In the pharmaceutical world, labelling change management is a notoriously complex affair, made more challenging because the physical labels tend to be handled by regulatory teams and manufacturing, and the art work by design teams – commonly 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 labelling 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 and systematic way.
In its bid to comply more readily and effectively with ever-evolving safety and quality standards, internationally, from EMA’s implementation of ISO IDMP to new FDA Pharm Quality/CMC specifications, the pharma industry could learn a lot from medical device manufacturers about effective enterprise labelling change management across the lifecycle of products.
Pharma’s great disconnect
The difference in approach between the two life sciences disciplines comes down to structure. However much the pharma industry has wrestled with regulatory compliance over the decades, companies have typically struggled to globalise processes because of their inherently disconnected nature. This has been due in part to the regional or country-specific nature of individual regulatory requirements, and the dispersal of product information across different teams and systems across the organisation. Some of the necessary information will exist in the corporate core data sheet, which belongs to the regulatory department and is used in regulatory information management. Other elements will reside in the company’s enterprise resource planning (ERP) system (effectively a production/supply chain silo); and in the laboratory information management system (LIMS). Meanwhile the ultimate signatory for labelling content is typically country-based, within the regulatory organisation.
This fragmentation – this lack of a ‘single source of labelling truth’ within the global organisation – has made it difficult for pharma brands to manage the integrity of labelling on a broad scale. It has also hampered any meaningful process automation around global labelling management. This, in turn, has contributed to the complexities, cost and risk that so many international pharma organisations still experience. That might be as they try to absorb each updated set of regulatory requirements around safety messaging, product transparency and so on; or each time that a change to company branding, product substances, or manufacturing processes necessitates a label edit.
By contrast, the medical device industry, which has come relatively late to the level of regulatory rigour experienced by other life sciences disciplines, has not grown up with this same legacy of information/content silos. That is because 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.), concocted in a distant laboratory.
This differing perspective stands medical device companies in good stead to manage regulated labelling 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 serialisation.
Reusable components lighten the load – and pave the way to automation
In contrast to pharma brands, device manufacturers are already thinking instinctively (as well as preempting the regulatory imperatives UDI and EU MDR) in terms of a single source of truth for labelling and artwork management – with the ability to hold approved compliant text, symbols and branding elements at a re-usable component level. This is in stark contrast to pharma organisations still drawing from single-use documents, 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.
Instead of capturing correct text and artwork manually each time a new need or labelling change arises (requiring rounds of approvals each time), device manufacturers are able to create labelling on demand, by 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. 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.
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 labelling 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.
Management of components is not an inherent skillset in pharma and beyond, so, to prevent the wrong elements being applied, automated rules are required to help to augment human intelligence and process, and reduce error. A holistic central system can provide new clarity too. When information or requirements change, a single labelling and artwork platform can provide at-a-glance insight of where the impact of this will be, by product and by country, so that change management becomes systematic and comparatively painless.
Demonstrable speed & efficiency gains
The risk mitigation and efficiency gains of such a structured, global approach to labelling management are emerging quite clearly from established use cases. Commonly, companies are seeing a 10-fold acceleration in the speed of identifying and editing affected labels when a change to content is required. A process that might have consumed weeks previously, across thousands of labels, can now be customised and executed in a matter of seconds, while inspiring unprecedented confidence that no product or market has been missed.
For the pharma industry to benefit from these kinds of controls and efficiencies, it must first address its current issues at source. There are numerous urgent reasons to do this, beyond the soaring burden of continuously evolving safety and transparency regulations. Life sciences is not a one-size-fits-all industry. Diverse customer groups in their respective markets have differing requirements, and labelling and messaging must be tailored accordingly. As personalised medicine becomes more of a reality, leading to increases in product variants, the need for precise controls over labels and patient instructions is heightened.
This is about economies of scale, too. While pharma companies may have managed thus far by implementing adequate controls to satisfy regulators, doing the minimum needed for compliance does not deliver value for the business. It does not simplify painful and costly complexity; transform the use of time and resources; drive down risk; or elevate the patient experience.
For too long in pharma, labelling has been treated as the orphan child, cast into the shadows of promotional materials and advertising, rather than considered critical to continued marketing authorisation, brand perception, market confidence, and patient safety. A look to how medical device manufacturers approach and hone their own labelling practices in response to new industry demands should serve as a useful reference point as they attempt to reprioritise their own output.
David Bennett is chief commerical officer at Kallik
