Diagnostics & IVD Manufacturing
Natech supports IVD and diagnostic device companies from early-stage development through high-volume commercial production.
FDA Registered Facility
Class 8 Cleanroom Manufacturing
Built for the Complexity of Diagnostic Manufacturing
Diagnostic Applications We Support
- Point-of-Care Diagnostics
- Molecular Diagnostics
- Immunoassays
- Lateral Flow Devices
- Clinical Laboratory Consumables
- Microfluidic Systems
- Sample Collection Devices
- Lab-on-Chip Technologies
Core Manufacturing Capabilities
Hands-On Engineering
Optimize designs for manufacturability before tooling begins.
- Design for Injection Molding (DFIM)
- Material Selection
- Mold Flow Analysis
- Tooling Support
Injection Molding
Precision molding for complex diagnostic components.
- Precision Injection Molding
- Insert Molding
- Overmolding
- Microfeature Molding
Production
Integrated secondary operations to simplify your supply chain.
- Cleanroom Manufacturing
- Assembly
- Inspection
- Packaging
- Validation Support
Quality
Quality systems built for regulated diagnostic manufacturing.
- ISO 13485 Certified Quality System
- FDA-Registered Facility
- IQ/OQ/PQ Validation Support
- Process Validation & Documentation
- Full Lot Traceability
- Automated Inspection
Automation
Improving consistency, throughput, and repeatability.
- Vision Inspection
- Robotic Handling
- Automated Assembly
- In-Line Inspection
- Custom Automation
- Error Proofing
How We Support Your Application
Whether you’re refining an early prototype or preparing for commercial production, our engineering team evaluates your project, identifies manufacturing risks, and recommends the right path forward.
Engineering Review
We review your part, application, and production goals.
DFM & Manufacturing Strategy
We optimize the design for manufacturability before tooling and production.
Tooling & Validation
Production tooling, process development, IQ/OQ/PQ support.
Early-Stage and Commercial Manufacturing
Injection molding, assembly, inspection, and packaging all under one roof.
Full Service Range
Comprehensive Design
for Manufacturing Services
- Design for Manufacturing (DFIM) to optimize manufacturability before tooling begins.
- Precision Injection Molding for complex, tight-tolerance diagnostic components.
- Microfluidic Feature Manufacturing with microstructures as small as 25 nanometers.
- Insert Molding & Overmolding for multi-material and integrated component designs.
- Medical-Grade Material Selection including COC, COP, polycarbonate, polypropylene, ABS, and specialty resins.
- Prototype & Pilot Manufacturing to support product development and design verification.
- Bridge Production to transition seamlessly from prototype to commercial manufacturing.
- High-Volume Commercial Manufacturing with scalable production capacity from thousands to millions of parts.
- Class 8 Cleanroom Manufacturing for contamination-controlled production environments.
- Automated & Semi-Automated Assembly for complete diagnostic subassemblies and finished devices.
- Vision Inspection & Automated Quality Verification to improve consistency and reduce defects.
- Packaging, Labeling & Final Pack-Out ready for distribution or downstream processing.
- IQ/OQ/PQ Process Validation Support to streamline regulatory compliance and manufacturing readiness.
- Lot Traceability & Documentation including controlled records, process documentation, and quality reporting.
- Engineering Collaboration & Program Management from initial concept through commercialization.
- Supply Chain & Production Scale-Up Support to ensure reliable manufacturing as demand grows.
Access Our Diagnostics & IVD Resources
Driven by Collaboration, Fueled by Continuous Improvement
IVD & Diagnostic Manufacturing FAQs
Natech manufactures components and consumables for a wide range of diagnostic applications, including lateral flow assays, immunoassay platforms, molecular diagnostics, point-of-care devices, and microfluidic lab-on-chip devices. We work across both the consumable and device component sides of the diagnostic supply chain.
Yes. Natech is ISO 13485 certified and FDA registered. We operate a Class 8 cleanroom specifically for sensitive diagnostic and medical device applications. Our quality systems are designed to meet the regulatory requirements of IVD and life science manufacturing.
Yes. We specialize in manufacturing microfluidic features and microstructures, with capabilities down to 25 nanometers using custom mastering and precision molding processes. We work closely with engineering teams to ensure microfluidic designs are optimized for production.
Yes. We regularly support IVD companies through the full production journey — from early-stage prototype runs and pilot manufacturing through commercial-scale production. Our process development and validation capabilities are built to make that scale-up reliable and controlled.
DFIM is the process of reviewing and optimizing a part’s design specifically for injection molding manufacturability. For diagnostics, where tolerances are tight and feature geometry is complex, DFIM is critical to ensuring the molding process produces consistent, functional parts at volume. Natech completes DFIM before any tooling begins.
Yes. In addition to precision injection molding, Natech offers automated and semi-automated assembly, testing, inspection, and packaging. This allows diagnostic manufacturers to consolidate their supply chain with a single, capable partner.
We work with a broad range of materials suited to diagnostic and medical applications, including polycarbonate, polypropylene, COC, COP, ABS, and various specialty resins. Material selection is part of our DFIM and engineering support process.
Natech is a preferred manufacturing partner for IVD startups. We offer initial engineering reviews and consultations, and our phased engagement model allows early-stage companies to work with us from early design through commercialization. We understand the pace and constraints of startup development.
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