Medsider: Learn from Medtech and Healthtech Founders and CEOs - How to Successfully Launch a New Medical Device: Interview with Mark Toland, CEO of Medical Micro Instruments

Episode Date: June 2, 2021

In this episode of Medsider Radio, we're chatting with Mark Toland, a veteran medtech executive who is the CEO of MMI, a startup medical device company in the robotics space. MMI stands for Medical Micro Instruments, and it’s an Italian company that’s developing a surgical robotic system capable of performing microsurgery on capillaries, small vessels, and other parts of the body existing robotic technology can’t reach. We’re going to dig into the robotics arena and chat about things like growing medtech startups, raising venture capital, positioning for an acquisition, and keys to successful commercial launches. First, here’s a bit more on Mark's background: Before MMI, Mark was the CEO of Corindus, transforming the company into a leader in vascular robotics before it was acquired by Siemens for $1.1 billion in 2019. Prior to Corindus, Mark was at Boston Scientific for over 15 years, serving as Senior Vice President, where he built the company’s global solutions business and led all aspects of the U.S. commercial team’s cardiovascular businesses, representing approximately $4 billion in revenue. He also serves on the Board of Directors for Cardiologs, a cardiovascular AI company, and Amplitude Vascular Systems, an intravascular lithotripsy company. He also serves as a partner and EIR at Biostar Capital, a healthcare-focused venture capital firm. Mark got his bachelor’s in business from the University of Louisville. Before we jump into the conversation, I wanted to mention a few things:If you’re into learning from proven medtech and healthtech leaders, and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You’ll get access to gated articles, and lots of other interesting healthcare content. Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced healthcare leaders about the nuts and bolts of running a business and bringing products to market. This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a medtech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, Premium members get exclusive Ask Me Anything interviews and masterclasses with some of the world’s most successful medtech founders and executives. Since making the premium memberships available, I’ve been pleasantly surprised at how many people have signed up. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, here's the link to the full interview with Mark if you'd rather read it instead.

Well, the first thing that I think has to be as clear as possible is, I'll call it the unified, consistent value proposition that gets created all the way from ground up to the CEO and can be articulated vertically in the organization, horizontally in the organization, and every customer says the same thing about the value proposition. So the simpler that you make the value proposition, the more repeat. It can be say, and the more you focus your attention on replication of that, the better it is from a value of problem. Welcome to MedSider Radio, where you can learn from proven MedTech and Healthcare Thought Leaders through uncut and unedited interviews. Now, here's your host, Scott Nelson.

Hey, everyone, it's Scott, and in this episode of Medsider Radio, I'm chatting with Mark Toland, a veteran medtech executive who is the CEO of MMI, a startup medical device company in the robotics space. MMI stands for medical micro instruments, and it's an Italian company that's developing a surgical robotic system capable of performing microsurgery on capillaries, small vessels, and other parts of the body existing robotic technology can't reach. We're going to dig into the robotics arena and chat about things like growing med tech startups, raising venture capital, positioning for an acquisition, and keys to successful commercial launches. But first, here's a bit more on Mark's background. Before MMI,

Mark was the CEO of Curendus, transforming the company into a leader in vascular robotics before it was acquired by Siemens for over a billion dollars back in 2019. Prior to Curendus, Mark was at Boston Scientific for over 15 years, serving as senior vice president where he built the company's global solutions businesses and led all aspects of the U.S. Commercial Team's cardiovascular businesses representing approximately $4 billion in revenue. He also serves on the board of directors for cardiologs, a cardiovascular AI company, as well as amplitude vascular systems and intravascular lithotripsy company. He also serves as partner in EIR at Biostor Capital, a healthcare focused venture capital firm.

Mark got his bachelor's in business from the University of Louisville. Okay, so before we jump into the discussion, I want to mention a few things. First, since you're listening to Medsider, you're probably aware of how expensive it is to run clinical trials. Anyone who spent time in the MedTech space knows that you typically need to commit hundreds of thousands of dollars, oftentimes millions, towards. clinical research. But it doesn't have to be that way. And here's why. ProofPilot is a new kind of hybrid clinical trial platform that enables you to run decentralized studies at costs that are 40 to 80%

