A medical device manufacturer faced an FDA recall of a critical diagnostic device due to incorrect labeling. Initially, the recall involved an estimated 500 units distributed at multiple distribution facilities. However, as the investigation progressed, the scope expanded to encompass several thousand devices globally.
Case Study
Recycling Biohealth Wearables at Scale
A leading international manufacturer of glucose monitoring systems faced a growing burden of responsibly handling these sensitive medical devices (particularly their contained lithium batteries, which require specialized recycling).
Unplugging the Past – Architecting the Responsible Retirement of a National Medical Device Network
A prominent ultrasound device manufacturer faced a significant challenge with a growing inventory of outdated units requiring secure and environmentally compliant disposal. Units were spread across 6,000 locations in the U.S., adding complexity to this case.