AMDD: 10-year History and Beyond

10-year History and Beyond

Nakano Central Park South 15F, 4-10-2 Nakano, Nakano-ku, Tokyo 164-0001

Table of Contents
Foreword ······································································································································· 3
Chapter 1

Prehistory to the AMDD (1990s-2008) ························································· 4
Column: Huimin Wang, First Chairman ··· 7
Column: Masataka Toyota, First Staff Director ··· 9

Chapter 2

Device Lag: History from Conflict to Dialogue –Near Revolutionary Reforms at the PMDA ············································ 12
Column: David Powell, Second Chairman ··· 15
Column: Isao Tanabe, Medical Journalist ··· 17

Round-table Chuikyo and 10 Years of the AMDD and Beyond,discussion as Told by Successive Expert Members ················································· 20
Attendees: Mitsuo Hirose, Akira Matsumoto, Makoto Tamura, Tamotsu Hiiro,
Toshifumi Hayashi, Kosuke Kato
Moderated by: Junko Kodama

Chapter 3

Cooperation and Collaboration with the MHLW and the PMDA
that led to the Pharmaceuticals and Medical Devices Act ············· 30
Column: Takashi Shimada, Third Chairman ··· 33
Column: Yasushi Takahashi, Acting Chairman, JACPF ··· 35

Chapter 4

Changes in the Insurance Reimbursement System for
Medical Devices and In-vitro Diagnostics (IVD) over
10 Years and AMDD’s Response ································································ 38

Chapter 5

The Road Ahead ····························································································· 46

10 Years of Innovation Saving Patients• Cardiovascular Surger y (Heart Valve Thoracotomy and Catheter Surger y) ··· 10• Cardiac Implantable Electronic Devices (CIED) ··· 11• Orthopedic Surger y (Artificial Joints) ··· 18• Orthopedic Surger y (Spine) ··· 19• Cerebrovascular Disease ··· 28• Diagnostic Imaging ··· 29• In-vitro Diagnostics (IVD)··· 36• Diabetes (A New Era of Glucose Monitoring) ··· 37• Dialysis ··· 44• Ophthalmology ··· 45

The History of the AMDD ·································································································· 52
Profile of the AMDD ············································································································· 54

Foreword
The American Medical Devices and Diagnostics Manufacturers’ Association (AMDD) is celebratingits 10th anniversary. We express our deepest gratitude for the guidance and encouragement we havereceived from all those involved with us.
Since its inception in April 2009, AMDD has acted as an intermediary to the Japanese Government andrelated administrative bodies. It is an industry group consisting of approximately 70 Japanese corporations that handle medical devices and in-vitro diagnostics (IVD) with their headquarters located mainlyin the United States.
Specifically, with the cooperation of related organizations, such as the Ministry of Health, Labor andWelfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA), we have been particularly active in our efforts to eliminate the long-standing issue of device lag and to build a regulatory systemthat takes into account the characteristics of medical devices. Our work has led to the acceleration of the
medical device review process, and device lag has been almost eliminated. In November 2013, our longheld vision of separating regulations on pharmaceuticals and medical devices was materialized as theenactment of the Pharmaceutical and Medical Device Act (revised Pharmaceutical Affairs Law), which
took effect the following year.
From 2016, for further credibility and transparency of the organization, AMDD changed from a voluntary organization to a General Incorporated Association (GIA). As we made the change to GIA, weestablished AMDD’s new mission, which is to provide valuable medical technology and information forthe healthy everyday lives of people. Medical devices and IVD are not only utilized in the treatment of
illness, but also in numerous other applications, such as prevention and improvement of conditions after
treatment. As an industry group that delivers such medical devices and IVD to Japanese patients under
our new mission, we continue to expand our activities.
Since 2017, we have been working on a policy recommendation called Value-based Healthcare to evaluate the value of innovation in medical devices and IVD, and some of our recommendations have been
incorporated in a “challenge application”. To that end, we have established a think tank called the AMDD
Medical Technology Policy Research Institute, which works on policy recommendations.
This booklet “AMDD: 10-year History and Beyond” summarizes the past 10 years and outlines ourroad ahead. Along with a record of AMDD’s main activities, it also summarizes the achievements of innovation over the last decade that have contributed to patient care in numerous disease fields. We would
be grateful if you could spend time to read this booklet.
Toward the next decade, in cooperation with the Japanese Government and related academic andindustrial organizations, while collaborating with the US government and the Advanced Medical
Technology Association (AdvaMed), we at AMDD will continue our activities including policy recommendations to contribute to the development of better medical care in Japan. We look forward to yourcontinued guidance and encouragement.

September 2019
Kosuke Kato
Chairman
American Medical Devices and Diagnostics Manufacturers’ Association (AMDD)

AMDD

3

Chapter1
Prehistory to the AMDD (1990s - 2008)
US-Japan Economic Frictions Led to theMedical Device Issue“for pacemakers, Japan relies almost 100% on imports, 90%

For the establishment of the AMDD in April 2009, Japan’s

invoice the purchase price as insurance claims, even ifhigh economic growth after World War II and the relation-

manufacturers mass-produce medical devices, pricing

ship between Japan and the United States played vital roles.

pressure would not work.” Therefore, “the Ministry of HealthGoing back to the 1980s when Japan-US trade tensionsand Welfare plans to set official prices for insurance claims

peaked, after post-war high economic growth as described inof which are made in the US. Since medical institutions

from April this year with the aim of lowering price levels.”“Japan as Number One: Lessons for America” by American
dominant across the world. The United States, in particular,

The Establishment and Activities of the
ACCJ Medical Devices / IVD Subcommittee

suffered from a trade deficit with Japan because of Japanese

Under these circumstances, the Chemical Daily, dated April

electronic products and cars. The United States tried to9, 1993, reported that an expert committee on special treat-stem the appreciation of the US dollar and aimed toment materials at the Central Social Insurance Medical

strengthen the Japanese yen through the 1985 Plaza

Council (Chuikyo) met to exchange views with the repre-

Accord, but the trade deficit continued even after the Accord.

sentatives of the American Chamber of Commerce in Japan

Prime Minister of Japan Nakasone and the US President(ACCJ), the European Business Council (EBC), the Advanced

Ronald Reagan agreed to initiate the market-oriented sector

Medical Technology Association (AdvaMed, formerly theselective (MOSS) talks in February 1985. According to the

Health Industry Manufacturers Association (HIMA)), andJapanese encyclopedia, the MOSS talks were “a method to

the US Department of Commerce. The aim was to summarize

discuss the US products that were internationally competi-

considerations regarding price ranges and revision rules fortive but could not enter the Japanese market in the Japan-US

special treatment materials by June 1993. The basis for pric-

trade negotiations, with a view to open the market to thoseing was presented as an idea based on function; however,products for individual sector, and discuss causes of trade

this was met with calls for it to be done by brand.

sociologist Ezra F. Vogel in 1979, Japanese products werebarriers.” One of the sectors was pharmaceuticals and medical devices.

4

The Nikkei Sangyo Shimbun, dated August 13, 1997,
reported that the Ministry of Health and Welfare released

What then happened to MOSS talks in the US-Japan tradefindings of its first distribution survey on medical devices

friction? For the answer, we can refer to an article in theon August 1. The survey showed that the price of pacemak-

Nihon Keizai Shimbun (Nikkei) dated April 22, 1990, titleders and PTCA balloon catheters (catheters for dilating the“Follow-up MOSS meeting on Pharmaceuticals and Medical

heart coronary arteries) increased from 1.2 times to 8 times

Devices in Tokyo after holidays.” The article describes thethat of Europe and the United States. Until then, the differ-meeting, where the two countries were to focus on official

ence between domestic and foreign prices has been raised

pricing of special treatment materials, such as pacemak-

as problems by the Japanese side. There was also a report

ers, and methods for calculating drug price standards.

that foreign manufacturers were raising shipping prices to

Nowadays, special treatment materials, such as pacemakers,

Japan. However, Leo Tilly, then Chairman of the ACCJ

are covered by the National Health Insurance and have

Medical Device Subcommittee (hereinafter “Subcommittee”),

official prices, but at that time there were no such official

stated that his Subcommittee had argued that many ofprices. For this reason, from April 1990, the Ministry ofJapan’s unique business practices and regulations are the

Health and Welfare created a policy for setting official prices

cause of the high costs, and this survey proved that thosefor insurance claims. However, the setting of official prices

claims were not wrong. He went on to say that the Subcom-

had negative pressure on profits for the US manufacturers,

mittee would continue to ask the Japanese Government for

which in turn led to criticism in the US of increasing tradefour deregulations. The newspaper outlines the fours dereg-

imbalances. This further strained negotiations between theulations; 1) Give preferential evaluation in medical insurance

two countries. The Nikkei article dated July 15 reported thatto medical devices with innovative technology (that allows

