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

July 26, 2019

MTQS Guest Header_Two Harbors Consulting_Becky Fitzgerald

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.



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Some of the Episode highlights include:

  • 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.



Two Harbors Consulting

Aligning True Quality and Compliance with MDDAP

FDA Case for Quality Program

Center for Devices and Radiological Health (CDRH)

FDA Case for Quality: 2018 Comprehensive Review

CMMI Institute - Medical Device Discovery Appraisal Program (MDDAP)

Capability Maturity Model Integration (CMMI)

Medical Device Innovation Consortium (MDIC)

MDIC Annual Public Forums

Medical Device Single Audit Program (MDSAP)

Premarket Notification 510(k)

Wibas - CMMI

Global Medical Device Podcast

Greenlight Guru True Quality Roadshow 2019

Greenlight Guru


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


MTQS logo - rectangle (1)

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.

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Nick Tippmann is an experienced marketing professional lauded by colleagues, peers, and medical device professionals alike for his strategic contributions to Greenlight Guru from the time of the company’s inception. Previous to Greenlight Guru, he co-founded and led a media and event production company that was later...

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