Accelerating Technology through Medical Device Incubation
Episode 467

Stanton Rowe, CEO of NXT Biomedical

Accelerating Technology through Medical Device Incubation

Creating an exciting path for science and health through a medical device incubator

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Accelerating Technology through Medical Device Incubation

Episode 467

Recommended Book:

The Mismeasure of Man

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NXT Biomedical

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Accelerating Technology through Medical Device Incubation with Stanton Rowe, CEO of NXT Biomedical was automatically transcribed by Sonix with the latest audio-to-text algorithms. This transcript may contain errors. Sonix is the best way to convert your audio to text in 2020.

Welcome to the Outcomes Rocket podcast, where we inspire collaborative thinking, improved outcomes and business success with today’s most successful and inspiring health care leaders and influencers. And now your host, Saul Marquez.

Saul Marquez:
Welcome back to the Outcomes Rocket, Sam Marquez here today I have the privilege of hosting Stan Rowe. He’s the CEO of NXT Biomedical. That’s NXT biomedical, a medical device incubator funded by Deerfield Capital, Johnson&Johnson, and Edwards Lifesciences. Stan recently retired from Edwards Lifesciences, where he was Chief Scientific Officer since 2008 and also served as Corporate Vice President, Advance Technology. He joined in 2004 when Edwards acquired Percutaneous Valve Technologies, a company he helped to found in 1999 and served as President and CEO. This company developed the first transcatheter aortic valve replacement. Now growing in popularity. So it’s fantastic to to be speaking with one of the gentlemen that started that that industry previously. Rowe was a Corporate Vice President for data scope and was the VP at JJIS Interventional Systems Division in Warren, New Jersey, responsible for the company’s coronary stent development efforts at JJIS and a related Cordis Corporation, Rowe held a variety of positions with increasing levels of responsibility, including leading the company’s business development, advanced technology, worldwide clinical research, and marketing groups. He’s on the board of directors of many different companies. He’s got, in my mind a PhD and results in medical devices. And so with that, we’re gonna be diving into medical device innovation, venture funding and all the things that you need to be thinking about from idea to conception to a company. So Rowe, Stan a privilege to have you on. And now looking forward to our conversation today.

Stanton Rowe:
Thank you very much. I feel it’s a real privilege to be here.

Saul Marquez:
So why did you decide to get into the health care sector?

Stanton Rowe:
Well, what I was going to coming out of college. The premier jobs were really in the pharmaceutical sector. And that’s where I started. I started I spent six years in pharmaceuticals and I enjoyed that sales clinical research, but reached a point where I decided the pharmaceuticals were very limited. All you could do is change the formulation and the Railroad Administration. And there’s just so much creativity to it. And that’s when I left the wonderful medical device business where I thought the limitations are the physics. So we saw what you could do but demise. But it’s limited only by physics. So you have a lot of opportunity to be really creative and help patients in unique ways in the medical device industry.

Saul Marquez:
Yeah, I agree with you, Stan, and there’s definitely been quite a change in the healthcare ecosystem within the last few years with the entry of digital therapeutics and digital health. This whole ecosystem has changed tremendously. And I’d love to hear your thoughts on the impact that’s had on and on medical devices and overall what you feel those shifts have have meant to the industry.

Stanton Rowe:
Well, I think certainly I think diagnostics are going to be affected by big data and wearables in very significant ways. Well, I think we’re going to have more targeted early interventions. I don’t think the therapeutic side has changed quite as much by those, but I think the overall environment is changing in interesting ways. I mean, the there’s been a flight of venture capital I take away from that device and then to more of the digital space where people get past or returns. I think the FTA environments really turned around. They’ve been very collaborative. They still have very high standards. But you can speak with them and they’re collaboratively in a way to help shepherd you through their requirements. So that’s very plausible on the regulatory side and Europe still yet to be determined. I think there’s a lot of concerns about MDR and the effects on the better device sector, how that’s going to impact us. But it’s going to obviously look a lot more like FDA, but I’m not sure it’s going to be as collaborative as they try to figure out what these regulations really mean and how they’re going to deploy them, force them.

Saul Marquez:
That’s certainly interesting. And so you’re you’ve done a lot of different leadership executive level roles in and in med device in your background and your experience, Stan, and today you’re working with a new firm, it’s called NXT, NXT. Tell us a little bit more about the focus there and what you believe needs to be on the minds of health leaders in med device and in general.

