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UDI: Is Your System Ready for Scale?

By Carolyn LaWell

Call it a forever project, program, capability—unique device identification (UDI) is gaining adoption globally and cementing its role as a normal business practice for orthopaedic companies. In theory, the ability to track a device throughout its lifecycle seems smart and necessary.

In execution, the requirement of UDI has led to layers of regulatory decoding, data collection and dissemination, additional costs and moments of confusion, annoyance and disapproval.

The U.S. is the largest orthopaedic device market and, therefore, the rollout of UDI systems worldwide will be on a smaller scale in other geographic regions. But once you decipher, understand and execute on different countries’ regulations, you’ll realize that it is a mammoth undertaking. With the EU and other Middle Eastern and Asian countries preparing to require UDI, experts say that now is the time to take a step back and examine your compliance process—specifically, your data.  

Read more about UDI compliance in BONEZONE.