Early Ergonomic Studies Can Help Combination Product Development

Early human-factor studies can address many questions on usability before combination products enter clinical testing, according to John Towns, a senior research fellow at Eli Lilly.

The FDA expects sponsors to demonstrate that iterations of device components have no impact on the delivery of a drug — for example, in prefilled syringes and auto-injectors under development — and human factors and ergonomics studies can help deliver that evidence, Towns said during a presentation at the Joint Regulatory Conference of the FDA and the Parenteral Drug Association in Washington, D.C.

While the design and materials of the primary drug container and closure may remain identical through the product’s development, changes in handles, needle guards and even labeling will need to be shown to have no adverse impact on the patient.