Visual Aids in Medical Device IFUs: Why They’re a Strategic Asset, Not Just Design
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.
- 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.
- 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.
- 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.
- 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.
- 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.
Case Studies from Global Leaders
Top global brands use visual strategies in their IFUs to boost user understanding, reduce risk, and ensure compliance. The examples below outline how visual aids improve usability across patient and professional settings.
Medtronic
For patient-use medical devices such as the MiniMed™ 780G insulin pump, Medtronic employs a highly visual IFU strategy that includes step-by-step pictorial guides, annotated screen captures, real-device photos, and QR codes linking to video tutorials. These visual tools improve comprehension across diverse user groups—including non-native speakers and patients managing their care independently.
→ See example: MiniMed™ 780G Quick Start Guide (PDF)
Philips
Philips, for example, uses real-life photo sequences and clear warning symbols in the IFU for its SmartCT Soft Mattress—helping healthcare professionals follow proper installation, removal, and cleaning steps with high accuracy. This approach minimizes ambiguity and supports behavior-based compliance across global markets.
→ See example: Philips SmartCT Soft Mattress IFU
Hansem Global’s Visual Documentation Expertise
At Hansem Global, we support medical device manufacturers with end-to-end technical illustration services for IFUs. Under the same roof, our teams collaborate across content planning, writing, translation, and visual design to deliver clarity, compliance, and speed.
Our services include:
- Step-by-step operational illustrations
- Concept visual aids for product structure and function
- Safety graphics aligned with ISO/ANSI standards
- Icon and pictogram sets for global use
- Scenario-based illustrations reflecting real user contexts
We don’t just draw diagrams but build visual systems that drive safer, more consistent device usage across markets. See our articles on visual aids in user manuals: Using Visual Aids for Effective User Documentation and The Role and Importance of Technical Illustrations.
AWG complements this by guiding companies through FDA regulations, submission strategies, and legal risk management.
Final Thoughts: Design for Performance, Not Just Appearance
In today’s regulated and globalized healthcare market, visual aids are no longer optional. They provide strategic advantages by enabling safe product use, supporting regulatory compliance, simplifying translation, and reflecting your brand’s commitment to quality.
Need help developing IFUs with effective visual aiding systems? Hansem Global and AWG are here to support your team, from concept to global rollout. Together, we will help you develop IFUs with visual aids that are not only readable—but also review-ready, risk-aware, and built to pass regulatory scrutiny.
Learn more about how we can support your FDA and other regulatory needs:
- Brian Cho, Hansem Global – [email protected]
- Neil O’Flaherty, Amin Wasserman Gurnani LLP – [email protected]
