Working Group Formed to Improve Medical Device Quality, Supply Chain Resiliency

Performance Review Institute (PRI) recently reported that representatives from the medical device industry, government, and industry associations have formed a new working group called, “Best Practices in Supply Chain Resiliency and Quality Working Group,” to identify and recommend best practices to improve medical device quality and enhance supply chain resiliency. The working group is being chaired by the MedAccred program, which is administered by PRI. It intends to improve these procedures by expanding MedAccred adoption through the tiers in the supply chain, identify best practices to supplement efforts in quality assurance and procurement strategies, and help mitigate supply chain risks.

As part of the working groups efforts, it will seek and evaluate lessons that other industries, including aerospace and automotive, have learned. The group will identify the highest value critical manufacturing processes in medical device development with an aim of implementing the MedAccred program more broadly to mitigate supply chain risk, reduce quality issues, and improve patient safety.

Additionally, the group will provide clear considerations for key stakeholders, including medical device OEMs and contract manufacturers, US FDA, US Department of Commerce, National Institute of Standards and Technology Manufacturing Extension Partnership (NIST MEP), MedAccred, MedMMAP, Medical Device Innovation Consortium (MDIC), Notified Bodies, Homeland Security, among others.

Of note, the group itself was inspired by the FDA Center for Devices and Radiological Health’s (CDRH) Case for Quality Initiative, which works to collaboratively advance quality, safety, and effectiveness of medical devices for improved patient safety and clinical outcomes.

The Best Practices in Supply Chain Resiliency and Quality Working Group members are available in PRI’s press release. When contacted, PRI was unable to supply MD+DI with further detail into the group or its workings.