Project Management Institute

Delivering Innovation in Healthcare Tech

Transcript

STEVE HENDERSHOT

It’s become cliche for companies to talk about how their innovations make the world a better place. But in healthcare … well, that’s one industry where it can often ring true.

ANDY MOLNAR 

I’ve worked in healthcare all my career. What I love about it is that it goes way beyond the day-to-day task because just as a company has a mission that it’s focused on, which basically in the last two companies I’ve worked in, has been to save lives and to reduce morbidity for patients and staff. That’s something that anyone can get passionate about and really feel on a day-to-day basis that they’re making a very significant difference. 

NARRATOR

The world is changing fast. And every day, project professionals are turning ideas into reality—delivering value to their organizations and society as a whole. On Projectified®, we’ll help you stay on top of the trends and see what’s ahead for The Project Economy—and your career. 

STEVE HENDERSHOT

This is Projectified®. I’m Steve Hendershot.

There’s good reason why innovation in the healthcare sector takes time. The research, the clinical trials, the regulatory challenges, they all take time, and generally speaking, it’s time well spent—because it means that new healthcare technologies are proven to be both safe and effective before they hit the market.

And as the pandemic disrupts our global health system, we see a world that demands innovation.

Today we’ll meet a couple of leaders whose work delivers that kind of cutting-edge thinking, including one whose disinfection robot was practically built for this moment. The other spearheaded a breakthrough that upgraded the world’s smallest pacemaker—and his team isn’t stopping there. 

Our sponsor for this episode is PMTraining.com. From live virtual classes to online courses available on demand, PMTraining equips students to earn PMI certifications including the Project Management Professional, or PMP®. And Projectified® listeners are eligible for discounts of up to $400 per class; just enter the link PMTraining.com/podcast.

Let’s begin with Leo Rapallini and his team at Medtronic, a company that this year released the Micra AV, a very, very small pacemaker—about the size of a vitamin—allowing the company to reach more patients while also promising fewer complications. Leo is vice president of R&D for the cardiac rhythm management business at Medtronic, a member of the PMI Global Executive Council. 

MUSICAL TRANSITION
STEVE HENDERSHOT 

A decade ago, when you started working on the first version of your tiny pacemaker, Micra VR, did you have the newer product in mind already? How did you decide how to stage development and what version to bring to market?

LEO RAPALLINI

So if you look at the pacemaker population, you have different type of needs. At the beginning, because of the significant amount of technology innovation we had to do, we decided to focus on a sense on the simplest version of a pacemaker that is called a single-chamber pacemaker. So a pacemaker that basically will send stimulus only to one chamber of your heart. And that’s basically where we started with the Micra VR project.

At a high level, Micra VR project can serve approximately 15 percent of patients that need a pacemaker. So it was an intentional choice because we wanted to get that first version in the market, have experience with that version and then potentially build upon that technology to then be able to serve more and more patients.

From a technological point of view, there were so many new things. We had to do a new battery, we had to do new electronics, we had to do a new way to deliver this pacemaker. We had to train physicians on how to this new procedure because the procedure was completely novel. And so there was enough novelty that we felt that starting from the simplest version was the right thing to do. And then obviously the long-term vision is to ultimately be able to serve every single pacemaker patient with a system that is miniaturized and doesn’t require a lead, and so it’s called leadless type of pacemaker.

STEVE HENDERSHOT

How did AV development change as a result of what you heard from doctors and from patients once the VR was in the wild?

LEO RAPALLINI

A couple of years after we launched VR, we knew that we were standing on really solid ground in terms of the technology working well, the technology being able to apply by a variety of physicians and operators in the U.S. and around the world. And so we knew that from a baseline technology had something really good to build upon. And that’s when we started working on obviously, how can we expand now the applicability of this type of pacemaker to a much broader group of patients, and that’s how we started the Micra AV project.

The other thing we learned a lot was the impact to patient. Before we launched a product, when we talked to physicians about the value of having a device that removes the need for subcutaneous pocket in the shoulder area, so something under the skin, they always thought about it as a cosmetic value. But what we learned from interactions with patients once the technology was available that the value that they saw was going well beyond just the cosmetic aspect.

There were several examples of maybe younger patients that had fainting events and they were recommended to put a pacemaker, but they didn’t want to put a pacemaker because they didn’t want to feel old. But once they were offered a Micra type of situation where now they don’t have this type of physical reminder and visual reminder that every day they have some problem with their heart, they actually accepted having a pacemaker implanted. And so we really realized that it was not only a cosmetic value, but there was some acceptance and psychological value for patients that we completely underestimated, both on the Medtronic side but also on the physician side initially. Honestly, it was a great thing to see, and that was one more reason why we wanted to invest in Micra AV to expand the value of this to more and more patients.

STEVE HENDERSHOT

While developing the Micra AV, your team had to figure out how to deliver pulses to different areas of the heart. What were the big challenges or barriers you had to overcome? 

