FDA Archives | PDD

How much Human Factors Usability is needed to prove a device is safe, effective and usable?

In my career I have been lucky enough to gain varying perspectives on the role of usability during the development of medical devices. I’ve worked as part of a design team with a responsibility for concept generation, preliminary research and detailed design. I’ve also worked as part of a human factors team with a broader remit for integrating human factors process across an organisation. One thing experience has taught me is that there is no ‘one size fits all’ when it comes to usability work.

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