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    User Research
    Industrial Design
    UX / UI Design
    Product Development
    Human Factors Engineering

    About Us

    We are a multidisciplinary, usability engineering and product design firm

    BlackHägen Design is a multidisciplinary, usability engineering and product design firm supporting start-ups through Fortune 100 companies. Our pragmatic approach to product design is well suited to safety-critical and environmentally challenging industries, and we have produced award-winning designs for many of those clients. At our core, user-centered design processes drive innovation and sustainable product development. This systematic methodology for translating research insights into design requirements and creating valuable intellectual property has contributed to over 100 patents and trade secrets for nearly three decades.

    We continuously optimize the quality of our methodologies and services through rigorous deployment of our Quality Management System, which is structured to be compatible with 21CFR 820 (FDA) and ISO 13485 and is easily adaptable to our clients’ in-house QMS for seamless documentation transfer.

    Our Work

    Optimize your design solutions and achieve beneficial patient outcomes that enhance healthcare excellence.
    Clear Filters
    ON-Q* with Bolus Pump Infusion Device
    avanos
    ON-Q* with Bolus Pump Infusion Device
    Avanos Medical
    ON-Q* with Bolus Pump Infusion Device
    Designed for Comfort, Simplicity, and Safe At-Home Pain Relief
    RIO Mechanical Tracking System
    rio-mechanical-tracking-system-3
    RIO Mechanical Tracking System
    MAKO RIO
    RIO Mechanical Tracking System
    Optimized robotic design for efficiency, ergonomics, and user feedback
    Versajet Handset Cost-Reduction
    smith&nephew-versajet-handset-design
    Versajet Handset Cost-Reduction
    Smith & Nephew
    Versajet Handset
    Affordable and versatile hybrid-use system
    Infusion Pump
    uxui_pump-medical-device-design
    Infusion Pump
    UI - Case Study
    Infusion Pump
    Redefining infusion pumps with usability, safety, and efficiency at the forefront
    Micromeritics AccuPyc
    Micromeritics-AccuPyc
    Micromeritics AccuPyc
    Micromeritics
    Gas Pycnometer
    The fastest, easiest, most accurate measurement of true density

    Our services

    Integrated Approach to Research and Development

    For three decades, BlackHägen Design has provided an integrated approach to research and development, focusing on mission and safety-critical devices, including Class I, II, and III medical devices. We provide suitable R&D support to entrepreneurs and start-up entities through to Fortune 100, multi-national and government-sponsored corporations.

    Services may be specific such as Conceptual Design, Feasibility Engineering, or Usability Testing, or turn-key from product definition through to pilot-production and validation. Our internal Quality System is designed to support regulated industries such as medical device development, conforming to FDA’s Quality System Regulation (QSR) and ISO 13485. We are periodically audited by Fortune 50 medical device manufacturers to ensure adequate compliance to the client’s QMS and are on the Approved Supplier List for many of the top 20 corporations.

    Clear Filters

    User Research

    Consistent User-Needs Discovery Informs the Design Process
    Conducting relevant research with all intended end-users at project inception is vital to fully understand market requirements, operational safety, and functional specifications. BH identifies and interviews all user groups to better understand the entire workflow spectrum, ensuring a holistic approach to defining design inputs, evaluating performance criteria that ultimately drive successful product validation.

    Industrial Design

    Interpreting User-Research into Powerful Product Concepts
    The industrial design process considers and integrates system-level architecture into a variety of mechanical concepts to explore the best-balanced solution that addresses user-needs, while optimizing the workflow experience through intuitive functionality, passionate aesthetics, and pragmatic efficiency. At BH, our designers are experienced in defining the best approach to mechanical layout, materials, finish, and methods of assembly that ensure ease of use, service, manufacture, and sustainability at the lowest unit cost.

    UX/ UI Design

    Delight End-Users by Developing Control Interfaces that Understand their Needs at every Level
    Superior user-experience relies on the successful integration of industrial and UI design, whereby all aspects of the user interface are thoughtfully and elegantly executed, resulting in efficient and accurate device operation. BH’s UI designers work closely with their ID and systems/software teams to embrace advanced technologies and control features that are logical, attractive, reliable, and highly efficient.

    Product Development

    Collaborative and Concurrent Engineering Evolution Results in Outstanding Product Solutions
    BH’s design engineering team work closely with human factors and user-experience members to fully understand the product vision as interpreted through powerful user-studies, respecting evolving innovation and product differentiation strategies. The combined team balance all desired project goals to determine the best system solutions that will ultimately drive the success of the product in its defined market.

    Human Factors Engineering

    Scientific, Risk-Based Methodologies Identify and Prioritize HFE Directives for Design Teams
    BH’s comprehensive HFE toolbox enables project teams to apply appropriate levels of usability oversight throughout the design and development process to ensure user needs and use-safety measures are integrated into end-product design. By integrating an iterative, cost-effective strategy from the earliest phases of design, culminating with a rigorous summative validation, we provide a quality-compliant process that demonstrates use-related safety and yields a superior commercial design.
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