Business Innovation Readiness Level (B-IRL): a novel framework for health innovation acceleration
Innovation management; technological maturity; TRIZ; digital health; bioinformatics
The translation of scientific advances into scalable and sustainable technological solutions faces methodological gaps in innovation management, especially in regulated sectors such as bioinformatics and healthcare. Classical maturity assessment models, which focus exclusively on technological development such as the Technology Readiness Level (TRL), are insufficient to navigate the integrated complexity of market, regulatory, and organizational factors. This thesis proposes and validates the Business Innovation Readiness Level (B-IRL), an integrated and adaptive framework for managing technological innovation projects in health. B-IRL is structured on three main methodological pillars: the application of the Theory of Inventive Problem Solving (TRIZ) for the creative structuring of problems and concepts; the operationalization of controlled experimentation cycles through the Trial Process Flow Diagram (Trial PFD); and continuous, multidimensional maturity assessment segmented into Technological (TRL), Product (ProdRL), Process (ProcRL), and Market (MRL) dimensions. The model introduces a logic of risk-adjusted strategic trajectories (Exploratory, Incremental, and Consolidated), allowing project governance to adapt dynamically to its uncertainty profile. Validation was conducted on two fronts: a prospective case study, applying the framework in the development of a digital platform for Autism Spectrum Disorder, and a critical retrospective analysis of an academic project. Results demonstrate that B-IRL supported the startup in its development, progressing from a conceptual idea to a solution validated in a real-world context, ensuring alignment between clinical value and technical feasibility while generating significant resource savings. Conversely, the retrospective analysis highlighted how the lack of an integrated readiness structure led to the early stagnation of a project with scientific merit. It is concluded that B-IRL constitutes a viable theoretical-methodological contribution to the field of healthcare innovation management, increasing the probability of success in translating complex technologies from the laboratory to the market.