What we do.

From the initial exploratory phase of product development through regulatory approval to post-market maintenance, USENSUS has the talent, tools and expertise to ensure your product fulfills expectations of your business, patients, customers, and regulatory agencies. Whether your product is for use in a clinic environment or a home, USENSUS can help you apply design thinking to create a positive user experience and build brand loyalty. We will tailor a service package to fit your needs, from an individual activity to a full Human Factors program.

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Services

Our capabilities cover the full range of Human Factors activities

INITIAL EXPLORATION

Define user needs, conditions of use and clinical practices to provide the design team with clear requirements that reduce downstream rework. Observational, interview, survey and literature review research methods yield the necessary data to craft user profiles, task flows, use specifications and UI requirements.

DETAILED UI DESIGN

Generate user interface (UI) design concepts and analyze them for potential use errors to achieve early mitigation of use-problems. Wireframing and prototyping tools bring UI concpets to life while design reviews, formative usability testing, and use error analysis root out problems and identify design improvements.

VERIFICATION & VALIDATION

Evaluate UI design with end users to ensure product meets requirements and user needs. Inspection and tracing activities confirm the product is on track with design input requirements. Iteration of formative testing confirms earlier design improvements and use error mitigations are effective while burning down project risk prior to validation. Summative usability tesing provides the evidence needed to demonstrate the final product is safe and effective for its intended use.

REGULATORY & COMPLIANCE

Structure an effective Human Factors story for the regulatory submission package: a Human Factors Summary Report for the FDA and an IEC62366 Compliance Report for the TUV. Standardize and integrate Human Factors activities into the quality system to improve product quality and regulatory compliance.

POST MARKET ANALYSIS

Analyze field performance data to expand market and user insight for improved product performance. Data mining complaint records can identify unmet user needs and new market opportunities while identifying use problems early can ensure patient safety is maintained.