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

This study proposes a comprehensive MedTech product innovation development framework tailored for university research commercialization within emerging mar‑ kets. 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 diferent types of inventions to drive academic research toward commercialization in clinical settings. Through detailed case studies, includ‑ ing innovations like albumin strip test, 3D-printed patient-specifc implant, COVID19 nasal spray, and AI platform for depression detection, and iterative refnement, the framework provides actionable guidelines for navigating the complexities of prod‑ uct 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 manu‑ facturing and quality management. By ofering a structured pathway, this research con‑ tributes to the theoretical and practical understanding of MedTech commercialization, aiming to enhance innovation success and healthcare impact in emerging markets.