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.
- Case for Quality: Originated due to auditing issue that revealed problems with the quality of medical devices from fully vs. non-fully compliant organizations.
- Capability Maturity Model Integration (CMMI): FDA selected model to help companies improve the quality of medical devices without more regulations.
- Multiple medical device entities produced proof of concept and pilot program to show benefits, effectiveness, and value of Case for Quality and MDDAP.
- Compliance vs. Quality: Medical device industry’s checkbox and compliance mindset can create direct and indirect impact on quality.
- MDDAP focuses on conversations with people; the intent and goals for documenting or recording are different.
- Processes vs. Attributes: Is there a way to predict if a project will succeed?
- Lessons Learned: Medical device industry isn’t great at estimating work, project management, and handling changes to non-functional requirements.
- Minor Changes, Major Impact: Ask for input, receive it, and make changes to build momentum for quality.
Memorable Quotes from this Episode:
“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
“TOMi Scope looks directly at the disease, not the eardrum.”
“The Gold standard is an otoscope, which unfortunately has a 50% misdiagnosis rate.”
“The biggest way we’ve funded this company so far has been through NIH grants.”
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MedTech True Quality Stories Podcast, powered by Greenlight 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.