The medical gas infrastructure in Colombia faces a silent crisis of regulatory and operational obsolescence that compromises patient safety and healthcare system efficiency. This article presents the results of comprehensive qualitative research integrating comparative regulatory analysis, interviews with high-level trade association actors, and the operational reality of Healthcare Provider Institutions in Antioquia. The study reveals a systemic disconnection between pharmaceutical regulation of oxygen monitored by INVIMA and infrastructure network regulation monitored by Health Secretariats, exacerbated by the validity of Colombian Technical Standard NTC 5318 from 2004, misaligned with modern international standards such as ISO 7396-1:2019 and NFPA 99:2024. The COVID-19 pandemic evidenced critical vulnerabilities in hospital oxygen supply systems, with demand increases of 74% that exposed the fragility of logistical models based on high-pressure cylinders. The findings validate the relevance of the process innovation proposed by BIOXIGEN S.A.S., based on supply centralization through cryogenic tanks and implementation of IoT telemetry, not only as a logistical improvement but as a clinical safety imperative given the evidenced vulnerability. The research demonstrates that regulatory obsolescence acts as a financial disincentive for safety investment, creating a “deregulation trap” that perpetuates risk systems. It is concluded that technological innovation from the private sector must lead the modernization of standards in the absence of state regulatory updates, transforming the supply model from “product sales” to “availability guarantee” through intelligent remote monitoring systems..
Keywords: medical gases, medicinal oxygen, IoT telemetry, cryogenic systems, hospital infrastructure, health regulation, ISO 7396, NFPA 99, patient safety, process innovation
How to cite this article: Marín Duque DM, Restrepo Gaviria LD, García Arango DA, Montoya Escobar CM, Echeverri Gutierrez MS., Structural Gaps and Regulatory Challenges in Medical Gas Supply Systems in Colombia: A Comprehensive Analysis for the Validation of Process Innovation at BIOXIGEN S.A.S...Int J Drug Deliv Technol. 2026;16(1s): 449-461; DOI: 10.25258/ijddt.16. 449-461