Failure Analysis Case Study for Medical Device Industry
2 min

Case Study: Failure Analysis for Medical Device Industry

Posted by: TÜV SÜD Expert

Next up on our Failure Analysis blog series, we will explore the applications of Failure Analysis in the Medical Devices industry. Read on as we share a case study from the industry.


Product safety, quality and efficiency are of paramount importance in the medical devices industry. Possibly more so than in other industries, malfunctions or failures in the medical sector can result in tragic casualties. 

It is for this reason that any such incident must be treated with utmost precision to investigate its causes and prevent reoccurrence. 

In this blog, we will look at 2 case studies related to medical devices, where our Failure Analysis team experts use advanced research technology to detect the root causes of failures.


In the first case study, a stainless-steel guide-wire broke during a heart operation. During the failure analysis investigation, it was found that the wire had fractured due to inappropriate material processing. The cause was thus found to lie in its manufacturing procedure, which had failed to stabilise the wire appropriately. 

Resulting from this finding, the hospital would be protected from potential litigation. The manufacturer, on the other hand, would have a basis on which to improve their production line. 

In this case, the manufacturing process was modified, based on our findings, and subsequent issues with the new process was delegated to our FA laboratories for further analysis.


In the second case study, a plastic tube-joint of an external Blood Circulation System separated during a heart operation. Failure Analysis Case Study for Medical Device Industry

Through failure analysis, we determined the root cause to be the poor bonding between the tubes.

Similar to case study 1, the results from this investigation played a crucial role in clarifying the hospital's legal responsibilities and offering valuable information for modifying manufacturing and Quality Assurance (QA) procedures.


Through the failure root cause analysis, our skilled experts provided advice and recommendations to the clients (hospitals) which protected them from potential litigation as the equipment failures have resulted from manufacturing process of the equipments.


Know more about our failure analysis testing services here.


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