Federated Sharing and Continuous Improvement of Medical Device Knowledge Artifacts: A Conceptual Model
Healthcare organisations use digital systems to exchange information from clinical cases. Medical centres with digital production facilities create device designs during care. These designs and production records often remain at the site that made them. Other sites may struggle to find a suitable design or learn what happened when staff used it. Mobile medical centres may also lose access when they work away from hospital systems. This paper proposes an artifact-centred model for a federated exchange infrastructure that lets hospitals and mobile medical centres share and improve medical knowledge while controlling their own records and decisions. An integrative literature review screened 910 records and mapped 240 publications across six questions. We read 72 publications in detail to trace the path from local use to a decision about shared knowledge. The review found no common process that links a record of local use to a decision about changing the knowledge shared with later users. The model keeps case data at each site and records which artifact version informed each use. Federation lets sites share reviewed versions and return records from use for review. Mobile units can receive artifacts before deployment and record their use while offline. After reconnecting, they can exchange these records with other sites. Point-of-care manufacturing shows how a medical device knowledge artifact connects a design to production records while the care site controls product release. Federation could form a governed learning network where one site's experience improves medical knowledge artifacts used elsewhere while authority remains local.