Stanton Rowe:
Sure. So I really enjoyed my time with Edwards very progressive, thoughtful company. That was a very steep growth curve. Mostly due to the transcatheter heartfelt. But, you know, the efforts of thoughtfulness that went behind that were pretty remarkable. So a lot of fun there. But my stupid idea of retirement is kind of going going back to that, which I loved the most, which is that very early stage of development where you’re taking a crazy idea and taking it through a feasibility process and prototyping and early testing. And how do I get there first? And man, does this physiology really work. And those are really complicated, interesting questions. I’m not so interested in it or talked about, but I’m not sure how much opportunity there is for mineral development today in today’s environment. But the next day, we have the privilege of being kind of pre-funded. I joke with people Saul and say I screwed up, I raised the money first and then all the products. And so we do have the privilege of backing from Deerfield Capital, which is a great firm out of New York that focuses on health care, and they manage about 10 billion dollars there. And Johnson&Johnson was interested in Edwards Life Sciences or such. So we have all three of those really reputable groups behind us financially, and they’re excited about what we’re doing and where we’re headed.

Saul Marquez:
Well, it certainly is is exciting. So congratulations on raising the money first.

Stanton Rowe:
Thank you.

Saul Marquez:
Half the battle. So you’re working at NXT now. You’re driving the business there. Tell us a little bit more about it and how you plan to make the companies that get built out of there improve outcomes and business model success.

Stanton Rowe:
Sure. Well, I have the privilege. The well, one of the key co-founders is a close friend of mine and a very skilled cardiologist named Rob Schwartz of them, Minneapolis. He spent many it was hard for quite a number of years after being at Mayo Clinic. Pretty unique guy because he has a masters in electrical engineering and then went to medical school. So quite an engineering background. I have a lot of patents and Rob has a lot more. I think have about 43 or so issued patent. Trump has about a hundred issued. And between our issue of their spending patterns, we have about 200. Between the two of us, so I would just say we’re fairly prolific when it comes to new concepts and ideas and we’ve invented quite a number of things together. That’s part of what’s behind an next tea. Then I hired an amazing group of early stage engineers that are very talented and are very comfortable in this early stage where it’s critical to really understand about us, understand the pathology and the anatomy, understand how to do design of experiments. And so, you know, I went from having 800 biomedical engineers to have 5. But the really good and we really have a lot of fun doing this early work of taking these big therapeutic ideas and taking them through this early process. Now, one of the benefits we have saw is because we’re pre-funded, we don’t have to go out and tell people what we’re doing. We don’t get very specific about the area as well. I mean, it’s it’s good because when you’re fundraising, you have to go shout to the world. Here’s what we’re doing and why we’re doing it. If it’s a really good idea, you just invite a lot of competition. We have the privilege of keeping things pretty quiet until we’re ready to go to a big medical meeting and say, hey, look, you know, the first 20, 20 patients we’ve done. Yeah. We’ll be pretty far along. So I appreciate what that funding means for us in terms of being able to keep things quiet and work our way through these early projects where, of course, there’s a lot of failure and learning and iterations to get to the point where you have something that you feel is commercially viable. I’m looking at the at the picture of your team, Sharp Group and the shout out the guy, Glen, Alex, of course, you mentioned Dr. Robert Schwartz and Joe and Rob. And then there’s you, Stan. So, yeah. I mean, this is exciting, you know, and I’m looking at this picture thinking, wow, you know, they’ve assembled such a cool team. Like, I could see this picture ten years from now. Hey, you know, the innovative devices that have helped improve outcomes. This is where it started. You know, the crowds.

Stanton Rowe:
A lot of fun. We just hired another person named Elliott who came from Medtronic. PhD and biomedical engineering from UCSD, a really skilled guy that’s in really well with the other other team members. And everybody brings a slightly different skill set. And this is one of the key things and early stage developed that you can’t really afford to have a second class team or have a team that culturally doesn’t fit. I really think that is so essential in this early stage that you you create an environment where the best argument welds. I learned a lot of that working with my Israeli team in Israel when we started working on the transcatheter heart felt we had to debate every issue extensively and then we could make a decision until you debated it, you couldn’t possibly make a decision. And it’s a really good process. Everybody gets to contribute. Sometimes you see aspects you didn’t see before. But to have that kind of healthy debate, that’s tough on the problems, not hard on the people, but focuses on the issues and the best arguments should win. And if you have the right people there, you can really have a fulsome debate about what’s the right way to go.

