Governance And Technological Change: The Effects Of Regulation In Medical Devices

Regulatory frameworks are a key institutional instrument for governance of change in socio-technical systems. One of the main problems in the extant literature
on the role of regulation in innovation systems is that it assumes a static framework, often overlooking the dynamic relationship between innovation and regulation. In this chapter we show the dynamic interaction between US regulation in medical devices and the technological evolution of a surgical implant, the hip prosthesis, first introduced in the market in the early 1970s’. We suggest that the burdensome regulatory requirements imposed on the deployment of radical innovations in medical devices have led to the exhaustion of the search path for safe incremental innovations: as hip prosthesis have entered the mature stages of their technological evolutions, incremental improvements have become riskier and have ultimately failed.