Minnesota MedTec
Minnesota MedTec specializes in custom medical products and components, focusing on high-quality, regulated standards, and innovative solutions for minimally invasive procedures across various medical specialties. With over 25 years of experience, they offer a wide range of services including extrusion, molding, tube processing, and product assembly, and are ISO 13485:2016 certified and FDA registered. Their mission is to provide reliable, high-performance medical device components and to be a trusted partner in the medical device industry.
Industries
Nr. of Employees
medium (51-250)
Minnesota MedTec
Products
Medical balloons (nylon, polyurethane, silicone)
Inflatable balloons for catheter applications produced with controlled material and process parameters to achieve specified compliance, burst pressure and inflation profiles.
Custom medical tubing (single- and multi-lumen)
Medical-grade tubing options including single-lumen, multi-lumen, multi-layer, multi-durometer and micro-bore variants produced from common medical polymers.
Braided and coil-reinforced shafts and braided tubing
Standalone braided tubing and braided/coil-reinforced shaft components for delivery systems and high-pressure lines with various carrier configurations and materials.
Extruded radiopaque marker bands and extruded marker-filled materials
Extruded marker bands using high-visibility radiopaque fillers (tungsten/blends) and alternative marker band fabrication for x-ray visualization.
Swivel connectors, miniature screws and hubs
Standard and custom connector components including swivel connectors, miniature screws, hubs and laser-welded assemblies sized for catheter interfaces.
Coated mandrels and mandrel tooling
Coated mandrels with lubricious coatings for extrusion, tipping and reflow operations, available in different core materials and coating chemistries to meet temperature and removal requirements.
Medical balloons (nylon, polyurethane, silicone)
Inflatable balloons for catheter applications produced with controlled material and process parameters to achieve specified compliance, burst pressure and inflation profiles.
Custom medical tubing (single- and multi-lumen)
Medical-grade tubing options including single-lumen, multi-lumen, multi-layer, multi-durometer and micro-bore variants produced from common medical polymers.
Braided and coil-reinforced shafts and braided tubing
Standalone braided tubing and braided/coil-reinforced shaft components for delivery systems and high-pressure lines with various carrier configurations and materials.
Extruded radiopaque marker bands and extruded marker-filled materials
Extruded marker bands using high-visibility radiopaque fillers (tungsten/blends) and alternative marker band fabrication for x-ray visualization.
Swivel connectors, miniature screws and hubs
Standard and custom connector components including swivel connectors, miniature screws, hubs and laser-welded assemblies sized for catheter interfaces.
Coated mandrels and mandrel tooling
Coated mandrels with lubricious coatings for extrusion, tipping and reflow operations, available in different core materials and coating chemistries to meet temperature and removal requirements.
Services
Design and manufacture of single- and multi-lumen tubing, micro-bore tubing, multi-layer and multi-durometer tubing using medical-grade polymers.
Injection molding, insert molding and overmolding of medical components and hubs with material and color control for prototyping and production.
Assembly of braided delivery systems, balloon catheters, sheaths, dilators, cables and other catheter-based assemblies with subassembly tooling and process control.
Rapid prototyping services leveraging in-house extrusion, braiding, molding and assembly to produce prototypes and pilot lots, with options to support design control and regulatory documentation.
Cleanroom packaging, validated heat sealing (including nitrogen backfill for Tyvek pouches), and coordination of sterilization and sterilization validation into manufacturing travelers.
Quality system implementation, control plans, test-method development, IQ/OQ/PQ validation execution, calibration and assistance with regulatory evidence for ISO 13485 and FDA registration.
Design and manufacture of single- and multi-lumen tubing, micro-bore tubing, multi-layer and multi-durometer tubing using medical-grade polymers.
Injection molding, insert molding and overmolding of medical components and hubs with material and color control for prototyping and production.
Assembly of braided delivery systems, balloon catheters, sheaths, dilators, cables and other catheter-based assemblies with subassembly tooling and process control.
Rapid prototyping services leveraging in-house extrusion, braiding, molding and assembly to produce prototypes and pilot lots, with options to support design control and regulatory documentation.
Cleanroom packaging, validated heat sealing (including nitrogen backfill for Tyvek pouches), and coordination of sterilization and sterilization validation into manufacturing travelers.
Quality system implementation, control plans, test-method development, IQ/OQ/PQ validation execution, calibration and assistance with regulatory evidence for ISO 13485 and FDA registration.
Expertise Areas
- Contract medical device manufacturing
- Catheter and balloon device manufacturing
- Micro-extrusion and multi-lumen tubing
- Polymer processing and compounding
Key Technologies
- Micro-extrusion
- Multi-lumen extrusion
- Braid and coil reinforcement
- Insert molding and overmolding
News & Updates
An article discussing strategies for protecting intellectual property in the medical device industry.
An article on selecting between stock and custom medical device components.
Minnesota MedTec is ISO 13485:2016 certified, demonstrating compliance with international quality management standards for medical devices.
An article discussing strategies for protecting intellectual property in the medical device industry.
An article on selecting between stock and custom medical device components.
Minnesota MedTec is ISO 13485:2016 certified, demonstrating compliance with international quality management standards for medical devices.