Device Design & Development

We have expertise in designing and manufacturing devices such as steerable tools, guides, delivery systems, and catheters providing access and/or therapy delivery for structural heart, neurovascular, peripheral vascular, and electrophysiology procedures.

Composite mesh catheters used by Nextern in medical device production

Our Approach

Our global facilities specialize in developing components such as introducer sheaths, braid/coil reinforced shafts, steerable shafts, precision laser cutting, welding, and post processing of Nitinol/specialty alloys.

Complex Delivery Systems

We specialize in the design, development, and manufacturing of complex, highly specialized catheters, steerable devices, and delivery systems for interventional markets. We’ve worked with partners on steerable balloon catheters, steerable neurovascular devices, and delivery devices for structural heart implants. As your vertically-integrated partner, we have the end-to-end services to guide you through the entire product development lifecycle.

Finished devices & components include:
  • Multi-catheter systems
  • Valve delivery and repair
  • Stent delivery systems
  • Steerable technologies
  • Handle design and assembly
  • Rail/Guide systems
Steerable Shafts & Delivery Systems

Our cross-functional team and vertically integrated supply chain have expertise to provide comprehensive engineering support and final product solution.

  • Unidirectional, bidirectional and quad‑directional devices
  • Single‑plane (single- or dual-wire), dual‑plane (4‑wire), and dual‑plane (single‑wire) deflection
  • Customizable articulation segments
  • Sub-3 Fr to 40 Fr diameters
Balloon Catheters & MicroCatheters

We have expertise in producing microcatheters used in neurovascular, cardiovascular, and peripheral vascular applications. Our goal is to design and manufacture innovative products that provide better patient outcomes and advance the field of medical technology.

  • Variable diameters
  • Laser-cut shafts
  • Coil or braid reinforcement
  • Multiple-durometer shafts
  • Advanced connectors and luers
  • Custom-molded hubs
  • Angioplasty
  • Stenting
  • Treatment of coronary artery disease
  • Treatment of peripheral artery disease
Extrusions & Molded Luers, Handles & Hubs

Our team has extensive experience designing, developing, and manufacturing these components and are dedicated to ensure that all our products meet regulatory requirements. We use advanced engineering and design software to create custom luers, handles, and hubs that are tailored to your specific medical device needs.

  • Single and multi-lumen extrusions
  • Injection molding
  • Overmolding
  • Insert molding
Braiding & Coiling

Braiding and coiling reinforcement techniques are used to optimize the catheter design to achieve the desired behavior and design requirements.

  • Increase kink resistance
  • Improve pushability
  • Improve torqueability
  • Improve flexibility
Tipping & Shaping

To achieve catheter tipping, Nextern uses advanced manufacturing techniques and technology, such as precision molding machines and glass dies that can create tips in a wide range of shapes and sizes.

  • J-Tip
  • Pigtail
  • Loop
  • Curved shapes
Pad Printing

Pad printing involves transferring ink from a silicone pad onto the surface of the component leaving behind a clear, precise, and permanent marking. This is a highly flexible and precise printing method that allows for the application of high-quality, multi-color graphics onto complex and irregularly shaped surfaces.

  • Cost-effective method for adding important information or branding to the medical device
  • Depth of insertion indication
  • Size indication

Manufacturing & Line Transfer

We specialize in niche medical instruments and devices to ensure accuracy and quality every time.

Manufacturability is a crucial aspect of commercially viable design; Nextern begins with this end in mind, making design transfer seamless. We maintain wholly-owned locations globally, which support our focus on tightly-controlled quality systems and supply-chain objectives.

  • Expand capacity
  • Reduce overhead
  • Consolidate suppliers
  • Minimize risk
Finished Devices

Our range of finished devices includes assembly, packaging, sterilization management, and shipping, all aimed at ensuring your device reaches your customers seamlessly.

  • Sterilization validation
  • Bioburden
  • Palletization
  • Packaging validation
    • Peel testing
    • Dye penetration testing
    • Package integrity testing
  • IFU management

Biosimulation Lab & Testing

The services provided in the wet lab are designed to mimic life-like situations that can only truly be captured through hands-on practice in order to facilitate product development, physician training, and regulatory testing.

Procedures we can facilitate include:
  • Cardiac, GI, spine, GYN, laparoscopic, neurology, etc.
  • Anatomical models
  • Beating heart
  • Vascular
  • C-arm
  • Ultrasound devices and counsels
  • Endoscopic towers and scopes
  • Microscopes
  • Insufflation and suction
  • Bovies, cautery
  • All surgical and procedural ancillaries
  • Specialized tools and instruments

Complex Delivery Systems

We specialize in the design, development, and manufacturing of complex, highly specialized catheters, steerable devices, and delivery systems for interventional markets. We’ve worked with partners on steerable balloon catheters, steerable neurovascular devices, and delivery devices for structural heart implants. As your vertically-integrated partner, we have the end-to-end services to guide you through the entire product development lifecycle.

