Presentation
MDD4 - Charting the course: A planning compass for human factors studies in medical devices
DescriptionCoordination of multiple formative and summative human factors/usability studies within a single project is often a complex activity requiring extensive planning to execute successfully. Early decisions need to be made on a variety of factors including product complexity, resources, project schedule, and geographic locations, to name a few. Medical device manufacturers may not have adequate resources to support this work, so they may rely on 3rd party vendors or contractors to supplement their own team. However, 3rd party vendors need to be qualified and trained to perform the work required and can have long lead times before they are able to support the manufacturer. Hiring contractors presents similar challenges such as long lead times to be onboarded and trained appropriately.
Based on our collective experience, a thought framework can help manufacturers consider key factors affecting the planning and completion of human factors/usability studies within a single project; thus, increasing predictability and improving on-time execution. This thought framework includes the following considerations:
1. Identify the appropriate scope of the usability study based on the combination of complexity of the device, design changes within the project, and necessary test data required to show effectiveness of risk mitigations.
2. Research user groups, use environments, and use workflow within the target geographical locations to identify the location logistics of usability testing (i.e., if testing is required in multiple regions or countries, testing of translations, etc.).
3. Ensure understanding of applicable global regulations to execute usability related requirements effectively and avoid delay of regulatory submissions.
4. Early resource planning for usability studies to determine adequate support for scheduled usability projects. If additional usability resourcing is required, account for the necessary lead time required to hire full time employees, contractors, or engage 3rd party vendors.
5. Identify test site location(s), required test equipment, test session scheduling, and other test logistics (such as recruiting of test participants, NDAs, etc.).
6. Consider how data collection and analysis will be performed to show effectiveness of risk mitigations.
This presentation will describe the thought framework, including its methods and considerations, to guide usability professionals in effective planning of usability studies for a project. The various elements considered in realistic planning will be presented, including the evaluation of project aspects which impact the project and testing timeline, use of 3rd party vendors or contractors for planning or test execution, and early identification and preparation for potential hurdles.
Based on our collective experience, a thought framework can help manufacturers consider key factors affecting the planning and completion of human factors/usability studies within a single project; thus, increasing predictability and improving on-time execution. This thought framework includes the following considerations:
1. Identify the appropriate scope of the usability study based on the combination of complexity of the device, design changes within the project, and necessary test data required to show effectiveness of risk mitigations.
2. Research user groups, use environments, and use workflow within the target geographical locations to identify the location logistics of usability testing (i.e., if testing is required in multiple regions or countries, testing of translations, etc.).
3. Ensure understanding of applicable global regulations to execute usability related requirements effectively and avoid delay of regulatory submissions.
4. Early resource planning for usability studies to determine adequate support for scheduled usability projects. If additional usability resourcing is required, account for the necessary lead time required to hire full time employees, contractors, or engage 3rd party vendors.
5. Identify test site location(s), required test equipment, test session scheduling, and other test logistics (such as recruiting of test participants, NDAs, etc.).
6. Consider how data collection and analysis will be performed to show effectiveness of risk mitigations.
This presentation will describe the thought framework, including its methods and considerations, to guide usability professionals in effective planning of usability studies for a project. The various elements considered in realistic planning will be presented, including the evaluation of project aspects which impact the project and testing timeline, use of 3rd party vendors or contractors for planning or test execution, and early identification and preparation for potential hurdles.
Event Type
Poster Presentation
TimeMonday, March 254:45pm - 6:15pm CDT
LocationSalon C
Digital Health
Simulation and Education
Hospital Environments
Medical and Drug Delivery Devices
Patient Safety Research and Initiatives