Client: Global medical device manufacturer
Service: Quality remediation and program governance
Result: ~$300M in held product revenue fully restored
The challenge
A new ISO standard requirement for patient implant cards meant a few hundred SKUs could not ship until labeling and supporting materials complied. The hold lasted many months and touched roughly $300M in product revenue.
The approach
I led the operations workstream of the recovery, partnered with a dedicated program manager, inside a cross-functional effort spanning Regulatory, Quality, Labeling and Commercial. Operations’ job was to make compliance physically happen across a few hundred SKUs: sequencing relabeling and rework by revenue and customer impact, keeping production and supply moving while held stock was brought into compliance, and giving leadership a clear view of what had been released and what was still at risk.
The result
All of the held product revenue, roughly $300M, was recovered, and the business came out with a clearer process for absorbing future standard changes.