Finished devices & components include:
  • Multi-catheter systems
  • Valve delivery and repair
  • Stent delivery systems
  • Steerable technologies
  • Handle design and assembly
  • Rail/Guide systems
Steerable Shafts & Delivery Systems used by Nextern in medical device production
Steerable Shafts & Delivery Systems

Our cross-functional team and vertically integrated supply chain have expertise to provide comprehensive engineering support and final product solution.

  • Unidirectional, bidirectional and quad‑directional devices
  • Single‑plane (single- or dual-wire), dual‑plane (4‑wire), and dual‑plane (single‑wire) deflection
  • Customizable articulation segments
  • Sub-3 Fr to 40 Fr diameters
Catheter component used in a medical device - Nextern
Balloon Catheters & MicroCatheters

We have expertise in producing microcatheters used in neurovascular, cardiovascular, and peripheral vascular applications. Our goal is to design and manufacture innovative products that provide better patient outcomes and advance the field of medical technology.

  • Variable diameters
  • Laser-cut shafts
  • Coil or braid reinforcement
  • Multiple-durometer shafts
  • Advanced connectors and luers
  • Custom-molded hubs
  • Angioplasty
  • Stenting
  • Treatment of coronary artery disease
  • Treatment of peripheral artery disease
Balloon catheter used by Nextern in medical device production
Extrusions & Molded Luers, Handles & Hubs

Our team has extensive experience designing, developing, and manufacturing these components and are dedicated to ensure that all our products meet regulatory requirements. We use advanced engineering and design software to create custom luers, handles, and hubs that are tailored to your specific medical device needs.

  • Single and multi-lumen extrusions
  • Injection molding
  • Overmolding
  • Insert molding
Coiled and braided shafts used by Nextern in medical device production
Braiding & Coiling

Braiding and coiling reinforcement techniques are used to optimize the catheter design to achieve the desired behavior and design requirements.

  • Increase kink resistance
  • Improve pushability
  • Improve torqueability
  • Improve flexibility
Tip of a tube used by Nextern in medical device production
Tipping & Shaping

To achieve catheter tipping, Nextern uses advanced manufacturing techniques and technology, such as precision molding machines and glass dies that can create tips in a wide range of shapes and sizes.

  • J-Tip
  • Pigtail
  • Loop
  • Curved shapes
Pad Printing

Pad printing involves transferring ink from a silicone pad onto the surface of the component leaving behind a clear, precise, and permanent marking. This is a highly flexible and precise printing method that allows for the application of high-quality, multi-color graphics onto complex and irregularly shaped surfaces.

  • Cost-effective method for adding important information or branding to the medical device
  • Depth of insertion indication
  • Size indication

Manufacturing & Line Transfer

We specialize in niche medical instruments and devices to ensure accuracy and quality every time.

Manufacturability is a crucial aspect of commercially viable design; Nextern begins with this end in mind, making design transfer seamless. We maintain wholly-owned locations globally, which support our focus on tightly-controlled quality systems and supply-chain objectives.

  • Expand capacity
  • Reduce overhead
  • Consolidate suppliers
  • Minimize risk
Medical device manufacturing process taking place in a lab
Finished Devices

Our range of finished devices includes assembly, packaging, sterilization management, and shipping, all aimed at ensuring your device reaches your customers seamlessly.

  • Sterilization validation
  • Bioburden
  • Palletization
  • Packaging validation
    • Peel testing
    • Dye penetration testing
    • Package integrity testing
  • IFU management

Biosimulation Lab & Testing

The services provided in the wet lab are designed to mimic life-like situations that can only truly be captured through hands-on practice in order to facilitate product development, physician training, and regulatory testing.

Nextern employees working in the Biosimulation lab
Procedures we can facilitate include:
  • Cardiac, GI, spine, GYN, laparoscopic, neurology, etc.
  • Anatomical models
  • Beating heart
  • Vascular
  • C-arm
  • Ultrasound devices and counsels
  • Endoscopic towers and scopes
  • Microscopes
  • Insufflation and suction
  • Bovies, cautery
  • All surgical and procedural ancillaries
  • Specialized tools and instruments

Advance Your Project

Begin a partnership with Nextern and gain experience and specialty capabilities for your medical device project.

Contact Us

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