California’s e-Pedigree law – the requirement that a package be traced as it’s aggregated into cases and pallets for shipment throughout the supply chain – is set to take effect in January 2015. Consequently, e-Pedigree regulations for the pharmaceutical industry are getting a lot of attention in articles, workshops, and water cooler conversations.
As an integral component of this discussion, serialization, which includes the use of unique identification numbers to track every pharmaceutical product from first suppliers through manufacturing and out to distributors, pharmacies and the consumer, is now a hot topic. E-Pedigree, an electronic record of the associated genealogy across the entities that took possession of and/or shipped or repackaged pharmaceuticals to the consumer, will soon require the ability to track and trace products electronically, all the way from packaging to dispensing.
While serialization and e-Pedigree is a pharmaceutical issue today, history tells us that soon medical device makers will be subject to the same standards, either from direct regulation, competition or customer pressures.
Not surprisingly, many pharma companies are behind in their implementation of serialization, or haven’t even started yet, risking not meeting this regulatory deadline. One reason given for delay is the considerable complexity of the task. Serialization cuts across virtually every company’s manufacturing and supply chain operations, so typically involves many different technology platforms spread across a wide geographical area. Some companies think they are playing it safe by waiting. They don’t want to be first adopters and pay the price of early bugs and problems in new technologies.
What is the best strategy if you’re a medical device company or supplier? Should you delay or embrace? It may be too early to embrace full serialization, but there’s no reason to delay getting started on the most critical building block – global trace and genealogy across your manufacturing operations. In fact, I’d argue there is every reason for you to move on this task today, if you haven’t already begun.
To start, unlike many of the challenges of serialization, global traceability for medical device manufacturing does not involve new or untested technologies or systems. We know how to build centralized management, standardized processes, and granular tracking of every activity surrounding the parts and processes of manufacturing.
What’s more, companies that have already done it say the visibility and control provided with a global trace and genealogy solution can quickly pay for itself. One return on investment is quickly limiting the damage from product failures and recalls – problems can now be isolated and contained much faster as soon as they develop, down to the region, plant or line, synchronized with a suspect component or out-of-compliance quality event. Those solutions that are extended out to the supply chain offer even further potential benefit. Other ways this type of solution pays for itself is with direct savings resulting from standardization, quality improvement and greater visibility into operations from both managing optimal inventory and customer service levels, among other factors.
Whatever the future holds, it appears reasonable to assume that serialization will require back stream traceability through manufacturing and supplier processes across your enterprise, tracking all activities along the way. That means every medical device manufacturing company will ultimately need global trace and genealogy that is delivered in a cost effective, expedient fashion. Given this assumption, the only real question is not “if” but “when” you will adopt such a solution, and what implementation strategy you will embrace. If you decide to embrace a platform-based strategy for global traceability and genealogy, then this approach is not only doable, it’s profitable. The sooner you embrace it, the further along you’ll be when the issue becomes urgent – and the further ahead you’ll be of the competition.
Where do you want to be when this inevitable regulation hits?