Regulators want patient and product safety information available in up-to-date, digital formats. What are the practical steps needed to being technology to life?
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.
Published in Pharmaceutical Manufacturing and Packing Sourcer
Although the life science industry has some way to go to match these ‘e-labelling’ experiences, regulators are making moves to change this through new directives and guidance. Asian markets and Australia are leading the way here, but steadily the trend towards e-labelling and digital patient information leaflets (e-PILs)/instructions for use (e-IFUs) is moving east and west.
Solving paper-based challenges
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 costly printed instructions being misplaced or damaged; poor accessibility due to very small print because the leaflets have to try to cover all bases; safety information being superseded; potential regulatory requirements: Section 508 (https://www.section508.gov/create/pdfs/) and European accessibility act – Employment, Social Affairs & Inclusion – European Commission (europa.eu).
Twin drivers for device regulation
Across many developed markets, the medical device industry is already subject to considerable regulatory change, geared to 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 which have seen a growth in both smart implanted and wearable devices, and 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 is being added all the time, around e-labelling. 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-labelling’ 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-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 Health Care Providers.
The current scope includes:
- 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 – via web sites and mobile apps – extended to patients. The idea is to have a robust digital platform in place before eventually going away from paper-based IFU inserts.
The benefits of e-labelling for device manufacturers & suppliers
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.
Operationally and reputationally, creators and suppliers of medical devices have much to gain by embracing e-labelling at their earliest opportunity. Benefits potentially 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.
Springboard to digital-first
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.
As medical device manufacturers prepare for a digital-first future, there are three critical steps that will provide an optimal 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 – simultaneous and ‘error-free’; and
- Ensuring global transparency and governance across the distribution and lifecycle of content – ‘controlled distribution’.
These three essential capabilities afford manufacturers the ability to transform accurate content into any format, to 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.
Executing e-labelling strategy
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-labelling strategy and plan, as follows:
1. Understand the regulatory landscapes & timeframes
Consider the current and future devices in scope and their target user groups.
2. Map the existing labelling process
Assess and map the existing labelling landscape, procedures and vendors to understand the company’s readiness for electronic labelling. Create a gap analysis to feed into any business case.
3. Scope the e-labelling project
Scope the e-labelling project to align with any immediate needs, focusing on current and future target markets and the devices sold into those regions. Also consider developing foundations for the future, and start with that vision in mind: including patient interaction with online resources to boost the safe use of the device. Look to more established markets (e.g. Asia and Australia) for examples of emerging best practice and target benefits. Target quick wins that can be championed and will provide evidence of early success.
4. Create a high-level project plan
Produce a high-level project plan, including key champions and stakeholders. This should include a cross-functional team to mirror the scope of e-labelling impact on a manufacturer. Build training and knowledge transfer into the resource planning.
5. Build & present an ROI/business case
Build the 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 monitoring these on an ongoing basis. Finally, communicate and celebrate all wins, to sustain momentum.
The shift towards digital product information delivery is inevitable, and companies should embrace the convenience and accessibility of digital product information. With the support of regulators and industry leaders, digital product information is set to become the new standard for medical device product information. Companies must leverage this opportunity to stay ahead of the competition and provide customers with the best possible experience.
About the author
Dr. Jutta Hohenhörst, Regional Sales Director at Schlafender Hase, has over 22 years’ experience in the pharmaceutical business. She has experience in different departments from Supply Chain Management to Strategic Marketing in F. Hoffmann-La Roche HQ, AstraZeneca and Fresenius HQ. While working for IQVIA during 2005 and 2012 she broadened her knowledge through strategic consulting projects in the pharma, medical device and hospital sector.
Schlafender Hase (https://www.schlafenderhase.com/) provides intelligent proofreading software for regulatory environments.