Why you should care about Usability and Human Factors
Product use errors are part of more than one third of device incidents reported to the FDA. That is why human factors studies are required for most medical device submissions. But beyond regulatory requirements, developing a device that is easy to use and developed with the user in mind will result in a device that users will enjoy working with.
If you start your development and then talk to end users, the probability of a redesign increases. If you fail summative testing, costs escalate, and timelines increase. Incorporating usability into your design plans early will lead to a better and safer product, reduced time to market, and reduce your capital burden.
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