By now, medical device developers are well-acquainted with FDA requirements for human factors and usability testing. But if you’re only doing the required pre-market regulatory submission testing, you’re missing out on the significant benefits that human centric design (HCD) can deliver to your sales numbers and your bottom line.
FDA requirements are focused on device safety and effectiveness. A truly human-centric process goes beyond safety and efficacy and looks at how the device will be received by its intended users and how it fits into their lifestyle or workflow.
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