Identifying and Prioritizing Key Challenges in Launching Startups in the Health Sector in Iran

Background: The health sector (HS) has emerged as a pivotal arena for startups, propelled by technological innovation and the increasing demand for transformative healthcare solutions. Despite this, startups in this sector face unique challenges that hinder their growth and sustainability. A systematic understanding of these barriers is crucial to fostering a supportive ecosystem and enhancing their contribution to healthcare advancement. Objectives: The present study aims to identify and rank the principal challenges encountered by founders when launching HS startups, providing actionable recommendations for entrepreneurs, policymakers, and stakeholders. Methods: A sequential-exploratory mixed-methods design was employed. Qualitative data were gathered through semi-structured interviews with 14 founders of successful health startups in Kermanshah province, selected via purposive sampling. Thematic analysis was conducted following Graneheim and Lundman’s (2004) framework. Quantitative validation involved a researcher-developed questionnaire administered to the same cohort, with data analyzed using the Friedman test to prioritize challenges by significance. Results: The analysis identified 68 critical challenges, prioritized using the Friedman test, and categorized into 15 key factors: (1) Regulatory and licensing hurdles, (2) economic and financial constraints, (3) gaps in knowledge and technology infrastructure, (4) organizational and team dynamics, (5) market and marketing strategy deficiencies, (6) underdeveloped entrepreneurial ecosystems, (7) technological and communication barriers, (8) social and ethical concerns, (9) healthcare system complexities, (10) inadequate training and empowerment, (11) technical limitations, (12) international market entry challenges, (13) inefficiencies in research and innovation systems, (14) knowledge transfer obstacles, and (15) cultural barriers. Conclusions: This study presents a prioritized framework to assist founders in proactively navigating challenges, devising risk mitigation strategies, and leveraging opportunities. For policymakers, the findings highlight the urgency of regulatory reforms, simplified licensing, and ecosystem development to foster innovation. Addressing these barriers can enhance the viability of health startups, driving sustainable advancements in healthcare delivery. The outcomes serve as a strategic guide for stakeholders to align efforts, optimize resource allocation, and strengthen the HS startup ecosystem, ultimately improving healthcare outcomes through scalable, technology-driven solutions.