AMDDearly treatment / discovery) because such devices can bringdevices in the Japanese market and the official price cuts at

down medical costs, 2) Allow overseas data to be used as

the time of the revision of medical fees for special treatment

they are for clinical studies (clinical trials) in Japan, 3) Cate-materials. Otherwise, companies may find it impossible togorize IVD as medical devices because they are closely relat-

continue business in Japan, which in turn would lead to aed to medical devices, unlike general drug products that arecrisis that disadvantages Japanese patients.

taken in the body, and 4) Shorten time to approval. Mr. Tilly

In 1999, the previously mentioned Bain Report which

commented in the article, “I question the simplistic view thatwas published in full by the Subcommittee, highlighted theif the price of medical devices goes down, the cost of medical

contributions of special treatment materials, IVD, diagnos-

care will go down. When the introduction of advanced devic-

tic imaging and other devices to Japanese healthcare and

es is delayed because of tight regulations, complicated proce-patients, and detailed that patients’ QOL and reduction

dures and red tape, we cannot serve the patients.”

of medical expenses was brought about by technologicalMoreover, under the headline, “The Report by the ACCJ :innovation of medical devices amid the increased nationalslow penetration of medical technology, urging the acceler-

medical costs. It was expected that proposed actions with-ation of new product approval,” the Nikkei Sangyo Shimbun

in the report would be seen by many government officials,

dated September 17, 1999 reported that “According to theand raised as an issue so that it would lead to the solution

report, titled ‘A Turning Point of the Japanese Healthcareof the above-mentioned issues. However, the report wasn’t

System’ (commonly known as the Bain Report), publishedwidely picked up by the media, and did not seem to haveby the Subcommittee, the implantable cardioverter defibril-significantly impacted government policy. This led to thelators (ICD) that prevent sudden death due to arrhythmia,

realization that there might be problems with communica-

liquid medium for tuberculosis diagnosis, and artificial joints

tion to stakeholders, including the media. Thus, a Task Forceare not gaining ground in Japan, as compared with overseas,

was launched by the main member companies of the Sub-against the backdrop of the slow approval process and thecommittee. External communication, which up to that point

low test fees. The Subcommittee stresses that the introduc-

had been handled internally, was to be carried out in concert

tion of new technologies will lead to improved quality of life

with external experts.

(QOL) for patients and reduced medical costs. Going forward,

The hired experts analyzed circumstances, and reiter-

it will distribute reports to related organizations, such as theated to the Task Force members: “Before talking about the

Ministry of Health and Welfare, and seek reform of the health-issues of approval speed and the reduction of medical fees,care administration.” This was the beginning of the Japanese

we must first consider that nobody knows about medical“device lag” issue, a term for the slow time to approval, which

devices and IVD. Even media do not know much except for

was raised as a major issue (non-tariff barrier).

trade papers. General papers and magazines fail to describe

Originally, the Subcommittee was established within thewhat constitutes medical devices (also known as medical

ACCJ by Mitsuo Hirose, then President of J&J Medical (nowinstruments or equipment), and have no idea that the devic-

Johnson & Johnson). Back then, he was watching discussions

es include not only injection syringes, surgical threads andin the Japanese medical device industry group which tended

needles, but also advanced medical technologies including

to make requests centering on their interests, and he decided

pacemakers, stents and artificial joints that significantly

to set up an industry group for foreign medical device

contribute to life-saving procedures and improvement in

manufactures to independently express demands that are dif-post-operative QOL.” Firstly, we must inform the general pub-ferent from the Japanese industry group. He also served as an

lic of the role/value of advanced medical technology and ofexpert member of Chuikyo from 1999 to 2005 while belonging

the presence of minimally invasive treatment that saves lives

to the Subcommittee. (Since then, expert members ofand contributes to the improvement of post-operative QOL.

Chuikyo have been appointed from AMDD member compa-

Secondly, we must explain why advanced medical technolo-

nies. Please also refer to the round-table discussion article

gy is not gaining ground in Japan and keep appealing to thefeaturing past expert members on page 20 of this journal.)

government although it may seem a roundabout approach.

Launch of Awareness Campaign,“the Role of Advanced Medical Technology”

of Medical Technology: Public Awareness Campaign (herein-

HIMA (later changed its name to AdvaMed) that had worked

in earnest in January 2002, and representatives of all mem-with the US Government since the 1980s, and the Subcom-

ber companies gathered on several occasions to be briefed

mittee (later changed its name to Medical device/IVD sub-on the purpose of the Campaign.

These broad-based ideas led to the launch of the Valueafter referred to as the Campaign). Preparatory work begancommittee) expressed concerns in 2000 that among all

In 2001, the Subcommittee aimed to plan for exter-

problematic issues raised up to that point, the country must

nal communication activities and set up a secretariat

take some sort of measures against the slow approval of new

and appointed a staff director within the Subcommittee,

AMDD

5

Dr. Yasuhisa Sakurai, Professor Emeritus, Tokyo Women’s Medical University, gives a keynote speech at a press conference during the Valueof Medical Technology: Public Awareness Campaign (October 2002)

Former Chairman of the ACCJ Medical Device / IVD Subcommittee,
Dr. Huimin Wang, discusses issues of medical devices and IVD at apress conference (October 2002)

dedicated to industry activities and external communica-

devices. Dr. Huimin Wang, then Chairman of the Subcom-

tion, using funding from companies belonging to the Sub-mittee (later the first Chairman of the AMDD) explainedcommittee.

the purpose of the awareness campaign. Over 50 people

The Campaign commenced with a message explaining

attended the press conference, including industry news

the great value of advanced medical technology. Rather than

media, economic media and general newspapers, and jour-

the Subcommittee working alone, it called for a coalition ofnalists, in addition to other related parties. A sense of

all stakeholders who support and promote such advanced

expectation was in the air that something new was on its

medical technology within the industry. Minimally invasive

way. Because minimally invasiveness is a value of medical

advanced technologies improve post-operative QOL anddevices that improvesshortens the length of hospital stays, and reduces medical

patients’costs. It was the solution to an issue of the Japanese health-

QOL, a QOL campaign

care system, and that was a major value of advanced

logo was also unveiled at

medical technology.

the

As an endorser of the campaign, we asked for the cooperation of Dr. Yasuhisa Sakurai, Professor Emeritus at Tokyo

press

conference,and covered in articles
on the following day.

Women’s Medical University, and a leading figure in bio-

The campaign’s primary purpose was to raise aware-

medical engineering in Japanese academia back then. He

ness and understanding of medical devices and IVD among

readily agreed to assume the role. At that time, Prof. Sakurai

the general public. The strategy was to conduct a series ofserved as Co-Chair of the Medical Engineering Technology

media lectures, and use examples of the latest advanced

Industrial Strategy Consortium (METIS) which was estab-

medical technology to promote its value to patients. How-lished as a national strategy for Japanese medical devices,

ever, the message the Subcommittee was to send was notwith Tsutomu Kanai, Chairman of Hitachi, Ltd. In addition,a promotion of individual company products, but rather ahe served key positions in biomedical engineering such as

representation of their product categories.

the President of the Japan Society for Biomaterials and the

Unlike pharmaceuticals, the advanced medical technol-

Vice President of the Japanese Society for Medical and Bio-ogy, therapeutic devices such as pacemakers, ICD, artificial

logical Engineering. He also served as Chairman of the Soci-joints, artificial heart valves, stents, diagnostic imaging

ety of Future Medicine, a representative of the Healthcaretechnology, and IVD were not something patients used on a

Research Park, and Chairman of a medical device industry

daily basis. Patients were not familiar with devices used forroundtable for METI. He himself was also frustrated by thetheir surgeries, while the general public’s recognition andlack of recognition and understanding of medical devices,

understanding of such technology was even further fromwhich play an equally important role as pharmaceuticals in

sufficient.

Japanese healthcare, and thus, he was actively involved in
the Subcommittee’s campaign.

