Advancing a Framework for the Adoption of Outbound Open Innovation Practices

Healthcare provision faces mounting pressures, including constrained public finances, workforce shortages, emergent diseases, climate change, as well as digital and geopolitical disruptions. The COVID-19 pandemic prompted a reduction in healthcare expenditure, underscoring the urgency of building resilience through integrated strategies that bolster research, knowledge transfer and technological capacity, to meet 2030 health objectives. Early-stage medical technology (MedTech) innovation is essential for widening patient access and requires novel organizational capabilities alongside sustained leadership commitment. This thesis presents a cross-country study of MedTech innovation in small and medium-sized enterprises (SMEs) in Germany, the United Kingdom and Ireland. Germany, due to its patent output, and its research and development (R&D) investment, which exceeds European Union targets, is used as a benchmark. Underpinned by the resource-based view and dynamic capabilities theories, the study examines how MedTech SMEs leverage internal assets to transfer knowledge via outbound modes of open innovation. In addition, the barriers to commercializing new technologies and forming collaborative partnerships are explored. The knowledge, skills and organizational capacities SMEs must develop to strengthen their ability to address challenges are identified. Guided by Braun and Clarke’s six-phase thematic analysis, the research draws on semi-structured interviews with senior managers, R&D leads and regulatory experts in each market as well as specialist investor. Six core themes developed relating to: 1) industry structure; 2) markets; 3) finance; 4) collaboration for new product development; 5) distribution; and 6) skills. Respondents consistently reported heavy regulatory burdens and delayed market approvals as major issues resulting in increased development costs. While the United States market attracts many European firms due to its scale and level of healthcare spending, domestic European markets posed challenges for SMEs surrounding regulatory heterogeneity, BREXIT-related barriers, and economic uncertainty. Financial constraints loomed large as SMEs navigated volatile valuations, concerns over equity dilution, and limited awareness of government support mechanisms. The thesis concludes that policy reforms to streamline regulation, enhanced funding opportunities and targeted training, especially in medical device regulations, could significantly improve SME survival rates and increase competitiveness. These reforms could be expected to yield improved health and economic outcomes, while promoting more equitable and improved access for all.