STRATEGIC MODELS FOR COMMERCIALIZING INNOVATIVE LABORATORY DIAGNOSTIC METHODS

Abstract

This article presents a strategic model for commercializing new laboratory diagnostic methods, using niche methods for assessing mitochondrial function as an example. Based on an analysis of successful cases (Mitome, Jinfiniti, My NAD Test) and regulatory practices (FDA, IVDR), the critically important stages of the transition from a scientific prototype to a marketable product were detailed, namely, clinical validation, intellectual property protection, regulatory registration, and insurance coverage. It was also found that the key factor for market success is not technological superiority, but the comprehensive synchronization of the scientific, legal, and economic components of the project. This model can serve as a practical guide for researchers and entrepreneurs in the field of biomedicine