Material Composition | Medical Device Production | Industry: Carbon Steel (ISO 10295) Our Base: P20 Steel + LSR (▲) (ASTM D2000) Our Advanced: Stainless Steel 316 + reinforced LSR (▲▲) (ASTM F138) | Base enhances durability/flexibility; Advanced offers highest corrosion resistance/biocompatibility. | Industry standard prone to corrosion; Advanced requires specialized maintenance. |
Surface Finish | High-Precision Medical Components | Industry: Ra 1.6μm (ISO 1302) Our Base: Ra 0.8μm (▲) (ISO 1302) Our Advanced: Ra 0.4μm (▲▲) (ISO 1302) | Base reduces defects; Advanced ensures ultra-smooth surfaces for medical-grade parts. | Base needs extra polishing; Advanced is costlier and time-intensive. |
Runner System | Mass Production of Silicone Parts | Industry: Hot runner systems (ASTM F42) Our: Cold runner systems (▲▲) (ASTM F42) | Cold runners cut material waste and simplify maintenance. | Less design flexibility compared to hot runners. |
Compliance Certifications | Regulatory-Compliant Medical Moulds | Industry: ISO 9001 Our Base: ISO 13485 (▲) Our Advanced: ISO 13485 + FDA 21 CFR Part 820 (▲▲) | Base meets medical standards; Advanced ensures full regulatory compliance. | Base may need extra certifications; Advanced incurs higher certification costs. |
Durability | High-Volume Production Runs | Industry: 50,000 cycles (ASTM E2568) Our Base: 100,000 cycles (▲) Our Advanced: 200,000 cycles (▲▲) | Base doubles industry durability; Advanced quadruples it for long-term use. | Base requires periodic maintenance; Advanced has higher upfront costs. |
Customization Level | Custom Medical Device Prototypes | Industry: Limited customization (ISO 10303) Our Base: Moderate customization (▲) (ISO 10303) Our Advanced: Full CAD integration (▲▲) | Base allows tailored solutions; Advanced enables rapid prototyping. | Base may have longer lead times; Advanced needs specialized design expertise. |