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SERVICES

Medical Device Manufacturing

We provide the tools you need to bring your medical device to market.

Our end-to-end medical device manufacturing services provide everything you need to take your project from prototype to production.

 

 

Capabilities

  • Production Engineering
  • PCB, Wiring & Cable Loom Manufacturing
  • Medical Device Assembly
  • Testing & Inspection
  • Procurement & Supply Chain Management
  • Aftermarket Servicing & Support

Fast, flexible and reliable manufacturing solutions

Take advantage of our end-to-end manufacturing services, established supply chain, and gain easy access to global markets without having to set up a factory yourself.

Our expert knowledge of performance materials and manufacturing processes, alongside established partnerships with machining, tooling, and fabrication experts, allows us to effectively handle all your production requirements from new product introduction (NPI), sustaining engineering, and medical device assembly to aftermarket servicing and technical support.

Our Capabilities

Production Engineering

Production Engineering (PE) acts as a bridge between the concept and product design phase and the manufacturing phase. Whether you choose pilot production or long-term manufacturing, our highly-qualified production engineers, technicians, and operators will oversee every aspect of your project to ensure a seamless transition when ramping up to volume manufacture. Even if your device has been designed by a third-party, we will liaise directly with your design authority to get a full understanding of their manufacturing requirements and timescales for completion.

PE is also responsible for technical file audits, generating manufacturing procedures and detailed works instructions, process validation (IQ/OQ/PQ), and training production operators.

PCB, Wire & Cable Loom Manufacturing

Using cutting-edge surface mount technology (SMT), we can deliver maximum flexibility regardless of batch quantity, resulting in fast turnaround and proving assurance that all PCBs manufactured perform to the highest standards. However, not everything is suitable for automation – that’s why we have a skilled in-house team of through-hole technicians too.

Nowadays, many medical devices incorporate complicated wiring harnesses and cable assemblies. Our technicians have extensive experience accommodating wiring harness and cable assemblies using both semi-automatic and skilled manual processes.

Medical Device Assembly

We can handle any manufacturing and assembly needs, from low-volume prototypes to high-volume production. You can count on us to deliver consistent quality and performance to reduce risk and provide added security.

Your medical device will be manufactured in a dedicated production work-cell, which becomes an extension of your company within our 3,000 m2 factory. Each cell is assigned operators, approved and controlled works instructions, tools, jigs, fixtures, and testing facilities.

Testing & Inspection

Our state-of-the-art automated test and inspection equipment assures that all devices manufactured to perform to the highest standards. We use Quins to capture, inspect and record high-quality images of every PCB before they are integrated into your device. For comprehensive test coverage, we use our in-house 3D automated optical inspection (AOI) system. It’s ideal for inspecting 0201 and 01005 components, 0.3 mm pitch, process control for defect prevention, and effective quality verification.

If required, we can perform a flying probe test to provide even greater coverage for complex PCB designs for a quick turnaround.

Procurement & Supply Chain Management

Utilizing our trusted global network of suppliers, we can source high quality and cost-effective materials and components to meet your project requirements. Using our in-house ERP system, we can track materials, parts, and components across our supply chain to provide full traceability throughout the lifecycle of your medical device.

We have established long-standing partnerships with our suppliers, built on trust, transparency, and open communication, enabling us to be proactive if notified of any proposed supplier changes.

Aftermarket Servicing & Support

No matter where you are in the world, we can provide global servicing and support post-manufacture. We can undertake and manage the following:

  • Device installation
  • Product repair
  • Scheduled maintenance
  • Product technical support
  • Device repackaging and distribution
  • Warehousing and logistics

 

Our Process

Stage 1: Project Planning

Taking the time to understand your idea, determine the scope of work, and create a comprehensive project plan.

All successful projects start with a great plan. Together with your team, our engineers will formulate a detailed project plan outlining the most effective route forward for your device. The plan is treated as a living document and is modified and updated where needed to keep your project on track and ensure we meet your expectations every time.

