New directives and guidance aim to connect patients, physicians and other stakeholders across the healthcare ecosystem with a consistently up-to-date information source for product and safety information that isn’t dependent on paper. Schlafender Hase’s Peter Muller explores the promise of e-labeling and practical next steps required to deliver on these directives.
Published in MedTech Intelligence
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, which takes them to the latest details, in an easily digestible format, often including audio and video options, for maximum accessibility.
Although the life sciences industry has some way to go to match these ‘e-labeling’ experiences, regulators are making moves to change this through new directives and guidance.
Asian markets and Australia are leading the way here, but the trend towards e-labeling and digital patient information leaflets (e-PILs)/instructions for use (e-IFUs) is moving east and west, with European and North American markets now promoting electronic alternatives to the folded physical inserts in tiny print that have traditionally accompanied medicinal and medical device products.
What Is e-labeling and Why Do We Need it?
e-labeling makes externally facing product information more dynamic and immediately accessible online or through an app. This information can be provided as a downloadable document, a 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 and healthcare providers) to access and digest, while also ensuring that the guidance is as up to date as possible.
Paper inserts 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 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 when 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 There may also be a level of risk to patients if they are accessing information that has been superseded
- 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
- Potential regulatory requirements, including Section 508 and the European Accessibility Act
Evolving Regulatory Requirements
Across many developed markets, the medical device industry is already subject to considerable regulatory change, geared toward improving device traceability and patient safety. These measures have been driven by high-profile safety events, such as the PIP breast implant scandal in Europe, and by advances in technology including a growth in both smart implanted and wearable devices, and an increase in combination products (devices and pharmaceutical products that work in concert).
EMA’s Medical Device Regulation and its in-vitro equivalent, IVDR, are among the updated sets of requirements designed to provide fit-for-purpose safety controls. And specific guidance around e-labeling is being added at a quick pace. In December 2021, the European Commission adopted a new Implementing Regulation (EU) 2021/2226 for the use of e-IFUs for medical devices, with application from January 2022. The Regulation adapts the conditions and requirements for going ‘paper free’ for manufacturers of medical devices, including software covered by EMA MDR/IVDR.
The term ‘e-labeling’ potentially understates 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-labeling by target user group. 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 health care providers and include:
- Implantable medical devices
- Active implantable medical devices
- Fixed medical devices and accessories designed to be installed, fixed, or otherwise secured at a specific location within a healthcare facility
- Medical devices equipped with an integrated system for displaying information for use (IFU) software governed by the MDR
A next phase will see digital resources, shared via web sites and mobile apps, extended to patients. The idea is to have a robust digital platform in place before eventually moving away from paper-based IFU inserts.
The Benefits of e-labeling
With patient safety and access to consistent information in mind, movements are afoot to ensure that e-labelling is harmonized around the globe, in line with international minimum standards. So, any investments made now will lay valuable foundations for eventual global delivery.
Operationally and reputationally, creators and suppliers of medical devices have much to gain by embracing e-labelling at their earliest opportunity. Potential benefits include:
- Opening access to new markets
- New process efficiencies throughout the supply chain
- Cost savings spanning resources, procurement, warehousing and transportation
- Reduced environmental impact, increasing sustainability
- A positive return to the bottom line and ultimately to shareholders
Transitioning to e-labeling
The changes required to deliver these benefits will be felt widely, and require a joined-up approach to transformation to minimize the pain and maximize the numerous potential gains. Many of the operational gains are based on the increased accuracy of content (getting all aspects of labeling right first time).
Paper and electronic versions of content will co-exist for a time, ensuring that all medical device users can access the information they need in the way they prefer to digest it, to maximize 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 interacting with online or app-based resources.
How To Get Started
By beginning the process now, companies can take early advantage of processes, procedures and solutions that deliver efficiencies across today’s labeling landscape and add new value for patients. As medical device manufacturers prepare for a digital-first future, they will be rewarded with long-term improvements, such as:
- Ensuring that content is correct, controlled and compliant at source – ‘right first time’
- Ensuring that content is transformed accurately across print and online formats – simultaneous and ‘error-free’
- Ensuring global transparency and governance across the distribution and lifecycle of content – ‘controlled distribution’
These three essential capabilities of e-labeling give manufacturers the ability to transform accurate content into any format that can then be published in a physical or virtual form, as well as posted to competent authority databases. A pragmatic approach to this is likely to involve the application of intelligent proofreading software, which can identify any anomalies swiftly and reliably.
Underpin all of this with an integrated infrastructure and simplified processes with real-time controls, and manufacturers will be ready to fulfill any e-labeling requirements, avoiding the need for major 11th hour resource expansions and costs to meet impending deadlines.
Practical Next Steps
If you are ready to move toward e-labeling capabilities, start with the end goals in mind and review all existing guidance, regulations and standards proposed by the Global Harmonization bodies to gain an understanding of today’s regulatory landscape and tomorrow’s potential. Then, take proactive steps to create and execute a coordinated e-labeling strategy and plan as follows:
- Consider current and future devices in scope as well as their target user groups
- Assess and map the existing labeling landscape, procedures and vendors to understand your company’s readiness for electronic labeling, and create a gap analysis to feed into any business case.
- Scope the e-labeling project to align with any immediate needs, focusing on current and future target markets and the devices sold into those regions. Look to more established markets (e.g. Asia and Australia) for examples of emerging best practices and target benefits. Target quick wins that can be championed and will provide evidence of early success
- Produce a high-level project plan, including key champions and stakeholders. This should include a cross-functional team to identify the scope of e-labeling impact on the manufacturer. Build training and knowledge transfer into the resource planning.
- Build and present an ROI/business case highlighting the benefits of the e-labelling initiative to patient safety and the business, including wider environmental sustainability gains, making sure to address the four strategic priorities of any manufacturer: financial; patient; operational; and growth.
Once the real work begins in earnest, devote time to defining the scope, objectives and key performance results, and monitor these on an ongoing basis. Finally, communicate and celebrate all wins to sustain momentum.
The explosion of e-commerce and mobile device use shows how quickly and dramatically shifts in consumer behavior can happen once new and convenient options are made available to them. Given the diverse benefits promised by e-labeling, it makes sense to be at the head of this trend.