CONTRACT MANUFACTURING ORGANIZATION – CMO

ORIOS LifeSciences provides flexible Contract Manufacturing Organization services for medical devices and complex medical components.

Our manufacturing facility includes an ISO 7 cleanroom of more than 200 m² and is designed to support customers from functional prototypes and pilot production through clinical batches and larger-scale commercial production.

Our philosophy is based on flexibility, responsiveness, transparency and strong technical expertise.

We can manufacture:

• Functional prototypes
• Components and semi-finished products
• Engineering batches
• Small series
• Clinical batches
• Pre-series
• Commercial production volumes

Our manufacturing capabilities cover a wide range of technologies for complex medical devices.

Technical Tubing Extrusion

ORIOS produces high-precision technical tubing using a broad range of medical-grade and biocompatible polymers, including:

• PU
• PEBAX®
• Nylon
• Fluoropolymers such as FEP
• PEEK
• TPE
• Other polymers according to project requirements

Our capabilities range from simple polymer tubing to more complex reinforced tubing designs.

Applications can include microcatheters, vascular devices, drainage systems and implantable medical-device components.

In-line dimensional measurement and quality control can be integrated to ensure process reproducibility.

Molding & Overmolding

We provide injection molding and overmolding solutions for medical-device components, including integration of metallic components, reinforcements, wires or other functional elements.

Balloon Forming

ORIOS has specific expertise in the forming and blowing of angioplasty and endovascular balloons.

Capabilities include:

• Complex balloon geometries
• Conical balloons
• Multi-diameter balloons
• Controlled-compliance balloons
• Short and long balloons
• High-pressure applications
• Low-compliance applications

Balloon manufacturing can be supported by burst, fatigue and compliance testing.

Welding & Reflow

Our manufacturing capabilities include thermal and laser welding as well as controlled reflow processes.

These processes allow the creation of robust assemblies and controlled transitions between materials of different hardness levels, particularly for catheter shafts.

Braiding & Coiling

ORIOS can integrate metallic reinforcements into catheter structures through braiding and coiling processes.

Materials may include stainless steel, nitinol, platinum-iridium, tungsten and other materials selected according to device requirements.

Crimping

Our crimping capabilities include:

• Balloon-expandable stent crimping
• Self-expanding stent loading
• Radiopaque marker crimping
• Profile reduction of catheter assemblies

Hydrophilic Coating

Hydrophilic coating processes can be applied to catheters and guidewires to improve lubricity and navigability.

Performance can be verified through friction, gliding and durability testing.

Sterile Barrier Packaging

ORIOS can support final packaging using medical pouches or blisters designed for subsequent sterilization.

Packaging activities can include:

• Single or double sterile barrier packaging
• Labeling
• Lot traceability
• Packaging inspection
• Sterilization coordination

ORIOS can also manage shipment to qualified sterilization partners using processes such as EtO, gamma or e-beam depending on device compatibility.

A major advantage of our CMO model is the integration of R&D, process development, testing, manufacturing and industrial equipment capabilities within the same organization.

Customers therefore benefit from continuity between development and production, full process transparency and strong technical support during scale-up.

We are looking for long-term manufacturing partnerships with medical device companies seeking a flexible European CMO capable of manufacturing complex catheters, balloon systems, technical tubing and other high-value medical-device components.