Human Factors & Usability Engineering

Designing safety, usability, and confidence into every interaction

Core Offerings

User research
Contextual inquiry & cognitive walkthroughs
Use error analyses
Expert reviews
Task and workflow analysis
Training, IFU, and packaging development
Formative & summative assessments
Usability documentation in compliance with regulations

User-centered by design, driven by data

At Key Tech, our Human Factors and Usability Engineering process is fully aligned with IEC 62366, combining deep expertise in psychology, accessibility, and ergonomics to design safer, more intuitive medical devices. We immerse ourselves in the user experience and real-world use environments, evaluating every design decision against human performance and safety goals. By understanding how people interact with technology, we reduce risk, enhance usability, and elevate the overall product experience. Getting human factors right isn’t just good design—it’s essential for regulatory success, patient safety, and real-world adoption.

Meet The Team

Human Factors and Usability Solutions

HumanFactors HFUseStudy

Define target user groups and appropriate test environment
Map and validate relevant user workflows
Identify critical tasks and develop structured test protocols
Conduct the study and evaluate task performance, ergonomic issues, and unexpected use scenarios
Analyze user interactions and provide recommendations for product refinements to enhance safety and usability

HumanFactors VOC

Clarify and align on the existing product vision– no matter how early or unrefined
Identify and engage with all relevant ‘customers’ across the value chain
Frame research questions to uncover a complete and nuanced understanding of user needs
Capture insights and deliver clear, actionable recommendations tailored to client goals

HumanFactors SurveyDesign

Collect objective and subjective user feedback through targeted surveys
Assess user satisfaction with current products, focusing on specific features and user segments
Visualize insights with clear, compelling graphs and diagrams for easy interpretation

HumanFactors PersonaDev

Develop detailed user personas to define goals, motivations, and behavioral patterns
Use surveys, interviews, and market research to build representative user archetypes
Create affinity maps to identify common user needs, frustrations, and habits
Assess the typical technical proficiency of your target users to inform design decisions

HumanFactors IFU

Develop technical documentation that promotes safe, intuitive use, and meets regulatory standards
Design clear illustrations and diagrams to support user understanding of device operation
Tailor content to the skill level and knowledge of your target users for maximum clarity
Ensure all labelling is intuitive, easy to locate, and simple to interpret

HumanFactors RiskAnalysis

Identify potential use errors and develop strategies to reduce risk
Conduct cognitive walkthroughs to evaluate device safety and workflows compliance with FDA and Human Factors standards
Review device inputs, labels, and displayed information to ensure clarity and prevent ambiguity
Provide accessibility guidance to ensure inclusive and user-friendly design