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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_POST202@linklings.com
SUMMARY:MDD4 - Charting the course: A planning compass for human factors s
 tudies in medical devices
DESCRIPTION:Poster Presentation\n\nEleanore Dias, Sarah Burleton, Michelle
  Dowell, and Chelsea Wanta (GE HealthCare)\n\nCoordination of multiple for
 mative and summative human factors/usability studies within a single proje
 ct is often a complex activity requiring extensive planning to execute suc
 cessfully. Early decisions need to be made on a variety of factors includi
 ng product complexity, resources, project schedule, and geographic locatio
 ns, to name a few. Medical device manufacturers may not have adequate reso
 urces to support this work, so they may rely on 3rd party vendors or contr
 actors 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 contractor
 s presents similar challenges such as long lead times to be onboarded and 
 trained appropriately.    \n\nBased on our collective experience, a though
 t framework can help manufacturers consider key factors affecting the plan
 ning and completion of human factors/usability studies within a single pro
 ject; thus, increasing predictability and improving on-time execution. Thi
 s thought framework includes the following considerations:   \n1. 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.   \n2. Rese
 arch user groups, use environments, and use workflow within the target geo
 graphical locations to identify the location logistics of usability testin
 g (i.e., if testing is required in multiple regions or countries, testing 
 of translations, etc.).  \n3. Ensure understanding of applicable global re
 gulations to execute usability related requirements effectively and avoid 
 delay of regulatory submissions.  \n4. Early resource planning for usabili
 ty 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 3r
 d party vendors.  \n5. Identify test site location(s), required test equip
 ment, test session scheduling, and other test logistics (such as recruitin
 g of test participants, NDAs, etc.). \n6. Consider how data collection and
  analysis will be performed to show effectiveness of risk mitigations. \n\
 nThis presentation will describe the thought framework, including its meth
 ods and considerations, to guide usability professionals in effective plan
 ning of usability studies for a project. The various elements considered i
 n realistic planning will be presented, including the evaluation of projec
 t aspects which impact the project and testing timeline, use of 3rd party 
 vendors or contractors for planning or test execution, and early identific
 ation and preparation for potential hurdles. \n\nTrack: Digital Health, Si
 mulation and Education, Hospital Environments, Medical and Drug Delivery D
 evices, Patient Safety Research and Initiatives
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