Human Factors Engineering
Designing for Safety, Usability, and FDA Compliance
Human factors engineering is an integral part of both medical device usability and safety (HE75 and IEC 62366-1). The process that we use helps us to clearly understand how users interact with your medical device product in a real-life and clinical environment. This, in turn, helps us to both reduce risk and improve performance, while meeting and maintaining FDA requirements for usability validation.
Our human factors practice is completely integrated with your development timeline. We start with formative testing that can be used to understand and influence design decisions, through to summative testing to validate the safety and performance of your device.
We conduct thorough use-related risk analyses to spot any possible hazards, and we create design controls that minimize user error throughout the product development cycle.
Our systematic observation and experimentation let us quantify cognitive workload, physical ergonomics, and environmental factors that affect device operation. Our specialists check user workflows, task sequences, and decision-making patterns to optimize usability. This step reduces the likelihood of failure modes.
Our testing looks at both documented use scenarios and plausible misuse conditions. We stress-test the products with diverse user groups and various levels of experience, physical capabilities, and stress conditions likely to be encountered in a clinical environment. Our thorough coverage makes your device work reliably for experienced professionals as well as for occasional users.
Why It Matters
A poorly designed device may cause potential harm to the patient. Our work approach makes sure that your medical device supports complete, intuitive, and error-resistant usage by clinicians and that it fully complies with the FDA's health and safety guidelines.
Besides regulatory compliance, targeted human factors engineering means that your medical device is successful, and clinicians trust it and prefer it to competitors. Users must be able to use your device with ease and confidence. This reduces training requirements, support costs, and raises overall user experience and satisfaction. These features have a direct impact on the product’s success in the market.
Our Approach
When we start the development, we build iterative testing into the process, from the earliest concept sketches to the finished working prototypes. This allows usability to match and shape the design, rather than just validate it. We draw on the experience of our human factors team to create procedural maps, environment schematics, and gather real-time user feedback.
We continue with a systematic process that is compliant with FDA standards and international best practices. We begin with extensive user and market research to understand the needs, limitations, and environmental conditions of your target user. This is the foundation of our formative testing. We test prototypes and early concepts with users to identify any potential usability issues, which can then be addressed before they become significant time delays and financial setbacks.
Through development, we conduct targeted usability tests, internal and external, to assess specific interface features and task flows. Through this, we learn how users process data, make critical decisions under pressure, and utilize the device in a real-world setting.
Our testing methods mimic real-world use conditions, such as environmental stress, time constraints, and multitasking scenarios, which are common in healthcare settings. This rigorous process makes sure that your device functions reliably in high-pressure medical environments.
Our Human Factors Services Include:
User & Ethnographic Research
Usability Testing
Accessibility Design
Workflow Analysis
Cognitive Ergonomics
Information Architecture
Feasibility Prototyping
Our services extend beyond typical usability testing to provide risk-based design analysis. This means we examine future use errors and implement design controls to minimize patient safety risks. We provide detailed use-related risk analyses that identify vital tasks, potential failure modes, and mitigation strategies that regulatory reviewers expect to see in your submission.
What You Get
You receive a comprehensive list of human factors documentation for FDA submissions, validated user interface requirements, along with validation reports that demonstrate compliance with HE75 and IEC 62366-1 standards, including detailed summative study protocols and results.
Our deliverables include actionable design recommendations, validated user requirements, and complete documentation packages that streamline your regulatory review process. We make sure that your device meets the highest standards for clinical safety and usability in real-world settings. Our report will serve as the basis for future regulatory submissions and product enhancements.
We provide detailed user persona profiles and clinical workflow maps that support future product development and market positioning efforts. Our summative evaluation reports include statistical analyses of task success rates, error rates, and user satisfaction rates. These demonstrate your device's usability across different user populations.
You also receive implementation support that helps your team integrate human factors principles into existing development processes. These include user interface design standards, usability testing protocols, and post-market surveillance guidelines, so that you have sustained compliance and product enhancement after launch.