Accola designs medical devices with patients in mind through an integrated human-centered design approach. Our team implements human factors and usability engineering throughout development to ensure devices are intuitive, easy to use, and aligned with real-world healthcare environments.
Our Expertise
Human Factors & Design
User & Use Environment Research
Our human factors team conducts targeted research to understand how users interact with devices in clinical environments. Using contextual inquiry, interviews, and observation, we identify workflows, needs, and environmental conditions that shape product use.
We leverage contextual inquiry, ethnographic studies, and reviews of existing data sources (including literature, ergonomic, and anthropometric research) to gain insights into user needs and use environments.
We analyze tasks and functions, explore early concepts, conduct exploratory studies, and develop detailed use specifications to inform user-centered design decisions.
Industrial & User Interface Design
We design and refine device interfaces, labeling, packaging, and instructions to support safe, intuitive use. This iterative, collaborative process incorporates feedback from users, engineers, and regulatory experts to ensure products are both user-friendly and compliant.
Our in-house design team specializes in industrial design, graphical user interface (GUI) design, and user experience/user interface (UX/UI) design.
Designers and HF engineers develop clear, structured interfaces and labeling systems that reduce the potential for use error and encourage consistent, reliable use.
Use-Related Risk Management
Our team manages use-related risks by analyzing real-world use scenarios to identify potential harms and mitigate them. This work supports product safety and ensures alignment with FDA and international regulatory expectations.
We conduct Use-Related Risk Analyses (URRAs) to identify and mitigate potential risks.
We perform hazard analyses, identify known use-related problems, and pinpoint critical tasks to enhance safety and usability.
We carry out comparative analyses to provide rationale for substantial equivalence, often eliminating the need for summative study data.
Formative & Summative Evaluations
Formative testing helps identify and resolve issues early in development, while summative studies validate that the device can be used safely and effectively by the intended users.
We conduct formative usability studies, concept evaluations, heuristic evaluations, cognitive walkthroughs, threshold analyses, and cognitive/workload assessments to iteratively refine design and usability.
We perform summative usability studies (HF validation testing), comparative studies, and knowledge task studies to validate safety, effectiveness, and user understanding.
Our Process
How We Approach Human
Factors
Research & Analysis
We first identify all relevant characteristics of the device’s users and usage environments, then analyze each task and associated use-related risks to ensure the product is safe, effective, and user-friendly upon release.
Design
Our design approach puts humans at the center of every process. Our teams include experts in human-centered design, industrial design, ergonomics, UX/UI, and engineering, all integrated and collaborating with one another to produce design solutions.
Evaluate and Refine
Formative evaluations are critically important to inform your device's design. When conducted iteratively during development, these evaluations help to confirm where the current design is on- or off-track, and what aspects should be improved and refined.
Validate
We use summative evaluations (HF validation testing) to prove to regulatory authorities that the product we’re developing can be used safely & effectively by the intended users in the intended use environments.
Locations
Current suites and ability to
set up studies anywhere.
Talk to an Expert
Accola combines engineering expertise, advanced manufacturing capabilities, and regulatory support from concept to commercialization to bring your ideas to life. Ready to turn your vision into reality? Talk to an expert today.