LEO RAPALLINI

The problem is that we wanted to get away from wires because wires in the heart are one of the main sources of complication. We really didn’t know exactly how to do it using traditional technology until a group of scientists in the research team tried to use an accelerometer that is already in the Micra VR device to instead of sensing the electrical signal coming from the upper chamber of the heart could basically sense the vibration coming from the upper chamber of the heart. So it’s a little bit like if you have like two musicians in two different rooms that have to play in sync, but now they cannot hear each other. So what we try to use is an accelerometer that feels the vibration coming from the other room, and now based on those vibrations, you can try to play in sync the music.

That was kind of the idea that we had to use the accelerometer to sense the vibration and then tying the operation of a pacemaker based on that. And that’s something that has never been done before, so we didn’t have any established path to do it. We had to completely invent these new algorithms and understand how to use these signals, and that was the big technological hurdle that we had to go through to be able to deliver Micra AV.

STEVE HENDERSHOT 

This was a multiphase, multiyear project. How was the team structured, and how did you manage the work from week to week?

LEO RAPALLINI 

If I look back at the Micra VR, in the moments where we had the most work from a development point of view, we had more than 120 engineers working on it. But as the project leader, I had a team that was called a core team where I had the representatives of all the key functions because, obviously, it’s a pretty complex, multifunctional project. So I had people from marketing, people from the engineering side, people from the clinical team, people from the regulatory team, from the quality team.

We managed through milestones that we had, through system integration points where we had so many new things, like we had a new battery, a new device, a new procedure where we had certain period of time we had system integration moments where we would verify that everything would work as a system. Because sometimes if the battery works by itself but it doesn’t work in the system, you still have a problem.

STEVE HENDERSHOT

What about the organizational culture? This was a long-term, R&D-heavy project that required a lot of innovation and patience. What kind of support did you need to see this through?

LEO RAPALLINI

I think one of the unique things about Micra VR and Micra AV is that this is a disruptive innovation coming from Medtronic that is also the market leader in pacemakers.

Usually the disruption comes from startup companies or smaller companies that take bigger risks. And the main reason is that the bigger company, the company that has the leadership, it’s really difficult for that company to take big risk, and it’s really difficult for that company to cannibalize your own market because every time we sell a Micra, most of the time we don’t sell a traditional pacemaker.

So you need a unique culture inside your group to really try to drive that disruptive innovation inside a big company. I was lucky enough to have a tremendous team that had the right passion for what we were trying to do, understanding of the value that we were bringing from a clinical perspective. But also the right ability to take appropriate risk but still keeping patient safety as top of mind. And ultimately, having a leadership team that believed in us. Those are elements that are not always easy to find in projects, and I think that was kind of the secret sauce or the secret recipe that made it possible.

STEVE HENDERSHOT 

That’s not just on the project team, right? It requires some C-suite backing to funnel funding toward an effort that, if it works, will undercut your own market-leading product.

LEO RAPALLINI 

Absolutely. So that’s probably the other side of the story. We had a group of executives that believed in it, although it was a big risk for them, and it was a big bet. Most of my time in the beginning of the development phase was actually spending a lot of time with executives explaining why we were spending so much money on this high-risk project. Because if you look at it, I was promising something high reward but five years from now, and they were judged on quarterly milestones and the end-of-the-year milestone. And so some executives were absolutely on board, and some executives were like, “Why are we spending all this money?”

There was actually a startup company that was trying to do something similar—that company ended up having some safety problem and so they never launched the product in the U.S. But we felt we had one- to two-year advantage over them. And so we were pretty comfortable in our place, and we were working through our development. And then one day, I get my marketing person showing up in my office with a press release from this startup company that they just implanted their first product in a human. And we realized that instead of being ahead of them one to two years, we were actually behind them by one year.

But what was interesting internally is that the conversation at the executive level changed completely from me trying to justify why we were spending all this money to the executives asking me, “Leo, how much money do you need to go faster?”

You know, what’s funny is that the fact that there was some other entity that would validate that what we were doing was actually the future completely triggered some of those executives that maybe were a little bit more reluctant to actually seeing, “Oh, this is happening. We’ve got to go fast.” And so, money didn’t become a problem in the second part of the project because we had this competitive dynamic playing out.

STEVE HENDERSHOT

So now that you’ve launched Micra AV, what’s next?

LEO RAPALLINI

Now with a combination of Micra VR and Micra AV, we can serve more than half of the patients that need a pacemaker, so it’s approximately 55 to 60 percent. So our next step is obviously trying to now serve the remaining 40 to 45 percent.

MUSICAL TRANSITION
STEVE HENDERSHOT

Healthcare tech encompasses a range of products, from surgical tools and diagnostics to implantable tech like pacemakers. It also includes technology designed to keep hospitals and other healthcare spaces clean and sanitary—something that’s especially relevant this year as the risk of infection is top of mind for everyone.

Indeed, the Danish company UVD Robots, which makes autonomous disinfection robots, intended its products to work in healthcare. But this year, as all kinds of organizations are grappling with how to keep their environments safe, UVD Robots saw interest increase across the board.

Projectified®’s Hannah Schmidt spoked with Andy Molnar, vice president of business development for the Americas, about the spike in demand for its products and about what’s next for robotics in health care.

MUSICAL TRANSITION
HANNAH SCHMIDT

The pandemic’s really disrupted nearly every industry. What kinds of changes are you seeing in your space?

