Transforming Regulatory Requirements into Product Excellence

Challenge

The client needed to assess and optimize their Instructions for Use before finalizing for regulatory submission. Critical objectives included:

• Evaluating user comprehension of the IFU to ensure clear communication of proper device use

• Identifying points of confusion in instructional content and visual elements

• Uncovering gaps between written instructions and actual user behavior

• Collecting feedback to refine messaging and improve user guidance

Solution

ClariMed designed and executed a comprehensive formative study that went beyond basic compliance testing:

• Strategic Participant Recruitment: 20 participants diagnosed with migraines, split equally between inhaler-experienced and inhaler-naïve users, ensuring insights across all potential user types

• Rigorous Study Design: The team documented use errors, difficulties, close calls, DNR tasks, and successes across three critical use scenarios

• Comprehensive Evaluation: Knowledge tasks assessed UI comprehension while subjective feedback revealed user preferences and concerns

• Root Cause Analysis: Probing questions determined the underlying reasons for use-related errors and difficulties, enabling targeted solutions

Results

Our formative study delivered critical insights that fundamentally improved the user interface:

• 18 UI Improvements Identified: Comprehensive recommendations addressed safety concerns and usability enhancements for the IFU, packaging labels, and device interface

• Proactive Risk Mitigation: Issues were identified and resolved before regulatory submission, preventing potential post-market complications

• Optimized User Guidance: UI modifications based on real user feedback ensured clear communication and intuitive understanding of proper device use

• Comprehensive Documentation: Detailed formative study report provided conclusions based on data with actionable recommendations for IFU and UI improvements

The study empowered the client to make data-driven decisions about their instructional materials, significantly reducing the risk of use errors while enhancing user comprehension for patients managing chronic migraines.

Ready to Transform Your Medical Device Launch?

Don't let usability issues surface after market launch. Our human factors expertise helps you identify and resolve critical design challenges early—ensuring regulatory success while creating products that truly serve your patients.

Schedule a Consultation Today →

Or explore our Human Factors Services to see how we can support your specific development needs.