has been edited for enhanced readability.
Audio embed script:
Scott Nelson: Dr. Johnson, welcome to the program. I appreciate you coming on.
Marie Johnson: Thanks Scott.
Scott Nelson: Let’s start with the accolades that you and your team at AUM have won over the past several years. You received the top cardiovascular innovation award in 2015, you’ve been named a top 10 med tech innovator in 2014, one of the top 100 creative people in business, and 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 AUM 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.”
Marie Johnson: Thanks for asking that question. I’m really embarrassed and I’m just humbled that you would have looked up these things about the company and about me. I’m 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 that 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 was a pretty important part of the product development process.
Scott Nelson: So it was really at that clinical trial standpoint where it really begin to resonate for you and your team. The word “disruptive” gets thrown around a lot, but your technology is truly disruptive. To level set everything for the audience, can you provide us with a high level overview of your technology, CADence, to describe what it does, and who it treats?.
Marie Johnson: Sure, absolutely. CADence is a noninvasive, handheld, nonintrusive fast way to rule out coronary artery obstruction in patients with chest pain in two or more risk factors.
Scott Nelson: Is it displacing a current sort of treatment algorithm for healthcare providers now?
Marie Johnson: It sure is. We have just finished a 1,000 patient clinical study, proving that we’re not inferior to a nuclear stress test in terms of ruling out obstructed disease. What’s important about that comparison is that a nuclear stress test can take between three and five hours up to two days where CADence requires only eight minutes to collect the data and the results will return back within 12 minutes.
Basically the patient has to lie on their back, breather 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 agent. It requires technicians, special facilities.
CADence is very easy to use. We provide a system where it can be performed anywhere a cellphone tower can be accessed and where there’s a room. Whereas a nuclear stress test in a lot of places around the country and around the world don’t even have access to that kind of technology.
Scott Nelson: This technology, the CADence system, that displaces the situation where the patient would have to go to the nuclear testing department to get that. There is certainly a lot more investment needed on not just the patient’s behalf, but the entire healthcare system as well. With your testing you are bypassing all of that and you can get the same thing accomplished in eight minutes. Is that true form a high level perspective?
Marie Johnson: It is. It’s eight minutes to collect the data and then another 12 minutes to get the results back. That’s exactly what we’re doing and that’s in terms of ruling out disease. So just consider going to the emergency department with chest pain, and you’re going to spend at least six hours there and a lot of times they’ll even keep you overnight. 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 setting, but CADence can be used really quickly to rule out coronary disease. Most people that are in the United States would know this, but heart disease is really the number one killer among Americans. One in three people will suffer from some type of heart disease.
Scott Nelson: You mentioned that you just finished up a 1,000 patient clinical trials as well.
Marie Johnson: 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 i’s important because it’s actually in the patient population where CADence will be used.
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 say publicly is that nine out of 10 times, if a patient is normal, we can tell the doctor that the patient is normal.
Scott Nelson: Wow, that’s impressive. Do you have regulatory approval? Or where do you stand from a regulatory approval standpoint?
Marie Johnson: Yeah, great question. We have our CE mark and we are able to sell in any place in the world where CE mark is accepted. We do have registration in those countries of course, but we also have approval in Canada, Australia, the Philippines, and are clear to sell in a number of other European countries right now. We are being used commercially in Germany and the Netherlands.
Scott Nelson: Great. I presume the FDA clearance is on the horizon at some point. Is there an anticipated date for that?
Marie Johnson: There is. We think that we will have our first clearance in Q2 of 2017 and then our second clearance, at Q4 of 2017. This is the first time I’ve ever said this publicly, but we have added ECG to our CADence system.
Scott Nelson: Oh wow. Congratulations.
Marie Johnson: Thank you so much. 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. The clinicians takes the data and we return that within 12 minutes too. Then it not only provides that ECG information to a clinician but then it also allows us to be even more accurate in terms of our assessment of turbulence in the coronary vessels because we can split out systole from diastole. So we can separate those sections of the cardiac cycle and it just is really terrific because it allows us even more a powerful assessment of that data.
