Medical Device Usability Engineering Services

Medical workers working in conference room

“When you put a medical device in front of real users, it’s eye-opening. Engineers who have worked in medical devices for years often assume users will understand things that aren’t intuitive to the average person. That’s exactly why CMD MedTech’s approach focuses on getting devices in front of actual users early and often–we help you discover these insights before they become costly problems.”

–Chad Gibson, Managing Partner

Medical device manufacturers are responsible for making sure that the people who use their devices can use them safely and effectively. FDA human factors requirements mandate rigorous processes to prove you’ve designed out potential use errors and foreseeable misuse situations before putting products on the market. With decades of experience helping all types of medical device manufacturers properly assess usability, CMD MedTech provides the specialized expertise needed to navigate these complex requirements efficiently and cost-effectively.

Why Choose CMD MedTech for Usability Engineering and Human Factors

Right-sizing expertise means we understand the overall risk of your product, what other devices have done on the market, and FDA’s expectations based on our extensive regulatory experience
End-to-end process management means we handle everything from early formative studies through final validation—unlike companies that focus solely on testing—ensuring all pieces fit together efficiently
Regulatory compliance assurance means our documentation conforms to FDA guidance and we know the issues that FDA focuses on from recent recalls and market feedback
Integrated project coordination means we plan formative studies to align with prototype development and coordinate timing with software, hardware, and mechanical engineering to avoid costly delays
Partnership flexibility means we can support the entire usability engineering process or specific components, and we work with specialized partners for complex multi-site studies when needed. We often partner with Priority Designs for their extensive expertise in designing and conducting summative evaluations and early formative evaluations.

PRICING FOR USABILITY ENGINEERING

Pricing varies depending on whether you need use-related risk assessments (URRAs), formative studies, summative validation, or the complete usability engineering process. Contact us for a customized quote based on your device risk level, user population complexity, and study requirements.

5-Step Process for Getting Started With Medical Device Human Factors

Develop a usability engineering plan that defines the overall approach and deliverables needed for your specific device and regulatory pathway

Create use specifications that identify who will use the device across its entire lifecycle, including end users, installers, and service personnel, along with their demographics and potential limitations

Analyze use environment to understand where and how the device will be used, including lighting conditions, noise levels, whether it's in a clinic or home setting, and any environmental factors that could affect usability

Conduct task analysis with PCA framework to map out every step where users interact with the device and analyze what they perceive, think, and do at each step, plus what might go wrong

Perform a use-related risk analysis (URRA) to identify potential use errors and foreseeable misuse situations, score them based on severity, and integrate findings into your overall safety risk management process

5-Step Process for Success With Your Usability Engineering Process

Execute formative studies early and often by getting prototypes in front of actual users throughout development to identify and address usability issues before final design

Revise the design and labeling based on user feedback by using formative study findings to modify interfaces, labeling, and instructions before committing to final mechanical and electrical engineering designs

Plan human factors validation logistics by recruiting 15 users per cohort, securing realistic use environments, and developing protocols that simulate actual use conditions as closely as possible

Conduct human factors validation by testing final products with final labeling in simulated real-world environments, ensuring no critical use errors occur that could result in patient or operator harm

Document everything for FDA review by providing comprehensive documentation showing the progression from early formative studies through final validation, demonstrating how identified risks were systematically addressed

Additional Services for Usability Engineering and Human Factors

Use Specification Development

Detailed documentation of intended users, use environments, and use-related risk analysis that forms the foundation for all subsequent usability engineering activities.

Task Analysis and Risk Assessment

Comprehensive mapping of user interactions with perception, cognition, and action analysis to identify where use errors might occur and feed into overall risk management processes.

Formative Usability Studies

Early-stage medical device user testing with prototypes to identify potential use errors before final design commitment. These studies are more informal and focus on gathering actionable data to improve device usability.

FDA Pre-Submissions for Usability

We (and FDA) recommend that companies submit a draft of their Human Factors Validation protocol to FDA for comment and feedback. This helps ensure that the Agency is aligned with the approach–before submitting as part of the 510(k) or De Novo submission.

Human Factors Validation (Summative Evaluation)

Final validation testing with 15 users per cohort using actual devices in simulated real-world environments to prove to the FDA that users can operate the device safely without critical errors.

FREQUENTLY ASKED QUESTIONS ABOUT MEDICAL DEVICE USABILITY ENGINEERING

Are formative studies required by FDA?

Formative studies are not strictly required, however, not performing early use assessments can result in unforeseen issues in the Human Factors Validation effort. Every medical device has something that needs tweaking from a user interface perspective, and formative studies for medical device user testing are much cheaper than discovering problems during final validation. CMD MedTech helps you design cost-effective formative study protocols that provide maximum value and reduce your overall project risk.

How many people do I need for human factors validation?

You need at least 15 users per cohort for summative evaluation. If both patients and doctors use your device, you need 15 patients and 15 doctors. This number is based on research highlighted in FDA Human Factors guidance.

When should I start thinking about usability engineering?

You should start as soon as you’re thinking about technical feasibility. You don’t want to develop prototypes and then realize the button needs to be twice its size because people’s thumbs are bigger, or discover other fundamental usability issues after you’ve committed to a design. CMD MedTech provides comprehensive medical device engineering and planning to ensure we’re thinking about human factors from day one.

What's the difference between formative and summative studies?

Formative studies are conducted early and often with prototypes to gather data and identify problems before final design. Summative evaluation is the final validation test with the actual device and final labeling to prove to the FDA that users can use it safely without critical errors. Some companies even “dry run” the summative evaluation as a formative in order to refine the protocol and identify potential use-related issues before they present themselves in the summative. Our team will help you determine which studies you need to ensure success.

How realistic do the test environments need to be?

For summative evaluation, the environment must be as realistic as possible. If it’s a surgical device, you need to simulate an OR suite. For home-use devices, you will often need to go into people’s homes. The FDA wants to see that any differences from real use are adequately explained and justified. CMD MedTech handles all the complex logistics of creating authentic test environments and works with human factors partners when necessary.

What makes CMD MedTech's approach different?

Our comprehensive task analysis and use-related risk assessment (URRA) process helps you avoid waiting months for hardware or software teams while ensuring formative studies provide actionable data that feeds directly into your design process. We help ensure you’re addressing usability throughout the lifecycle of feasibility and product development–an approach which helps ensure design and labeling changes are considered and implemented in a way that minimizes overall program time and cost.

Medical Device Usability Engineering and Human Factors