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Case study: Patella Instrument Set 2017-05-19T11:11:42+00:00

Case study: Patella Instrument Set

For an existing patella implant a new instrument set was needed bases on an existing design. We generated such an instrument set within a project using our 5 stage approach. After finishing the project we also delivered a number of sets, CE marked by BAAT.

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Stage 1: Explore

In this case almost all work was already carried out by the customer. We only helped to fully define the instrument set and finalizing the design requirements and technical specifications. Moreover we carried out the risk management aspects of the project.

Stage 2: Design

There was already a design available. However, some minor critical issues needed to be addressed, particularly with respect to the sizes and strength of the insertion pins. These critical parts where manufactured first and verification tests where carried out in house . The design of rest of the set was already considered as completed.

Stage 3: Engineer

Actually the project really started in this stage. Here all instruments where fully engineered  into detail. The manufacturing process was rather straight forward so we paid no special attention to that. The result of this stage is a complete set of manufacturing drawings. One prototype set was manufactured for final review.

Stage 4: Validate

All In this phase we validated the design, using the prototypes as manufactured in the Engineer stage. Validation tests with respect to cleaning an steam sterilization have been performed. moreover a sawbone trials was carried out in cooperation with the surgeon team that was involved in the project. The set was CE marked by BAAT.

Stage 5: Transfer

A first batch of sets were delivered including the technical file of the instrument set. As post market clinical follow up the first surgeries were documented to support the claims as made in the surgical technique.