About a month ago, I listened to a podcast that I really enjoyed. It was an interview with Steve Gompertz, a partner with QRx Partners and a long-time expert in Quality for the medical device industry. And what I loved about the discussion was how much of Gompertz's experience resonated with my own.
The medical device industry is—for obvious reasons—one of the most heavily-regulated industries in the country or the world. My own work has been in less-heavily regulated areas like telecommunications and automotive diagnostics. So I expected to hear about an environment much stricter than any of the ones I'm used to.
But no! What Gompertz learned about working under FDA regulation was exactly what I learned about working under a regimen of central directives in global companies: the structure of rules looks burdensome from the outside, but inside there is actually a fair bit of room to breathe.
After all, it's not in the interest of the FDA for medical device companies to go out of business. They just want the devices to be provably safe before they are used on human beings. Therefore, Gompertz points out, the FDA largely regulates what you have to do, but leaves it up to you to figure out how to do it. This gives you a lot more leeway than many people realize, leeway that you can use to make regular improvements in your processes and methods. He tells stories of specific changes he made one time or another, which his colleagues were sure the FDA would reject—and the FDA auditor loved them. "Why don't other companies do it this way, when it's so much simpler?"
There's more, but I'd rather let him speak for himself. This, though, is exactly how Quality ought to be done.
Oh wait! Before I forget, Greenlight Guru is hosting an Ask-Me-Anything event with Steve Gompertz in a couple of weeks, on September 7. You can get more information and register for it by following this link here.
And here's the interview.
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