Product Design & Development
End-to-end product design and development services for medical devices, in vitro diagnostic instruments, and life sciences equipment—solving complex workflow automation challenges, accelerating innovation, and streamlining the path to commercialization.
FIH Health & Biotech designs and engineers complex, regulated medical devices, in vitro diagnostic instruments, and life science equipment from early concept through design transfer and into scaled manufacturing. Our multidisciplinary team includes systems, mechanical, electrical, test, manufacturing, firmware, and software engineers, and we partner with clients to develop innovative, 21 CFR Part 820 and ISO 13485-compliant solutions.
What Design & Development Services Does FIH H&B Provide?
FIH Health & Biotech provides product design and development services for medical devices, diagnostic instruments, and life science equipment and consumables. With deep expertise in fluidics, robotics, optics, smart sensors and image processing, precision motion control, thermal management, value engineering, embedded systems, and wireless technologies, we help transform our clients’ most complex workflows into compliant, scalable, market-ready products. By applying Agile methodologies within a robust regulatory framework, we rapidly iterate, prototype, and de-risk designs while ensuring full traceability, design verification, and process validation from concept to commercialization. This approach reduces development timelines and facilitates efficient regulatory approvals.
Engineering Depth and Breadth
Complex instrument development can see increased timelines, costs, and decreased quality when multiple disciplines are handled across partners instead of addressed under one roof. Our team spans fluidics, optics, motion, electronics, software, and mechanical design and development. From initial requirements definition, prototyping, design and development of hardware, firmware, software, consumables, and more, FIH Health & Biotech helps transform our clients’ most complex workflows into compliant, scalable, and market-ready products.
Systems Engineering & Program Architecture
Workflow Automation
Consumables & Microfluidics
Optics, Smart Sensors & Image Processing
Precision Motion Control
Embedded Controllers & Systems
Software & Firmware
Robotics & Automated Handling
Wireless Systems
Thermal Control
Human Factors & Usability Engineering
Value Engineering & Design for Excellence (DFx)
For a more in depth look at our engineering expertise, check out our Expertise & Applications page→
Design for Compliance, from the Start
Regulatory success starts with the design, not the submission. FIH Health and Biotech applies a Design for Compliance methodology that establishes design controls, risk management, and quality requirements directly into the product development lifecycle, in accordance with 21 CFR 820.30 and ISO 13485. Risk-based decision-making follows an ISO 14971-aligned process from concept through design transfer, so manufacturability, scalability, and regulatory readiness are integrated into the commercialization journey from the start.
A more in-depth look at our quality system can be seen on our Quality & Regulatory page →
Global engineering model for cost-conscious innovation.
Our design engineering team spans San Diego and Taiwan, giving programs access to deep technical talent, scalable engineering capacity, and a flexible cost structure often not available from a single-region team. That same structure carries a released design directly into FIH Health & Biotech's manufacturing infrastructure rather than across a partner boundary. This effectively mitigates the quality, time, cost, and re-engineering risks often associated with design transfers to new manufacturing environments.
Looking to scale production? Check out our Contract Manufacturing services and capabilities here →
Applications
Our design and development team supports programs across:
Diagnostics & IVD instruments · Point-of-care testing devices · Cell & gene therapy instruments · Digital health & medical wearables · Drug delivery devices · Sample prep & lab automation · Life science instruments · Clinical & RUO consumables
Development Accelerators: KORAL™ & SmartSleds™
FIH Health & Biotech is more than a CDMO, with platforms and solutions designed to accelerate your commercialization journey.
KORAL™ is FIH Health & Biotech’s modular workflow automation co-development platform for complex diagnostic and life-science applications. It combines liquid handling, configurable automation, workflow-specific SmartSleds™, labware, support for custom consumables, and workflow software in a reusable architecture designed to accelerate workflow development and provide a foundation for commercial product development.
SmartSleds™ are configurable or custom-developed automation modules engineered to add the processing, sensing, detection, thermal control, fluidics, motion, and consumable handling required by your workflow. SmartSleds™ can be engineered for KORAL™ or compatible liquid handlers you already own, adding workflow-specific functions that reduce sample transfers and manual handling while improving workflow efficiency and repeatability.
The FIH Advantage
FIH Health & Biotech combines full-discipline engineering depth with Foxconn-backed global manufacturing scale, supporting medical device, diagnostics, and life science programs from early concept through sustained, scaled production.
At FIH Health & Biotech, commercialization support spans design, manufacturing, and automation: the same engineering team and ISO 13485-certified quality system carry a program from requirements definition through design verification, design transfer, and volume production. And with a global footprint, vertical integration, and Foxconn scale, we help you reduce the risk, cost, and time across the entire commercialization journey.
FIH provides the engineering depth, regulatory discipline, and manufacturing infrastructure to take your most complex instrument, device, or consumable from CONCEPT TO CURE™.