In pharma, labeling change management is a notoriously complex affair already. It’s made more challenging because the physical labels tend to be handled by regulatory teams and manufacturing, and the art work by design teams, usually at third-party agencies. None of this is very well coordinated, and it can be very difficult to see the current status of output, the likely impact of planned changes, and what will be involved to roll them out wherever they are needed.
By contrast, in medical device manufacture adherence to engineering principles sees labeling treated as an assembly line involving known modular content elements — effectively a ‘bill of materials,’ whether output is physical or digital. From the carton and Instructions for Use (IFU) insert to the packing box with its own barcode and even online patient information, all are layers of the same process and are managed in a coordinated, systematic way. And I think the pharmaceutical industry could learn a lot from medical device manufacturers about effective enterprise labeling change management across the lifecycle of products.
No Single Source of Truth
Fragmentation — a ‘single source of labeling truth’ within the global organization — has made it difficult for pharmaceutical brands to manage the integrity of labeling on a broad scale. It’s also hampered any meaningful process automation around global labeling management which, in turn, has contributed to the complexities, cost and risk that so many international pharmaceutical organizations still experience. By contrast, the medical device industry, which has come relatively late to the level of regulatory rigor experienced by other life sciences disciplines, has not grown up with this same legacy of information/content silos. Medical device manufacture is a discrete, engineering-based industry based on assembling finished products from pre-built and vetted components, rather than a process-based industry working with less tangible formulations (5mg of this substance, 2mg of another, etc.) assembled in a distant laboratory.
This differing perspective stands medical device companies in good stead to manage regulated labeling content systematically and efficiently on a global scale, as new requirements come into play, including the EU Medical Device Regulation, Unique Device Identification (UDI) in the US, and global product serialization. Why? Because device manufacturers are already thinking instinctively in terms of a single source of truth for labeling and artwork management, allied to an ability to hold approved compliant text, symbols and branding elements at a reusable component level. This is in stark contrast to pharma organizations who are still drawing from single-use documents, and manually copying and pasting content into designated label formats. It gives them an agility and real-time responsiveness that pharmaceutical companies can only dream of.
What this looks like in practice: instead of capturing correct text and artwork manually each time a new need or labeling change arises, a process requiring rounds of approvals each time), device manufacturers are able to create labeling on demand, calling up already-approved content elements from an enterprise label library according to specified parameters or rules. This paves the way for smart automation: the ability to assemble new or updated labels in real time, without having to call up the artwork studio, or set in motion new rounds of content review and approval. The reality is that, although end-stage human checks should still be applied, 98% of label preparation can be automated, so that if X device is being assembled for Y market the label creation process ‘knows’ to call up elements A, B and C.
Re-Orienting Our Approach to Labeling
The ideal scenario is a write-once/read-many approach, where approved master content becomes the definitive source of everything that follows, and becomes the only point where fundamental content component editing takes place. The ‘component’ part is important here: these master labeling assets are not single, fixed entities — but rather a series of interconnected building blocks, or modules, which can be reassembled ad infinitum for different purposes and for different countries and contexts. And users of this approach report a 10-fold acceleration in the speed of identifying and editing affected labels when a change to content is required, transforming a process that might have consumed weeks across thousands of labels into something that can be executed in seconds.
For too long in pharma, labeling has not been treated as critical to continued marketing authorization, brand perception, market confidence, and patient safety. A look to how medical device manufacturers approach and hone their own labeling practices in response to new industry demands can serve as a useful reference point as the sector works to re-orient its approach here.