Presentation
Human Factors Meets Design Validation: Creating Efficiencies While Meeting Requirements for Both Disciplines
DescriptionTopic: Understanding the intersection of human factors and design validation: creating efficiencies while meeting requirements for both disciplines.
Application: For medical device manufacturers looking to incorporate best in practice human factors while still meeting existing internal design control processes.
Background: As Human Factors continues to find its footing within the medical device development process, efforts have been made to introduce efficiencies to allow for formative and summative testing within existing product development processes. This has the potential to allow companies to save time and employee resources while incorporating industry-standard research practices to produce cutting-edge safe and effective medical devices. To integrate human factors testing into FDA’s design control process, Stryker has developed a model in which human factors summative testing has been completed in combination with design validation.
Overview of Presentation: This talk will address best practices and lessons learned as this model has been developed cross-functionally across multiple research studies. The following topics will be further defined and discussed during the talk.
1. Comparison of design validation and human factors goals (where they align and where they don’t) during formative and summative testing.
a. While the overall goal of design validation is to ensure that users' needs are met, the goal of human factors is to ensure safe and effective use by the intended users in the intended use environment. In some cases, these goals overlap, especially when considering effectiveness of compensating provisions for use errors. However, there are many cases in which these goals diverge, and it is up to the researchers to understand this divergence and how it affects study design.
b. Human Factors Engineers should not act as design validation engineers and design validation engineers should not act as HFEs. These two roles are better served as a partnership, complimenting each other, rather than combining into a single role.
2. Study design and implementation, including:
a. Materials development (such as protocols, moderator’s guides, and datasheets)
b. Distribution of resources (such as notetakers, moderators, audio/video, etc.)
c. Data collection practices (such as directed vs. simulated use)
d. Acceptance Criteria (Pass/Fail approach in Design Validation vs HF Summative)
e. Study flow (such as how to address root cause probing alongside design validation questioning)
3. Discussion of efficiencies that may be introduced to aid in report writing for both human factors and design validation.
Application: For medical device manufacturers looking to incorporate best in practice human factors while still meeting existing internal design control processes.
Background: As Human Factors continues to find its footing within the medical device development process, efforts have been made to introduce efficiencies to allow for formative and summative testing within existing product development processes. This has the potential to allow companies to save time and employee resources while incorporating industry-standard research practices to produce cutting-edge safe and effective medical devices. To integrate human factors testing into FDA’s design control process, Stryker has developed a model in which human factors summative testing has been completed in combination with design validation.
Overview of Presentation: This talk will address best practices and lessons learned as this model has been developed cross-functionally across multiple research studies. The following topics will be further defined and discussed during the talk.
1. Comparison of design validation and human factors goals (where they align and where they don’t) during formative and summative testing.
a. While the overall goal of design validation is to ensure that users' needs are met, the goal of human factors is to ensure safe and effective use by the intended users in the intended use environment. In some cases, these goals overlap, especially when considering effectiveness of compensating provisions for use errors. However, there are many cases in which these goals diverge, and it is up to the researchers to understand this divergence and how it affects study design.
b. Human Factors Engineers should not act as design validation engineers and design validation engineers should not act as HFEs. These two roles are better served as a partnership, complimenting each other, rather than combining into a single role.
2. Study design and implementation, including:
a. Materials development (such as protocols, moderator’s guides, and datasheets)
b. Distribution of resources (such as notetakers, moderators, audio/video, etc.)
c. Data collection practices (such as directed vs. simulated use)
d. Acceptance Criteria (Pass/Fail approach in Design Validation vs HF Summative)
e. Study flow (such as how to address root cause probing alongside design validation questioning)
3. Discussion of efficiencies that may be introduced to aid in report writing for both human factors and design validation.
Event Type
Oral Presentations
TimeWednesday, April 211:30am - 12:00pm EDT
LocationHarbour A/B
Medical and Drug Delivery Devices (MDD)