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G&H | ITL

G&H | ITL provides end-to-end design and manufacturing services for medical devices, in-vitro diagnostics, and laboratory instruments.

Medical Device Design

We create solutions to complex design and engineering challenges.

Our medical device design services help customers accelerate time to market cost-effectively while minimizing risk.

At G&H | ITL, we thrive on a technical challenge. Our cross-functional team approach to problem-solving means that we can solve the most complex R&D challenges. With decades of experience across multiple disciplines and industries, our skilled engineers have the know-how to get your medical device to market.

We can help you realize your vision and progress your initial concept through detailed design, rigorous engineering, prototyping, and testing.

World-Class Engineering

Our experienced systems engineers will review and evaluate all technical aspects of your medical device from the start of your project. From concept generation, design and development, to testing and validation, our systems engineers will identify and mitigate risks and perform in-depth testing throughout the development lifecycle.

Our systems-based approach includes:

  • Requirements capture
  • System concept design architecture (SCDA)
  • Systems analysis
  • Design for manufacturing (DFM)
  • Risk management (ISO 14971)
  • Device testing

We utilize in-house and external testing facilities that are equipped for functional testing and performance analysis to give you the confidence that your device performs exactly as you need it to.

Mechanical design is at the core of the product development lifecycle. Our skilled mechanical engineering team provides a framework for bringing all disciplines together throughout concept development, systems design, prototyping, and detailed medical device design for the medical, healthcare, and life sciences industries.

  • SolidWorks Composer and SolidWorks Product Data Management (PDM) system
  • Rapid prototyping, including in-house 3D printing
  • Building prototypes for performance testing including, alpha, beta, and pilot prototypes
  • Integrating industrial design to meet both aesthetic and functional requirements
  • Materials selection
  • Casework design using various methods, including injection molding, RIM molding, vacuum casting, rapid machining, etc.
  • Microfluidic cartridge design and prototyping
  • Disposable design including reagent packs, bespoke cuvettes, microplates, microfluidics, smart cartridges, etc.
  • Design of precision linear and rotary movement and transfer systems utilizing DC and stepper motor controllers
  • Fluidics and high precision pipetting, level sensing, gated pressure dispense, positive displacement, and flow cell technology
  • Optical measurement systems using lamps, LEDs, and lasers
  • Thermal control systems architecture and modeling
  • Pneumatics for mechanical automation and fluid dispensing systems
  • Electronics packaging design to meet project and regulatory requirements
  • Design transfer support, including sustaining engineering

Our dedicated team of electronics engineers take a holistic approach to design and development, combining superior engineering with meticulous design and function to ensure the best possible design integration for your medical device.

  • Embedded hardware, processor, and FPGA controlled circuits using the latest ARM, NXP, and PIC devices in addition to 8- and 16-bit microcontrollers
  • Small, efficient FPGAs to large SoC FPGAs, including Altera (Intel) and Xilinx (AMD)
  • PCB, schematic, and layout design using Altium Designer
  • Multi-layer and Flexi-rigid PCBs
  • Analog circuit design for a wide variety of sensors and actuators to microcontrollers, ADCs and DACs
  • Component selection including high-quality PCB, audio-visual and electro-mechanical components
  • Interface and cable wiring design
  • DC and stepper motor controllers
  • Real-time motion and temperature control
  • Optoelectronics
  • EN 60601, EN 61010, EN 61326, and ISO 14971

Whether we are starting from scratch or building upon existing code, our seasoned software and firmware engineers have a breadth of experience working with programming languages, microcontrollers, connectivity technologies, PC and mobile operating systems, embedded GUI, and other programming disciplines.

  • Programming primarily in C (C++, C#) or Python, but we have significant expertise in .NET, Java, Visual Basic and LabVIEW, and other OpenSource languages
  • PC operating systems including, Windows, Linux, and Mac OS
  • Mobile app design including iOS and Android
  • Bare metal programming and real-time operating systems (RTOS)
  • Communications interfaces including RS232/RS422, I2C, SPI, UART, USB, CAN-bus, etc.
  • Connectivity technologies including USB, Ethernet, Wi-Fi, Bluetooth, RFID, NFC, etc.
  • Programming for 8-, 16- and 32-bit microcontrollers
  • Ultra-low-power applications to specialized, high-integrity firmware for medical devices
  • Processes including DC and stepper motors, heating, and cooling elements, and high precision fluidics dispensers.
  • Graphical user interface (GUI) development
  • Software verification, validation, and risk analysis
  • EN 62304 standards

Bringing together our industrial design and human factors expertise, we can help you understand how users interact with your technology and translate those insights into informed, intuitive medical devices that meet key project deliverables and global regulatory requirements.

Taking a user-centered approach, we design concepts based on the insights gained and needs identified in the early stages of your project. Our creative industrial designers and skilled engineers will work with you to generate design concepts that are innovative, practical, and deliver a great user experience.

From concept sketches, 3D CAD modeling, and photorealistic renderings to rapid prototypes, our industrial design team will guide you through the concept development process to ensure your design is feasible, meets customer requirements and user needs, and is designed with manufacturing in mind.

We operate a comprehensive Quality Management System (QMS) to control design, development, and manufacturing processes for medical devices entering into worldwide markets.

Our robust QMS is certified to ISO 9001:2015 and ISO 13485:2016 and compliant to FDA 21 CFR Part 820 to ensure that all devices are fit for their intended purpose, meet the required specifications for quality and safety, and comply with national and international regulatory requirements.

  • ISO 9001 & ISO 13485: We are audited and accredited to ISO 9001:2015 and ISO 13485:2016. Our Quality Management System also incorporates ISO 14791, ISO 62304, and ISO 62366 standards to ensure a robust and fully compliant regulatory framework.
  • FDA 21 CFR Part 820: ITL has been an FDA-compliant medical device manufacturer since 1983. We have considerable experience supporting customers with FDA pre-market approval (PMA) and 510(k) applications, and de novo classification requests for US market access.
  • MDR & IVDR: We are compliant with 2017/745 MDR and 2017/746 IVDR, enabling us to support the CE marking process for medical and in vitro diagnostic devices. We have the capabilities to design and manufacture Class I, IIa, IIb, and III medical devices and all classes of IVD medical devices.
  • MDSAP: As a contract manufacturer, it is not possible for G&H | ITL to be registered to MDSAP, however, our experienced regulatory consultants are able to provide support with all MDSAP activities and audits.
  • NMPA (CFDA): With in-country representation for medical devices, we have hands-on experience supporting customers with NMPA/CFDA approvals and have established strong partnerships with Clinical Research Organizations.