Medical Device Innovation and Development Policy Research Unit

Established: Sep. 30, 2009

(*The unit was abolished in June 2016, part of their research continuing under Technology Governance Policy Research Unit)

Photo by AP/AFLO



The Japanese Government has already intitiated several reforms to promote growth in healthcare and in the delivery of the latest drugs and medical devices. For example, the "5-Year Strategy for the Creation of Innovative Pharmaceuticals and Medical Devices" was agreed among Ministries on April 26, 2007. There remains, however, a large gap between agreed goals and how things stand at present. The reforms have yet to translate into national economic growth.

The Research Unit on Medical Device Innovation and Development was established in 2009 to support R & D in the medical device industry, where public expectations are for a rapid growth in the improvement of standards of healthcare and for innovation which would positively impact growth in the national economy. From a broader perspective, the Unit seeks to address alternative solutions for national economic growth and enhanced public welfare with respect to product liability issues, regulations for patient safety, and other systems related to the medical device industry, and to provide policy recommendations.


Over the course of its three-year program, the Unit seeks to address the following issues:

  1. Regulations for Research using Investigational Devices
  2. The Approval Process based on the Classification and Support System for Reviewers
  3. Product Liability, Recall and Component Part Suppliers' Liability (Contractual Schemes for Indemnification, State of the Art Defenses, and Affordability of Liability Insurances, etc.)
  4. Transparency in Fee Schedules (Pricing): Health Technology Assessment (HTA) for Innovation and Sustainable Financing in National Healthcare Insurance
  5. The Patient Centered Approach in the Age of E-Health


Ryozo Hayashi (Visiting Professor, Graduate School of Public Policy)


Norio Higuchi (Professor, Graduate Schools for Law and Politics)
Ichiro Sakuma (Professor, Graduate School of Engineering)
Toshiya Watanabe (Vice Director and Professor, Policy Alternatives Research Institute / Professor, Department of Technology Management for Innovation, Graduate School of Engineering / Executive Director, Executive Vice President, the University of Tokyo)
Chiaki Sato (Project Associate Professor, Graduate School of Public Policy / Associate Professor, Faculty of Law, Aoyama Gakuin University)