An Ontology for the Adoption of Medical Devices in Health Care Organizations: Design and Development Study.

Authors

Sara Vannelli, Daniele Spoladore, Filippo Visintin

Published in

Journal of medical Internet research. Volume 28. Pages e88366. Jul 10, 2026. Epub Jul 10, 2026.

Abstract

The health care industry is witnessing a rapid proliferation of medical devices. Health care organizations need effective tools to identify devices that best align with their needs, and ensure seamless integration into clinical processes. Existing conceptualizations of expert knowledge remain fragmented, and no comprehensive decision support systems exist to assist stakeholders in evaluating and introducing new medical devices. Ontology-based approaches offer a promising avenue to formalize such complex, multidisciplinary knowledge.
This study aims to develop and validate an ontology designed as the backbone of a decision support system to facilitate the informed adoption of medical devices in health care organizations.
The ontology was developed using a 5-phase methodology: (1) Elicitation of knowledge through a systematic literature review, a review of existing conceptualizations, and expert interviews; (2) Conceptualization of a preliminary conceptual map; (3) Co-design of a refined map through focus groups with experts; (4) Development of the ontology using the Protégé ontology editor; and (5) Validation of the ontology through interviews with experts. Forty experts from 13 companies across 3 European countries participated, ensuring multidisciplinary coverage.
The resulting ontology provides a modular and comprehensive conceptualization of medical devices that balances granularity, conciseness, and practical relevance. It explicitly models key dimensions required for informed adoption decisions, including medical conditions addressed by the device, health services enabled, roles and activities of health care professionals, manufacturer-related information, medical device applications, and structured evidence derived from Health Technology Assessment reports. The ontology's instantiability and practical applicability were validated by populating it with data from 4 Health Technology Assessment reports and by expert assessment, confirming its ability to address stakeholders' core decision-making needs.
This study presents a validated ontology to support the informed adoption of medical devices in health care organizations. It addresses a literature gap by providing a comprehensive, structured conceptualization of medical devices that meets stakeholders' key information needs. By formalizing complex expert knowledge, the ontology lays a foundation for future research and the practical development of decision support systems that enable transparent, effective, and efficient medical device adoption.

PMID:
42430220
Bibliographic data and abstract were imported from PubMed on 11 Jul 2026.

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