Module 18 - Drug Device Combinations and Other Technologies

07/12/2023

DDCP Knowledge

Question – Where do people use rescue inhalers?

What is seen is that there are three use environments where users of this device would use it in:

Where do patients mainly use their inhaler at home?

0% 5% 10% 15% 20% 25% 30% 35%

a) Bathroom b) Bedroom c) Gym/Fitness Room.

Now we have to understand why ? Clinically, there are reasons as to why – stress, exercise etc. Humanly, there are ways in which we live, and habits that we learn. For example – storage. We learn to store it conveniently.

The Organisation for Professionals in Regulatory Affairs

Human Factors for drug device combination products

9

DDCP Knowledge

Question – Where do people use rescue inhalers?

Now we have a good idea of where users will use the inhaler. This is very important data. If we extrapolate this to the user population, then it is theoretical data . It is predictive .

Where do patients mainly use their inhaler at home?

0% 5% 10% 15% 20% 25% 30% 35%

To check its prediction, a human factors study should be performed that checks this theory. The Human Factors study can validate the data – through observation of the intended users in these use environments – importantly, in the human factors study, the participants should be given the choice to choose which use environment they would want to use – it is a bias to choose for them!

The Organisation for Professionals in Regulatory Affairs

Human Factors for drug device combination products

10

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