Clear, usable Instructions for Use that support safe, efficient, and confident device use.

We create instructions for use (IFUs) as an integral part of the holistic user interaction and experience with the same care and attention as the device hardware, software, and consumables.  We combine user-centered design, human factors, technical writing, and visual design to make complex tasks easy to understand and complete quickly, and supporting the brand for market success.

‍

‍

Our IFU Expertise

‍

Task & User Workflow Discovery

We start by discovering what the IFU materials need to be through design research, observing real-world use, and SME interviews:

• Tasks, workflows, and environments
• Pain points, workarounds, and sources of frustration
• Opportunities to better support user needs

This ensures that the IFU supports the efficiency of completing tasks, reducing errors, and ease of use.

Heuristic Reviews & Benchmarking

We review competitive IFUs and related systems to:

• Improve intuitiveness and ease of navigation
• Match the system and instructions to the real world
• Advocate recognition rather than recall

User-Centered Design

Using a user-centered, human factors–informed process, we design IFUs that:

• Are easier to follow and understand
• Support recognition over recall through clear structure and visuals
• Improve confidence and efficiency during task completion
• Formative Usability Evaluation & Validation:
  • Confirm users can find, understand, and apply information
  • Identify opportunities to improve clarity and flow
  • Refine the design based on user feedback

IFU Content Strategy

We prioritize and organize content to support clarity and way-finding including:

• Task-based organization aligned with user workflows
• Clear messaging and logical information hierarchy
• Tailor the content to intended use, use cases, and FDA guidelines

Technical Writing + Visual Design

We integrate clear technical writing with purposeful visual design:

• Concise, action-oriented instructions
• Visuals aligned with your brand, hardware, and software UI
• Diagrams and layouts that reduce cognitive load

‍

The Outcome

Our IFU services help teams:

• Improve task efficiency and ease of use
• Reduce confusion and use errors
• Deliver consistent, high-quality documentation
• Strengthen the overall product and brand experience

Well-designed IFUs are more than documentation, they’re a key part of how users successfully experience your product.

Frequently Asked Questions

Why should IFUs be considered part of the product design process?‍

IFUs directly influence how a device is understood, used, and trusted. Treating them as part of the product design process ensures they align with real user workflows, reduce risk, and support safe, effective use from the start.

What are the risks of treating IFUs as an afterthought?

‍Late-stage IFUs often reflect internal assumptions instead of real-world use. This can lead to unclear instructions, increased use errors, and a disconnect between the device and its documentation, impacting both safety and user confidence

How does a user-centered approach improve IFU design?

‍A user-centered approach ensures instructions are built around how people actually think and work. By focusing on workflows, decision points, and pain points, IFUs become easier to navigate, easier to understand, and more effective during real use.

Can poor IFU design delay FDA clearance?

‍Yes. Confusing or poorly structured IFUs can contribute to use errors in validation studies, leading to additional testing, redesign, or requests for more data from the FDA—ultimately delaying timelines and increasing costs.

What makes KEK Design’s approach to IFUs unique?

‍At KEK Design, IFUs are treated as a designed experience, not just documentation. By integrating human factors, content strategy, and visual design, we create IFUs that are intuitive, brand-aligned, and seamlessly connected to the product.

‍

‍