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Background

A medical device manufacturer wanted to conduct a validation study to determine if the use of their mobile patient monitoring solution was safe and effective for the intended users in the intended use environment. 

Our task was to evaluate if nurses and physicians of different specialties could operate the interface (desktop & mobile) to locate different parameters and to recognize malfunctions and notifications.

Approach

  • 90-minute face-to-face sessions with n = 15 nurses and n = 15 physicians in a simulated hospital office use environment.

  • Participants were asked to perform different use scenarios with the software, including knowledge-based tasks.

  • Performance evaluation based on pre-defined acceptance criteria.

  • Root cause probing for any observed use difficulties.

Outcome

The mobile patient monitor system could be used safely and effectively by the intended users. Some remaining issues with notifications and alarms were discovered. 

  • uintent delivered a summary report together with the data collection sheet, with recommendations to mitigate the existing risks from the issues encountered. 

  • The writing of the HFE report remained with the client.

Method

Summative usability test

Duration

5 weeks

Healthcare

Validating a Mobile Patient Monitoring Solution for HCPs

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