In the evolving landscape of regulatory writing, it has become clear that creating clear and compliant documents is no longer enough. Building off the principles of lean authoring, regulatory writers must now consider holistically the experience of those who will review the documents. This is where human-centered design (HCD) principles, traditionally used in product and user experience (UX) development, can revolutionize the way we approach submissions. Just as product developers focus on user needs, regulatory writers can adopt HCD to create submissions that reduce cognitive load and enhance the reviewer’s experience.
What Is Human-Centered Design?
Human-centered design is a problem-solving framework that prioritizes the end-user’s experience. In product design, this means building products that are intuitive and easy to use. In regulatory writing, it means understanding how a reviewer interacts with the content—considering their time constraints, mental energy, and the complexity of the information presented.
By applying HCD to regulatory writing, we focus not only on compliance but also on making the submission process smoother and less burdensome for reviewers. This approach can lead to faster reviews, better comprehension, and ultimately, quicker regulatory approvals.
Reducing Reviewer Cognitive Load
One of the key principles of HCD is reducing cognitive load—the mental effort required to process information. In regulatory submissions, this translates to writing that is straightforward, well-organized, and easy to navigate. Here’s how you can integrate this principle into your writing:
– Use clear headings and subheadings: Break down complex sections with descriptive titles that guide the reviewer through the document.
– Minimize jargon: Avoid overly technical language where simpler terms will do. Even specialized reviewers appreciate clarity.
– Use visuals wisely: Tables, charts, and graphs can reduce the effort required to interpret large amounts of data, but they should be clean and purposeful, not overwhelming.
By adopting these tactics, regulatory writers can ease the mental effort on the part of reviewers, allowing them to focus on critical analysis rather than untangling the information.
Designing for Time Constraints
Reviewers are often working against tight deadlines. HCD encourages us to think about how we can make the most of their limited time. Here’s how:
– Prioritize key information: Place critical data and conclusions upfront, allowing reviewers to quickly grasp the most important points.
– Summarize effectively: Use executive summaries or overview sections to give a snapshot of the document’s contents before diving into details.
– Consistency across documents: Maintaining a uniform structure across different submissions helps reviewers anticipate where to find information, saving them time in navigating new documents.
Designing with time constraints in mind ensures that reviewers can easily locate what they need, leading to a more efficient review process.
Improving Information Consumption
Different reviewers may engage with the content in different ways. Some may prefer a linear read-through, while others will skim and dive into sections of interest. HCD helps us cater to these varying preferences by:
– Layering information: Present high-level summaries first, with the option to dive deeper into appendices or detailed sections as needed.
– Interactive elements in digital submissions: When possible, leverage digital features like hyperlinks and bookmarks to allow easy navigation between sections.
– Clear signposting: Make sure each section logically connects to the next, and use cross-references to highlight related content, making it easier for reviewers to explore further.
These strategies align with lean authoring, a methodology that emphasizes efficiency and clarity in writing. Lean authoring, as championed by Gregory Cuppan, seeks to streamline the writing process without sacrificing quality. Incorporating HCD principles can take lean authoring to the next level by not only making documents more efficient to produce but also more efficient to review.
The Future of Regulatory Writing: A Human-Centered Approach
The next frontier in regulatory writing will be shaped by how well we can adopt principles from other disciplines like UX and HCD. By focusing on the reviewer’s needs—reducing cognitive load, respecting time constraints, and improving information consumption—we can create submissions that are not only compliant but also much easier to review. This, in turn, can lead to faster approvals and a more collaborative relationship with regulators.
As the regulatory landscape continues to evolve, human-centered design will become an essential tool for regulatory writers aiming to stay ahead. By putting the reviewer at the center of the writing process, we are not just simplifying submissions—we are shaping the future of regulatory communications.
