Module 14: Design Development and Certification of Medical Devices

Device Knowledge

Question – Where do people use rescue inhalers?

In summary:

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If you don’t know the answer – perform user research to find out!

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Then take the knowledge gained and check it out!

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Perform a human factors study in the right manner – remove bias!

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The result – verification of the use environment.

Why is this important?

If you don’t then test the design of the inhaler in the right use environment, future data could be unrealistic and create negative bias. Regulators will see that you performed the process differently!

The Organisation for Professionals in Regulatory Affairs

Human Factors and Usability Testing during development