As regulatory changes, public demand and pure economics drive more labelling content online, what are the considerations for managing all of this? Kallik’s Graham Francis offers some best-practice advice.
As a part of the EU’s new Medical Device regulations, any device manufacturer with a website will need to publish user information to it in electronic form. Other international jurisdictions have similar requirements, all of which places new emphasis on e-labelling as a discipline: the electronic publishing of labelling content, including Instructions/Directions for Use (IFU/DFU).
As well as being a compliance consideration, this also presents an opportunity for manufacturers to streamline processes for managing, publishing and updating their labelling content more broadly. Yet to maximise the associated benefits, and take advantage of greater control and cost-efficiency, medical device manufacturers will need to adopt a more joined-up and coordinated approach to labelling management: one that can help with the migration to electronic labelling, while also taking a lot of the pain out of managing regional translations and market-specific variations of regulated content.
e-labelling is not a new premise; nor is its use limited to the life sciences industry. Making the latest product information available online adds value across a broad spectrum of industries including food & beverage, lifestyle products, consumer goods, and more.
Its appeal to businesses is considerable. Paper-based product labelling, and IFU/DFU production, is resource intensive - both from a manufacturing and an environmental perspective. This is compounded by the need to print materials in multiple languages. The new EU MDR rules require IFUs to be printed in all 24 European languages, potentially doubling the number of pages of current paper leaflets. This could mean that printed IFUs no longer fit in the box supplied with a device; at the very least it will have an impact on shipping validations, device packaging and supply-chain optimisation.
Meanwhile, editing, reviewing and publishing printed materials takes time, with a detrimental impact on speed to market. Errors are expensive to fix and there’s no guarantee that users will receive the latest updates. From a safety perspective, meanwhile, lengthy multi-lingual booklets can be difficult to read, using small fonts to save space.
Printed labels are similarly challenged. Prior to EU MDR, a device being shipped to France would only need English and French. Now, the same label must be printed in multiple languages. There simply isn’t sufficient label real estate to do this.
Business drivers for e-labelling: improved efficiency, agility & enhanced patient safety
Many device manufacturers are already publishing their IFUs electronically. There is nothing in published regulations to say this cannot be done, but companies are obliged to ensure that online versions do not deviate from printed versions otherwise regulatory approval may be compromised.
It is well worth getting this right. Removing reliance on physical labels in product packaging saves cost, time, paper and space – while eliminating the risk of IFUs/DFUs becoming lost or separated from their associated devices. Electronic versions have the potential to be more accessible as well as durable - that is, not subject to fading, contamination or absent pages.
Electronic IFUs (eIFUs) also lend themselves to greater creativity, paving the way for animation, video and voice prompts for additional guidance. Hyperlinks to other published resources and real-time access to online specialist help can also be included.
e-labelling also makes it possible to reflect the latest safety information: eIFU content can be updated immediately and frequently, to reflect post-market surveillance, further enhancing device safety and improving patient outcomes.
From a product and package perspective, organisations are beginning to explore the feasibility of moving a portion of their printed content to their web site, to free up valuable label real estate.
All of this requires a more dynamic approach to label creation, along with closer integration of systems and processes underpinning the approval and publishing of content.
Making it happen
e-labelling is well within the scope of today’s technology, as long as organisations can bring together all the different elements. In medical device manufacture, this is no mean feat.
First, there often lacks an accurate and complete overview of all approved labelling components, output and activity. Also, device labelling tends to have evolved over time. Systems, people and processes supporting labelling and artwork creation will have changed several times during the lifecycle of any device so there may be a lack of clarity around who has the latest version and where this resides. Promotional and web site content will almost certainly have been created by completely separate teams; and IFUs & DFUs by yet another. Factory labelling for shipper cartons and labelling printed on products and packaging will have been managed separately too.
Moreover, organisations can find themselves supporting multiple versions of the same devices across different markets. The automotive industry provides a good analogy for this. Automotive manufactures will continue to sell older generations of the same product into emerging markets, extending their product life cycle and increasing return on investment with minimal additional development. When it comes to satisfying the spectrum of international regulatory requirements and meeting patient safety obligations, the medical device industry finds itself in a similarly complex scenario. Each generation of device needs a version-specific IFU. Localised manufacturing and printing may suffice for paper-based IFUs, but presents a much greater issue when regionalised content needs to be captured and published via the manufacturer’s web site that might appear to be out of date.
Limitations of current systems and processes
Johnson & Johnson, Beckton Dickinson and Abbott Vascular are among those medical device manufacturers already publishing their IFUs to their web sites. In the main, these take the form of a PDF – that is, a static electronic version of the printed IFU or booklet.
With an appropriate framework supporting the publication and distribution of these documents, it is possible to embark on an e-labelling strategy with this approach. But even this brings with it some management complexity. For instance, there is no guarantee that the team tasked with publishing IFU content online will select the correct version. This could result in online and printed IFUs being out of alignment – a situation potentially exacerbated across country borders, where alternative versions of content come into play. And many web postings of content remain manual upload processes, increasing the scope for error.
As regulations change, products are updated, instructions need to be clarified or errors need to be rectified, these complexities are magnified - increasing the risk of discrepancies. Without having a ‘single source of labelling truth’ to work from, there is a heightened risk that printed and electronic versions won’t match.
To maximise the benefits of e-labelling, and contain risk, there needs to be greater coordination between assets, so that everything is current and connected. The cloud offers a way forward here, providing a means to allow diverse, dispersed teams to do what they need to using the same approved master labelling assets. These can be stored as individual components – even as groups of components for a given use case - that can be brought into play as needed, depending on the given output and context.
Capturing content from multiple sources to build this master resource is a not inconsiderable undertaking, so to be ready to reap the full benefits of e-labelling, manufacturers will need to align their plans now.