tailieunhanh - Six Sigma for Medical Device Design by Jose Justiniano and Venky Gopalaswamy_6

Tham khảo tài liệu 'six sigma for medical device design by jose justiniano and venky gopalaswamy_6', kinh doanh - tiếp thị, quản trị kinh doanh phục vụ nhu cầu học tập, nghiên cứu và làm việc hiệu quả | 58 Six Sigma for Medical Device Design Table Tips to improve statistical analysis during product development Do s Don ts Consult a subject matter expert before making decisions. Have criteria for success so that decision making is simplified. Use one confidence level usually it is 95 for all analyses for consistency. Blindly accept output from statistical software. Always have an expert interpret the results and get their signature of approval to avoid future problems. Use statistical software without completing some basic software validation activities for your company. Use electronic spreadsheets unless they are verified. of the least used in the design of medical devices. This aspect always baffled us since this tool can help the designers and design engineers understand key aspects of the medical device and its packaging with fewer experiments than what is traditionally done. This also means that less time and money can be spent during design and development which is something management always wants. When DOE is utilized the preferred method of practitioners is classical DOE and not Taguchi approaches. We have found various reasons for this including familiarity with the tool and lack of appreciation or understanding of when the Taguchi approach is applicable. Irrespective of the DOE approach used follow the interventions in Table . Statistical tolerancing Statistical tolerancing of subsystems and subassemblies and components based on overall product design dimensions must be done up-front in medical device design and development to ensure proper medical device form fit and function. Since product performance depends on robust design and robust manufacturing processes all the learning must occur upstream in the design cycle. Process design and development is one area where less attention is paid during design and development. Since product design engineers are focused Table Tips to improve Design of Experiments Do s Don ts Use DOE as early in the