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Ever since the emergence of Industry 4.0 as the synonymous term for the fourth industrial revolution, its applications have been widely discussed and used in many business scenarios. This concept is derived from the advantages of internet and technology, and it describes the efficient synchronicity of humans and computers in smart factories. By leveraging big data analysis, machine learning and robotics, the end-to-end supply chain is optimized in many ways. However, these implementations are more challenging in heavily regulated fields, such as medical device manufacturing, as incorporating new technologies into factories is restricted by the regulations in place. Moreover, the production of medical devices requires an elaborate quality analysis process to assure the best possible outcome to the patient. Therefore, this article reflects on the benefits (features) and limitations (obstacles), in addition to the various smart manufacturing trends that could be implemented within the medical device manufacturing field by conducting a systematic literature review of 104 articles sourced from four digital libraries. Out of the 7 main themes and 270 unique applied technologies, 317 features and 117 unique obstacles were identified. Furthermore, the main findings include an overview of ways in which manufacturing could be improved and optimized within a regulated setting, such as medical device manufacturing.

A Systematic Literature Review of Industry 4.0 Technologies within Medical Device Manufacturing