Material Compliance | Medical procedures requiring safety | Industry: Non-certified silicone (may cause irritation) → Our Base: ASTM F2313-compliant silicone (certified for medical use) ▲ → Our Advanced: ASTM F2313 + ISO 10993 biocompatibility (reduces allergic reactions) ▲▲ | Reduced risk of allergic reactions (Base), Enhanced safety with biocompatibility (Advanced) | Higher cost for Advanced version (Advanced) |
Flexibility & Durability | Home use for comfort | Industry: 30% flexibility (ISO 527-2) → Our Base: 50% flexibility (ISO 527-2) ▲ → Our Advanced: 70% flexibility (ISO 527-2) ▲▲ | More comfortable for prolonged use (Base), Adapts to varied anatomies (Advanced) | Stiffness in Industry versions (Industry) |
Sterilization Resistance | Clinical settings needing repeated use | Industry: 10 autoclave cycles (ISO 17665-1) → Our Base: 20 cycles ▲ → Our Advanced: 50 cycles ▲▲ | Longer lifespan for frequent reuse (Base), Durable for institutional use (Advanced) | Limited reuse cycles in Industry versions (Industry) |
Color Customization | Personal preference/clinical ID | Industry: 1–2 colors → Our Base: 5 colors (FDA 21 CFR 177.2600 compliant) ▲ → Our Advanced: 10 colors + custom hues ▲▲ | Choice for user comfort (Base), Easy patient differentiation (Advanced) | Limited options in Industry versions (Industry) |
Expandability Range | Gradual therapy progression | Industry: Fixed size → Our Base: 3 size adjustments (custom certification) ▲ → Our Advanced: 5 sizes + adjustable diameter ▲▲ | Adjustable therapy stages (Base), Customizable fit for individual needs (Advanced) | One-size-fits-all limitation (Industry) |
Portability & Storage | Travel or home use | Industry: Bulky storage → Our Base: Compact (100mm folded, ISO 3801) ▲ → Our Advanced: Ultra-compact (50mm folded) ▲▲ | Easier to carry (Base), Fits in pockets (Advanced) | Space-consuming in Industry versions (Industry) |