Seamless Transition of Global Product Distribution to Meet Unique Device Identifier (UDI) Compliance

Problem Statement icon

Problem Statement

New Regulations​

This medical device industry leader faced a daily $1.4MM loss of sales revenue across 40 different products due to changes in hazardous product labeling requirements, and needed to determine how to comply with the regulations by the deadline without interruptions to the global product pipeline.

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Objective

Comply Without Disruption​

Plan and implement a new process to introduce compliant versions of 120 labels spanning 40 different products while ensuring continuity of product supply to all global markets while minimizing product and raw materials scrap or redirection of distribution channels.​

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Solution

Just in Time​

We honed in on the specific needs in each regulatory regime and created narrowly tailored plans and just in time release schedules for each of the several hundred product and country registration combinations. ​

To expedite the process, we enhanced the change control workflow and partnered with the global supply chain to rapidly implement the changes​

Success Factors icon

Success Factors

Managing Reality​

Due to the vast number of global parties, it was critical to manage stakeholders early to align on timeline and sequencing.​

Market needs and country supply levels required rapid adjustments and socialization of the revision schedule.​

Resource availability variability required proactive bandwidth management to avoid any delays.​

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Outcomes

Savings & New Model​

Timely regulatory compliance protected the 41% of annual revenues at risk and reduced projected product obsolescence by 95%.​

The new agile change control workflow became adopted for all future high-impact projects. ​

Project governance model was adopted as the standard for delivering cross-functional, global complex projects. ​