A rule of project management is to define the scope before starting work, or even developing a schedule. By scouring lists of products, we determine the items requiring UDI updates – new labeling, GUDID submissions, direct marking. Rarely, the goal is to address the entire list. Rather, we divide the list, forming multiple prioritized lists based on risk class, sales, and patient need. We work the high-priority list, deferring the others for later, assuming our information and assumptions are reliable. We build the haystack. Completing list 1 yields a sense of accomplishment, which turns to dread when examining lists 2, 3, and the rest.
Tactical thinking leads us to building these haystacks – lists to repeatedly analyze and correct, while new items are added, removed and altered. Regardless of the platform, stand-alone or marginally integrated systems become disconnected as business and product portfolio evolves. A more effective way would be to incorporate these UDI attributes and compliance status in a Product Lifecycle Management (PLM) or other core systems. This enables all stakeholders to easily assess compliance and, most importantly, maintain the list of items requiring UDI remediation.
Selling such enhancements is challenging – simple solutions appear sufficient, requiring little investment, a few database queries, and analyst man-hours to assemble. Sustainable system business cases are often based on cost projections and compliance risk, making them susceptible to skepticism and rejection; set aside for initiatives with more tangible benefits. It is only after repeatedly inspecting the haystack and scrambling to remediate “missed” items do we realize the benefit of what could have been done from the beginning.
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.
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.