Medical Device Development
G&H | ITL's multidisciplinary team combines design knowledge, engineering expertise, and problem-solving skills to create innovative design concepts.
G&H | ITL provides end-to-end design and manufacturing services for medical devices, in-vitro diagnostics, and laboratory instruments.
Since 1977, G&H | ITL has been a trusted partner to many medical device companies; providing innovative and reliable solutions to complex engineering and manufacturing challenges.
The projects we work on are diverse, stimulating and challenging. No two are the same. From devices enhancing and improving cancer staging treatment to intelligent drug delivery systems and point of care diagnostic testing, we’re leading the way.
We aren’t just another design consultancy or contract manufacturer. We provide true end-to-end design and manufacturing solutions to startups and OEMs developing life-saving medical technology, diagnostic devices, and scientific instruments for healthcare and life science industries. Our uniquely comprehensive range of vertically integrated capabilities can help your device progress quickly, reliably, and cost-effectively through every phase of its development lifecycle.
From concept development, detailed design, and rigorous engineering to prototyping, pilot production, and full-scale manufacturing. We utilize our in-house tools, expertise, and state-of-the-art technology to streamline the process and speed up regulatory approvals of Class I, II, and III medical devices.
Company size doesn’t matter to us. Whether you’re a cutting-edge startup or a global OEM, we have the flexibility and scalability to handle your project. Our ISO 13485 certified and FDA-compliant facilities enable us to provide our customers with world-wide support and access to global supply chains and markets.
In August 2018, ITL was acquired by Gooch & Housego PLC. G&H is a photonics technology business headquartered in Ilminster Somerset, UK with operations in the USA and Europe. A world leader in optical designing, testing, and manufacturing, they work with OEM customers worldwide, providing optical systems, assemblies, and components for demanding applications.
As part of the wider G&H Group, we have access to their technology, expertise, and resources, allowing us to provide design and manufacturing for applications including microscopy, medical imaging, and surgical lasers.
With over 45 years’ industry experience, a proven track record in regulatory approval and device commercialization, we have worked on over 600 projects at various stages of their product development lifecycle.
Regardless of the stage or complexity of your project, our experienced team works in close collaboration with you to mitigate risks, optimize costs, and most importantly, manufacture safe, reliable, and compliant medical devices for your end-users.
We are ISO-certified and FDA-registered. We proudly maintain a highly controlled Quality Management System to assist you in designing, developing, and manufacturing medical devices for worldwide markets.
With facilities in the UK and US, we can provide a faster, more cost-effective market entry of your device. Gain easy access to global supply chains and markets, and benefit from worldwide servicing and support.
We understand that IP is at the heart of every new medical device. As part of our commitment to transparency and collaboration, we make every effort to ensure that any IP generated remains with you.
"We collaborated with G&H | ITL to help to develop and manufacture our first medical device Sentimag®. The Sentimag® system has now been widely adopted in the breast cancer market all around the world, and G&H | ITL has been a highly supportive partner during our growth. We enjoy working with G&H | ITL and their ongoing dedication to Endomag makes them feel like part of our team."
"I can strongly recommend G&H | ITL as an experienced development partner while also operating as a skilled and reliable manufacturer. It is this combination of skills that underpins G&H | ITL's value proposition to MedTech business such as OrganOx. G&H | ITL is an excellent fit with OrganOx given their track record of successfully bringing medical devices to market, coupled with its UK headquarters and US presence."
"We came to G&H | ITL with a clear vision and a very basic prototype. While we knew what we wanted, it was clear we were going to need help to bring our idea to life. There were distinct requirements of the device and, after a reassuring first meeting, it was clear G&H | ITL understood the challenges. The friendly - and most importantly - plain-speaking team explained their decisions at every stage so we always felt included in the design process."
"We chose G&H | ITL for this project because of their considerable experience in in-vitro diagnostics and microfluidic development. Working in partnership with their engineers has been an absolute pleasure; their systematic and disciplined approach has been invaluable to us throughout this journey. G&H | ITL's achievements together with our latest progress with miniaturization of magnetic detection is a quantum leap in disposable self-testing."
"G&H | ITL has been a trusted partner on two projects for Momentum. Their expertise in diagnostic instrumentation and project management helped us answer complex technical questions about how to automate new disruptive clinical diagnostic testing. The team is very responsive, able to move on ideas and new challenges quickly and deliver against expectations. A pleasure to work with."
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