The Power of Networking in Medtech, Challenges in Developing the Renal Denervation Market, and the Value of Cross-Functional Experience: Interview with Shaun Bagai, CEO of RenovoRx


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Shaun Bagai is the CEO of RenovoRx.  He has over 16 years of medtech experience across multiple functional areas like clinical research, sales, marketing, and market development. He was instrumental in developing the European market for renal denervation, which led to the acquisition of the first renal denervation company, Ardian, by Medtronic in 2011.

Most recently, Shaun led global market development for HeartFlow, which included directing Japanese market research, regulatory/payer collaboration, and Key Opinion Leader (KOL) development, ultimately resulting in a company investment to form HeartFlow-Japan.

Interview Highlights with Shaun Bagai

  • Shaun’s reaction to Medtronic’s acquisition of Ardian back in 2011.
  • The power of mentorship and networking and their impact on Shaun’s career.
  • How Shaun landed in medtech with TransVascular before it was purchased by Medtronic in the early 2000’s.
  • How Shaun’s experience in a field-based sales capacity has helped him throughout his career.
  • Shaun’s transition from Medtronic to Ardian and the biggest challenges he faced while developing the market for renal denervation.
  • Shaun’s cross-functional experiences while helping to build HeartFlow-Japan.
  • What Shaun and his team are building at RenovoRx and what lies ahead for the company.
  • Shaun’s favorite business book, the CEO that inspires him, and what he would tell his 25-year old self.

Read the Interview with Shaun Bagai

Scott Nelson

Hey there, ladies and gents, welcome to another edition of Medsider Radio. On today's program we've got Shawn, the guy who is the CEO of Reno Rx. He has over 16 years of med tech experience across multiple functional areas like clinical research, sales, marketing in market development. He was instrumental in developing the European market for renewed innovation, which led to the ultimate acquisition of the first Reno's renovation company Ardian by Medtronic in 2011. Most recently, Shawn led global market development for heart flow, which included directing Japanese market research, regulatory payer collaboration and key opinion leader development to create value, resulting in a company investment to form what is now heart flow. Japan. You are some of the things we're gonna cover in this interview. Shawn's reaction to Medtronics acquisition of RD in back in 2011 the power of mentorship and networking and their impact on Shawn's career. How Sean landed in Med Tech with Trans Vascular before it was purchased by Medtronic in early two thousands. How Shawn's experience in a field based sales capacity has helped him throughout his med tech career. Shawn's transition from Medtronic toe guardian and the biggest challenges he faced while developing the market for renowned innovation. Shawn's cross functional experiences while helping to build heart flow Japan. What Shawn and his team are building at Reno are X and what lies ahead for the company and, lastly, Shawn's favorite business book at the CEO that inspires him and what he would tell his 25 year old self. So without further ado, let's get to the interview with Shawn, the guy Sean. Welcome to the program. Appreciate you coming on.

Shaun Bagai

Thank you. Gotta appreciate the opportunity

Scott Nelson

before we talk about Rin ovo r X, the company that you're currently CEO of. Let's start with RD in and take us back to the time when Medtronic acquired already in in November of 2010. What were you doing for them at the time?

Shaun Bagai

November 2010 maybe everyone to clock a little bit more. I was pulled into already and to kind of help wrap up their existing clinical study. It had very positive results, given my both my clinical research myself background and then transition them more into market development and sales. So back at that time frame, we had launched in Europe, kind of a pilot launch. And my role is mostly European market development, Germany being the biggest market. I really spent most of my time in Germany. In fact, I was flying it almost every week to get the product off the ground. My job and my role was training positions became one. The lead trainers. It already in market development, work in sales work.

Scott Nelson

Got it. I wanted to start there because I think most of my audience will be familiar with Aryan considering the size of the acquisition by Medtronic. And on that note, it was a very sizable acquisition, considering the size of our idea at the time. I know Reno the innovation was a very, very sexy a sort of therapy, and I say was sort of in the past tense because, you know, I don't know how many companies are you know are still developing products for renewed innovation. But on that note, did the large acquisition surprise you just as much as it did? A lot of people kind of from from an outsider's perspective,

Shaun Bagai

you know, to be honest, it didn't surprise me all that much, given the market potential there. We've all living through my days of Medtronic or many years of Medtronic and the stent wars, so to speak. We were basically creating a market in hypertension that's four times the stent size as far as market size goes, and it was really creating a brand new market for something that hadn't really been paid attention to a lot of the drugs that you know of for hypertension or treating downstream effects of the core issue and already and really found a way Thio. I wouldn't say cure. But to potentially treat the core of the disease and the market potential is huge. I think the potential definitely was there. As you probably know, I think there are about 70 companies that had started to embark down a road of development in that same space soon after the acquisition and to date there are still, I think a lot of companies were wiped out. A lot of the fund stride up, but including Medtronic, a lot of companies that are trying to revamp the technology take the learnings both from the positives in the mistakes that were made previously on study, design and even technology to some small degree and make that successful. So I don't think it was very surprising. I think the results of the next clinical study where the most shocking to most especially for people on the inside, we all worked very close with the physicians firsthand, and we've seen patients that really were able to reduce a lot of the medications and increased quality of life and potentially life extension as well from the treatment. So I think the technology definitely does work. I think the studies to be designed better, and that's what I believe. Medtronic has restarted the next study for the next generation device as well, so surprising acquisition, not so much surprising results in the next clinical study. Absolutely

