Medical device companies creating product labeling and quality documentation with MDR/IVDR compliance in mind may find that their traditional approaches to these types of content may no longer work. The old document-based approach of creating IFUs, operating manuals, quality reports and technical documentation does not lend itself to control of regulated content, multichannel publishing, and efficient and accurate change management. This is crucial in the new paradigm presented by MDR/IVDR.
Structured content authoring for MDR/IVDR compliance
The solution for long-term, efficient MDR/IVDR compliance is a comprehensive content strategy, supported by structured content authoring, content management, and content delivery integrated with automated translation workflow.
Challenges with the traditional approach to medical device content
The current document-based approach to content management falls short of an efficient solution due to the unstructured approach inherent in publishing tools like InDesign and Microsoft Word. Versioning and change tracking are manual, and there is no sharing of content across document types and products. Each document is manually republished with any update or change.
In addition, standalone publishing tools contain no workflow. However, where workflow does exist, in a QMS system for example, there is typically no content management. All this inefficiency multiplies exponentially as the language requirements for MDR/IVDR are applied.
Siloed departments are creating and updating their own content for Packaging, Labelling, Marketing, and Quality. Each siloed effort loses on potential reuse across these content types. In addition, the requirements for post-market surveillance will generate data that will drive updates to technical documentation, quality and safety reports, instructions for use, and product inserts. Depending on the device class, these safety reports must be updated regularly.
A medical device company with 200 products can potentially have IFUs, User's Guides, packaging, and safety docs that will require regular updates - all containing shared content. As the multitude of SKUs required per region and country are included, the complexity grows. The traditional siloed, document-based approach will not be up to the task long term.
Finally, traditional approaches to content delivery are focused on product where modern search and web experience is lacking. All of this results in slower time to market, higher costs to market, and risks to quality and compliance.
Structured content approach – the Acolad solution
A content strategy that is focused on abandoning the document-based approach, identifying where content is commonly used and varies, defining a change management process, and shifting to a structured content authoring model addresses these challenges. A structured content approach breaks up content into topics that enables reuse, change management, and automated publishing in multi-channel formats. Key content - whether it be claims, regulatory information, localization information, or common topics shared across products or within a product line - can be identified and managed so that documents are automatically created based on the assembly of the appropriate components.
Enabled by content management system (CMS) technology, versioning and change traceability is automated and workflows are integrated. At Acolad, we can integrate the CMS with our automated translation workflow system that feeds content to translation and back into the CMS. Coupled with the use of translation automation (translation workflow, computer assisted translation, and machine translation), further gains in efficiency and reduction in time to market across the global strategy can easily be achieved and result in a robust end-to-end solution.
Finally, an integrated delivery portal where user-friendly formats and powerful topic-based search functionality is available delivers an improved user experience. Through the delivery platform, end users of the content can provide feedback and valuable analytics can be captured.