Presentation
Learnings and recommendations on the role of human factors for on-market products
Event Type
Oral Presentations
TimeWednesday, June 8th3:30pm - 4:00pm EDT
Location
DescriptionThis presentation will cover learnings from my experience as a human factors (HF) practitioner in Pharma/Biotech working to support on-market device combination products and the importance of collaborating with commercial stakeholders and others responsible for on-market support of these products (i.e. lifecycle management, product care, post-market teams), including device engineering, packaging, regulatory, quality, complaints management, operations, and manufacturing 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:
• Having a seamless connection 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 product quality review processes, as well as feeding back information into development of future similar products. I can also cover some of the potential pitfalls where contributing HF expertise adds value.
• Comparing and 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 safe 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 contribution during preparation for new product introductions when creating and rolling out these materials and resources in collaboration with commercial stakeholders (e.g. marketing / brand teams, trainers, sales specialists, access services).
• The importance of human factors in post-validation design changes, both supplier initiated changes and manufacturer initiated changes. Design changes requiring HF input can be for the intended use and the user interface.
• Having a seamless connection 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 product quality review processes, as well as feeding back information into development of future similar products. I can also cover some of the potential pitfalls where contributing HF expertise adds value.
• Comparing and 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 safe 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 contribution during preparation for new product introductions when creating and rolling out these materials and resources in collaboration with commercial stakeholders (e.g. marketing / brand teams, trainers, sales specialists, access services).
• The importance of human factors in post-validation design changes, both supplier initiated changes and manufacturer initiated changes. Design changes requiring HF input can be for the intended use and the user interface.
Author
