Design

A device’s user interface (UI) allows users, such as healthcare professionals and patients, to interact with the product. The interface may comprise displays, controls, and other touchpoints found on devices as large as an MRI scanner or as small as a blood glucose meter. Regardless of device type and scale of its user interface, poor design can be the root cause of potentially harmful use errors.

Our medical device UI design approach calls for conducting a substantial amount of user research to determine user interface design requirements and balancing functional and aesthetic goals. We collaborate with our clients to produce refined designs by generating many concepts, prototyping and user testing the most promising concepts, and converging on the best solution.

Medical Device Design and Prototyping

In the course of user interface design, we often build interactive prototypes, which might take the form of a physical or virtual model. Prototypes enable effective design presentations and usability tests leading to the identification of design strengths and opportunities for improvement. They can also serve as a dynamic means to specify a final design that eliminates ambiguities posed by written specifications alone.

Our prototypes may model physical elements such as controls, indicators, and overall product forms, as well as virtual elements such as readouts, waveforms, icons, menus, and dialog boxes. In a matter of days, we can build prototypes of complex devices and software applications using tools such as SolidWorks, Adobe Illustrator and HTML, leading to a computer-based, physical (e.g., 3D-printed), or hybrid model.

Labeling and Instructions for Use (IFU) Design and Evaluation

In the medical device industry, most regulators require devices (including combination products) to include validated labeling, which normally includes on-product labels and instructions for use. Poorly designed labeling can trigger use errors even if the product’s physical and/or computer-based user interface elements are well designed. We can help you communicate to users how to properly operate your device by designing easy-to-understand and follow labeling that incorporates optimized features such as:

To develop effective labeling, we start by defining user requirements and developing promising concepts in the same manner as for other user interface elements. Our labeling reflects established human factors principles and lessons learned from countless prior development efforts. The result is validated labeling schemes that help ensure a device’s safe, effective, and satisfying use.

User Interface Design for Your Medical Device or IVD

Our approach to hardware and software user interface design depends on the nature of the product to some degree. Our general approach to designing UIs follows:

Conduct user research and prepare a vision statement

Conduct hazard, task, and use-related risk analyses

Develop design specifications

Develop multiple design concepts

Down-select to preferred design concept(s) based on customer and user input

Develop detailed design(s)

Build prototype(s)

Conduct formative evaluations (e.g., cognitive walkthrough, formative usability test)

Develop refined and final design

Iterate the preceding three steps, as appropriate

Validate the final design (with a human factors and design focus)

Document the full-scale design