HERE’S WHAT WE EXCEL AT

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.