Patients, providers, and companies are already experiencing the benefits of FDA’s Case for Quality Program and CMMI Institute’s Medical Device Discovery Appraisal Program (MDDAP).
Today’s guest is Becky Fitzgerald, principal and co-founder of Two Harbors Consulting. She’s passionate about her involvement with Case for Quality and being a lead appraiser for MDDAP.
In this episode, Becky gives listeners an inside look into her instrumental work and involvement with FDA's Case for Quality and MDDAP programs, how these initiatives started and have evolved since, and valuable lessons learned along the way.
“It’s a really fresh and refreshing way to look at the health of companies making life-saving, life-sustaining technologies.” Jon Speer
“Predictability and consistency - those are the very things that do, in fact, impact quality, but they don’t get recognized.” Becky Fitzgerald
“Quality has lost its purpose within a lot of companies. It’s almost become an impediment to getting things done. It’s about patients receiving our products.” Jon Speer
“The product will be made better, faster, with higher quality. That’s the benefit that we’re going for.” Becky Fitzgerald
ABOUT MEDTECH TRUE QUALITY STORIES PODCAST
MedTech True Quality Stories Podcast, powered byGreenlight Guru, takes listeners on a storytelling journey through personal narratives of MedTech executives who offer real-world, actionable advice to industry leaders for guidance towards future imagination, implementation, and innovation of True Quality medical devices.
Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...