Bringing a novel silicone or multi-material plastic device to market requires more than just CAD drafting. Yude Technology serves as your co-engineering team—offering rapid elastomeric prototyping, material selection, DFM simulation, pilot validation (EVT/DVT/PVT), and cleanroom production.
Our structured phase-gate development process mitigates technical risk, controls tooling investment, and ensures full compliance with ISO 9001, FDA, and ISO 13485 standards.
Transforming rough sketches or 2D/3D CAD files into manufacturable engineering models.
Producing functional prototypes for mechanical fit, ergonomic testing, and fluid sealing tests.
In-depth rheology and thermal simulations to eliminate defects prior to steel cutting.
Engineered multi-cavity tooling manufactured via CNC high-speed milling and mirror EDM.
Comprehensive engineering trials (T0, T1, T2) verifying dimensional Cpk and performance.
Ramping up to full production inside ISO Class 7 cleanrooms with complete traceability.
Choose the optimal prototyping technology based on project lead time, budget, material fidelity, and target sample quantity.
| Prototyping Technology | Lead Time | Sample Quantity | Material Fidelity | Dimensional Tolerance | Ideal Application |
|---|---|---|---|---|---|
| SLA / DLP 3D Printing | 1 – 3 Days | 1 – 5 Pcs | Simulated Resins (Not real LSR/Plastic) | $\pm 0.10\text{mm}$ | Visual design concepts & spatial fit check |
| Vacuum Casting (Silicon Tooling) | 5 – 7 Days | 10 – 30 Pcs | PU Polyurethane Elastomers (Shore 30A–80A) | $\pm 0.15\text{mm}$ | Functional testing, pre-launch marketing samples |
| Aluminum Rapid Soft Tooling | 7 – 12 Days | 100 – 2,000 Pcs | 100% Real LSR, HCR, or Thermoplastics | $\pm 0.02\text{mm}$ | Functional sealing, clinical trials, regulatory testing |
| Production Steel Tooling (H13/S136) | 25 – 35 Days | 100,000+ Pcs | 100% Real Production Material | $\pm 0.005\text{mm}$ (ISO 3302-1 E1) | High-volume commercial mass production |
For critical functional tests (e.g., medical fluid seals, keypad tactile feedback, or overmolding adhesion), 3D prints often fail to mimic real elastomeric performance. Yude's Aluminum Rapid Tooling delivers authentic LSR parts using real production resins in as little as 7 business days.
We adhere strictly to international contract manufacturing qualification milestones to guarantee smooth factory scaling.
Primary Goal: Verify that the part geometry meets basic mechanical design requirements and functions within the larger product assembly.
Primary Goal: Ensure the part withstands real-world operational stress, environmental exposure, and regulatory standards.
Primary Goal: Validate production line repeatability, cycle time, Cpk capability, and automated quality checks at target volume.
Selecting the optimal polymer formulation is essential for physical performance, chemical stability, and cost control.
Hardness Range: Shore 05A to 80A
High purity, two-component platinum-cure silicone. Exceptional tear strength, rapid cycle times, and temperature resistance from $-60^\circ\text{C}$ to $+200^\circ\text{C}$. Available in Medical, Food-Contact, Optical, Self-Bonding, and Conductive grades.
Hardness Range: Shore 20A to 90A
High Consistency Rubber processed via compression or transfer molding. Ideal for large gaskets, heavy-duty industrial seals, keypads, and cost-sensitive high-volume seals requiring high mechanical toughness.
Hardness Range: Shore 40A to 80A
Combines the wide temperature stability of silicone with superior resistance to harsh chemicals, fuels, oils, and automotive solvents. Widely used in aerospace and automotive powertrain seals.
Substrates: PC, ABS, PA66-GF, PBT, PEEK, TPE
High-performance rigid plastics designed for structural housings, optical lenses, and overmolding substrates capable of enduring LSR curing temperatures during two-shot molding.
Have a physical sample without CAD files? Our metrology lab recreates production-ready 3D solid models with micron-level precision.
Non-contact optical scanning captures complex freeform organic surfaces, micro-textures, and flexible elastomeric geometries without physical contact deformation.
Transforming dense point-cloud mesh data into clean, parametric STEP or IGES solid models in SolidWorks, complete with native feature trees and wall thickness corrections.
Generating 3D color deviation heat maps comparing scan data to CAD models, ensuring tight tolerance compliance ($\pm 0.005\text{mm}$) before tooling approval.
A: While 3D printed rubber-like materials exist, they do not mimic the thermal, chemical, or tensile performance of real LSR. Yude offers **Aluminum Rapid Soft Tooling**, delivering 10 to 2,000 real LSR injection-molded parts in 7 to 12 days at a fraction of standard steel tooling cost.
A: Yes. We provide full material certification packages including FDA 21 CFR 177.2600, ISO 10993 cytotoxicity compliance, LFGB food-contact declarations, and REACH/RoHS compliance. Our ISO Class 7 cleanrooms support full batch traceability.
A: Our PPAP Level 3 package includes: Part Submission Warrant (PSW), Design FMEA, Process Flow Diagram, Process FMEA, Dimensional Inspection Report (FAI), Control Plan, Gage R&R Study, and Process Capability Studies ($C_{pk} \ge 1.33$).
A: We sign formal Non-Disclosure Agreements (NDAs) prior to reviewing any project files. All CAD models, drawing files, and proprietary mold designs are stored on secure, encrypted internal servers with strict access controls.