Module 18 - Drug Device Combinations and Other Technologies

07/12/2023

Evaluating DDCP’s in Human Factors and Usability Studies

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 for drug device combination products

35

Evaluating DDCP’s in Human Factors and Usability Studies

Performing studies and tests:  If FDA compliance is required, some tests can be performed globally, but the Summative Human Factors (Validation) Studies must be performed in the USA. The same for China.  If CE Marking is required, then there is no requirement to test in a specific location.  Sample size requirements are defined in the FDA and NMPA Human Factors Guidances.  The number of Formative Usability Studies should be based upon the risk of the drug delivery device and the amount of innovation it includes – typically this is 3-6 to ensure there are no critical use errors recorded but also to gain a much higher level of user performance (often >97%).  More Formative Studies is better to de-risk the Summative Human Factors Test.  Formative Studies can be performed before Comparative Use Human Factors Studies (for ANDA devices) if there are concerns on the Threshold Analysis.

The Organisation for Professionals in Regulatory Affairs

Human Factors for drug device combination products

36

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