Scott Nelson: Congratulations on that addition. That’s very cool news. So, you’ve currently got CE mark, clearance is on the horizon, now if we had the chance to rewind the clock even further, can you provide an overview of how the idea and concept for the CADence system came to be?
Marie Johnson: Sure, absolutely. 14 years ago, I was working with a 3M lent man 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 our goal was to automatically detect heart valve pathology. I am not a clinician, I’m an engineer and so I use my husband as a test subject. I collected lots of data from him and he was 41 years old, six foot two, 180 pounds in excellent condition.
He swam three days a week, and nine months after I started my PhD, died from a sudden cardiac event. He had a vulnerable plaque rupture in his widow maker, coronary artery that’s the left interior descending coronary artery. It was a complete surprise. I had a four year old and 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.
A 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 to the vessels. I discovered a lot of literature about times and places where this similar phenomena had been described and that phenomena is using acoustic to detect coronary disease.
There was a guy back in 1967, his name was Dock, and he described a case study about a guy who had come into a Brooklyn DA 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 where it was from. 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 rapture on the LAD vessel.
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 their conclusion that they didn’t hear the sound all the time and so they couldn’t trust it clinically. In addition to that, the sound’s really quiet and so you can’t pick it out. 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 a business.
Scott Nelson: I’ve always been intrigued by med tech founders and what drives their passion, and clearly there’s a personal story here. If I go back to that time period, your husband passes away completely unexpectedly, you’ve got two young children, and you moved to Italy. What was kind of going through your head at the time? I’ve got to think that a lot of people wouldn’t have made those types of efforts with two young kids. So where do you think that drive and that passion comes from?
Marie Johnson: I 100% agree with you. People thought I’d lost my mind, 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, it’s easy to keep moving forward when you feel that you’ve got something ordained on your life.
Scott Nelson: I wouldn’t have expected you to answer in that fashion, but certainly I can completely appreciate that. How long were you over in Italy then? Before you came back to The States?
Marie Johnson: I was there for half a year.
Scott Nelson: This may be a little bit more of a personal question, but your kids, are they teenagers now?
Marie Johnson: Yes. So, my daughter’s 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. They’re just excellent human beings and wonderful kids.
Scott Nelson: They’re seeing entrepreneurism lived out right before them. I imagine those skill sets will come in handy down the road. Such a great story. I would encourage everyone, if they want to hear Dr. Johnson touch on a little bit more detail in regards to the background, there’s a great TED Talk that she gave a while back that is definitely one to watch.
Let’s transition and talk more about AUM and how you went from studying the technology over in Italy, moving to the west coast, and becoming a part of the Stanford Biodesign Program. First, how do you go about raising money when you do not have deep connections with venture capitalists? Can you talk a little bit about that part of the AUM story?
Marie Johnson: Yeah, absolutely. Can I step back just a little bit? Because 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 out on their website to try to entice entrepreneurs to take the product commercial. You know what was kind of funny? I could never understand why, over years, nobody saw the potential of the device. You know what Scott? It was because it was math.
Scott Nelson: Interesting.
Marie Johnson: I mean, to me it was so obvious. Well, I went onto the Stanford Biodesign Program, not even expecting to do anything with my invention. It didn’t even occur to me. I went into 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.
I came back and here’s where I started. I don’t know if you remember, years ago there were some stimulus grants available. They called them the Qualifying Therapeutic Delivery Project Grants. Basically they were grants or tax breaks, I think. I took the grant, so I don’t know what the deal is 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 Stanford, The Biodesign 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. So I remember, I went to the bank and I had to open a bank account to actually receive this money from the government. The banker asked me if I wanted to get checks and a credit card. I looked at him and I thought, “Why would I want to?” But when I got the credit card in the mail I thought, “Well, I have a business. I actually have this vehicle to move money.”
