In their never-ending drive to comply more quickly and effectively with what seem to be ever-evolving safety and quality standards, regulated industries could learn a lot from medical device manufacturers — specifically about effective enterprise labelling change management across the lifecycle of products.
A recent post on LinkedIn by Kristian Marquardsen about the benefits of taking a modular approach to commercial content in the pharma industry provides inspiration here. As he states in the article, “The reasons for pursuing a modular content approach are simple. Global brand teams can essentially create ‘LEGO bricks’ of content that each market can adopt and adapt really fast and cost-efficiently to whatever channel and platform is relevant for them, here and now.”
Marquardsen is right – a modular approach to content creation and change is exactly the right approach. With that in mind, it’s worth looking to the example of the medical device industry which is inherently good at using this modular approach.
How medical device teams work
In medical device manufacture, an inherent 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 IFU to the packing box with its own barcode all are layers of the same process, and everything gets managed systematically and efficiently. And as the medical device industry has come relatively late to the level of regulatory rigour demanded by other disciplines, especially life sciences, it has not grown up with the same legacy of information/content silos experienced in other regulated sectors. That’s because medical device manufacture is a discrete, engineering-based industry, using assembling finished products from pre-built and vetted components, rather than a process-based industry working with less tangible formulations put together in remote centres.
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. In sharp contrast, in other regulated industries, such as pharma, this structured approach to generating and managing information and materials has been sorely lacking. As a result, label change management is a notoriously complex affair, made more challenging because physical labels tend to be handled by regulatory teams and manufacturing and the art work by design teams, typically at third-parties.
The issue is that this is not well coordinated, meaning it can be 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. The effect of this is spiralling complexity, as disparate teams try to monitor and govern packaging and labelling content and instructions for use, and get caught up in trying to keep on top of what’s registered with regulators, what goes on, and inside, the packaging; and increasingly, what is stated online in e-labelling and smart labelling.
Regulators’ expectations and controls over what needs to be declared, and how, are becoming more rigorous, while the growing frequency with which alterations need to be made to statements and patient instructions for use (IFUs), is intensifying the challenge facing regulatory affairs, quality and safety teams as well as design, manufacturing and distribution operations.
The ideal scenario is a cloud-based labelling platform and 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/modules which can be reassembled as needed and as long as needed for different purposes, countries and contexts. And when information or requirements change, a single labelling and artwork platform provides at-a-glance insight of where the impact will be, by product and by country, so that change management becomes systematic and comparatively painless.
It’s this kind of systematic rigour that regulated industries need to adopt, particularly in the light of intensifying granularity and continuously evolving data-centric safety and quality standards, all the way from EMA’s IDMP to new FDA Pharm Quality/CMC specifications.