ICS medicals design capabilities

Your Catheter Design Partners

At ICS Medical Devices we accompany you on your catheter design journey by acting as an extension of your team.

By combining your clinical expertise with our catheter  expertise, we develop an optimum product solution.

Innovative catheter design from ICS medical devices

An Experienced Team

We know there is a huge amount to consider in the catheter design process – the voice of customer, user needs, clinical use, shaft and handle design, packaging design, design testing, sterilization and critically, design for manufacture.

With over 100 years of combined product design and development experience, our expert team has a 360-degree view of the catheter design process allowing us to see potential opportunities and challenges at an early stage – saving you time and money in your journey towards scale manufacturing.

Catheter Design & Development Process

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Speak to one of our engineers about how our design processes and expertise can help accelerate your product along its development lifecycle.

Catheter Design & Development Process

Click on the various stages to see more information

Come to us with an embryonic idea or a full specification and together we can take it forward.
Based on your requirements and needs we can go straight to Prototyping or enter the Design & Development process.

Accelerate

We provide rapid engineering input to ensure your idea accelerates quickly and efficiently through its lifecycle.

Review

Collate the data and learnings and review together with the customer. Define our options for improvement and inputs into future concept specification and prototype iterations.

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Plan/Spec

Discuss the approach, set the targets and define the deliverables. Develop the specification for the concept(s) including design, raw materials, prototype build and testing against the targeted performance requirements.

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Build

Construct and build the concept(s) using our internal expertise and capabilities.

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Test

Inspect and challenge the performance of the concept against its targeted requirements, stress the concept to understand its robustness, evaluate the data and develop conclusions.

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Design

In the Design Loop your idea is translated to a concept and that concept is planned designed, built, and tested.

Accelerate

Accelerate

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 – Design Validation – Manufacturing.

Your concept is fine-tuned, improved and optimised with a view to achieving Design Freeze.  We look at the total solution for your product in the context of the overall system, including DFx (design for x) and specifically DFM. In design realisation we can consider all elements including, handle design, accessory devices, packaging design, sterilization requirements, manufacturing methods etc.

We work proactively in aiding you to meet your V&V milestones: e.g. CE marking, FDA approval or approval for a clinical study. We support your design assurance requirements, generate DV protocols, execute testing and complete DV reports. We can support your design control and contribute design control elements into your overall product design control.

Making sure your product is manufacturable and scale ready. We manufacture low-volume builds during DV, clinical trials and early stages production, we expand and scale with you as your product enjoys success in the field. 

Accelerate

Accelerate

We have the flexibility to work closely with you at pilot manufacturing stage when demand is unpredictable and to retain that close relationship as you scale and your product becomes more successful in the market.

Your concept is fine-tuned, improved and optimised with a view to achieving Design Freeze.  We look at the total solution for your product in the context of the overall system, including DFx (design for x) and specifically DFM. In design realisation we can consider all elements including, handle design, accessory devices, packaging design, sterilization requirements, manufacturing methods etc.

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We work proactively in aiding you to meet your V&V milestones: e.g. CE marking, FDA approval or approval for a clinical study. We support your design assurance requirements, generate DV protocols, execute testing and complete DV reports. We can support your design control and contribute design control elements into your overall product design control.

Read More

Making sure your product is manufacturable and scale ready. We manufacture low-volume builds during DV, clinical trials and early stages production, we expand and scale with you as your product enjoys success in the field. 

Read More

Catheter Design

Design is where your idea is translated from a concept on paper to a proven and robust prototype and specification. We do this in an agile but controlled and systematic process that involves planning, prototyping, testing and review. The primary goal is to get design answers to the right questions and quickly facilitate informed decisions, thereby allowing us to iterate effectively and efficiently towards your final catheter design solution. The goal is to achieve a Concept Select which we can advance with confidence to full development and design freeze.

  • 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 against the targeted performance requirements.

  • Build+

    We 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 – our technicians are committed to making every prototype a good prototype. We are flexible - if changes are required to improve the output we help make those changes happen.

  • Test+

    We 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 will evaluate the data and with you develop conclusions on results and input these into the next steps.

  • Review+

    We collate our data and learnings and review together with the customer. We help define the options for improvement in the catheter design or alternate design and provide inputs into future concept specification and prototype iterations and options.Either the review will feed into our next concept design iteration or we will have enough data and confidence to confirm our ‘Design Select’ and to move to the next phase of your product development.We believe in an agile, flexible and responsive process, where plans are defined and structured but prototyping and testing is quick. This generates valuable learnings and innovative solutions to your design challenge. 

Catheter Development

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 – Design Validation – Manufacturing.

  • 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, 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. 

  • Design V&V+

    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.

  • Manufacturing Ready+

    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.

Why ICS Medical Devices?

At ICS Medical Devices we have vast experience in catheter design and development lifecycles, with a deep understanding of the risks and opportunities involved.

Serving the medical device world globally, we provide guidance and support to help shape your strategy, and we take great pride and satisfaction from seeing our customers’ products enjoy success in the field.

Our customers are our priority – we understand that they need rapid response rates, concise engineering input, engineer to engineer communication and a partner with the ability to react quickly to market opportunities.

Case Studies

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.

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

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