Metix Medical
Medical Device Interface Usability Testing
Problem
While preparing for FDA 510(k) submission, multiple usability risks were identified through formative research, with the potential to compromise user safety and effectiveness in clinical workflows. Beyond regulatory compliance, there was a clear opportunity to improve the overall user experience in high-pressure environments.
Goal
To validate that the device could be used safely and effectively by its intended users and to reduce the risk of use errors. This included producing a usability engineering report for FDA submission while also enhancing clinician confidence, training, and ease of use.
Solution
User-Centred Design Enhancements
Introduced a "press and hold" safety feature to prevent accidental activation; addressing a critical usability risk identified during QA testing.
Information Architecture & Content Design
Created clear, concise Instructions for Use (IFUs) and Quick Reference Guides (QRGs), optimised through clinician feedback and usability testing for comprehension under high-pressure situations.
Learning Experience Design
Developed training videos and interactive quizzes to support user readiness, ensuring clinical staff could efficiently internalise workflows prior to testing.
Design for Testing
Designed realistic task scenarios to simulate emergency transport and hospital use environments; ensuring tasks were representative of real-world use, not just regulatory benchmarks.
Company
Metix Medical
Role(s)
Lead UX Designer/ Usability Engineer
Team
Design: Lead UX Designer, Product Designer, UX/UI Designer
Engineering: Embedded Developers, Web Developers, Product Engineers
Quality & Compliance: Regulatory / QARA Specialists, QA Engineers
Leadership & Coordination: CTO, COO, OEM Product Lead
Methods
Risk-based task analysis
Usability engineering (IEC 62366-1)
Formative and summative usability testing
Training and labelling design
Simulated use environment setup
Cross-functional collaboration
Deliverables
Usability test plan
Feature specification for "press and hold" interaction design
Instructions for Use (IFU)
Quick Reference Guide (QRG)
Training videos and quizzes
Usability Engineering report
Full documentation for FDA 510(k) submission
Tools
Adobe XD, Photoshop, Illustrator, Premiere Pro and After Effects
Google Forms, Sheets and Docs
Timeline
12 month validation process (end-to-end)
UX Research
Embedded GUI
Medical Device
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Full case study coming soon…
A detailed walkthrough of the full usability engineering process, including visuals, testing insights, and documentation highlights, will be added soon
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