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Development and testing

Human Factors studies 

 

Ergonomics and Human Factors is a crucial discipline focused on analyzing and enhancing how people interact with devices, both physically and cognitively, in their work environments, particularly emphasizing the prediction and prevention of misuse. In the healthcare sector, minimising errors and related risks is paramount for ensuring patient safety and enhancing clinical performance.

 

The principles of Human Factors are essential in designing healthcare solutions that meet human needs, understand the impact on clinical workflows, and adhere to safety, security, usability, and risk assessment regulations. By drawing on these principles, it's possible to design healthcare products that seamlessly integrate into clinical settings, improving human-machine interaction and ultimately contributing to better healthcare outcomes.

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From April to June 2022, more than 600,000 incidents were reported to the National Reporting Learning System - NRLS - from England.

NRLS (National Reporting and Learning System) National Patient Safety Incident Reports: commentary October 2022 

How we can help

 

Our evidence-generation work packages are designed to ensure that design, testing, and documentation, activities are fully compliant with relevant Human Factors and usability-related standards (e.g. ANSI/AAMI/ISO 14971, AAMI/ANSI HE75, ANSI/AAMI/IEC 62366, IEC 60601). We collaborate with internal & external stakeholders to:

  • Identify user needs and critical usability issues associated with both anthropometric and cognitive measurements for medical devices.

  • Evaluate potential use errors and use-related hazards via drafting use scenarios and task analyses

  • Identify critical tasks and contribute to risk mitigation strategies

  • Contribute to user interface designs by providing heuristic design guidance

  • Generate evidence to design Instruction for Use (IfU) and Standard Operating Procedures (SOP) 

  • To plan and execute formative and summative usability evaluations

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We apply a range of human-centred design and risk management tools including:  

  • Stakeholders Analysis

  • Process analysis and clinical pathway

  • Hierarchical Task Analysis

  • Ethnographic research 

  • Usability testing 

  • Heuristics evaluation

  • Use Errors Analysis

  • Failure Mode Effect Analysis (FMEA) 

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