Presentation
Use of Advanced Human Factors Research Testing Methods in the Development of Robust Force Criteria for Design, Testing and Validation of Prefilled Syringe (PFS) Devices for Use by Target Populations
Description The design and development of prefilled syringe (PFS) devices as combination products is a complex biomechanical and anthropometric problem involving the need to objectively measure Newtonian force, EMG activation levels, 3D spatial tracking and dynamic plunger travel. These variables require utilization of complex data capture methods integrated into a cohesive data stream. The problem is further complicated by the need to capture and scale data based on the use of HF best practices for meeting the anthropometric range of users in terms of strength and coordination.
The session will focus on case studies utilizing advanced data capture methods conducted over a 3-year period in highly structured lab-based studies. The panel will be composed of senior development executives from the Merck Device Development and Human Factors Research Team (2), Akero Therapeutics Senior Director of Packaging and Human Factors Engineering (1), and Mauro Usability Science President and Director of Research (2). The panel will adhere to the following format:
1. Introduction and statement of the problem
2. Review of existing literature on PFS force design criteria
3. Study design and special problems with complex data capture
4. Study findings: Discussion of data analysis and high-level summary of findings
5. Specific learnings for others conducting such research
6. Conclusion and study limitations
Each panelist will cover one topic area as defined above. The presentation will include video and photographic data of study set up and in-process demonstration.
The session will focus on case studies utilizing advanced data capture methods conducted over a 3-year period in highly structured lab-based studies. The panel will be composed of senior development executives from the Merck Device Development and Human Factors Research Team (2), Akero Therapeutics Senior Director of Packaging and Human Factors Engineering (1), and Mauro Usability Science President and Director of Research (2). The panel will adhere to the following format:
1. Introduction and statement of the problem
2. Review of existing literature on PFS force design criteria
3. Study design and special problems with complex data capture
4. Study findings: Discussion of data analysis and high-level summary of findings
5. Specific learnings for others conducting such research
6. Conclusion and study limitations
Each panelist will cover one topic area as defined above. The presentation will include video and photographic data of study set up and in-process demonstration.
Event Type
Discussion Panel
TimeTuesday, March 263:30pm - 4:30pm CDT
LocationContinental Ballroom, Lobby Level
Medical and Drug Delivery Devices