Module 14: Design Development and Certification of Medical Devices

Device Knowledge

Question – Where do people use rescue inhalers?

If you do not know – find out!

It is easy to sample a group of users and ask them – they will mainly be truthful, and the data is going to be representative of the population. This is user research!

Where do patients mainly use their inhaler at home?

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

0% 5%

The Organisation for Professionals in Regulatory Affairs

Human Factors and Usability Testing during development