Case Description
Client Background
A high-end surgical device company developing an innovative disposable vascular closure device used for rapid femoral artery sealing after cardiovascular interventional procedures.
Client Pain Points
- Miniature components, including suture pushers, safety latches, and positioning hooks, required dimensional tolerances within ±0.01 mm.
- Medical-grade polymers such as PC, ABS, and PEEK needed high mechanical strength and biocompatibility for blood-contact applications.
- Burrs, flash, or deformation could affect assembly accuracy, smooth operation, and reliable suture deployment.
Customization Process
The customer provides 3D drawings, materials, and quantities - OEM medical mold design - mold manufacturing - Class 10,000 cleanroom injection molding - sterilization packaging - shipment.
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Our Solution
Precision Tooling
Developed multi-cavity hot-runner molds using precision wire EDM and mirror EDM to achieve burr-free components and tight dimensional tolerances.
Micro-Machining
Applied high-precision machining techniques to produce miniature suture deployment components with accurate structural details.
Process Optimization
Implemented scientific injection molding with real-time cavity pressure monitoring to minimize internal stress, warpage, and flash.
Cleanroom Inspection
Conducted molding and packaging in ISO Class 7 cleanrooms, supported by 100% automated optical inspection for dimensional and surface quality.
Results and Achievements
Achieved smooth suture deployment without snagging or mechanical binding in simulated clinical tests.
Maintained stable mass-production yields above 98.5%, accelerating commercialization.
