Harnessing the Potential of Paligo for Medical Device Manufacturing

GxP-regulated industries produce a lot of documentation as part of compliance with regulatory agencies, and medical device manufacturing companies are no exception. From product specifications and user manuals to quality control and clinical trial SOPs and other documents, the amount of detailed documentation required to support every device is significant.

Not only is a lot of documentation created, but it’s often in multiple languages and can require lengthy review and approval processes. When you are managing all this documentation using multiple systems, it’s easy to miss things or make mistakes (something you can’t afford to do). It’s not uncommon for regulatory approval to get delayed due to missing, inconsistent, or inaccurate documentation.

What if ‌you could provide your medical and technical writers, quality analysts, subject matter experts, and reviewers with an environment that helps them create accurate, reliable, and consistent content? One that enables them to reuse content across documents, supports the creation of documents in multiple languages and helps them get that information in the right hands (and the right format) faster.

A component content management system (CCMS) is the right tool for the job. We will discuss why and how the Paligo CCMS applies the right features and capabilities to support your documentation needs.

As an industry, pharma is realizing that using a document as the unit of content is cumbersome, costly, and complicated to manage on a large scale. Many are contemplating the move to a Structured Content Authoring environment.
– Val Swisher, Content Rules (Data Not Documents)

When a medical device manufacturing company submits a new medical device for regulatory approval, a lot of documentation is included in the submission process. Specific requirements and documentation may vary depending on the regulatory authority and the type of device or drug, but the amount is still significant.

A few examples:

• Detailed documentation on the device’s manufacturing processes, quality control procedures, and specifications to ensure consistent production and product quality.
• Comprehensive labeling and packaging details, including product labeling, instructions for use, warnings, precautions, and any relevant patient information leaflets.
• User guides, installation guides, field maintenance manuals, and product manuals explain how to install, use, and maintain devices.

It takes time to create all this content, and the review and approval process adds even more time. It’s not uncommon for it to take up to 5x longer to produce content for pharma and medical device manufacturing companies than for other industries.

Here’s where the trouble begins.

Yes, a great deal of documentation is required for regulatory approval, but there is also a lot of similar content between documents. As a result, technical and medical writers do a lot of copying, pasting, or duplicating content across documents. Not only is this inefficient and time-consuming, but it’s risky because errors can happen.

Then there are inconsistencies across documents from revisions, terminology usage, and meaning. These inconsistencies confuse readers and reviewers. They prolong the review process and could‌ cause problems for the end consumer.

What happens when a piece of content needs to be updated? Maybe it’s a section in a document that is used in multiple documents (like a product description or a warning). Authors need to search for every place that content is used and update it manually. If that content is written slightly differently or uses different terminology, it may never be found to get updated, leading to inspection problems. Also, if only one or two sections of a document are updated, the entire document still has to go through the review and approval process, which takes more time and is a redundant effort.

As an example, Paligo works with a company that produces variations of a medical device and needs separate product and installation manuals for each variation. There is a lot of common information between variations, and writers were either cutting and pasting or manually rewriting the same information repeatedly. When a document review required a change in a warning (admonition) used throughout the document or in the other versions, the writer had to manually find and make the changes in each document, affecting the review process for all documents.

What we’ll show you is how this company resolved its content challenges using structured authoring and the Paligo CCMS.

You’ve probably heard stories of delayed device approvals because the documentation wasn’t complete or accurate. And you likely have your own horror stories about the efforts required to create the required documentation or keep it updated. But it doesn’t have to be this way. Structured authoring and a component content management system (CCMS) answer these challenges.

When you create your documents using a structured content model, you create and manage content topics (or components) that you can reuse across documents. When a change is made to a topic, every document that includes it is updated. You don’t have to review the entire document, only the updated topic, when a change is made.

Now you might think your writers need to know XML to write structured content. They don’t. When you use the Paligo CCMS, you can easily create and manage reusable content without needing to work directly with XML. Instead, writers focus on creating content, pulling in reusable content components from the library, and writing custom content where necessary. Security is put in place to ensure that only those allowed can access content for reuse and that only approved writers can change reusable components.

If changes are made to a component reused in other documents, those documents are automatically updated. And review and approval is only necessary for the updated component, not the entire document(s). The content is also separated from its styling, so writers don’t need to worry about formatting for different documents or publishing channels.

