Chapter 16 - Human factors validation testing of combination products

Abstract

Prefilled syringes, pen injectors, inhalers, auto-injectors, and transdermal patches are all examples of products that combine a drug or biologic with a delivery device. These combination products are increasing in popularity and promise to reduce the cost of healthcare delivery while improving patients’ quality of life. As with other medical devices, makers of combination products are required by regulators to validate that their products can be used safely and effectively by intended users in intended use environments. This typically includes conducting human factors validation testing. While conceptually similar, there are differences in the design of human factors validation tests of combination products. These differences stem from the fact that combination products include use-related risks related to the drug itself, as well as to nuanced differences in how the centers of the FDA who lead the review of combination products and medical device submissions view human factors. In this chapter, we review additional considerations for the design of human factors validation tests for combination products relative to tests for other medical devices. We also discuss a related type of human factors test, that may be used in lieu of a human factors validation test of a combination product involving a generic or biosimilar. For companies that wish to establish that their combination products are substitutable or interchangeable, a comparative use human factors test may be needed.