Clarkston Strengthens Medical Manufacturer's Procurement, Ensures EU Compliance
Clarkston Consulting, a specialist in process optimization, has successfully completed a project with a medical manufacturer. The project aimed to strengthen procurement processes, manage a product transfer initiative, and ensure regulatory compliance.
Clarkston began by partnering with cross-functional teams to define cost models, timelines, and strategies for phasing in and out of deliverables. They also led global customer communication strategies. Initially, the manufacturer had reduced its supplier base from over 30 to just two but faced challenges in executing the product transfer.
Clarkston stepped in to complete outstanding product transfer activities, oversee the transfer of missed component SKUs, and supervise the transition of purchased finished goods. The project's scope was expanded to include updating purchasing procedures for compliance with EU Article 120 on significant equivalency. Clarkston supported these efforts by defining required documentation for supplier equivalency, creating a RACI matrix, and outlining labeling and regulatory obligations.
The project was completed successfully with strengthened procurement processes, regulatory compliance, and a framework for sustained success in managing OEM and kit component sourcing. A comprehensive lessons learned workshop was facilitated to drive leadership visibility into opportunities for improvement.