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Get up and running quickly with an annual license fee and launch as many trials as you like with an unlimited number of participants. To get started, visit MedSight or Radio.com for, slash proofpilot. Again, that's MedsiderRadio.com forward slash proofpilot. For the Medsider audience, with an annual contract, ProofPilot will provide IRB approval for your first study at no cost. Some exclusions apply, so visit Medsiderradiot.com forward slash proofpilot to learn more. Okay, second, if you're into learning from proven MedTech leaders and want to know when the new content and interviews go live, head over to medsider.com and

sign up for our free newsletter. You'll get access to gated articles and live. of other interesting healthcare content. If you want even more inside info from MedTech experts, think about a MedSider premium membership. We talked to experienced healthcare leaders about the nuts and bolts of running a business and bringing products to market. This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a MedTech startup for an exit. In addition to the entire back catalog of MedSider interviews over the past decade, premium

members get exclusive Ask Me Anything interviews and masterclasses with some of the world's most successful MedTech founders and executives. Since making the premium memberships available, I've been pleasantly surprised at how many people have signed up. So if you're interested, go to Medsider.com to learn more. All right, without further ado, let's get to the interview. All right, Mark, welcome to Medsider. Appreciate you coming on. Hey, Scott. Thanks for having me. All right. Let's start off by learning a little bit more about your personal background as well as MMI. And then we'll kind of, we'll kind of use that as a jumping point, right, to get to more to more kind of lessons learned and insights that you've kind of picked up on over the,

over your career in MedTech. But I provided a brief intro to your background at the outset of this, this conversation for the listeners. But I always like to kind of, you know, pass the baton to you and hear your kind of your high level overview of your career trajectory in MedTech. So let's start there. And then we'll learn a little bit more about MMI. Yeah, that sounds good, Scott. You know, my background is, I call it the curiosity background. I was always interested in trying to find ways into where health care was going. The early part of my career, everything was starting to transition from, I'll call it,

open surgical techniques to minimally invasive techniques, particularly in anything centered around arteries or veins. And so it's funny, I started in open heart surgery doing work with a company by the name of Sherwood, Davis, and Gek is my first job out there. And then transitioned into, you know, minimally invasive work at Boston Scientific, which attracted me the most to that type of company. One of the things that we focused our attention on at Boston was, you know, putting ourselves in a position where, we could go to solve an unmet need in medicine. And we didn't do it with one product. We traditionally did it with the portfolio products and a solution-based where you were always

added value into the equation with the physician. So I learned early on the working hand-in-hand solving clinical problems with physician was really the key to success. It's not so much, you know, do you have a shinier widget? It's working with physicians in cases to go solve problems. that they currently face today. And if you keep that in your focus viewpoint of developing technology over time, it usually works out well for you.

Right. And you ended up spending, you mentioned your first kind of gig, so to speak, at Sherwood, Davis, and Gack. And then you spent the, gosh, almost, what, 15 plus years then, maybe more, maybe close to 20 at Boston Scientific, correct? Kind of moving up the ranks through the, in various commercial roles. Yeah, that's right. So I carried the bag, which I'm super proud of because it gives you some reality to how things work in the street. I started off in the peripheral bascler division. And then over the course of a series of acquisitions, I was thrown into, I'll call it the broad plumbing side of the house, which is peripheral bascler, neuro, and also interventional cardiology. I had a unique opportunity to go inside and work in the corporate headquarters to prepare for the launch of our drug-looting stint called taxes.

That probably was the biggest learning experience of my early career was thinking about how to make it successful as it possibly could be from a standpoint. It's actually still a Harvard business review today. It was called 70, 70 and 70 was our launch strategy, which meant 70% market share, 70% penetration of drug-looting stints. And we want to do it within 70 days of going up against J&J. And we actually accomplished it not in 70 days. We accomplished it in 17 days. And it was the biggest transformation of wealth at the time. from one company to another.

We went from selling $0.00. And then 17 days after the launch, we were selling $10 million a day of taxes. So it took the company from a billion dollar revenue company to a $3 billion revenue company overnight. So that was a tremendous learning experience for me on how to commercialize a product in a big field and gain acceptance and adoption. and really transform the space in general. I then kind of went from there to do commercial management work out in the field.

