Module 14 2022

24/03/2022

Evaluating drug delivery devices in Human Factors and Usability Tests Most studies and tests are performed in –  Research facilities (with viewing capability)  Actual real-life use environments  Simulated-use environments

Many drug delivery devices are used where the patient needs or wants to use them. This is mainly with the Carer or Nurse or on their own – i.e. at home. Many drug delivery devices require management and this is the new trend – self-management. This is not well understood! Managing medication regimes at home is extremely variable and this is what human factors aims to understand. IEC 60601-1-11:2015 focuses on home use medical devices that are electronic.

The Organisation for Professionals in Regulatory Affairs

Human Factors and usability testing during development

25

Evaluating medical devices in Human Factors and Usability Tests  Performing studies and tests:  If FDA compliance is required, some tests can be performed globally, but the Summative Human Factors (Validation) Test must be performed in the USA.  If CE Marking is required, then there is no requirement to test in a specific location.

 Sample size requirements are defined in the FDA Human Factors Guidance and the MHRA Human Factors Guidance but NOT in IEC 62366-1. This is because it links to ISO 14971 – a risk based approach.  The number of Formative Usability Studies should be based upon the risk of the drug delivery device and the amount of innovation it includes.  More Formative Studies is better to de-risk the Summative Human Factors Test.  The regulation is not a minimum! There is value in exceeding the requirements to benefit the user!

The Organisation for Professionals in Regulatory Affairs

Human Factors and usability testing during development

26

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