When examining the role that human factors play in a medical device clinical study, it’s important to adopt a wider viewpoint than the traditional focus on the interaction between patients and the devices that are being investigated. The Clinical Human Factors Group (CHFG) has put forward a definition of what human factors actually encompass:
“Enhancing clinical performance through an understanding of the effects of teamwork, tasks, equipment, workspace, culture, organization on human behavior and abilities, and application of that knowledge in clinical settings” (Dr. Ken Catchpole)
It’s clear from the CHFG’s perspective that human factors refers to far more than just simple man/machine relationships. While this concept is important across the board during medical device development, clinical research must take on a greater leadership role when it comes to human factors due to the responsibility for patient safety that is inherent in any investigation.
Applying human factors to a clinical trial is not only an effective means of protecting patient health, but it can also help to ensure that a study is more efficient and that better outcomes are achieved. Creating interdisciplinary teams involving representatives from trial sponsors, vendors, and site personnel has a positive impact on almost every stage of an investigation.
During the design phase, avoiding the temptation for each group of stakeholders to remain ensconced in their respective silos can introduce important alternative perspectives on the viability of a given protocol. Integrating human factors principles into day-to-day operations also provides guidelines for how to assemble effective teams where transparency, frequent communication, and clear leadership, roles, and responsibilities are paramount. This same philosophy can also be used to promote compliance with ethical and safety standards throughout the trial, as well as more effectively manage resources.
Medical device companies stand to benefit from expanding their current understanding of human factors and applying this concept across a wider range of activities. Particularly when designing and executing a clinical trial, a strong implementation of human factors awareness can make it easier to more effectively manage and react to the realities of a given investigation.
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Aptiv Solutions Blogging Team