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DTSTAMP:20240325T185836Z
LOCATION:Salon C
DTSTART;TZID=America/Chicago:20240326T164500
DTEND;TZID=America/Chicago:20240326T181500
UID:HFESHCS_2024 International Symposium on Human Factors and Ergonomics i
 n Health Care_sess128_POST189@linklings.com
SUMMARY:MDD5 - An Integrated Framework for Comprehensively Defining, Desig
 ning, and Evaluating Medical Devices
DESCRIPTION:Poster Presentation\n\nKellen Crosby, Jessica Franklin, Ben Da
 vis, Jonathan Dalton, and Leah Swanson (THRIVE)\n\nHistorically, Medical D
 evice (MedTech) companies have been technology-driven rather than user-cen
 tric, operating in commonly structured tech silos such as mechanical and e
 lectrical engineering and software development. These silos are optimized 
 to their parts rather than addressing the entire stakeholder journey (nurs
 es, physicians, and family members) and the patient experience. Merely com
 plying with user testing regulations and guidelines do not make an organiz
 ation user-centric, and ambiguous and rigid development structures discour
 age the collaborative work needed to deliver the entire patient experience
  and improve clinical outcomes.\n \nHow do we evolve the device design and
  development process to launch a competitive product that successfully mee
 ts user needs, brings a highly satisfying user experience, and achieves FD
 A approval, all within the current constraints of tight product developmen
 t timelines and budgets? \n \nWith increasing importance placed on the use
 r and patient experience while maintaining appropriate rigor in evaluating
  the safety, effectiveness, and usability, we will propose a new integrate
 d device definition, design, and validation framework. This multidisciplin
 ary approach integrates the disciplines of Design Research, Human Factors 
 Engineering, and User Experience Design into a cross-functional design tea
 m capable of delivering solutions that reduce device definition, design, a
 nd regulatory timelines. This framework will enable device manufacturers t
 o craft a stronger, more compelling case that they have considered all asp
 ects of the use of a medical device—from understanding the needs and pain 
 points to identifying opportunities for effectively addressing those to de
 veloping design requirements centered on the use, user, use environment, a
 nd context of use (including a renewed focus on the emotional aspects of u
 se), to designing for an optimal and enjoyable user experience, to evaluat
 ing against the more appropriate heuristics and user needs, as well as saf
 ety and usability and submitting a robust case of good design and evaluati
 on to the FDA for approval.\n\nABOUT THRIVE\n \nTHRIVE is a strategic desi
 gn and research firm innovating at the frontiers of health and well-being.
 \n\nWe work with ambitious leaders to build brands and experiences that pe
 ople love through Informed Design™. Our work gives leaders, teams, and org
 anizations the courage and conviction to move confidently forward and desi
 gn what's next.\n\nOur in-house human factors professionals have decades o
 f experience in human factors psychology and applying human factors method
 s in various work environments and industries. Our human factors specialis
 ts are up to date on the latest regulations set forth by the FDA in the Un
 ited States and other regulators worldwide and guide organizations from a 
 strategy and execution perspective.\n\nWe have extensive experience applyi
 ng human factors to products ranging from medical devices used by speciali
 zed healthcare professionals in clinical environments to combination produ
 cts used by laypeople in the home to in-vitro diagnostic systems or reproc
 essing workflows used by technicians in the lab.\n\nTrack: Digital Health,
  Simulation and Education, Hospital Environments, Medical and Drug Deliver
 y Devices, Patient Safety Research and Initiatives
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