by Michael Sarachman
Regulatory compliance is challenging; each rule presents unique challenges. UDI is particularly challenging because most of its requirements are not directly related to the product lifecycle – such as product requirements, quality or performance. Rather, it focuses on product identification and master data, topics typically not prioritized by most product development teams. As a result, product development and design quality teams have not naturally taken-on UDI responsibilities, relying on artwork designers, master data administrators, regulatory affairs, or a combination of these groups to address requirements. Without clear accountability, organizations leave themselves open to significant UDI compliance risk.

Many organizations have developed dedicated systems to collect and submit UDI data, but find it challenging to integrate them into business processes. Therefore, product launches and changes seemingly need to address UDI by exception, relying on checklists or procedures to trigger GUDID submissions.

Examining the UDI data lifecycle may present answers to solving the UDI by exception problem. Most UDI-relevant data are developed early in the product definition process, as basic product characteristics and label requirements are defined. By leveraging this output and layering on regulatory and commercial data, a continuous end-to-end solution can be put in place. This approach inherently includes functional approvals, content verification, and stage gate reviews, to ensure data completeness and accuracy without the risk of steps being missed. Such an integrated approach allows an organization to develop UDI master data in parallel with existing product development tasks, making UDI compliance “free.” While it can never truly be free, the right strategy and well-planned and managed investments, can make it appear to be.



USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM's assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

About the Author
Michael is a team lead with the USDM Unique Device Identification practice, where he assists clients with UDI compliance programs, as well as a broad range of labeling, supply chain and master data challenges. He is a PMP-certified project manager and brings broad experience in medical device manufacturing, supply chain, order-to-cash and labeling standards. Mike holds a MBA in Operations Management from Drexel University and a BS in mechanical engineering from Rensselaer Polytechnic Institute.
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