30 min listen
Design Validation vs. Human Factors Validation
FromGlobal Medical Device Podcast powered by Greenlight Guru
Design Validation vs. Human Factors Validation
FromGlobal Medical Device Podcast powered by Greenlight Guru
ratings:
Length:
34 minutes
Released:
Nov 7, 2019
Format:
Podcast episode
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?
Today’s 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.
Some of the highlights of the show include:
● What constitutes human factors validation? It involves an international standard and FDA guidance on rules that medical device professionals need to follow.
● Design validation focuses more on what’s expected during the audit of a human factors file, if you have a product that is a high risk for harm or injury.
● Most companies don’t know how to intertwine human factors within design and development practices. Use common sense to make a good product design.
● FDA 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.
● Past sales criteria is a major difference between design and human factors validation because it’s difficult to define and measure ease of use.
● Understand all elements that could impact a product’s design. Study your users and use environment before identifying and fixing design issues.
● A task analysis identifies each step users need to take and serves as evidence that you considered their needs and made necessary compromises.
● Mary Beth busts myths related to human factors and design validation, such as needing three people to evaluate and provide feedback on your product’s design.
Today’s 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.
Some of the highlights of the show include:
● What constitutes human factors validation? It involves an international standard and FDA guidance on rules that medical device professionals need to follow.
● Design validation focuses more on what’s expected during the audit of a human factors file, if you have a product that is a high risk for harm or injury.
● Most companies don’t know how to intertwine human factors within design and development practices. Use common sense to make a good product design.
● FDA 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.
● Past sales criteria is a major difference between design and human factors validation because it’s difficult to define and measure ease of use.
● Understand all elements that could impact a product’s design. Study your users and use environment before identifying and fixing design issues.
● A task analysis identifies each step users need to take and serves as evidence that you considered their needs and made necessary compromises.
● Mary Beth busts myths related to human factors and design validation, such as needing three people to evaluate and provide feedback on your product’s design.
Released:
Nov 7, 2019
Format:
Podcast episode
Titles in the series (100)
Insider Tips and Best Practices Regarding the 510(k) Submission Process from a Former FDA Reviewer: One important piece of documentation that medical device companies rely on to get them through the regulatory process is the premarket notification 510(k). Since the FDA will refuse to accept submissions that are missing the appropriate documentation... by Global Medical Device Podcast powered by Greenlight Guru