Development Services

World-class catheter design and development.

4
Design teams
50+
Engineers
4
Development cleanrooms
100s
Products under our belt

We do three things at once

Clinically relevant

We start with the patient and the clinical need.

Manufacturable

We design for manufacturability.

Regulatory-clearable

We map the regulatory pathway alongside the design, so the device you develop is one you can actually bring to market.

How a program runs

ConceptClinical need translated into design inputs and a regulatory path.
DevelopmentPrototyping, test method and process development, and materials sourcing.
TransferDesign moved into a validated, repeatable production process.
ProductionScaled manufacturing under our quality system.

What a partnership includes

Cross-section of a braided catheter shaft showing the outer jacket, braid layer, and inner liner

Development partnership

  • Clinical feedback synthesized into specifications
  • Market needs translated into product designs
  • Rapid iteration and parallel design paths
  • Regulatory strategy defined early
  • Production issues considered from day one
Design verification chart showing measured performance against upper and lower specification limits

Regulatory, clinical & quality

  • Global regulatory strategy
  • FDA meeting preparation and attendance
  • Pre-Subs, IDEs, 510(k)s, PMAs, de novo
  • Clinical strategy and protocol development
  • Quality system development
  • FDA inspection prep (QSIT & BIMO)

Quality & certifications

A few of our work areas

Cardiac Electrophysiology

Mapping, ablation, and lead delivery systems.

Structural Heart & Cardiac Assist

Delivery systems and large-bore access devices.

Peripheral Vascular

Thrombectomy, drug delivery, and peripheral access.

Endoscopy & Endosurgery

Optical assemblies and flexible shaft construction.

Minimally Invasive Delivery

Introducers, dilators, and delivery systems.

Vascular Access

Access sheaths and custom valve designs.

See what we build
We can ramp.Not just a contract manufacturer.Regulatory expertise, in-house.Your idea is not just a print to us.R&D meets manufacturing.We de-risk your product launch.
Contact Us