Catheter Design Process | Medical Device Manufacturer

ICS medical team member inputting into the catheter prototype design process

Plan & Spec

We work with you to define the scope, set the targets and define the deliverables for the project. We help develop the specification for the concept(s) including the catheter design, raw materials required, prototype builds and testing strategy.

Prototype

Construct and build the concept(s) using our internal expertise, know-how and capabilities. We will design and iterate on the spot if we see opportunity for improvement in the design or if we see challenges and risks to your product.

Test

Inspect, test and challenge the performance of the catheter concept prototype against the targeted requirements defined in the specification phase. We can stress the concept prototype to understand its robustness and characterise its performance, and we evaluate the data with you.

ICS Medical prototyping capabilities utilising their class-leading technology and facilities.

Review

Collate data and learnings and review together with you. Define the options for improvement in the catheter design and provide inputs into future concept specification and prototype iterations. Either the review will feed into our next concept design iteration or we will have enough data and confidence to confirm ‘Design Select’

Catheter Product Development Process

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.

Catheter Design & Development Process

Click on the various stages to see more information

Catheter Design & Development Process

Click on the various stages to see more information

Case Studies

Customer A

Customer B

ICS Galway, Ireland case studies image-1

Customer A is an early stage start-up of creative people closely linked with the treatment of patients in the clinical environment. The customer was accumulating and screening great ideas for new and disruptive catheter products but had no internal capability or process to translate these from an idea to a tested prototype that was generating data and learnings from which decisions could be made.

The ICS Medical Devices team met with the customer and translated the idea into a target product specification with a plan to produce prototypes and a suite of testing to challenge the design. ICS Medical Devices completed the catheter prototype build and testing, and additional prototypes were tested by the customer and demonstrated with their KOLS. The learnings were accumulated and used as key inputs into the next design round, and over a series of agile but structured design iterations the
customer achieved a workable prototype and design specification, generating enough data to support their Series A funding process.

Customer testimony “Will and Maeve produced our first functioning prototype in under two weeks. It was a really incredible turnaround.  We subsequently used these prototypes when closing our Series A funding. It was invaluable to have these high-quality prototypes in the fundraising phase.”

ICS Galway, Ireland case studies image-2

Customer B had a therapy solution that needed access and delivery to its anatomical location. The customer engaged ICS Medical Devices for an ‘Accelerate’ event where we took their clinical and technical catheter concept through our brainstorming process to generate ideas for successful delivery of the therapy.

During the process we asked leading design input questions not previously asked and provided the customer with insights and knowledge that hadn’t been raised before. We generated ideas which, together with the customer, we screened and filtered based on key product success criteria. We then progressed the selected ideas to concept development where the concepts were developed and specifications for each concept were built.

The output for our customer was key concepts to support pitches to investors, concepts to help convey the product message to KOLS, and concepts to support their IP position.

Your Catheter Design Partners

Catheter Ideation & Design Process

Catheter Product Development Process

Catheter Design & Development Process

Catheter Design & Development Process

Sample Catheter Design & Development Products Include

Case Studies

Contact us at ICS Medical Devices to get our team involved in your project today.