Module 14 2022

24/03/2022

Evaluating medical devices in Human Factors and Usability Tests Commonly, medical devices are either studied or tested. Formative Usability Studies focus on user interfaces, design and development of these user interfaces. Summative Usability Tests focus on performance of the intended users with the device.

The focus is to ensure that the intended users can use the device in the intended manner, in the intended use environment using the intended user interfaces. Medical devices now include more than just a device – apps, software, integration with other devices, packaging, smart-instructions etc. Evaluation of medical devices must focus on the system – all components including software and all user interfaces.

The Organisation for Professionals in Regulatory Affairs

Human Factors and usability testing during development

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Evaluating medical devices in Human Factors and Usability Tests Key elements that studies and tests look at –  The intended users  The use environments  The user interfaces Most studies and tests are performed with –

 Nurses (Hospital, Care-Home, Community, Specialist etc.)  Patients with the conditions/injuries/medical condition  Personal/professional Carers who manage the patient(s) Most studies and test are performed focusing on how the medical device interacts with the patients body:  Orally  Through surgery/intervention  By injection/infusion  Through the skin  By inhalation  Through absorption

The Organisation for Professionals in Regulatory Affairs

Human Factors and usability testing during development

24

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