Labelling Solutions Mechanising label production is the way forward
Medical device manufacturers can leapfrog ahead in a central compliance process, thanks to their engineering-orientated approach, argues Kallik’s David Bennett
I
n their drive to comply more quickly and effectively with ever-evolving safety and quality standards, other regulated industries can learn a lot from medical device manufacturers — specifically about effective enterprise labelling change management across the lifecycle of products. That’s because the makers of these devices
are often able to create labelling effectively on demand by calling up already-approved content elements from an enterprise label library, according to specified parameters and rules. This gifts them the basis for truly smart labelling automation, namely the ability to assemble new or updated labels in real-time, without having to call the artwork studio, or set in motion new rounds of content review and approval. Although end-stage human checks should still be applied, it turns out that around 98 per cent 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, for example.
A HOLISTIC, CENTRAL SYSTEM The ideal end-game here is a write-once/read- many approach, where approved ‘master content’ becomes the definitive source of everything, and indeed becomes the only point where fundamental content component editing takes place. The ‘component’ part is very important, and 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, however. So, to prevent the wrong elements being applied, automated rules are advisable to help to augment human intelligence and process and reduce the risk of 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 is systematic and comparatively painless. With the ability to hold approved compliant text, symbols and branding elements at a reusable component level like this, such an approach to labelling gives the medical device manufacturing sector an agility and real-time responsiveness that other regulatory industries can only dream of. The pharmaceutical industry is a case in point; however much the industry has wrestled with regulatory compliance over the decades,
12 April 2020
firms 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, for instance, 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), Product Data Management (PDM) or laboratory information management system (LIMS). Meanwhile, the ultimate signatory for labelling content is typically country-based, residing within the regulatory team. This fragmentation/lack of a ‘single source of labelling truth’ within the global pharmaceutical organisation has made it difficult for pharmaceutical brands to manage the integrity of labelling efficiently and at scale. It has also hampered any meaningful process automation around global labelling management, in turn contributing to the complexities, cost and risk that so many international pharmaceutical organisations still experience (e.g. 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 manufacturers approach the problem with ‘engineering-thinking’ as it’s an 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.), put together in a distant laboratory.
The good news is this
different perspective stands medical device companies in very good stead to manage regulated labelling content systematically and efficiently on a global scale, as new requirements come into play such as the imminent EU Medical Device Regulation, US Unique Device Identification (UDI), and global product serialisation. That’s timely, as the risk mitigation and efficiency gains of such a structured, global approach to labelling management are emerging very clearly. On average, companies who have implemented such an approach report a 10-fold
acceleration in the speed of identifying and editing 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, providing unprecedented confidence that no product or market has been missed.
NO PRODUCT OR MARKET IS MISSED There are numerous urgent reasons to do this beyond the soaring burden of continuously evolving safety and transparency regulations. Diverse customer groups in their respective markets have differing requirements, and labelling and messaging must be tailored accordingly. And this is also very much a story about economies of scale; while firms 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 also does not simplify painful and costly complexity, transform the use of time and resources, drive down risk, or elevate the end user experience. Summing up, for too long labelling has
been treated as a bit of a Cinderella, pushed over to the area of promotional materials and advertising instead of where it should be, as critical to continued marketing authorisation, brand perception, market confidence, and patient safety. A timely look to how medical device manufacturers approach and hone their own labelling practices in response to new industry demands will serve as a useful benchmark for organisations.
kallik.com
convertermag.com
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