A Post-market Decision-Making Framework for Medical Devices in Hospital Settings: the THE Mini-HTA Tool

Hospital adoption of medical devices requires structured governance mechanisms capable of integrating clinical, economic, organizational, and patient-centered dimensions. However, hospital-based health technology assessment processes remain heterogeneous and often lack standardized yet adaptable frameworks.

We present the THE Mini-HTA ('THE' is the acronym for the Tuscany Health Ecosystem research project within the PNRR-Piano Nazionale di Ripresa e Resilienza (National Recovery and Resilience Plan)-as part of which the tool was developed), a hospital-oriented decision-support tool for post-market medical device evaluation. The framework combines a standardized set of ten dimensions and 39 criteria, derived from the EUnetHTA^® Core Model and expanded to include new criteria, with a structured governance architecture that differentiates process coordination from domain-specific expert evaluation. The decision model is based on PROMETHEE, a non-compensatory multi-criteria decision analysis approach, aimed at preventing inappropriate compensation between critical criteria. An automated platform supports the full evaluation workflow, generating individual and collective rankings and enabling sensitivity analyses. The tool was implemented for assessing two implantable cardioverter defibrillators in an Italian tertiary care hospital highly specialized in cardiology and cardiac surgery.

The real-world application provides initial empirical evidence of the tool's operational feasibility in a real decision-making context, involving domain experts with different expertise, a clinically relevant comparative problem, which represent the conditions typically encountered in hospital-based post-market medical device evaluation. The outputs of the tool can support final deliberation and reporting by clarifying where the comparative advantages originated and the magnitude of residual differences between alternatives, while reducing perceptions of a "black-box" decision process.

The THE Mini-HTA provides a scientifically grounded and operationally implementable framework to strengthen hospital-level health technology assessment. Future research should validate the tool across a broader range of medical devices and healthcare settings, and examine its integration into routine health technology assessment workflows.