Scott Nelson

good point. I know Medtronic is still enrolling patients. I think in there. I think it's HT and three there US trial right now. And I believe Boston Scientific still in the game. Think ST Jude might be as well I don't I don't recall the list of companies that offered up my head, but you're right. I mean, you mentioned coronary or stent wars, I should say. I mean, it seemed like there was renewed innovation wars, you know, at the time of, you know, at the time or shortly thereafter, you know, Medtronic acquired guardian before. I want to definitely get into what you're doing now as well as kind of your career in my attack, because I think there's going to a lot of interesting antidotes for a lot of people to learn from before we go there. Your general thoughts on Rina innovation, considering you know, the initial judicial results of the trial back. And I think, too, that was at 2012 ish, something like that, maybe early 2013 and then seemed like, you know, based on those results, a lot of people exited the game. Are you still, you know, even though you're not necessarily involved in that space anymore? Are you still hopeful that, you know, really innovation will become a therapy that most patients will have access to at some point the future?

Shaun Bagai

Absolutely. I'm actually very bullish on technology. It's something that I was able to know. That's one thing I love about. Being in this type of career is I get to dive in the science for a deeply innovating. The sympathetic nervous system definitely made sense. If you looked at the early studies that guardian did we actually d enervated one kidney the time, and we showed a reduction of hormones that that were then caused by the cascade of the sympathetic nervous system. So we did definitely prove concept. The science was working and definitely made sense. I think the aftermath is really clinical study design patient selection could become a primary player in this, And as for his treatment goes, I'm not sure if a blading each renal artery with R F Energy X number of times is the most optimal. I think whether it's our f ablation or cry ablation or some other way of attacking the sympathetic nervous system, the hyperactive are overactive, given lifestyle choices and kind of the dye that people take makes sense. So I'm not sure what the end result will look like, but I think some level of innovation for hypertension is gonna be a major treatment option sometime in the future without having a crystal ball. Not sure if it's a few years away, or many more than that,

Scott Nelson

and it seems like I still, you know, converse with as you do, probably as well. You know, people that are still active in that in that space or loosely affiliated with the innovation space. And it seems like the kind of think along the same lines, you know, those that you included, as well as others that were closely involved with the with the early trials are still very bullish and very positive on what that many eventually look like. So cool. I just wanted to get your brief. It take on that. So before we go, you know, kind of rewind the clock all the way back to your early days at Trans Vascular. Let's level set the audience. I provided you know, your bio, of course, in the in the intro. But tell us a little bit more about what you're doing at ran over our X, the product that you will eventually commercialize, and the general sort of therapy or disease state that you're after

Shaun Bagai

course. Serena Bar X has developed a delivery system, if you will. It's a dual balloon catheter that provides a lot of flexibility and adjustability on delivering therapeutic to the peripheral vasculature. The advantage here is we're able to stop blood flow to a segmented part of the artery and deliver at high volume high doses of therapies. Initially, that the Katherine's been used in Goa, Nadal vain sclerosis been used for liver treatments were doing a couple of studies right now in the pancreatic cancer space. Given the large unmet need for paying credit cancer, one of the biggest issues with pancreatic cancer treatments to date is that the drugs simply do not get in the tumor's. The tumor's unlike other solid tumors using livers comparison are relatively a vascular hyper vascular, meaning that there aren't a lot of feeders feeding the tumor. So there's not a nisi target to deliver localized therapy, too. It also poses a problem when you get to stand the chemotherapy. The systemic chemotherapy favors going everywhere except for the pancreatic tumor because of the lack of blood supply. So this catheter, the rhino calf, is able to isolate segments of their arteries that feed the tumors and were able to give high doses of chemotherapy. And we've been studying this now and I Polish Market registry study to date. So really, the first focal point from a clinical research standpoint is pancreatic cancer, where there's a large unmet clinical need.

Scott Nelson

Thanks for the 80 overview there. I appreciate it, and you did receive a CEO mark back in late 2015. Correct?

Shaun Bagai

Correct. In fact, we're seeing Mark and subsequent FDA clearance were cleared back in 2000 late 1014

Scott Nelson

for

Shaun Bagai

the broad indication of delivering therapeutics. Powerful vasculature. If you look at the space of kind of localized, targeted delivery, most catheters in the space, including interventional oncology, have a broad indication it's very difficult to get a drug device combo cleared. You can imagine. I know so in this space, it's very common to have kind of a broader indication. Let physicians decide which vessels would make most sense to treating and what therapeutics to deliver.

Scott Nelson

Very good. All right, cool. So I definitely want to dive Maur into your experiences at Ran over our X and kind of what the lessons that you've been able to take throughout your career and how you're applying them to what you're doing now. But let's take the next few minutes and kind of dive a little bit deeper into your your background in your career. So you started as a clinical research manager at Trans Vascular. I don't have the date in front of me, but this was, I think, correct me if I'm wrong. But your first foray into the world of med tax. So tell us a little bit about that experience and what got you into the medical device face.

