Agnes Cwienczek, Amplexor
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Electronic Product Information: A Roadmap to the Business Benefits

By Agnes Cwienczek
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Agnes Cwienczek, Amplexor

Digital technologies offer more efficient and patient-friendly distribution of the up-to-date manufacturing details and safety advice mandated by regulators. But many firms in the medtech sector are not maximizing the opportunity to deliver regulated product information digitally.

Health and regulatory agencies across the world are showing increasing interest in introducing standardized requirements for electronic product information (ePI). At the same time, patients and healthcare professionals are increasingly receptive to digital delivery of ePI. But the potential ePI technology offers medtech companies to increase efficiency, decrease error and delay, and accelerate time to market is perhaps the factor that is driving the digitalization of product information most of all. The article highlights the business benefits of electronic product information and suggests how companies might begin to scope the work required to reap the rewards of digitization.

Paper-based instruction leaflets to inform patients and healthcare professionals of when and how to use medical devices, and advise them about any safety considerations, are an anachronism in the digital world. Although they may remain an important option for populations without ready access to the Internet, paper leaflets are far from the most effective or efficient means of disseminating critical information. The documents may be mislaid, or the print may be very hard to read, and there may be several pages to plow through because of the detail companies need to cover—not to mention the multiple languages that may need to be included.

The concern is that health professionals may find it difficult to find the content that is relevant and important to them. More critically, paper-based product information or instructions-for-use can soon go out of date, either because new safety signals have been identified since the current batch of products went into distribution, or because devices have been sitting in a cabinet for months or years. Getting updated safety guidance out with products can take months or even years, depending on companies’ cycle times and how much stock is already out in markets.

Moves to Standardize ePI

Standardized requirements for ePI are on the horizon, encompassing the package leaflet for patients and the summary of product characteristics (SmPC) for healthcare professionals. Issuing product information electronically will promote more confident decision-making among healthcare professionals, making it easier for them to search for the latest safety advice.

Digitization will enable medtech companies to put all of the latest details and advice about a product online, accessible via a mobile phone, a web link, or by scanning a barcode/QR code on a product label. For human pharmaceuticals, publishing electronic product information is already mandatory in the United States, while Canada, Brazil, the EU and Asia are piloting or looking at programs too, defining guiding principles and polling the market for feedback. Meanwhile medical device manufacturers shipping to the EU are already required to publish up-to-date product and safety information online if they have a website.

For the medtech sector, a gradual shift towards digital product information delivery would deliver many benefits, ranging from accelerating speed to market with the latest safety advice, boosting the patient experience and patient outcomes, and building trust. Another substantial advantage is cost efficiency.

Building Capabilities for Publishing Regulated Content

The ability to publish ePI online will relieve the pressure on paper-based information publishing, and all of the logistics involved, not to mention the potential for label/leaflet wastage each time information or messaging changes. Shorter change management/publishing cycles contribute to accelerated regulatory processes, resulting in improved speed to market with products, and strengthened continuity of supply. However, organizations must have streamlined and reliable means of managing and approving changes to content if they are to reap cost efficiencies.

With so much to gain as product information goes digital, it follows that medtech companies should embrace the potential at their earliest opportunity. But this can only happen when their information and content management processes are ready to roll out accurate information and update it at frequent intervals, as needs dictate, across global markets.

This is not a trivial requirement and most medtech companies are not ready. Their capabilities for publishing regulated content tend to be so constrained that larger companies typically outsource their labeling management requirements. It feels easier to send data and get print-ready files, than to contemplate transforming regulatory content management backbones to better support process innovation.

The need to deliver electronic product information creates a robust use case for structured content authoring, where companies can confidently assemble the latest, correct information (which has been approved for use), for the current purpose. If companies had a facilitating content management backbone extending from one end of the organization to the other, globally, and were able to work with approved core data assets that had been captured in a structured way to enable easy re-use, they would have the potential to transform the way they manage labeling—and publish changes online (which even older labels would link to, because the web address/ QR code wouldn’t change).

Transforming Content Lifecycle Management

There are a number of steps medtech companies must take before they can start capitalizing on ePI efficiencies. Successful transformation of label content lifecycle management will rely on improvements to content, technology and processes. That is, any investment in technology to support digital transformation must be matched by measures to assess, connect, clean up and restructure current data sources; and new thinking about how information and content processes could be managed in future to drive new, more effective and efficient labeling strategies.

Companies should start to unify as much of their information and content preparation as possible, in accordance with common regulatory requirements. Using the controlled vocabularies set out by electronic submission standards (currently xEVMPD in the EU, to be succeeded by the more detailed ISO IDMP-based requirements; regulatory agencies can provide the recommended schema), they can start to impose improved consistency in the way regulated product information is constructed. This will help create solid content components or building blocks for all labeling.

Establishing a definitive repository for correct, current, approved content assets is essential too— along with details of current product registration status and submission activity globally, including information about which labels are in circulation and where. Considerations might include: Will we need a conversion tool to analyze, compare and transform existing labellng information and how do we stay aligned with evolving IDMP data parameters? It is a good idea to identify areas suitable for carrying out a small pilot project, to test assumptions and the planned approach to change.

An end-to-end regulatory information management (RIM) platform will play an important part, forming the backbone across which all active and historic content, along with associated status information, can be viewed and managed.

Delighting Customers with Digitalization

There is no time to wait for regulators to mandate change to electronic product information delivery. Continuing with current labeling practices and product information delivery is unsustainable. Digitization offers real opportunity, not only to drive efficiency but also to add value through greater information accuracy, easier content validation, accelerated regulatory processes, rapid safety updates, and the phasing out of frequent print updates and the potential for wastage each time information changes. Transforming to digital-first ePI delivery will enable companies to serve existing customers better and win new ones.

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