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F-50 Gas Vent Filter

Client: Smiths Medical

Objective: Return Smith’s Medical blood gas vent/filter back to market, with minimal impact to previous manufacturing process.

Activities 

  • Detailed failure mode analyses
  • Tolerance analysis
  • Addressed molding-related component and feature failures, and packaging related use errors by redesign, re-engineering, tooling improvements, and UI & packaging changes
  • Improved verification, in-line and end-of- line test methods and data analysis
  • Validated manufacturing and quality processes
  • Rented space, and set up a manufacturing line we would eventually ship to Mexico, fly down, and show the manufacturers how to run

 

The Goddard team was initially retained by Smiths Medical to conduct a detailed failure mode analysis of their F-50 gas vent filter. The product had been removed from the market due to a number of failures occurring in the field. Our root cause analysis segued into a multi-year project to redesign the product, and its packaging, and included seeing the process validating through to conclusion.

Due to its nature and use, it is absolutely necessary that this product is deployed quickly. By conducting a Human Factors Engineering (HFE) study, interviewing users and investigating potential product and packaging hazards, our team identified a number of engineering and design deficiencies. Next we posited our solutions for the deficiencies uncovered, ran trials of those solutions, and eventually delivered an engineered redesign of the F50 disposable kit including its packaging with a validated quality process. The redesigned disposable kit eliminated all in-field failures, and enabled the rapid deployment of the F50 successfully, resulting in the product passing all prior failed tests when resubmitted for clearance.

Results

  • Got product to pass all failed tests when resubmitted to the FDA
  • Product went back into manufacturing, still on the market

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