Hello Everyone,
Human Factors study considered users to assess the adequacy of the combination product user interface design to eliminate or mitigate potential use-related hazards. Human factors study is perform to consider the complexity of the combination product and the nature of the safety.
The Human Factor study evaluates
• the ability of the user to perform critical tasks
• the ability of the user to understand the information in the packaging and labeling, such as product labels or instructions for use, that inform the user’s actions and that are critical to the safe and effective use of the combination product.
There are some HF studies such as HF formation and HF validation that evaluate the risk.
HF formation- This type of study process to assess user interaction with the product and identify potential use errors. It also inform the need for user interface changes and inform the content of the HF validation study.
HF validation- This is final finished combination product user interface can be used by intended users without serious damage or errors. This study demonstrate that hazards has been eliminated or the benefit of product use outweigh the residual risk of the product.

Question for all, What are the Human Factors issue relate to combination product? And what other types of HF studies might need to be conducted for the combination product?