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 the project is feasible – quickly, but not costly. We can develop proof-of-concept sample parts for you. Our normal lead time is 1-2 weeks, but can expedite to 2-4 days if needed. Cost is minimal since we usually utilize off-the-shelf tooling in our R&D lab, which contains over 400 die geometries and hole drill bits. What you can expect from our technology and equipment are flashless tips and burr-free holes.
You might need help with material selection: We can help you determine what material will work best in terms of performance and manufacturability by running samples with each material type.
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 14644-1 Certified Class 7 cleanroom. We can produce any quantity for short or long term 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 and the MI Series is a smaller, manual indexing option.
