A Firsthand Account of the Origins and Outcomes of FDA’s Case For Quality and MDDAP

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, including how these initiatives were started and have evolved since, as well as 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.