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BEGIN:VEVENT
DTSTAMP:20240325T185837Z
LOCATION:Continental Ballroom\, Lobby Level
DTSTART;TZID=America/Chicago:20240327T091500
DTEND;TZID=America/Chicago:20240327T093700
UID:HFESHCS_2024 International Symposium on Human Factors and Ergonomics i
 n Health Care_sess154_INDLEC264@linklings.com
SUMMARY:Tailoring HF Development/Validation Processes to Software and its 
 Changes
DESCRIPTION:Oral Presentations\n\nKelly Watson, Maya Friedman, Christine B
 rydges, and Brooke Matthews (Tidepool) and Samantha Sye and Jack Giacomini
  (Core Human Factors, Inc.)\n\nIntegrating mobile and digital technologies
  into medical devices is the next frontier of healthcare. Digital healthca
 re tools can empower lay users to take a more active role in their own car
 e than ever before. The easily accessible, rapidly deployable nature of th
 ese devices also allow medical device companies to be more responsive to e
 volving user needs, post-market surveillance data, and competitive technol
 ogies. In order to leverage the potential benefits of accelerated developm
 ent cycles, regulatory processes and paradigms need to evolve to keep pace
 . This joint presentation from the Tidepool Project, a 501(c)(3) nonprofit
  organization dedicated to developing innovative technologies in the diabe
 tes space, and Core Human Factors, human factors experts specializing in m
 edical devices, will explore potential avenues for bringing human factors 
 practice into the age of rapid technological advancements. \n\nThe present
 ation will cover:\n\n- Leveraging the full wheelhouse of human factors met
 hodologies to support development of medical software and interoperable de
 vices. Employing flexible task lists, variable study formats (i.e., in-per
 son vs. remote), a tunable study scope and responsive, iterative stimuli c
 an all support making human factors research expeditious, efficient, and c
 ost-effective. \n\n- The importance of establishing documentation systems 
 up front. In an age of ever-evolving device interoperability, having forwa
 rd-looking risk analyses and protocols sets companies up for more agile de
 velopment and supplemental validation as needed.\n\n- Bringing FDA into th
 e development process as a partner, rather than an adversary. FDA need not
  (and should not) be seeing devices for the first time during submission. 
 Involving FDA reviewers throughout device development, through the pre-sub
 mission process and other pathways, can smooth submission and communicatio
 n between FDA and industry.\n\n- “Safe” Plug and Play Interoperability: Ho
 w the human factors process can be leveraged to validate software revision
 s and new device integrations.\n\nTrack: Medical and Drug Delivery Devices
 \n\nSession Chair: Christoph Jordi (Ypsomed AG)
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