Device-Makers Like Baxter Are Lining Up To Let CMMI Evaluate Their Manufacturing Site Capabilities. Here's What To Expect If You're Appraised

Baxter Healthcare's Elizabeth Zybczynski was excited when she first heard that her company would join a US FDA pilot program to measure the capability and maturity of medical device manufacturing sites. Having worked in the aerospace and defense industries before moving to the health-care arena, Zybczynski knew that the tried-and-true Capability Maturity Model Integration (CMMI) approach could elevate quality in the device industry. CMMI Institute's Kimberly Kaplan and CMMI appraisers Becky Fitzgerald and George Zack explain the maturity model process that Baxter – and 13 other manufacturers – have gone through, from initial intake phone calls to the unveiling of final appraisal results. The second of a multi-part Medtech Insight feature series on the appraisal of manufacturing capability and maturity, and what it means for the medical device industry.