Shaun Bagai

No, it's It's funny. Sometimes careers happened. My locker. I met transvestite. Even everyone. The clock will further. I met Trans Vascular back in 97 when I was doing a summer internship at the Stamford Animal Lab, and the clinical research manager of The Times, said, Hey, if you ever need a summer job or maybe even a winter break job would love, we've got research associates. If you want to come join us, will be great. When I was applying to med school, I had a year off base in between what would have been university in med school, and I called up and said, How about a job for a year? Are supposed to a summer? And they had just someone similar as a research associate departing from med school who was helping with pre clinical research on different clinical research aspect. And after a few short interviews, I was able to secure that. So I spent a year of trans vast where Maura, as a research assistant or research associate, released that that was the plan and then go up to med school. I was very lucky to then gain Josh Mack ours, you Dr Josh backers you probably will know as a mentor

Scott Nelson

who

Shaun Bagai

over the course of months steered me to maybe consider different options than going to med school. So it started off taking pictures of pig hearts and packing catheters for animal studies, and was quickly able to get in a position of doing Maur physician training, more animal work and then eventually taking over the clinical research activities. A trans vascular once. And this is the kind of a funny story is Josh came up to me and close the door, and I kept questioning. Joshua are peppering Josh the questions on why he didn't practice medicine as an M D. Given that all his medical bound. And he finally said, Look, I think you'd be great in the industry. Given what you've done in trans vascular so far, why don't you tell your boss you're not going to med school? And then when you get into med school, make it more difficult choice? Because by then, your career should have taken off, and you're probably doing something more than just taking pictures of pig hearts from there. I did just that and said, Look, medical may be an option, but I want to see where my career could take me in the meantime, and by the time a I got in the Temple Med School in Philadelphia by Tommy I came off the waiting list and got my acceptance. I was already managing clinical research, taking over kind of the three clinical projects. We had a trans vascular, primarily in Europe, and by then I could definitely see a pathway forward in industry. One of the things that resonated with me most and this is what Josh has been such a great mentor to me is that one is that I love diving in a technology and then shifting. And I think my crew has shown that where I been ableto dive in the science of different technologies. I'm not sure if you call it a d D or just

Scott Nelson

having fun with

Shaun Bagai

different areas of medicine. Another thing you recognize and this is something that he was very passionate about is that as an entrepreneur, he's been able to affect many more patients to different companies. That he started and helped build. And that really instilled a lot upon me when I decided not to go to med school is that I can affect many more patients by helping build companies helping do things, and this will kind of plane in the already in story and why I went already and a CZ. We'll talk about that later. But that's really how I got my start in med Tech and fell in love with both the device side, the medical technology, the science behind medicine and then kind of layering the business pieces of my career grew from there,

Scott Nelson

got it be. And and before we knew, it was the early two. Thousands of my research here is correct. And then, you know, you transitioned onto Medtronic in a in A in a very commercial capacity. But before we go there, what do you think? You know, Josh or Dr Mack our saw in your early days, that sort of cost him to say, encourage you to to pursue more of an industry track. Now that versus the medicine out. You

Shaun Bagai

know, it's funny, you ask because there was one thing that always resonated with me, and it was that whenever I was given something to do, and this is what I recommend, any kind of young person getting started in any career, for that matter is I devoured whatever that project was. I tried to do it the best I possibly could, no matter how small the task and learn the most I could during that time period and take on as much as possible. I think being naive and hungry, I think it was a month three in the company. I asked Josh if I could attend one of the board meetings to learn being a CEO. Now I know that's definitely not something that a research assistant does.

Scott Nelson

Papa New abort me. In

Shaun Bagai

fact, the my older colleague made fun of me for the question. But in retrospect, I think that was just my personality. I wanted to learn as much that possibly could. I think the other piece that he saw that he mentioned to me is I like driving things to completion. And I think that's something that that he saw on trying to get things done and projects done. There are so many different things and tasking to be done in the industry at any position that having the ability and the skill set and desire to drive completion would probably suit me well if I stayed in that course. If that makes sense

Scott Nelson

and it does a lot and it makes makes perfect sense, I mean, it's like 22 characteristics. I guess that that maybe are easy to understand yet Ah, lot more rare, I guess, to experience firsthand, You know, someone that's really ambitious, but at the same time, you know, wants to execute and wants to see something you know, go from start to finish. So very cool. Now that's a good story. I doctor, rumack hours name keeps coming up. I think in these conversations, I recently interviewed Ted Lambs and who you're probably familiar with and at neo track. You know, obviously he's ah, he's colleagues with with Dr Mac Mac are they go back to their Clarin days and even before that at it explore Matt. So let's up and go

Shaun Bagai

back to populist as well. So Ted was the I think it was R and D manager or director at Trans Ass Killer?

Scott Nelson

No, Till he Yeah,

Shaun Bagai

So I worked very closely with Ted. In fact, we had some great trips to Europe together, doing first and men. In fact, I never get a chance to talk to, you know, he's I've got about four or five mentors, and Ted was the one who was not my direct boss, but he really helped guide in shape my early career by being kind of the mentor on the voice. In fact, he is a doctor by PhD to

Scott Nelson

Dr Lampson.

