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
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