Regulation and innovation under Industry 4.0: Case of medical/healthcare robot, HAL by Cyberdyne
Michiko Iizuka & Yoko Ikeda
#2019-038
Innovations using emerging technologies (artificial intelligence,
robotics, the internet of things), are said to improve productivity and
quality of life. On the other hand, the diffusion of such innovation
involves risks and uncertainties regarding safety. Generally, these
risks are managed by government by means of regulation. Yet it
increasingly falls short on governing emerging technology due to
innovations' global connectivity, commercialization and heightened risk
& uncertainty. These pose challenges to firms for commercialization
because emerging innovations often do not come under the existing
product categories nor corresponding regulations. This study answers how
product based on emerging technology commercialize, overcoming existing
regulatory barriers on safety, using firm strategies and role of
standards played, through an examination of the case of Cyberdyne, a
successful medical/healthcare robotics company in Japan. Cyberdyne
developed and commercialized the world's first product using cybernics
in wearable medical/healthcare device. The case illustrates the
increasing complexity of safety regulations and role of standards for
firms to innovate applying emerging technologies. It concludes with an
exploration of policy considerations regarding the regulation in dealing
with emerging technologies under Industry 4.0.
JEL Classification: O33, F23, I18, L15
Keywords: Regulation, standards, Industry 4.0, emerging technology, robotics, institutional arbitration, rulemaking, Japan