This thesis investigates the socio-technical barriers to the diffusion of medical-grade caffeine for neonatal care in Malawi, and proposes a strategic framework for overcoming them. Despite its long-standing inclusion in the World Health Organization Model List of Essential Medicines, caffeine citrate remains absent from Malawi’s Essential Medicines List and unregistered by the Pharmacy and Medicines Regulatory Authority. As a result, the medicine is structurally excluded from national procurement systems, leaving neonatal units dependent on less effective alternatives such as aminophylline. The case is emblematic of a broader paradox in global health: therapies that are well established and endorsed internationally may still fail to diffuse in low-resource settings when institutional and systemic preconditions are missing.

The research applies the Technological Innovation System framework to diagnose the functional weaknesses of Malawi’s neonatal pharmaceutical innovation system. This diagnosis reveals several incomplete or misaligned building blocks: (i) absent innovation-specific institutions (notably Pharmacy and Medicines Regulatory Authority registration and Malawi Essential Medicines List inclusion), (ii) weak network formation between clinical actors and policymakers, (iii) insufficient resource mobilisation for small-volume neonatal medicines, and (iv) limited knowledge diffusion across professional and institutional boundaries. These weaknesses are compounded by broader influencing conditions typical of low-resource health systems, such as donor-driven priorities, budget ceilings, foreign exchange constraints, and sociocultural preferences in neonatal care. Together, these factors explain why caffeine—despite robust global endorsement—has not been adopted in Malawi.

To translate the Technological Innovation System diagnosis into actionable insights, two complementary lenses were added. A pharmaceutical supply chain analysis localised barriers within Malawi’s procurement and distribution architecture, mapping how donors, manufacturers, and domestic institutions interact through the Central Medical Stores Trust, the Christian Health Association of Malawi, and parallel donor-financed channels. This perspective highlighted concrete entry routes for caffeine, such as (i) integration into the Central Medical Stores framework contracts once registered, (ii) donor-financed neonatal commodity lines, and (iii) semi-autonomous Christian Health Association of Malawi procurement. A power–interest analysis then mapped the feasibility of activating these routes, showing that high-power but low-interest actors (Ministry of Health on Malawi, Pharmacy and Medicines Regulatory Authority, Central Medical Stores Trust) act as critical gatekeepers, while international organisations (World Health Organisation, UNICEF, Global Fund, Clinton Health Access Initiative, M´edecins Sans Fronti`eres, IDA Foundation) combine both power and interest to drive change. By contrast, clinicians, Christian Health Association of Malawi facilities, and patient groups are highly interested but lack structural power, underscoring the need for coalition-building and advocacy.

The study concludes that Malawi’s innovation system does not currently provide the conditions required for a classical niche introduction strategy, as outlined by Ortt (2013). Instead, a preparatory stage is needed, where systemic capacity is gradually built to enable future diffusion. Four priority interventions emerge: (1) mobilising clinical champions and professional associations to advocate for inclusion in the Malawi Essential Medicines List and Malawi Standard Treatment Guideline, (2) engaging regulatory and technical authorities—including Pharmacy and Medicines Regulatory Authority and Health Technical Support Services—in targeted reliance-based dialogues to reduce transaction costs of registration, (3) securing donor alignment by positioning caffeine within maternal and newborn health financing envelopes, and (4) exploring pooled or regional procurement arrangements to overcome minimum order quantity and affordability constraints.

Beyond Malawi, this thesis makes three contributions. First, it demonstrates the value of the Technological Innovation System framework for diagnosing pharmaceutical diffusion challenges in low-resource health systems, highlighting how gaps in innovation-specific institutions—rather than product performance—can be decisive bottlenecks. Second, it integrates supply chain and stakeholder analyses into the Technological Innovation System perspective, creating a meta-analytical pathway that links structural diagnosis to operational entry points and political feasibility. Third, it offers a transferable strategic framework that can guide the introduction of other underutilised neonatal medicines in Sub-Saharan Africa.

By combining socio-technical systems analysis with operational and governance perspectives, this thesis shows that the diffusion of caffeine citrate for neonatal care cannot rely on regulatory endorsement alone. It requires coordinated interventions across institutions, supply chains, and actor coalitions. The framework developed here provides both a concrete pathway for introducing caffeine in Malawi and broader insights into strengthening pharmaceutical innovation systems in comparable low-resource contexts.