Global, Scalable Manufacturing for Complex Medical and Life Science Products

FIH Health & Biotech is a global CDMO supporting the production of complex diagnostic instruments, life science equipment, and regulated medical devices at scale.

Our ISO 13485- and ISO 9001-certified manufacturing operations are engineered for consistent, repeatable, and scalable production. We provide high-precision manufacturing across electronics, plastics, machining, automation, and final assembly—enabling customers to move from design transfer and new product introduction (NPI) into sustained global production with speed, quality, and confidence.

End-to-End Medical Device Manufacturing Capabilities

FIH provides end-to-end medical device contract manufacturing services that span component fabrication, subassembly, system integration, and finished device production.

By housing these capabilities within a unified manufacturing environment, we reduce complexity, improve quality and process control, and accelerate scale.

Global Manufacturing Infrastructure

FIH Health & Biotech operates a vertically integrated, global manufacturing network across the Americas and Asia, supporting medical device and life science production from prototype builds through high-volume manufacturing.

Our infrastructure includes:

• Over 2.5 million square feet of advanced manufacturing space

• Digitally enabled, validated manufacturing systems with MES, traceability, and automation

• Lean manufacturing and GMP-compliant, ISO 13485-certified quality systems

• Advanced electronics manufacturing, precision plastics molding and machining, and automated assembly operations supporting programs from low-volume, high-complexity builds through high-volume production

• Cleanroom manufacturing environments for electronics assembly, injection molding, and precision assembly of optics and consumables.

• Multi-region production footprint across the Americas and Asia supporting supply chain resilience, manufacturing regionalization and localization, and country-of-origin strategies

• Global supply chain and component sourcing with traceability and compliance with RoHS, REACH, WEEE, and conflict minerals regulations

• Sustainability and environmental stewardship, including greenhouse gas reduction targets, renewable energy commitments, and certified zero-waste manufacturing initiatives aligned with global ESG frameworks

Our manufacturing model is built to support design transfer, new product introduction (NPI), production ramp, and scale-up across multiple manufacturing sites, enabling customers to move from prototype into sustained global medical device and life science production.

Manufacturing operations are supported by validated processes, embedded quality systems, and rigorous process controls, as detailed on our Quality & Regulatory page.

SMT & PCBA for Medical & Life Science Device Manufacturing

FIH Health & Biotech delivers high-reliability electronics manufacturing, PCBA, and Surface Mount Technology (SMT) assembly for medical devices and life science instruments that require tight process control, traceability, and scalable production.

Our electronics manufacturing operations support both regulated and RUO products, from prototype and NPI builds through sustained volume production, backed by advanced component sourcing, qualification, and lifecycle management within a global supply chain.

Assembly Capabilities

• High-density PCBA and SMT assembly for complex medical and life science electronics

• Fine-pitch components, micro-BGAs, and advanced packages

• Multilayer PCB population with controlled, validated processes

• Automated pick-and-place and reflow soldering in digitally enabled production environments

• Closed-loop process control with SPI, AOI, and 2D/3D X-ray inspection (AXI)

• Advanced electrical test, including in-circuit and functional testing

• Automated SMT material management and reel storage systems integrated with MES for real-time inventory control and component-level traceability

SMT and PCBA processes are standardized across our global manufacturing network, enabling consistent quality, repeatability, and efficient transfer as programs scale or regionalize production.

Precision Machining & Metal Components for Medical & Life Science Devices

FIH Health & Biotech delivers precision CNC machining for metal components used in medical devices and life science instruments where tight tolerances, repeatability, and process control are critical. Our machining operations support both prototype and production programs, with a focus on dimensional accuracy, surface finish, and long-term manufacturing stability.

Capabilities include:

• CNC machining with secondary operations for complex, tight-tolerance components

• Controlled and validated CNC programs with change management and first article inspection (FAI)

• Precision machining of complex geometries and multi-part assemblies

• Structural, mechanical, and functional components for instruments and devices

• Controlled processes for repeatability, fit, and functional performance

• Integration with injection molding, electronics manufacturing, and final assembly

Machined components are produced to ensure consistent fit, function, and repeatable performance at production scale.

Injection Molding & Tooling for Medical & Life Science Devices

FIH Health & Biotech delivers precision injection molding and tooling for both disposable consumables and durable medical device components, engineered for tight tolerances, repeatability, and regulatory compliance. Our integrated molding operations combine advanced tooling, process control, and automation to ensure consistent part quality from prototype through sustained production.

Capabilities include:

• Engineered thermoplastics and medical-grade resins for biocompatible and performance-critical components

• Precision mold design and fabrication, including high-cavitation, interchangeable molds and multi-shot tooling

• Advanced injection molding processes, including thin-wall, micro-molding, 2K, and liquid silicone rubber (LSR) molding

• Statistical process control (SPC) with capability analysis (Cp/Cpk) and real-time quality monitoring

• Simulation-driven mold design and thermal/material flow optimization with automated material handling and temperature control

• Tooling qualification and process validation, supported by first article inspection (FAI) and process capability studies

• Integration with downstream operations, including insert molding, overmolding, and automated assembly

By integrating molding with downstream assembly and finishing, we maintain dimensional consistency, surface quality, and functional performance as programs scale into commercial production.