Shaun Bagai

But he knew more about what we're doing that any clinician we ever met. So he was the one who taught me how to train physicians. And I think you really helped shape my life or my career as well.

Scott Nelson

Yeah, that's that's good to know. Now that that interview, if you wantto for those listening, I want to go back and listen to it. It's fairly recent may be published a month or two ago with Ted Lambs and Who's the founder of Neo Tracked And it's a great I mean, obviously he's He's very bright, very articulate, tells their story really well, but I think what what one of the big takeaways I have from our conversation was just I mean, he's so down to earth, you know, and when willing to share what he's learned along the way, So I just was very appreciative of that conversation. So definitely good one. If you want to go back and listen to it, that's gonna know what a small world sounds cliche. But how true industry. Yeah, No kidding. No kidding, right? I mean, everyone. I think everyone that it's been a while, you know, agrees that MedTech is a small world. But it's like, you know, it's these types of discussions works like, Wow, it really is really a small, so well, especially if you live in Northern California, where you're at. But let's transition on t your move overto. Medtronic, coming coming out of Trans Vascular, spent about six years and in a field based capacity both, you know, as a clinical, you know, marketing rep as well as a kind of a pure play sales rep as well. It seems like, you know, quite a bit different than what you were doing it trans vascular. So talk to us a little bit about that, and what I really want to hone in on is is your experience in the trenches with physicians and how that's translated into some of your other moves that you know it already in a hardware And, you know, now we know of our ex.

Shaun Bagai

It's a valid question, because, and again, I can't. I can't emphasize enough how important mentors are in Building one's career, and I'll take you back to to you know, exact things that push me towards Medtronic are three for the other three people, if you will. One is is as I decided not to become a physician. My gold did. I think of the age of 24 25 at that point was to someday be able to help build medical device companies. Justus, Dr Mac are, was doing with the Trans Vascular at the time is CEO and founder And he said, Look, Shawn, if you want to do this at some point knowing inherently how products were sold and exactly like you said being in the trenches, getting the sales experience is paramount to success, as as an executive down the road. Both coming from Dr Josh Mack are and also Dr Rain over Mani, who was a relative of mine who is very famous in the cardiac world. She said exactly the same thing. If you're not going to med school, go do sales and be inquired by Medtronic. With such a stellar sales channel having the opportunity, get my foot in the door for and in fact, I tried to guide younger people on how to get job, a job that Medtronic and sales, and it is very difficult to get that level of skill position. That would be an invaluable experience. So I did just that. And the goal there. I think Alan Millen also your problem there with us. Well, I think he was head of sales around that time, and he basically said, Look, come on board if you can be a marketing manager and train all of their sales reps and sales trainers and physicians on the technology acquired by Trans Vascular. Given that I was one of the physician trainers, then that might be a good transition after a year or so into a sales position and sound like a perfect fit, an opportunity given where my mentors were guiding me, you know, go. Incidentally, it took about two years, I think, before I sailed territory opened up where I had to. Manager take a chance on someone with no sales experience in that position. After a year of training sales, reps actually went back to Ted Lampson, who has remained a mentor of mine and said, Look, I've been training sales reps. Is that count? Can I go get my next job yet to

Scott Nelson

have a field

Shaun Bagai

and, you know, and and as a good mention, Woody said, Absolutely not. You know, carrying a number is very different than carrying a bag in the sense that you really learn what sales reps have to do, what the mindset is, how you really incentivize that correct behaviors. And I think getting the sales experience besides learning how to work with physicians learning how to train positions was done. But really, carrying a number helps one get that perspective of how to build and run cos

Scott Nelson

you know, it's It's such great advice. And as you can probably imagine, I listen to, ah, fair number of of other podcast to, especially in the early stage, kind of like tech space, if you if you want to call it that. And I can always tell when Ah, founding a founder or a CEO of an early stage company has has had sales experience because their interviews are always that much better. They just like it's just it's the intuitively get like what actually works, you know, and what what is really going to resonate with their ideal audience it and it seems like that's always the case, and it's it's interesting that you see that I myself went, You know, I've spent my early career in a largely in a sales based field day sales capacity in the attack, and when I first came into marketing, I was really just surprised at how how little folks that had spent their entire careers internally inside inside a large company, how little they sort of grass. But what it really you know what really works? You know what kind of messages resonate with, you know, with whether its position audience or another health care provider. So I can completely relate to what you're talking about and really to be. To be fair, vice versa. You know, a sales rep that thinks they can run, run a company without spending time, you know, internally, you know, dealing with sometimes, you know, the bureaucracy and layers and whatnot probably doesn't have a true appreciation for that kind of the full circle of of a med tech company. But I saw that on your, you know, kind of looking at your background. I wanted to definitely talk about your sales experience. What that out, how that's translated toe something some of these other experiences in your career? No,

Shaun Bagai

that's that's actually you bring up a very good point because it goes both ways. And I think having that marketing kind of stint at Medtronic for the first couple years gave me more appreciation for what went on in house. And and as I trained sales reps from the country when it became more of a sales trainer in certain product lines of Medtronic, I definitely felt the frustrations of the sales reps with the quote unquote in House people

Scott Nelson

marketing

Shaun Bagai

manager Never get it where his sales reps, of course, from mission is the way the sales reps usually

Scott Nelson

think. Yeah,

Shaun Bagai

it was actually great to be able to translate that, you know, knowing the regulatory hurdles that had to be overcome knowing the, you know, the internal politics that had to be overcome to make things happen. You know, having that perspective on both sides of that line was definitely helpful. So I think you you definitely appreciate the breath of experience necessary to certain things.

