In the study preparation phase, the intended users, use scenarios, and use environment are researched and identified to develop an in-depth understanding of how the users interact with the product.

Once the intended users, uses, and use environments are defined, the Human Factors risk management process can be initiated. A task analysis should be utilized to identify how the user will interact with the product, including their perception of the steps, their thought process, and how they will physically engage with the design.

Task analysis creates a foreseeable sequence of events, which can identify what is known as a hazardous situation. A hazardous situation according to the FDA is a circumstance in which people, property, or the environment is/are exposed to one or more hazard(s).

The hazardous situation will drive the risk management process to identify the hazard the user may be exposed to, which is the potential source of harm. According to the FDA, harm is defined as injury or damage to the health of people, or damage to property or the environment. There are varying degrees of severity of harm, and the severity must be determined by a medical professional.

The resulting severity of harm will drive identification of task criticality. A critical task is defined by the FDA to be a task which, if performed incorrectly or not performed at all, would or could cause serious harm to the patient or user, where harm is defined to include compromised medical care. The severity of the harm, in conjunction with an estimated probability of occurrence the hazardous situation is to occur (often determined by a medical professional and the results from a known use errors analysis), results in determination of use-related risk.

As the Human Factors Validation study protocol is prepared, any previous Human Factors inputs are reviewed. This includes the review of Formative Evaluations conducted earlier in the Human Factors & Usability Testing process which may explore the user interface design strengths, weaknesses, and unanticipated use errors. The results of the Formative Evaluation are incorporated into Human Factors risk management deliverables to finalize critical task determination before the Human Factors Validation Protocol is finalized.

Once the risk management documents have been updated following the Formative Evaluations and task criticality has been determined, all necessary inputs are in line to finalize the test protocol. These items have a significant impact on content such as task sequencing, success criteria, participant eligibility criteria, and moderator questions. As a best practice, the finalized protocol should be submitted for review by the FDA to gain concurrence on the test population and the protocol.