Engineered for IVD (In Vitro Diagnostic) manufacturers, POC (Point-of-Care) device developers, and clinical diagnostic labs, our high-resolution electroformed molds are purpose-built to produce microfluidic diagnostic chips—from rapid antigen test chips to nucleic acid amplification (PCR) chips. With ultra-tight ±0.002mm tolerance and optimized compatibility with PDMS (polydimethylsiloxane) and glass substrates, they ensure precise replication of micro-channels (10–300μm width/depth) and functional structures (reaction chambers, valve seats), directly supporting accurate, repeatable diagnostic results.
Microfluidic diagnostic chips demand molds that solve 3 critical pain points ordinary molds fail to address:
- Tolerance Gaps Ruin Detection Accuracy: Generic molds with ≥0.005mm tolerance create inconsistent micro-channel dimensions, leading to uneven fluid flow (e.g., delayed sample mixing in PCR chips) and false positive/negative results;
- Substrate Incompatibility Causes Chip Scrap: Poorly optimized molds struggle with PDMS (sticky, high-shrinkage) or glass (brittle, tight bonding requirements), resulting in 15–20% chip 报废率 (scrap rate) during demolding or bonding;
- Low Resolution Loses Functional Details: Diagnostic chips rely on tiny structures (e.g., 50μm-wide reagent reservoirs, 20μm-thin valve gaps) that standard molds can’t replicate, rendering chips non-functional.
Heya solves these by combining high-resolution electroforming technology with substrate-specific design—turning diagnostic chip production from a “risky process” into a reliable, scalable workflow.
We tailor every mold to your diagnostic chip’s unique microfluidic design and substrate needs, with flexibility to handle even complex functional structures:

Our molds are engineered to meet the strict standards of clinical diagnostics, with specs that directly impact chip performance and assay reliability:

- Medical-Grade Certifications: Molds meet ISO 13485 (Medical Device Quality Management System) standards—critical for IVD products requiring regulatory approval (FDA 510(k), CE IVDR).
- Biocompatibility Assurance: Electroforming materials (99.95% pure nickel, nickel-copper alloy) pass ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation) tests—no leachable contaminants to compromise biological samples (blood, saliva, cells).
- Cleanroom Manufacturing: Molds are produced in a Class 1000 cleanroom (ISO 14644-1) to avoid dust/particle contamination—essential for diagnostic chips where even 1μm particles can block micro-channels or interfere with assays.
- Traceability: Full batch records (material certificates, dimensional inspection reports, cleanroom monitoring data) are provided—supporting regulatory audits (e.g., FDA inspections) for IVD products.
- IVD Manufacturers: For high-volume production of rapid diagnostic chips (e.g., COVID-19, flu, malaria tests) where ±0.002mm tolerance ensures consistent assay performance.
- POC Device Developers: For compact diagnostic chips (e.g., handheld blood glucose monitors, on-site pathogen detectors) requiring small, precise micro-structures and PDMS/glass compatibility.
- Clinical Research Labs: For custom diagnostic chips (e.g., personalized cancer biomarker tests) with unique microfluidic layouts—our DFM support accelerates prototype iteration.
Need a high-resolution mold for your microfluidic diagnostic chip? Upload your 2D/3D design file (CAD/STEP)—Heya’s engineers (with 5+ years of IVD mold experience) will provide a free DFM report (including substrate compatibility tips) and detailed quote within 24 hours.