The longtime Edwards Lifesciences leader built a struggling spinoff into a structural heart powerhouse with patients as the primary purpose.
Mike Mussallem with an Edwards Lifesciences patient on one of the heart valve company’s patient days [Photo courtesy of Edwards Lifesciences]
But success wasn’t a sure thing for Edwards Lifesciences when it spun out out of Baxter in 2000.
“The securities analysts didn’t love us, let’s put it that way,” he said. “We needed a lot of improvement. … It wasn’t apparent that we were destined for greatness. It was a slow road. You have to be tough enough and courageous enough to come in every day … and say, ‘We’re going to make this happen.'”
In an interview with Medical Design & Outsourcing, Mussallem shared some of the lessons he’s learned about innovation and leadership as he starts his next chapter: advancing medtech through the Linda and Mike Mussallem Foundation and the Stanford Mussallem Center for Biodesign.
“People think of it as kind of a light switch, but the innovation process is a long, arduous one that takes a lot of commitment and carries with it a ton of failure,” he said. “You’re going to be disappointed on a regular basis, but [it’s about] trying to fail fast, pick yourself up, learn from what just happened, make an adjustment, and create a culture that encourages that.”
Spinning off to innovate
Mussallem’s first job after earning his chemical engineering degree was at a plant that made and filled antifreeze bottles, where he was a production supervisor for about 30 people on the line.
“Most of them were women my mother’s age,” he said. “Being the supervisor taught me a good lesson. I thought bosses told people what to do, and I found out right away that’s not the way it works. You ask people if they would like to join you on the journey.”
Seeking a more fulfilling career in medtech, he joined Baxter in 1979. After working with different units that made high-volume products like IV bags, he took charge of the cardiovascular business in 1994.
“It became personal,” he said. “A patient would lay down multiple times each day and have a successful outcome — or not. That kind of feedback, that kind of palpable feeling was something that really resonated for me personally, and I fell in love with the business.”
Read more: What Mike Mussallem learned from his first (and maybe worst) jobs after engineering school
Founded in 1958 by the developers of the Starr-Edwards mitral valve, Edwards was purchased by Baxter in 1985. But in the 1990s it was Baxter’s poorest-performing business, while cardiovascular competitors like Medtronic, Guidant, Boston Scientific and St. Jude were excelling. Something needed to change.
“When you analyze it — and it didn’t take a lot of analyzing — what [we were] missing was innovation,” he said.
Well before the spinoff, Mussallem started studying what separated the best innovators from the worst. What he learned from Stanford Biodesign’s focused approach to innovation and others would influence the course he and his team set for Edwards.
Stanford Biodesign’s “needs-driven process wasn’t about the ‘a-ha’ moment where somebody had a great idea,” he said. “It was more doing a deep dive into really understanding what the needs were, looking at multiple approaches, and then from that trying to identify the best approach for the deep need.”
Mussallem struggled to put his new innovation know-how to work within Baxter, which ran its businesses for efficiency and cash flow over R&D.
“We developed a strategy plan that said we either need to invest a lot in this business or exit,” Mussallem said.
Baxter had a history of successful spinoffs, so it was an easy call. Mussellem asked to lead the way.
Irvine, California-based Edwards is now the world’s 23rd-largest medical device manufacturer, with more than $6 billion sales in 2023, compared to $804 million in 2000.
For the first few years as an independent company, Edwards divested products and got smaller as it searched for the best path forward. They considered peripheral vascular diseases, atrial fibrillation, transmyocardial revascularization and even becoming a biotech focused on angiogenesis to grow new coronary arteries. Over time, they realized they should stay close to home with structural heart.
“For Edwards to be good at what it did, it needed to be an innovator,” Mussallem said. “We purposely chose a focused strategy [on] only structural heart disease. The thought was to understand it really deeply, to innovate in that space, and to innovate to make our current technologies better, but also — what else could be? Truly innovating from scratch was an element of our strategy.”
Mussallem’s successor, Edwards CEO Bernard Zovighian, described Mussallem as an empathetic, humble leader, and said one of his greatest strengths is his ability to foster innovation.
“Mike’s vision was to pioneer big innovations and breakthrough technologies, underpinned by high-quality science,” Zovighian told MDO. “Today, we continue to build on Mike’s vision by defining new categories, leading these categories and ultimately delivering sustainable and long-term growth for our company.”
Read more: What Edwards Lifesciences CEO Bernard Zovighian learned from Mike Mussallem
Building a culture for innovation
This illustration shows how the Edwards Sapien 3 transcatheter heart valve is implanted inside a patient’s heart. [Illustration courtesy Edwards Lifescienes]
“Being able to replace a heart valve in under an hour all over the world and have great success with patients going home in a day or so, that’s stunning. It’s still mind-boggling to me,” Mussallem said.
Like the founders of Edwards — Dr. Albert Starr and engineer Miles “Lowell” Edwards — PVT’s founders were also doctors and technical experts. That sort of collaboration “is where the magic happens” in medtech, Mussallem said.
