We Optimize Usability.

Through human-centric testing and design iteration.


We evaluate the usability of product concepts or prototypes, in order to inform design decisions and fulfill FDA requirements.

Clinvue offers a range of services aimed at addressing FDA / CE Mark usability guidelines and can be customized to couple with our clients' existing knowledge-base or address their unique resource constraints.

Preliminary Usability Analyses

Heuristic Analysis
Formally evaluate user interface against well-established design rules or heuristic guidelines.

Expert Review
Engaging clinical and human factors experts to provide personal opinions regarding the usability and safety of an envisioned product's user interface, based on professional knowledge and experience.

Exploratory Human Factors / Usability Studies

If not already completed, we can provide primary research in the intended use environment to build a complete understanding of key products, end users, environments, and processes the envisioned product will interface with. This step identifies issues that may not be apparent through analytic techniques or discovered through conversations with end-users, such as environmental conditions (e.g. lighting, temperature, storage) or unanticipated product handling.

Formative Studies
Iterative testing of simple product mock-ups, prototypes, or components in simulated-use modes to optimize the device design and ensure human factors/ usability validation testing results will be successful. Clients have also found these studies valuable in helping to determine a preferred device architecture.

Labeling and IFU Studies
We're experienced in developing and testing graphic mockups to help assess the clarity and effectiveness of all labeling (e.g. instructions for use, quick reference cards, packaging labeling).

Design Iteration

Developing and Testing Risk Mitigation Strategies
Iterative ideation and testing of modifications to the device interface or user instructions to address problems identified.

Human Factors / Usability Validation

Summative Studies
Final human factors test prior to FDA / CE Mark approval and product release, demonstrating that the device can be used safely and effectively. Requires a minimum of 15 participants from each intended user group, using a representable final product under expected use conditions.


This Delivers Unique Value By:

  • Delivering a comprehensive usability risk assessment
  • Identifying, prioritizing, and mitigating use-related risks
  • Providing human factors / usability validation testing data on strategies implemented to mitigate significant use-related risk
  • Providing a robust documentation of testing protocols, conditions, results, analyses, and conclusions for inclusion in the Design History File
  • Arming product development teams with end user feedback on key human factors and usability risks, helping to foresee potential usage errors and determine the most appropriate device architecture to pursue
  • Offloading usability project management to an unbiased third-party, alleviating pressure on internal resources

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