6

postoperative

The first lecture of the media lecture series started in
February 2003, looking at mammography for early detection

In this way, the Subcommittee built its key message, pre-of breast cancer as a representative example of diagnos-

pared materials to convey the value of medical devices andtic imaging. In those days, the incidence of breast cancer,

held many discussions with various stakeholders. In Octo-

mainly among young women, was increasing and aware-ber 2002, a press conference was held for the launch of theness of breast cancer was growing through the Pink Ribbon

Campaign at the Imperial Hotel in Tokyo. Professor Yasuhisa

Movement. The lecture attracted great interest. The media

Sakurai gave a keynote speech on the value of medical

lecture was attended by breast cancer patient groups and

AMDD

Words from the Chairman

Former Chairman on
10 Years of the AMDD

Huimin Wang, First Chairman (2009 - 2010)
It was in 2002 when I became Chairman of the ACCJ
Medical Devices and IVD Subcommittee (hereinafter “Subcommittee”), the predecessor of the AMDD. In the same
year, Edwards Lifesciences Ltd, which I currently lead, spun
off and became independent after taking over the cardiovascular product business of Baxter Ltd. For several years the
Ministry of Health, Labour and Welfare (MHLW) had alreadyconsidered the “issue” of so-called internal and external
price differences when overseas medical device manufacturers sold their products in Japan. The MHLW had
surveyed the prevailing market prices in other countries
and was considering the introduction of a foreign average
price (FAP) system to adjust the prices of those items whose
price was significantly different from the average. This was
an extremely big challenge for us, and the Subcommittee
had considerably heated discussions with the MHLW
concerning the value of medical devices.
During this period, Bob Hurley, President of Baxter, who
was my boss and Chairman of the Subcommittee, asked
me to accompany him to the MHLW as an interpreter. He
stood in front of the director’s desk and started to express
his opinions of the domestic and foreign price differences.
As I was interpreting, we were told, “I understand what you
are saying, but make an appointment next time.” I was very
surprised that he had not even made an appointment. It wassuch a huge challenge to deal with this “issue”. Unfortunately,
the FAP system was introduced in April 2002 and is still inplace today.
I took office as Subcommittee Chairman amid suchturmoil, and there was a lot to tackle. With a paper on direct
investment in Japan at the ready, I visited and had heateddiscussions with numerous related organizations andparties, including the MHLW, concerning aspects such as theneed to eliminate the Device Lag, which was a major issue
along with FAP at that time. This was eventually taken up by
the Council on Economic and Fiscal Policy and led to a bold
policy to eliminate the Device Lag. This ultimately developed into the Medical Device Review Acceleration Action
Program at the MHLW. During this process, the division in
charge at the MHLW often requested me to provide detailed
data and papers by midnight of the same day for the various
recommendations that we advocated. I am very muchindebted to my assistant at that time, who helped me late
into the night on many occasions.

Then came a problem with governance. We were informedthat the ACCJ’s proposals and other submitted documents
must be approved by the board of directors. Organizational
governance is naturally expected but strict adherence may
have stymied and halted some industry activities. I discussed
the issue many times with the ACCJ executives, but they did
not come around to my way of thinking.
I had a strong conviction that it would be better to act
independently of each other and communicated this conviction to the heads of the main member companies of thecommittee, and most of the members agreed. We preparedourselves for independence and the current AMDD was established on April 1, 2009. I served as the inaugural Chairman.
Masataka Toyota, who acted as Staff Director at the Subcommittee, visited member companies with me to explain
this independence. And he worked tirelessly to create afoundation for the new organization, including negotiating totransfer the budget for activities from the ACCJ Subcommittee to the new organization, enacting a new organizationalname and CIs, and creating the articles of incorporation. I
am very grateful to him.
The AMDD has matured as an organization in the 10 years
since its inception. There has been no such dramatic change
as when the FAP system was introduced, and the medical
device approval system has improved considerably. It seems
as if there is a lack of a sense of crisis as in the ACCJ era. However, the risk remains that the recent changes to the Japanese
healthcare system may cause some companies to forego theintroduction of new products in the near future. Now we must
think about what we can do as suppliers of medical devices
and IVDs. We can present a bigger vision: how the medical
system should be amid Japan’s declining birth rate, aging
population, and the security of medical finances; and how
medical devices should be positioned against such a background. These are visions from a broader perspective: weshould state that medical devices and IVDs will demonstrate
their true value by improving treatment quality and patient
QOL and explain how we want their value to be appropriately
evaluated.
I believe that one of the important roles of industry
groups is to present larger visions that make Japan healthier.
(Corporate Vice President, Japan, Asia and Pacific, Edwards
Lifesciences)

Pink Ribbon representatives. Subsequently, the media lec-

sium, titled Toward Patient-Centered Medical Care (breast

ture series, which introduced advanced medical technolo-

cancer, diabetes, pacemakers) were held. At each event,gies step-by-step, continued intensively for two years; once

Professor Yasuhisa Sakurai’s lectures on the value of med-

every two months (26 times to date). A media forum thatical devices and IVD from an academic standpoint plus thefocused more on healthcare issues, and a patient sympo-

Q&A sessions, helped to deepen the media understanding of

AMDD

7

Toward Patient-Centered Medical Care symposium (October 15, 2004), attended by patient group representatives

advanced medical technologies, which significantly contrib-in Japan. This gave a big impact, not only on the medical

uted to raising awareness (these presentation materials candevice industry, but also on the healthcare administration.

be found on the AMDD website).

In December 2009, Subcommittee Chairman Huimin Wang
and Vice Chairman Jean-Luc Butel held a press conference

Approval Speed of Advanced Medical Technology

as the Subcommittee published a Viewpoint, titled, “Improve

In the 2000s, a social problem surfaced: there was a time

Patient Access to Advanced Medical Technologies.”

lag of several years before drugs developed and approved

Meanwhile, aside from the Subcommittee, the Foreign

overseas (particularly anticancer drugs) were approved by

Direct Investment (FDI) Task Force established within the ACCJ

the MHLW in Japan. This is called a drug lag. The same thingannounced in their Viewpoint in March 2004 that the delay inhappens with medical devices and IVD, and this is called

approval of medical devices would alienate foreign directa device lag. In particular, the approval review system wasinvestment into Japan, which would be a big blow to the Japa-

inadequate. Even though there were many drug reviewers,

nese economy. ACCJ FDI Task Force and Subcommittee mem-

those dedicated to medical devices were limited, and thisbers explained this Viewpoint to various key opinion leaderscaused a delay in approval, thereby creating a device lag.

who were influential to the Japanese healthcare system.

The Subcommittee surveyed how far the approvals of med-

Haruo Shimada, an economist who was one such opinion lead-

ical products of the Subcommittee members were delayed,

er, noticed this Viewpoint when he was President of Chiba Uni-

causing the device lag, so that they could actively advocate

versity of Commerce and Chairman of the Cabinet Office Invest

for government policy change. The survey results wereJapan expert panel. The device lag issue was on the agenda of

published in October 2008 as the “2008 Device Lag Survey”

the Council on Economic and Fiscal Policy, and was included in

known as the Device Lag Report. In December 2008, the Sub-

the Government’s basic economic and financial policy, orcommittee held a press conference on the subject.

‘Honebuto’ Policy, which was compiled in June 2008. This

On the heels of the Device Lag Report, the media (news-

led to the formulation of

papers, magazines and TV) that had mainly covered the ben-

the Medical Device Review

efits of medical device, including lifesaving advantages andAcceleration Action Pro-

improvements to patient QOL, began to report intensively

gram aimed at eliminatingthat the latest medical devices reach the Japanese market

device lag in the MHLW.

several years after they have been marketed overseas, andPlease refer to Chapter 2

those devices are two or three generations old, placing Japa-

and subsequent chaptersnese patients at a disadvantage. Thus, “Device Lag” becamefor details on the device

a buzz word in the media. Intensive media coverage contin-

lag issue, which paved theued from 2006 to 2009 when the AMDD was established. But

way for a major change inwhat triggered the buzz was a seven-part series in the eve-

Japan’s approval system,ning edition of the Asahi Shimbun, titled, “Seven Wonders

and led to collaborationof Japan’s Medical Devices.” The article was written by Isao

with the MHLW / PMDA

Tanabe, who was a staff writer for the paper’s healthcarethat resulted in revisions

and medical section. He strongly voiced concerns over theto the Pharmaceuticals

slow approval of medical devices and the lack of actions
from the administration to accelerate the approval process

8

AMDD

Asahi Shimbun, February 4, 2006,
evening edition

Affairs Law in respect tomedical devices.

