How to Successfully Launch a New Medical Device: Interview with Mark Toland, CEO of Medical Micro Instruments

We recently caught up 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.

But 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. Mark is also 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.

Listen to the Interview with Mark Toland

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Read the Interview with Mark Toland

The following interview has been lightly edited for readability.

Mark, welcome to Medsider! Please tell us a bit more about your background.

If I had to use one word to describe my background, it would be “curiosity”. I’ve always been interested in trying to discover where healthcare is going. In the early part of my career, everything was beginning to transition from open surgical techniques to minimally invasive techniques, particularly in procedures involving arteries or veins. I started in open-heart surgery doing work with a company called Sherwood Davis & Geck and then transitioned into minimally invasive work at Boston Scientific. One of the things that we focused our attention on at Boston was putting ourselves in a position where we could solve an unmet need in medicine. I learned early on that working hand in hand solving clinical problems with physicians was really the key to success.

You spent over 15 years at Boston Scientific. Tell us more about your career there.

I started off in the peripheral vascular division and then over the course of a series of acquisitions, I was thrown into the broad plumbing side of the house, which is peripheral vascular, neurovascular, and interventional cardiology.

I had a unique opportunity to go inside and work in the corporate headquarters to prepare for the launch of our drug eluting stent called Taxus. 70, 70, and 70 was our launch strategy, which meant 70% market share and 70% penetration within 70 days. And even though we were competing with J&J, we actually accomplished it. But not in 70 days. We accomplished it in 17 days! We went from selling zero dollars, and then 17 days after the launch, we were selling $10 million a day of Taxus. So, that launch took the company from a billion-dollar revenue company to a three-billion-dollar revenue company almost overnight. That was a tremendous learning experience for me on how to commercialize a product in a big field, gain acceptance and adoption, and really transform the space in general.

Almost simultaneously, we decided to buy Guidant, which sold pacemakers and defibrillators. I eventually rose up to lead that effort in the United States and ran all the US commercial businesses, which equated to about four billion dollars at the time, and something like 3800 employees.

One of the challenges that we faced with the acquisition of Guidant is that we were forced to work through several warning letters and product challenges. We really focused on integrating the businesses together while simultaneously investing in the future, particularly in some of the areas that Boston was over-leveraged in. 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 heart. So, we made a series of acquisitions that I was part of that helped return the company back to growth. When you look at the company today, they're less reliant on products like stents and pacemakers than they were previously.

A challenge that a lot of these companies face is their products are commoditized and they’re forced to rely on delivering a certain price point, which is how they win contracts. At Boston, we felt like we delivered more value than just the price of a stent or the price of a pacemaker. So, we built a whole global business around that still exists today. I remember I did an analysis at one point where 63% of Boston Scientific's revenue came from 75 customers. So, consolidation in the marketplace was paramount to success.

I definitely witnessed a change in the business model. It went from physician focus early in my career to a blend of corporate administration plus clinicians.

It seems like we're in this transition period in the vascular space. Because of the procedural movement out of the hospital, we're back to a direct-to-physician model. It'll be interesting to see how that trend evolves.

Yeah, I think the office-based lab (OBL) market is going to continue to explode, particularly as we work our way through COVID. It’s a good example where patients just don't really want to go to hospitals anymore. So, if you can build a really focused business model around OBLs, I think that could work.

Mark, when you think about your 15 to 20 years at Boston Scientific, can you boil down your success to some key factors?

Willingness to take on tough challenges is important and gives you opportunities for experience. I always jumped at experiences like these first versus paths that involved more money. I was lucky at Boston because it’s one of these companies that believes if they’re employees can do one thing, why can’t they go try four more things on top of it? I love that. I was always one of these types of people that wanted to take on more and more responsibility.

When companies are having a tough time, the recruiters start to call, a lot of people think the grass is greener, and they decide to jump ship because they don't feel like they're playing for the winning team. But here’s some advice: sometimes, there's more opportunity in front of the challenged companies than there are in front of the successful companies. Your competition to get promoted is lower because there are not as many people hanging around in companies like that. I stuck it out at Boston through the challenging times and benefited a lot.

I tell everybody, when thinking about their careers, look at life by decades. In your 20s, you should get your education. In your 30s, you should get your experience. In your 40s, you really should go do and lead so in your 50s, you can have more options in front of you. If you stick with that philosophy, it usually works out. When I was in my 30s, I took any job that gave me experiences that I didn't previously have.

