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Product Development

VistaMed has deep clinical experience developing and manufacturing complex catheter and medical device systems for demanding applications.   We offer a breadth of product development capabilities that encompass everything from refinement of concepts and processes to test method development and design verification:

Product Development and Process Development:

  • Concept refinement
  • Iterative loop testing and prototyping
  • Design confirmation
  • Design freeze/testing and documentation

Design Verification:

  • Characterization testing
  • Engineering analyses (DOE, tolerance analyses, FEA, etc.)
  • Review of historical data
  • Design confirmation testing
  • Product performance testing
  • Biocompatibility testing
  • Accelerated aging shelf-life testing
  • Real-time shelf-life testing
  • Packaging verification testing

Test Method Development:

  • FEA
  • Reliability testing
  • Limit testing
  • Limited conditioning (humidity, temperature, etc.)
  • Bubble emission package testing
  • Tray/pouch seal testing
  • Ex-vivo testing
  • Sterilization validation
  • Dye penetrant package testing
  • Full package conditioning/ship testing/aging