Shannon MicroCoil Design Centre
Shannon MicroCoil offers clients a one-stop service for medical device design.
We can assist you every step of the way in the design of your medical wire device.
From taking a set of performance requirements and specifications, right through to design for manufacturability – we have the tools and expertise to help you achieve your goals.
Step 1: Requirements
Generally we start with a roundtable meeting to discuss the overall requirements of the medical device or device component. The requirements capture includes
- material specifications
- geometrical considerations and constraints
- regulatory requirements
- manufacturing techniques
- documentation requirements
- validation plans
- the development cycle from prototype to production.
Step 2: Prototypes an Evaluation
Following this, preliminary designs are explored within the requirements envelope and device prototypes are produced for evaluation on the bench. At this stage, some refinements will usually be identified leading to a second generation prototype for more in depth evaluation possibly in animal or human cadaver studies. This refinement loop may undergo numerous iterations if required.
Step 3: Medical Device Freeze and Clinical Evaluation
Following a successful evaluation, the client may consider the device or component at design freeze and ready for proper clinical evaluation. All relevant documentation pertaining to the design is prepared and signed off for inclusion in the client Design History File.
Step 4: Planning for Manufacture
While this phase of the product testing cycle is in progress, the manufacturing criteria are set out – the process steps, required equipment, validations, raw material supplier requirements, packaging, sterility and so forth. The client may wish to place manufacture of the product at another site, in which case we can migrate the process with a full specification package.
One Stop Service for Medical Device Development
In addition to our core capabilities, we have an extensive network of industry partners providing a broad range of capabilities which we can integrate into the design and development process thus allowing us to offer you a one-stop service for your medical device development.