In the U.S. and other regulated markets, Instructions for Use (IFUs) for medical devices must meet high standards. Such a practice is mandated not only for safety and clarity, but also for regulatory compliance and global usability. A growing number of manufacturers now recognize that visual aids aren’t just design enhancements. They are essential tools for ensuring safe product use, reducing user error, meeting FDA expectations, and improving localization efficiency.

In this article, we explore five strategic benefits of incorporating well-designed visual aids into IFUs and outline the approaches needed to achieve each goal. We also highlight real-world examples from leading global brands, and show how Hansem Global and Amin Wasserman Gurnani LLP (AWG) help medical device manufacturers create documentation that performs.

To support this critical task, Hansem Global and AWG offer a joint solution that bridges regulatory content and legal compliance. Hansem Global brings deep expertise in multilingual documentation and usability-focused IFU development, while AWG provides unique legal insights into FDA labeling rules, submission procedures, and enforcement risk. Together, we help manufacturers create IFUs visual aids that are not only effective but also FDA-compliant, submission-ready, and defensible.

1. Drive Immediate User Response to Risk

Visual aids such as warning icons, prohibited action symbols, and color-coded graphics are critical in helping users quickly recognize and avoid danger.

• In urgent or repetitive use environments, users often rely on instinct, not careful reading.
• Visual aids reduce cognitive load and prompt faster, safer reactions.

To align with the FDA’s Human Factors Guidance, which stresses visual clarity in risk communication, especially for high-consequence procedures, you should:

• Emphasize hazardous zones or prohibited actions with clear graphics.
• Compare incorrect and correct procedures to reinforce proper usage.
• Support Human Factors Engineering by enabling intuitive user behavior.

2. Increase Accessibility for All User Types

Visual aids support comprehension for non-experts and first-time users. They must be accessible to patients, older adults, and users with limited English proficiency.

• Your IFUs must work for more than just physicians or technicians.
• In home-use devices, visual-first IFUs often determine whether a product is adopted or returned.

To improve accessibility for diverse user types, you should:

• Use sequential illustrations for device setup, cleaning, or maintenance.
• Convert complex processes into intuitive, story-like visual flows.
• Design for independent use, so users can operate the product safely without external help.

3. Improve Localization and Translation Efficiency

Most U.S. manufacturers target global markets, requiring IFUs in multiple languages. Visual aids reduce text volume and minimize room for interpretation, leading to faster and more accurate localization.

• Well-planned visual aids can typically reduce translatable content by 15 to 30%.
• Reusing visual aids across all languages maintains brand consistency, lowers costs, minimizes translation errors, and speeds up review cycles, resulting in shorter time to market and more scalable document workflows.

To maximize the benefits provided by visual aids, you should:

• Develop effective visual aids that meet the requirements of all relevant standards and regulations.
• Structure your IFUs to maximize the use of visual aids and facilitate smooth, efficient translation.

4. Ensure Procedural Clarity and Regulatory Readiness

Procedures such as installation, cleaning, and component replacement are often misunderstood when conveyed through text alone.

• Misunderstanding leads to user frustration, product damage, and increased support calls.
• Visual aids, such as diagrams and procedural illustrations, provide clarity across all skill levels.

To develop IFUs that are easy to understand and use, you should:

• Guide users step-by-step with task-based visual aids.
• Standardize performance regardless of user experience.
• Offer concrete evidence of risk mitigation in FDA submissions.

Note When Philips Healthcare issued a recall for patient table slippage risks in its Allura and Azurion systems, the corrective action included visual quick-reference materials with enhanced procedural illustrations—showing how visual design became a central part of regulatory response. See FDA Class I Recall Notice.

5. Reinforce Brand Credibility and Professionalism

A visually polished IFU isn’t just helpful. It reflects the quality of your brand.

• Buyers, regulators, and clinical partners all assess your documentation.
• A clear, consistent visual system elevates trust.

To develop IFUs that reinforce your brand, you should:

• Use a unified graphic style across formats (PDF, app, video, web).
• Align with expectations for digital-first, high-end medical products.
• Support marketing and customer education with cross-channel materials.