Mapping policy instruments and challenges in health innovation development: implications for the role of early HTA - an umbrella review

Health innovation encounters challenges across the innovation lifecycle. Although various policy instruments aim to support innovation, their alignment with stage-specific challenges remains unclear. This study synthesizes evidence to examine how innovation challenges and policy responses are distributed across the health innovation lifecycle, with particular attention to the role of early Health Technology Assessment (early HTA).

We conducted an umbrella review of review-level studies that examined health innovation challenges and related policy instruments. A comprehensive literature search was performed across five databases, including PubMed, Web of Science, Embase, Scopus, and CINAHL. Twenty-four eligible studies were included and synthesized using a well-established analytical framework. Innovation challenges and policy instruments were mapped across stages of the development pathway and linked to the contributions of early HTA.