Catheter Ideation & Design Process Services

The Development phase is where your product is evolved from the design select into a commercial product. We journey with you through the product lifecycle:

Design Realisation-

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

Sterilisation requirements

Manufacturing methods & DFM.

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).?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).?

Design Validation-

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.

Design for Manufacture-

The?final?stage?of?the Development phase?is to make your catheter product?manufacturable?and scale ready. We manufacture low-volume?pilot 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.