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Overview

From initial design to high-speed/high-volume automated production, Dukane plastic joining experts understand the unique challenges that medical device manufacturers face during each step of the program life-cycle. 
Our experienced medical segment applications and engineering teams provide responsive engineering and application support to efficiently bridge your design, development, regulatory compliance and production requirements. 
Let Dukane's experience and world-class customer support be your competitive advantage as you take your next medical device to market. 

Development & Validation

Choosing the right partner is critical to the long-term success of your medical device plastic joining program. Dukane’s medical application and engineering team will work with you hand-in-hand during ALL phases of the development process to ensure that your program meets stringent FDA & MDR requirements, is efficiently validated, and is set up for high yield and high volume production.

Dukane Development & Validation Services

  • Design and Material Consulting
  • Expedited Prototype Tooling
  • Global Application Engineering and Prototype Welding Labs
  • Small run prototype validation runs*
  • Advanced weld data collection & Management Tools
  • Simple & Intuitive process setup w/Servo Repeatability & Accuracy

FDA/MDR Compliance

The demand to meet stringent regulatory requirements by the Federal Drug Administration (FDA) CFR 21-Part 11 and the European Union’s Medical Device Regulation (MDR) requires every medical device to be traceable in the event of a product failure or recall. Manufacturing process must support validated production quality controls as well as redundant weld data collection and secure weld data transfer to regulatory authorities if required.

Dukane Compliance Features

  • CFR 21-11 Compliant
  • Multi-Level Password Protection (fully customizable & traceable)
  • Optional Bar Code Scanning for weld data traceability
  • LAN networking protocols for redundant (back-up) weld data collection
  • Clean Room Ready Designs

Precise, Accurate and Flexible Welding Solutions

Dukane offers the largest array of plastic joining technologies for medical device manufacturing including Servo-Ultrasonics, Clean Laser, Spin, Infrared, Vibration & Hot Gas processes allowing us to GUIDE our partners into the RIGHT joining solution for their unique assemblies.

Dukane Advanced Welding Solutions for Medical Device Manufacturing:

High-Volume/High-Speed Automated Production

All Dukane processes have been optimized to meet a variety of automation needs and can easily be transferred from a validated lab setting to high speed automated assembly systems.

InfinityTM line of SERVO controlled ultrasonic welding systems - Automation Features:

  • Ergonomics and Mounting - Multiple thruster size options….
  • Product Connectivity - Ethernet IP/ OPC-UA / Industry 4.0 / Fieldbus Connectivity
  • Key- Safety Features
  • Network and data collections options
  • Bar Code Scanning Integration
  • High Speed Servo Actuation

NRG Laser Plastic Welding Line - Automation Features:

  • Modular Design
  • External Machine Controls
  • Air-Cooled Lasers
  • CE, CSA and UL Certifications

 

DUKANE CERTIFIED AUTOMATION PARTNERS

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Dukane Care

CALIBRATION & PM SERVICE

Calibration and Preventative Maintenance are critical for ensuring the quality, consistency and compliance of your welding processes. By regular calibrating your equipment, you can optimize performance, ensure regulatory compliance and improve the efficiency and reliability of your manufacturing process.

DukaneCare Advantages:

  • Global Service & Calibration Offices
  • On-going Application & Product Support

Multi-Year Calibration and PM Service Agreements Learn more about Dukane After Market application and manufacturing Support Services.

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Great Things Are Happening At Dukane

Upcoming Event
MedTech Webinars 2024
Enroll now for our upcoming webinars on plastic welding tailored to meet the requirements of Medical Device Assemblies. Secure your spot today!
Upcoming Event
Jul 18, 24 | 8:30 AM | CST
Laser Plastic Welding Seminar: A Roadmap for Engineers from Design to Production
Laser plastic welding session will covers a range of crucial topics. From providing technical design insights and best practices to discussing material selection, including color requirements and limitations, we delve into every aspect.
Upcoming Event
Nov 03, 24 | 9:00 AM | CST
Pack Expo 2024
Join Us At Pack Expo 2024 - November 3th-6th, 2024
News Release
When it comes to Nonwoven Hygiene, Don’t Get Stuck on Adhesives!
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Insights From Dukane
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Explore Our Products In Action
Everyone Is Talking About Dukane
"The variability in the molded parts prevents you from really being able to use pneumatic welding well because that variability in the parts gives you variability in the weld. With servo welding, you can manage that variability and still get a good weld because you can draw enough energy in to move the plastic to get the weld finished. You can control di..."
MANUFACTURING ENGINEER
NORDSON MEDICAL
"Our R&D department had a Branson Ultrasonics AED 3.0. We were looking for more accuracy and repeatability in our welding processes. Our manufacturing facility in Ireland had experience with Dukane and suggested we should work with the Dukane iQ Servo Welder. The iQ Servo was easily able to achieve the accuracy and repeatability we were looking for and t..."
R&D ENGINEER AT SURGICAL IOL
ALCON LABORATORIES
"A small plastic stem was being damaged during welding and we were unable to optimize the weld settings on our pneumatic sonic welder to alleviate this issue. iQ Servo Ultrasonic Welder with patented Melt-Match® technology eliminated the problem. The data collected during the servo process optimization had a tighter standard deviation and a significantly..."
PROCESS ENGINEER
BARD ACCESS SYSTEMS, INC.
"iQ Servo Welder gave us the accuracy, consistency, and detailed control of the welding process. We were able to achieve an improved weld, and this helped us in achieving our goal of a watertight seal on a Polycarbonate part. The most specific feature we found in the Servo welder that improved our welding process is repeatability and speed control. We go..."
OPERATIONS MANAGER
PRADCO-FISHING
"iQ Servo offers us the versatility that we require to weld a wide range of materials, even high glass content materials. The Melt-Match® feature allows us to use significantly less force and energy to achieve a good weld. The fine positioning control has even allowed us to weld assemblies and trap components to create a seal without damaging the trapp..."
NEW PRODUCT DEVELOPMENT
RL HUDSON
" With iQ Servo and Melt-Match® technology, we have a scientific level of control & repeatability in the welding process which was completely unavailable on pneumatic equipment. The ability to control the melt rate of the plastic using velocity profile & melt detect features absolutely results in the lowest possible failure rates and the highest producti..."
PRESIDENT
TecNiQ
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ONE WORLD ONE DUKANE has been our mantra for global expansion. No matter where you are in the world you will get the same experience working with Team Dukane. To service and support our customers we have manufacturing facilities, tooling centers, and offices located worldwide

The easiest and fastest way to connect with our worldwide technical experts is to fill the CONTACT US form.

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