In 1908, the first Model T was created and more than 15 million were sold through mid-1927, proving that a focus on core product can create a tidal wave of success. The plan and processes Henry Ford put in place to create the Model T revolutionized the automotive industry.

Having a streamlined set of processes is still important for manufacturing a quality product today. But the Model T not only tells the story of efficiency and mass production; it also depicts the story of quality, proving that they are not mutually exclusive.

The medical device industry is no doubt tough to do business in, what with the constant threat from multiple competitors and the constant scrutiny from the FDA. Noncompliance with the FDA’s 21 CFR Part 820 and Part 11 can result in a number of costly consequences, including audits, recalls, production stoppage, substantial fines, and potential lawsuits.

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