Navigating Legal and Financial Barriers : A multiple-case study of MedTech SMEs Entering the English Market

Sammanfattning

AbstractTitle: Navigating Legal and Financial Barriers - A multiple-case study of MedTech SMEs Entering the English MarketResearch question: How do MedTech SMEs overcome entry barriers when entering the English MedTech market?Purpose: The aim of this study is to develop a theoretically grounded market analysis to identify specific risks and entry barriers for small- and medium-sized enterprises (SMEs) in the medical technology (MedTech) sector entering the English healthcare market, and how the SMEs overcome these barriers. The research provides a comprehensive perspective on the institutional environment to offer strategic managerial implications for navigating these obstacles.Method: An explanatory, qualitative multiple-case study was undertaken using a deductive approach. Primary data was collected through semi-structured interviews with representatives from three case companies (MedTech SMEs that recently entered the English market) and two market experts with experience in regulatory and financial strategies. This was complemented by secondary data from official governmental websites.Conclusions: Although theoretically a "liberal market," England presents significant bureaucratic hurdles for MedTech SMEs. Key obstacles include "regulatory heavy" MHRA/MDR approvals and financial constraints driven by high trial costs and the NHS’s near-monopsonistic bargaining power. Success depends on "strategic pivoting"—adopting research or academic trajectories to gain legitimacy and achieve "insidership" within the market’s complex business networks.