This training will provide an overview of human factors for combination products (i.e., products that combine drugs or biologics with devices, such as prefilled syringes, pen injectors, auto-injectors, and inhalers). The training will explain the need to conduct human factors activities when designing combination products; identify and describe the elements of the human factors process, including the central role of risk management; and explain the benefits of performing these activities as part of combination product development.

The training will describe best practices for human factors processes and explain the FDA’s expectations regarding human factors information and data provided in premarket submissions. It will discuss processes for identifying user needs, generating task analyses, identifying problems (including use errors and difficulties) that could occur during product use, analyzing use-related risks, conducting a variety of human factors formative evaluations, planning and conducting human factors validation studies, analyzing usability study data and residual use-related risk and determining need for product modifications. It will cover the possible need for actual-use testing in addition to simulated-use testing and/or for a pre-clinical human factors validation study.

The training will also cover the essential elements in ANSI/AAMI/IEC 62366-1:2015/Amd. 1:2020 as well as FDA guidance documents that provide advice on how to practice human factors for combination products. It will also explain differences between human factors considerations for medical devices (reviewed by the FDA’s Center for Devices and Radiological Health, CDRH) and for combination products (reviewed either by FDA’s Center for Drug Evaluation and Research, CDER, or its Center for Biologics Evaluation and Research, CBER).

Over the course of (6) hours, the attendee will be able to:

• Understand the need to include human factors activities during combination product development.
• Understand the critical role of risk management and its relationship to the human factors process in the context of combination product development; and 
• Understand the entire human factors process for combination products.