Getting Personal With Edwards’ Mike Mussallem: Hard Work, Giving Back And Changing The Practice Of Medicine
‘Let’s be givers, let's give back to the communities more than we ever take. Let's have the communities that we live and work in say, boy, I'm glad Edwards is here. They make us stronger.’
In this new series titled Getting Personal, we talk to new and veteran senior executives about their journeys to corporate leadership, their motivations, passions, and the peaks and valleys of running a medtech company. Medtech Insight sat down with Mike Mussallem, CEO of Edwards Lifesciences, the leading seller of transcatheter aortic valve replacement (TAVR) devices, at the company’s Irvine, CA-based headquarters.
Listen to the podcast below:
With 22 years at the helm of Edwards Lifesciences Corp., Mike Mussallem vies for the longest-standing CEO in medtech.
Much has changed in two decades, certainly in the global heart valve space that Edwards Lifesciences leads, but also in the prominence of social inequality issues in political discourse and public consciousness around the globe.
Headquartered in Irvine, California, where the median property value of a home in 2020 was $861,700 and median household income $108,318, according to DataUSA, Mussallem is keenly aware that while Edwards’ growing campus offers tremendous opportunities for many, its benefits may not be equally distributed across populations. He and other medtech leaders will address health inequities and their causes at the upcoming AdvaMed Medtech Conference in Boston. (Also see "CEO Perspectives: COVID Impacts On Supply Chain, Digital, At-Home Care, And Medtech’s Place In ‘Food Chain’" - Medtech Insight, 4 Nov, 2021.)
Mussallem grew up in Gary, Indiana, famously known for being Michael Jackson’s birthplace and home to U.S. Steel’s Gary Works, where he spent summers earning money for college. He was raised in a warm, loving family and looked up to his older brother, George, who was born with Down syndrome. Mussallem’s wife, Linda, coincidentally also grew up with an older brother with Down syndrome. The couple is known for donating time and money to related charitable causes, among others.
Giving back is also a cornerstone of Edwards’ culture. Edwards invested more than $30m and employee hours in an initiative called Every Heartbeat Matters, which aims to improve the lives of an additional 2.5 million underserved structural heart and critical care patients by the end of 2025. The Edwards Lifesciences Foundation has gifted almost $130m to non-profit organizations worldwide.
One of the biggest challenges for Mussallem is to maintain the company’s culture, including a vibrant spirit of innovation, as Edwards grows. See our full interview below which has been lightly edited for content and brevity.
Beyond that, we’re also engaged in organizations that relate to the help that I got when I was growing up, whether it's trying to do something nice for places like Gary, Indiana, or do something nice for the college where I was able to get an engineering degree [bachelor’s degree in chemical engineering and honorary doctorate from the Rose-Hulman Institute of Technology] and generally support those that have a willingness to work hard and move up and need a little bit of a break in life.
[At Edwards] We think about trying to do big things to change the practice of medicine and give better futures for patients and try to have extraordinary quality and extraordinary integrity and a great place to work where all employees are respected. But this other part of giving back to the communities is something that we take very seriously.
Here we have Edwards with a beautiful headquarters in beautiful Irvine, California, but not very far from here are families and schools that have communities where they’re food-insecure and they don't end up graduating from even high school, let alone college, and they don't end up having bright futures. We work very strongly with United Way and the American Heart Association – the list is quite long of all the charities that we support in the local area.
One that I'm most proud of actually is Washington Elementary School, which is an elementary school not far from here where, boy, it's really tough. I want to say 70 to 80% of the kids are food-insecure and they don't have secure homes. Our employee base here has just embraced them, and they do things that are charitable for them.
But probably the thing that's most impressive is just the way that they engage with them and try and open their eyes to a future of science, technology, engineering and math that would stimulate them to get excited. So whether it's little lectures in the classroom or building model rockets together, or have them come to campus and experience what life is like here, just a chance to try and inspire these kids for a better life.
We also have a culture that prioritizes innovation and picking chances to do something big, like change the practice of medicine and then backing it up with evidence. I'm so proud of what we've done, for example, in areas like transcatheter aortic valve replacement. To actually be able to routinely replace valves around the world in under an hour and have patients go home in a day or two has just turned out to be a remarkably positive development for patients with aortic stenosis.
And those have turned out to be very difficult engineering problems to be able to address the leaks of those valves. We feel like the time is right now to be able to apply technology to be able to repair and replace mitral and tricuspid valves. The Pascal is the first US approval of a system that is commercially available to address mitral valves that leak. There is one other competitor that's already done this [Abbott] and we're very pleased to be able to bring Pascal on the scene, and we think it will be welcomed by the customers that are there. (Also see "TCT 2022: Edwards Ready To Take On Abbott In Mitral Repair Market With ‘Premium’ Device" - Medtech Insight, 22 Sep, 2022.)
