Group Name: Best Practices in Medical Device Supply Chain Resiliency and Quality Working Group 

Approval Date: August 31, 2023 

Purpose: 

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 focusing through the tiers in the supply chain, identifying best practices to supplement efforts in quality assurance and procurement strategy, and to help mitigate supply chain risks.​ 

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The Working Group will provide clear recommendations to key stakeholders for consideration, such as FDA, US Department of Commerce, NIST/MEP, medical device manufacturers, MedAccred, and Homeland Security. 

The Working Group was created to address current medical device industry challenges: 

• Quality issues and risk within the medical device sub-tier supply chain​ 

• Lack of medical device manufacturer visibility at sub-tier suppliers​ 
• Onshoring / Nearshoring of the supply chain 
• Limited visibility and industry utilization of the MedAccred program​ 

Membership: 

The Working Group will be composed of representatives from the following stakeholders: 

• Medical Device manufacturers 
• Suppliers 
• Government agencies 
• Trade associations 
• Contract Manufacturers/Contract Sterilizers 

Meetings: 

The Working Group will strive to meet every 3 weeks for 1-hour via Microsoft Teams to discuss progress on its goals and to identify new challenges. Meetings will be open to all members. 

The Chair will be responsible for scheduling meetings and for sharing meeting summaries with members after each meeting. 

Communication: 

The group will communicate with its members through a variety of channels, including email and social media. 

Decision-Making: 

Decisions will be made by consensus. If consensus cannot be reached, the group will vote. 

The Working Group will initially be chaired by a representative from the MedAccred program. 

Goals: 

The goals of the Working Group are to: 

• Identify risks in the medical device supply chain that impact quality and resiliency 
• Identify and document best practices from non-medical device industries (Aerospace, Automotive, etc.) to address identified supply chain risks 
• Identify challenges and potential solutions to medical device industry implementation of MedAccred 
• Communicate identified best practices broadly among key stakeholders  
• Define/clarify Regulatory Body expectations for utilizing MedAccred as a tool to oversee supply chain 

• Develop value proposition and reposition MedAccred as a business initiative, rather than solely a quality or procurement initiative. 

Timeline: 

The Working Group will work towards achieving its goals over the next six months. 

Evaluation: 

The Working Group’s progress will be evaluated every six months. The evaluation will be based on the following criteria: 

• Growth of medical device manufacturers as MedAccred Subscribers 

• Baseline Subscribers (August 15, 2023):  

• Large OEM Subscribers – 8 
• Small/Medium OEM Subscribers – 0 
• Pending Subscribers – 2 

• Growth of MedAccred Accredited supplier manufacturing facilities in strategic critical process technologies (Plastics Injection Molding, Sterilization, Sterile Device Packaging, Printed Board Assembly)  

• Baseline MedAccred Accreditations (August 15, 2023):  

• Total MedAccred Accreditations (also includes Heat Treating, Welding, Cable & Wire Harness Accreditations): 67 
• Sterilization: 14 
• Printed Board Assemblies: 14 

• Plastics Injection Molding: 29 
• Sterile Device Packaging: 2 

• # of procurement personnel participating in MedAccred 
• # of Working Group recommendations published 

Budget: 

No budget required. Any funding required to participate in Working Group meetings and activities is to be provided by individual Member companies. 

Dissolution: 

The group may be dissolved by a vote of the members.