Defining Medical Device Ecosystems: A Systematic Literature Review

Medical devices are used across a wide range of healthcare environments, from inside the human body to home settings, outpatient clinics, and advanced clinical facilities. Although the term medical device ecosystem (MDE) is widely used by stakeholders in healthcare, industry, academia, and government, it remains undefined in the academic literature. This study conducted a systematic review of 162 articles drawn from six major academic databases to determine whether a formal definition exists. No explicit definitions were found in the literature; however, definitions of related ecosystems—such as health informatics, digital platforms, and industrial systems—were identified in ISO standards. These sources informed the development of a working definition of MDEs as complex, interconnected sociotechnical systems that deliver engineered medical devices for clinical use under the oversight of regulatory authorities. In a second line of inquiry, full-text articles were analyzed using text mining techniques, including lemmatization and bigram frequency analysis, to identify recurring thematic patterns. This analysis revealed four dominant themes across the literature: clinical use of devices, their realization through manufacturing, regulatory governance, and a pervasive need for data across all stages of the device lifecycle. Together, these findings underscore the growing relevance of MDEs and demonstrate the value of formalizing the concept to support improved research, system design, and regulatory coordination across the medical device landscape.