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Identifying and Satisfying New Human Factors Requirements Through Good Study Design

Dixon J, Aston-James DE, Cox BD.

RDD Europe 2013. Volume 1, 2013: 153-162.

Abstract:

Human factors engineering (HFE) has become an important aspect of inhaler device development. International standards and regulatory guidance have provided recommendations intended to improve the usability of medical devices to reduce use error, harm to users, and product recalls. Delays to combination product launches have, nonetheless, occurred as the pharmaceutical industry and regulators work towards a shared understanding of acceptable drug delivery device usability and how this should be demonstrated and justified. This article describes the key features of a robust inhaler HFE process, directed specifically at meeting regulatory requirements discussed in the guidance documents. A clear and coherent narrative in the HFE summary report should be submitted as part of the regulatory package. This narrative should present a clear understanding of the inhaler interface and its use, including the role of the instructions for use (IFU) and any other aspects of the system, which perform a usability function (e.g., packaging). Significant understanding exists at the outset of the development project and making this knowledge explicit at the earliest opportunity is certain to be valuable. There are three fundamental elements to be addressed from the outset of a coherent HFE process: early characterization of the potential hazards associated with device use error, identification of the opportunities for use error, and early consideration of the potential drivers (root causes) of these use errors. These foundations point to the importance of well designed IFU for inhalers. An iterative design-test approach, involving real users, has been shown to be valuable and effective. Finally, some practical observations on the design and conduct of human factors (HF) studies, particularly validation studies, are provided.