Medical Device Services

Galway Biomedical provides end-to-end design, development and manufacturing support to medical device companies seeking an ODM (Original Design Manufacturer) partner to bring their product to life, from initial concept prototyping through to fully packaged medical implants. Leveraging extensive biomaterial expertise, equipment experience and process know-how, Galway Biomedical prides itself on being able to support clients bringing ideas or established medical devices to market.

Our Development Process

Phase 1 - Concept Phase 2 - Development Phase 3 - Manufacture

Phase 1 - Concept

Concept Feasibility & Initial Prototyping

In this initial phase, Galway Biomedical’s goal is to create a functional prototype based on client requirements and design inputs. The process varies on a client-by-client basis. Galway Biomedical can operate as an ODM partner or simple prototype manufacturer of a client's design to bring a concept to life.

The Galway Biomedical team brings a wealth of industry experience to every project, adhering to best practices and standards from the beginning through to finished device. This enables informed discussions regarding the path to completion from the initial phase.

Phase 2 - Development

Process Development

This phase concentrates on further developing the prototype and optimising performance. Galway Biomedical engineers focus on establishing a defined and repeatable manufacturing process.

When the desired performance is achieved, the project moves to design lock, resulting in a specification which will proceed to a rigorous testing plan.

The final specification will also identify equipment and material requirements. This enables the project to move to the next phase – Scaling & Manufacturing.

Phase 3 - Manufacture

Scaling & Manufacturing

The final step will entail full scale volume production for your component. This will include material sourcing, project management, , equipment acquisition and installation (if required).

During this stage our production engineering team will liaise with our in-house quality team, creating documentation around the design.

All components are built in our ISO 7/ Class 10,000 cleanroom.