Almost simultaneously to that, we decided as an organization to buy a big company, but in McGaignton doing pacemakers and defibrillators. So we felt like there were a lot of synergies between those two companies, meaning one on the interventional side of the house, the plumbing side of the house, and two on the electrical side of the house. So we continue to try to do leverage models in the organization to see if we could leverage dollars from one portfolio to another portfolio. And so I eventually rose up to lead that effort in the United States

and ran all the U.S. commercial businesses, which equated to about $4 billion. at the time and something like 3,800 employees. It was an interesting time in the company. Boss of Scientific was what I call this peak and valley type of company where it's either doing really well or it's not doing as well. One of the challenges that we faced with the acquisition of guidance is that we were forced to work through several warning letters

and product challenges. So as a result, it's had a little bit of a step back. and we really focused our efforts on integrating the businesses together, but then simultaneously investing in the future, particularly in some of the areas that Boston was over, I'll call it over leveraged in. So we had too much business in stents, too much business in pacemakers and defibrillators,

and we needed to broaden the portfolio into other products like structural hard. So we made a series of acquisitions. that I was a part on that helped return the company back to growth and kind of what you see the company today. They're less reliant on drug-gluiting stents and pacemakers than they were previously. And I had a good fortune to kind of see a lot of that work being done, helped with a lot of the work, and then drove a lot of the results. In addition, one of the last jobs I had of Bossa Scientific was doing what I considered building

value beyond the product. One of the challenges a lot of these companies face is that products are commoditized and just relying upon whatever best price point that you can get is how they win contracts. And Boston felt like we had more value to bring than just price of a stint or price of a pacemaker. So we built a whole global business around it that still exists today. And one of the key differentiators for Boston Scientific, particularly as it relates to their approach with key IDNs like HCA and other institutions that control so much business for that company. I remember I did an analysis at one point in time where 63% of Boston Scientific's revenue came from 75 customers.

Wow. So the consolidation in the marketplace was paramount to the success of any company and how you dealt with that consolidation was critically important. Yeah. You had 185 hospitals in the U.S. The decision was made in Nashville, Tennessee, as a good example. Wow. Yeah, that's incredible.

It reminds me of a stat, and I don't have it handy, but I wish I did because it referenced how much control Optum has right now, almost, you know, across the entire health care ecosystem with the small exception of hospitals, right? It's an amazing and an amazing amount of decision-making kind of health care decision-making power that comes out of one organization. So, yeah, that's incredible considering the top line revenue that you managed, you know, that ultimately that came down to, you know, about 80 accounts or so. That's incredible. Yeah, it was definitely, I definitely witnessed the change of the business model, right?

It went from, you know, physician focused early in my career to a blend of corporate administration and physician focused. You had that, you know, I called it the, you know, the military approach. You had to have, you know, kind of all four entities, the Air Force, the Army, the Navy, and the Marines to go to go fight the battle and win contracts with some of these huge massive healthcare systems. Yeah. And almost to a certain extent, I guess maybe this is just within certain specialties, but it almost seems like we're in this transition period where because of the procedural movement out of the hospital. that we're almost kind of back into a physician, a direct-to-physician, you know, we're approaching anyway, kind of a direct-to-physician model within certain specialties, right? You know, kind of back to that environment, especially with the influx of, you know, office-based labs.

And then when you look at like the spine and orthopedics market, like so many of those cases are being done outside the hospital now. It'll be interesting to see kind of watch that, to see how that, you know, that trend continues. Yeah, I think the OBL market's going to continue to explode, particularly as we as we work our way through, COVID. You know, that's one of the areas where, you know, patients just don't really want to go to hospitals anymore. So if you can, if you can build a really focused OBL, I think it's going to continue to evolve. Right, right. Yeah, no doubt, no doubt. On that note, and I know we'll probably spend a little bit of time talking about, you know, lessons that you learned at Curendas, but you then left Boston Scientific kind of in early, early 2016 to run Curendus, which, and you had it, it seems like

a pretty amazing run for close to five years at Karendas and are now with MMI. So on that note, I think we'll kind of go back in time and I want to ask you some questions, probably especially in relation to your time at Boston and Karendas. But for folks that aren't familiar with MMI and what you're doing, you know, where you're spending most of your time now, can you kind of give us an idea of what you're doing at MMI and how it's different than what I consider a bit of like the kind of the noisy robotic environment, right? Because we're no, you know, it's no longer just intuitive anymore. There's, there's a lot of, a lot of companies playing in this space. So maybe, maybe tell us a little bit about

MMI and, and why you kind of made the, made the move to kind of take over, take over a CEO of that company. One of the things that I did after I was exiting Caryndus into, or integrating Caryndus into the Siemens Health and Hears company was have the ability to kind of look around and see what technologies were being worked on, some decisions that I had to make around to do a big company, small company. And so when I was thinking about the robotics space, to your point, I wasn't very interested in doing Me Too robotics, which is everybody, I'll call it chasing intuitive. And I described that as indoluminal or endoscopic robotics.

