By Graham Francis, Channel Marketing Manager at global enterprise labelling solutions company Kallik.
In heavily regulated industries - including medical device manufacture, pharmaceuticals, chemicals and cosmetics - demand is intensifying for accurate, compliant and contextually-relevant product labelling.
This has become a board-level topic now, given its strategic importance in reducing barriers to entry into new markets. At the same time, product transparency and process traceability are rising rapidly up regulators’ agenda, which is putting renewed pressure on global organisations to ensure they can provide the right product information and safety advice, for each market and customer group, however and wherever healthcare providers and consumers need to access it. The rise in e-labelling and electronic publishing of information is a further significant driver for change.
It is no coincidence that respected market analysts such as Gartner and IDC are predicting significant growth in spending on solutions for managing all of this. So what are the drivers that will prompt new urgency around investment in such software in 2020; what are the challenges and issues that manufacturers and brands need to bring under control; and what does good look like? In this article, Graham Francis, Channel Marketing Manager at Kallik, sets out five important drivers for building a global labelling strategy over the year ahead.
e-labelling best practice for the medical device industry
e-labelling is the electronic publishing of labelling content. For medical devices, this includes the Instructions/Directions for Use (IFU/DFU), printed labels on both product and packaging, plus promotional materials including advertising. Under the new Medical Device regulations, due to go live in May 2020, any device manufacturer with a web site must publish user information there, in electronic form.
As well as being a compliance consideration, this also presents an opportunity for manufacturers to streamline processes for managing, publishing and updating content. Electronic IFUs can be more dynamic and interactive in application, including the use of animations, video and voice prompts to provide additional guidance – the kind of advances regulators and patient groups want to see more of, to make content more accessible and user-friendly to patients/device users. Hyperlinks to other published resources and real-time access to online specialist help can also be included.
However, many companies do not yet have a holistic approach to managing labelling content. Publishing IFUs/DFUs both in print and online can add complexity and potential for continuity risk, without a ‘single source of labelling truth’ to work from. Drawing on best practices adopted in adjacent industries, Kallik’s Graham Francis explores how a more joined-up and coordinated approach can help with the smooth migration to electronic labelling and user content creation, while removing the pain from managing regional translations and market-specific variations.