Contribution

What I have Witnessed in
10 Years of the AMDD

Masataka Toyota, First Staff Director
Congratulations on 10 years of the AMDD. I served as Staff
Director for nine years from July 2003 to March 2012. Seven
years have passed since my retirement, and I currently devote
my time exclusively for local volunteer activities. However,I can say I had the most joyful and fulfilling time of my life inthat position.
I remember clearly when I went to have an interview
with Dr. Huimin Wang, then Chairman, accompanied by
Yasushi Hirano who was my predecessor and a colleague
in my previous job. Dr. Huimin Wang, Edwards Lifesciences
President, and ACCJ Committee Chairman, was 15 years
younger than I. However, he was a very pleasant man of
integrity; his position didn’t go to his head, and he didn’t
waste his words, and he always wore a smile. He said to me,“This job is about protecting the health of the people.”That brought home just how noble the job is. At the sametime, the working environment seemed to respect people
with ability, regardless of age, so I was eager to work there.
Throughout my nine years there, these notions were my
motivations.
The major event during my tenure came when the
AMDD became independent of the Subcommittee at the
ACCJ 10 years ago. ACCJ is a huge organization which represents all American industries, including aircraft, financeand agricultural products. For the smooth operation of theorganization representing broad sectors, strict rules werein place that all external documents should be checked inadvance. The Medical Devices and IVD Subcommittee was

frequently required to submit documents to the MHLW, andJapanese documents had to be translated into English oneach occasion, then have them checked by the ACCJ.
However, in reality, circumstances were often more difficult
because the government demanded that documents be
submitted by the following morning. There was immeasurable relief and benefits to be affiliated with the ACCJ, but after
consultations with various parties, it was decided that it
would be better to be independent for speed and efficiency. In
preparation, we visited each relevant organization, including
the ACCJ, the MHLW, the US Embassy, AdvaMed, and relatedindustry groups, not to mention all the member companies,
to explain carefully our decision and gain their understanding. As we transitioned to a new organization, we were facedwith difficult challenges, such as naming the new organization and transferring the membership fee balance collectedby the Subcommittee to the new AMDD. Everything wascompleted safely utilizing professional companies andthanks to the cooperation from the ACCJ.
Here we are 10 years later, and I’m overjoyed to say that
the AMDD continues to develop as an important industry
group for medical devices and in-vitro diagnostics (IVD),
while fulfilling its mission to deliver the world’s mostadvanced medical technology to Japanese patients. My
hope is that the organization will continue to prosper while
protecting the health of the people for the next 10 years, orthe next 10 decades.

Inaugural AMDD board meeting, after being founded in April 2009

AMDD

9

10 Years of Innovation Saving
Patients

Cardiovascular Surgery (Heart Valve Thoracotomy and Catheter Surgery)
The heart is divided into four chambers. Four valves keep theblood flowing in one direction. Problems in the function of thesevalves are known as valvular heart disease. Valve replacement
surgery, one surgical treatment for valvular heart disease, is toremove a deteriorated valve from a patient and replace it witha biological or mechanical valve. Since the first valve replacement surgery in 1952, a number of artificial heart valves havebeen devised as technology has advanced. In the same way,surgical techniques themselves have advanced remarkably, andvalve replacement surgery is now a very common procedure. In
recent years, minimally invasive treatment methods with less
impact on a patient’s body, are gaining ground.

History of artificial heart
valvesBasic research into artificial heart valvesbegan in the 1940s, and in 1960 ball valves
were marketed as the first artificial heart
valve products.
Subsequently, a thinner, disc-shaped
valve (referred to as a mechanical valve)
was developed and replaced the ballvalves. Currently, the mainstream mechanical valves are two-leaf models which arehighly durable and widely used across theworld.

Two-leaf valve

Stentless biologicalvalves fabricatedfrom porcine aorta

Artificial heart valves also include tissue valves made from biological materials.
In 1956, a donated human valve was collected for treatmentusing a homograft (homogeneous valve) in which the valve istransplanted into the descending thoracic aorta of a patient withaortic regurgitation. However, homografts are difficult to obtain.
As an alternative, porcine valves with stents; porcine aortic
valves that are inserted into three stents, came into clinicaluse. In the 1970s, a bovine pericardial valve with stent; bovine
pericardium, was used for the leaflet, came into clinical use.
In the 1990s, a stentless tissue valve processed from a
porcine aorta was developed and is still in use after a numberof improvements. Long-term durability has been a challenge
for biological valves, but improvements in structure and methods of fastening leaflet tissue, especially in the 2000s and later,
have accelerated better design and calcification suppression
treatment, further improving hemodynamics and durability.
Moreover, tissue valves that use metal-free stents and tissue
valves that have the function of expanding the annulus frame
has been developed in anticipation of new treatments.
The ever-evolving tissue valve is used across the world totreat valvular heart diseases.

The evolution of surgery andminimally invasivenessTissue valves that expand
the annulus frame

10

AMDD

Surgical procedures also continue to
evolve. Usually, in valve replacement
surgery, a sternal incision is made toopen the ribs and approach the heart. However, from around2000, minimally invasive cardiac surgery (MICS) that makes asmaller incision to approach the heart has been introduced. In
addition, surgery using thoracoscopes and surgical robots is also
being introduced for the treatment of valvular heart disease.
In 2002, Alain Cribier and his team made the world’s firstsuccessful clinical use of transcatheter aortic valve implantation (TAVI), in which a tissue valve was placed in a human
without opening the chest. Since then, a number of improvements have been made in tissue valves for TAVI. Now theestablished method is to crimp a tissue valve to the tip of thecatheter, transport it to the valve position mainly through asmall incision in the leg and place the tissue valve. The method is now widely used in the world, particularly on patientsfor whom open heart surgery is not an option.
The arrival of TAVI gave rise to a new treatment method;
TAV in SAV (also known as Valve in Valve). For those patients
who have already undergone valve replacement surgery
using a tissue valve, but subsequently need a second valve
replacement, this new method allows the placement of thesecond tissue valve through the catheter without anotheropen heart surgery. It is very advantageous for patients since
they can select treatment without another open heart surgery
because tissues once incised through surgical procedures often
fuse, making it difficult to conduct a second surgery.
In the treatment of valvular heart disease, valve repair is
widely performed to shape the valves. Various types ofannuloplasty rings andbands are used for atrioventricular valves such as
mitral valves. Catheter
treatment is now clinicallyavailable in the field ofvalve repair, using a catheter to approach the valve
and form the valve by
pinching the leaflets with a Transcatheter aortic valve implantation(TAVI)
clip-shaped device.

Procedure to form a valve by pinching the leaflets with a clip-shaped device

Increased therapeutic and product options allowed theselection of the optimal artificial valve and optimal treatment
method for an individual patient’s condition. In addition, thedevelopment of less invasive treatments and medical devices
that make them possible, contribute to an improvement inquality of life (QOL) by reducing the burden on patients, suchas fast post-operative recovery and less conspicuous surgicalscars.

10 Years of Innovation Saving
Patients

Cardiac Implantable Electronic Devices (CIED)
CIED is the common name for cardiac implantable electronic
devices. One of the epoch-defining events in the past 10 years
was the emergence of MRI-conditional devices. Conventionally,
CIED covered by metal cases were contraindicated for MRI.
MRI was used more frequently in Japan than in Europe or theUS, and there were great expectations from healthcare
professionals. Companies spent an enormous amount of timeand energy to develop a device and a test method to assess
the impact on CIED units and leads, and to secure anddemonstrate patient safety during MRI scans. Discussion offurther validation methods will be necessary in accordancewith MRI advancements such as higher resolution.
The second major innovation was the development ofleadless devices. The benefits of a leadless pacemaker include
the elimination of infections associated with the implanting
procedure of pacemakers with leads; and there is no chest
protrusion from the traditional pacemaker implantation technique, where the device is placed in the heart chamber, thus
freeing patients from cosmetic and lifestyle restrictions. The
concept of leadless pacemakers has been present since the1970s, but it was not technologically feasible until recently.
The concept was created as a result of the integration ofnumerous technologies, including miniaturized electronic
circuits and batteries, electrodes that stimulate the myocardium
tissue lodging mechanisms, sensors that distinguish between
body movements, heart movements and enabling MRI.
Additionally, a subcutaneous implantable cardioverter
defibrillator (S-ICD) system was developed; it can perform
shock treatment in a similar fashion to the ICD system, without
placing a lead in the heart. Because the S-ICD system does notplace leads into blood vessels, clinical results show a decreasein the incidence of intravascular infection, and that of heart
perforation and pneumothorax during the implantation procedure that intravenously places a lead. As such, it is expected to
improve patient prognoses. The S-ICD is also MRI-conditional,
therefore post-implantation workup is possible.
The third innovation was the inclusion in CIED of
implantable devices that are not therapeutic devices but
have diagnostic functions only. They were expected tomonitor cardiac rhythm and to demonstrate the ability todetect arrhythmia, particularly atrial fibrillation, and areused to investigate the cause of cryptogenic stroke and to

