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Medical Device case studies - UK manufacturing - UK moulders

Complete Manufacturing Project Management

The Challenge:


GEKO is a uniquely small, portable medical device used in hospital for Deep Vein Thrombosis Prevention.

To take their product to market, the company needed to find a manufacturer, operating under ISO 13485, able to translate the concept idea of this device into working manufacturing processes.

 

 

 

 

 

 

 

The Solution:

Key capabilities: Injection mould critical product components within a cleanroom environment.

Complex assembly: The GEKO device is assembled from four main sub-assembly components including one electrical board and two adhesive surfaces. Europlaz was asked, as a leading complete service medical contract manufacturer, to take the class II medical device from concept design to clinical batch manufacture.

The GEKO is a disposable item which means production volumes are naturally high and manufacturing speeds need to keep up. The cleanroom design and environment at Europlaz match this requirement perfectly to ensure efficient working practices can be used throughout assembly. Europlaz suggested cost effective solutions for all aspects of production including a process of over-moulding which cut out timely assembly processes.

Europlaz cost effectively deliver:

  • Sturdy plastic housing around the electronic component
  • An optimized adhesive layer
  • Over-moulding
  • One touch on/off button
  • Class 7 cleanroom moulding, assembly and ultra sonic welding

 

Europlaz is currently developing a process of automation to manage an anticipated increase in demand.