Commercialising smart drug delivery systems: A business model innovation framework for bioscience start-ups

The commercialization of Smart Drug Delivery Systems (SDDS), such as stimuli-responsive nanoparticles, implantable microchips, and AI-integrated biosensors, offers significant potential for advancing personalized medicine. However, emerging bioscience startups face substantial challenges in translating these innovative technologies into market-ready products. This study aims to develop a comprehensive Business Model Innovation Framework to assist SDDS startups in navigating the commercialization process. Through thematic analysis of interviews with five early-stage SDDS startups, the study identifies key barriers, including regulatory uncertainty, high R&D costs, and fragmented value chains, while also uncovering successful strategies employed by startups to overcome these obstacles. The proposed framework integrates market readiness, technology readiness (TRL mapping), business model design, and strategic partnerships, offering a structured approach to align technology with market demands and regulatory requirements. The findings highlight the importance of early regulatory engagement, adaptive business models, and cross-sector partnerships in accelerating commercialization. This framework provides startups with a roadmap to overcome common challenges and successfully bring SDDS technologies to market.