ICS Medicals inspection and quality control capabilities

Catheter Manufacturing

ICS Medical Devices is an ambitious enterprise with a state-of-the-art facility for you to utilise in pilot manufacturing and to scale into when your product is successful in the market.

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

Pilot manufacturing services
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

Validation process at ICS Medical
Validation

We can validate your product’s process and production to comply with your requirements.Validation will be to an agreed Master Validations Plan (MVP) and strategy. We focus on helping to ensure the product is of the highest standard and quality, and allowing optimisation of destructive testing and inspection criteria requirements for the product and process.

Volume manufacturing that is efficient and of the highest quality for medical device clients
Volume Manufacturing

Our focus in ongoing commercial production will be constant. With your product in our lean processes, we focus on build efficiency, throughput, quality, yield and supply chain.We are always striving to ensuring our medical device manufacturing outputs match the product market demands with a safe and reliable product supply.

We are committed to your success and any requirement to scale your production is a good indicator of your market success. We support scaling of production lines in many ways including incremental steps with ongoing DFM opportunities, process & method improvements, tooling & fixturing development and optimisation, automation opportunities, quality yield improvements and supply chain improvements. To achieve step changes in scale we have options including full line / part line duplication, and the addition of extra shifts to match your demands. Manufacturing output can be anything from 1 to 10,000 units per week – we will grow with you.

Broad expertise

Quality

Our expertise is in catheter technology and medical device manufacturing with a clear focus on product quality. We collaborate with our customers to build smart product specifications and standards for their product. We train our operators to the highest standards and give them full awareness of their customer and the clinical demands of the product.

Cleanroom

We produce finished device solutions from our qualified class 8 cleanroom, up to and including packaging and sealing of your product. With 2500sq/ft of available space we have the capacity and the capability for you to scale.

Broad Scope

Access devices (sheaths & catheters), delivery systems (balloon expandable and self-expandable stents, valves and implants for structural heart applications) and integrated devices (EP catheters, catheters with novel integrated technologies) are just a selection of the various types of catheter we work with.

Supply Chain

What we don’t have in-house we can source through our networks and trusted supply chains. For example, we are experienced and proficient in the specification and sourcing of balloons, laser cut tubes, and machined / moulded components. We are comfortable developing a supply chain solution for you and happy to work with any supplier specifications you have.

ICS Medical subimage

Contact us today

Speak to one of our engineers about how our facilities and processes can scale with you from pilot to volume manufacturing.

ICS Medical Devices pilot manufacture scale

Flexible and scalable

When we say we are flexible, we mean it.

If you are not at the stage of needing the full rigour of a full manufacturing line, we will not enforce those rigours on you, and you will still receive full build control and product traceability.

We are experienced in scaling your medical device manufacturing from pilot to volume manufacturing. This includes specification of fixtures and equipment, operator recruitment and training, line balancing, process & method improvements, inspection standardisations, use of meaningful KPI metrics on-line, focussing on yield and throughput. We take a collaborative approach on process validations with smart validations focussing on key processes and validating at the right time in the customer’s life cycle.

From catheter design to commercialisation

From the very start of your journey with us, be that at Design or Prototyping phase, we are already considering the manufacturability of your product.

Design for manufacture is a key consideration in our design process, decision making, and design selection process. That could be how to improve the design to optimise the process or it could be choosing the best supply chain options for your product.

During design and prototyping, we challenge the specification in order understand the requirements. Once developed we challenge the capability of the product against the specification and help you to make design decisions based on solid engineering data.

Case Studies

ICS Galway, Ireland case studies image-1

Our international customer was a startup developing a unique, differentiated, and somewhat complex product for a structural heart application. The customer was entering DV & clinical trials and their volumes were deemed too small for their current CMO who could not continue to support their needs. The customer required a solid, reliable and safe solution that would collaborate with them with the required urgency.

 

ICS Medical Devices reviewed and quickly understood the specification. We responded with a plan and quotation to secure a new supply chain and initiated process development and capability testing on key bonds and requirements for the product.

 

ICS Medical Devices successfully improved key processes, including elimination of adhesive bonds in favour of thermal bonds and improving robustness of all bonds. We proposed and executed changes to components specification and tolerances to further optimise the final device dimensional capability. ICS Medical Devices tackled some historical process challenges the product had by treating the customer as a priority, allowing ICS to focus on the product and its processes and develop solutions to safeguard the quality and the supply of the part even in its current low volume status.

 

All engineering and testing was completed with data supplied to customer to rationalise and support each change ICS implemented. Upon successful completion of development and supply chain qualification, ICS implemented full quality and control systems, training, inspections, testing and product release procedures to supply the product to the customer.

ICS currently supply this valued customer an improved quality product. The customer now has a product supply route for a quality product that is reliable, repeatable, flexible and meets their quality expectations. The customer can now implement additional design improvements, ongoing supply and scale their demand with us.

ICS Galway, Ireland case studies image-2

Our customer was in a challenging situation as they pursued design freeze and clinical trial milestones crucially required to secure future investment in their company. At the same time our customer realised their current design had a cost of goods that was too high to be successful in the market. They had ideas on how to improve but were running out of time to implement in the current design cycle.

 

After approach and review with the customer, we proposed a plan to design and build new components – reengineered and simplified to eliminate much of the materials cost but still satisfying the product requirement.

 

After successful build at ICS and testing by the customer, ICS Medical Devices progressed to installation of systems and methods to facilitate the build of 1000 assembly components required to support the customer DV program. Within three weeks of starting, ICS supplied the first 250 pieces and followed up with an additional 250 pieces every three days to satisfy the customer build into the final assembly. We are now working with this customer in ongoing clinical trials.

ICS Galway, Ireland case studies image-3

Our customer was an early stage start-up with a novel approach for a new therapy in the structural heart space. They were tasked with a key feasibility trial in order to meet a key project milestone and satisfy their investor expectations. Based on our experience in product development and manufacturing, and our deep understanding of what is required for development and manufacturing, ICS Medical Devices was asked to support some key assemblies for their product feasibility trial.

 

ICS took control of the material specification and process specification. We secured raw materials to specification; completed development on critical laser welds, thermal bonds, jacketing pouch seal and packaging processes; set up process methods, quality systems and controls, build traceability, training and inspections to support the feasibility build.

 

ICS completed the feasibility builds within the customer schedule, facilitating that customer to get to a successful trial. The customer achieved their milestone, successfully demonstrating product efficacy and this was presented to investors and ultimately helped to secure our customer’s next round of investment to advance the project.

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ICS Medical Devices is based in Galway, Ireland’s Medical device hub, so we’re centrally located to serve the medical device industry globally.

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