Presentation Title:

Overview and 
     Purpose:

This presentation describes how distribution analysis methods have been used to solve a wide variety of problems that are different from the classical life data problems generally associated with these techniques. Distribution analysis methods were taught to a group of engineers and scientists engaged in developing advanced technologies for implantable cardiac leads. During the following year, the engineers and scientists used these methods to evaluate the cyclic bending stress of implanted leads, the fatigue performance of lead terminals, the time required to conduct a fatigue test, the time required to perform a certain medical procedure and the electrical performance of stimulating electrodes in vitro and in vivo.

Through these experiences, the group developed a deeper appreciation of the nature of variability and the importance of understanding and evaluating variability throughout the technology development process. This bias for statistical thinking that has had profound and beneficial effects on the department and the company. The presentation also addresses the role of the manager and the leadership and organization aspects necessary to ensure the successful implementation of the program.  

Author/ Presenter:

Keywords:

Distribution Analysis, Medical Device, Advanced Technology, Fatigue, Test Planning, Management Role, Business Objectives, Organizational Effectiveness, Professional Development