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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.

 

Disciplines

  • Systems Engineering
  • Mechanical Engineering
  • Electronics Engineering
  • Embedded Software & Firmware Development
  • Industrial Design

Putting patient needs first with exceptional product design and engineering

Here at 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

Engineering is core to what we do. Our flexible, collaborative approach, in-depth industry knowledge, and commitment to quality enable us to deliver safe, reliable, user-centered medical devices.

Systems 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.

Mechanical Engineering

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.

Electronics 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 Software & Firmware Development

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.

Industrial Design

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.

 

ISO-certified & FDA-registered Solutions

ITL is accredited and audited to BSEN ISO 13485:2016 and BSEN ISO 9001:2015. Our Quality Management System additionally incorporates BSEN ISO 14791, BS EN 62304 and BS EN 62366, amongst others to ensure a fully compliant regulatory framework.

Bring your innovation to market with confidence

Although every project is unique, our medical device design and engineering capabilities also include:
  • Microfluidics & Fluid Dynamics
  • Optics Engineering
  • Thermal Control Systems
  • Prototyping
  • Risk Management & Regulatory Compliance
  • Project Management

Our Capabilities

Microfluidics & Fluid Dynamics

We have a rich and diverse history in the design and development of microfluidic devices, diagnostic cartridges, and disposables, providing a unique advantage to customers looking to develop a point of care testing system.

Optics Engineering

Our in-depth knowledge of optics enables us to design robust yet highly accurate solutions for medical applications, including ophthalmology, microscopy, and endoscopy. We can integrate lenses, filters, light sources and detectors, and provide support with image analysis, temperature control, and deep cooling.

Thermal Control Systems

Our breadth of experience in thermal control and thermal transfer techniques helps us establish the best thermal management solution for your medical device to ensure safe and reliable performance

Prototyping

From alpha and beta prototypes to pilot production, we can produce prototypes to meet all project requirements, including the development of high-fidelity concept models for user research and injection molded parts required for verification testing.

Risk Analysis & Regulatory Compliance

We provide regulatory consulting services to help guide your medical device through to compliance with international safety standards such as EN 60950, EN 61010, EN 60601, UL, CSA certification as well as EMC testing.

Project Management

Your project will be undertaken by a dedicated team encompassing the required skillset for your project, with an experienced project manager as your single point of contact. We encourage regular progress meetings to keep you up-to-date so that costs and timescales are tracked to the project plan and remain fully transparent.

 

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 chose 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. ITL’s achievements together with our latest progress with miniaturization of magnetic detection is a quantum leap in disposable self-testing. "

Mika Laitinen, Managing Director, Magnasense Technologies Oy

"We came to 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 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."

Alec Mills, Co-founder, DAME

"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

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

Contract Manufacturing

Regulatory Consulting