Integrating Intellectual Property Protection into a Quality Management System in a Healthcare Organisation

This study examines how intellectual property protection and quality management interact inside a modern public hospital, and how the two can be integrated through a single operational framework. Medical technology, especially in neurosurgery and imaging, increasingly arrives bound by patents, software licences, and exclusivity clauses that shape what the hospital can buy, repair, or interconnect. The international literature on intellectual property in healthcare is mostly legal-theoretical or strictly clinical, while the pragmatic perspective of the hospital manager, who has to reconcile clinical imperatives, accreditation standards, and contractual constraints, remains underdeveloped, particularly in the Romanian setting. The research followed a retrospective, observational design over five years, from 2020 to 2025, in a Romanian county emergency hospital. The sample combined 53 public procurement files with 643 patient observation records, drawn from three departments selected for their high exposure to intellectual property issues. Three hypotheses were tested, on the cost-quality relationship of patented technology, the hidden risks of unmanaged intellectual property inside the quality management system, and the role of open innovation in softening monopolistic effects. All three hypotheses received empirical support. The cost-quality relationship proved non-linear, with diminishing clinical returns past a threshold of technological “newness". Unmanaged intellectual property generated hidden costs and operational risks: equipment downtime, vendor lock-in, and accreditation findings tied to non-compliance. Open innovation, value-based negotiation, and shared-intellectual-property partnerships emerged as realistic paths to soften the monopoly without restricting access to modern technology. The paper proposes an integrated intellectual property management cycle inside the quality management system of a public hospital, treating intellectual property as a structural variable on the same level as clinical and financial risk. The framework offers hospital managers and policy-makers a working tool for reconciling innovation, accessibility, and accountability in publicly funded medical institutions.