AMDD Vol.26
NEWSLETTER

Nov 2017

English translation of the Japanese newsletter

CONTENTS- Japan’s Healthcare Challenge- About the AMDD Advocacy Committee- Patient’s Voice: Nuclear Medicine Treatment in Cancer CareHigh Hopes for RI (radioisotope internal radiation therapy)- Voice from the Local Government: Support of Medical Device Development at the
Saitama Leading Edge Project- AMDD Holds Extraordinary General Meeting- AMDD Participates in the Kasumigaseki Summer Holiday Event, “Kasumigaseki Kid’s
Day”- Value of Medical Technology<Diagnosis and Treatment of Cancer>: Reducing
Discomfort and Enhancing Diagnostic Capabilities to Increase the Rate of
Mammography Screenings- AMDD Revamps Regular Member Meetings

Japan’s Healthcare Challenge
Characteristics of Japan’s Healthcare“Aging” is an important consideration for healthcare in Japan, but it is not simply about
age. The speed at which Japan’s population is aging is a defining characteristic. It took 25
years for the population’s percentage of senior citizens, aged 65 and older, to grow from 7%
to 14%. In contrast, it has taken around 100 years for France and Sweden. Japan is aging atfour times the speed of France and Sweden. In just 25 years, Japan will need to facefundamental societal issues, such as social security system reforms, labor issues, and family
dynamics. Furthermore, as Japan’s population is aging more rapidly than other Asian
countries, such as Korea and Singapore, we need to be able to share Japan’s lessons andexperiences with the rest of Asia.
While Japan has initiatives aimed at reducing the overall age of the population, theperformance of Japan’s healthcare has become comparable to that of the U.S. and Europe.
Japan’s national healthcare expenditures are approximately 42 trillion yen, or 9.6% of theGDP, while for Canada, it is 11.2%. Although the healthcare expenditures are notsignificantly different, the population aged 65 years and older in Japan is 23.3%, while Canada
is 14.4%.
Although Japan’s population is more aged than Canada’s, Japan’s health care expenditures arelower. This is an accomplishment that should be recognized. Health insurance in Japan is“universal health care,” which covers everyone living in Japan, with copayment fees1considerably reduced for patients. Japan is a country with high quality health care and a worldclass medical insurance system.
Looking Towards the Future to Create New Processes
As things stand, it will be difficult to support sustainable innovation from the mid-21st
century onwards.
Although venture corporations in regenerative medicine from the U.S. and Europe have beensuccessively entering the Japanese market, research and development of pharmaceuticalproducts and medical devices in Japan often lag behind the U.S. and Europe. The focus on
absolute safety and efficacy requires approvals, which takes a considerable amount of time.
It is important to expedite this process, while reducing costs.
Creating an environment that facilitates market entry is crucial for venture corporations, so
research costs must be lowered. Newly developed pharmaceutical products and medical
devices could be launched with a provisional price using the “conditional early approvalsystem,” and the official price would be later determined, based on real-world data.
New processes are vital. Safety must of course be ensured, but in terms of efficacy, once acertain degree of efficacy is presumed, the product could be launched. After this, the official
price would be determined by taking costs and expected efficacy into account; the price could
be revised using data which is gathered quickly and inexpensively. Both public and private
sectors should work together to create an environment which makes this process smooth.
Currently, drug prices are determined by costs, such as development costs and selling or
distribution costs, but going forward, the benefit to patients’ value should be prioritized.
Drug prices should not simply be a matter of reduction; rather, it may involve raising prices
for products when necessary.
Japan is a medical device mecca. Japan has significantly more medical devices, such as MRIs
and CTs, compared to other countries. In order to cover the costs of expensive medical
devices, excessive medical care may be unavoidable. An effort should be made to consolidate
the number of surgical assist robots and particle therapy facilities, which are otherwise likely
to increase in the future.
There are many other innovative medical challenges to be undertaken, including thedevelopment of genome therapies for cancer and the use of artificial intelligence. The
Ministry of Health, Labour and Welfare (MHLW) is determined to tackle all of thesechallenges.
Chief Medical & Global Health Officer, MHLW
Dr. Yasuhiro Suzuki
Graduated from the Keio University School of Medicine in 1984.
Entered the MHLW the same year. Dispatched to the World HealthOrganization in 1998. Appointed to current post from July 2017, after
serving as: Director of the Research and Development Division of the
Health Policy Bureau from 2005, Deputy Director-General of thePandemic Influenza Experts Advisory Committee from 2009, Director
General for Health and Medicine of the Ministry of Defense from 2012,
Assistant Minister for Technical Affairs of the MHLW from 2014, andDirector-General of the Health Insurance Bureau of the MHLW from 2016.