Saul Marquez:
And so and just the way that that your business here sits in the overall process of that development life cycle, I think it’s brilliant. You know, they have to have a skunk works sort of mechanism that companies can leverage outside of the traditional. Let’s acquire the things that we see our starting to work. You comment on that?

Stanton Rowe:
But, you know, I think there’s a couple of other incubators out there that incubate ideas. The foundry does that SCHIEFFER that does that or too that I can think of. And they do it well. They do it really well. We’re a little different in that we are pre-funded. And certainly the majority everything we’ve done today has started with kind of internal ideas. Now, what what happens here, just like what happens is happened to be in the past as you think you have a brilliant early idea that no one’s ever thought of. That is until you go into the PAB literature. And you. Find out and say what he thought of this. They may not have developed that and they may not have had exactly the same idea, but there’s enough overlap that we need to to reach out and include other people. And we we’ve funded that situation already. But it’s fun to have the capability to bring in other people who have thought about things similar way. And so we can’t do that as well. And I do think this sits fairly uniquely in the ecosystem. That device and that our input are big, difficult therapeutic concepts and our output is startup confidence that we’re set up that way. And it’s pretty unique. We’re funded for 5 years through these folks. So then the objective is to spend out 5 to 8 startups over that period of time.

Saul Marquez:
Ok. So 5 to 8 total in the span of 5 years. OK. I don’t even know where that is. You don’t feel good about anything again. You think you’re going to totally blow it out of the water and new more. What are your thoughts?

I mean, I think that’s incredibly ambitious if you think about it. I mean, I’d say it Edwards it took us about 18 months to go from concept just through DV Design Validation of Verification before you could do even think about doing the first and vana. Then you’d be another 9 months before you do first and bam. So if you think about five years spinning out, five date companies is incredibly ambitious, but that’s kind of what we are. We’re in. We’re incredibly ambitious. And so we’re I would say we’re kind of on track so far.

Saul Marquez:
Man, that’s so exciting. Yeah. And it’s about shooting high, thinking big. You know, there’s there’s no fun in average. And I love what you said earlier. That’s great. You can’t afford to have a second class team. You can’t afford to live a boring life of average. You got to do awesome stuff. So I got to give you kudos for that, Stan.

Stanton Rowe:
Well, that’s what makes life fun, is swinging for the fences every time you write about.

Saul Marquez:
And so I know you guys I mean, when did you start? Then when was the official start date of the next tee?

Stanton Rowe:
We started September 2019.

Saul Marquez:
OK. So you’re about a year in.

Stanton Rowe:
That’s right. That’s right.

Saul Marquez:
And so in that year, Stan, what would you say is is an example of results you’ve already created?

Stanton Rowe:
So we’ve worked on 3 different projects. We and investigated a good bit more. I mean, this is, again, a team of 4 to 5 people. We did something kind of unique in that we developed a really interesting concept and we were able to test that clinically using off the shelf products. So we’ve been able to go in and do first in human with a spot, an optimal product. But with the given the severity of the disease, the risk benefit still made a lot of sense. And we’ve been able to help a number of patients in our early clinicals. And so we’ve been in clinic already. We’ve almost to a design phrase with our first product looking to spend out that company hopefully by Q1 or so. And our second project’s about to I would say we’ll go into clinic again close to Q1 for our second project and working very actively on the third. So, yeah, we got a lot going on.

Saul Marquez:
I’d say that’s awesome. Congratulations on that. And as you and your team have gone at it, it’s been a year. What would you say is a setback that you’ve had that that early on you’ve learned a lot and has created results for you because of what you learned?

Well, I think we frequently learn things in the you know, I would say the process of product development is a process of running down the walls and trying to figure out what your way around it. And, you know, we’ve done that both times under Reno, really. It’s also a process of understanding patients. And one of the things I see that people do with good intentions, but it’s not the right thing, is when you go out and ask doctors marketing questions, doctors are really good at answering medical questions. They will have insights into patients and needs and procedures that you will never have because you have done it. But that frequently moves into questions about the market. Well, do you think what’s the opportunity for this and how many people will do it? I don’t think doctors are going to answer a marketing question. Do you have to answer those yourselves? Yes. And one of the best examples of that,Saul, was when I when I started PVT, the Percutaneous Valve Company, and I wanna talk to some of the top valve surgeons in the world. Not one of them thought it was a good idea.

