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Design & Prototyping

Our design process is user-centered, iterative, and risk-based, and has proven to deliver safe, reliable, innovative, and approvable solutions with outstanding usability and user acceptance.

User Interface Design

User interface specification

As the basis for medical device user interface design, we define all measurable cognitive and physical performance specifications. Our process systematically incorporates user requirements analysis data, known use problems, hierarchical task analysis, and use-related failure modes and effects analysis.

  • Specification of use-related cognitive and physical performance

  • Specification of risk control measures

  • Specification of accompanying materials

  • Training specification

Concept design

We translate user-interface-related specifications into design outputs, conceptualizing innovative medical device user interfaces, user instructions, and effective training materials. Our approach is systematic and optimized toward use-related safety, effectiveness, and user acceptance. We strongly recommend beginning design concept development and iteration as early as possible. In early project stages, design iterations are cost efficient and significantly increase the likelihood of project success.

  • Hard- and software user interface design (UX, IA, and UI)

  • Packaging and labeling design

  • Instructions for use

  • Training materials including training videos

  • Alarm systems design

  • Design guideline development


We develop mockups and prototypes of hard- and software user interfaces including packaging, labeling, instructions for use, and training materials for all design and development stages. Our prototypes span non-functional cardboard mockups and sketch drawings for early concept evaluation, to functional software mockups and 3D CAD-designed hardware prototypes for pre-summative evaluation.

  • Hard- and software mockups and prototypes

  • Packaging and labeling samples

  • Printed user instructions

  • Training materials including videos

  • Bespoke test dummies and test rigs

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