In the first part of our series, we understood documentation is almost as important as the device itself for the people who use medical devices – whether they’re clinical professionals or patients. Detailed, easy-to-follow instructions, specifications and other technical documentation ensure they’re using the device properly and safely.
Organizations creating and maintaining this content often face barriers in the documentation process. In the first article of this series, we explored the core challenges of four key medical device documentation use cases: medical writing, regulatory submissions, labelling and materiovigilance.
In each case, disconnected review processes, differences in approach between stakeholders and a lack of consistency lead to medical device companies struggling to produce clear, accurate documentation in a timely manner.
Removing bottlenecks and simplifying this content pipeline requires a new approach to creating documentation: structured documentation. Here’s how it works – and how it helps.
Structured content componentizes your documentation
Using a structured content approach, you can break your documentation into small, reusable components that are easy to create, manage, edit, localize and distribute. You only need to create a specific component once; it’s then stored in a central repository that allows you to place that information into a variety of outputs.
Say you’re creating a “warnings” section for a new blood pressure cuff that will be replicated across multiple documents, including the instructions for use and technical file. Using structured documentation, you’d only need to author that section once and insert it into each document – with no need to copy and paste anything.
Let’s explore the key benefits of this structured documentation approach in more depth.
Five ways structured content improves medical device documentation processes
With the flexibility, reusability and easy change propagation offered by a structured content management system, you can replace tedious manual work with automated content workflows to boost efficiency and accuracy in your documentation.
1. Improve content (re)usability with content components
With structured content components, you can eliminate duplication – a common cause of delays and inaccuracies in medical device documentation.
Your source content can be reused across all your documentation types, even if you’re manufacturing devices to different specifications or releasing a new iteration. If that section requires updates – after feedback from regulators, for example – you can simply edit the core component, which will automatically update all the documents using it. This also prevents content from going out of date, which can put patient safety and regulatory compliance at risk.
2. Eliminate paper-based processes and information loss with a digital system
Many stakeholders in the content creation and management process still rely on inefficient, outdated paper processes to review documents, share feedback and collate information.
With a structured content management system, you can centralize and digitalize all your documentation processes. You can create, review, approve and distribute all content, from design and development specifications to post-market data, through an integrated online platform. Not only does this simplify your content workflow, it also cuts out the risk of vital information being lost at the bottom of a paper pile on a stakeholder’s desk.
3. Streamline localization processes and reduce translation costs
With traditional content creation processes, submitting documentation for different markets often creates a bottleneck while you wait for each document to be translated into your target language.
Once translated, you can store componentized content in multiple languages and reuse it in future publications. With no need to resubmit whole documents for translation, you’ll save on localization costs and reduce time to market.
4. Increase transparency for content development with metrics
Because structured content is so granular, you can use your digital management system to track your documentation’s progress through the workflow.
By creating a dashboard to display this analysis, content teams and subject matter experts get a clear overview of the whole process. There’s also the bonus of a chance to identify any stages where the pipeline slows down, so you can refine your workflow over time.
5. Increase compliance with dynamic data integration
Digitalizing your content creation process offers a unique chance to create a more integrated lifecycle for your medical device.
By connecting your data collection systems with the structured content authoring environment, you can automatically pull data directly into content components and document templates. This means every piece of content you produce will be supported by the latest accurate information – crucial for responding to post-market surveillance and adverse effects reports.
Tridion Docs: Your structured content management platform
As an intelligent, headless component content management system, Tridion Docs can help you streamline your medical content processes, ensuring you meet all your production, compliance and post-market responsibilities.
Its collaborative digital platform allows content authors, stakeholders and subject matter experts to work together more closely on medical device documentation, accelerating your workflow and reducing their workload.
With Tridion Docs for Medical Devices, you can easily create multilingual content that’s user-friendly, compliant and ready to evolve alongside your devices.
Discover how you can improve your medical device content with Tridion Docs for Medical Devices.