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About the AMDD Advocacy Committee
The topics of health care and social security are covered in the news every day, both in print
and on TV. Healthcare issues are also frequently addressed in politics. In response to thistrend, AMDD recently established the Advocacy Committee. The following is an explanationof the role and characteristics of the Advocacy Committee.
The Advocacy Committee
Until now, AMDD has responded in various ways to issues, such as regulatory affairs andreimbursement, within the medical device industry. The respective committees are involvedin making proposals to the government, as well as releasing information to the public throughPR activities. However, due to the recent heightened interest in health care, and particularly
the enhanced awareness of issues related to health care expenditure, the required methodsof communication are becoming more diverse than ever before.
The role of the Advocacy Committee is to create and strategically communicate AMDD’s
policy proposals and initiatives’ key points to relevant stakeholders. In other words, the main
purpose of the committee is to build relationships and gain support from individuals andentities which the other committees would not regularly reach directly, such as members of
the Diet, local governments, government offices, and medical associations.
Current Activities
Activities have been focused on the reimbursement system, including making proposal
revisions, as well as supporting and following up on AMDD projects which aim to improve
the reimbursement system. Examples of these are the project started in 2014 to redefine theidentity of AMDD and the project started in 2016 to propose a new insurance
reimbursement system (value-based health care).
The committee has made various proposals, aligned with global trends, to ensure that medical
devices are recognized and evaluated based on their value to society. AMDD believes that
this will lead to the prompt availability of globally innovative medical technologies in Japan.
The committee has been closely communicating with relevant parties, regarding theestablishment of fair and transparent processes, the establishment of various systems basedon global standards, and the creation of an environment that guarantees equal and faircompetitive conditions.
The Advocacy Committee has made efforts to incorporate the perspective of economic
efficiency, which widely benefits society, in order to make proposals more acceptable tostakeholders, rather than focusing on only the interests of the industry. The committee often
collaborates with medical device industry associations in Japan and Europe to create
proposals and explanatory materials within the joint framework of Japan, Europe, and the
U.S. AMDD can make a strong appeal, with a unified voice and a consistent statement;
however, with regards to matters that require more attention, AMDD can create proposals
and make suggestions independently. Three medical device organizations jointly compiled
materials, which were presented by their chairmen, including AMDD Chairman Kato, at the“Public-Private Dialogue on the Development of Innovative Medical Devices,” where the
Minister of Health, Labour and Welfare and relevant ministry and industry executives held
discussions, in October 2017.
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The support of the U.S. Department of Commerce and Department of State is extremely
important for AMDD. We also work closely with the Advanced Medical Technology
Association (AdvaMed), a medical device industry organization in the U.S., to approach theJapanese government. The U.S. embassy in Japan plays an important part in maintaining thisrelationship, and it has supported AMDD in various ways in the past.
Future Activities
The U.S. recently elected a new president, and Japan had a general election. With the changes
and transfers in public offices in the U.S. and Japan, the political environment surrounding
medical devices has continued to change this year. The Advocacy Committee is increasingly
expected to log these political changes quickly, conduct analyses, compile the views of
AMDD, and communicate their views through the best channels. Although the Advocacy
Committee’s resources are limited, with the strength and cooperation of members, thecommittee will strive for effective communications.
Representatives at the Public-Private Dialogue on the Development of Innovative Medical
Devices (October 6, 2017)

Mr. Kosuke Kato, AMDD Chairman

Mr. Katsunobu Kato, Ministerof Health, Labour and Welfare

Director of Healthcare Economics and Government Affairs,
Johnson & Johnson K.K.,
AMDD Advocacy Committee Chairman
Mr. Jun Sekiguchi

