Development
DEVELOPMENT SOLUTIONS
Catheter Development Solutions Tailored to Your Needs
ICS Medical Devices specialises in transforming catheter concepts into commercially ready products.
First in human trials supported
At ICS Medical Devices we accompany you on your catheter design journey by acting as an extension of your team.
By merging clinical insights with advanced engineering, we deliver innovative catheter development solutions that meet the needs of startups and OEMs alike.
Innovative Catheter Development for Every Clinical Application
At ICS Medical Devices, we take pride in pushing the boundaries of catheter technology. By combining clinical knowledge with precision engineering, we create solutions that are functional, reliable, and scalable.
Our Areas of Specialisations
Structural Heart
Neurovascular
Heart Failure
EXPERTISE IN CATHETER DEVELOPMENT
Accelerate your next innovative catheter development
Experts in complex catheter solutions
Bring us your idea and together we’ll make it the best it can be.
Our experienced engineering team will challenge your catheter design concept and develop a roadmap to accelerate your product to prototype and pilot production.
PROJECTS WORKED ON
With over 600 years of combined product design and development experience, our expert team has a 360-degree view of the catheter development process allowing us to see potential opportunities and challenges at an early stage – saving you time and money in your journey towards scale manufacturing.
Specialised Catheter Solutions for Complex Needs
ICS Medical Devices is a leader in developing custom catheter solutions for advanced clinical applications. Our products include sensor-integrated designs, cryotherapy balloon catheters, and other technologies that address complex challenges in your medical device development journey.
Our expertise spans the design and development of complex devices, including:
Steerable Catheter Shafts
Balloon Catheters
Implant Delivery Catheter
DEVELOPMENT PROCESS
Our Proven Development Process
We employ a structured agile approach to NPI, transforming ideas into commercially viable products:
Idea
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.
Design
- Plan/Spec
- Build
- Test
- Review
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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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Construct and build the concept(s) using our internal expertise and capabilities.
-
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.
-
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.
Development
- Design Realisation
- Design V&V
- Manufacturing Ready
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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.
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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.
Manufacturing
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.
Idea
Manufacturing
Manufacturing
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.
Development
- Design Realisation
- Design V&V
- Manufacturing Ready
-
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.
Ideas
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.
Design
- Plan/Spec
- Build
- Test
- Review
-
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.
-
Construct and build the concept(s) using our internal expertise and capabilities.
-
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.
-
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.
Your Trusted Partner in Catheter Development
Whether you’re a startup advancing an idea or an OEM seeking to develop a next generation device, ICS Medical Devices has the experience and capabilities to ensure your success.
We bring vast expertise and dedication to every project:
- 600+ Years of Combined Expertise: Extensive knowledge in catheter design and development.
- Agile, Systematic Approach: Streamlined processes to accelerate time-to-market.
- Comprehensive Solutions: Support across the entire product lifecycle, from concept to scale manufacturing.
- ISO 13485 and FDA compliant design control with full support through development and regulatory pathways, backed by a clear quality agreement matrix defining roles and responsibilities.
- End‑to‑end project management including scope, cost, budget oversight, communication continuity, risk mitigation, and solution delivery.
ICS’sNPI process governs the transition from design to commercial manufacturing, aligning early design and manufacturing strategy, while identifying challenges and guiding development with customers. It drives open communication, transparent decision‑making, and adherence to regulatory and Quality System requirements to improve overall project success.