Your Catheter Design Partners

Your catheter concept is fine-tuned, improved and optimised with a view to achieving a Design Freeze specification. In design realisation we can consider all elements in the design lifecycle if you require, including handle design, accessory devices, packaging design, sterilization requirements, manufacturing methods etc.The design is characterised, challenged, and stressed to failure, giving us a clear insight into what it can and cannot do. This enables us to flag potential risks and whether these need to be addressed before moving forwards. In testing, the catheter design is challenged; here in our labs, in your labs, in cadavers, in animal trials and GLP. The objective is to design, develop and test your device to achieve a robust and efficient design freeze specification ensuring it has the optimum confidence to successfully meet its testing requirements in any subsequent design verification and validation testing program.We look at the total solution for your product in the context of the overall system, we consider DFx (design for x) and very specifically DFM (design for manufacture).  Our experience and expertise allow us to guide your project safely from design into manufacture and manufacturing at scale. One of the first and most fundamental questions we ask is; what are your target COGS for the device? This is a critical, often delayed and misunderstood boundary for design, development and decision making. Experience is key in helping to steer and shape the design process before critical decisions are made. 

We take your Design Frozen Specification and assist you in taking it through its Design Verification and Validation process.We work proactively in aiding you to meet your milestone, be that product CE marking, FDA approval or approval for a clinical study.We support your builds, on a developed pilot line with the full control, training and traceability you need for your product release. We support your design assurance requirements including generating DV protocols, execute testing and completing DV reports.Testing can be coordinated and executed on your behalf, including custom test design and setup, training, and test method validations as required. We can support your design control and contribute design control elements into your overall product design control.The objective in V&V is to support your product to achieve its regulatory approval requirement be that CE Mark, FDA approval or approval for use in clinical study.

The final stage of the Development phase is to make your catheter product manufacturable and scale ready. We manufacture low-volume builds during DV, clinical trials and early stages production, and we expand and scale with you as your product enjoys success in the field. Manufacturing may be the last step, but at ICS, manufacturing readiness starts at prototyping and design selection where decisions are made with manufacturing in mind. It continues throughout the development phase where we characterise the process and challenge the windows to fully understand the capabilities of the design. Our manufacturing lines process braid and coil assemblies, complex sub-assemblies, and full devices including packaged and labelled devices.We can manufacture short-run build during DV and clinical trials and low-volume builds during the early stages, and we expand and scale with you as your product enjoys success in the field.