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BEGIN:VEVENT
DTSTAMP:20240325T185834Z
LOCATION:Salon C
DTSTART;TZID=America/Chicago:20240325T164500
DTEND;TZID=America/Chicago:20240325T181500
UID:HFESHCS_2024 International Symposium on Human Factors and Ergonomics i
 n Health Care_sess111_POST148@linklings.com
SUMMARY:MDD8 - Early Formative Testing Strategies for User-Driven IFU Deve
 lopment
DESCRIPTION:Poster Presentation\n\nValerie Gernazian, Abhinita Pandey, and
  Alex Hummel (Agilis by Kymanox)\n\nHuman Factors testing is important for
  the development of Instructions For Use (IFU) because it facilitates data
  driven IFU updates and guides design changes to eliminate or mitigate use
 -related hazards identified during product development. Despite efforts to
  create an effective, user-friendly IFU, usability testing with real devic
 e users will almost always uncover needed improvements. Testing the IFU on
  the intended user population will not only uncover IFU usability issues b
 ut will also facilitate a better understanding of real-world use of the IF
 U and the product. However, it is often the case that IFU related Root Cau
 ses (RCs) are discovered late in product development cycle which can make 
 them difficult to reconcile, especially in projects where many of the User
  Interface (UI) design components are locked in place. \n\nBeyond the "rul
 es" established by FDA's guidance documents and current thinking, there ar
 e few (if any) standard guidelines that apply to all labeling studies. Tes
 ting and iterating the IFU early and often ensures that usability issues a
 re addressed prior to validation testing. In order to design an effective 
 labeling evaluation protocol, it is imperative to consider aspects such as
  the user groups and their unique characteristics, the environments and co
 ntexts of use, and the critical tasks. To be most effective, IFU-focused t
 esting should incorporate real-world simulated use scenarios in addition t
 o knowledge task questions. This holistic approach helps manufacturers ide
 ntify and mitigate risks early and enables user-driven optimization of the
  IFU. We will present formative IFU testing approaches that incorporate: \
 n• Knowledge questions to assess whether users can find and comprehend inf
 ormation provided in the IFU. \n• IFU-optional simulated use scenarios to 
 observe whether and how users choose to engage with the IFU and to explore
  the reasons for their choices.\n• IFU-guided simulated use scenarios to a
 ssess whether users can follow the IFU easily without use errors or diffic
 ulties.\n\nTrack: Digital Health, Simulation and Education, Hospital Envir
 onments, Medical and Drug Delivery Devices, Patient Safety Research and In
 itiatives
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