Scott Nelson

Yeah, yeah, no doubt. Well, for the sake of time, let's move on to your previous two experiences before Renova, Iraq, the 1st 1 being an already and I know we already touched on this, but I am curious. How did you end up transitioning from? You know your role as a coronary sales rep to ah your time at at Aryan,

Shaun Bagai

So I can't mention enough about how mentors play a role in my career. At the time, Andrew Cleland was a good friend of mine. I think we probably start drinking beers together through very close friends. I am really early twenties, and over the years he was kind of a more of a life mentor to me on which direction I should be taking my career. What an honest you break up with my girlfriend, things like that. And

Scott Nelson

so

Shaun Bagai

I think, over multiple conversations with Andrew about what I'm doing with my life in general, he started to see ah fit as already in transition from our was planning on in transition from a clinical company to a commercial company, given my clinical research background and my sales background, and he introduced me to Greg Bacon, who was head of sales and marketing the time, and this was very premature for ah mehd company or a tech company to hire a sales person, and it was basically

Scott Nelson

a

Shaun Bagai

bunch of fun, either. Happy hours, breakfasts and lunches with Greg Bacon on him asking me. And this is someone who had extensive market development, of marking experience with zero sales experience on how I would approach the market with the already in technology and until after a few months of this kind of free advice on getting to know Greg, it made sense for me to come on board and to kind of take over and help with market development. We're working with Greg and Mike Wallace, who was the director of marketing album the time, So it was almost an ongoing dialogue that made an easy fit. I don't think, actually had a formal interview to that entire process. It

Scott Nelson

was more of

Shaun Bagai

Ah, no

Scott Nelson

brainer

Shaun Bagai

at that point. That's kind of the getting into already in part, I guess, you know, it's for the exiting Medtronic piece. It was an interesting time because my goal was to go into sales, learn it and get out. I spent about five years and sales, and I really hadn't seen a technology that was gonna change medicine as much is already in. So I think it was a perfect fit for me. And perfect timing was looking for something to then do more than just sales, that that makes sense and the opportunity already. And what's a perfect combination of my previous experiences from an intellectual stimulation standpoint? I got to work with animal studies. I was there with the early technology. I got to train physicians. I was helping the clinical research and then helping the market development in sales. So it was basically everything I'd done before with that piece of me that didn't go to med school. That thought someday on a change medicine.

Scott Nelson

And

Shaun Bagai

given that we're opening a new market for hypertension, this was my first chance and more of a kind of a management level to have an effect on health care.

Scott Nelson

I got it, and at first blush it looked like the move from from your role at Medtronic coronary sales rep to what you were doing. It already seemed like a pretty big stretch. But I guess you know, hearing you describe your background and not on the trans vascular, but especially, you know, early you're early days with, you know, transitioning under the Medtronic umbrella. It seems like that didn't make a lot of sense. And it's interesting hearing you describe how, how sort of you you made that movinto already in. I mean, jeez, talk about at the power of mentorship and networking. You know, I think most people would have loved to be in that in that role at that time. But on that note, it's certainly probably wasn't all, you know, all all roses. So it was their duty to recall it. One of the more challenging aspects of your time and already in and sort of what you learned from that experience,

Shaun Bagai

I think one of most challenging and I, you know, I I look up to mentors and people have taught me a lot. I think the most challenging piece was We're trying to figure out how to commercialize the technologies. We're going from a clinical company to commercial company. We're going back and forth on pricing. There's a piece of capital equipment, They're disposable catheters. We were deciding what the sales footprint should look like we were. We were a few kind of market development managers which were blend of clinical and or sales people mostly in Europe, and I think the most challenging period is when were we weren't hitting the enrollment numbers. You are my guest sales numbers right off the bat, and it was a matter of and I'll teach me more strategy as well as a matter if we don't have enough resources for this. And and Greg Bacon kind of barked at us. Well, you know, if that's the issue, let's get more. Resource is I never wanna hear that excuse ever again. Let's strategize on how we're gonna attack this market and if it's more resourceful for resource is there. But I never want to hear their excuse if we say we don't need it.

Scott Nelson

So

Shaun Bagai

I think that was a big learning experience for me is that people can always make excuses why things don't happen. But it's really important to step back and put plans in place to actually gain success coming off of that, we re strategize how to enter the market, which positions we should be talking to, what the bearers were, and we overcame them and, you know, we really blew it out from a sales perspective without early market

Scott Nelson

adoption

Shaun Bagai

in Europe after that?