4Patient’s Voice
Nuclear Medicine Treatment in Cancer CareHigh Hopes for RI (radioisotope internal radiation therapy)
Dr. Kenichi Oi
DDS, Program Director, Cancer Support Community Japan, NPO
Hope for cancer patients and their families lies in the establishment of
accurate diagnostic methods and the development of effective treatments.
Nuclear medicine, which has both therapeutic and diagnostic capabilities,
has the possibility of progressing towards personalization.
Nuclear medicine treatments (radioisotope internal radiation therapy) such as radioiodine I
131 for thyroid cancer, strontium 89 chloride for bone metastases, yttrium 90 for malignant
lymphoma, and radium 223 dichloride for bone metastatic castration-resistant prostatecancer is covered by insurance in Japan.
In the U.S., there are reports of radioembolization therapy as a treatment for unresectable
hepatocellular carcinoma and colorectal liver metastases. Yttrium-90 microspheres are
injected in cancerous tissue to stop blood flow and to reduce or eliminate tumors, with thesynergistic radiation effects of yttrium-90.
Microspheres were one of the medical devices that were recommended for early introduction
into Japan in the MHLW’s “10th Investigative Commission on the Early Adoption of
Medical Devices with High Medical Needs,” in January 2009. Although hepatic arterial
embolization and transhepatic arterial chemoembolization using microspheres is covered byinsurance in Japan, radioembolization therapy has yet to be covered by insurance.
Cancerous tissue is frequently found deep, far from the surface of the body. When irradiating
cancerous tissue deep within the body, irradiation of the surrounding healthy tissue isunavoidable. When attempting to deliver large amounts of radiation to the cancerous tissue
without damaging healthy tissue, there are cases where it is more efficient to irradiatecancerous tissue from within the body, rather than to irradiate from outside.
In June 2015, the Cabinet approved a written response stating that, “the necessary response
will be considered, and research and development will continue to be promoted,” regarding
the deregulation and popularization of nuclear medicine treatment in Japan. However, thespread and popularization of nuclear medicine therapy, which includes radioembolization, anoninvasive, highly effective therapy that places an emphasis on Quality of Life (QOL), issignificantly delayed in Japan.
The Japan branch of the Cancer Support Community, a global nonprofit patient advocacy
group headquartered in Washington, DC, in the U.S., has been providing psychosocial
support, education, and healthy lifestyle programs to patients and their families in Japan since
May 2001.
Striving to improve cancer care in Japan, the Cancer Support Community established the
National Conference for Nuclear Medicine Theranostics in December 2016 with help from5the Japanese Society of Nuclear Medicine (an academic association), the Japan Radioisotope
Association (an industry association), and PanCAN Japan (a nonprofit organization thatprovides support for patients with pancreatic cancer).
Going forward, the conference will conduct initiatives to improve the environment
surrounding nuclear medicine treatment and promote appropriate nuclear medicine
treatment through advocacy activities.

Voice from the Local Government
Support of Medical Device Development at the Saitama Leading Edge
Project
Initiatives of the Saitama Medical Innovation Network(Saitama Prefecture)
Promotion Office, Leading Edge Industrial Division,
Department of Industry and Labor, Saitama Prefecture
The Strengths of Saitama Prefecture in Healthcare-Related Industries
Since FY2014, Saitama prefecture has been promoting their Leading-Edge Industry Design
Project (Leading Edge Project), which aims to provide support for commercialization,
productization, and industrialization of leading edge industrial fields, including: nanocarbons, medical innovation, robotics, new energy, and aerospace. Innovative research will
receive resources from universities and research institutions, as well as access to special
technology from corporations.
Saitama prefecture has a high potential to grow healthcare industries because it producessome of the most pharmaceutical products and medical devices in Japan. Saitama prefecture
also has a high concentration of manufacturing companies including optics industries. This
project seeks to further attract healthcare-related industries by utilizing Saitama’s appeal andpromoting innovation in the development of medical devices.
Establishment of the Saitama Medical Innovation Network
The Saitama Medical Innovation Network is a healthcare initiative from the Leading Edge
Project. The network was established with medical device companies, universities, research
institutions, and companies seeking to enter the market.
Saitama Prefecture and Saitama City work together to attract healthcare industries by holding
seminars on the development of medical devices and providing opportunities for network
members to meet. A total of approximately 350 companies and organizations from industry,
academia, and health care participate in the network. Members are from both within andoutside the prefecture.
The Saitama Medical Innovation Network’s projects support phases from (1) market entry,(2) research and development, and (3) commercialization.
One example of the network’s activities is matching the needs of the healthcare field withcorporations. This initiative, led by the Saitama Industrial Promotion Public Corporation, is
where healthcare industry manufacturers and sellers are matched with physicians, and the6manufacturers’ listen to what is needed in the healthcare field. Matches are mediated by the
Saitama Industrial Promotion Public Corporation; after the matches have a discussion, theircoordinators advise the manufacturers about research and development.
The Saitama Medical Innovation Network also holds a “Medical Device Prototype Contest,”
to support commercialization of prototype medical and health devices. In this contest,
winners are awarded monetary prizes (including a grand prize of 5 million yen), with theintent of subsidizing costs for regulatory approval after product development. It is a uniquecontest, which places the spotlight on prototypes, and subsequently helps corporations
envision a product which creates revenue.
Participation in the network is not limited to medical device corporations, but is open to any
corporation or organization related to, or interested in, health care. This includes
corporations seeking entry into the market, universities, research institutions, medical
institutions, and supporting institutions, from both within and outside the prefecture.
Interested parties should contact the Promotion Office, Leading Edge Industries Division,
Department of Industry and Labor.
(Phone: 048-830-3737, e-mail: a3760-03@pref.saitama.lg.jp).

