Is Treating Your Labels Like Your Machines the Way Forward?

Do medical device manufacturers bring new advantages to labelling compliance thanks to their engineering-orientated approach? asks Kallik’s David Bennett

In the pharmaceutical world, labelling change management is a complex enough affair already. But it’s made all the more challenging because the physical labelling side tends to be handled by regulatory and manufacturing teams, while the artwork by design teams is typically managed at third-party agencies. None of this is well coordinated and it can be difficult to see the current status of output, the likely impact of planned changes, and what will be involved to roll out these changes wherever they are required.

By contrast, in medical device manufacture, adherence to a core set of engineering principles sees labelling treated as an industrial procees. That usually involves 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 box containing barcode information, even online materials, all are seen as facets of the same process, and are handled in a systematic way.

The pharmaceutical industry should take heed. In the industry’s effort to comply more effectively with ever-evolving safety and quality standards, internationally, from EMA’s implementation of ISO IDMP to new FDA Pharm Quality/CMC specifications, it could learn a lot from medical device manufacturers.

Issues in the pharmaceutical industry

The difference in approach to labelling between the two disciplines ultimately rests on structure. 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 globally. This lack of a ‘single source of labelling truth’ has made it difficult for this class of enterprise to address the integrity of labelling on a broad scale.

By contrast, the medical device industry, which has come been exposed relatively late to the level of regulatory rigour experienced by other life sciences disciplines, has not had to address this same legacy of information/content silos. That’s because medical device manufacture is a discrete, engineering-based industry, based on assembling finished products from pre-built and vetted components as opposed to a process-based industry working with less tangible formulations concocted in a distant laboratory.

This differing approach stands medical device companies in good stead to manage regulated labelling content systematically and efficiently on a global scale, as well as meeting requirements such as the EU Medical Device Regulation, Unique Device Identification (UDI) in the US, and global product serialization.

Reusable components to automate

In contrast to pharmaceutical brands, device manufacturers have a single source of truth for labelling and artwork management — with the ability to hold approved compliant text, symbols and branding elements at a reusable component level. Such a holistic central system can provide real 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.

Plus, the risk mitigation and efficiency gains of such a structured, global approach to labelling management are emerging quite clearly. Commonly, companies using this approach to labelling report a 10-fold acceleration in the speed of identifying and editing affected ls when a change to content is required.

All this is a very different picture to the pharmaceutical industry, where organisations still draw mainly from single-use documents, manually copying and pasting content into designated label formats. It also gives device makers an agility and real-time responsiveness that pharmaceutical companies can only envy.

Life science is not one-size-fits-all

The risk mitigation and efficiency gains of such a structured, global approach to labelling management are emerging quite clearly. For the pharmaceutical 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 rocketing burden of regulations. Diverse customer groups in their respective markets have differing requirements, and labelling and messaging must be tailored accordingly.

And 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. A look by pharmaceutical industry leadership into how medical device manufacturers approach their own labelling practices will serve as a very useful reference point as they attempt to optimise this core business process.

The author is Chief Commercial Officer at Kallik, the market-leading enterprise labeling company