Integrating Human Factors and Usability Testing into Medical Device Risk Management

Abstract

The application of human factors in medical device development is a required component of pre-market submission by regulatory bodies, including the US Food and Drug Administration (FDA). While manufacturers commonly manage product development with the risk management approach of standards such as ISO 14971, the integration of human factors and usability may not be as familiar and effectively integrated. However, the human factors process must communicate directly with risk management steps that companies already have in place. This paper provides an introduction to human factors for medical devices as an integrated component of risk management. Qualitative user research methods are presented that are useful in conducting this work, and are based on the authors’ research on participatory design methods for medical devices in Uganda.