Module 14: Design Development and Certification of Medical Devices

Device 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?

10% 15% 20% 25% 30% 35%

0% 5%

To check its prediction, a human factors study should be performed that checks this theory. The Human Factors study can verify 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 and Usability Testing during development