You left Boston Scientific in early 2016 to run Corindus, and after a stellar 5-year run, you’re now with MMI. Tell us more about MMI and why you made the move to take over as CEO of that company.

When I was thinking about the robotics space, I wasn't very interested in chasing Intuitive. Everybody else is running after endoluminal robotics. Large companies are trying to build platforms. What I refer to platforms, I'm talking about data integration, machine learning, how it integrates with the robot, etc. The small companies are just trying to find niches.

MMI is doing something completely different. We're an open surgical robotics company. You've got all types of different surgeries: plastic reconstructive, lymphatic, organ transplant, open heart, trauma, etc. Pretty much any type of surgery where physicians are connecting nerves or vessels together. All that work is still done by hand, no matter how small the tissue is. But there are limitations with the human hand. So, the vision of MMI is centered around how to integrate robotic technology with microsurgery.

When you think about suturing nerves or arteries, you're sticking and piercing upwards of 20 times with a suture. So, there’s a significant opportunity to reduce trauma to a vessel or nerve. At MMI, we’re focused on microsurgery and super microsurgery because that makes the most sense. We're restoring critical blood flow and sensation in nerves and arteries that need to be reconnected. That's completely different than all the endoluminal players that are chasing Intuitive.

You can be a physician that doesn't necessarily have microsurgical skills and the robot comes right in over your shoulder and allows you to sew an artery that's 0.5 millimeters in diameter.

We're super excited that our system has approval in Europe already and we're getting ready to start our US clinical trial this year.

I love your high-level breakdown of the robotics market and how MMI is doing it differently. When you think about the company and what's ahead over the next two to three years, what excites you the most?

I love the exploratory aspect. One of the things that excites me is that nobody's ever done this with robotic technology. We’re walking arm-in-arm with the clinicians in this type of discovery mode every single day. I’m excited to see dramatic patient outcomes; benefits for people who need critical restoration of blood flow or nerve capacity who weren’t able to receive therapy prior to this technology. It can really have a dramatic impact on patients.

Tell us a little more about your clinical trial strategy at MMI.

We've got big goals for the next two years. All of the tech and manufacturing is based in Italy. We've got a team of over 50 people in Pisa today and we’ll likely be closer to 100 by the end of the year. We're going to selectively commercialize in Europe because we’ve got CE Mark approval. We need to go do some clinical trials, collect evidence, which will help us align around potential FDA approval. We hope to have our US trial complete by early 2022 with a likely US commercial launch by the end of 2022.

Mark, how has your team in Italy been able to execute so quickly and efficiently?

Here's what worked really well: MMI had three co-founders that shared a common vision and had the experience to compartmentalize the work. So, one of the co-founders spent over a decade at Intuitive and has a tremendous amount of experience. Then, the other co-founders were the young guns who were like, “We’re going to build a prototype and we’ll come back and show you what we’ve got.”

So, they built an alpha model within two years. They built a beta model within three years and we’re onto our third-generation platform within five years. So, I think it was a combination experience, vision and attitude to just get the work done. You can do that a lot easier in smaller companies. Sometimes, for example, companies will default to hiring 100 engineers to build a robot. But, that can actually be counterproductive.

The MMI team has compartmentalized the work into hardware, software, and instruments. So, you're able to move quickly across all three areas of the robotic platform. I think we've got close to 30 granted patents with another 80 filed as of right now. So that's a lot of patents for a company that's only five years old.

For anyone intrigued by this technology, where should they go to learn more?

Microsurgical robotics is still in its infancy, so you likely won’t find much on it. If you go to our website, you'll be able to pick up some insights around the product itself, the Symani Surgical System.  We're continuing to ramp up videos covering all of our work to date. We've completed our first in human trial in Europe and are aiming to get that published soon. So, you're going to continue to see and hear more and more about MMI and the technology.

Mark, you also joined Biostar Capital around the middle part of last year. Give us a high-level overview of the firm.

Biostar is a healthcare venture capital group founded by an interventional cardiologist and  previous CEO of Boston Scientific. I learned a lot about their organization when they took a risk and invested in Corindus in the early phases. When we exited Corindus, we discussed what we might want to do together, and Biostar approached me about being a partner and an entrepreneur in residence.

Historically, Biostar has been focused on cardiovascular and orthopedics, but starting to move in different directions within healthcare, including AI, digital and other areas. My role with Biostar affords me an opportunity to look at some of these early-stage technologies with two things in mind. Number one, do I want to help operationally manage, and number two, how should we think about the capital structure in these companies to get them up and going.

