Cisco Vicenty tells how the US agency will structure its pilot program for device-makers with less-than-stellar compliance histories that want to use the CMMI maturity model framework to improve the quality and maturity of their manufacturing organizations – and clean up their compliance problems along the way. The FDA – which is partnering with the Medical Device Innovation Consortium (MDIC) and Pittsburgh’s CMMI Institute on the voluntary pilot – will offer the opportunity to 10 firms “that have had a negative inspection outcome, a warning letter, or possibly other regulatory action,” Vicenty explains to Medtech Insight. The pilot launches next year.

The pursuit of quality can be a daunting task for device-makers. One wrong step can cause costly product recalls affecting patient health – among other troubles tied to poor quality products and processes. To help firms move toward a goal of best-in-industry quality, US FDA, through its Case for Quality initiative, has convened a pilot program to measure a manufacturer's capability and maturity to help put it on a path to continuous improvement. The pilot uses an industry-tailored version of the Capability Maturity Model Integration (CMMI) model and method, developed jointly by FDA, industry and CMMI Institute.

The agency urges sponsors to keep patient safety “first and foremost” in determining how to continue a clinical trial during a natural disaster, public health emergency, or other crisis.