Scott Nelson

Yeah, it's a great sort of best practice and that there's some challenges that if you're knee deep, think they're sort of un, you know they're gonna be extremely difficult to cross. But, you know, you know, taking a step back and sort of looking at things from it from a fresh lens, you know, you get, you get the sense that, you know there's always some sort of solution for that. For that underlying challenge, I should say there's an underlying solution to that challenge that that sort of waiting to be found if you're you know, if you're if you can take fresh look at things. So it's a good story there. So let's move on to heart flow. I want to ask you a few questions about your experience at heart flow before we get to reign over our X here but at heart flow, you built a foundation for, you know, for what? What now is heart flow Japan. You know, heart flow, Another company that was acquired by by Medtronic. You've got sort of a trend trend going on here all cos you're at our eventually acquired by Medtronic. So talk to us a little bit about what you built for. You know what eventually became heart flow? Japan, especially regards to serve the cross function experience that you had, you know, dealing with, you know, regulatory, impair collaboration. Kay Well development, clinical research, et cetera.

Shaun Bagai

So artful is interesting because this is something I've been in the med device space my whole career. And this was Ah, diagnostic, even a software's of service diagnostic for assessing cardiac disease and was brought in to help commercialize primarily in Europe was initial plan soon after, I think it was the first kind of sales person after the VP of sales there was hired. They failed the primary important. The study, which was comparing the Harpo technology to an invasive diagnostic approach and the VP of sales, subsequently left the company, and I was working directly with the CEO for quite a while. So given that the primary endpoint failed commercialization that for it's pretty much went down the tubes as well as you can imagine, actually helped run the next study that put a heartful back on the map. So my role of heart flashy almost reverted to a clinical research position where I ran a clinical study like a sales person would on. How do you increase enrollment? How do you increase quality of enrollment? I was training physicians as well. The fun part for me was it was able to utilize. This is, you know, just moving the company. Strategically. I was able to utilize different people from different divisions in the company, too. And that's why I say cross functionally, toe help run eat sites. We had a marketing person, for example, cover a couple sites in London. We had more of kind of a researcher in person, couple of cover sites in Australia, let's say, with different backgrounds. So it was a good experience on trying to find skill sets within people. That isn't their core skill. Set of that makes sense. So it's in a startup environment. It's good to kind of many people have to do different things, So it's a good way to kind of find skill sets and match those up. So during the that year or two at heart flow, it was a matter of running the study and and at the same time we're looking in the Japan and the reason why Japan was of interest is because they value propositions make a lot more sense for what our flu is doing. A. They utilized CT technology does heart disease, which is what what heartful is based on. Two is the physicians or salary, so there's not an incentive to do more diagnostic testing and put more Stenson. So the first few trips were assessing the market. They're pretty soon thereafter, we used a couple of their sights. Is our clinical research sites? Was able to both dr the Clinical Research Process and see if there's potential business there. So from that point, I was able to, you know, very lucky to pull in. A few good resource is Andi. I think my biggest mentor there became Campbell Rogers, who came in and take over a chief medical officer. And and he had a lot of connections with positions in Japan from his corner three days and was able to open a lot of doors that I was able to go back in and make connections with kind of the top physicians to form advisory boards, work with local consultants to get us in front of the version of the FDA, which is called a P. M d A. And their version of CMS fuel, which is called M H L W. So it was really kind of having those initial meetings to prove out the value propositions in the country start the initial dialogues, get the process going that eventually became the basis for what's now heart flow. Japan. Towards the end of my tenure, they actually hired a general manager based in Japan and now have a whole team that they're building that market. They just did receive P M. D A clearance approval and reimbursement soon to follow. So I think that's a far as a revenue source. That's gonna be the biggest revenue stream for heart. Flew in the very near future is in Japan.

Scott Nelson

Got it, and I think I misspoke. I said, Ah, heart flow was acquired by Medtronic. I'm not sure why I had that in my notes to be on TV. I had decided my notes here, this trend of companies being acquired by Medtronic, and I'm not sure why I thought that that's that's my fault so hard it was not quite acquired by Medtronic, but on that note, let's kind of springboard into into your time now at ran over our X And I think you landed there in 2014 right at Renault Bo. Yeah, okay. Before we jump right into the current time is are there a couple of experiences and, you know, maybe one or two that you can think of at heart flow that you sort of You find yourself kind of going back to that have, you know, sort of either either key learning points or just things that you've been ableto to use now at Renault Bar X.

Shaun Bagai

Yeah, I think one of the things that and this actually was resonated both came true because of already and And one of our ex are sorry with this came through with the already in heart flow. Is that more and more? I think they're certain medical technologies that cross different specialties of medicine, you know, kind of rewind a little bit to talk about that with already in as much as this was, the technology was to be used by intervention radio. It's an eventual cardiologists. The patients were really controlled by the hypertension specialist in the Biologist, So the sales aspect of the market entry aspect was kind of two folders. How do you get the users and the physicians who like to use the technology to use it? But more importantly, how do you overcome the barriers of their opposition of the nephrologist and hypertension specialists? I want to hold on to the patients. Harper was the same thing. It was a matter of. We have CT physicians and radiologists who want to maybe send patients for heart flew exams. But the interventional cardiologists control the patients, and they'd rather put the patient the table. To do an intervention, you know, and or an invasive diagnostic run over is very simple. Would burn over, are very similar with one of our axe. It's a matter of overcoming the barriers of the medical oncologist who deliver chemotherapy systemically, and we're looking at more targeted approach. So I think

Scott Nelson

the

Shaun Bagai

lessons learned from in fact, both of those companies have really helped a lot with one of our axes. Making sure that you don't ignore specialty is when there's ah when there's a disease state or ah, patient base that that is really cross functional across specialty.