Saul Marquez:
Is that right?

Stanton Rowe:
I said Percutaneous Valves? Listen, we treat all the patients. We have perfect outcomes. This is a stupid idea, you’re going to kill people will never work. It’ll never be durable. It will never perform as well as a surgical valve. You should just stop right now before you humiliate yourself. That was my very consistent feedback from the top people in the world. You have no idea what you’re doing. This is never going to work.

Saul Marquez:
That’s really interesting. And so you were getting that feedback. What kind of reflection or, you know, like what went on in your mind, Stan, that said, you know what? I appreciate your feedback, but I’m going to do it anyway.

Stanton Rowe:
Well, so I take the feedback seriously. But you have to take it in the vein of, well, let’s get specific. What is it that you’re really worried about? You say we can’t make it durable. Why can’t we make a general? OK. Well, I don’t really know. They just say we have 30 years of experience for surgical well. So, of course, it’s never going to be as durable. But if we made it from the same materials, the same basic designs, why couldn’t we? Right. Right. You it was one thing after the other. You can’t stent open your x the nose, which is what we’re doing. We’re taking this stinted valve and we’re standing open aortic stenosis, whereas surgeons cut it out surgically. We hence can’t stand it open. We cut it out. It’s a raw. Really? Why is that? Because when we put balloons, anterior or extra gnosis, we can open it up. Why do you think we can’t spit it out? So if you start peeling back their criticism and you see it as a problem to solve and proof that you have to develop, then it just becomes part of the problem that you’re solving for. Yes. Rather than taking the overall criticism, we say you should just quit now. OK. I don’t accept that. And maybe what it comes down to as some level, Saúl, is that the best innovators have a little streak of nihilism. And I do Right., which says all we can do better. What we have out there. Well, it’s OK. But we can really do better. I mean, what? Why are we satisfied with those? We could do better. And so if you have that that little bit of nihilistic, I mean that in a positive way. Not sure. No, I get sick of it. But you have to have a little bit of that contrarian streak to be a good innovator. And I think that as you listen to those kind of jaded comments with your own bit of skepticism. Well, thank you. I understand your perspective. I understand you cut out this disease every day, but that doesn’t mean I can’t do it a different way.

Saul Marquez:
Yeah, that’s interesting. You know. You know what’s funny is I think about. I mean, you and the group that you’ve established assemble and along with yourself, you guys are problem solvers, thinkers, engineers and a friend of mine, her dad is is an astrophysicist then you recently say, hey, check out my channel. I just started broadcasting my my classes out there and it was so neat. I guess I just sat in virtually in one of his classes and I just heard the arguments back and forth, very healthy arguments by smart people. They’re like trying to prove it with equations and stuff. I was totally lost then. But but what I really enjoyed was the healthy back and forth that you’re talking.

Stanton Rowe:
Yes. Yes. Yeah, I think that’s critical. It is critical internally and it’s important externally because it helps you vet out the issues that you’re going to see to have those healthy debates with these physicians where I mean, you have to know what you’re talking about. OK. You can’t walk it, right. So tell me about this disease. So it’s incumbent upon us as developers in biomedical engineering to be really, really well educated before you walk out. But, you know, one of my examples of that is, you know, I develop coronary stent technology. I knew a lot about stents, delivery systems, those things when we started developing Percutaneous heartfelt, which was very helpful. But I didn’t know anything about Valve or heart disease was not nearly enough to ask even intelligent questions. So, of course, I you know, I went to these meetings. I started attending the valve sessions. But the other thing I did that was really helpful to me is I went and bought one of the fellows textbooks, cardiothoracic surgery, and I just sat down and read that thing. It was torture, but it was very helpful because, I mean,.

Saul Marquez:
You get through the whole thing?

Stanton Rowe:
I don’t. Yeah, I did that. And I think what you have to do is you have to dedicate yourself to really understanding this area that you’re walking into. And by the way, that means that the history of. Yeah. Because that is the way that clinicians see the world is through the history of their their subspecialties.

