Key Performance Indicators at manufacturing workflow in specific medical devices:A Systematic Literature Review

Abstract

In the health sector, specifically by facture treatment, it is fundamental to understand clinical and technical requirements to provide a specific solution for patients and surgeons, mainly on complex procedures. But the human resource is dynamic in both, industrial an academical sectors. Usually, the knowledge has been constructed on iterative processes trough multidisciplinary approach that involve surgeons and designers. But often, collaboration work is conducted without conscious about metrics which could provide historical performance. This is essential to provide feedback in the process, to propose improvements, and also to enhance traceability and learning skills. In our context, it is crucial because of the need to provide affordable solutions by using scare resources. To start the design of a suitable strategy which faces those aims, first, we conducted a systematic review related to reported cases. We focusing on works were technological resources and multidisciplinary collaboration was essential for specific device development. A bibliometric study was conducted with 421 documents from PubMed and Web of Science. Then, 51 documents were selected to be exhaustively review, in order to understand patterns about performance. Finally, 5 documents were identified by snowball specifically related to Key Performance Indicators on different sectors where PLM strategy was applied, summarizing 169 KPIs. As a conclusion, the authors recommended implementing 8 KPIs in medical device development.