G&H | ITL

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.

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.

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.

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.

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.

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.

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 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.

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

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.

Generate early design concepts and proof of principle prototypes to help identify key risks 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.

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.

Conduct verification testing on alpha prototypes to ensure your device consistently meets the specifications, 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.

Generate detailed work 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.

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 GMP 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.