Scott Nelson

Yeah, that makes sense, really understanding that patient pathway and who controls the, you know, the patient, her who influences the patient decision the most along that along that journey. I have to think it's just a hunch, but I have to think your experience in the field based sales capacity has really probably helped. Helps you sort of that that probably I would imagine that probably comes naturally to, you know, Is that a safe, safe? Guess

Shaun Bagai

e. I think it does, but I think

Scott Nelson

a

Shaun Bagai

lot of it is is really paying attention, you know, getting out in the field, talking to positions to

Scott Nelson

really make

Shaun Bagai

sure the markets there. And that's something that I think is one of the most gratifying parts of my job is actually being, you know, front and center. And that's something being in a small company and being a CEO of a small company, I get to Dio is to get out in the field, work with positions, be in the operating room and really see exactly like you said. You know, how does the patient pathway work? And I think that definitely helps. To be successful in different areas of medicine

Scott Nelson

makes a ton of sense. So what's let's talk a little bit more about run over. Relax. I know you kind of give us. Ah, you know, high level overview. But you said, you see, marked in what was in late 2015 but FDA cleared. And what was that? It was late 14 14 2014. Okay, so kind of you mentioned that you're currently enrolling, enrolling patients right now in a in a U. S trial. Is that right?

Shaun Bagai

Correct. We have, ah, post market registry study in the U. S. Phone going part of that. We actually just finished the safety study in pain credit cancer patients in the U. S. As well. So we're we're tracking patients right now to see how they dio

Scott Nelson

cousin. Kind

Shaun Bagai

of the general population. That makes

Scott Nelson

sure, Sure. And so when you were at heart flow, how did you end up? Getting to Lenovo Rx was another story of just your connections and your networks that have brought you here

Shaun Bagai

Exactly. It seemed like a that point. The US launch was not imminent, given the both the FDA and reimbursement, I think they in fact, I have a lot of close friends there. I think I had a bet with who's gonna get FDA clearance first? Hard floor. One of our action. I

Scott Nelson

won by

Shaun Bagai

a couple weeks.

Scott Nelson

Okay,

Shaun Bagai

you know, So there's some headwinds in the U. S. Heart flood. Japan was getting off the ground. The founder of renewable Rex, Dr Rampton and got from El Camino Hospital was coincidently a Custer mine when I was a Medtronic many years ago. One of the things I have always tried to do is keep in touch with everybody.

Scott Nelson

Heard that

Shaun Bagai

I can. And so he approached me a while back about the fact that their CEO a step down for family reasons, they're looking for a replacement. And I, to be honest, thought it wasn't ready for a CEO role. Yet I feel like I still have some more things to learn. And then months later, timing worked out where the previous potential CEO Canada dropped out of the race on day were interviewed a few candidates and he said, Look, come meet the board. I think this is right for you, given your experiences and backgrounds

Scott Nelson

on,

Shaun Bagai

and he had me come interview the board of directors. The rest is history.

Scott Nelson

Got it. That's cool. So were you at now in terms of like the livestock life cycle of the product. You've got regulatory approvals in Europe in the U. S. You enrolling patients in a post market registry? So do you envision commercializing this At some point in your future?

Shaun Bagai

I do potentially so

Scott Nelson

maybe

Shaun Bagai

everyone a little bit as faras. How you know, the timing of when I came on board, we had just supplied to the FDA. And this is one of the reasons I think, why Doctor got thought this would be good for me. And well, I think for me was a good fit is that they were just a part of the FDA designed for manufacturing was done. For the most part, we've begun manufacturing the next stage of the company. Ever since I took over, we've gotten FDA clearance. We've gotten our device patents issued. We've done our first inhuman, you know, in a few different disease states, we finished our safety study in the pancreas. The next phase the companies to finish off a post market registry. The data is looking phenomenal. Where at least pancreatic cancer patients are living longer with us side effects that they would see from systemic chemotherapy is far is where this is going. That's that's always the double edged sword for every small device company is. Do you raise funding and higher sales force? Or is this actually a great tuck in from one of the larger companies?

Scott Nelson

Sure,

Shaun Bagai

and that's yet to be determined. You know, I

Scott Nelson

The

Shaun Bagai

great thing about the markets were looking into is that there are very concentrated hospitals do these types of procedures so one could attack the market with a small sales force. But I could definitely see this as a fit with a larger company down the road.

Scott Nelson

Got it makes sense, especially as more and more large Fatih JIC start to get into the interventional oncology space. I think when you look it seems like when you look at that that I owe space. There's a lot of large strategic ce that aren't in it. It seems like that that maybe that are sort of just on the cusp of maybe getting into it. So it seems like it makes sense from a from an image standpoint, But I also couldn't agree with you more in regards to, you know, have you know, rolling out a tie Very targeted sales force to that. That select number of you know to call in that This is a select number of hospitals and I d ends to do these types of procedures. So, So cool. So I know you've raised a little bit of money and kind of last question. I guess before we get to these last three rapid fire questions, Jeff plans t raise additional additional rounds of financing the future.

