Date of Publication :5th November 2025

Abstract: TThis paper presents a novel approach to the design and development of medical devices through the Adaptive User-Driven Innovation (AUDI) methodology, specifically framed to meet India’s unique healthcare demands and industry landscape. The AUDI methodology, combining elements of Design Thinking, TRIZ, Lean Startup, User-Centered Design, Agile development and Reverse Engineering, creates a hybrid approach that addresses the limitations of conventional design frameworks. It emphasizes user empathy, iterative innovation, and regulatory alignment, making it suitable for the multidisciplinary and compliance-heavy field of medical device design. The proposed methodology’s structured approach enhances affordability, adaptability, and usability for underserved rural healthcare sectors while supporting the growing medical tourism industry. With a focus on rapid prototyping, rigorous validation, and market fit, the AUDI framework supports ethical standards and data security, ensuring safe and effective devices. This research aims to establish AUDI as a model for scalable, high-quality medical device innovation in India, aligning with government initiatives and fostering a self- reliant industry capable of meeting both domestic needs and global market demands.

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