Med-tech veteran Chuck Swanson will lead St. Cloud State's unique program that helps companies work with the FDA.
Everyone knows Chuck, say Twin Cities medical technology insiders.
Well, not everyone knows Medtronic Inc. veteran Charles Swanson, described as a "global leader in medical device regulatory affairs." But anyone who has attempted to negotiate the medical-device approval process with the Food and Drug Administration (FDA) has felt the frustration that comes with navigating the behemoth regulatory agency. That's where Swanson comes in.
Earlier this month, St. Cloud State University named Swanson to head its small and unique Master of Science in Regulatory Affairs and Services program, which began last fall.
Swanson retired from Fridley-based Medtronic three years ago after heading its regulatory affairs department for nearly three decades. He also helped develop many of the FDA's medical device guidelines and procedures.
The Star Tribune asked Swanson about his new position, which involves shaping the young program.
Q How did you get involved in the program?
A I retired from Medtronic three years ago and have been doing some consulting for them since then. I hooked up with the St. Cloud program last spring -- they'd been looking for a director and they kept passing resumes by me. I told them that from a salary standpoint, you can't compete with industry for the director's job. And you weren't going to find somebody in academia who has the experience and expertise in regulatory affairs. So what you really need is someone who wants to make a career change, like a retiree.
Q Like you?
A [Laughs] I told them I'd do it on a part-time basis because I do enjoy retirement.
Q What do you think of the program?
A It is a program that is desperately needed. There's such a lack of regulatory experience in the Twin Cities area and around the country.
Q Where would people completing the program get a job?
A They would probably go into a regulatory affairs department within a medical device company. They might be in a design role, or quality assurance or marketing role. Someone in marketing who really wants to understand what regulatory activity is all about [could enroll] to help them do a better job. Or, they might be in the health industry.
Q Is there a shortage of folks who know the regulatory process?
A Yes. Unlike a lot of programs, St. Cloud tries to try to make it more hands-on, rather than academic.
Q Why is it so hard for medical device companies to negotiate with the FDA these days?
A Well, FDA regulations keep growing and becoming more challenging. Also, in recent years there's more of an enforcement mentality in making sure you are complying to the letter of the law. There is a more thorough evaluation of products, particularly [sophisticated] products before they even reach the market and better post-market surveillance, watching the product to see how it performs after it's been on the market.
I'm sure you're aware of some of the problems that have occurred with [heart] defibrillators and drugs like Vioxx. It's natural for the FDA to say, "How can we address these problems and prevent them from recurring?"
Q Anything else?
A FDA learns from experience -- they either modify their rules, or add additional pieces. Particularly on pre-market review, they're always finding new questions based on new technologies, or experiences with similar products.
Q FDA gets lot of criticism. Does the FDA does a good job?
A I think they do as good a job as they can, given the resources that they have.
Q So, you're retired, right? Did you get tired of playing golf?
A You can't play golf every day. Having spent as long a career (in medical devices) as I have, you just don't turn your back on it. [The St. Cloud program] really piqued my interest.
Q Is it true that everyone knows Chuck?
A I'm reasonably well known in the medical device regulatory profession, I guess. I've been around for so long.
Janet Moore • 612-673-7752