Stage 2: Concept Definition & Feasibility

Generate early design concepts and proof of principle prototypes to help identify key risk areas and establish feasibility.

With a comprehensive plan in place, it’s time to start bringing your idea to life. From user experience to industrial design and systems architecture, our concept development phase saves you time and money. Our engineers will examine the basic principles of your idea, the technology, and the regulatory requirements and generate concept designs that are not only aesthetically pleasing but satisfy the required functionality and add demonstratable value.

Stage 3: Design & Engineering

Refine the design and develop 3D CAD models and detailed drawings ready for pilot production prototyping and testing. 

With a strong understanding of user needs and a feasible concept agreed, our skilled designers and engineers will further refine the design, creating 3D CAD models and proof of principle prototypes to test and evaluate device performance and ensure it meets specification. It’s the real “nuts and bolts” of the development process, from mechanical, electronics, and systems engineering, to software and firmware development; this is where your device begins to take true form.

Stage 4: Prototyping & Verification

Conduct verification testing on alpha prototypes to ensure your device consistently meets the specification, user needs, and intended use.

It’s time to transform the CAD model into a functional, tangible device. Utilizing prototyping methods, including 3D printing, rapid molding, and laser sintering, we can deliver small batches of alpha and beta prototypes for validation and verification, testing, and regulatory submission. At the end of this stage, your device is ready for transfer to manufacturing.

Stage 5: Pilot Production

Generate detailed works instructions, set up the production work-cell, validate assembly processes, and complete technical documentation and regulatory submissions.

Our in-house Production Engineering team is responsible for the design transfer, from creating detailed work instructions and work-cell set up to process validation and operator training, ensuring a seamless transition from design and development to volume manufacturing. Even if your device is designed by a third-party, we can still support you with new product introduction.

Stage 6: Volume Manufacturing

Full-scale manufacturing, sustaining engineering, and risk management of your device within an ISO 13485 and FDA GMP accredited environment.

As an ISO-certified and FDA cGMP compliant medical device manufacturer, our customers have access to skilled technicians and resources throughout our global manufacturing sites. Your device will be assembled, tested, and packed within a dedicated, project-specific work cell, each with its own operators, work instructions, tools, jigs, fixtures, and testing areas. Our rigorous process controls and quality inspection methods ensure we deliver safe, reliable medical devices on-time and to specification.

Our results speak for
themselves

From world-leading OEMs to small, one-person startups, we are proud to have partnered with some of the most recognized names in the MedTech industry to bring to life cutting-edge medical devices that enhance and improve the lives of patients worldwide. 

 

Our commitment to exceeding customer expectations for quality, delivery, and service has earned us our reputation as one of the most progressive and trusted medical device design and manufacturing partners. But don’t just take our word for it. Discover why 90% of our customers choose to partner with us time and time again.

Some clients we've helped

client-GSK
client-Endomag
client-OrganOx
client-Dysis
client-KCL
client-Dame
client-Momentum
client-Kimal
client-UoB
client-BioPerfectus
client-Exroid
client-magnasense
client-Optos
client-UoN

What our clients say

"We collaborated with 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 ITL has been a highly supportive partner during our growth. We enjoy working with ITL and their ongoing dedication to Endomag makes them feel like part of our team."

Eric Mayes, Managing Director, Endomag

"I can strongly recommend ITL as an experienced development partner while also operating as a skilled and reliable manufacturer. It is this combination of skills that underpins ITL’s value proposition to MedTech businesses such as OrganOx. ITL is an excellent fit with OrganOx given their track record of successfully bringing medical devices to market, coupled with its UK headquarters and a US presence."

Craig Marshall, CEO, OrganOx Limited

"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."

Sumi Thaker, CEO, Momentum Bioscience Ltd

Discover how we can support your next medical innovation

Whether you’re looking to develop an idea or concept into a commercially viable product, or you need help progressing one specific stage of your project, we can help.

Other Services

Concept Development

Regulatory Consulting

Design & Engineering