Presentation
Hello From the Other Side (Continued): Cross-Industry Trends in FDA Feedback From HF Consultants
DescriptionContinuing the series, we propose to lead and contribute to 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an up-to-date view of the everchanging (and, sometimes conflicting), regulatory expectations, including those that are unpublished yet representative of current thinking, emerging between releases of key guidance documents.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, if accepted, the panelists will review the various feedback FDA provided within the past year 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.
Subject to change, of course, based on the FDA feedback the panelists receive in the months leading up to the symposium, 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 and descriptions
- Nuances on success criteria and blurred expectations between agency divisions
- Continued scrutiny on leading prompts and growing scrutiny of URRAs
- Feedback regarding training methods and target decay (or delay) times between training and testing sessions
- Situations in which dyad or team testing may be appropriate, rather than 1:1 test sessions
- Requirements to satisfy FDA expectations on participant demographic distribution
- Requests for due diligence HF studies that are not driven by serious harm
- Evolving expectations for special testing methods, such as self-selection studies for OTC products and comparative use HF studies for proposed generic products
- Opportunities to perform comparative and other analyses en route to forgoing HF validation testing
If this proposal is accepted, the individuals listed in the table below have confirmed they will participate in the panel (Name, Title, Consultancy Name):
Sara Waxberg McNew, Chief Scientific Officer, Design Science
Allison Strochlic, Senior Research Director, Emergo by UL HFR&D team
Christina Mendat, Managing Director, Eurofins Human Factors MD
Wayne Ho, Managing Director, Healthcare Human Factors
Tony Andre, Owner and Founding Principal, Interface Analysis Associates
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 applications (including mobile medical applications).
Note that we have conducted this panel since the HFES HCS in 2022, and each year the panelists receive positive feedback on the high level of value and engagement. Recognizing that the FDA representatives are not currently planning to attend the 2025 Symposium, this panel may be viewed as even more valuable for this year’s event. If possible, we would like to have additional conversation about the possibility of a format that includes a more interactive component or Q&A.
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, if accepted, the panelists will review the various feedback FDA provided within the past year 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.
Subject to change, of course, based on the FDA feedback the panelists receive in the months leading up to the symposium, 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 and descriptions
- Nuances on success criteria and blurred expectations between agency divisions
- Continued scrutiny on leading prompts and growing scrutiny of URRAs
- Feedback regarding training methods and target decay (or delay) times between training and testing sessions
- Situations in which dyad or team testing may be appropriate, rather than 1:1 test sessions
- Requirements to satisfy FDA expectations on participant demographic distribution
- Requests for due diligence HF studies that are not driven by serious harm
- Evolving expectations for special testing methods, such as self-selection studies for OTC products and comparative use HF studies for proposed generic products
- Opportunities to perform comparative and other analyses en route to forgoing HF validation testing
If this proposal is accepted, the individuals listed in the table below have confirmed they will participate in the panel (Name, Title, Consultancy Name):
Sara Waxberg McNew, Chief Scientific Officer, Design Science
Allison Strochlic, Senior Research Director, Emergo by UL HFR&D team
Christina Mendat, Managing Director, Eurofins Human Factors MD
Wayne Ho, Managing Director, Healthcare Human Factors
Tony Andre, Owner and Founding Principal, Interface Analysis Associates
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 applications (including mobile medical applications).
Note that we have conducted this panel since the HFES HCS in 2022, and each year the panelists receive positive feedback on the high level of value and engagement. Recognizing that the FDA representatives are not currently planning to attend the 2025 Symposium, this panel may be viewed as even more valuable for this year’s event. If possible, we would like to have additional conversation about the possibility of a format that includes a more interactive component or Q&A.
Event Type
Discussion Panel
TimeWednesday, April 28:30am - 10:00am EDT
LocationHarbour A/B
Medical and Drug Delivery Devices (MDD)