Medical Device Prototyping
Meet your launch goals! CATHTIP’s Development Team is available to support your R&D Department in formulating fabrication methods for the production process. Whether it is a simple tip, multi-lumen hole pattern, or a complex assembly with multiple materials and operations, the CATHTIP team stands ready to perform the work for proof of concept all the way to production. Contact us and we can discuss your project details.
CATHTIP PROVEN PROCESS, STEP #1: Rapid Proof of Concept
Proof of Concept
You have a project – a new catheter that needs to be developed or an existing part that needs to be improved. You might be on a tight timeline and want to know if your application is feasible – quickly, but not costly. You can send your materials and we can develop proof-of-concept samples rapidly in our R&D lab on our original equipment. Our extensive off-the-shelf tooling library contains hundreds of tipping die geometries and a wide of range hole-forming bit sizes. Save valuable time and money to get the preliminary sample results you need. You can expect flashless tips, burr-free holes, and any other catheter tip or hole-forming operations you need.
You might not have finalized part specifications: We can help you identify what will work best for performance and manufacturability with our quick-turn development samples produced from your exact materials.
CATHTIP PROVEN PROCESS, STEP #2: Prototyping
Prototyping
Your medical device needs to be precise. In the Prototyping Stage we help you optimize the design and produce custom tooling to meet tight tolerance requirements (+/- .0003″). The CATHTIP team has years of expertise designing and developing production-worthy components.
We first analyze customer drawings and discuss the design with the customer. Then the tooling is drafted and reviewed. Next we have the tooling manufactured and once received, we verify that tooling was made to spec and can produce quality parts. Lastly, we develop a recipe and produce exact-to-spec samples and ship them to the customer to do their testing.
CATHTIP PROVEN PROCESS, STEP #3: Process Refinement
Process Refinement
CATHTIP’s process refinement optimizes the process and is critical to move that catheter into successful, high-quality manufacturing. It is also a valued step to improve the current quality level of an existing catheter product.
For the customer to integrate repeatable semi-automation, we replace the elements of the development process that were done manually with production grade stainless steel and anodized aluminum tooling and fixtures. This facilitates long-term, repeatable quality production. Manual operation variables are removed and development data collected to set and provide optimal output parameters.
CATHTIP PROVEN PROCESS, STEP #4: Contract Manufacturing
Clean Room Production
After your catheter process has been refined by CATHTIP product specialists, you can choose one of two paths. 1: Purchase the equipment and custom tooling to run production at your facility. 2: Have the parts produced by CATHTIP-trained technicians in our ISO 13485 Certified Class 7 cleanroom. We can produce any quantity depending on what makes more sense to your organization.
CATHTIP PROVEN PROCESS, STEP #5: Machine Acquisition
Machine Acquisition
TIPPING: CATHTIP offers two superior RF catheter tipping machine models – The Magnum and The Quantum. Both machines use the same black box tooling sets to produce premium-quality parts. Both provide repeatable processes, rapid cycles, and high yield rates – whether in high-volume production or R&D lab work.
HOLE FORMING: CATHTIP offers two superior burr-free, hole-drilling platforms utilizing our proprietary Flow-Thru™ core-capture technology. The 400 Series provides custom automation for your hole formation requirements. The Flex-Drill provides a flexible, cost-effective option for hole-forming prototypes and early development applications.
