MediGate: a MedTech product innovation development process from university research to successful commercialization within emerging markets

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Abstract
This study proposes a comprehensive MedTech product innovation development framework tailored for university research commercialization within emerging markets. The MediGate framework, built on the Augmented Stage-Gate model, addresses the unique challenges of MedTech innovation, including regulatory compliance, stakeholder engagement, and market dynamics. The framework integrates critical decision-making criteria for different types of inventions to drive academic research toward commercialization in clinical settings. Through detailed case studies, including innovations like albumin strip test, 3D-printed patient-specific implant, COVID-19 nasal spray, and AI platform for depression detection, and iterative refinement, the framework provides actionable guidelines for navigating the complexities of product development. These guidelines ensure alignment with clinical needs, regulatory requirements, and market strategies. The research highlights the importance of early-stage valuation, reimbursement strategies, legal and IP considerations, and manufacturing and quality management. By offering a structured pathway, this research contributes to the theoretical and practical understanding of MedTech commercialization, aiming to enhance innovation success and healthcare impact in emerging markets.

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