Kobe Declaration 2019
For the Continuous Development of Innovative Medical Devices
through Collaboration across Industry, Academia, Government, and the Medical Profession
Preamble
Japan is becoming a super-aging society ahead of the rest of the world, and needs to realize “healthylongevity” with people living in good health and remaining socially active long into old age.
For this purpose, it is indispensable to develop innovative medical devices that are useful for maintaining
and promoting health, and for providing high-quality medical care. However, Japan is behind whencompared to some countries in the globally competitive field of therapeutic medical devices.
In recent years, various attempts have been made in numerous parts of Japan in order to promote thedevelopment of domestic medical devices, such as matching seed technology to unmet clinical needs, andintroducing the US-style medical device development ecosystem. Various problems have also beenidentified, notably in regard to the development climate and the availability of human resources.
Achievements in the field are limited.
On November 8, 2019, stakeholders and leaders of medical device development in the United States andJapan gathered at the “Japan-US 6th Annual Medtech & Healthtech Innovation Forum Kobe” to discussvarious challenges that must be confronted together in medical device development.
This forum DECLARES the outcomes of discussions in Kobe will become the cornerstone of the sustainableadvancement of medical device development in Japan.

1. Discussion Outcomes at “Japan-US 6th Annual Medtech & Healthtech
Innovation Forum Kobe”(1) Response to a Super-Aging Society•••

Establish a unique scheme that enables citizens, including the elderly, to actively participate in productdevelopment and evaluation, and use the scheme as a demonstration model applicable to super-agedsocieties across the world.
Promote preventive medicine, and accelerate the development of services for encouraging seniorcitizens’ social participation and of communication tools based on digital health.
By combining minimally invasive medical devices with imaging technology and AI, endeavor to develop
innovative medical devices that can provide safe and precise treatment with less burden on the elderly.

(2) Establishment of infrastructure to promote the development of innovative medicaldevices focusing on therapeutic devices～Formation of a “Japanese Ecosystem” for developing medical devices based on
industry-academia-government-medical collaboration～••••

Provide medical device developers with clinical sites that are open as spaces for innovation creation in
medical institutions.
Build recognition across industry, academia, government and the medical profession that a diverse
team of experts from different fields is important in initial medical device development, which requires
high creativity.
Develop human resources who are well-versed in the medical device development process and capableof overseeing projects and leading the team.
Through collaboration across industry, academia, government and the medical profession, create anenvironment where trained human resources can immerse themselves in the development of innovative
medical devices.

2. Looking ahead to the next 20 years～New challenges for Kobe Biomedical Innovation Cluster～
The Kobe Biomedical Innovation Cluster reached a milestone of 20 years in October 2018, and it has grown
to become one of the leading biomedical clusters in Japan, bringing together industry, academia, and themedical profession.
Kobe Biomedical Innovation Cluster – The Next 20 Years:••

With this forum as a new start, we will continue the discussion between industry, academia, government
and the medical profession so that Kobe can become a leading model area for innovative medical device
development based on industry-academia-government-medical cooperation.
Together, we will strive continuously to create innovative medical devices that contribute to therealization of a “healthy longevity society” by respecting the efforts and the will of all parties involved in
medical device development, and by working together to build partnerships in cities and regions inJapan and overseas, in a spirit of productive competition.

November 8th, 2019
Kobe City
Foundation for Biomedical Innovation at Kobe
Kobe University
US-Japan Medtech Frontiers

About「Kobe Declaration」
Kobe City, Foundation for Biomedical Research and Innovation at Kobe (FBRI), Kobe University
and US-Japan Medtech Frontiers (USJMF) co-hosted “6th Annual Medtech & Healthtech
Innovation Forum” , which was held on November 8th, 2019. This forum aimed to support thepromotion of medical device development through the lectures and panel discussions by leading
experts both from US and Japan. In the forum, various topics in relate to medical device
development ecosystem in Japan were discussed, and we have concluded with “KobeDeclaration” by expressing our determination to continuously promote the innovative medicaldevices development for many years to come.