Division of Medical Device Research Program on Practical Application of Health Technology for Developing and Emerging Countries

Outline

Key Fields Medical Device Development(1st)
R&D phase Basic Study, Applied Study, Nonclinical Study/Pre-clinical Study, Clinical Study, Clinical Trials, None
Contact
E-mail: shinko-kiki”AT”amed.go.jp(Replace"AT"with @.)

Overview

Developing countries are faced with a set of public health issues that differ from those of Japan, which means their needs for medical devices may also be specific to them. To develop products that cater to their needs and price standards, the program supports pre-market-launch R&D at actual clinical settings in developing countries, including identification of needs and concept formulation through the design approach.

FY2018 budget

310 million yen

Program Outline

The program promotes R&D of medical devices in full consideration of needs in developing and emerging countries, especially Thailand, Indonesia, Vietnam and Malaysia. Assistance is offered by support providers versed in design approach.

Initial Stage of Development

In the first program year, the design approach including biodesign is adopted. Researchers will immerse themselves in local medical institutions in developing and emerging countries to observe and identify their needs, translate the needs into specific product design needs, list them in order of priority, formulate concrete product concepts, and create prototypes based on the concepts. In the process, business feasibility assessments are performed in preparation for product launch.

Later Stage of Development

In the second and third program years, strategies are formulated to prepare for early regulatory approval and commercialization and R&D is conducted for all stages from prototype creation to regulatory approval. The program seeks to thereby contribute to solving public health problems in developing and emerging countries as well as to globalizing Japanese medical care.

Program Management Framework

Program Supervisors (PSs) and Program Officers (POs) are assigned to manage the program.

PS, PO

PS and PO
Name Seigo Kitano
Affiliation MD, Ph.D.
President, Oita University

Target 

Private corporations looking to advance into the global market by developing technologies tailored to developing and emerging countries. (Eligible applicant bodies are R&D units/divisions, research institutes or other organizations of private corporations.)

Project size

10 to 30 million yen per year including indirect expenses of 30%.

Research period

Maximum of three years.

Last updated 06/21/19