Presentation
Hello (Again) from the Other Side: Cross-Industry Trends in FDA Feedback from HF Consultants
DescriptionThis will be a panel comprising of five senior leaders from Human Factors (HF) consultancies (panelists listed below) who work almost exclusively in healthcare, to discuss trends they have identified based on the feedback the US Food and Drug Administration (FDA) has provided a variety of medical device and pharmaceutical manufacturers.
Compared to HF experts working within industry, HF consultants get a privileged view of cross-industry FDA correspondence and often help facilitate FDA communication with various manufacturers that are developing a wide range of products. This enables HF consultants to develop and maintain an up-to-date view of the everchanging (and, sometimes conflicting), regulatory expectations, including those that are unpublished yet representative of current thinking, emerging between releases of key guidance documents.
In preparation for the panel, the panelists will review the various feedback FDA provided within the past 2 years and consolidate key points to enable a thorough review and identification of trends. All FDA feedback shared and consolidated among the panelists, and subsequently with symposium attendees, will be anonymized and the client (Sponsor) will not be identified. Rather, feedback will be shared in the context of the product type and phase of development (e.g., pre-submission or submission) during which the feedback was received.
During the panel, the panelists will share and discuss only those points that go beyond FDA’s published guidance documents. For example, the panel will not reiterate that the FDA wants HF validation tests to include at least 15 representatives per distinct user group nor that such testing should be conducted in the US. Rather, only confirmed or suggested changes to these “standing expectations” or information beyond the documented guidance will be shared.
Based on an initial consideration of relevant points, we expect the panel might cover some topics such as the following:
>>> Requests for actual use HF validation studies in addition to simulated use HF validation studies
>>> Requests for increased environmental realism during simulated-use studies
>>> Feedback regarding training methods and target decay (or delay) times between training and testing sessions
>>> Specific requirements for characteristics and evaluation of pediatric user groups, as well as caregiver-pediatric dyads
>>> Specific requirements related to participant sample diversity, including literacy levels, ethnicity, and other factors
>>> Increased attention on younger children that are not intended users (i.e., including younger children in the case a younger child is prescribed a product)
>>> Requests to present use-related risk analyses in different formats and/or with additional details
>>> How to best phrase use scenario and knowledge task prompts related to FDA’s concern about leading prompts and only providing “clinical context”
>>> Evolving expectations for self-selection studies, including unique aspects associated with recruitment, test conduct, and sample size
>>> Simulating realistic customer support phone lines and interactions
>>> Expectations for validating reprocessing of critical and semi-critical medical devices: simulated use vs validating labeling
>>> Validation of alarms on critical care devices
Allison Strochlic - Senior Research Director, Emergo by UL HFR&D team
Sara Waxberg McNew - Chief Scientific Officer, Design Science
Tony Andre - Director and Partner, Interface Analysis Associates LLC
Wayne Ho - Managing Director, Healthcare Human Factors
Rachel Aronchick - Technical Director, Eurofins Human Factors MD
The panelists will draw upon their expertise and decades of combined experience to interpret FDA’s feedback and share specific (yet still client-anonymous) case studies, when appropriate. The panelists will reflect on FDA feedback regarding medical devices, combination products, and Software as a Medical Device (SaMD) applications (including mobile medical applications).
Compared to HF experts working within industry, HF consultants get a privileged view of cross-industry FDA correspondence and often help facilitate FDA communication with various manufacturers that are developing a wide range of products. This enables HF consultants to develop and maintain an up-to-date view of the everchanging (and, sometimes conflicting), regulatory expectations, including those that are unpublished yet representative of current thinking, emerging between releases of key guidance documents.
In preparation for the panel, the panelists will review the various feedback FDA provided within the past 2 years and consolidate key points to enable a thorough review and identification of trends. All FDA feedback shared and consolidated among the panelists, and subsequently with symposium attendees, will be anonymized and the client (Sponsor) will not be identified. Rather, feedback will be shared in the context of the product type and phase of development (e.g., pre-submission or submission) during which the feedback was received.
During the panel, the panelists will share and discuss only those points that go beyond FDA’s published guidance documents. For example, the panel will not reiterate that the FDA wants HF validation tests to include at least 15 representatives per distinct user group nor that such testing should be conducted in the US. Rather, only confirmed or suggested changes to these “standing expectations” or information beyond the documented guidance will be shared.
Based on an initial consideration of relevant points, we expect the panel might cover some topics such as the following:
>>> Requests for actual use HF validation studies in addition to simulated use HF validation studies
>>> Requests for increased environmental realism during simulated-use studies
>>> Feedback regarding training methods and target decay (or delay) times between training and testing sessions
>>> Specific requirements for characteristics and evaluation of pediatric user groups, as well as caregiver-pediatric dyads
>>> Specific requirements related to participant sample diversity, including literacy levels, ethnicity, and other factors
>>> Increased attention on younger children that are not intended users (i.e., including younger children in the case a younger child is prescribed a product)
>>> Requests to present use-related risk analyses in different formats and/or with additional details
>>> How to best phrase use scenario and knowledge task prompts related to FDA’s concern about leading prompts and only providing “clinical context”
>>> Evolving expectations for self-selection studies, including unique aspects associated with recruitment, test conduct, and sample size
>>> Simulating realistic customer support phone lines and interactions
>>> Expectations for validating reprocessing of critical and semi-critical medical devices: simulated use vs validating labeling
>>> Validation of alarms on critical care devices
Allison Strochlic - Senior Research Director, Emergo by UL HFR&D team
Sara Waxberg McNew - Chief Scientific Officer, Design Science
Tony Andre - Director and Partner, Interface Analysis Associates LLC
Wayne Ho - Managing Director, Healthcare Human Factors
Rachel Aronchick - Technical Director, Eurofins Human Factors MD
The panelists will draw upon their expertise and decades of combined experience to interpret FDA’s feedback and share specific (yet still client-anonymous) case studies, when appropriate. The panelists will reflect on FDA feedback regarding medical devices, combination products, and Software as a Medical Device (SaMD) applications (including mobile medical applications).
Event Type
Discussion Panel
TimeMonday, March 2510:30am - 12:00pm CDT
LocationContinental Ballroom, Lobby Level
Medical and Drug Delivery Devices