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Short abstract

This paper presents a three-tier PPIE framework — Involvement, Engagement, and Consultation — for Phase-0 medical device research, reconceptualising participation as a mosaic of knowledge exchange rather than power transfer.

Long abstract

Phase-0 clinical studies occupy a distinctive and underexplored position in the translational research landscape. Operating at the interface of engineering feasibility, experimental medicine, and regulatory science, they involve value-laden decisions about acceptable risk and the quality of early evidence rarely subjected to public scrutiny. Patient and Public Involvement and Engagement (PPIE) has become central to health research governance, yet its application to medical device development and early-phase trials remains limited and theoretically underdeveloped.

This paper presents the PPIE strategy developed for MicroTex, a programme engineering medical devices to advance Phase-0 trials for infection and inflammation therapies. Drawing on Tritter's (2009) critique of power-transfer models and departing from hierarchical frameworks such as Arnstein's Ladder, we propose a three-tier participatory architecture in which distinct epistemic relationships between researchers and publics are recognised and operationalised simultaneously. Rather than treating participation as a scalar variable of power, we conceptualise it as a mosaic of knowledge exchange, where deliberation, transparency, and breadth of societal voice serve distinct functions in responsible innovation.

We argue that public participation here is not merely procedural but constitutive: it shapes what counts as meaningful evidence, acceptable risk, and legitimate translational progression in a domain where regulatory frameworks are still evolving. The strategy integrates a social justice lens to address structural inequities in representation.

This paper contributes to STS debates on biomedical governance, the epistemics of patient knowledge, and participatory structures that meaningfully inform — rather than merely legitimate — early-stage innovation.