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DTSTART:19700308T020000
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BEGIN:VEVENT
DTSTAMP:20251016T135208Z
LOCATION:Grand C/D North
DTSTART;TZID=America/Chicago:20251014T113000
DTEND;TZID=America/Chicago:20251014T115000
UID:HFESAM_ASPIRE 2025_sess185_ICS112@linklings.com
SUMMARY:Addressing Risk for Standalone Drug Products at the Source
DESCRIPTION:Natalie Abts (Genentech)\n\nIn recent years, many pharmaceutic
 al companies have formed robust human factors teams to address changing re
 gulatory requirements for application of human factors engineering to medi
 cal devices and combination products. Since devices are the primary regula
 tory focus, stand-alone drug products often get overlooked, and the potent
 ial for serious, use-related risk can go unnoticed. Using a successful cas
 e study of applying human factors to the user interface of a standalone dr
 ug product, this presentation will demonstrate the importance of human fac
 tors even when not strictly required by health authorities, and will also 
 identify critical inputs for determining the scale of human factors work a
 nd normalizing it with stakeholders that may have little exposure to human
  factors science.\n\nTrack: Health Care\n\nSession Chair: Alexandra Watral
  (Mayo Clinic)\n\n
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