If the good people of Orange County felt a gale force wind a few weeks back, it may have been a sigh of relief coming from the Irvine, Calif. headquarters of Edwards Lifesciences Corp. (NYSE:EW) after the FDA finally gave a much-anticipated green light to the company’s Sapien transcatheter aortic valve.
Edwards had been hanging fire since July, when an FDA advisory panel recommended that the federal watchdog agency approve the device.
We figure CEO Michael Mussallem didn’t spend too much time patting himself on the back. The Edwards boss doesn’t blow his own horn much, but then again, he doesn’t have to. When you are first to the U.S. market with a catheter-based aortic valve that could change the face of heart surgery, actions tend to speak louder than words.
Come hear the Edwards story with Mike Mussallem on December 12
We caught up to Mussallem, who will be our guest of honor at the MassDevice Big 100 Regional Roundtable West Dec. 12, to ask him about what he loves about working in health care and how he got into med-tech in the first place. We also asked what his biggest mistake as a manager. Here’s what he had to say:
MassDevice: How did you get your start in the medical device industry?
Mussallem:In 1979, I was a young engineer working in manufacturing at Union Carbine, making antifreeze and going to business school in the evenings because I was a little restless and not feeling like I was growing and developing.
The industry I was in was a little too slow-moving and deliberate for my preference. I heard about the exciting, growing medical technology industry, sought out a new career direction and decided to join Baxter as a senior engineer doing process development for intravenous fluids. I have enjoyed many challenging assignments with Baxter, and Edwards, ever since.
Join us in Irvine to hear the rest of the story in person.
MassDevice: What do you enjoy most about working in the medical device space? Why was this industry a good fit for you?
Mussallem:First and foremost, our work has a very important and meaningful impact on the lives of the patients we serve, which makes jobs in this field a source of great pride.
Additionally, the medical technology industry is very dynamic, characterized by innovations both large and small. This creates an exciting climate of constant change and evolution that I really enjoy.
Finally, I appreciate the global nature of this work. As the diseases we address are often similar around the world, our industry has a strong international presence. This has given me the opportunity to travel and build relationships around the world, which I find tremendously enlightening and personally enriching
MassDevice:: What’s the biggest mistake you’ve made in your career?
Mussallem:I feel as though I have made a lot of mistakes in my career over the years, which isn’t all bad and means that I had the good fortune to take a chance on new ideas.
While it’s difficult to say which one was the biggest mistake, I think that acquiring a leadership position in perfusion services for Baxter in the mid ’90s ranks close to the top.
I believed that combining our existing product business with a service business would lead to positive synergies. I did not realize that the combination would put us into a difficult position with existing customers, nor did I fully understand that the competencies required to run a successful service business were very different from those required for a product business.
After several years of effort, we sold the service business and learned that we are best off focusing on our strengths.
Register now for the MassDevice Big 100 Roundtable West, slated for Dec. 12 in Edwards’ hometown, Irvine, Calif.