BEGIN:VCALENDAR
VERSION:2.0
PRODID:Linklings LLC
BEGIN:VTIMEZONE
TZID:America/New_York
X-LIC-LOCATION:America/New_York
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:19700308T020000
RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:19701101T020000
RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTAMP:20250327T203346Z
LOCATION:Harbour A/B
DTSTART;TZID=America/New_York:20250402T113000
DTEND;TZID=America/New_York:20250402T120000
UID:HFESHCS_2025 International Symposium on Human Factors and Ergonomics i
 n Health Care_sess118_INDLEC300@linklings.com
SUMMARY:Human Factors Meets Design Validation: Creating Efficiencies While
  Meeting Requirements for Both Disciplines
DESCRIPTION:Oral Presentations\n\nShelby Long and Vandhana Narayanan (Stry
 ker) and Stephanie Wiltman (Bold Insight)\n\nTopic: Understanding the inte
 rsection of human factors and design validation: creating efficiencies whi
 le meeting requirements for both disciplines. \n\nApplication: For medical
  device manufacturers looking to incorporate best in practice human factor
 s while still meeting existing internal design control processes.  \n\nBac
 kground: As Human Factors continues to find its footing within the medical
  device development process, efforts have been made to introduce efficienc
 ies to allow for formative and summative testing within existing product d
 evelopment processes. This has the potential to allow companies to save ti
 me and employee resources while incorporating industry-standard research p
 ractices to produce cutting-edge safe and effective medical devices. To in
 tegrate human factors testing into FDA’s design control process, Stryker h
 as developed a model in which human factors summative testing has been com
 pleted in combination with design validation.  \n\nOverview of Presentatio
 n: This talk will address best practices and lessons learned as this model
  has been developed cross-functionally across multiple research studies. T
 he following topics will be further defined and discussed during the talk.
  \n\n1. Comparison of design validation and human factors goals (where the
 y align and where they don’t) during formative and summative testing. \n  
    a. While the overall goal of design validation is to ensure that users'
  needs are met, the goal of human factors is to ensure safe and effective 
 use by the intended users in the intended use environment. In some cases, 
 these goals overlap, especially when considering effectiveness of compensa
 ting provisions for use errors. However, there are many cases in which the
 se goals diverge, and it is up to the researchers to understand this diver
 gence and how it affects study design. \n     b. Human Factors Engineers s
 hould not act as design validation engineers and design validation enginee
 rs should not act as HFEs. These two roles are better served as a partners
 hip, complimenting each other, rather than combining into a single role.  
 \n2. Study design and implementation, including: \n     a. Materials devel
 opment (such as protocols, moderator’s guides, and datasheets) \n     b. D
 istribution of resources (such as notetakers, moderators, audio/video, etc
 .) \n     c. Data collection practices (such as directed vs. simulated use
 ) \n     d. Acceptance Criteria (Pass/Fail approach in Design Validation v
 s HF Summative) \n     e. Study flow (such as how to address root cause pr
 obing alongside design validation questioning) \n3. Discussion of efficien
 cies that may be introduced to aid in report writing for both human factor
 s and design validation.\n\nTrack: Medical and Drug Delivery Devices (MDD)
 \n\nSession Chair: Taylor Kunkes (Healthcare Human Factors, Toronto Genera
 l Hospital)
END:VEVENT
END:VCALENDAR