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Case Study 1: Product Litigation Failure Analysis

In 1993, three companies jointly produced a medical device product. One company was a Fortune 100 company. The second company was a thirty year old small device manufacturer. The third company was a start-up manufacturing company. The small manufacturer needed to move to a new facility and contracted with the start-up company to produce product during the move. The large company produced the raw materials for both the start-up and the small manufacturer. The product that was produced during the period when the three companies functioned together was distributed by a fourth Global Sale and Distribution company. This product failed in the Clinical setting causing injury to many people around the world. Litigations ensued both between injured patients and each of the companies and between the three former partners. For nearly four years each of the three companies attempted to determine the root cause of the product failure. None of the three companies were successful.

Medical Development Services, Inc. was contacted by one of the companies on a Sunday morning four weeks prior to the trial date. MDS was requested to undertake a project to determine the cause of the failure. MDS was given only four weeks to accomplish the objective. The MDS project leader knew that very talented personnel had attempted to solve the problem. However, each of these organizations had limitations. In each case the technical personnel's objective was to prove their organization was not at fault. Therefore, studies that might show they were at fault were not done. Additionally, each organization was limited to investigation technology they had onsite. MDS was not limited by either of these constraints. Therefore MDS decided to undertake the project.

To accomplish the project, MDS linked together the very best laboratories in the United States and Canada that had specific technologies. MDS generated a comprehensive, statistically based, investigation protocol that included testing by the special laboratories, quality data acquisition, and testing by the manufacturer. Over the course of two weeks the protocol was executed. MDS then statistically analyzed the protocol data. The root cause was determined to a confidence level of 99.99%. The final report was issued by MDS in slightly less than three weeks from project initiation. The case was settled out of court within three hours of the issuance of the MDS report.

To do this project, MDS personnel made one trip to the customer's facility to initiate the project. MDS personnel made one trip to the customer's facility to manage the testing conducted at the customer's facility and to collect product samples. MDS personnel made one trip to the attorney's facility to deliver the final report. All other activities were accomplished electronically. There were two reasons MDS was able to determine the cause of the failure when the others could not. The first reason was MDS had only one objective. The second reason was MDS could utilize the best suited resources in the world to accomplish the task. The reason that MDS completed the objective in such a short time was that data was moved between facilities electronically. This case study shows the power of Digital Work processes.