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SERVICES

Medical Device Development

We transform innovative ideas into a commercial reality.

Our multidisciplinary team combines design knowledge, engineering expertise, and problem-solving skills to create innovative design concepts.

Capabilities

  • Concept Generation
  • Feasibility Studies
  • Industrial Design
  • CAD Modeling
  • UI/UX
  • Rapid Prototyping
  • Design for Manufacturing (DFM)
  • Risk Management
  • Project Management

Every world-leading innovation starts with an idea

From aesthetics and differentiation to usability and human factors, there’s a lot to consider when developing a medical device. Working through a systematic product development process, our team of industrial designers and engineers will refine your concept to ensure it is commercially and technologically viable and designed with manufacturing in mind.

With over 40 years’ industry experience, we combine design knowledge, engineering expertise, and problem-solving skills to create innovative design concepts.

Our Capabilities

Concept Generation

Getting the conceptual design process right is the foundation of successful medical device development. Our creative industrial designers have decades of industry experience and the know-how to transform your idea into an innovative new design concept.

Feasibility Analysis

From the start of your project, we will assess your concept’s technical and commercial feasibility, helping you to understand your commercialization goals, optimize the design for manufacture, and reduce risk.

Industrial Design

Our experienced 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.

CAD Modeling

Utilizing state-of-the-art technology and the latest CAD software, our team can transform your design from rapid, rough sketches to fully rendered drawings, allowing you to visualize concepts and simulate how your device will perform in the real world.

UI/UX

Our specialist team of designers and engineers combine skill, experience, and knowledge to create innovative and reliable solutions to complex design challenges, focusing on end-user experience. By having a deeper understanding of how users will connect with a device, we can create informed, ergonomic medical devices with a GUI interface that is intuitive for the user.

Rapid Prototyping

Using a range of rapid prototyping techniques and utilizing our in-house 3D printing capabilities, we can produce early proof of principle prototypes for usability testing, enabling you to explore new ideas and fine-tune designs quickly and easily.

Design for Manufacturing

As a full-service design and manufacturing partner, we understand the value that comes with creating production-ready designs. That’s why we apply design for manufacturing (DFM) principles during the concept, feasibility, and development stages of every project to ensure each device designed can be repeatedly and reliably manufactured, reducing time-to-market and overall production costs.

Risk Management

Risk management is an integral part of medical device development and applies to every phase of the development lifecycle. We incorporate BS EN ISO 14971 requirements into our quality management system to provide a rigorous, risk-based approach to design and manufacturing while effectively demonstrating compliance within the scope of a project.

Project Management

Our proven, structured approach to project management allows us to manage medical device projects of any scale and scope. Our approach focuses on achieving customer goals through:

  • Documenting requirements, defining the scope, and developing project plans
  • Identifying, analyzing, and mitigating risk
  • Managing estimated project costs and timelines
  • Design verification and process control
  • Stage gate review

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

"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

"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

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

Design & Engineering

Contract Manufacturing

Regulatory Consulting