Module 14: Design Development and Certification of Medical Devices

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

Where do patients mainly use their inhaler at home?

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

0% 5%

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 and Usability Testing during development