Catheter Manufacturing Services
Details
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
Our expertise is in catheter technology and medical device manufacturing with a clear focus on product quality. We train our operators to the highest standards and give them full awareness of both the customer and the clinical demands of the product to ensure the highest standards in the manufacturing medical device process.
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 medical device production space we have the capacity and the capability for you to scale.
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 production we offer.
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.
Flexible and Scalable
If you are not at the stage of needing the full rigour of a full cathether 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, focusing on yield and throughput. We take a collaborative approach on process validations with smart validations focusing 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.
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