Clarkston Helps Medical Manufacturer Streamline Supply Chain, Ensure Regulatory Compliance
Clarkston, a consulting firm, has successfully partnered with a medical manufacturer to enhance processes and complete a crucial product transfer initiative. The project involved reducing the supplier base, updating purchasing procedures, and ensuring regulatory compliance.
Initially, Clarkston was tasked with completing outstanding product transfer activities, overseeing the transfer of missed component SKUs, and supervising the transition of purchased finished goods. However, the manufacturer faced challenges in reducing its supplier base from over 30 to just 2.
Clarkston stepped in to support this process by defining required documentation for supplier equivalency, creating a RACI (Responsible, Accountable, Consulted, Informed) matrix, and outlining labeling and regulatory obligations. This helped the client expand its scope to include updating purchasing procedures for compliance with EU Article 120 on significant equivalency.
Throughout the project, Clarkston partnered with cross-functional teams to define cost models, timelines, phase-in/phase-out strategies, and ownership of deliverables. The project was deemed successful with strengthened procurement processes and regulatory compliance.
Upon completion, a comprehensive lessons learned workshop was facilitated to drive leadership visibility into opportunities for improvement. The client was positioned for sustained success in managing OEM and kit component sourcing, thanks to Clarkston's expert guidance and support.
