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BEGIN:VEVENT
DTSTAMP:20260715T161117Z
LOCATION:Rhinelander Gallery
DTSTART;TZID=America/New_York:20260323T164500
DTEND;TZID=America/New_York:20260323T181500
UID:HFESHCS_2026 International Symposium on Human Factors and Ergonomics i
 n Health Care_sess106_POST278@linklings.com
SUMMARY:Designing the Right Device the Right Way: HFE Incorporation Throug
 hout Product Development
DESCRIPTION:Teresita Pileggi and Sara McNew (Design Science)\n\nHuman Fact
 ors Engineering (HFE) has often been thought to apply for validation activ
 ities, as summative studies are frequently required for medical devices an
 d combination products to submit to regulatory bodies. However, it is stil
 l an ongoing effort to encourage industry recognition that HFE can be util
 ized for additional assessments throughout the product development process
  beyond validation studies. There are opportunities well in advance of des
 ign validation to incorporate user touchpoints to get productive feedback 
 to improve a product that manufacturers can take advantage of. As such, th
 is presentation aims to outline the key areas where HFE can play additiona
 l roles during development to the advantage of overall product success, as
  well as provide techniques to communicate this importance to key stakehol
 ders and effectively integrate HFE into discussions throughout the process
 .\n\nThis presentation will step through a few case studies for the audien
 ce to highlight theoretical scenarios that may be applicable, and various 
 HF techniques and strategies to utilize in their own practice such as:\n•	
 Force injection usability study results informing user requirements (e.g.,
  injection time, force to inject, force acceptability thresholds)\n•	Itera
 tive IFU Testing providing users the opportunity to review, use, and recom
 mend changes for IFUs to work collaboratively with end users towards clear
  and understandable labeling\n•	Inclusion of ease of use assessments with 
 representative end users into early clinical trail questionnaires (e.g., E
 nd of study questionnaire for the participant to evaluate the ease of usin
 g the product, in conjunction with their actual use experience).\n•	Sketch
 es, 3D printed mockups, and virtual concept assessments to orient developm
 ent engineering and end user expectations on a product (e.g., product dime
 nsions, form factor acceptability, audible/visual/tactile alerts)\n•	And m
 ore! \n     o	Human Capability Requirements \n     o	Field Research & Cont
 extual Inquiry \n     o	Comparative Evaluation \n     o	Heuristic Analysis
  \n     o	Expert Review \n     o	Early & Later Stage Formative Studies  \n
      o	Rankings & Ratings \n     o	Secondary Packaging Layout & Accessibil
 ity Reviews\n     o	User Feedback During Clinical Trials\n\nThroughout the
  phases of product development, additional opportunities to incorporate HF
 E activities provide supplemental assurance that the products and devices 
 have been both designed correctly to meet their design input specification
 s, and for the correct intended uses. They also allow HFE practitioners to
  take full advantage of their time and resources during already allotted H
 FE activities. For example, while participants are scheduled to participat
 e in a validation study, additional time could be allocated to their sessi
 on to perform the user needs validation. Or formative study task success c
 riteria can be drafted in such a manner to fulfill user requirement verifi
 cation in addition to providing user feedback on the product or device des
 ign.\n\nAs outlined in AAMI TIR59:2017, HFE is most impactful if incorpora
 ted throughout the entirety of the product development lifecycle and not v
 iewed as a “checkbox activity” at the end of validation to be able to subm
 it to regulatory bodies. This presentation highlights some overlooked area
 s of opportunity for HFE practitioners to integrate HFE assessments and te
 chniques to not only design safe and effective products but maximize user 
 satisfaction as well.\n\nTrack: Digital Health, Hospital Environments, Pat
 ient Safety Research and Initiatives, Medical and Drug Delivery Devices, S
 imulation and Education\n\n
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