Monica Burt on Why Most MedTech Companies Are Doing Quality All Wrong—and How to Fix It Before It Breaks You
“We often joke that we’re the Green Berets of quality,” says Monica Burt, founder of MB&A. “When things go sideways—an FDA audit is imminent, a system is unraveling, or a product launch is on life support—we get the call.”In this candid conversation with The MedTech Digest, Monica Burt pulls back the curtain on why most MedTech companies are doing quality all wrong—and how her team is helping them fix it before it breaks them. From debunking the myth that more paperwork equals more compliance, to rebuilding systems that actually enable innovation, Burt’s insights are equal parts sharp, strategic, and human.