ANDY MOLNAR

Well, I think we are seeing an awful lot of innovation going on right now in relation to the COVID-19 pandemic. There’s nothing like a pandemic to concentrate everyone’s mind and suddenly bring resources to bear, which otherwise are not necessarily available to strengthen innovation and speed of innovation. I think one of them is protocols, really, and the awareness of protocols that are needed. Healthcare is used to having infection prevention protocols, but hotels and airports and schools and dental practices and multiple other industries are not used to this process.

It’s interesting. In these times, infection prevention has become everyone’s business all of a sudden—not just healthcare and not just even the businesses that have the responsibility of staff. We’re all more conscious of social distancing and face masks and those kind of measures, which means that we’re all looking out for infection prevention as individual citizens in the state, in the country.

HANNAH SCHMIDT

Let’s now turn to UVD Robots. At the beginning, this project’s main goal was to create an autonomous disinfection robot to prevent hospital-acquired infections, and it launched and then the coronavirus pandemic happened. How has this affected demand and projects related and everything going on with this?

ANDY MOLNAR

It’s funny how COVID has affected things in some ways, because whilst our mission was for hospitals, hospitals really just became so overwhelmed with COVID cases. Unless you are servicing equipment in hospitals or needed to be in the hospital for reasons of health, they really didn’t want to see us in relation to robots, because they were just trying to keep up with what they were doing. And so instead literally every other sector that you could imagine took off.

So we had to pivot from more of a healthcare focus in the hospital, let’s say, environment to healthcare protection in other environments. It was unbelievable globally the interest, the demand, the number of daily inquiries through literally every channel you could imagine from social media, email, phone calls, about people considering options and how to proceed. And I think that was probably true for everyone in the sector that had PPE equipment or other forms of equipment. We saw a huge spike in March time, 2020 of demand.

HANNAH SCHMIDT

With this spike in demand, how did you meet this? Was your manufacturing and supply chain affected with the coronavirus pandemic as well?

ANDY MOLNAR

Certainly, it was a big challenge to scale up because obviously the demand had increased significantly, and you need to be able to produce sufficient quantities of a complex autonomous robot which are produced in Europe and then to be shipped to multiple countries. Consideration was given to multiple production points, but rather than the company expanding its own production points, instead the company expanded its supply chain to have multiple sources for different parts of the robot so that there was more supply there.

And it enabled the company to actually do more assembly on-site and not necessarily have to produce everything themselves because that would have really slowed down things. We actually were able to increase approximately tenfold our production capacity during this period of time, which we continue to do, and with a lot of flexibility around the ability to scale up further according to needs. So yes, the supply chain, as we know in PPE and other sources, was strained, but I think we were in a slightly different area of demand to I suppose other areas. And so we were able to find multiple sources for different components that we are able to continue and expand production a lot during that time.

HANNAH SCHMIDT

And what would you say was the biggest challenge for the teams and the people working on this project to meet demand?

ANDY MOLNAR

Well, it actually can be a little bit overwhelming at times because of the demand. I think one of the challenges is prioritization and focus, because it seems like everyone everywhere would like the same thing at the same time, and it’s impossible to do everything at the same time. So you have to as a team collect your thoughts and make decisions on: How do we prioritize actually what we are working on internally so that the expertise that everyone has in each different department and sector can be channeled to its best effects to produce, to supply, to operationalize and market and reach everyone that we’re trying to reach?

Can the company do it perfectly? No, but it can do a good job with solid teamwork and good internal communication and actually a very fast-moving, lean approach to decision making so that doesn’t slow us down. So I think as an organization, we handled that I think well under the circumstances, not easy circumstances. Inevitably everyone worked a lot longer and harder but also tried to find ways to do things smart, to be productive during the time.

HANNAH SCHMIDT

Let’s talk about robotics in healthcare. What role does robotics play now, and how do you see that evolving in the next 10 years?

ANDY MOLNAR

It plays an ever-increasing part in healthcare, for good reasons, I believe. Because whilst I don’t believe it’s a case of robots taking over from humans, I think it’s very much a case of robots helping humans to do more value-added work than more mundane work. I could foresee quite an uptake in robotic technology in hospitals, and it will become a more common thing to see robots driving up and down the corridor, as you do already see some cleaning robots in action in hospital setting. We have a lot of clever mechanisms there that we have put into the robotic technology that I think is ever increasingly going to be in hospital environment.

MUSICAL TRANSITION
STEVE HENDERSHOT

The coolest thing about innovations like these is to consider the long and uncertain road that project teams had to follow to get to this moment. There was no pandemic when UVD Robots started working on its project to create a disinfection bot; teams designed and created it, then found their robot in high demand. And success was anything but certain when the Medtronic team started working on really little pacemakers more than a decade ago. But that effort ultimately paid off, as well.

Thanks again to our sponsor, PMTraining.com. From live virtual classes to online courses available on demand, PMTraining equips students to earn PMI certifications including the Project Management Professional, or PMP®. And Projectified® listeners are eligible for discounts of up to $400 per class; just enter the link PMTraining.com/podcast.

NARRATOR

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