New approaches to learning and regulation in medical devices and diagnostics: insights from Indian cancer care

ABSTRACT This paper offers a first step to analysing sub-sector variation in firms’ learning and the types of leads or lag in industrial regulation in the Indian health industry, one of the world’s largest and broadest suppliers in critical generics, vaccines, and diagnostics. Sub-sector variation in an industry’s learning and regulation trajectory has received relatively little attention in economic development literature and has potentially important consequences for the design of the industrial policy. Our argument rests on the transfer of complexity of learning in a sub-sector to generic industrial regulations. The paper appeals to evolutionary and institutional (E-I) approaches in economics, which have made significant contributions in improving the understanding of how firms learn, and applies a qualitative heuristic focused on co-evolving institutional domains to extract some insights from the dynamics of the diagnostics and devices sector. The paper finds that although firms continue to learn and innovate, persistent regulatory challenges to firms are generated by the misapplication of industrial policies to diagnostics and devices that were intended for pharmaceuticals and vaccines. Our findings suggest sub-sector specific changes are needed on value priorities for policy design, use, and regulation of diagnostics and devices in healthcare.