So they're doing something indoluminal in a procedure, a surgical robotic procedure. And there's a lot of companies doing it. The large companies are trying to build platforms. The small companies are just trying to find niches. And what I mean by platforms, you know, I'm talking about data integration, machine learning, how it integrates with the robot. And some of the small companies are just trying to find niches that the other companies aren't focused on today.

MMI is doing something completely different. So, you know, it's a technology that focuses on open surgical robotics. So if everybody else is chasing indoluminal robotics, think about everything that's still open. So let's kind of lay those out. You've got plastic reconstructive surgery. You've got lymphatic surgery. You've got organ transplant. You've got coronary or bypass.

You've got trauma. You've got potentially ophthalmology. You've got anything that you need to connect tubes, meaning that you say you need to connect nerves together. You need to connect an artery and asthmosis together. All that work is still done by hand. 100% of it. It's all done by hand, no matter how small the nerve or the artery would be.

And there's limitations that we know of the human hand, which is the fact that as you age, your tremor increases. Number two is the human hand is only so small, so your visualization is less. And probably number three, it's not quite as precise as a robotic approach would be. So the whole vision of MMI was centered around how can you start to integrate a robotic technology into microsurgery or supermicrosurgery where there's only a few number of physicians that can do it, period. You integrate that with the visualization solution that provides you magnification.

And then you're basically taking your hands down to 20x the movements. What the hypothesis of that is, and we've seen in our preclinical data, is when you think about suturing nerves and suturing arteries, you know, you're basically sticking and piercing that artery 20 times with a suture. The idea is that you can potentially reduce trauma to that vessel, which trauma to that vessel leads to other problems associated with blood restoration. So we're an open surgical robotics company. We happen to be focused early on on microsurgery and supermicrosurgery because that makes the most sense. And we're restoring critical blood flow. and sensation in nerves and arteries that need to be reconnected.

That's completely different than all the indoluminal players that are chasing, intuitive, and the work they're doing. So you can imagine you can be a physician that doesn't necessarily have microsurgical skills today, and the robot comes right in over their shoulders and takes their hands down 20X, and now they can sew that artery that's 0.5 millimeters in diameter that they weren't able to do with the human hand before. So it's really going to test the boundaries of what we can do. We don't even really know yet.

We're super excited that it's gotten approval in Europe already, and we're getting ready to start our U.S. clinical trial here this year, but we don't even know the capabilities that could have. I've got physicians from all walks of life, all specialties we're interested in doing exploratory work. You can imagine pediatric cardiothoracic physicians. they're working on, you know, baby's hearts. You can imagine the neurosurgeons that are trying to understand, hey, does this have applications

up into the brain? Because nobody's ever seen a robot this small before. And nobody's ever seen the precision movements that we've been able to accomplish. Got it. That's super interesting. And I love kind of your high level kind of breakdown of the robotics market, right? Like you've got all these players that are, as you mentioned, kind of chasing after intuitive in the endoluminal space.

but then MMI is taking a completely different approach. Before we kind of get into, you know, dig into your background a little bit more, and I get the chance to ask you kind of some more pointed, you know, advice-related questions. When you think about MMI and like what's ahead over the next, you know, two to three years, what excites you the most? I love the exploratory aspect of this. So one of the things that excites me is that nobody's ever done it. There's no blueprint for it.

You know, there's, it's something that you walk arm in arm with the clinicians in a discovery mode every single day. So when you're looking about testing the technology and there's not, there's not even, you know, a clinical trial published on this work yet, you're talking about, you know, creating a frontier that doesn't exist. That, that to me, you know, gets me excited. to leave my fingerprints all over an area of medicine to evolve and, you know, a dramatic patient outcome benefit for people that need, you know, critically restoration of blood flow and or nerve capacity that weren't able to receive the care prior to this technology. It can really have a dramatic impact on patients. Got it.

Yeah, that's cool. It'll be fun to see kind of that exploratory or discovery kind of process. kind of play out over the next few years. And then just to make sure that I understand things correctly. So you've got, with MMI, you've got an approval in Europe. It sounds like you're ready to, or you're close to kickstarting trials here in the U.S. Is most of the R&D based in Italy then? It is, yeah. So we've got three big goals in the next 24 months. You hit the nail in the head. We're going to selectively commercialize in Europe. We've got C.E mark approval. The second thing we're going to do is we need to go do some clinical trials and collect clinical evidence and particularly aligned around getting FDA approval.

