Meeting of Representatives"Project to Develop the Human Resources that will Carry theFuture of Medical Devices"(Abbreviation: Mirapro Project)
ReportDecember 10, 2020

European Business Council (EBC) Medical Devices and IVD Committee
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UnrestrictedProject Overview
Purpose
1. Revitalizing the medical equipment manufacturing and distribution industries and developing
human resources to which to entrust the future
2. Improving the ability to make policy proposals for the future of the medical device industry
3. Constructing a human resource network with industry, government, and healthcare professionals
Period of implementation and past meetings
Period of 2 years (11 meetings scheduled)
1st meeting: Thursday, July 29, 2020
2nd meeting: Saturday, September 19, 2020
3rd meeting: Monday, November 30, 2020
Breakdown of participants in the first period
Industry (14 groups, 29 people), MHLW (10 people), PMDA (9 people), METI (1 person)
Participating organizations: JIRA, JEITA, Nichi-Iko, MT JAPAN, JAHID, Home Health Industry
Association, JDTA, JOIA, JMOIA, JAIMA, JFMDA, JCLA, AMDD, EBC
Participants from the EBC
Ms. Narumi Hayashi, Pharmaceutical Affairs Department, B. Braun AESCULAP, Ltd.
Mr. Tomohiko Matsukawa, Public Policy Department, Philips Japan, Inc.
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Themes (Planned)
Planned themes for each session
For the first half of the period: Fiscal year 2020 (Jul, Sep, Nov, Jan, Mar)To discuss the present situation and the foreseeable future of the medical device industry

1
7/29 (Wed)Committee
in charge

Themes and lecturers

PurposeThe present situation and the foreseeable
future of the medical device industry:
Learning the “change”

To learn from predictions about the future globalposition of Japan and the medical device industry anddiscuss what will be expected of us

Industrial
Policy Office

To learn how medical devices are used in medical
settings; to study the related regulations and actual
conditions in medical settings; to discuss promising
medical devices and what the industry should be like.

PMS
Committee

The lecturer will introduce the technologies that are
currently visible and discuss their impact on industry
associations.

Industrial
Policy Office

Current state and future of health carefinancing and the insurance system

To learn about the current state and future prospectsof health-care financing and the insurance systemfrom the viewpoints of the government and theindustry; and discuss their ideal form.

Materials andDevice
Insurance
Committee

Summary of issues in the medical device
industry

To learn about the stable supply of medical devices,
including current status and issues; and discuss items
that should be addressed as regulations among theimportant issues that have been discussed.

Sales andMaintenanceCommittee(Legislation
Committee)(Lecturer: Mr. Nakano, JAAME)

2
9/19 (Sat)

Efforts to take safety measures in medical
settings and expectations to promote theirdevelopment(Lecturer: Dr. Nagao, Nagoya University Hospital)

3
November

4

Innovative technologies that support
medical devices(Digital, AI, Big Data, etc.)

January

5March– About medical device distribution– Looking back

JFMDAPage 3

Themes (Planned)
Planned themes for each session
For the latter half of Period I: Fiscal year 2021 (May, Jul, Sep, Nov, Jan, Mar)
Discuss regulations necessary for the medical device industry
Theme and lecturer’s image
1 Collection, utilization, and system of clinicalevidence

To discuss how the collection and utilization ofclinical trial and post-marketing data should bestudied in Japan and overseas

Clinical Evaluation
Committee

2 International harmonization of regulations andattempts at internationalization

To learn about the current state of international
harmonization and internationalization ofregulations; and discuss the ideal state

International Policy
and Strategy
Committee

3 The healthcare industry as a whole and thedefinition of medical devices

To discuss the current situation and the ideal
situation for products that straddle the gap between
medical device and non-medical device (healthapps, welfare equipment, etc.), both in Japan andoverseas

Legislation
Committee

4 Ideal form for medical device regulations

To decide upon a framework for considering theresults of issue identification in the first fiscal year,
and to discuss the ideal form for medical device
regulations in Japan while learning about the statusof regulations in each country.

QMS Committee
Legislation
Committee(PMS Committee)

To review and summarize proposals thus far

Legislation
Committee

5– Lessons to learn from medical device regulationsof the past
– About quality assurance for medical devices– Thought on pre-marketing and post-marketing
regulations, etc.

6 Summary of proposals on ideal form for medical
device regulations

Page 4Committee incharge

PurposeJFMDA(Clinical EvaluationCommittee)

Summary of each session
1st Session
Lecturer: Dr. Shohei Nakano, Managing Director of Japan Association for the Advancement of Medical
Equipment
Theme: The present situation and foreseeable future of the medical device industry – Learning from“change” –Content of Group Work
What actions would be needed to realize the following scenarios for 2040?
(1) Scenario of unique regulations for Japan as a single market(2) Scenario in which Japan becomes the leader in low-cost generic drug regulations in Asian andemerging countries as a developed country facing new problems (declining birthrate and aging
population, curbing medical expenses)(3) Co-regulation scenario in which PMDA cooperates with FDA (mutual recognition, etc.)
2nd Session(Lecturer: Dr. Yoshimasa Nagao, Vice Director, Nagoya University Hospital)
Theme: Patient safety issues in medical devices
Content of Group Work
(1) The medical community feels that improvements in the safety of medical devices have been slow.
Why has progress been slow?
(2) What measures are there to reduce medical device incidents without relying solely on warnings?
(3) Create an error classification form (checklist) that would be helpful in the development of safe
medical devices.
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Summary of each session
3rd Session
Lecturer: Dr. Takashi Suzuki, Medical Device Strategy Institute, Japan Association for the Advancementof Medical Equipment
Theme: Artificial Intelligence in Medical Devices
Content of Group Work
(1) Think of one medical device that uses AI.
(2) Discuss the following points of the "post-marketing performance change" of the medical device.
• Name all of the stakeholders• Who is responsible for post-marketing performance changes?
• What advantages or disadvantages does post-marketing performance change bring, and forwhom?

For a report on the 2nd session and lecturers’ overall evaluations of the 1st and 2nd sessions, see IKIREN
Journal No. 111 (AUTUMN).
http://www.jfmda.gr.jp/ikiren_news/Page 6

Thoughts on the work thus far
Narumi Hayashi, Pharmaceutical Affairs Department, B. Braun AESCULAP, Ltd.
All of the participants were highly motivated, and we had very meaningful discussions each time. Ingroup work we must get results within a short period of time, but it was a great learning experience
because the diverse expertise of the participants made it possible to discuss things that I could neverhave discovered by myself.
Since I had no previous active participation in industry associations, I was meeting most of the people
for the first time. At the same time, because I was a participant from EBC, I was asked questions,particularly about overseas regulations, several times by the participants. Through this project, I hope
to expand my network of contacts so that we can share our expertise, and I would like to do my best to
make this rewarding for both myself and others.

Tomohiko Matsukawa, Public Policy Department, Philips Japan, Inc.
Each table included representatives of both industry and the government, so we learned by listening to
the government's views and conveying the industry's views while considering the differences inposition on each theme.
Because each of the industry groups handles different types of products, they approach the issues
from very different standpoints, and that made for mutual exposure to fresh perspectives. I would liketo continue to deepen my knowledge through discussion of various themes while expanding mynetwork of contacts, and I hope to recycle knowledge back to the EBC through my activities in theJFMDA.

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