We also think though these kinds of patients with these diseases are not going to be addressed by one technology. It’s going to take a toolbox. We’re not just bringing Pascal, but we're going to bring replacement technologies as well. And then we also have a bunch lined up for the tricuspid valve. So we have, I think, just in the area of mitral and tricuspid, probably six or seven pivotal trials going on right now.
So you should treat people when their aortic valve closes to one-square centimeter, which is the current indication, and not wait for symptoms. We’ve run this large clinical trial where patients with symptoms or without symptoms are being randomized to either being watchfully waited, which is the current standard, or get TAVR and we'll see what group is doing better at the end of two years.
That's the study that we look forward to seeing results in 2024. We think it'll be groundbreaking because we think it confuses both patients and physicians when you introduce this idea of ‘Oh, you also have to have symptoms,’ because it’s difficult to know. Is that symptom because I'm just getting older or do I have something else wrong with me or is it related to my aortic stenosis? We can take that confusion out of the system. (Also see "TCT 2022: Edwards' Pascal Matches Abbott's MitraClip In CLASP IID" - Medtech Insight, 22 Sep, 2022.)
As you get larger, do you let systems creep into the company that causes people to get more conservative and not really reach for big innovations? And what goes along with these big innovations is also failing. Do you decrease your tolerance for failure? And, you know, if you're going to be a bold innovator, then failure is part of it. Maintaining culture is one of the greatest challenges.
Acquiring PVT [privately held medical technology firm Percutaneous Valve Technologies for $125m in cash] back in 2004 was a little scary. That was a lot of money for us. But as big as those [decisions] were, just the smaller decisions along the way on whether we should discontinue a program are the kinds of things that challenge me on a regular basis.
Because for every time you hear a program that should have been canceled two or three years ago, I also know that there are winning projects that faced adversity and could have been shut down several times, but people decided to persevere, and they found a way through the problems and solved them.
So this idea of should we stop, or should we keep going, I find very challenging, and it's one that we try not to delegate, but to keep it at the most senior levels of the company. If you’re going to innovate, you constantly have these kinds of decisions.
The biggest thing when you discontinue a program is how you end up treating the team that was engaged in that program, because in many cases, they have put their heart and soul into that innovation, and to respect that, and not in any way to have that team feel like they were failures.
It’s really healthy to be surrounded by people that just are different and think differently. I especially value people that are learners. I also like people that are independent thinkers with their own original ideas and not just regurgitating those of others.
If you're looking for a leader, this idea of someone that brings others along, and they're less focused on themselves, but count as their accomplishment those that they have brought along, that is very special.
And our employees knew that and they showed up. Now, obviously, we like everybody else have tried to learn how to operate more remotely and faster and so forth, and we’ve learned a lot of lessons that have carried over to today. But we're still dealing with the pandemic and I feel like we're still learning from that and still adjusting as a company and as a society to what life is going to be like living with COVID.
Because we know it's so different if you're running a manufacturing operation in Singapore than if you're running an R&D project in Irvine or you’re trying to support patients in a far-away hospital. I think we're still learning about what really works best. I don't know that we've really finished this project. It's one that we're still adapting on, but we have a wide variety of practices across the company.
And it was a reminder about all those good habits that sometimes can go away. It also was a reminder to me of how much value that I get from personal interaction with people, because when we did have the chance to travel again, I found that the conversations that I had, the depth of the conversations, the relationships, the trusts, were stronger when we were back in person again, and so I personally have found that to be very rewarding to be re-engaging.
Now, I won't say that I haven't learned a lot from books. I remember early on, when we were forming Edwards Lifesciences, I was inspired by Clayton Christensen's book “The Innovator’s Dilemma.” He was arguing why market leaders couldn't be the innovators and I was convinced to prove him wrong, even though I have tremendous respect for Clay
And what are the reasons for that? Or is there something wrong with the system that serves those people? Are they being served by doctors that look like them and talk like them and they’re comfortable having relationships with? Is there sufficient clinical data that's being generated by those groups?
There's a lot of really thought-provoking questions. We probably need to improve in terms of the way that we operate. So we'll talk about that. I'm going to be involved in a CEO unplugged session. Our Lifetime Achievement Award winner this year is going to be Lester Knight [CEO of Allegiance Corp. and Lester is a long-time friend. We'll have some fun celebrating Lester. It’s also the 10th anniversary of MedTech Innovator.