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UID:HFESHCS_2022 International Symposium on Human Factors and Ergonomics i
 n Health Care_sess173_INDLEC246@linklings.com
SUMMARY:Learnings and recommendations on the role of human factors for on-
 market products
DESCRIPTION:Oral Presentations\n\nLearnings and recommendations on the rol
 e of human factors for on-market products\n\nPoker\n\nThis presentation wi
 ll cover learnings from my experience as a human factors (HF) practitioner
  in Pharma/Biotech working to support on-market device combination product
 s and the importance of collaborating with commercial stakeholders and oth
 ers responsible for on-market support of these products (i.e. lifecycle ma
 nagement, product care, post-market teams), including device engineering, 
 packaging, regulatory, quality, complaints management, operations, and man
 ufacturing representatives. These learnings may also be relevant to other 
 types of products and organizations. This topic may cover learnings and/or
  recommendations in the following areas:\n•	Having a seamless connec
 tion between the HF data and expertise from development, use-related risk 
 assessment, defect categories, information collected from complaints call 
 centers, assessment of complaints, and periodic risk review / annual produ
 ct quality review processes, as well as feeding back information into deve
 lopment of future similar products. I can also cover some of the potential
  pitfalls where contributing HF expertise adds value.\n•	Comparing a
 nd contrasting the role of the health authority-required product labeling 
 and promotional labeling that is instructional in nature, as well as other
  resources and interactions and their impact on supporting patients in saf
 e and effective use of the product to help set the product up for success 
 on the market. I can also share how human factors can make a valuable cont
 ribution during preparation for new product introductions when creating an
 d rolling out these materials and resources in collaboration with commerci
 al stakeholders (e.g. marketing / brand teams, trainers, sales specialists
 , access services).\n•	The importance of human factors in post-valid
 ation design changes, both supplier initiated changes and manufacturer ini
 tiated changes. Design changes requiring HF input can be for the intended 
 use and the user interface.
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