“When the technologists — whether they’re engineers or scientists or whatever — are exposed to the problem as opposed to exposed to the solution, that’s where the ideas come from,” he said. “… That exposure to the problem is often missing because it’s tough for technology people to get experience directly with patients and really see what’s going on with them and do a deep study of their condition. It’s when you really understand it from the patient’s perspective and that clinical perspective, that deep introspection, that’s where the ideas come from and that’s when you start dreaming about what could be.”
“You have to decide purposely that you’re going to make that happen,” he later continued, “and it doesn’t happen without real leadership from above to make the time to do that, to devote a chunk of time and resources to running down some alleys that might be dark.”
Free webinar: Nitinol knowledge with former Edwards Lifesciences Engineering SVP Ming Wu
PVT co-founder and CEO Stan Rowe — who later became chief scientific officer at Edwards — said Mussallem was committed to making TAVR available for patients, despite overwhelmingly negative feedback from surgeons who felt it wasn’t technically feasible or even necessary.
“There were many times Edwards could have bailed out,” Rowe told MDO. “… You’ve got to give Mike and the team huge credit for saying, ‘I’m going to look beyond my key customer and work to adopt something that is disruptive to my key customer.'”
Instead, Mussallem and Edwards focused on the patients who could benefit from TAVR because they were not candidates for open surgery or who had a high risk of complications, knowing that TAVR could take off — and take business from those surgeon customers.
“What it takes to succeed, sometimes, is to endorse a disruptive technology,” Rowe said. “If it works, it can be hugely profitable for you, and if it doesn’t, at least you’ve been in control of it. That, I think, was a lot of Mike’s perspective on this. He didn’t want a Boston Scientific or Medtronic to develop this and then disrupt the surgical side.”
Innovation also requires a culture that encourages curiosity and learning, where employees don’t fear punishment for honest mistakes.
“Culture is one of the most important elements of a successful company,” Mussallem said. “Of course, you have to have a great strategy, you have to have a great team and a business plan and all that, but if your culture is not aligned, it doesn’t work very well. Finding the element to glue everybody together and for people to broadly rally around was something that I became obsessed about.”
He made it clear with a sign on his desk: “It’s the patient, stupid,” modeled after the message that helped Bill Clinton win his first run for president.
“There are a lot of competing factors when you’re working inside a company: schedules to hit, budgets to hit, regulators to keep happy, key opinion leaders to keep happy,” he said. “We have a lot of people to keep happy, but let’s never lose focus of the patient, because that’s ultimately our customer’s customer, and if we get that right, we’re probably going to be OK.”
Edwards Lifesciences CEO Bernard Zovighian (left) and retired CEO and Chair Mike Mussallem [Photo courtesy of Edwards LIfesciences]
“He believed that by putting patients at the center of everything we do, we could achieve remarkable outcomes,” he said. “This philosophy became the cornerstone of our company, guiding our decisions and actions. Mike’s unwavering commitment to this principle inspires all of us to strive for excellence in our work, knowing that our efforts ultimately benefit patients around the world.”
First, the company started sporadically inviting patients to meet the employees who hand-sewed their heart valves or inspected the implants for defects.
“We would watch these unbelievable reunions between patients and the people that made the valve,” Mussallem said. “The patients would put their arms around our people and say, ‘Thank you for saving my life.’ … It inspired the patients, and it inspired our people. So you say, ‘OK, how do we bottle that?'”
Edwards then created short videos featuring patients for company meetings and started bringing patients in more frequently to meet with employees, which led to regularly scheduled days with dozens of patients.
“It was inside our people all the time,” Mussallem said of the patient-first culture. “It was just unlocking it.”
Mussallem encouraged medtech professionals to search for meaning in their own work to bring out their best selves.
“You might surprise yourself in terms of what you can accomplish. … It’s unique to each of us in terms of what matters,” he said. “We might stumble around for a while, and it’s OK to not have the perfect job or the perfect boss, but you owe it to yourself to find fulfillment.”
Mussallem’s next chapter
Linda and Mike Mussallem have been married since 1976. [Photo courtesy of the Linda and Mike Mussallem Foundation]
“Mike demonstrates all the courage, grit and determination needed to transform medicine and surgery, and through that vision has saved and extended thousands of lives,” Makower told MDO. “Mike persevered through many challenges as he transformed Edwards Lifesciences into the innovation powerhouse it is today. He invested in science, technology and clinical studies to bring percutaneous valve replacement into reality against many odds, all [while] Edwards was a relatively small public company. Almost an impossible task, but the outcome has been transformative for the treatment of valve disease worldwide.”
Makower declined to disclose the size of Mussallem’s financial commitment to the program, but called it “a meaningful start to our endowment campaign to secure the future of Biodesign for generations to come” as the program expands its offerings.
Mussallem and his wife, Linda, have launched a charitable foundation to support healthcare innovation, whole-person health and two underserved populations: pediatric heart defect patients and people born with Down syndrome. (Mike and Linda both had older brothers with Down syndrome.)
“The idea here is to really transform care, and I believe it’s very much possible. I think innovation will be a key part of that,” Mussallem said. “… We never would have imagined we’d have the privilege of having a foundation. For my wife, Linda, and I to be in a position to be able to give back is something that we take very seriously.”
Read more: Mike Mussallem plans to support medtech innovation in these four areas