System Integration & Final Assembly

FIH Health & Biotech specializes in system-level integration and final assembly for complex medical and life science instruments, integrating electronics, mechanical systems, optics, and fluidics into validated, production-ready platforms.

Our integration operations combine precision assembly, custom fixtures and test development, and comprehensive reliability validation—supported by semi-automated and fully automated process steps where appropriate—to support NPI, production ramp, and sustained manufacturing.

Capabilities include:

• Electromechanical, optical, and fluidic system integration with sub-micron alignment, vision-guided assembly, precision fixturing, calibration, and functional verification

• Advanced optical module integration and verification, including active sensor-to-lens alignment and bonding, beam shaping and collimation, precision multi-axis and piezo stage integration, illumination uniformity calibration, and MTF, interferometry, and spectrophotometric testing

• Advanced fluidic system assembly and validation, including manifold bonding, seal integrity under pressure, bubble and vapor-lock management, thermal control, and micro-leak detection

• Wireless and RF system integration and test, including antenna placement and bonding, EMI/EMC shielding and isolation, over-the-air (OTA) and conducted testing, total radiated power (TRP) and radiation pattern measurement, and VNA-based tuning and return loss (S11) verification

• Custom in-line and end-of-line test and inspection systems, including optical, fluidic, RF, acoustic, and pressure decay testing with automated data capture

• Validated assembly processes and fixtures under change control, including process validation (IQ/OQ/PQ), torque and compression control, error-proofed assembly, and precision bonding operations

System integration processes are designed for repeatability, traceability, and scale, enabling consistent product performance as programs transition from prototype and NPI into sustained manufacturing.

Automation & Advanced Manufacturing Processes

FIH Health & Biotech designs and deploys semi-automated and fully automated manufacturing systems for medical devices, diagnostics, and life science products, including consumables, wearables, and other production-scale platforms. These systems are applied across assembly, test, and materials processing workflows.

Capabilities include:

• Automated assembly and joining processes, including ultrasonic welding, heat staking, laser welding, and precision mechanical assembly for housings, cartridges, and device enclosures

• Precision fluid handling, fill, and seal automation, including volumetric and gravimetric dispensing, reagent degassing, bubble and vapor-lock prevention, membrane and foil sealing, and in-line leak and seal integrity testing

• Advanced adhesive and materials processing, including controlled adhesive application, closed-loop volume monitoring, UV and thermal curing, biocompatible material handling, and micro-gasket and O-ring placement

• High-precision part feeding and handling automation, including flex feeding, step feeding, spring feeding with entanglement control, magazine and tray systems, and robotic part transfer with custom end-of-arm tooling (EOAT)

• Robotic automation for molding and assembly integration, including 3- and 6-axis robotic mold tending, press-to-press transfer, overmolding workflows, in-mold labeling/decoration (IML/IMD), and automated downstream assembly

• Precision converting, die cutting, and lamination processes, including rotary and flatbed die cutting, multi-layer lamination, kiss cutting, micron-level registration, and vision-registered cutting for adhesive and membrane components

• Automation with manufacturing execution, documentation, and traceability, including MES integration, electronic batch and device history records (EBR/DHR), process parameter capture, in-line inspection, and validated software (GAMP, IQ/OQ/PQ)

These automation platforms reduce operator variability, improve process consistency, and enable higher-throughput, lower-variation production while maintaining the documentation and regulatory standards required for regulated manufacturing.

Value-Added Manufacturing, Finishing & Aftermarket Services

FIH Health & Biotech provides value-added manufacturing, finishing, and aftermarket services for medical devices, diagnostics, and life science products.

We support customer programs with third-party services including kitting and labeling, repair and refurbishment, spares and FRU management, and logistics operations in accordance with customer requirements.

Capabilities include:

• Cosmetic finishing, decoration, and surface treatments, including pad printing, inkjet and laser marking, hot transfer and hot stamping, sandblasting, polishing, buffing, and in-mold decoration (IMD/IML)

• Painting and coating operations in controlled environments, supporting one- and two-component (1K/2K) coating systems, solvent- and water-based coatings, soft-touch finishes, metallic base coats, and high, medium, and low gloss top coats

• Customer-specified kitting, labeling, and configuration services, supporting build-to-order, regional, and program-specific requirements

• Repair, refurbishment, and returns processing, including screening and triage, swap and exchange programs, cosmetic and functional restoration, and requalification testing

• Spares and FRU (Field Replaceable Unit) management, including inventory handling, staging, and customer-directed logistics support

• Reliability testing and quality verification, including environmental, mechanical, ESD, ingress, cosmetic, optical, acoustic, and parametric testing

A Global Manufacturing Partner for Medical & Life Science Devices

The FIH Advantage

FIH Health & Biotech combines global manufacturing scale, vertically integrated capabilities, and deep experience in complex, regulated products to support medical device, diagnostics, and life science companies. We support programs from design transfer and NPI through production ramp and sustained manufacturing, with the production systems, ISO 13485–certified QMS, and automation expertise required for high-performance, regulated products.

Our customers choose FIH because we bring together advanced electronics manufacturing, precision plastics molding and machining, system integration, automation, and value-added services within a single global manufacturing network—reducing supply chain complexity, improving execution speed, and enabling predictable scale.

FIH provides the manufacturing expertise, operational execution discipline, and global footprint to support your product across its lifecycle.

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