About the Project

To improve the usability of medical devices and minimize use errors, the FDA now requires human factors testing as part of the 510(k) submission process. Healthcare Human Factors (HHF) has assisted numerous US- and internationally-based vendors in completing human factors evaluations as part of this FDA submission process. Our evaluation methods typically consist of a heuristic evaluation, iterative formative evaluations and a final validation testing. All methods are aligned with the FDA’s recent Draft Guidance on Human Factors Engineering, as well as other established international standards.

Examples of products evaluated include infusion pumps, self-injectors, medication safety software systems, combination products and disposables. In addition, we have vast prior experience conducting usability testing of anesthesia machines, physiological monitors, CT scanners, radiation therapy technologies, and Health IT tools.

Heuristic Evaluation

Why:

We will conduct a heuristic evaluation to identify any deviations from best design practices and suggest recommendations to address them. This is a quick and cost effective method for identifying usability issues without involving real users. Ideally, a heuristic evaluation is conducted early in the design process.

How:

Human Factors Specialists will inspect the user interface of the product for usability. Using a checklist of usability principles (or heuristics) as a guide, each component of the interface will be evaluated according to how well it satisfies each principle.

Deliverable:

We will provide a prioritized list of usability issues identified, along with recommendations to address these issues.

Formative Evaluations

Why:

Iterative rounds of formative evaluation will be conducted with end users to identify usability issues, provide recommendations for mitigations, and then re-evaluate the product to assess the effectiveness of these mitigations at reducing usability issues.

How:

Representative end users will participate in low-fidelity usability tests and completed a series of tasks using the product. Human Factors Specialists will observe users’ interactions with the product and note any usability issues they encounter.

Deliverable:

Based on our expertise with medical technologies, we will identify root causes of these usability issues and provide a prioritized list of recommendations for mitigation strategies.

Validation Testing

Why:

Following formative evaluations, we will conduct a high-fidelity validation test with end users, in accordance with the FDA’s Draft Guidance for Human Factors in Medical Device Design. The purpose of this evaluation will be to demonstrate that users can perform critical tasks while using the product in a safe and effective manner.

How:

We will recreate hospital wards, living rooms or other high-fidelity use environments in our usability labs to allow representative users to carry out tasks while using the product in a realistic setting. To add to the high fidelity of the simulation, actors will play the role of nurses, family members or patients and interact with participants in a realistic manner. Human Factors Specialists will monitor the test proceedings and document any use errors, close calls, operational difficulties, and instances necessitating assistance.

Deliverable:

We will synthesize findings from the high-fidelity validation test in a report for the FDA, along with detailed root cause analyses for each issue.

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