Building and Sustaining a Culture of Quality
Division: Biomedical Division
In 2011, the U.S. Food and Drug Administration (FDA) launched a case for quality (CfQ) initiative focused on improving product quality and patient safety by instilling a culture of quality into the medical device industry. This is shifting the medical device focus from regulatory compliance to sustained device quality for improved patient outcomes. The case for quality has evolved and expanded, and now includes the Medical Device Innovation Consortium (MDIC), the Capability Maturity Model® Integration (CMMI®), ASQ, Advamed, Xavier Health, and biomedical stakeholders—device manufacturers, physicians, hospitals, and patients.
Metrics for use in the program and three dashboards are in the works. A pilot program involving a number of companies is underway, and initial results are strongly positive. The message for the future is clear: Measurable best practices in design and production are becoming the FDA's and society’s expectations in the not too distant future.