Prototype Catheter Manufacturer: Your Partner in Clinical Success
Catheter Prototyping for Accelerated Iterative Design
Our Rapid Prototyping services provide quick-turn iterative builds and concept testing to establish essential performance requirements. This early-stage feasibility work helps refine user needs and establish critical design inputs before transitioning to advanced development phases.
By accelerating these iterations, we eliminate logistical delays and help your team reach regulatory submission faster.
Design for Manufacturability (DFM) at Scale
Many programs struggle at scale because they rely on “artisan” or handmade techniques that are difficult to replicate in high-volume production.
Our engineers prioritize Design for Manufacturability (DFM) to ensure that your catheter design is robust, repeatable, and cost-effective. We address potential failure modes early to avoid locking in inefficient processes.
ISO 13485 Catheter Manufacturer
Every project is developed and manufactured within our ISO 13485:2016 certified centers of excellence to ensure total regulatory alignment from day one. Our validation activities provide the critical data-driven confidence needed for successful regulatory submissions and commercial release.
Seamless New Product Introduction (NPI) and Manufacturing Transfer
Successful manufacturing transfers involve our NPI experts long before the design is frozen to ensure a smooth hand-off to production. We utilize a rigorous phase-gate process to scale your device while maintaining strict quality, repeatability, and cost controls.
This proactive strategy allows us to capture value and margin improvements while they are more cost effective to implement.
Mastering Complex Sub-Assemblies and Precision Laser Components
We leverage proprietary braiding, coiling, and reflow processes to solve the industry’s most challenging engineering hurdles for complex sub-assemblies. Our facilities integrate advanced precision laser components, including cutting, welding, and ablation for high-performance delivery systems. This single-source depth is essential for specialized clinical segments like electrophysiology, neurovascular and structural heart applications.
Let's Partner
We cannot wait to collaborate with you in our dedicated R&D lab for real time feedback during rapid prototyping, design iterations, testing, and more!
ISO 13485:2016 Certified
FDA Registered
300+ Employees
3 Minneapolis Locations
ISO 7 & 8 Cleanrooms