Design of Experiments

Use of Exponential and Binomial distributions for assessing risks of failure and confidence levels under various scenarios (sample size and observed number of failures)

Client: TERUMO Cardiovascular Systems Corporation


Terumo Cardiovascular Group (Terumo CV Group) is a growing subsidiary of Terumo Corporation, a multi-billion dollar global medical products company based in Japan. Terumo CV Group manufactures, distributes, and markets life sustaining medical devices. These devices need to be rigorously tested and results support the computation of probability of failures using statistical techniques.


The overall objective of the project was to conduct design of experiments to assess the risks of failure of medical units and confidence levels under various scenarios.


A report provided a brief review of the definition and characteristics of the Exponential and Binomial probability distributions, as well as the performance of statistical tests of hypothesis and the computation of the associated risks of errors. Numerical examples illustrated these concepts and demonstrated how the tables of results included in attached Excel spreadsheets should be interpreted.