USABILITY ENGINEERING FOR MEDICAL DEVICES

FROM USE-RELATED RISKS TO USABILITY VALIDATION

How should usability engineering be planned and executed so that it provides meaningful evidence for the safety and effective use of a medical device?

A robust usability engineering process begins with a clear understanding of the intended use, intended users, use environment and user interface. From there, manufacturers need to identify critical tasks, foreseeable use errors and hazard-related use scenarios, and connect these systematically with the device risk-management process.

The process should then translate these findings into testable user-interface requirements and appropriate usability risk controls. Formative evaluations can be used to identify usability weaknesses and refine the user interface, Instructions for Use and safety information before the final usability validation is performed.

Summative usability evaluation should demonstrate, under representative conditions of use and with representative intended users, whether the identified critical tasks can be performed safely and effectively and whether the implemented usability-related risk controls are effective.

ELLECOM supports manufacturers in planning and executing the complete usability engineering process from use specification and usability risk analysis through formative evaluation, summative validation and the preparation of traceable usability engineering documentation.

HOW WE CAN SUPPORT YOU

• Use Specification and intended user definition
• Identification of critical tasks and foreseeable use errors
• Usability risk analysis and hazard-related use scenarios
• User Interface Specification
• Integration with ISO 14971 risk management
• Formative usability evaluation
• Summative usability evaluation planning and execution
• Development of test protocols, moderator forms and questionnaires
• Evaluation of Instructions for Use and safety information
• Usability Engineering File and final evaluation documentation
• Traceability between usability risks, controls and validation evidence