BLACKHAGEN-DESIGN INC
Summary
Design & Development of Medical Devices, Contextual Inquiry/Ethnography, Quantitative & Qualitative Analysis, Research Translation & Synthesis, Strategic Device Definition, Formative Usability Studies, V&V Planning & Testing, Summative Usability Testing, Design Validation, Industrial Design, UE Planning & File Mgmt, UX Design, Use Safety Risk Management, Human Factors Engineering, Systems Engineering, Electro-Mechanical Design, User Interface Development, Prototype Development, Regulatory Integration
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Description
BlackHägen Design (BH) is a cross-disciplinary strategic research & product development firm. With a user-centered approach to product definition & design development, BH offers valuable, proven & efficient R&D methodologies to achieve optimized design solutions. We have performed Contextual Inquiry and Usability Engineering projects in 20 countries, including North America, Europe & Asia-Pacific. BH has played a critical role in minimizing failure modes associated with usage error through intuitive user interface design.By developing & deploying kinematic test models & immersive research techniques in global ethnographic studies, BH maximizes the usability of disposable devices & electro-mechanical systems while minimizing use-error & procedural cost, enhancing clinical procedures & the continuum of care. BH has a documented history developing Class I, II & III medical devices while supporting FDA/QSR, ISO 13485 & AAMI guidelines for good design practices & quality assurance.
