The healthcare industry has witnessed a complete transformation in the last couple of years in all areas starting from the providers, payers and medical device manufacturers, to outsourced service providers. With the safety and integrity of medical devices becoming a strategic priority, the ability to track and trace these devices at a global level has gained higher significance. Although there are few systems in place already, the Unique Device Identification (UDI) system aims to adopt a modern and harmonized approach of tracking with the best use of technology. The U.S. Food and Drug Administration (FDA) led the global initiative to put this together.The stipulated legislation for UDI is expected to herald a new era in improved patient safety and healthcare business processes, enabling easy tracking of medical devices. UDI can fundamentally change and improve the way we order, purchase, distribute, and use medical devices. Its implementation, however, calls for a structured approach between all healthcare stakeholders. This whitepaper outlines the evolution, current scenario, and future of UDI implementation. It also describes challenges to global impact and offers suggestions on out-of-the- box and cost-effective Cyient approach.

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