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.