Shaun Bagai

I think that's one thing I've learned is the CEO is you're always fundraising,

Scott Nelson

right?

Shaun Bagai

You know, I think this has been an interesting exercise for me. I probably least funding company. I've worked with and being small and nimble and having very dedicated founders give a lot of time to the company. We've been extremely capital efficient, but I could foresee, you know, in the next few months were trying to put together a strategic plans for next couple years. I could see around potentially coming up right now. We're talking to strategic to see what other milestones would be necessary for some type of a partnership and try to lay this plans that but I wouldn't be surprised if we're looking into funding and they're not too distant. Future.

Scott Nelson

Yeah, very good. I think it be fun to do around to have this conversation, maybe sometime next year, to kind of get an update on where you guys are and what you've learned since then. So anything else you want to share before we get to these last three rapid fire questions?

Shaun Bagai

I think you know, one of the things that I get asked a lot is especially now. We were involved in much of him there with the Stanford Start X program.

Scott Nelson

Yeah, loosely. Yep.

Shaun Bagai

So it's It's kind of an incubator. It's It's been fun, you know, Given, given how many mentors have kind of shaped my career, it's been fun, kind of giving back little bit mentoring younger, younger entrepreneurs. Younger CEOs, I think one of the, you know, if I could give a couple of piece of advice, you no one is. Always do what you say you're gonna do. I found it very interesting how, as you go through, especially different groups of medical device professions, sales, marketing, this is training that a lot of people promise things they don't deliver on. I think that's one thing I learned very early in my mentor is definitely deliver. What your promises are and and keeping in touch with people has been invaluable. I think it's got given, Given what you've done with your side. You've probably seen that more often than not that people kind of fall off the radar, but keeping in touch with people. And, you know, I've connected with physicians across different companies. It's amazing that a couple doctors in Germany that I've worked with two different companies and just, you know, an email now and then. I'm not a big Facebook fan, to be honest,

Scott Nelson

but similar

Shaun Bagai

call here, and they're definitely goes a long way for serving the future.

Scott Nelson

Yeah, it's It's such good advice. You're right. I mean, I've certainly experienced that. I wouldn't say I'm a master at that. By no means I certainly could could do a lot better, but yeah, just ah, a simple phone call tax message. You know, a short to sentence email. I mean, it does. It does wonders for sure, but very good stuff. So I want to be sensitive to your schedule, Shawn. So let's get these last three rapid fire questions. The rapid fire in nature, you don't necessarily have to answer. Answer the questions and that sort of theme. Let's go with the 1st 1 What's your favorite business book?

Shaun Bagai

You know, this is something that come to me recently, and it's been proved invaluable for this job. If you're sure if you've heard of a book called The Hard Thing about Hard Things.

Scott Nelson

But then world. Yeah,

Shaun Bagai

it's been almost a Bible about how to try to sleep better at night when you're when you're trying to run a company, especially the first time the CEO, I think the advice in there and seeing, running and building company through someone else's eyes. When you don't have a lot of people to talk to about it who have vested interest in different parts, your business has been very hopeful.

Scott Nelson

That's a good one. So is there a CEO that you're following or one that has really inspiring in the past?

Shaun Bagai

You know, honestly, I think I've mentioned to you so far that have really been a big part of my career growth. And it's you know, Dr Josh Mack on Andrew Cleland have been

Scott Nelson

two

Shaun Bagai

very different stages of my career that I've definitely helped me out a lot on what I should be doing. What it should be thinking about

Scott Nelson

Very good. I had a feeling that you were gonna go to Ah, go to those two guys. But the last one, if you had a chance to rewind the clock, what would you tell your 25 year old self?

Shaun Bagai

You know, I think my my crew was taking off, and I think the biggest thing looking back 25 maybe tell myself to be more humble, If that makes sense, you know, I think they're you know, certainly success comes with an arrogance that you might you might ignore miscues that would definitely help your growth. And, you know, if I could turn back the clock, that's probably one piece of advice to give

Scott Nelson

myself good. Wait in in the conversation. I think it's healthy advice for anyone for sure. So Sean thinks that thanks a ton for your willingness to have this conversation. I'll have you hold on the line real quick as we wrap this up, but But again, just thanks again for taking the time out of your day. And for those listening that want to learn more about ran over our X All linked to that in the show notes. Just Google, Ron Ovo r X, and you'll probably find it. But again, you can find those links in the in the shadows to this episode. But Sean thinks that thanks for doing this. Thank you. I'm Scott. I appreciate it. All right, everyone, until the next episode of bedside. Or take care. Thanks again, ladies and gents, for listening. This episode has been brought to you from the W C. G studios here in Minneapolis. And don't forget to grab your pan optic stacking blueprint by visiting reach. Fire digital dot com for slash met cider Again that's reached fire digital dot com forward slash met cider. Okay, bye for now.

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