High Precision Electroformed Mold Factory For Medical Devices
Direct Supply Micro-Channel Components
As a specialized factory focusing on high precision electroformed
molds for medical devices, we directly supply critical
micro-channel component molds to medical device manufacturers,
diagnostic tool producers, and microfluidic chip developers. Our
core capability lies in crafting electroformed molds that replicate
the tiny, intricate micro-channels (0.01–0.5mm width/depth)
essential for medical applications—where fluid flow precision,
surface biocompatibility, and dimensional accuracy directly impact
diagnostic reliability and patient safety. By combining in-house
electroforming expertise with direct supply, we eliminate middlemen
to deliver molds that meet strict medical standards, from prototype
to mass production.
Why Our Electroformed Molds Excel for Medical Micro-Channel
Components
Medical micro-channels (used in diagnostic chips, lab-on-a-chip
devices, or drug delivery catheters) demand mold performance that
generic machining can’t achieve—our electroformed solutions address
three critical needs:
- Micro-Channel Precision: Even 0.005mm deviation in channel width can disrupt fluid flow,
leading to inaccurate test results (e.g., in blood sample
analysis). Our electroformed molds maintain ±0.002mm tolerance,
ensuring uniform flow rates across all channels;
- Surface Smoothness: Rough micro-channel walls cause fluid turbulence or sample
adhesion, compromising diagnostic accuracy. Our electroforming
process delivers Ra ≤0.008μm mirror finishes, eliminating "dead
zones" where samples might stagnate;
- Biocompatible Materials: Medical components require mold materials that won’t leach
contaminants. We use high-purity nickel (ISO 10993-compliant) and
copper-nickel alloys, ensuring the micro-channel parts produced are
safe for contact with biological fluids.
Core Advantages for Medical Micro-Channel Production
1. Ultra-Precision for Micro-Channel Geometry
Our electroformed molds are engineered to replicate the most
complex micro-channel designs:
- Tight Tolerances: ±0.002mm for channel width/depth, ±0.005mm for spacing between
parallel channels—critical for multi-assay diagnostic chips where
reagent mixing ratios depend on precise flow;
- Complex Configurations: Perfectly replicates serpentine, branching, or 3D stacked
channels (common in lab-on-a-chip devices) that CNC machining would
distort or miss;
- Batch Consistency: Every mold in a production run matches the master design,
ensuring micro-channel parts from the first to 100,000th unit
perform identically—vital for regulatory compliance (e.g., FDA,
CE).
2. Biocompatible & Clean Production
We adhere to medical manufacturing standards at every step:
- Material Compliance: Molds use high-purity nickel (99.9% pure) or copper-nickel alloys
tested to ISO 10993 (biological evaluation of medical devices),
ensuring no toxic leaching into micro-channel parts;
- Cleanroom Production: Electroforming and finishing occur in Class 10,000 cleanrooms to
avoid particulate contamination—critical for molds producing
components used in sterile environments (e.g., IV catheters);
- Traceability: Full material certificates, inspection reports, and process logs
support your regulatory submissions (e.g., FDA 510(k) for
diagnostic devices).
3. Direct Supply: Faster, More Reliable for Medical Timelines
As a factory direct supplier, we streamline your production:
- Rapid Prototyping: 7–10 days for prototype molds, with 24-hour design feedback to
refine micro-channel layouts (e.g., optimizing corner radii for
smoother flow);
- Scalable Production: From 1–5 prototype molds to 100+ mass production molds, with
consistent lead times (15–20 days) to meet medical device launch
schedules;
- Technical Collaboration: Our engineers work directly with your R&D team to optimize
micro-channel designs for electroforming (e.g., adjusting draft
angles to prevent channel collapse during demolding), reducing
costly redesigns.
Applications: Where Medical Micro-Channels Matter Most
Our molds produce micro-channel components for:
- Diagnostic Devices: Lateral flow assay chips, PCR test cartridges, and blood sample
analysis chips (where precise fluid flow ensures accurate results);
- Drug Delivery Systems: Micro-fluidic catheters and implantable drug release devices
(where channel uniformity controls dosage rates);
- Lab-on-a-Chip Technologies: Portable diagnostic tools for point-of-care testing (where
miniaturized channels enable compact, user-friendly designs).
Technical Specs Meeting Medical Standards
| Specification | Details | Value for Medical Production |
|---|
| Micro-Channel Tolerance | ±0.002mm (width/depth); ±0.005mm (spacing) | Ensures consistent fluid flow; reliable diagnostic results |
| Surface Finish | Ra ≤0.008μm (mirror) | Prevents sample adhesion; reduces fluid turbulence |
| Material | High-purity nickel (ISO 10993-compliant), copper-nickel alloys | Biocompatible; safe for biological fluid contact |
| Cleanroom Class | Class 10,000 (ISO 8 Class 7) | Minimizes particulate contamination; meets sterile standards |
| Lead Time | 7–10 days (prototypes); 15–20 days (mass production) | Aligns with medical device development timelines |
Let’s Partner for Medical Precision
Need high precision electroformed molds for your medical
micro-channel components? Share your 3D designs (CAD/STEP) of
micro-channel layouts, and we’ll provide:
- A free DFM (Design for Manufacturability) report focusing on fluid
flow optimization;
- Prototype molds with full inspection data (CMM measurements of
channel dimensions);
- Compliance documentation to support your regulatory submissions.
As your direct factory partner, we’re committed to delivering the
precision that medical devices demand—no compromises, no delays.
