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Long, long ago, just before Congress created the Medical Device Act in the land of Lilliput, the Kendall Company identified an opportunity to manufacture and market a device conceived at Northwestern University for the early detection of cervical cancer. Due to the small size of the device and the inherent presence of tissue contamination, a disposable device was called for.
After two years of repeated and unsuccessful attempts to have the device manufactured by every known needle and device manufacturer in the country, they referred the project back to one of Kendall’s three engineering facilities. The object was to simplify and modify the design, eliminating those features which were believed to be too difficult for current manufacturing technology, then to find or develop a source to manufacture the device. The project was assigned to a design engineer with a reputation for solving the most difficult problems in innovative ways. In addition, he had many years of manufacturi... [Details] |