In the past, Biostar has usually participated in very early rounds: seed, Series A, and Series B. That’s been the DNA of Biostar.

For other medtech entrepreneurs, what advice would you give about raising capital in those early stages?

The most important thing you can do is find the unmet need your technology is meant to solve for. Most founders and companies have a tendency to focus on their product versus the solution. So, my advice is to focus on what you're trying to address.

Then, the second piece of the equation is to focus your attention on the business financials. What do the dollars and cents look like? To get funded, you’ve got to figure out how to monetize the organization and how to increase valuation.

A lot of companies will spend 80% of their time on the product and then 20% on the business. I would actually flip it and instead focus on the business model first and your product or solution second. It's the reverse of how companies tend to think about things. So many startups do it in reverse because they're so proud of what they've built that they focus too much on the tech and not enough on the business problem.

When you think about all the various product launches you've been involved with, what are some of the key lessons you’ve learned?

The first thing is a unified, consistent value proposition that’s generated all the way from the ground up to the CEO. And it needs to be articulated vertically and horizontally within the organization so every customer hears the same thing about the value proposition. The simpler you make the value proposition, the more repeatable it can be. All the way from the message that’s delivered by the CEO in the earnings call down to the individual sales rep. If they can mirror one another, that has a massively powerful impact.

Number two, you need amplification. This is so important in the field of robotics, especially. I always tell people that if you're a physician who’s thinking about becoming a robotic specialist, you’re not going to ask the opinion of a robotics CEO like me. You’re going to ask a physician who’s using the product. That amplification in the clinical community is as important as your own internal team's united effort on the value proposition. So, if you get both of those working in a unified manner, the impact you can have in the marketplace is pretty dramatic.

Mark, let’s transition to some rapid-fire questions. What’s the best piece of advice that you'd give to other medtech entrepreneurs?

Don't be afraid to pivot. A great example was at Corindus, where our goal was to try to figure out how we could do something the physician couldn't do. And the number one thing we felt like they couldn't do was to treat a patient outside the hospital. There are a lot of cardiologists, so that's not a big problem in terms of access to care for heart attacks. It was a big problem with strokes, though. So, we pivoted the company to neurovascular. And as a result, we increased the valuation of the company considerably and ended up selling to Siemens Healthineers because we didn’t have a single cardiology play anymore due to the neurovascular pivot.

Are there a few medtech leaders that you find inspiring?

My previous boss at Boston Scientific, CEO Hank Kucheman, and I work together at Biostar Capital. I brought in the previous CEO of Boston Scientific, Jim Tobin, to my board at Corindus. The current CEO at Boston Scientific, Mike Mahoney, and I work closely together. The leaders that I've worked with, and shared some battles in the field, are the ones that I still rely on. These are the types of people that I really feel like are my mentors to this day.

If we stepped into the Medsider time machine and turned back the clock to your late 20's or early 30's, is there anything you'd do differently?

I would focus my attention on a broader series of activities. When you're young and trying to do job A, you singularly focus on that particular job. Instead, I would have probably broadened my experience and done some consulting work, maybe with some early startups. I was in a big company at the time, but I probably could have brought some experiences into startups, particularly on the commercial side.

Imagine you are a sales rep and you focused on your duties 24/7. Just imagine if you spent Saturday and Sunday doing some project management work with an early-stage startup that's getting ready for commercialization. Maybe you can help build their operating plan around the commercial strategy. You'd probably add value to the equation.

What's the best place for folks to follow you or follow MMI?

We’re still a private company so the website is probably the best approach. We’re just now at the tip of the iceberg in terms of generating clinical evidence, publishing our data, and hitting other important milestones. Within the next 24 months, we’ll be evolving from tech dev to a high-growth surgical robotics company. So, there’s definitely a lot more to come.

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If you’re looking for a contract manufacturer that specializes in minimally invasive interventional devices, you need to consider Switchback Medical. Here’s why:

First, their world-class engineering team has deep domain expertise in the endovascular space. Think of pretty much any interventional device and a Switchback engineer was probably involved in its creation. I can’t think of another R&D partner with the sheer amount of knowledge and experience they have in the vascular arena.

Second, Switchback recently launched BioSim Innovations, a full-on biosimulation lab that uses human & animal models, as well as cell, tissue, & organ cultures. It’s the perfect lab for physician training, preclinical model development, and device testing.

Demand is incredibly high for an experienced design & manufacturing partner like Switchback Medical. But for the Medsider community, Switchback is offering to expedite your quote to the top of the stack. Email me right here and I’ll personally provide an intro to their leadership team.

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