Towards a Unified Biomedical Engineering Governance Framework for Emerging Technologies in the Nigerian National Health System

Emerging biomedical engineering technologies including AI-driven diagnostics, genomics-guided therapeutics, nanotechnology-based drug delivery, and implantable neurostimulation devices are entering the global healthcare market at an accelerating pace, but the Nigerian national health system lacks a theoretically coherent and practically implementable governance framework for their safe, equitable, and effective adoption. This dissertation develops an original unified biomedical engineering governance framework for emerging technologies in the Nigerian national health system, making contributions to both health governance theory and biomedical engineering policy science. The theoretical framework is built through a multi-stage development process. An analytical review of existing medical technology governance frameworks in six African countries, the UK, USA, and WHO global guidance identifies theoretical gaps in existing frameworks, particularly regarding dynamic technology assessment under uncertainty, equity-responsive access governance, and adaptive regulatory capacity for fast-moving technology classes. A normative governance theory is then developed drawing on regulatory theory, justice theory, and complex adaptive governance literature, specifying the institutional architecture, decision process design, stakeholder participation principles, and regulatory capacity requirements for effective emerging technology governance in the Nigerian federal health system context. Empirical grounding is provided through structured expert consultation with one hundred and twenty stakeholders across six geopolitical zones representing technology developers, regulators, clinicians, patient advocates, and health economists, and through case analysis of governance failures and successes in three technology introductions in Nigeria over the past decade. The unified framework specifies legislation amendments, institutional restructuring, regulatory pathway designs, and capacity building requirements. Original theoretical contributions include the adaptive governance model for technology uncertainty and the equity-responsive access governance theory. Keywords: biomedical engineering governance, emerging technologies, national health system, regulatory framework, Nigeria.