Hydrosurgery
Versajet
Services Provided
Program / Project Management
Risk Management
Systems Engineering
Electrical Product Safety
Client Background:
This client, a UK-based multinational medical device company, required urgent improvements to address an existing product’s reliability.
The product is in routine use in Operating Theaters as a means of removing diseased soft tissue with extreme accuracy and precision, in a manner that is as tissue-sparing as possible. Its design consists of an electronic console, and disposable elements, such as handpieces, that are used within the sterile field.
Client’s Request(s):
The client provided Reliability Testing data and key findings from an internal audit. They requested an analysis, followed by proposals for corrective action.
The client also requested, if possible, our help in engineering improvements to further customer satisfaction, reduce complaints and product failures, and minimize production bottlenecks and waste.
Project Actions:
In addition to the services listed above, our staff reviewed the reliability test data and proposed a revision of the test protocol to conform to best practices. We found cause to repeat reliability testing and proposed and outsourced product testing to a local test house.
Outcome:
The outcomes of this project revealed significant gaps in best practices relating to documenting product reliability and failures. By addressing these gaps and moving towards industry best practices, proper failure testing produced actionable results.
As a result of testing per the new process, we isolated the problems as inherent to the disposable handpieces, rather than the console.
We proposed and implemented design changes to the handpieces. Complaint rates were reduced significantly and the long-standing internal audit was resolved.