Identifying value opportunities and risks early in health technology innovation: development of the Early Health Value Signals framework

Abstract

Preprint notice: This is the submitted pre-review author version of a manuscript submitted to BMJ Innovations on 22 September 2026. This version predates peer review and has not been revised in response to reviewer comments. The record includes the main manuscript and supplementary material. Abstract Background: Health technologies can fail to reach patients not because they do not work, but because problems of value, adoption, evidence, and access surface only after key development choices have narrowed the options for responding. Early-stage innovators need a proportionate way to confront these questions while the technology and its pathway are still open to change, before formal health technology assessment (HTA), modelling, or market-access work is feasible. Methods: We developed the Early Health Value Signals (Early HVS) framework as an author-led conceptual proposal drawing on established literature and professional experience, refined through an AI-assisted structured multi-perspective challenge in which a large language model critiqued provisional questions from technology-development, clinical, patient, provider, health-economic, market-access, payer, procurement, entrepreneurial, and investor viewpoints. A targeted non-systematic literature search subsequently checked for central omissions and adjacent prior art. No empirical validation, external consensus process, or stakeholder participation was undertaken. Results: The process produced seven diagnostic questions and one action question, interpreted across seven value perspectives (Producer, Policymaker, Provider, Payer, Procurer, Patient, Public). The multi-perspective challenge led predominantly to consolidation rather than expansion of the architecture, explaining why the framework is deliberately small. Historical cases illustrate how the questions map to recognisable downstream value and adoption problems. Conclusions: Early HVS is a deliberately small, expert-facilitated framework for surfacing value and adoption signals while development choices remain open, intended to precede and inform HTA, modelling, evidence planning, and market-access work. Its content, structure, and usefulness require empirical evaluation.