Case Study: Key Surgical achieves FDA-compliant labeling efficiency with Innovatum

Key Surgical - Customer Case Study

Key Surgical, a leading medical device manufacturer serving sterile processing and operating room teams, needed to modernize its product labeling process to keep up with FDA requirements and growing international labeling demands. Its manual, database-light workflow was time-consuming, error-prone, and lacked strong controls for revisions, approvals, and translations. Innovatum helped Key Surgical address these challenges with ROBAR, embedded BarTender software from Seagull Scientific, and QuickLabel’s Kiaro! printer.

With Innovatum’s solution, Key Surgical created a formal label management process for creating, reviewing, revising, releasing, and approving labels and translations, while also improving branding and private-label flexibility. The new system reduced manual steps, improved productivity, strengthened compliance, and cut implementation time from an estimated 6–9 months to about one month. Innovatum’s ROBAR platform also gave Key Surgical a central repository for UDI attributes and streamlined uploads to the FDA GUDID, saving time and reducing opportunities for error.

Key Surgical

Lena Cordie

Director Operations