Challenge:

Design, test and commercialize three buffer solution containers that integrate with a new hemoglobin A1c blood analyzer for a medical device client.  The instrument is used for diabetes diagnoses and maintenance.  The containers are bag-in-box (BIB) pressure vessels that plug into the test equipment interface ports.

 

Work Performed:

• Conceptualized buffer container design and how they would work with a new automated high output Hb A1c blood testing instrument

• Specified the optimal molding process for the container outer shells

• Redesigned the closure method used for the container that greatly reduced the final cost of the assembled containers.

• Developed the assembly process for the BIB/pressure vessel units

• Worked with the container manufacturer to create custom test equipment

• Completed and documented all required FDA testing for the highly regulated containers.

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Results:

Quick approval by the FDA and successful launch of new diagnostic instrument.