Medical device regulations, industrial capabilities, and affordable healthcare technology development : case studies from the United Kingdom and South Africa

Abstract

This thesis concerns the influence of healthcare systems regulation on firm-level capabilities and affordable healthcare technologies. Regulatory change is highly contentious, critics arguing that regulatory changes interfere with the efficiency of the market, and advocates arguing that well designed regulatory changes make markets more efficient and ensure market outcomes are more equitable. To date, very few studies analyze the influence of regulatory change on the medical device industry, and its ability to manufacture and supply affordable healthcare technologies. To respond to this gap, this research employs the Sectoral Systems of Innovation (SSI) approach as a theoretical framework to analyze the influence of regulatory changes on industrial capabilities in medical device industries and affordable healthcare technologies in South Africa and the United Kingdom. A mixed-method approach, focusing on three cases of regulatory change, emphasised documentary analysis and questionnaire-guided interviews to collect primary and secondary data from different sources in the healthcare systems of the two study countries. Regulatory changes facilitated some firms to create new strategies and innovative capabilities. Regulatory changes enabled some firms to develop close collaborative linkages with external providers in search of competitive advantage and improved market positioning. One reactive regulatory change, in particular, illustrated negative influence on innovative capabilities. Smaller firms were at a particular disadvantage in adapting to regulatory change. In the South Africa case, the more stringent regulatory requirements made it hard for domestic suppliers to enter the supply chain and led to joint ventures mainly with multinational corporations. The thesis argues, with empirical evidence, that a more enabling and discriminating regulation that takes into consideration of firms’ technological capabilities can achieve intended goals more efficiently and effectively, than constraining and indiscriminate regulation.