For nearly two decades, BlackHägen Design (BH), an integrated research and development organization, has developed leading-edge user research and product designs for start-ups to Fortune 50 companies (Class I, II, and III medical devices).

To ensure good design practices, usability, and quality assurance, BH:

  • Employs a quality assurance process that conforms to
    • FDA’s QSR and ISO 13485 requirements
    • ANSI/ISO/IEC standards
    • Client regulatory audits
  • Minimizes potential use error while optimizing efficacy and user satisfaction by translating formative usability studies into
    • Robust requirements
    • Innovative design solutions
  • Maximizes device usability from single-use instruments to electro-mechanical systems that
    • Enhance clinical procedures
    • De-skill technique and procedures
    • Develop competitive advantage in the market
    • Minimize regulatory impact
    • Drives positive patient outcomes
  • Develops, fabricates, and deploys kinematic test models of an appropriate resolution during immersive research and usability testing.

BH services include:

  • Contextual Inquiry
  • Ethnography
  • Quantitative & Qualitative Analysis
  • Task Analyses
  • Procedure Mapping
  • Research Translation
  • Device Definition & Development

  • Systems Engineering
  • Electro-Mechanical Integration
  • V&V Planning and Testing
  • Formative/Summative Usability Studies
  • Prototype Development
  • Regulatory Integration