Presentation
Beyond Evaluation - HFE as a Key Contributor to Multi-Disciplinary Product Development
SessionSystems (MDD4)
DescriptionThe HFEs Healthcare Symposium is a Human Factors-specific event. Therefore, the topics, rightly, focus on Human Factors Engineering. But we often talk about it in isolation, disassociated from the other disciplines which make up the multi-disciplinary product development process, and the context in which Human Factors operates. I would like to take some time to look outside ourselves and our own discipline and think about our place in the universe - the product development universe.
The regulatory framework – both IEC 62366 and the FDA guidance – was set in place to ensure safe and effective use of medical products and clear labeling and instructional materials. An unintended consequence of this framework though over the span of its existence has been an ever-increasing focus on the evaluative aspects of HFE – formative and validation testing – as the means by which we evidence safety and effectiveness. The path to a successful medical product submission includes a robust program of Human Factors activities throughout the entire development process, but a disproportionate amount of the energy and effort behind Human Factors activities throughout development is often focused on testing and evaluation. Human Factors has so much more to offer in terms of producing creative, usable solutions that successfully integrate both innovation and evaluation in the development process.
This talk will explore how and where Human Factors Engineering contributes to multi-disciplinary product development from the very earliest stages of problem definition through to product launch. Through the lens of an exemplar product development process ranging from Requirements Definition, Concept Generation, Preliminary Design, Iterative Detailed Design, and Verification & Validation this talk will discuss how and what Human Factors contributes at each stage, which disciplines are the usual and closest collaborators, what ‘good’ looks like, and creative approaches to conducting informal Human Factors evaluations and translating the learning back into the design of a product or system as it matures. The goal is to inspire HFEs to think of themselves beyond their role as evaluators of other people’s ideas and understand how their expertise and insight contributes to creating usable, accessible, simple, navigable, and understandable interactions which create an enjoyable as well as safe and effective use experience.
The regulatory framework – both IEC 62366 and the FDA guidance – was set in place to ensure safe and effective use of medical products and clear labeling and instructional materials. An unintended consequence of this framework though over the span of its existence has been an ever-increasing focus on the evaluative aspects of HFE – formative and validation testing – as the means by which we evidence safety and effectiveness. The path to a successful medical product submission includes a robust program of Human Factors activities throughout the entire development process, but a disproportionate amount of the energy and effort behind Human Factors activities throughout development is often focused on testing and evaluation. Human Factors has so much more to offer in terms of producing creative, usable solutions that successfully integrate both innovation and evaluation in the development process.
This talk will explore how and where Human Factors Engineering contributes to multi-disciplinary product development from the very earliest stages of problem definition through to product launch. Through the lens of an exemplar product development process ranging from Requirements Definition, Concept Generation, Preliminary Design, Iterative Detailed Design, and Verification & Validation this talk will discuss how and what Human Factors contributes at each stage, which disciplines are the usual and closest collaborators, what ‘good’ looks like, and creative approaches to conducting informal Human Factors evaluations and translating the learning back into the design of a product or system as it matures. The goal is to inspire HFEs to think of themselves beyond their role as evaluators of other people’s ideas and understand how their expertise and insight contributes to creating usable, accessible, simple, navigable, and understandable interactions which create an enjoyable as well as safe and effective use experience.
Event Type
Oral Presentations
TimeTuesday, March 269:30am - 10:00am CDT
LocationContinental Ballroom, Lobby Level
Medical and Drug Delivery Devices