Streamlining regulated global content: how Insulet modernized publishing with DITA

This post is a summary of a presentation delivered at LavaCon by Bill Swallow and Melissa Lesh. Leah Catania also contributed heavily to the presentation.

Insulet, a leader in insulin pump hardware and software, experienced rapid global expansion. By early 2026, the company’s Omnipod insulin pumps were distributed across multiple global markets. However, the legacy desktop publishing processes that served the company in its early days could no longer keep pace with its expanding product lines, complex integrations, and strict regulatory demands.

To overcome these bottlenecks, Insulet made a strategic transition to DITA. Here is how they modernized their enterprise content operations, navigated Good “X” Practice (GxP) compliance, and streamlined global content delivery.

The challenge of desktop publishing in a rapidly growing market

In Insulet’s early days, documentation was simple: one product, one country, and one language. As the business scaled to support multiple products, languages, and partner product integrations, content development quickly became overwhelming.

The team relied on traditional desktop publishing with over 100 InDesign files—one for every product or market variant. Every guide was manually maintained without source control or traceability of who modified what content when. Copied and pasted content, such as warnings and cautions, were not consistently updated across all variants. Errors were caught late in the process, and translation costs soared as untracked updates required redundant translation work.

When a new R&D project emerged with entirely new delivery requirements—including in-app learning content—Insulet recognized that traditional desktop publishing could no longer support the business requirements.

Navigating GxP in content operations

Because user guides, instructions for use (IFU), and product labeling directly affect patient safety, Insulet’s content operations fall squarely under Good “X” Practice (GxP) standards (Good Manufacturing Practice, Good Documentation Practice, and Good Clinical Practice).

Maintaining compliance and data integrity during a content transformation required a structured approach to tool validation:

1. Define system requirements
   Determine exact functionality needed to manage and publish regulated content.
2. Determine validation scope
   Identify what requires formal validation and what needs remediation. 
3. Execute test runs
   Draft rigorous test cases, secure formal approval, group them into test runs, execute testing, and archive approved results with strict segregation of duties.

By formalizing GxP processes within the new toolset, Insulet established full auditability and source control over its regulatory content.

The move to structured authoring and intelligent reuse

Insulet partnered with Scriptorium to move from unstructured InDesign files to structured content management using DITA and a centralized CCMS. Moving to a single-source structured environment unlocked new publishing channels and dramatically improved translation efficiency.

In addition to maintaining existing print and digital PDF outputs, Insulet introduced automated mobile-first HTML publishing. This allowed the same core DITA content to feed directly into in-app contextual help for mobile software applications.

With translation baseline tracking inside the CCMS, Insulet eliminated redundant localization work. Instead of re-translating entire manuals, the system automatically identified and packaged modified content for translation.

The business impact

The move to DITA transformed Insulet’s content operations, delivering clear value to the business, authors, and end users.

• Business and executive wins
  Dramatically reduced localization costs, accelerated time-to-market for new regional expansions, and enabled modern delivery channels like in-app contextual help.
• Authoring and production efficiency
  Eliminating manual copy-paste workflows and tedious InDesign formatting reduced redundant work. Authors gained centralized source control, a domain-specific content model, and full transparency across released versions.
• End-user quality and safety
  Standardized content models ensured consistent warnings, cautions, and instructions across every document type and variant, reinforcing trust and patient safety.

Key takeaways

1. GxP takes time: Always overestimate the timeline needed for formal GxP requirements, test case drafting, and validation sign-offs.
2. Account for the learning curve: Mastering structured authoring, DITA architecture, CCMS workflows, and metadata taxonomy simultaneously is a steep learning curve for team members.
3. Plan for concurrent operations: Ongoing product releases and operational work do not pause for a content migration. Strategy and resource allocation must account for active business demands during implementation.