Editor's note:The following is an excerpt from an Edwards case study. Read the full case study and find out more about the Medical Device Discovery Appraisal Program (MDDAP) here.
Edwards was an early adopter of the MDDAP program. The company's Draper, Utah facility completed its first MDDAP appraisal in 2017 as part of the program pilot. There were challenges in shifting the organization's approach from the compliance mindset that they were accustomed to, to a performance-focused mindset. Today, Edwards has enrolled their entire manufacturing footprint, but this article focuses solely on the Draper facility's experience in the program.
How MDDAP Helped Edwards Deliver on Its Mission to Give Patients Access to High Quality Medical Devices
The first appraisal focused on the following business functions: quality engineering, quality assurance, shared services, manufacturing engineering, and operations. The initial MDDAP Appraisal is standardized to provide a baseline view for all new industry participants that include the following CMMI Practice Areas:
- Requirements Development and Management (RDM)
- Planning (PLAN)
- Estimating (EST)
- Monitor and Control (MC)
- Managing Performance and Measurement (MPM)
- Configuration Management (CM)
- Process Quality Assurance (PQA)
- Technical Solution (TS)
- Product Integration (PI)
- Governance (GOV)
- Implementation Infrastructure (II)
Participants can tailor their appraisal in alignment with their business objectives in ongoing years. They can select the Practice Areas that they believe can provide the most value for their strategic objectives for their annual reappraisals (year 2+), as long as the three core Practice Areas (GOV, II and MPM) are included.
The MDDAP appraisal results highlighted opportunities for Edwards to address organizational performance in a way that is not typically addressed in a compliance-based audit. The facility was given the flexibility to align improvement opportunities with their company's objectives and culture. The facility is now considering changes to business practices that are not compliance-related, but which have an indirect and significant impact to their mission of providing safe, effective, and high-quality medical devices.
Find out more about Edwards' experience with MDDAP here.