Subcutaneous implantable cardioverter defibrillator(S-ICD) system

Leadless pacemakerdiagnose syncope with unknown causes. As they were nottreatment devices, it was imperative that CIED be particularly small in size for Japanese who are resistant to invasive
implantation of foreign objects in their bodies. After much
hard work, the current sized device resulted. At the end of
2018, the Basic Act on Measures against Stroke and Cardiovascular Disease came into effect, making the prevention
and effective treatment of stroke and cardiovascular diseasenational policy. Since atrial fibrillation is a major cause of
cerebral infarction and a factor of incidence and aggravationof heart failure, the role of devices that continuously diagnose and monitor heart rhythm 24/7 is expected to increase.
New fields that we expect to see in the next 10 years include
telemedicine, patient monitoring, and prognostic improvements using AI and IoT. While Japan’s declining birthrate andaging population squeeze the national budget and a longer
healthy life-span is desired, there is a need for efficient medical care. Work-style reform of healthcare professionals is alsourgent. Efficiency that does not compromise healthcare quality
will be the responsibility of the entire healthcare industry. It is
now deemed possible to collect biological information, including the heart rhythm of a patient, and process and analyze thedata, then use it to constantly monitor the patient’s condition,and give warnings or suggestions for improvement.
The collected information can then be linked to moresophisticated external AI and IoT. By connecting it tophysicians and patients, we can create a world in which
immediacy and convenience are enhanced, and efficiency
is enabled. With increasing public awareness of health,self-management of health through wearable devices suchas smart watches will increase. Heart rhythm monitoringwith a wrist watch device is also becoming feasible, andthis may allow patients to present data in the future, which
are used by medical institutions. To that end, a number
of issues need to be addressed, including: information
security; establishment of a system for collaboration between
clinics, hospitals, and medical institutions; challenges ofhealthcare economy; and data reliability. To stay up to date,
the promotion of collaboration among industry, academia,
hospitals, and government must be planned for the next 10
years.

Implantable ECG recorder

AMDD

11

Chapter2
Device Lag:
History from Conflict to Dialogue –Near Revolutionary Reforms at the PMDA
On August 26, 2008, Dr. Tasuku Honjo, who at the time

are shown below.

was a member of the Council for Science and Technology,
participated in a “Public-Private Dialogue on Innovative

2. Device Lag Survey

Drug Discovery”. There he stated that reforms close to a

The device lag survey impacted numerous areas. In 2008, therevolution would be necessary to deliver the latest medical

ACCJ conducted the “Time Clock Survey” (survey period:

devices and medicines to the Japanese people ahead of theApril 2005 to March 2008), which found that, compared withrest of the world.

the US, device lag in 2008 was about 2.9 years for new
medical devices (PMA 1 equivalent 29 items), and about 3.6

1. Request to increase the number ofPMDA reviewers

years for products other than new medical devices (510 (k) 2equivalent 126 items).

“If the number of reviewers is increased, the number ofWhen the average total review period was comparedinquiries will increase accordingly, so we are fine with things

between Japan and the US, the results were as follows

as they are,” responded the ACCJ Medical Devices and IVD(the average total review period of the US FDA follows in

Subcommittee (hereinafter ACCJ) when asked if the number

parentheses):of PMDA reviewers for medical devices should also be1) New medical devices (PMA): 21.1 months (10.1 months)

increased in a similar manner as when the MHLW increased2) Products other than new medical devices (510 (k) ): 14.3

the number of PMDA reviewers for pharmaceuticals in themonths (2.2 months)

latter half of 2006.
A year later, the Director of the Evaluation Management

Review period by reviewed area and the comparison with

Division at the Pharmaceutical and Food Safety Bureau (nowthe US are summarized in Figure 1. Although there were

Pharmaceutical Safety and Environmental Health Bureau)

variations depending on the area, no review period in Japanand the Director of the Medical Device Evaluation Division

was shorter than that of the US. We can see many fields with

were again before the ACCJ, asking to “increase the number

no difference between new medical devices and genericof reviewers.” The ACCJ stated that it would first seek to set

ones, or where the difference is not as distinctive as in theout the necessary conditions rather than simply accepting

US. This is presumed to be an adverse effect of the samethe increase in reviewers and costs. During a preparation

reviewers examining new medical devices and genericperiod of about one year, we published the 2008 Device Lag

versions in Japan. The PMA and 510(k) review tracks are

Survey (October 2008)1). Excerpts from the recommendations

separate in the US.

Recommendations for shortening review periods
1. T he Least Burdensome Approach will be introduced as theunderlying philosophy and principles for reviews and consultation
thereof.
2. F
 or consulting on and reviewing improved devices and genericversions, only the minimum necessary information will be requested
to determine Substantial Equivalence.
3. T he PMDA will set a performance goal every year, which should beshown in a percentile method to secure accurate predictability ofthe timing of product introduction. In the future, the approval cohortshould be switched to an application cohort so that the reform
results are consistent with performance.

Recommendations for the recruitment of reviewers andtraining
1. When hiring reviewers, they should be
actively hired from the private sector andassigned according to man-hours.
2. Introduce systematic education programsfor improvement related to reviewers’
product knowledge and technique related toreview. The ACCJ will also cooperate.
3. The ACCJ and other medical deviceorganizations will provide venues forseminars to raise the quality of all applicants.

1

PMA: Pre-Market Approval, high risk Class III review process2510 (k): Also called Premarket Notification. It comprehensively evaluates the substantial equivalence (purpose of use, technical specifications, efficacy) andsafety of devices in comparison with those that are legally marketed in the US, and approves domestic marketing of medical devices in the US.

12

AMDD

3. Formulation of Accelerated Review
Action Programthat the Director of the Office of Medical Device Evaluation

In response to recommendations from the May 20, 2008

The MHLW served as a buffer during the heated debate.

Division was calm and collected in addressing the situation.

meeting of the Invest Japan expert panel and with the sup-

The AMDD had initially requested that the PMDA

port from the ‘Honebuto’ Policy approved by the Cabinet

disclose performance data, but the request was declined.

on June 27, 2008, the Medical Device Review Acceleration

Thus, the industry group continued to seek improvements

Action Program began in earnest on December 11, 2008.

by presenting its own results from the Time Clock Survey

The outline is shown below. Almost all of ACCJ’s proposals(Table 1). At the time of the 2008 survey (the foundation

were accepted. Medical device groups, including the ACCJ,

for the Device Lag Survey), participating companies (allreceived approvals ahead of time to increase commissions,

ACCJ members) numbered only 43. Subsequently, the EBC

which serve as funds for additional reviewers, under theand the Japan Federation of Medical Devices Associations

condition that the contents of the recommendations were

(JFMDA) agreed with the significance of the industry

achieved. The IVD industry group did not agree with thiscollecting its own data. As of 2012, 219 of the 347 member

policy, and therefore, this was not included in the action

companies responded (63% response rate), covering 702

program. However, an action program specializing in IVDof 1,213 approved items (PMDA data), which accounts for

was later formulated and achieved similar results.

approximately 60% of the total. With that, we were able

It was also agreed progress would be checked at abiannual review meeting.

to confront the PMDA with overwhelming evidence. As aresult, the PMDA gradually began to disclose performancedata, eventually making it possible to exchange construc-1. Improve quality by increasing the number of reviewers(phased increase from 35 to 104) and by bolstering training
2. Implement a three-track review system (new / improved /generic)
3. C larify review criteria
4. E stablish a standard total review period (median), progress
management• New medical devices (conventional): 14 months• New medical devices (prioritized): 10 months• Improved medical devices (with clinical data): 10 months• Improved medical devices (without clinical data): 6 months• Generic medical devices: 4 months

4. Heated debate at Action Program
Review meeting

tive opinions.
Table 1. Time Clock Survey conducted by AMDD during the Action
Program

Time ofsurveyslow and the reviewers were incompetent, but the PMDA
responded by claiming the quality of applications was poorand the writing was illegible. Despite the fact that the tenorof the meeting was far from typical, it was impressive to see

Organization

Number ofparticipatingcompanies

2008

April 2005
ACCJ Medical Device
43
onwards
and IVD Subcommittee
companies
March 2008
(Now AMDD)

2010

January 2008
onwards
AMDD, EBC,
December JMED (now MT Japan)
2009

214
companies

2011

January 2010
onwards
December
2010

AMDD, EBC, JFMDA

269
companies

2012

January 2011
onwards
December
2011

AMDD, EBC, JFMDA

219
companies

In December 2009, the first review meeting was held. Japanese organizations were quick to claim that reviews were

Surveyperiod

EBC: European Business Council in JapanMT JAPAN: Medical Technology Association of Japan
JFMDA: The Japan Federation of Medical Devices Associations

Figure 1. Comparison of review periods by review field: PMA equivalent products vs. 510 (k) equivalent products

