Beyond Technology Readiness Levels: Developing and Evaluating an Industry 5.0 Innovation Readiness Framework for Regulated Life Sciences Manufacturing

Preprint / Submitted Manuscript. This record contains the version of the manuscript originally submitted to the Journal of Pharmaceutical Innovation. The peer-reviewed Version of Record is available at https://doi.org/10.1007/s12247-026-11116-6 Purpose Regulated life sciences manufacturing organisations face increasing pressure to adopt Industry 5.0 (I5.0) innovations while maintaining patient safety, product quality, data integrity, and regulatory compliance. Existing assessment models provide useful perspectives on technical maturity, expectation dynamics, and organisational innovation capability, but do not fully assess whether an innovation is ready to progress responsibly in a regulated, multi-stakeholder environment. Methods This paper develops and preliminarily evaluates an I5.0 Innovation Readiness Framework for regulated life sciences manufacturing. Using design science research structured through the Double Diamond process, the framework was developed through literature review, advisory feedback, workshops, case-based application, surveys, and thematic analysis. Results The framework comprises three linked tools: the Innovation Maturity Assessment, Innovation Maturity Rubric, and Innovation Readiness Levels. Across two workshops involving 16 experienced practitioners, the framework supported clearer discussion of readiness and improved visibility of adoption risks. In Workshop 2, 91% agreed that Innovation Readiness Levels were clearer than Technology Readiness Levels, 82% found the framework useful for comparing innovation timelines, and 75% would recommend it. Conclusion The findings distinguish innovation readiness from technology readiness and indicate the need to assess technical, regulatory, organisational, stakeholder, and societal dimensions together when evaluating I5.0 innovation in regulated manufacturing.