Empowering users through effective IFU design

Published: July 2025

Caitlin McPhee

Graphic Design Consultant

Jimmy Mower

Design Consultant

An effective Instructions for Use (IFU) is a critical aspect of any medical device system. It enables users to understand and correctly perform essential tasks, often in high-stakes or time-sensitive environments. To achieve this, developers must have a deep understanding of the intended users and the real-world contexts in which the instructions will be followed. By tailoring content and format to meet these needs, IFUs can minimise errors to ensure safe and effective use of the device.

What makes a good IFU?

User Considerations

The first step is identifying and understanding the intended users. This audience may range from trained healthcare professionals familiar with similar procedures to individuals using a device for the very first time. Recognising the experience level of users helps shape the tone and visual language of the IFU, and whether it should adopt a more clinical, precise style or a friendly, approachable one.

To help users navigate an IFU with confidence, we apply clear visual hierarchy, Gestalt principles¹, and information chunking to structure content in a logical and intuitive way. Directionality, such as the use of arrows, numbered steps, and progressive disclosure encourages users to follow instructions in the intended sequence. This guided experience reduces cognitive load and ensures key actions are not missed, even under pressure.

Key user characteristics such as age, cognitive ability, education level, literacy, language proficiency, and cultural background all influence how well instructions are understood and followed. In addition, users may have varying levels of dexterity, hand strength, visual acuity, or may be living with disabilities that affect how they interact with the device and its instructions. To address this challenge, the FDA recommends that IFUs be written at or below the national average reading level.

Ultimately, a deep understanding of the user population during the design phase enhances the effectiveness of the IFU during Human Factors (HF) studies and regulatory submissions.

Journey Mapping

Journey mapping is a process that visualises the full user experience – before, during, and after interacting with the device. It helps understand when and where the IFU will be used, and what intended users may be thinking or feeling during this process. Their needs can be anticipated early, and development can be streamlined. If the device has not already been developed, we can design both the device and the IFU in parallel.

For more information, see our article on the strategic benefits of journey mapping.

Emotional Considerations

Psychological barriers such as health anxiety or the fear of hospitals and injections can make device use stressful. Users may feel overwhelmed, reluctant to carry out instructions without a clear indication that they are performing the actions correctly. This is why an IFU should have reassuring, straightforward instructions without overly technical jargon, reducing uncertainty and information overload. Addressing these issues will improve usability and reduce the likelihood of future revisions.

Environmental Considerations

The context of use of an IFU can significantly impact usability. Whether the device will be used at home, in a clinic, or hospital, defines what level of lighting, noise or distractions the intended user will be exposed to. For example, if instructions ask to listen for a click, this might be more difficult in a noisier environment, which in the IFU would mean clear and bold auditory visualisations are essential. Additionally, in lower lighting conditions, text and illustrations must have the appropriate level of contrast and scale to ensure user comprehension.

Space constraints should also be considered. Requiring users to unfold a large IFU may limit where they can follow the instructions. In those scenarios, we must consider alternative options such as using a smaller format or even providing a digital version of the IFU that can be accessed via a QR code. Anticipating the appropriate format early in the process prevents time-consuming layout changes further down the line.

Contextual Considerations

Healthcare professionals often wear gloves, which can reduce grip and make it harder to handle large-format IFUs. To maintain sterility and ease of use, instructions may need to be presented in a format that avoids direct handling, such as a flat single sheet or wall-mounted poster.

Material choice is just as critical. We should consider matte-coated or smudge-resistant paper stocks that are easy to grip and won’t tear or slip when handled with gloves. Laminated or water-resistant materials can further protect against wear in clinical settings. By making these considerations early, we help ensure IFUs perform as they should in real-world settings.

Translation Considerations

Translations often expand English text by up to 30%, especially in languages like German or French—creating layout challenges such as text overflow or misalignment.

To prevent this, we design IFUs with flexible layouts, extra spacing, and dynamic text handling. By planning for global rollout from the start, we reduce the need for redesigns and can ensure consistency across all regions.

Designing IFUs That Deliver Results

At Shore, we design IFUs that are intuitive, give users confidence to perform tasks and build trust with brands. This is achieved by applying usability principles, validating through real-world testing and with robust information architecture and elegant graphic design. Our IFUs guide critical actions with clarity and support a smoother path to regulatory approval.

But effective IFUs go beyond good design – they consider user needs, regulations, and business goals. This is why we speak the language of design, human factors, regulatory, and marketing teams, ensuring all stakeholder input is integrated without compromising clarity or usability.

If you have a project that requires an IFU, Shore can help you reach an effective solution. Contact our Business Development Team to find out more.

¹ Gestalt Principles are principles/laws of human perception that describe how humans group similar elements, recognize patterns and simplify complex images.

Related Insights

UX & UI

The strategic value of journey mapping when developing medical devices

Human Factors

How to avoid negative transfer in medical device development

Human Factors