So we're going to do a trial to do that. We should have that complete by early 2022 and likely have a U.S. commercial launch by the end of 2022. So three things. European Selective launch, U.S., I'll call it a U.S. ID trial. and then commercialized in the United States sometime in late 2022. All the tech dev and all the manufacturing is based in Italy. It was an interesting discovery session for me on that when it came to the capabilities that the team has over there. One of the things that is probably an unknown secret, particularly in Pisa,

is there's three universities that focus their attention on biomedical engineering and even the field of robotics. So the talent pool is significantly high for well-educated biomedical robotic engineers that are looking to do some cutting-edge work. We've got a team of over 50 people in PISA today and growing close to 100 by the end of the year. And I've been just thoroughly impressed with the caliber and the type of the people that were able to recruit into the company from Italy that has such a profound background in the space.

It's really allowed the company to accelerate their development efforts. One of the things that I brag about all the time about the team and what they did is they built, they're probably on, I'll call it a third version of the robot. And it's done. It's completed in Europe. And it's only took them five years to do it with about 25 months. million dollars of capital spent. If you were to ask me just randomly how long it would take and how much money would take to go start up a robotics company, I would say it would be seven to ten years and it

take you 75 to 100 million dollars. So they did it half the time with a third of the money. Wow. So I don't want to, I mean, that brings up a question that I didn't necessarily have on the list. But I mean, as you've thought about that more, right, their ability to move to not only innovate, come up with an innovative approach to a product, but move extremely fast and be really efficient with capital. Have there been a couple of key things that you've learned as you studied that? Or like what really drove their ability to execute in that type of fashion? Well, one of the things that I think it worked, so here's what worked well. You had three co-founders that I think had the common vision and had the experience to,

all consider it compartmentalize the work. So one of the co-founders spent, you know, over a decade at intuitive, you know, worked on the XI, the current product on the market today, and just has a tremendous amount of experience. And then a couple other of the co-founders were the young guns who really, well, like go-build robot, right? Go build prototype and come back and see what we got. So they built an alpha model within two years.

They built a beta model within three years. And then they've got the, well, we've got kind of our third-ish generation in five years. So I think it was a combination of the experience, the vision, and just the go get work done to go build the prototype that I think makes a difference. And you can do that a lot easier in these smaller companies versus these bigger companies. Sometimes, you know, I think what companies will do is they'll say, hey, let's go hire 100 engineers to go build a robot. Sometimes that's actually counterproductive. Right. You know, they, they, this team started it off small, smart, and, and with the, with the whole idea of, let's go build a product, see what we got.

And right now, the nice thing is that they've compartmentalized the work into hardware, software, and instruments. So you're able to move quickly. on all three areas of building the robotic platforms. And then along the way, they did a really impressive effort of ring fencing the intellectual property. So I think we've got close to 30 granted patents with another 80 filed right now. So that's a lot of patents for a company that's only five years old. Yeah.

Yeah, no doubt. Wow, it seems like you've got an impressive team to work with. And I love your, I love kind of how you like sort of, summarize that, right? You've got someone that sounds like a founder that had a tremendous amount of domain expertise, but then a couple others that were, you know, that didn't sort of like intellectually think they needed a much bigger team. They just said, well, let's go do this. Let's go build, you know. And so it didn't have any sort of preconceived notions that they just were willing to like get their, get their hands dirty and go get it. So no, that's, that's great to

hear. And for those interested in MMI and learning a little bit more, we'll certainly link to it in the show notes for this specific interview. But I mean, what is the best place? For someone that's intrigued by this technology or wants to learn more, like would you direct them to the website? Is that the best place, Mark? Yeah, definitely the website.

It's just such a pioneering early field of medicine of being microsurgical robotics that you're going to find a lot on it, even if you were to Google it. So if you go to our website, you'll be able to get a good insight into the product itself, the Samani surgical system. we're continuing to ramp up the videos of our work to date.

We've completed our first inhuman in Europe and looking to get that published here soon. So you're going to continue to see and hear more and more about the MMI and the technology. But you won't find a lot out there on a Google search. So we're checking out our website. Hey there, it's Scott. And thanks for listening in so far. The rest of this conversation is only available via our private, podcast for MedSider Premium Members.

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