A Health Technology Assessment of the Strokefinder MD100 For Early Detection of Stroke and Traumatic Brain Injury in the Rwandan Healthcare System

Abstract

Stroke and traumatic brain injury (TBI) are leading causes of death and disability in Rwanda. Care is frequently delayed due to limited access to computed tomography (CT) imaging outside major referral hospitals, fragmented referral pathways, and household financial barriers. The StrokeFinder MD100 is a portable, non-ionising microwave-based device that provides a “stroke / no-stroke” output to support early triage in emergency settings. The Health Technology Assessment (HTA) presented in this thesis draws on three sources: (i) a structured review of international clinical studies on the MD100, (ii) semi-structured interviews with Rwandan stakeholders across neurology, emergency medicine, the national ambulance service (SAMU), biomedical engineering, and health policy, and (iii) health-economic modelling aligned with Rwanda’s resource constraints and willingness-to-pay assumptions. Organisational, ethical, and legal implications are analysed using the European Network for Health Technology Assessment (EUnetHTA) Core Model. Evidence from European and Australian cohorts shows high sensitivity (~90–96%) and moderate specificity (~70%) for detecting the presence of stroke, confirming suitability as a triage support tool. Interviewees anticipated benefits particularly in SAMU ambulances and district hospitals, where diagnostic delays are greatest. Economic modelling shows that cost-effectiveness depends on high utilisation: at ~1,000–1,500 scans per device per year, per-patient cost (~USD 13–16) falls within the commonly used cost-effectiveness benchmark of approximately one to three times Rwanda’s Gross Domestic Product (GDP) per capita (≈ USD 970). The primary budget impact is the capital cost (≈ USD 80,000 per device), and sustainability requires reliable maintenance, operator training, and integration into structured triage protocols. Ethical and regulatory findings highlight the need for equitable deployment, clear communication of the device’s triage purpose, and Rwanda Food and Drugs Authority (Rwanda FDA) oversight for clinical validation and post-market monitoring. A phased implementation is recommended, beginning with a local clinical validation study at one of the national referral hospitals—CHUK, King Faisal Hospital, or Rwanda Military Hospital—followed by targeted expansion to SAMU and selected district hospitals. Further research is required to generate local diagnostic performance data and refine cost estimates.