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Six Sigma for Medical Device Design by Jose Justiniano and Venky Gopalaswamy_7

Tham khảo tài liệu 'six sigma for medical device design by jose justiniano and venky gopalaswamy_7', kinh doanh - tiếp thị, quản trị kinh doanh phục vụ nhu cầu học tập, nghiên cứu và làm việc hiệu quả | 72 Six Sigma for Medical Device Design the second data set had been generated using an automatic one. Obviously the problem was the test method at hand. However the firm decided that they could not switch to the automatic technique because regulatory and quality said that switching over could imply problems with the product already in the distribution channels. Insufficient funding e.g. small companies may not have all that is needed to present sufficient objective evidence or just enough for adequate assessment of the VOC besides a PMA submission will cost more than 200 000 U.S. in 2004 . Reliability engineering in the medical device industry that we know today began in the late 1960s. This is 30 to 40 years late when compared with other industries. One important fact about reliability engineering is that the basic mathematical methodologies such as parallel and systems reliability prediction are easy and straightforward to understand by those who know probability and statistics. What is always a mystery is that specific applications that a company may choose to arrive at the estimation of mean life and failure modes. In fact the reliability methodologies including life testing can be as valuable to a company as its intellectual property. A way to overcome this shortcoming is investing long hours and many resources to do modeling and analysis. This is typical of aerospace and semi-conductor industries i.e. high-technology firms . If we think of the number of recalls in the medical device industry see later in Chapter 6 and think of an equal number of recalls of commercial airplanes we would not dare to fly Table 4.1 depicts a good relationship between aerospace and medical device reliability. Sometimes the best medical device solutions might imply a need to wait until the design of the next generation for a product line. However what if survival depends on positive cash flow for the short term In the United States historically whoever comes to the market first .