Localization is another critical aspect of medical device manufacturing documentation. Manufacturers provide their devices to multiple countries and regions, requiring documentation in multiple languages. Different documentation is also required in some instances, or additional information is needed in existing documents. A CCMS fully supports the localization process and manages the publication of translated documents to multiple output formats.

Not every CCMS provides the same capabilities, so let’s focus on how the Paligo CCMS helps you overcome the challenges mentioned around cutting and pasting, duplicating, and translating documents.

There is a lot of duplicate content in medical device documentation. The same content written for the product manual may also exist in a user manual or an installation manual. The goal is to create that same content once and make it available to writers as they create the required documents.

For example, the medical device company mentioned above that produces several device variations and requires different installation and user manuals for each variation benefits from content reuse. First, the technical writer creates the common content, including a term, or sentence fragment, to an entire reusable topic, tagging them so they are easy to find through search or the component library. Then, as each document variation is created, writers can pull in the common content and write unique content as needed.

Another good example is creating admonitions (warnings, tips) that are reused in and across medical device documentation. In the Paligo CCMS, you create the warning and set it as a reusable component. Then, everywhere you need that warning, select it from the list and add it to the document.

These are just some content types you can create and manage with the Paligo CCMS. Others include:

• Product packaging and instructions for use
• Internal documentation, such as field maintenance manuals
• Legal content (e.g. certifications), including in front-matter, appendices, or separate manuals
• Research publications

In all of these examples, if the text of the reusable content is updated, you only have to make the change once, and it’s reflected everywhere it’s used.

As you know, medical device manufacturing is subject to many regulations, and these regulations outline the documentation that is required to gain regulatory approval. When you sell your product in multiple countries or regions, you are often required to produce different documentation or have different information in your standard documents.

The Paligo CCMS provides filtering (also known as profiling or conditional content) that enables you to include or exclude content from a document depending on certain conditions. You can filter entire components or elements in a component, like a paragraph or set of steps. So, for example, you must have specific information on your packaging label for the EU that is not required for the United States (US).

Filtering allows you to create one version of a document that includes or excludes certain content depending on who it is published for. There are filtering attributes for product name, audience, market, country, and others.

You can also leverage metadata on topics to do the same thing. In this case, you simply apply your taxonomy to a component (topic) and then filter on profiles that are mapped to the specific taxonomy terms.

Filtering and metadata can also be applied to producing content in multiple languages. By assigning a filter or a taxonomy term to your topic, when you publish that content to HTML or PDF for a specific language, only the content assigned to that language will print in the document.

Translation costs are dramatically improved with the Paligo CCMS because you translate components and not full documents. Translators only translate content once, reducing the effort required and speeding up the entire process.

In addition, Paligo integrates with ‌leading Translation Management Systems for a seamless localization workflow.

Managing reviews and approvals can be one of the most time-consuming aspects of creating documentation. For example, before discovering Paligo, one customer used a PDF-centric review tool where reviewers would access a PDF version of the documentation and comment. The author would then need to compare the marked-up PDF with their editable version and make the necessary changes. The updated PDF would then be submitted for review.

Review and approval in the Paligo CCMS is seamless. Subject matter experts can review the documentation directly in the CCMS via a Web browser and apply comments. The author can then go in and accept, edit, or reject the edits. They can also use the comments to ask questions or discuss changes, improving collaboration.

The Paligo CCMS offers many other features and capabilities that support medical device manufacturers and pharma companies, including version management and auditing (supporting 21 CFR Part 11).

Errors and delays in medical device documentation are costly. Patients can die if instructions are confusing or wrong, and critical products that save lives are slow to get to market because documentation takes too long to create, review and approve, and publish. The Paligo CCMS enables manufacturers to reduce these risks by providing a collaborative environment that focuses on efficiency and control.

With the Paligo CCMS, creating documentation, reviewing and approving it, producing it in multiple languages, and publishing it in different formats and versions is easier and faster. It also simplifies document sharing between internal departments and external reviewers while ensuring your documentation complies with regulatory requirements. If you are a medical device manufacturer looking to improve your document production, sign up for a demo and see how the Paligo CCMS can help you.