Risk Management and Formative Human Factor

3/12/2018 16:05 - 16:35

Auto injector is one of the delivery device that users self-injecting in home setting appreciate. It is easy to use, does not look too “medical/aggressive”. Many of them are currently marketed. There are differences in their handling but at the same time they can look similar. Using an auto-injector on a regular basis or only occasionally in emergency situation may make a difference in terms of use errors.

Is it the reason why the FDA has placed the auto injector on the list of devices that need to demonstrate safety and efficacy at least with HFE summative study and even sometimes with real use study?

What could be done to better support the user of auto injectors?

Technical development: Differentiation (right drug, right dosage), handling (different mental models), intuitiveness (identification of needle end, click associated with end of injection). What can be improved? Connectivity, feedback identification, cap removal?

Regulation perspective: Harmonisation of the handling steps by developing some standards like it is done in the automotive field? Pro/Cons

Muriel Didier, Human Factors Team Head, Novartis