Koven cardiovascular innovation

Your Biomedical Design & Development Partner

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Is your acceptance criteria optimized?  Are all your metrics resolved?  A well formed and comprehensive Design Input Specification (DIS) will help you stay on track.

Our team can transform your concepts or user needs into a set of measurable product metrics to determine technical feasibility.  We provide outside and objective perspectives and can offer valuable guidance and advice, OR we can complete a full DIS review.

According to the FDA, your DIS must be testable, measurable, unambiguous, and traceable -- we can help you ensure that your DIS excels in all these criteria!

Distilling volumes of information and data into concise, measurable metrics enables you to tackle project uncertainty with greater confidence. We can clarify the "fuzzy" front end of your development project and give you results you can firmly grasp.

We can help with:

  • Refining your problem statement
  • Defining the intended use
  • User needs assessment & definition
  • Competitive product benchmarking
  • Intellectual Property consideration
  • Scientific / clinical publication reviews
  • Identifying applicable & relevant International Standards
  • Translating needs into engineering metrics
  • Regulatory concept review
  • Reimbursement concept review
  • Risk management
  • Usability engineering / human factors

We invite you to read our blog post "Kickstart your DIS: 6 Approaches to Generate Design Inputs"

Design Input Specifications