Medical devices
Guidelines for designing inclusive instructions for use that accommodate varying literacy and cognitive levels.
Inclusive device instructions empower diverse users by aligning language, visuals, structure, and pacing with varied literacy, numeracy, and cognitive needs, ensuring safety, clarity, and meaningful usability outcomes for everyone.
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Published by Justin Hernandez
July 19, 2025 - 3 min Read
When designing instructions for medical devices, authors should prioritize plain language, concrete terms, and direct sentences that explain actions in the order they are performed. The goal is to minimize cognitive load by reducing jargon, using everyday words, and defining any essential terms at first mention. Visual cues, such as icons and color contrasts, must reinforce the text rather than contradict it. Consistent terminology avoids confusion across sections, and examples illustrating common scenarios help readers connect the instructions to real-life use. Additionally, accessibility considerations should guide typography choices, including font size, line height, and ample white space, so that readers with reduced vision or processing speed can navigate the information with ease.
A robust approach combines structured content with flexible presentation. Start with a concise purpose statement that relates the device to a tangible benefit, followed by a clear, stepwise sequence. Each step should describe what to do, what to expect, and how to verify successful completion. Where possible, use numbered steps, short sentences, and active voice. Include warnings and cautions in dedicated, visually distinct blocks to prevent ambiguity. Provide troubleshooting sections that address the most common user errors. Test translations for accuracy and cultural relevance, and ensure the layout remains legible on screens of varying sizes and print formats.
Use plain language and proven design patterns to support diverse readers.
In practice, inclusive design begins with user research that captures the range of potential readers—older adults, non-native language speakers, and individuals with cognitive differences. Early findings should inform a style guide that governs vocabulary, sentence length, and the use of diagrams. When prototypes are created, usability testing should observe whether participants can locate information, interpret icons, and perform the steps without external assistance. Documented feedback should be iterated into revisions that improve readability and reduce the need for external glossary references. Accessibility audits, including screen reader compatibility and color contrast checks, are essential before finalizing any official release.
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Clear labeling of sections and consistent formatting across the manual help users build a mental model of the device quickly. Visuals must be legible and relevant, not decorative, with captions that explain what the image demonstrates. Icons should be universally understandable or accompanied by text explanations. The inclusion of alternative text for images ensures screen readers can convey meaning, while tactile or high-contrast elements support users with limited vision. Step descriptions should avoid implied steps that assume prior knowledge, instead spelling out actions, expected outcomes, and safe completion criteria in unambiguous terms.
Build in multilingual support with culturally aware, adaptable guidance.
When addressing numeracy, present measurements and thresholds in multiple formats—words, digits, and simple visual scales—so readers can interpret data without calculation. Use consistent units and avoid unnecessary decimals that might confuse interpretation. If risks or dosages are involved, present ranges with clear boundaries and a direct statement of the action required if a limit is reached. Graphs and charts should be accompanied by textual summaries that translate the visuals into actionable guidance. Finally, offer a quick-reference card or a laminated summary that users can consult without scrolling through the full manual.
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Cognitive load can be reduced by distributing information into short, digestible sections that users can complete in a single sitting. Avoid long blocks of text; instead, present each concept as a discrete, memorable idea. For complex operations, provide checklists, but ensure they remain accessible by screen readers and are printable. Language should remain neutral and inclusive, avoiding gendered terms and culturally loaded phrases. The design should enable recovery from mistakes by guiding users back to a safe state, with clear commands for undoing or pausing a process if they misstep.
Emphasize safety-focused, outcome-oriented guidance in every segment.
Multilingual materials should not merely translate content but reframe examples to reflect diverse contexts and experiences. Choose translation partners who understand medical terminology and the device’s regulatory environment. Provide glossary entries for terms that lack exact equivalents in other languages, and supply pronunciation guides for tricky terms. Visuals must be validated across languages to ensure icons and color cues retain their meaning. If the device is used in different regions, tailor the safety instructions to reflect local regulations while preserving core risks and protective actions. You should also offer audio versions of key steps for users who prefer listening over reading.
Accessibility extends beyond language; it encompasses how information is experienced. For users with memory or attention challenges, segment information into small, repeatable units and include brief summaries at the end of each section. Implement a consistent navigation pattern so returning readers know where to find troubleshooting, maintenance, and safety content. Use supportive features like glossaries and tooltips that can be explored on demand. Provide feedback mechanisms so users can report confusing passages, which drives continuous improvement of the instructions and the device’s usability.
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Measure impact, iterate, and verify accessibility improvements persist.
Safety-focused instructions must clearly distinguish between routine use and actions that deviate from normal operation. Use direct, actionable verbs like “insert,” “press,” or “confirm,” and pair them with observable outcomes, such as a notification light or an audible cue. Include explicit warnings about incompatible actions and potential harm. Design the layout so critical steps appear at the top of the page or screen and are easily skimmed. In hot or moist environments, provide additional guidance for maintaining safe handling and ensuring device integrity. Regularly remind users to consult a clinician if they experience persistent issues.
The practical success of inclusive instructions rests on a robust validation program. Recruit participants who reflect real-world diversity in literacy, numeracy, language, and cognitive ability. Use both qualitative interviews and quantitative task success rates to gauge whether users perform steps correctly without assistance. Document failures in a structured manner and categorize them by root cause—ambiguous wording, complicated graphics, or inaccessible formats. Apply findings to refine wording, restructure sections, and adjust visuals so that future users encounter fewer obstacles and can complete the tasks safely and confidently.
A transparent approach to evaluation includes setting measurable targets for comprehension, speed, and error rates. Collect user feedback at multiple touchpoints, including after onboarding and during routine maintenance. Track whether users with different literacy levels report the same confidence and clarity in following the instructions. Use iterative rounds of revision and retesting to confirm that changes produce tangible benefits, such as reduced help requests and fewer misuses. Publish a brief accessibility updates section with each major release to demonstrate ongoing commitment to inclusivity and safety.
Finally, embed a culture of inclusive practice within organizational processes. Establish roles responsible for accessibility governance and allocate budget for ongoing usability testing. Train authors, designers, and reviewers to consider diverse user needs from the outset, not as an afterthought. Create templates and checklists that enforce inclusive criteria across all documentation and ensure regulatory compliance remains intact. By treating accessibility as a core product value, teams can deliver instructions that genuinely empower every user to use medical devices safely and effectively, regardless of their background or abilities.
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