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