A Medical Device Design Transfer (MDDT) is a process of transferring medical device design information from Research and Development (R&D) to Production, for the purpose of producing the medical device. It is worth noting that if the MDDT process takes place prematurely (without doing design verification, design validation, and process validation), it poses a severe risk to start-up medical device organisation. Ultimately, a poorly executed MDDT process can result in quality challenges with manufacturability, repeatability, and consistency during large-scale production of the medical devices. Therefore, this study, conducted at a selected South African organisation, Organisation X, aimed to investigate how the MDDT process can be optimised. The research adopted a qualitative approach. Data was collected using semi-structured interviews. The target population included three key participants, namely, the lead design engineer, the lead manufacturing engineer, and the production manager, who are employees of Organisation X. The interview transcripts were analysed using thematic analysis. A pilot study was used to ensure the validity of this research instrument, and therefore the reliability of the research results.  The study’s findings revealed that effective MDDT depends on well-structured documentation, availability of skilled resources, effective training and knowledge transfer, clearly defined roles and responsibilities, and cross-functional collaboration. The study identified five potential risks associated with the MDDT process. Consequently, the findings identify four critical steps that should be incorporated into the optimised MDDT procedure. Ultimately, the study emphasises the significance of documenting and transferring tribal knowledge.

Keywords

Medical device design transfer, quality management system, design and development, design control