AMDD

13

Figure 2. Relation between the number of inquiries for generics and the total review period (including partial change applications)

5. Two Obstacles Hindering Success:
Generics Reviews and Backlog:

ness of the system in the case of a fully matured organization;

1) Generics reviews

years of review experience, a lot of Buddies for new andhowever, in organizations where 68% of staff have less than 33)Team reviews were conducted on new and improved

semi-new staff will be produced. Additionally, the leveling of

medical devices, and improvement began to be noticed toreview standards across all fields also had a negative effect ofa certain extent. However, no improvement was noted inraising the overall review level.” Based on this view, the PMDA

generics. To investigate the cause, the correlation between

shifted its direction to the formulation of review standards

the number of inquiries and the review period was examinedthat take into account the characteristics of each field.

using data from the 2011 Time Clock Survey (Figure 2). The
3)

dots to the right of the performance goal lines, represented

2) Backlog 4)

by the dotted lines, are items that were not approved within

Backlog was the most burdensome issue during the Action

the overall review period for the items. Although individual

Program. Even though a number of initiatives had been

circumstances are not known, it is surprising that in one case

implemented, considerable backlogs remained in field 2

for a generic, the total screening period was 1,300 days and(dentistry) and field 6 (orthopedics) (see Figure 3) at the end

included 11 inquiries. For generics it was requested that theof 2011.

number of inquiries be limited to 1 to 2 or at most 3.

Backlog was the factor discouraging us the most.

In response to this, the PMDA implemented a Buddy

As long as backlogs remained, performance goals could

System (a system that pairs experienced reviewers withnot be achieved. We motivated ourselves and focused on

inexperienced ones) in April 2011 for the review of genericsolving the backlog issues by remembering that once it was

medical devices. While at the same time, the field barrier

resolved, performance would naturally improve.

was also eliminated to level out the variation across fields.
Although the AMDD was grateful for the PMDA’s initiatives

6. Action Program results 5)

for improvement, we determined that mindset was the mostFrom the 6th Action Program Review meeting, held on July

important factor in conducting generics reviews. For

24, 2012, the boxplot (Figure 4) proposed by the AdvaMed

example, we recommended that reviews focus only on thewas adopted. It allowed us to instantly grasp the upper anddifferences in comparison with previously approved

lower limit proximity values, 25th, 50th, and 75th percentiles

products, and that devices be evaluated in their entirety

in the total review period.

rather than by their raw material components, as in the caseof pharmaceutical products.
The following quote4) from the PMDA on September 2012is about the Buddy System: “We could expect the effective-

14

AMDD

Around this time, the PMDA released new data one after
another. In particular, snapshot data were innovative since
they clearly showed how many backlogged items existed
and where they were.

Words from the Chairman

Former Chairman on
10 Years of the AMDDDavid Powell, Second Chairman (2010 - 2012)
It was an honor to serve as AMDD’s second Chairman, at atime when the members of AMDD were working closely with
doctors, hospitals, governmental and bureaucratic leadership to reduce device lags and device approval gaps. Our
goal was to ensure more people understood the unlimited
potential of advanced medical technology and how suchinnovation could provide a substantial contribution to thereformation of the Japanese medical care system.
I very much appreciated the collaborative teamwork
and leadership provided by all AMDD Board members, theAMDD staff and our member companies on the critical topics we addressed, especially during a period of significant
currency valuation challenges. During this time, AMDD performed detailed data analyses, multi-national comparisonsof medical device and diagnostics approval processes, various reimbursement schemes and shared these and otherinsights with MHLW, governmental and other policy makers
and key opinion leaders. In addition to testifying to governmental committees and working groups, AMDD publishedvarious white papers in our effort to share our findings in aclear manner. With a primary and common focus to accelerate the approval process for new, valuable products into
the Japanese medical system, even competing companies
will put aside their differences in order to collaborate for the
benefit of society.
With the deepest condolences to everyone affected bythis tragic disaster, I was nevertheless very fortunate to see
such collaboration become more impactful, when on Friday,
March 11, 2011, the Great Tohoku Earthquake and tsunami
struck off the coast of Japan. As Chairman of AMDD, it was

As a result of joint efforts of the PMDA and the appli-

very important that all member companies worked together and with key governmental officials and organizations tomeet the critical needs of society, our healthcare system andof everyone directly affected by the earthquake, tsunami
and resulting nuclear disaster. Former Chairman Wang-san,along with others, worked closely with myself and AMDD
leadership to maximize our response.
Immediately after the earthquake and during the ongoing aftermath, AMDD and MHLW realized we needed toquickly create unofficial guidance related to the transportof medical goods through the nuclear zone, into and out of
hospitals and clinics and how to handle product returns, inaddition to other, never-before-experienced situations. It
was a challenging time for society and an important time formy family and me to remain in Japan, to ensure I was able tocontinue working closely with other AMDD and government
leaders, as well as everyone in my company.
I am proud and thankful to have been a part of AMDD
during its formative years and to have worked with so manystrong, cooperative leaders throughout society. We wereable to see the device gap and device lag shrink and begin
the journey of ongoing improvement. I share my deepest
appreciation to everyone who worked hard to help me succeed and to help me learn about the wonderful aspects ofJapan’s healthcare system and society. I wish great successfor AMDD as it enters its second decade.

intensively cleared in the 2nd year.

cants, the backlog was resolved. In the 9th Action Program

However, the 50th percentile is insufficient in terms of

Review meeting (final meeting) on December 17, 2013, it wasapproval predictability. Therefore, the Collaboration Plan

confirmed that all data had shown improvement over 5 years

for Medical Device Review Acceleration (FY2014 - 2018)as compared with the figures at the time when the Action

was started in April 2014 for another 5 years. The theme

Program was initiated. Table 2 compares the results of thewas to improve the quality of reviews and applications,

total review period in 2009 and 2013 for the improved (without additional clinical studies) and generics categories. Data
for new and improved medical devices (with additional clinical studies) are omitted because they include partial change
applications known for extremely short review periods.
Figure 5 shows the transitions of generics review periodusing a boxplot. Not only the median is improved, but also
the height of the box gets lower and the whiskers become
shorter, indicating less variation. It shows that backlog was

Table 2. Comparison of improved (without clinical studies) andgenerics total review periods in 2009 and 20132009 (at the start)

2013 (in the end)

TargetResults

TargetResults

Improved
11 months(without additional
50thclinical studies) percentile

13.2
months41%

6 months
50th
percentile

6.9
months50%

8 months
50th
percentile

12.9
months36%

4 months
50th
percentile

3.5
months59%

Application
category

Generic

AMDD

15

Figure 3. By review field: approval, under review, number of applications (as of December 31, 2011)

Figure 4. Description of Boxplot

Figure 5. Generics approval distribution (total review period)

and the performance goals were switched to a percentile1)	The performance goal was to shorten the total review

method and application cohort, as recommended in the

period, and both government and the industry shared2008 Device Lag Survey. From April 1, 2019, the third roundresponsibilities. The AMDD worked to fulfill its ownof the Collaboration Plan for Optimizing Medical Device

responsibilities while putting forth requests.

Regulations and Reviews (FY2019 - 2023) began. Time2)	Discussions were based on objective data. In particu-

Clock monitoring continues and efforts will be made onlar, counter-data independently collected by industry

the new theme of optimization of regulations and reviews.

groups were available.
3)	The US review system was introduced. This was made7. From Conflict to Dialogue

possible by the effort of AMDD’s RAQA committee

Thanks to the Action Program, relationships between

members, and largely attributed to the contributions

government and medical device organizations, and rela-of Phil Agress of the AdvaMed, who provided muchtionships between the PMDA and applicants dramaticallyinformation about the US FDA review system, and theimproved. The device lag between Japan and the US has

great achievements of Susumu Nozawa, who was based inbeen significantly shortened (Comparison with Europe is

the US (BD at that time) and joined the RAQA Committee.

not made as their system is different.). In some instances,

4) The presence of the MHLW, who acted as a buffer.

products are approved faster in Japan.

5)	US governmental support. Once every six months, weWhat were the success factors of the Action Program?