AMDD Holds Extraordinary General Meeting
On September 14, the American Medical Devices and Diagnostics Manufacturers’
Association (AMDD) held an extraordinary general meeting. AMDD Chairman Kosuke
Kato (Managing Director, Edwards Lifesciences Corporation) opened with an overview ofthe Medical Technology Policy Institute, that was slated to be established on October 1, 2017as a new organization within the association. The institute’s mission is to conduct mid-tolong-term research and suggest government policy changes in order for medical technologies,
including medical devices and in vitro diagnostic devices, to make greater contributions toJapan’s health care. At the extraordinary general meeting, the establishment of the instituteand budget additions were approved after deliberations.
Dr. Yasuhiro Suzuki, Chief Medical & Global Health Officer, Ministry of Health, Labourand Welfare gave the keynote address entitled “Japan’s Healthcare Challenge.”(Please refer to page 1 for a summary of Dr. Suzuki’s address)(From left)

Mr. Kosuke Kato,
AMDD Chairman
Dr. Yasuhiro Suzuki,
Chief Medical & Global Health
Officer, MHLW

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AMDD Participates in the Kasumigaseki Summer Holiday Event,“Kasumigaseki Kid’s Day”
The American Medical Devices and Diagnostics Manufacturers’ Association (AMDD)
participated in “Kasumigaseki Kid’s Day” on August 2 and 3, in Kasumigaseki. During theevent, AMDD exhibited in a booth within the MHLW office entitled, “Let’s Touch Cutting
Edge Medical Devices that Save Lives.” This year’s exhibits were divided into the themes“diagnosis,” “emergency,” “treatment,” and “in-home care” with the goal of making it easierfor children to understand.
The children went around the booths, spending an
enjoyable day of their summer vacations actually
touching medical devices from the four themes. The
children seemed to be surprised by the vast variety ofdevices.
Many companies from AMDD participated, createdquizzes for the respective themes, and earnestly
explained the medical devices and treatments to thechildren.

The Value of Medical Technology<Diagnosis and Treatment of Cancer>
Reducing Discomfort and Enhancing Diagnostic Capabilities toIncrease the Rate of Mammography Screenings
One reason that patients avoid undergoing breast cancer screenings with mammography isbecause of the discomfort and pain of testing.1
A next-generation mammography device was developed, incorporating the opinions ofJapanese patients, technicians, and physicians in order to reduce the pain and discomfort oftesting. Technicians corrected breast positioning, and applied the minimum pressure required
for the exam. Based on the input from technicians, patients use a self-pressurizing function
with a wireless remote control, and the patients apply the pressure themselves, to the extent
that they do not experience discomfort. In addition, the device’s exterior is designed toalleviate the nervousness which patients often feel upon entering the examination room; thebreast support plate, that comes in contact with the patient, is thin and rounded and the face
guard is also curved to reduce neck pain while taking the X-ray. In recent years, the diagnostic
capabilities of mammography have been enhanced with the development of digital breast
tomosynthesis (DBT). Multiple studies have reported results where recall rates have been
reduced and cancer detection rates have been increased, using simple mammography andDBT screenings concurrently. The next-generation mammography devices that are gentle
on women are expected to be widely used to increase the rate of mammography screenings.
*1: Digital Mammography A Holistic Approach, Peter Hogg, Judith Kelly, Claire Mercer,
2015(Text: Ryosuke Higashio, GE Healthcare Japan K.K.)

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Product Name: Senographe Pristina™
Proprietary Brand Name: X-Ray Diagnostic Device for Breast
Cancer Mammography Senographe Pristina
Medical Device Registration Number: 228ACBZX00013000

AMDD Revamps Regular Member Meetings— Monthly Meetings and Lecture Meetings —The AMDD conducts regular meetings, and under the leadership of the Membership
Committee, the content of these meetings was revamped in April 2017.
“ Lecture Meetings” and “Leadership Forums” are currently being trialed. Prominent
instructors for the respective industries provide lectures to executives of the member
companies. The lectures are themed with societal and industry trends. Lively discussions havefollowed each lecture.
<Past Meetings>
Lecture Meetings
 “Value-Based Healthcare” (Speaker: Dr. Shohei Nakano, Japan Association for the
Advancement of Medical Equipment)
 “Healthcare Systems Required for the Advancement of Medical Technologies”(Speaker: Mr. Tetsuyuki Tatsuoka, Deloitte Tohmatsu Consulting LLC)
Leadership Forums
 “Risk Management for Business” (Speaker: Mr. Shigeru
Nakajima, Lawyer, Nakajima Transactional Law Office) “Diversity and Inclusion as a Management Strategy”(Speaker: Mr. Akira Matsumoto, Chairman and CEO,Calbee Inc.)

July Leadership Forum

Value of Medical Technology
Our mission is to make more people understand the unlimited potential of advanced medical
technology and its contribution to the reformation of the Japanese medical care system
Note: All opinions in this newsletter are the personal opinions of the authors, and do not necessarily
represent the opinions and activities of AMDD.

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