The relationship between human factors and design controls often creates confusion in the medical device industry. Today’s guests are Russ Branaghan and Bryant Foster from Research Collective, a human factors and user experience consultancy. In this episode we discuss how to integrate human factors into design controls to reduce risk and improve patient outcomes.

Some of the highlights of the show include:

● Research Collective helps design medical devices that are easy to learn and efficient to use to reduce risk and improve patient outcomes.

● Product development involves experts and scientific knowledge about how people work, make decisions, and learn to reduce risk.

● Human factors is defined as area that applies all human sciences to design of products and processes.

● Usability consists of four components: Easy to learn, efficient to use, memorability, and subjective satisfaction.

● Human factors (above the neck) and ergonomics (below the neck) are one and the same, but have slightly different connotations.

● Best practices for human factors include understanding, testing, and evaluating user needs, capabilities, and limitations.

● Class II and III (some Class I) products require usability testing that includes observation. Design input should be objective and measurable.

● Victory Lap: Validation usability study should represent culmination of work completed to make sure people can use the product.