Saul Marquez:
Super interesting. Yeah. And I think that’s a that’s a really great, great point to make. And so thinking through your the way that you’ve done things and now you’re a year and maybe you want to share one of your proudest moments from NXT or or maybe you want to share it from your career in general.

Stanton Rowe:
Sure. I guess one of the most impactful things for me is I remember going to visit a would be a it was absolutely instrumental to us and developing the transcatheter valve. Amazing partner. He was the chief of cardiology for Wall France that would to visit him after we’d done a few, you know, several, the first in human studies. So that was kind of update and walk through some of the things we’re doing. But, you know, a personal visit to PRO-WALL and I’d been meeting with him. And it just so happens that one of the early patients had come back for their 1 year, 6 month or 1 year follow ups. And she heard that I was there in the hospital and she tracked me down. And then her broken French-English said to me, thank you for saving my life. Mm hmm. And it’s one of those things we all aspire to do in biomedical engineering. That’s why we do what we do. It’s why we went into this field. And when it happens to you, it’s incredibly rewarding to know that you really are impacting the lives of patients. So so that’s that’s what we look for. We have the pictures of patients on the walls in our office. And it was very fulfilling to hear hear that from a patient in the know that we had really fundamentally changed.

Saul Marquez:
What a great story. Did you take her picture?

Stanton Rowe:
I do have her picture.

Saul Marquez:
Nice. Now, that’s a great.

Stanton Rowe:
I received a Christmas Christmas card from her daughter even after her death. Years later. Because, you know, using every patient, we say we impact the whole family.

Saul Marquez:
Oh, for sure.

Saul Marquez:
And we don’t always think about that. But it was reminder to me how important it was to their family that she told me she had gone down to the south of France with her family. And that was time, something she could not possibly done before she had a transcatheter valve procedure.

Saul Marquez:
Wow, that’s great. And folks, you listening to this? I mean, this is a you know, we’re taking a glimpse in the history where the valves started and and then really stands sharing some great advice with us. Peel back that criticism, turn it into a problem to solve. Don’t be afraid of it. I think if you’re brave enough and thoughtful enough to do that, what ensues could be the future of health care. And so great message here from Stan. What would you say is the most exciting thing you’re working on today? You probably can’t tell me, can you?

Stanton Rowe:
Not really. I guess that’s probably I would have the benefits that we can keep things quiet. Yeah. Know, we are plotting a couple of big revolutions. And I’m really, really excited about it. I couldn’t be having more fun. And by quote unquote, retire. But my wife just laughs when I call it replied that.

Saul Marquez:
She think you’re crazy?

Stanton Rowe:
No, she knows I’m passionate.

Saul Marquez:
Yeah, she knows. She knows this is what keeps you going?

Stanton Rowe:
That’s right. That’s right. She has been basically supportive through the years to do that.

Saul Marquez:
God bless her.

Stanton Rowe:
Yeah,.

Saul Marquez:
That’s awesome. That’s awesome. Hey, well, thank you for your support. Miss Rowe. And many more things to come here. And so getting to the lightning round here, Stan, we got a couple of questions followed by your book Ready?

Stanton Rowe:
OK. Yeah.

Saul Marquez:
What’s the best way to improve health care outcomes?

Stanton Rowe:
You know, from my perspective, it’s take on the big, tough problems. There’s only very, very limited room for incremental development. It’s not much fun and I don’t find it very rewarding. We’ve got to take on the big things.

Saul Marquez:
I agree. That’s great. And what’s the biggest mistake or pitfall to avoid?

Stanton Rowe:
You know, I would say I think of two things. One is a symbol, a first class time get the very, very best people because you can’t afford not to have them, but be very cognizant about the culture of that team. In other words, she can have bright people that are disruptive. You’ve got to have a cohesive team with a great culture. I always say the second thing is don’t over promise. I think you have to have very realistic plans if you over promise and create this idea. I’m going to solve this problem next year. And you don’t you can suffer the consequences of bad start. But I see a lot of people with long bridge rounds that strongly bad for them.

Saul Marquez:
How do you stay relevant despite constant change.

Stanton Rowe:
Lead to change.

Saul Marquez:
And what would you say is an area of focus that drives everything at NXT?

