I recently came across a great commentary in the August 2021 issue of “Pharma Technology Focus.” The article is titled, “MDR set to transform how MedTech firms approach content management,” written by Barbara Peraltor, Director of Life Science Solutions at Amplexor. 

Barbara makes a number of pertinent points in the article:

The recently implemented EU Medical Device Regulation (MDR) and the upcoming In Vitro Diagnostics Regulation (IVDR) have new requirements that will greatly impact the content associated with medical devices in the EU

        • Labels need to be readable by a lay person
        • Implantable devices need a Summary of Safety and Clinical Performance (SSCP)
        • Content needs to be updated regularly, as MedTech companies evaluate more data gathered from patients

MedTech companies need a content strategy that focuses on the short and long term to meet the challenge

Various content-producing departments need to share information, rather than maintain content silos

MedTech content needs a single source of truth

MedTech Needs Structured Content

To meet the demands of MDR and IVDR, it is clear that MedTech needs to move to a structured content ecosystem. Structured content offers tremendous benefit to MedTech:

Content is created in reusable chunks called components, enabling a “write once/use everywhere” single source of truth.

Content is separate from format, allowing the same components to be published to multiple devices and channels.

Components can be shared across silos, eliminating the need for duplicate or triplicate writing and approval efforts.

Write once/use everywhere means that content is written, reviewed, approved, stored, updated, and retired one – and only one – time.

        • Saves time
        • Improves quality
        • Lowers cost

MedTech Needs State of the Art Content Management

To be successful, components are best stored in a component content management system (CCMS). A CCMS is a content management system that stores components, rather than documents. A CCMS can provide data-rich information about each component including:

        • Versioning
        • History
        • Branching
        • Ownership 
        • Where used tracking
        • Relationships such as parent/child and source/translation information
        • Check in / Check out capability
        • Workflows such as collaborative review routing
        • Publishing status

Unlike a CCMS, traditional flat file storage systems cannot provide the type of robust information MedTech needs to make decisions about content. 

XML Authoring 

Many structured content ecosystems are based on XML. XML is the most proficient environment for component content management. There are a number of XML authoring tools on the market, with differing levels of complexity. 

However, more and more CCMSs include a simplified authoring environment built into the management system itself. These authoring tools hide the complexity of XML authoring, making the environment easy to use like MS Word or Google Docs. 

Content Should Drive Tools, Not the Other Way Around

Planning is critical to the success of any content strategy. It is important to have a clear understanding of your current content environment and the state that you need to achieve. Analyzing the gap and creating a phased approach to closing the gap will help ensure your success. 

Don’t be persuaded by the latest bright shiny object. Far too often, companies select a tool without having a clear strategy. This leads to content being “shoehorned” into a tool that doesn’t suit its needs. Always take a content-first approach.

Work with a Trusted Partner

As Peraltor states, “A good partner can help with a pilot project and ROI modelling to show the savings possible from adopting a particular approach and system.”

At Content Rules, we have 27 years of experience helping customers design, build, and execute structured authoring solutions. We have worked with dozens of MedTech companies to help them implement the best solution for their content requirements. Drop us a line today to find out how we can help you, too. 

Val Swisher
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