Anyways, 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 Stanford 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 on together strong pitches, they teach you a variety of topics that Intersect with translating a technology. So insurance reimbursement, deregulatory or OUS regulatory things, business models, putting teams together.
So I had this background and I had learned from these incredible entrepreneurs and innovators. So that’s what I did. I started putting together my overview and cold called a lot of groups. Got on some angel groups, I got onto their radar, I made some presentations and then I always say that the first $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.
I’ll tell you, I worked with this woman who had been at Medtronic and she helped me put my business plan together. 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 start working from that, massaging it and get it into this PowerPoint format so that you can start pitching your ideas.
Scott Nelson: I could completely understand where you’re coming from. There’s this notion in Silicon Valley right now, at least in the tech vertical, that business plans are irrelevant and it’s all about iterating every eight to 12 weeks. But the reality is that writing a more formal plan and getting those into slides and telling that story with data, that helps to really foster this foundation for the company moving forward.
So those first few months, after the grant and once you got the credit card and then check writing ability, you spent most of that time, at least early on, trying to raise additional financing, is that correct?
Marie Johnson: I did, and the first thing I did with my cash was, and this sounds kind of crazy. I knew that getting it into a form, the handheld, and taking the math and putting it into the actual device would be pretty straightforward once I had enough money. But what I knew intuitively up front was that we needed to lay out a plan for how we would prove it clinically.
So I hired someone who had a lot of stats backgrounds 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 straight forward. So I just started cold calling and made appointments.
Scott Nelson: Funny, a lot of people think that there’s a mystique about the world of raising money. The reality is, it’s cold calling, it’s sales. 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 Stacy Enxing Seng 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 soon that we can go into that in a little bit more detail. One of the avenues that she recommended for early stage founders was grant money, friends and family, foundation money. It was really good.
What it sounds like to me is that you spent your time trying to figure out, “Where are some low hanging fruit that I can raise some additional funds?”
Marie Johnson: Definitely. So I think in part, if the entrepreneur isn’t passionate or really that sold out to whatever idea they are pitching, it’s easy to pick up on it. But my passion has never waned. One more thing I should tell you Scott, when I spend money I see my investor’s faces before me. We are so careful with the way we spend money. We’re very considerate with respect to our stewardship of that money. So I think over the years we have proved ourselves really trustworthy and so we have raised three rounds. We’ve raised $10.3 million from individual investors. I don’t have any institutional investors in my whole right now.
Scott Nelson: Wow. On that note, regarding financing, I interviewed the founder of Saphion five or six months ago, and they didn’t have a traditional venture capital firm lead any of their rounds. It was all through angels and individual investors. So looking back, is that something that you’d recommend to other medtech entrepreneurs? Or would you do it differently the next time around?
Marie Johnson: 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 speak to one of these folks. I would do it exactly the same way.
Scott Nelson: Well that’s good to know. So you’ve raised three rounds and are you currently raising money again, or do you follow the philosophy that you are always passively raising money? What’s your approach to that?
Marie Johnson: I don’t always passively raise money because I’m still concentrating on the business but we are raising our convertible rounds right now.
Scott Nelson: If someone was interested in possibly investing, is the best way is to reach out to you directly?
Marie Johnson: Yeah, definitely.
Scott Nelson: Let’s talk a little bit about the business model and then a little bit more about your clinical trial too. In regards to the business model, it seems like your device could potentially play within this consumer world of FitBit and iWatch and that whole consumer centric realm, but obviously you went down a different path. So explain to us your take on maybe those two different directions and why you pursue the one that you ended up running down.
Marie Johnson: 100% happy to talk about that. So the American Heart Association and the American College of Cardiology guidelines indicate that testing asymptomatic patients is not a good idea and my ultimate goal is to test every person under the age of 40. That’s ultimately getting to the point where we’re eliminating that 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 cost downstream and also it’s higher risk of patients if you have them undergo additional testing.
So I think it would definitely be a great fit in the consumer market. It’s a point of care, it can be performed anywhere. At this point though we are concentrating on patients with chest pain and trauma risk factors. We think it’s the best thing that we can do for the patient and for the public.
