Digitising the Medical Devices Industry

KWSP were approached by an ink manufacturer to design, build and develop a printing cell for a flexible robotic manufacturing line which produces medical devices.


The Challenge

  • Design, build and develop an FDA / GAMP compliant manufacturing cell
  • To run 360 days / year, 23 hours / day
  • redundancy and automated cleaning and print head recovery
  • Line running at 10,000 parts / hour
  • ‘Blank sheet’ to integration in 10 months

The Requirements

  • Seamless integration of the system into the host cell (mechanically, electrically and for automation)
  • Demonstrate compliance with high regulatory standards

The Approach

  • Collaborative engagement with manufacturing line owner
  • Failure modes designed through use of review and control tools (DFMEA, PFMEA)
  • Use of linear motors to improve cleanliness and reduce wear of parts
  • Ongoing compliance verification through use of GAMP tools

The Results

  • Delivered 7 axis cell according to original aggressive timeline
  • Delivered to budget
  • System integrated into host machine well
  • System passed acceptance tests without remedial correction
  • System is compliant with the all applicable regulatory frameworks