16

AMDD

were contacted by the US Embassy to report on theContribution

What I have Witnessed in
10 Years of the AMDD

Isao Tanabe, Medical Journalist
Grateful for the past and hopeful for the future
Congratulations to the AMDD on the 10th anniversary. I
revisited the website and recalled the era of the predecessorof the AMDD, the ACCJ Medical Device and IVD Subcommittee (hereinafter “Subcommittee”).
As an Asahi Shimbun reporter, my focus was on newtechnologies and treatments that help patients. Many of the
new treatments are attributed to imaging devices and review
methods rather than drugs. However, many Japanese device
manufacturers are small businesses, and most of themrefused interviews, saying that publicity is not supported by
the MHLW. Around that time, I learned of the Subcommittee,
which had the latest device information from the US, andwas willing to disseminate the information to patients. The
Subcommittee provided us media with technical information on new devices from 2002.
In October 2004, I acted as the moderator in a general
symposium, Toward Patient-Centered Medical Care, held by
the Subcommittee. The speakers; Dr. Yasuhisa Sakurai, Professor Emeritus of Tokyo Women’s Medical University, andSusumu Hidaka, Vice Chairman of the Japan Association of
Cardiac Pacemaker Friends, have since passed away. And
Takako Watt of the Breast Cancer Network Japan (“Akebono-no-kai”) has retired from her 40-year-tenure as Chairman.
I feel the passing of time.
Thanks to the Subcommittee and the AMDD, we wereable to discover and learn about the latest treatments. They

talked about not only minimally invasive devices and technologies that they wanted to sell, but also serious issues
including patient quality of life, prevention of infection andmaintenance inspections, and medical economy. I assume
that it was because the public and patients needed to understand healthcare correctly in the West. I think that these
activities changed public knowledge in various ways, andled to speedier resolution of device lag problem.
I’m retired now but I still go to New Year parties, andI am so happy to see old faces there. I find it very Western when I see not only the former government officials but
also former workers in companies are now working for theirrivals.
It is strange but in Japan, there have been a tug of war
going on, bypassing the patients, between the manufacturers
who want to raise prices and the healthcare professionals
who pay for the products and wish to lower prices.
However, with an aging population and spiraling medical
costs, the survival of the medical insurance system is injeopardy. To continue a system beneficial for the medical
product buyers, patients, and healthcare professionals, it isimperative that we address wasteful medical practices,
excessive medication and tests, and high-priced medical caredisrelated to costs. These are the times when the wisdom
and leadership of the AMDD are once again put to the test.
(Former Asahi Shimbun Staff Writer)

progress to the Director of the International Trade

more effective and safer medicines and medical devices toAdministration’s Office of Japan from the US government.

medical sites faster,” is also our mission at the AMDD.

It’s not our intention to refer frequently to the US but

We would like to pay tribute to the PMDA for achieving

we cannot deny the fact that we learned a lot from them.

“reform close to a revolution” and to Dr. Tatsuya Kondo, its

Our major success factor was that we were able to take fullformer Director who led those reforms.

advantage of the strengths of the US business association.
As a result, we were able to, albeit gradually, create thestrong relationship we have now. We were rewarded when the
PMDA requested us to provide training for new employees, as
the PMDA had been adamant about not relying on theindustry. We were able to work together on the inspection
and training at AMDD member-company manufacturing
facilities and their training facilities. As those opportunities
increased, the PMDA was able to gain a deeper understandingof the products and know-how needed for reviews.
Now the PMDA has become an Asian leader and theReference1)	ACCJ Medical Device and IVD Subcommittee:“2008 Device Lag Survey:
Supporting Governmental Initiatives to Accelerate Reviews (October2008)”
2)	MHLW: Medical Device Review Acceleration Action Program, December
11, 20083)	Junko Kodama: “Medical Device Review Acceleration Action Program:
The Outlook from the Turning Point: 2011 Time Clock Survey”, Pharmaceuticals and Medical Device Regulatory Science. 2011, 42 (7). P. 573-9.
4)	Junko Kodama: “Medical Device Review Acceleration Action Program:
3rd Year Validation”, Pharmaceuticals and Medical Device Regulatory
Science. 2012, 43 (9). P. 811-22.
5)	Junko Kodama: “Medical Device Review Acceleration Action Program:

PMDA of the world. The PMDA’s philosophy, which translates

Final Year Validation and New Collaboration Plan”, Pharmaceuticals andas: “We strive to be a bridge of hope for patients by delivering

Medical Device Regulatory Science. 2014, 45 (4). P. 306-21.

AMDD

17

10 Years of Innovation Saving
Patients

Orthopedic Surgery (Artificial Joints)
History of artificial joints and the current status
Artificial joint replacements has evolved by the developmentof implants during the past 50 years. Improved materials haveextended durability exponentially, which is directly linked
to long-term results, and improved design has been reviewed toreproduce function close to human biology. The surgical procedurecontinues to evolve dramatically, including patient-friendly minimally invasive surgical techniques, effective approaches to earlyrecovery, and currently robot-assisted improved precision.
With these developments, the evaluation of artificial joint
replacement has moved from the search for simple long-term
results to the evaluation of their range of motion, and to patientsatisfaction today.
It is no exaggeration to say that the current artificial joint
replacements are expected to provide stable long-term results forjoint diseases such as osteoarthritis and rheumatoid arthritis.
These developments in artificial joint replacement haveshortened the length of hospital stay and accelerated recovery,
resulting in higher patient satisfaction. The number of cases,
even with knee conditions alone, has doubled in Japan over the
past decade; however, its prevalence rate is far lower than thatin other countries, which is not well known. Westerners whovalue an active life choose artificial knee joints at an early stage
if they experience strong pain and X-rays confirm a decreasein the cartilage tissue around the knee joints. In Japan, thenumber of hip replacement procedures are only 1/4 of theaverage in OECD countries, and knee replacements, only 1/2.
In particular, when compared to the countries with the highest
number of cases, the number of hip joint replacements are 1/7
or less and knee joints, 1/4 or less in Japan.

The importance of maintaining mobility
in aging societies
Japanese have one of the top life expectancies in the world.
However, the bones and joints are not able to cope with thelonger life-span. The main cause of long-term care is stroke forthe pre-elderly (65 to 74 years old), and is motive organ
disorder, including debility due to aging, fractures and falls, andjoint diseases, for the very elderly (older than 75 years of age).
Furthermore, motive organ disorder is not only a causative
disease for support or long-term care, but also a risk factor forindirect dementia and long-term care that hampers social
participation. Arthrosis affecting motor system, particularly
joint function, is directly linked to healthy life expectancy. For
arthrosis of the knee alone, there are already 10 million patientswith painful joints. The number of potential patients is said tobe about 30 million. Early intervention can reduce medical
costs and realize improved QOL and prolong healthy lifespans.
In this way, orthopedic medical devices contribute significantly to extend healthy life expectancy. If patients receive
appropriate diagnosis and treatment options, they can havethe opportunity to take an effective course of action at an earlystage, including surgery before the bones and joints weaken.
This can reduce the risk factors of indirect dementia and longterm care that hampers social participation.

18

AMDD

To realize this, for example, diagnosis of joint function(beyond patient inquiry / X-rays) can be added to health checkups. Then, the risk of developing arthrosis can be identified at
an early stage to pave a way for an appropriate treatment intervention.

Economic backgroundThe economic impact of undermining healthy life expectancy
is enormous. It has been suggested that knee joint damage
has a major impact on a country’s economy. A study by theAmerican Academy of Orthopaedic Surgeons concluded that
artificial knee joint replacement can save approximately 40,000
dollars in medical treatment costs, which brings the social benefit between 10,000 to 30,000 dollars1). According to the economists’ survey, hip replacements in Japan can reduce eventual
medical costs by more than 2.9 million yen2). Research on
direct and indirect costs for the treatment of end-stage knee
osteoarthritis found that total knee replacement (or total knee
arthroplasty (TKA)) is a very effective operation, and 90% of
patients reported that they are pain-free, return to work, andhave a significantly improved standard of living. The researchalso reveals that bone and joint disorders account for a numberof workdays lost for 440 million workers per year, surpassing
any other medical condition3).
However, many of the joint conditions are chronic, progress
relatively slow, and they are overlooked and viewed as part of
the aging process. Restoration of worn-out joint cartilage to its
original condition is difficult and such cartilage gradually deteriorates with age. If patients put up with pain over many years
and postpone treatment, sarcopenia may develop. Then the
innate mobility is undermined; loss in terms of social contribution is extremely large.
Approximately 3.5 million workers are taking care of theirfamilies, and every year over 100,000 of them leave their jobs
to give care and nursing. Reducing the risk of dementia andlong-term care can result in mitigating the risk to patients, theirfamilies, and people around them in regard to their social participation and economic activities.
Improving in-depth knowledge of the general public onknee and hip joints is an important agenda in a super-aging
Japanese society. Information overload, a harmful effect oftoday’s information society, makes it difficult to select reliable
information. Against this backdrop, the AMDD’s Orthopedic
Committee has a duty to actively improve correct healthcare
literacy for citizens, together with local governments andmedical institutions.