Scott Nelson: So long term in order to meet those goals and have everyone tested below the age of 40, it would require a little bit more pro-active effort on the consumer’s behalf. But I completely understand. I don’t think the health care system nor most people in general are ready to go down that path or they’re that pro-active. Unless you are talking to a very specific audience, that bio hacking audience. You probably know that audience that I’m speaking about. They’d probably love to get their hands on your technology and test themselves.
So you’ve gone down this path that’s a little bit more traditional medtech where you eventually want to get societal support. Once you have FDA clearance here in the US, is this something that you hope insurance companies will cover and then reimburse for?
Marie Johnson: Yeah, 100%. We hope that they see the worth and we think we can take a tremendous amount of cost out of the system.
Scott Nelson: Yeah, absolutely. It would seem like that. Coverage reimbursement might be the biggest beast to tackle.
Let’s talk a little bit more about your clinical trial. So if I understood you correctly before, do you have two trials in place? One that’s around 1,300 patients and then another one that’s a thousand patients. Is that correct?
Marie Johnson: No. We have 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 NUS perspective blinded studies. Our FDA study as the turbulence trial.
Scott Nelson: Okay. So when you went about 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 come to life?
Marie Johnson: 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 the answer, the gold standard associated with our test. So we would pretty easily be able to match up those two things; our test results and then the angiogram test result, proving that the technology worked. We went to FDA and suggested the study and they required us to step back, collect the patient data at the point of stress testing, and so that was pre-nuclear stress test is what we decided was 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 end point. What we discovered in the middle of the 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’d be about maybe a 40/60 split in terms of disease to normal patients. But what we discovered was that about 15% of all patients who undergo nuclear stress tests are positive.
So that made our study just about three times, almost four times as big as we thought it would originally be. So there are about 10 million nuclear stress tests performed every year and in about 10% of those, the patients actually have some disease. So nuclear stress tests are vastly over prescribed for normal patients, and that’s an $11 billion industry.
Scott Nelson: Wow, those are some big numbers. I wouldn’t have expected that to be that big. Were those numbers specific to the US alone, or is that worldwide?
Marie Johnson: Specific to the US alone.
Scott Nelson: On that note, for your clinical trial, did you enrol patients just here in the US or did you enrol patients in Europe as well?
Marie Johnson: For our large clinical study, they were 21 clinical trial centers around the United States. We had done post-market registry study in the Netherlands and also in Germany.
Scott Nelson: With respect to managing the clinical study itself, did you do that internally or did you work with a CRO?
Marie Johnson: We did that internally. We did look at CRO’s 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 kept an eye on the data. We did lots of monitoring visits all over the country but we opted to not use a CRO just because it’s so expensive.
Scott Nelson: It seems like a beast to tackle, especially managing it internally with the company your size but obviously you’re able to do it successfully. What are some of the best practices or challenges that you encountered and what advice can you offer up to other people that are in the same boat or considering starting a clinical trial and don’t know whether to manage it internally or work with a CRO?
Marie Johnson: A 100% and I am 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 CADence 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 is reviewing regulations and then I could have an engineer that would travel along with them to train them on how to use the device. 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 Albert who was one of the senior VP’s at Medtronic over regulatory. She was also chief at CDRH at FDA and I talk to her at length about monitoring requirements because I think that’s 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 the way that we interpret those regulations is really what they meant. This was really reiterated by Susan to me, 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 by these regulations. I just want to be careful about how I’m saying this because we did not cut corners. We used statistical masses. 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 the research coordinators write this down on a piece of paper, and then the monitor will go in and just check to make sure the data is correct. So they’ll look at box A, and box A is age 25 and then we’ll go into the patient’s record. Is it 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 to 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.”
Scott Nelson: Wow. 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.
