Medical

NAI offers world class connectivity manufacturing solutions for the medical industry including ISO 8 Class 100k cleanroom manufacturing capabilities.  We are ISO 13485 certified in our Hermosillo, Mexico and Suzhou, China facilities and have a world class quality management system specifically tailored to and able to support the rigorous PPAP & IQ/OQ/PQ requirements of the regulated medical device industry.


QUALITY CERTIFICATIONS

 


 

NAI’s Medical capabilities include but are not limited to:

  • High Technology solutions for processing very fine gauge wires for cardiac ablation and other medical catheter applications.
  • Extensive manufacturing experience in integrating PCBAs into advanced medical cable solutions.
  • Ultrasonic welding experience specific to medical cable assemblies.
  • Extensive experience with injection molding, premolding, & overmolding for medical applications including proprietary processes for bonding overmolds to cable jackets to prevent moisture intrusion.
  • Medical connector design and development experience for a wide range of medical applications and devices.
  • Automation experience for high-volume, low-cost disposable medical cable assemblies.
  • Medical grade material selection based upon experience related to sterilization, biocompatibility and bonding.
  • ISO 8 Class 100k cleanroom capability and expertise.

Success Story

Splitting Hairs - The innovative way NAI addressed stripping 40 gauge wire

NAI was approached by a medical customer to assemble several cables designed for use within a new, state-of-the-art cardiac ablation system.  The challenge was that one cable consisted of multiple 40 gage quad cables that required stripping for contact termination on one end and window stripping on each of the four conductors on the opposite end.  Conductors smaller than the size of a human hair.

The NAI Design and Development team worked closely with a laser stripping machine developer to design a process and the necessary equipment. Finding the right laser was a major milestone in the success of this project and the precision required for this process yielded a machine that utilized a highly repeatable translation and rotation system. 

Developing process and equipment for a ±2.5 micron tolerance application stretched our capabilities.  Small details like temperature stability, shielding from electrical interference, cleanliness, and suppression of static charge all became factors in achieving a process capable machine.

The end result was an affordable, high yield assembly using cutting edge technology and processes developed specifically for this unique cardiac ablation application.