The opportunity — and obligation — of leadership in medtech
Mike Mussallem has earned his place among the greatest medtech leaders ever.
Mussallem took Baxter’s struggling cardiovascular business public as Edwards Lifesciences, serving as CEO and chair for more than two decades as the company developed and commercialized revolutionary structural heart procedures like transcatheter aortic valve replacement (TAVR).
For our latest Leadership in Medtech issue, we interviewed Mussallem and some of his Edwards contemporaries for their insights on leadership and innovation. Medical Design & Outsourcing readers already know how important it is for device developers to focus on patients and listen to clinicians when searching for opportunities to innovate. But the story of TAVR at Edwards shows what’s possible when medtech leaders feel obligated to develop new options for patients even when their surgeon customers say they’re not needed — or possible.
And Mussallem’s career should cause medtech professionals to reconsider their own opportunities to lead. When he joined Baxter in 1979, his first engineering project wasn’t glamorous but gave him an opportunity to prove himself. It was the same situation when he moved from manufacturing to R&D and when he later took over the underperforming cardiovascular unit that he and his team would grow into Edwards Lifesciences.
“It became a theme for me, because it was a chance for a young guy to get a lot of responsibility,” he said. “And if you put your head down and you put a team around it, you can make some progress — and we made some things happen.”
This issue of Medical Design & Outsourcing also features an interview with Dr. Michelle Tarver, the new director of the FDA’s Center for Devices and Radiological Health. She says she wants to improve collaboration with device developers to support innovation while ensuring devices are effective and safe.
She’ll need the medtech industry’s help, especially as Donald Trump returns to the White House with a slate of nominees to lead the U.S. Department of Health and Human Services, the FDA and other federal agencies. Speaking shortly after the election, FDA Commissioner Dr. Robert Califf said industry support will be the biggest factor in keeping talented employees and their expertise at the FDA.
“It’s pretty clear that the gist of this administration from everything that’s been said is to change a lot of things, and how it gets changed depends on who gets appointed to key positions and how the various policies play out — and also, I think as FDA is concerned, how the broader regulated industries see things and play into this. … In times of change and chaos, there’s also opportunity.”
As always, I hope you enjoy this edition of Medical Design & Outsourcing — and thanks for reading.
– Jim Hammerand, Managing Editor
Medical Design & Outsourcing
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