Case History: Eastern Medical device company

The client is a supplier of test kits used to detect specific medical conditions.

They were concerned about GS1 Healthcare compliance in their number assignment to products, including sale units and shipping containers. The numbering system they have in place has come from all directions. Some of their European distributors assigned some of their numbers, and they weren’t sure whether they had ever been “registered”. Other numbers were from a legacy database they’ve used for years.

Shipping container was also confusing to the client because the same product is packaged in several different ways, depending upon where it was being shipped. Sometimes the sale unit was packaged in a 12 pack inner carton, then in a 4 pack master carton. At other times, the several different sale units would be bundled together in a sample kit which became a new sale unit, which was then packaged in an 8 pack inner carton and then in a 6 pack master carton. Still other customers required different configurations of packaging, some recurring, some custom. How should these various packaging schemes be numbered and how are all the trading partners made aware of the total system? The client didn’t have any sort of notification procedure in place.

The client was also confused about which symbology to use at the item level and at the shipping level. They had been using EAN13 on most of their item level packages, and the client wasn’t sure that was correct. But some customers had insisted on ITF14’s for certain SKU’s.

Finally, the contact person at the client location was newly appointed to head the labeling department, where some personnel had worked for a number of years, and were familiar with “the way things have been done”. Whether or not things had been done correctly was unclear.

The goal for this consultation was to get the client ready for implementing EDI in their trading partner relationships, and to be GS1 Healthcare compliant by the 2013 sunrise dates.

Overall, this was all about GS1 Guidelines and Standards. The challenge for this and many similar companies is to inform a functioning group of people to all acquire a common understanding of what is required to make their company compliant. While each member of the team had more than sufficient intelligence to read and understand the GS1 documentation, they didn’t have the time to do this at work, and the team would still need to meet and coalesce their knowledge, ask questions about specific issues concerning them, and establish a foundation of common knowledge and practice for moving forward.

The seminar we presented was a broad overview of the GS1 Healthcare Standards, with a specific examination of how they could adapt (or in some cases, replace) their legacy numbering system into a compliant system.

Because the client could only devote several hours of one day to this, we agreed to an open-ended follow-up period during which they would have unlimited access to us for clarifications and questions. We have had several months of steady dialog with this client and when it seems appropriate, we will suggest another on-site meeting of several hours duration.