Practical next steps for device manufacturers & distributors as regulators demand the digital delivery of customer-facing product information in place of paper inserts
A Schlafender Hase guide
In the consumer world, it’s now common practice to access product information online. For detailed instructions or information about manufacturing practices, safety advice and so on, users can scan a QR code or go to a web address. This will take them to the latest details, in an easily digestible format – often including audio and video options now, for maximum accessibility.
Although the life sciences industry has some way to go to match these ‘e-labelling’ experiences, regulators are making moves to change this through new directives and guidance.
The aim is to connect patients and healthcare providers with the very latest product and safety information on demand. This has practical implications for the way manufacturers and distributors of medical devices create and manage their market-facing information and packaging.
This short article distils the key information companies need to know about the changes. A more detailed eBook which explains the evolving regulations, and delves deeper into the roadmap for change, is available to download here.
What is e-labelling, and why is it coming?
Electronic labelling, or e-labelling, makes externally-facing product information more dynamic and immediately accessible online or through an app. That could be as a downloadable document, as shorter-form searchable text, or in alternative formats such as audio- or video-based instructions. The idea is to make important information easier for users (patients, caregivers or healthcare providers) to access and digest – while also ensuring that the guidance is as up to date as possible.
Paper inserts (instructions for use – IFUs; or patient information leaflets – PILs) present a number of practical challenges that can be readily solved in the digital age. These include:
- The risk of instructions being thrown away, misplaced or damaged;
- Poor accessibility/digestibility – e.g. due to very small print, and the fact that the leaflets have to try to cover all bases, cramming in as much information as possible for every eventuality;
- Limited shelf life. Paper-based IFUs/PILs are printed in bulk leading to waste once product/manufacturing information or safety advice needs to be updated. There may also be a level of risk to patients if they are accessing information that has been superseded.
- At a practical and logistical level, paper inserts are costly to produce, they add weight and density to packaging, and the process of printing and transporting them is not environmentally friendly.
Regulators’ evolving requirements
Across many developed markets, the medical device industry is already subject to considerable regulatory change, geared to improving device traceability and patient safety. Specific guidance is being added all the time, around e-labelling. (Details are set out in our eBook).
The term ‘e-labelling’ potentially underplays the scale of change that will be involved as digital information delivery becomes the default for medical device product information and instructions for use.
Appreciating this, EMA is phasing in e-labelling by target user group in Europe. For now, the provision to provide IFUs in an electronic format instead of paper form is limited to certain medical devices and accessories intended for use under specific conditions. These are devices used by ‘professional’ healthcare personnel.
A next phase will see digital resources – via web sites and mobile apps – extended to patients. The idea is to get a robust digital platform in place before eventually doing away with paper-based IFU inserts altogether.
With patient safety and consistent information access in mind, movements are afoot to ensure that e-labelling is harmonised across the globe, in line with international minimum standards. So any investments made now will lay valuable foundations for eventual global delivery.
The benefits of e-labelling for device manufacturers & suppliers
Operationally and reputationally, creators and suppliers of medical devices have much to gain by embracing e-labelling at their earliest opportunity. The potential benefits of e-labelling will span the whole business:
- Open access to new markets;
- New process efficiencies throughout the supply chain;
- Cost savings spanning resources, procurement, warehousing and transportation;
- Reduced environmental impact, increasing sustainability; and
- A positive return to the bottom line and ultimately to shareholders.
- Time Savings
- Information control and access to up-to-date compliance information
- Allows for products to reach market sooner
The changes required to deliver these benefits will be felt widely, and require a joined-up approach to transformation to minimise the pain and maximise the numerous potential gains.
Many of the operational gains are based on the increased accuracy of content: of getting all aspects of labelling right first time.
Transitioning to e-labelling
Paper and electronic versions of content will co-exist for a time, ensuring that all medical advice users can access the information they need in the way they prefer to digest it, to maximise patient safety.
This overlap as e-labelling is phased in offers device manufacturers the chance to align and hone their content management – with a view to gradually phasing out the reliance on paper, as device users become more comfortable with interacting with online or app-based resources in real time.
By getting ahead now, companies can take early advantage of processes, procedures and solutions that provide a digital platform for the future, deliver efficiencies across today’s labelling landscape, and add new value for patients.
Why start now?
The explosion of e-commerce and mobile use shows how quickly and dramatically shifts in consumer behaviour can happen once new and convenient options are made available to them. So it makes good business sense to be ahead of this trend.
As medical device manufacturers prepare for a digital-first future, there are four fundamental steps that will provide the perfect springboard to this:
- Ensuring that content is correct, controlled and compliant at source – ‘right first time’;
- Ensuring that content is transformed accurately across print and online formats – ‘error-free’; and
- Ensuring global transparency and governance across the distribution and lifecycle of content – ‘controlled distribution’
- Implement the correct tools to help reduce unnecessary manual work and manage steps #1 -#3
Our eBook provides a walk-through of the practical next steps medical device manufacturers should be planning now.
To download our eBook, click here.