NEW WORKING GROUP ESTABLISHED TO IMPROVE MEDICAL DEVICE QUALITY AND SUPPLY CHAIN RESILIENCY

PUBLIC STATEMENT, January 30, 2023, Representatives from the medical device industry, government, and industry associations have formed a working group to identify and recommend best practices to improve medical device quality and enhance supply chain resiliency.

The purpose of the Best Practices in Supply Chain Resiliency and Quality Working Group is to improve medical device quality and supply chain resiliency by expanding MedAccred adoption through the tiers in the supply chain, identifying best practices to supplement efforts in quality assurance and procurement strategies, and to help mitigate supply chain risks. The working group will provide clear considerations for key stakeholders, including medical device OEMs and Contract Manufacturers, U.S. FDA, U.S. Department of Commerce, NIST Manufacturing Extension Partnership (NIST MEP), MedAccred, MedMMAP, MDIC, Notified Bodies, Homeland Security, and others.

As part of its efforts, the working group will seek and evaluate lessons learned from other industries including aerospace and automotive. A critical outcome will be to identify the highest value critical manufacturing processes in medical device development with the aim of implementing the MedAccred program to mitigate supply chain risk, reduce quality escapes and improve patient safety.

The new working group was inspired by the U.S. FDA Center for Devices and Radiological Health’s Case for Quality Initiative, which seeks to collaboratively advance the quality, safety, and effectiveness of medical devices to improve patient safety and clinical outcomes. The working group is being chaired by the MedAccred program, which is administered by the Performance Review Institute.

For more information on this new working group, contact Justin McCabe, MedAccred Operations Manager, at jmccabe@p-r-i.org or Paul Sumner, MDIC Program Director, Case for Quality, at psumner@mdic.org.

Working Group Members:

· Bob Lizewski, VP, MedAccred, Performance Review Institute (Chair)

· Jay Solomond, EVP and COO, Performance Review Institute

· Justin McCabe, Operations Manager, MedAccred, Performance Review Institute

· Kim Killackey, VP, Quality Management System, Baxter Healthcare

· Srinivas Koneru, Sr. Director, Global Procurement, Baxter Healthcare

· Tiffany Abrams, Sr. Director, International Quality, Global Sourcing, Edwards Lifesciences

· Tony Knight, Sr. Director, Global Supplier Quality, Medtronic

· Scott Goolsbey, Sr. Program Manager – Procurement Programs, Stryker

· Alberto Romeu Toro, Manager, Global Supplier Quality, Stryker

· Jeff Bovee, Global Manager, Quality Systems and Regulatory Compliance, Benchmark

· Ed Engelhard, VP, Corporate Quality, Solar Atmospheres

· Erin Keith, Sr. Advisor, Compliance and Quality Program, OPEQ, CDRH, FDA

· Francisco Vicenty, Case for Quality Program Manager, FDA

· Tammy Beckham, Associate Director, Resilient Supply Chain & Shortages Program, CDRH, OST, FDA

· Anne P Reid, Deputy Director, Office of Medical Device and Radiological Health Operations, ORA, FDA

· Rhonda L Mecl, Operations Staff Director, Medical Device and Radiological Health Operations, ORA, FDA

· Jyoti Malhotra, Divisions Chief of Extension Services at NIST MEP

· Doug Devereaux, Sr. Industrial Specialist, NIST MEP

· Andrew Peterson, General Engineer, NIST MEP

· Bill Donohue, President and Executive Director, Genedge

· Scott Schein, Director, National Network Programs, Genedge

· Joe Sapiente, Vice President, Clinical Science & Technology, Medical Device Innovation Consortium (MDIC)

· Paul Sumner, MDIC Program Director, Case for Quality, Medical Device Innovation Consortium (MDIC)