Why Are So Many Medical Device Companies Stuck In Inspection Mode?

Why are so many medical device companies still stuck in inspection mode trying to apply a band aid on problems instead of designing quality into their product?

This is something I have wondered about for a long time. I think some of it comes from these companies desperately focusing on just meeting compliance requirements dictated by regulations.

The med device industry is extremely compliance-driven - no doubt about that. But will solely focusing on compliance make you a best in class organization?

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