{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F989a9ea9-0c95-4822-b5cf-892d4a0ccbe2","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Design Validation vs. Human Factors Validation","description":"Human factors and risk create a lot of confusion in the medical device industry. What do you need to do from a design control perspective? \n\nToday\u2019s guest is Mary Beth Privitera, principal - human factors at HS Design and AAMI Human Engineering Committee co-chair. She describes the similarities and differences between human factors vs. design validation. \n\nSome of the highlights of the show include:\n \n\u25cf\tWhat constitutes human factors validation? It involves an international standard and FDA guidance on rules that medical device professionals need to follow.\n\u25cf\tDesign validation focuses more on what\u2019s expected during the audit of a human factors file, if you have a product that is a high risk for harm or injury.\n\u25cf\tMost companies don\u2019t know how to intertwine human factors within design and development practices. Use common sense to make a good product design.\n\u25cf\tFDA helps developers understand what they need to do and document early on during the design process to avoid validation issues with a product later on.\n\u25cf\tPast sales criteria is a major difference between design and human factors validation because it\u2019s difficult to define and measure ease of use.\n\u25cf\tUnderstand all elements that could impact a product\u2019s design. Study your users and use environment before identifying and fixing design issues.\n\u25cf\tA task analysis identifies each step users need to take and serves as evidence that you considered their needs and made necessary compromises.\n\u25cf\tMary Beth busts myths related to human factors and design validation, such as needing three people to evaluate and provide feedback on your product\u2019s design.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/2749365a-f2cb-47dd-b820-ea91b0e843d6/54c5e4a6-676a-4dfa-85c8-b6ab3bf58925.jpg"}