Our Services
SINCE OUR INCEPTION IN 2001, we’ve had the opportunity to work with some terrific companies on many innovative devices covering a broad range of diagnostic and therapeutic indications.
We help our clients succeed by collecting, analyzing, and interpreting customer and end-user data, by applying well-understood but seldom practiced human factors principles, and by utilizing the knowledge and advanced techniques from the science of human factors to improve the usability and safety of medical devices.
HUMAN FACTORS STUDIES
EXPLORATORY RESEARCH
Early stage research with users to gather user needs and requirements.
IN-SITU OBSERVATION
Observing patients and HCPs in actual use settings interacting with on-market devices.
FOCUS GROUPS AND INTERVIEWS
Moderator-led explorations of product attributes and use considerations.
FORMATIVE STUDIES
Studies that engage representative users with prototype device, labeling, and packaging design to inform iterative design.
COMPARATIVE USE
Statistically-powered comparisons of combination products to establish substitutability and interchangeability for generics or biosimilars.
VALIDATION TESTING
Summative testing to demonstrate to regulators that a device can be used safely and effectively by intended users in intended user environments.
ANALYTICAL METHODS
USE-RELATED RISK ANALYSIS
Structured assessments of perception, cognition, and action components of tasks required to use a product leading to the identification of potential use errors, hazardous situations, and critical tasks.
THRESHOLD ANALYSIS
Side-by-side comparison of a proposed product relative to an on-market reference product to establish whether differences in critical design attributes may affect use.
USABILITY BENCH TESTS
A systematic review of a device user interface relative to heuristics, established principles, and best practices to identify usability strengths and weaknesses.
ERGONOMIC ASSESSMENTS
Structured review of the physical design of a device to evaluate how well the design supports comfort, performance, and ease of use.
ANNEX C REVIEWS
Reviews of legacy products relative to the requirements for analysis and documentation defined in Annex C of 62366-1:2015.
ADVANCED TECHNIQUES
EYE TRACKING
Understanding what users attend to and ignore is key to effective design. Don’t fly blind.
TACHISTOSCOPIC METERING
Rapid presentation techniques to understand whether your labeling or device communicate critical information immediately.
TIME AND MOTION ANALYSIS
Stop video analysis of the physical actions users perform when handling your product.
WORKFLOW MAPPING
Capture and analyze the activities single or multi-user teams perform when utilizing a medical device.
POST-MARKET DATA MINING
Analyzing, synthesizing and structuring post-market data to mine insights into actual use.
LABELING AND GUI DESIGN
INSTRUCTIONS FOR USE
Effective directions for guiding user behavior and communicating key messages.
CARTON AND ON-DEVICE LABELING
Branded, yet informative carton and device labels that meet regulatory requirements and adhere to best practices.
WARNING AND CAUTION LABELS
Communicate safety critical warnings and cautions clearly and effectively.
GUI INTERACTION DESIGN
Simple, efficient, and intuitive navigation and screen layout for embedded software, desktop applications, and smartphone apps.
GUI VISUAL DESIGN
Branded, visually engaging, aesthetically appealing, and highly usable graphical interface designs for software applications.
CORE COMPETENCIES
Simulated-use testing is a core capability and a fundamental tool in our human factors toolbox. We utilize advanced techniques such as eye tracking and retrospective performance probing to get the most out of the data we collect.
We’ve tested more than two-thousand end users, including healthcare professionals, patients, and caregivers, for a wide variety of medical devices and combination products.
We are a “pure” human factors consultancy. It is all we do. It is what we know.