Simplifying Health Concept Maturity Levels Assessment using the Trognon CML Inventory

The Health Concept Maturity Levels (CML) model provides a structured framework for guiding MedTech projects from inception to market, integrating technological, programmatic, and user-centered dimensions. However, earlier applications revealed overlaps in ethical and regulatory considerations between the “Need” and “Programmatic” factors, signaling a need for refinement. In response, the Trognon CML Inventory was developed to address these limitations and enhance clarity, consistency, and ease of use. The revised model establishes constant criteria for each factor and sub-factor at all nine levels, thereby offering a clear progression and reducing redundancy. A new expert-oriented matrix further streamlines evaluations by providing a concise, criterion-based tool for rapid project appraisal. This inventory aims to foster more robust alignment of ethical, regulatory, and clinical validation requirements with technology development, while supporting Living Lab initiatives that emphasize collaboration among researchers, clinicians, patients, and industry partners. By systematically delineating each dimension of MedTech innovation, the Trognon CML Inventory underscores the multifaceted nature of healthcare solutions and promotes the adoption of transparent, iterative processes. Future validation efforts, including computational methods and canonical approaches such as factor analyses, will help assess the model’s effectiveness in various MedTech contexts, thereby ensuring its continued relevance and adaptability.