Manufacturing

MANUFACTURING SOLUTIONS

Catheter Manufacturing Solutions

Advanced capabilities for the delivery of high-quality, scalable catheter manufacturing solutions.

Whether an established OEM seeking a manufacturing partner to meet stringent quality standards or a startup advancing a new catheter design, ICS Medical Devices offers the expertise and infrastructure to ensure consistency, compliance, and efficiency.

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Products FDA approved

We provide supply chain ownership, quality systems, and internal, integrated medical manufacturing capabilities and capacities; allowing control and release of your product to you for the market.

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Class 8 Clean Rooms

Manufacturing Solutions

We provide a structured approach to catheter manufacturing, ensuring scalability to meet market demands. Our expertise spans pilot manufacturing, validation, and high-volume production, with continuous improvements in process efficiency, automation, and quality control.

Pilot Manufacturing

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Pilot Manufacturing

Pilot builds can be to support your Catheter Design Verification and Validation, clinical trials or an early or limited product release. From here we can continue to support low-volume manufacturing, complete validations or scale up towards volume manufacturing; driven by your demand

New Product Introduction (NPI)

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New Product Introduction (NPI)

ICS’s NPI 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.

Volume Manufacturing

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Volume Manufacturing

Optimised for efficiency, throughput, and quality yield. Lean manufacturing principles ensure reliable high-volume catheter production, tailored to market demands.

SCALE

Scalable Catheter Manufacturing Solutions

Manufacturing scales with demand, and ICS Medical Devices ensures a custom approach at every stage. For early-stage production, full manufacturing rigors are applied only when necessary, while maintaining complete build control and traceability.

With expertise in scaling from pilot to volume manufacturing, our approach includes fixture and equipment specification, operator training, line balancing, process optimisation, and inspection standardisation. Smart validations focus on critical processes, aligning with product lifecycle needs to ensure efficiency, quality, and compliance.

Our state-of-the-art facilities support scalable production capabilities ranging from 1 to '000's of units per week, ensuring your manufacturing processes grow with your product’s success.

We produce finished device solutions from our qualified class 8 cleanrooms, up to and including packaging and sealing of your product. With up to 28,000sq/ft of available medical device production space we have the capacity and the capability for you to scale.

Case Studies

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Client C

Transforming a High-Risk Supply Challenge into a Scalable Solution

Our international customer, a startup developing a complex structural heart device, faced challenges as their volumes were too small for their current CMO to support during DV and clinical trials. They needed a reliable partner who could respond with urgency. ICS Medical Devices quickly reviewed the specifications and provided a plan and quotation to secure a new supply chain. We initiated process development and capability testing on critical bonds and requirements. We improved key processes, replacing adhesive bonds with thermal bonds and enhancing overall robustness. Component specifications and tolerances were optimised to improve dimensional performance. By prioritising the customer and addressing historical process challenges, ICS ensured quality and supply reliability even at low volumes. All engineering and testing were completed with data provided to support each ICS change. Following successful development and supply chain qualification, ICS implemented full quality systems, training, inspections, testing, and product release procedures. ICS now supplies the customer with a reliable, high-quality product. The customer has a secure supply route, enabling ongoing design improvements, scalable production, and consistent quality.
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Client A

Pilot Manufacturing

Our customer faced a challenge as they pursued design freeze and clinical trial milestones essential for future investment while realizing their current design’s cost of goods was too high for market success. With limited time to act, they needed an efficient solution. After reviewing the situation, we proposed designing and building new, reengineered components, simplified to reduce material costs while meeting all product requirements. Following successful builds and customer testing, ICS Medical Devices implemented systems to produce 1,000 assembly components for the customer’s DV program. Within three weeks, we delivered the first 250 pieces, followed by 250 more every three days to support final assembly. We now continue to work with this customer on ongoing clinical trials.
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Client B

Building to a Successful Feasibility Trial

Our customer, an early-stage start-up developing a novel therapy in the structural heart space, needed to complete a key feasibility trial to meet project milestones and investor expectations. Leveraging our product development and manufacturing expertise, ICS Medical Devices was asked to support critical assemblies for the trial. ICS took ownership of material and process specifications, secured raw materials, and developed critical laser welds, thermal bonds, jacketing, pouch seal, and packaging processes. We established process methods, quality systems, traceability, training, and inspections to support the feasibility build. ICS completed the builds on schedule, enabling the customer’s successful trial. The milestone demonstrated product efficacy, which was presented to investors and helped secure the next round of funding to advance the project.
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Client C

Transforming a High-Risk Supply Challenge into a Scalable Solution

Our international customer, a startup developing a complex structural heart device, faced challenges as their volumes were too small for their current CMO to support during DV and clinical trials. They needed a reliable partner who could respond with urgency. ICS Medical Devices quickly reviewed the specifications and provided a plan and quotation to secure a new supply chain. We initiated process development and capability testing on critical bonds and requirements. We improved key processes, replacing adhesive bonds with thermal bonds and enhancing overall robustness. Component specifications and tolerances were optimised to improve dimensional performance. By prioritising the customer and addressing historical process challenges, ICS ensured quality and supply reliability even at low volumes. All engineering and testing were completed with data provided to support each ICS change. Following successful development and supply chain qualification, ICS implemented full quality systems, training, inspections, testing, and product release procedures. ICS now supplies the customer with a reliable, high-quality product. The customer has a secure supply route, enabling ongoing design improvements, scalable production, and consistent quality.
Contact Us

Client A

Pilot Manufacturing

Our customer faced a challenge as they pursued design freeze and clinical trial milestones essential for future investment while realizing their current design’s cost of goods was too high for market success. With limited time to act, they needed an efficient solution. After reviewing the situation, we proposed designing and building new, reengineered components, simplified to reduce material costs while meeting all product requirements. Following successful builds and customer testing, ICS Medical Devices implemented systems to produce 1,000 assembly components for the customer’s DV program. Within three weeks, we delivered the first 250 pieces, followed by 250 more every three days to support final assembly. We now continue to work with this customer on ongoing clinical trials.
Contact Us

Client B

Building to a Successful Feasibility Trial

Our customer, an early-stage start-up developing a novel therapy in the structural heart space, needed to complete a key feasibility trial to meet project milestones and investor expectations. Leveraging our product development and manufacturing expertise, ICS Medical Devices was asked to support critical assemblies for the trial. ICS took ownership of material and process specifications, secured raw materials, and developed critical laser welds, thermal bonds, jacketing, pouch seal, and packaging processes. We established process methods, quality systems, traceability, training, and inspections to support the feasibility build. ICS completed the builds on schedule, enabling the customer’s successful trial. The milestone demonstrated product efficacy, which was presented to investors and helped secure the next round of funding to advance the project.
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Our Capabilities

Prototyping

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Development

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