Human Factors & Usability for Medical Devices

Get the Human Perspective on Your Medical Devices

Objective human factors analysis is vital to developing medical devices that perform effectively in the hands of real-world patients and healthcare providers. Exponent assists manufacturers with human factors and usability design evaluations for medical devices, in vitro diagnostics, and combination products — from registration, regulatory compliance, use-related risk management, and usability assessments to postmarket activities.

Medical device design and user interaction testing

Design challenges for medical devices, combination products, and in vitro diagnostics, include technological complexity, interactivity with associated devices and services, and compliance with medical device regulations and industry best practices. Many manufacturers and developers integrate usability assessments into their design process to identify and mitigate both foreseeable and unforeseen use-related hazards and risks.

Exponent offers unique medical device evaluations, integrating human factors with mechanical and biomedical engineering to provide bespoke product support — from proof of concept, through development, to premarket regulatory submissions, to postmarket safety and efficacy management.

Exponent has multiple user study labs for conducting simulated-use tests, user group evaluations on intended use populations, and use-related risk analysis (URRA) in risk management for a wide range of medical devices and components. We also offer evaluations of use-related documentation and labeling and postmarket surveillance support.

Download our medical device human factors brochure to learn more.

Services

For 50+ years, we’ve thrived on solving unstructured problems that require bespoke solutions. Some of our services include:

• Preparing robust FDA regulatory submissions including human factors engineering (HFE)/usability engineering (UE) reporting in premarket approval (PMA), 510k, and De Novo submissions

• Performing human factors URRA, failure mode and effects analysis (FMEA)/usability hazards, and fault tree analysis to help identify tasks that, if performed incorrectly, could cause harm or impact device longevity

• Conducting research to understand real-world use in a user’s environment

• Assessing labeling, device instructions, and safety information for user comprehension

• Addressing usability issues within the iterative design lifecycle, including testing of device labeling and effectiveness of instructions and training and allowing manufacturers to address design challenges and optimize development efficiency

• Summative validation testing to demonstrate that a device can be safely used by the intended user group utilizing multimodal approaches for collecting behavioral, psychological, and physiological measures for inclusion in FDA regulatory submissions

• State-of-the-art usability labs (e.g., user study labs, cadaver labs) in strategic locations across the U.S.

• Product liability and risk mitigation analysis (e.g., design, labeling/IFU)

• Risk assessment support based on postmarket surveillance data analytics, for example, 522 Postmarket Surveillance Studies or Risk Evaluation Mitigation Strategy (REMS) development and implementation

• Conducting robust preclinical formative and validation testing for combination products that considers human factors for new, abbreviated new, or investigational drug applications; biologics 33 license applications; premarket approval applications; etc.

What Can We Help You Solve?

With expertise in over 90 disciplines and hundreds of capabilities, tools, and methodologies — we get to the root of even the most complex challenges and give you the objective answers you need.