Presentation
Some Imagination Required – Getting Creative with Human Factors Simulation Use Testing Strategies
DescriptionA key component to the human factors (HF) process during product development is the evaluation of use-related tasks. In the healthcare space, a variety of users from healthcare providers to patients may be required to complete critical tasks during HF testing related to the product. However, real-world use rarely equates to observed use in a simulated test environment. Regulatory guidance encourages human factors professionals to make every effort to simulate the use environment that an end-user might experience, including the evaluation of each context of use (or scenario) for a medical device or combination product.
Translating the real-world experience to a simulated use scenario comes with a host of challenges. The emphasis on realistic simulation is more crucial for human factors validation applications, including the simulation of the use-related task itself and factors such as biologic responses to a medical device or medication therapy. For human factors formative evaluations, it is permissible for the simulation to be more rudimentary; often an early iteration of the product user interface itself is being tested; some imagination may be required!
This lecture will dive into the components of human factors formative evaluations and validation studies that are difficult to simulate, and strategies for approaching these nuanced aspects of use-related performance. There are multiple avenues for application of the learnings from this presentation, including human factors strategy, formative evaluation and validation study protocol design, and human factors best practices to apply in difficult research situations.
Topics will include:
• Simulation strategies for evaluating performance for product use-related tasks that are not possible to simulate exactly (for example, environmental distractions, training decay, and how to simulate a helpline).
• Environmental considerations for simulation and observation of use-related tasks,
• Guidance on human factors protocol elements to consider for early to late-stage formative evaluations and human factors validation studies.
• Type of feedback being seen from the FDA for simulated use evaluations, including environmental considerations, user group recruitment, moderator script, simulated use scenario participant engagement, and root cause analysis.
Translating the real-world experience to a simulated use scenario comes with a host of challenges. The emphasis on realistic simulation is more crucial for human factors validation applications, including the simulation of the use-related task itself and factors such as biologic responses to a medical device or medication therapy. For human factors formative evaluations, it is permissible for the simulation to be more rudimentary; often an early iteration of the product user interface itself is being tested; some imagination may be required!
This lecture will dive into the components of human factors formative evaluations and validation studies that are difficult to simulate, and strategies for approaching these nuanced aspects of use-related performance. There are multiple avenues for application of the learnings from this presentation, including human factors strategy, formative evaluation and validation study protocol design, and human factors best practices to apply in difficult research situations.
Topics will include:
• Simulation strategies for evaluating performance for product use-related tasks that are not possible to simulate exactly (for example, environmental distractions, training decay, and how to simulate a helpline).
• Environmental considerations for simulation and observation of use-related tasks,
• Guidance on human factors protocol elements to consider for early to late-stage formative evaluations and human factors validation studies.
• Type of feedback being seen from the FDA for simulated use evaluations, including environmental considerations, user group recruitment, moderator script, simulated use scenario participant engagement, and root cause analysis.
Event Type
Oral Presentations
TimeTuesday, March 269:37am - 10:00am CDT
LocationSalon A-4
Simulation and Education