MedAccred program publishes white paper on medical device manufacturing

In a white paper, ‘Supply Chain Resiliency in Medical Device Manufacturing: The Core Foundations’, Justin McCabe, operations manager for the MedAccred program, discusses the four key areas that medical device companies must focus on. 

He explains how up to 80% of supply chain disruptions for OEMs are caused by lack of visibility and transparency at lower levels in the chain; a need for tools to assess Suppliers accurately and identify risk, and difficulties in allocating resources to identify and mitigate against risks.  

In response, Justin McCabe details the core foundations which are required for resilient supply chains: visibility; control; flexibility, and collaboration, and describes how the MedAccred program is continuing to address each of these needs.   

McCabe said “MedAccred is an industry-managed approach for oversight of critical supply chain processes. It assures quality, verifies compliance with all applicable regulatory requirements and reduces risks to patient safety from product shortages or failure. It brings clear business benefits to OEMs and their suppliers from the ground up.” 

OEM Subscribers to the MedAccred audit and accreditation program include Baxter, Becton Dickinson, Boston Scientific, Edwards Lifesciences, Medtronic, Philips Healthcare, Roche Diagnostics and Stryker. Subscribers determine the audit criteria to ensure their exacting standards can be met. MedAccred Auditors visit Suppliers to audit technical aspects of their processes and ensure that any nonconformities are remedied before the Supplier is placed on the MedAccred Accredited Supplier list. 

McCabe added “Through our accredited Supplier list, OEMs are assured about their existing Suppliers’ capabilities and critical processes that they might not have detailed knowledge about. The list also gives OEMs a way to assess the suitability of potential suppliers when they want to diversify their own Supplier list, develop new products or move production to new regions. Suppliers benefit from MedAccred accreditation too. It gives them assurance that they fully understand what existing customers need and it can pre-qualify them to win new business.” 

In a recent MedAccred customer survey, 85% of supplier respondents reported improved customer satisfaction as a result of their involvement in the MedAccred program, and 52% said they had won new business.