Stanton Rowe:
I think it’s this concept of open creative debate and creating that environment where we can all turn around and bounce ideas off one another in a very collaborative fashion. It definitely changes the way we operate.

Saul Marquez:
Powerful. And what about your book? Stan, what little book would you recommend to the listeners?

Stanton Rowe:
So what are the books that I would like to read? I have read these very delts books by Stephen Jay Gould, who’s a biological anthropologist who’s dead now. He was the top professor at Harvard for decades. And he wrote a book that kind of surprised me because I didn’t know most of this is about a Darwinian process. We’ve lived through. But he wrote this book called The Best Measure of Man. That was a really interesting book about bias in science. And it was a wonderful reminder of how important objectivity is. What we do every day,.

Saul Marquez:
It’s a great message. Great. And give me the name of the book again Stan.

Stanton Rowe:
The Best Measure of Man.

Saul Marquez:
The Best Measure of Man by Gould.

Stanton Rowe:
Yes. Stephen Jay Gould.

Saul Marquez:
Awesome recommendation, folks. You know, you could find all of the resources discussed here, including that book, a full transcript, links to NXT and the work that stands up to just kind of outcomes a rocket that health in the search bar type in NXT. You’ll find that there, Stan. You know, we’re getting close to the end here, but I am curious, what would you say the role AI has in med device innovation today?

Stanton Rowe:
So I think, you know, A.I. is taking big data and sorting through it in ways that show us patters and provide information that we don’t, it’s impossible for our brains to process. And so I think that in things like diagnostics and wearables, those kinds of things, it’s going to have a big impact. I think the the machine learning process as it could get better and better over time, which is important. I see it in that device, especially in this wearables revolution, that we’re going to send patients home with very small wearable devices where the transmit data. This data is going to be analyzed and fed back to probably nursing stations. But the the analysis will go back to our our medical professionals and tell us when we start moving off track, that’ll be especially helpful in things like the chronic disease states like heart failure, where there, you know, somewhere around 15 million patients around the world walking around with heart failure. Heart failure hospitalizations are the second leading cause of hospitalization in the United States, second only to giving birth to babies. And if we can intervene early because we know what’s going on at home, I think those are going to be really important benefits for the prevention of hospitalization and the optimization of home care.

Saul Marquez:
So you’re thinking mainly the impact will start in patient monitoring and diagnostics.

Stanton Rowe:
Correct.

Saul Marquez:
Yeah, I think it’s an interesting, interesting thought there and something for everybody to think about as far as this become. This this use of A.I. becomes more real. Something for everybody to walk away with allow, Stan. This has been an incredible interview. I just want to say thanks and leave us with the closing thought. I’d love if you could just give us something to think about as we walk away and also the best place where the listeners could check out and continue the conversation.

Stanton Rowe:
Absolutely. You know, I think early stage product development those is messy. It’s fraught with doing the wrong things, testing the wrong things, not understanding boundary conditions, learning a lot about pathology and anatomy and sometimes asking questions no doctor knows. It’s really tough and there’s no clear path many times. But what comes out of a is an opportunity to help tens of thousands of patients. Some startling for me personally, I’ve worked on products that have been on literally billions of patients. And at the end of the day, to know that you’ve done something to help needy patients and give them alternative therapies that may be avoided surgeries or treated them when they otherwise can be treated is a really great privilege to be able to stand up and say, this is what I do for a living as I help these patients. It’s hard to call it work. It’s a great privilege to do it.

Saul Marquez:
And that’s why you’re still doing it.

Stanton Rowe:
That’s right.

Saul Marquez:
I think it’s great then. And I appreciate that, that insight. And where can the listeners connect with you or learn more about the work that you’re up to now?

Stanton Rowe:
Well, you can connect with us. We have a Web site www.nxtbiomedical.com. Thanks for the interest of the listeners. And so. Thanks for the privilege of being on your podcast.

Saul Marquez:
Hey, it’s it’s a pleasure to have you, Stan, and wishing you guys luck here in the remaining 4 years. I have a feeling you guys are going to just do an incredible job and get those 5 the companies out. So kudos to you guys and thanks again for for your time.

Stanton Rowe:
Yes, thank you. Bye-Bye.

Thanks for listening to the Outcomes Rocket podcast. Be sure to visit us on the web at www.outcomesrocket.com for the show notes, resourses, inspiration and so much more.

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