12 Aug Addendum Labeling in the Medical Device Industry
The story sounds similar across many consulting engagements; businesses with multiple business systems and processes created through mergers and acquisitions with a desire to consolidate and harmonize. See Linda’s Blog regarding 5 Keys to Acquisitions
On a recent consulting engagement with our long-term customer, I was engaged to assist with a little-known problem to many people outside of the medical device industry; finding a scalable technical solution to address the requirements for Medical Device labeling (AKA Addendum Labeling). Countries have specific regulatory requirements similar to the Food and Drug Administration Title 21 of the Code of Federal Regulations for Medical Device Labeling. Labeling consists of pairing medical devices with addendum components that range from country-specific labels (with batch, serial, or pricing information), Instructions for Use (IFU), special power cords, holographic stickers, and everything in between. Because the addendum activities are country-specific and are not known at the time of production, the IT solution must be performed at the time of distribution activities. As with anything in the medical device industry product safety, documentation, and traceability are paramount to any IT solution.
The team was dealing with the daunting task of harmonizing two very similar but distinctly different business processes with a goal to centralize and manage regulatory data for tens of thousands of finished materials proliferating out to related addendum requirements and 73 countries at their Tier 1 Distribution Centers. While several options were evaluated (both SAP and non-SAP Solutions), the unique requirements led the team to design a custom solution to meet the needs of the customer.
Phoenix Endeavors consulting partners and our customer designed a custom SAP solution that houses the regulatory requirements (similar to a shipping BOM) and couples them with distribution activities. On the front end, a Web Dynpro workbench was created to provide an easy to use user interface on the shipping operations floor. The workbench automatically prints labels through a third-party software and allows bar code scan verification for components associated with the shipped materials to ensure compliance and traceability with each country’s requirements. Supporting the core solution: a myriad of configuration tables, interfaces, and reports that were designed to allow business scalability. After it was all said and done, three interfaces (labeling software, third-party PLM, and SAP-GTS), 30 SAP technical objects, and 23 Custom Tables were developed to support the project.
While challenges existed throughout (two SAP Support pack upgrades, two system refreshes, two large separate parallel SAP implementations), the project has been successfully implemented at three Distribution Centers and supporting shipping to 37 Countries. To date, there have been over 18,000 deliveries processed and nearly 1.6 million activities processed providing the business with valuable metrics for improving the processes. The project is also realizing a 50% efficiency gain and more importantly 100% traceability to the components being shipped with the products consistent with country-specific regulatory requirements.
I would like to thank our Client’s IT Staff and Business Partners in making this project a success and allowing Phoenix Endeavors to be a part of this unique project.