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Production test fixtures development for a medical device

Our client asked:

Our client was working with a Contract Manufacturing Organisation (CMO) and asked us to develop bespoke equipment for manufacturing a medical device. The required test fixtures were for use during production for in-line and end-of-line testing. This involved designing new equipment as well as refining legacy equipment.

The project story:

The manufacturing test fixture development needed to run in parallel with the product development to achieve aggressive product launch timelines. We undertook the following activities:

  • Conducted a detailed gap analysis of existing designs and documentation, and presented a report to the client team
  • Wrote and reviewed test equipment engineering requirements, taking account of the evolving device design
  • Designed mechanical and electrical components
  • Created manufacturing drawings and specifications
  • Procured prototype parts
  • Assembled and functionality tested first-off prototypes
  • Refined design and manufacturing drawings and specifications
  • Reviewed designs with the client and CMO, trained CMO in use of test equipment
  • Handed over design and manufacture to client and CMO

Client benefit:

The result was a turn-key production process which required minimal technical know-how for the operator. It provided improved repeatability and reliability of the production process.

The deliverables included:

  • Product requirement specification and product design specification
  • Design database (BoM, CAD, schematics, assembly drawings)
  • Functionally tested units