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Presentation

Considerations for leveraging human factors data in combination products
Event Type
Oral Presentations
TimeWednesday, April 142:20pm - 2:40pm EDT
LocationMedical and Drug Delivery Devices
DescriptionIndustry is trending toward certain device platforms being more widely used and commonly available across a variety of intended uses. Human factors is integrated into medical and drug delivery device development, and manufacturers develop their products to be robust with strong supportive data packages. It may be desirable to leverage these data packages when the same device is used for new products to reduce testing. At the same time, manufacturers desire to focus resources to innovate with new technologies, where human factors can have a greater impact. As companies continue to seek use of existing device platforms for new intended uses, interest will continue to grow in leveraging prior human factors data for common device platforms to bring beneficial new medicines and medical technologies to patients faster .

Any strategies to leverage data must be consistent with health authority expectations and must be clearly articulated. Comparisons of the user interface have been somewhat straight-forward and FDA has published several relevant guidances in recent years to improve clarity in their expectations for this. However, there continues to be ambiguity around how nuances in intended use of products using the same device platform may impact the ability to leverage data from one product to the next and what the expectations are for content and level of detail necessary to support an evaluation of a proposed leveraging strategy and rationale. This presentation will:
• Discuss our understanding of health authority expectations on leveraging human factors data
• Share a methodology to evaluate whether it is appropriate to leverage data
• Explore case studies to highlight common challenges
• Provide recommendations on how to communicate your strategy and rationale to seek advice from health authorities
Author
Human Factors Engineering Manager