Project Overview
A medical robotics company required precision components for their surgical robot system. The project demanded USP Class VI biocompatibility, extreme precision, and resistance to repeated sterilization cycles.
Challenge
The primary challenges included:
- Biocompatibility: USP Class VI certification required
- Sterilization Resistance: Must withstand 1,000+ autoclave cycles
- Extreme Precision: ±0.025mm tolerances for robotic accuracy
- High Temperature: PEEK material for autoclave temperatures (134°C)
- Documentation: Full biocompatibility and sterilization validation
Solution
Our engineering team developed a comprehensive solution:
Material Selection
- Medical-grade PEEK (Polyetheretherketone)
- USP Class VI certified resin
- Excellent sterilization resistance and biocompatibility
- High strength and dimensional stability
Precision Manufacturing
- High-precision tooling with hardened steel inserts
- Climate-controlled production environment
- CMM verification on all critical dimensions
- Clean room packaging for contamination prevention
Validation
- USP Class VI biocompatibility testing
- Autoclave cycle testing (1,000+ cycles)
- Dimensional stability verification after sterilization
- Mechanical property testing pre/post sterilization
Results
The project exceeded all targets:
| Metric | Target | Achieved |
|---|---|---|
| Biocompatibility | USP Class VI | Certified |
| Sterilization Cycles | 500 | 1,000+ |
| Dimensional Cpk | �?.67 | 1.85 |
| Production Volume | 20K units | 50K+ units |
| Quality Escapes | 0 | 0 |
Key Success Factors
- Medical Expertise: Deep understanding of biocompatibility requirements
- Material Knowledge: PEEK selection and processing expertise
- Precision Capability: Advanced tooling and inspection
- Validation Rigor: Comprehensive testing and documentation
Customer Testimonial
“CoreLMould’s PEEK components are critical to our surgical robot’s performance. USP Class VI certified, 1,000+ autoclave cycles validated, and perfect precision. Their medical manufacturing capabilities are exceptional.”
- VP of Engineering, Medical Robotics Company