Marie Johnson: It’s incredible and so that’s what happens. I think it’s really hard to manage these kinds of studies just because your people are out all over the country and they interact with the cardiologists, with the nursing staff, and with the coordinators at the hospitals. But that’s where the bulk of the money goes, it’s just into monitoring the data.
Scott Nelson: Wow. In a conversation I had with Duke Rohlen, when they were doing their clinical trial, 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 increase enrolment in an era where a lot of times clinical trial enrolment is pretty difficult.
Marie Johnson: Yeah, I agree. We have great relationships there and coming up with ideas to get patients to join clinical studies, I think you’re a 100% on for all of those things. With these small new ounces, 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 the job and to actually get patients that fit within criteria and within really our patient population and the goals for our commercial launch.
Scott Nelson: Yep, absolutely. Hearing your story, it seems like you’ve been able to recruit and build out a team of really solid people. It started with the lady you got to know at Medtronic even just taking on this clinical trial thing, 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 have you been able to track those people and keep them motivated internally when at times they are probably quiet overworked considering that you’re at a startup? Can you talk to us a little bit more about that?
Marie Johnson: Sure. So I think the clinical need and the drive to solve this problem is the reason why people stay with the company. Just like you mentioned, it’s a lot of work. It’s overworked, 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 similar DNA, they want to work together and it’s easier to retain that talent.
Scott Nelson: Sure, it sounds like you’ve got a pretty good culture there, a lot of smart people that are willing to hustle.
Marie Johnson: Oh we do, and one more thing I would say 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. 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. I would say that the business does change over 12 to 16 weeks and you have to be agile and the team has to be comfortable with that kind of quick change.
Scott Nelson: What’s next for AUM? We’ve talked a little bit about this, but looking back over the last 13, 14 years, would you do anything differently? Or is there something that you think, “If we could just done it this way, I think we would have gotten there a lot faster”?
Marie Johnson: Sure. So yes, absolutely the answer is that. 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 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 old staff it gets really exhausting. I wouldn’t have let people work until one in the morning. I should have said, “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, and make sure that people take time off.
Then maybe the second thing that I would add on is maybe raise a little bit more money upfront just all at once instead of piece mailing it all together. I may have done that 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 am currently looking for a Chief Commercial Officer and also a VP Sales and Marketing that wants to join our team and help us ramp up commercially. We’re ready, we’ve got commercial products ready by January 1, and I want to hire someone that has a strong commercialization background and who has a lot of energy and wants to take on a disruptive product.
Scott Nelson: That’s great. So with the last few minutes here, I’ll just ask a few quick rapid-fire questions. Is there a favorite business book that comes to mind or one that you recall that has made an impact over your career?
Marie Johnson: Yes and my son makes fun of me. It’s Dale Carnegie’s book, How to Make Friends and Influence People. I swear to you my son makes this hysterical but yeah, I think it’s been very helpful.
Scott Nelson: 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 the one that’s the most impactful over their career. So is there a CEO or business leader that you are either are following right now or one that’s inspired you over the last five years or so?
Marie Johnson: A 100% yes. So I have two; Dennis Worre is one. I think he’s an incredible leader and then also Bob Holsen. He’s just a terrific motivator and has a great business mind and I think, not medtech, but I think Stan Hubbard is pretty remarkable too.
Scott Nelson: I love those answers. Lastly, we’ve rewound the clock quite a bit in this interview but if we had the chance to do it again and we go back to your 25 year old self, is there something that you’d tell her?
Marie Johnson: Well, I was working at General Motors at the time and I was working out at Sandusky, Ohio and I really never thought that I would do anything but be an engineer in the car industry and so I would just say, take more chances. Don’t be afraid.
Scott Nelson: You’ve certainly taken that advice. There are going to be opportunities. Take your chances. As you say, don’t turn them down. Marie, I can’t thank you enough for coming on the program. Such a great story. Thanks Dr. Johnson for coming on.
Read more Medsider interviews here.
The post How to go from idea to commercialization: Interview with Dr. Marie Johnson, Founder of AUM Cardiovascular appeared first on MassDevice.