Reference1)	http://newsroom.aaos.org/media-resources/Press-releases/benefitsofkneereplacement.htm#rel2)	https://www.advamed.org/sites/default/files/resource/eiu_study_final_japanese.pdf
3)	Burden of Musculoskeletal Disease, U.S. Bone and Joint Initiative, 2011

10 Years of Innovation Saving
Patients

Orthopedic Surgery (Spine)
In recent years, the outcome evaluations and healthy life expectancy that are discussed in the context of medical administration, are strongly related to lifestyle-related diseases and medical disorders. Meanwhile, no matter how healthy the internal
body is, if the musculoskeletal function supporting it is not ingood condition, a patient is not truly in good physical health.
Looking at the future social structure of Japan, it is very important that people stay active suitable to their age and lifestyle.
Daily activities such as walking, standing straight, sitting on a
bed or wheelchair, swallowing and breathing without problems
are all deeply related to the vertebra (spine). To achieve true
quality of life, the spine literally functions as a backbone.
To deliver optimal and safe treatment for patients with spinal disorders, the spinal surgery field, and the medical devices
and systems for such use, have evolved significantly over the
past decade. The following three innovations are introduced:

1. Innovation for minimally invasive surgery
Traditionally, it was necessary to approach spinal surgery
with a large incision and opening up of skin and muscle (Figure1). However, with the development of minimally invasive surgery that reduces damage to the body, the development andimprovement of medical devices for such surgery are now intheir advanced stage. Typical examples are a discectomy of alumbar disc herniation under endoscopy and microscopy, percutaneous pedicle screw fixation using a cylindrical surgicalinstrument (Figure 2), and percutaneous vertebroplasty that
performs percutaneously balloon dilation and cement injection
for spinal compression fractures. These minimally invasive surgical procedures significantly reduce operation times and blood
loss, contributing to shortened post-operative hospital stays.
Medical device manufacturers are shifting their efforts from
simply selling the products to the industry-government-academia initiatives to offering training for introducing new technology and calling for safety in cooperation with academic societies and the PMDA.

Figure 1

2. Innovations for improving surgical safety
As surgery has become less invasive and the patient population
undergoing spinal surgery continues to expand, improvementof safety has become increasingly more important. In order toachieve more accurate surgery, navigation systems assisted bycomputer technology are gaining ground. Based on image datataken before surgery with an X-ray fluoroscopic apparatus, a3D simulation is performed to determine the insertion position
and angle of spinal screws. Benefits during surgery include
accurate surgical operations by overlapping the operation sitewith a planning image displayed on a monitor, and lower radiation exposure to both the patient and physician due to reduced
use of fluoroscopy. In order to mitigate the post-operative riskof nerve paralysis, a nerve monitoring device was developed
to observe changes in neurological symptoms during surgery.
Devices and software aimed at improving the safety of spinal
surgery continue to advance.

3. Innovation for maximizing clinical outcomes
Innovations for maximizing clinical outcomes obtained from spinal surgery derive from the products and from evidence-building. Examples derived from products include vertebral cages
that are surface-treated with titanium for better fusion withpatients’ bones, cervical artificial vertebra discs that preserve
cervical spine mobility, and new bone grafting materials (humandemineralized bone matrices) with osteoinductive characteristics. Examples derived from evidence-building include a surgical database in the form of a registry, which the Neurospinal
Society of Japan and the Japanese Spinal Instrumentation Society are working on. These efforts of collecting big data in the
spinal field facilitate Japanese evidence-building and global
transmission of the information.
Innovation in the field of spine surgery outlined above willcontribute to preventing people from becoming bedridden, anurgent issue for Japan, and to the shift from hospitalization tohome care and nursing. Comprehensive innovation in the spinal
field that combines hardware including medical devices, andsoftware including education, evidence-building, and patientawareness, are indispensable for healthy Japanese life expectancy.

Figure 2

AMDD

19

Round-tablediscussion
Central Social Insurance Medical
Council (Chuikyo) Discussion

Chuikyo and 10 Years of the AMDD and Beyond,as Told by Successive Expert Members
Attendees (in order of term of office)Mitsuo Hirose (1999-2005), Maverick Group representative, former President of Johnson & Johnson K.K.
Akira Matsumoto (2005-2011), Director at Rizap Group, former President of Johnson & Johnson K.K.
Makoto Tamura (2011-2017), Head of AMDD Medical Technology Policy and Research Institute, former Vice Presidentof Abbott Japan Co., Ltd.

Tamotsu Hiiro (2017-2018), President and CEO of McDonald’s Japan, former President of Johnson & Johnson K.K.
Toshifumi Hayashi (2018-present), Director of the Government Affairs at Edwards Lifesciences Ltd.
Kosuke Kato, AMDD Chairman, President of Edwards Lifesciences Ltd.
Junko Kodama (Moderator), Chair of AMDD Public Awareness Committee, Senior Director of Public Affairs at Edwards
Lifesciences Ltd.
(Titles are as of the time of the roundtable discussion)

The expert members of the Special Committee on Medical Materials under the Central Social
Insurance Medical Council (Chuikyo) are representatives of member companies of the AMDD or
its predecessor, the ACCJ, who have been delegated by the MHLW. They have expressed theirfrank opinions concerning medical fees and other issues from the viewpoint of the medical devices
and in-vitro diagnostics (IVD) industry.
Here, we look back discussions at Chuikyo over the past 20 years with five former and incumbent
expert members, and asked them to talk about the achievements and difficulties within the industry,
together with a few anecdotes.

20

AMDD

The decades before and after Chuikyo
participation
Kodama (Moderator): I am excited to see here former andincumbent expert members of Chuikyo. Thank you all for
coming today.
Kato (Chairman): I would appreciate it if we could
discuss how we struggled to bring good medical devices
to Japan, and if we could talk freely along those lines.
Hirose: Yes, that’s the backbone. That is the reason that
I wanted to create the predecessor to the AMDD. In those

Mitsuo Hirose

days, even if you joined a Japanese organization torequest something to the government, the Japanese

Hirose: The Japan Medical Association was mostorganization didn’t understand about foreign manufac-

opposed.

turers and avoided you like the plague. So, it was only aMatsumoto: There were differences in the arguments ofmatter of time before we decided to create our own

Chuikyo and that of the AMDD. Basically, Chuikyo is theorganization. The ACCJ Medical Device and IVD

place to discuss money, most importantly medical fees,

Subcommittee (hereinafter, the Subcommittee), thethen naturally drugs. Materials came last. We weren’t

predecessor to the AMDD, was created within the ACCJ

a major player. However, back then, in the latter half ofby three individuals; myself, 3M Medical’s Sam Narbon,

Hirose-san’s tenure, I remember various issues surfaced.

and Becton Dickinson’s Mark Thorndal.

Kodama: Yes, let me just go through those issues.

Kodama: Hirose-san, you belonged to the Subcommittee,

Foreign Average Price (FAP) was introduced in 2002,

but what led you to become an expert member atduring Hirose-san’s term. Prior to that, because of the

Chuikyo? According to our records, you’ve been an

Prefectural Purchase Price System, medical devices wereexpert member since 1999.

given late approval although their prices were freely set

Hirose: Since around 1997, we had been frankly expressing

by the manufacturer. In 2000, the Prefectural Purchasewhat we wanted. Then the MHLW was suggesting

Price System was abolished.

it would be better to include a foreign representative.

In Matsumoto-san’s term, the phrase “innovation

When I told them to consider foreign-affiliatedevaluation” started to be heard, and in 2012 during

companies more, they asked me to join.

Tamura-san’s term, Australia was added to the FAP.

Kodama: So after asserting yourself, you got a seat.

A new evaluation rule was set up for accelerated

That’s how it started, isn’t it?

introduction of insurance. Those days were marked by

Hirose: You have to keep asserting, even if they dislike

volatile exchange rates, and the establishment of theyou for it. Eventually, they’ll listen to you.

Special Committee on Cost-Effectiveness Evaluation

Hiiro: So the expert membership started around yourunder Chuikyo in 2012.

time?

Owing to the prevailing view within the AMDD that theHirose: Yes, I was the first.

insurance system would not work, a value-based

Hiiro: I thought so. Was there a medical device expert

health care project was launched which led to a C1

group before that?

challenge in Hiiro-san’s term. Along with the C1

Hirose: There was a materials committee.

challenge application (a mechanism that allows the

Hiiro: Who was the representative?

reimbursement application as C1 for those products

Hirose: The one perceived to be the head of thewhose safety, effectiveness, and medical economics arematerials committee was Kenichi Matsumoto, theverified based on post-marketing clinical and non-clinical

President of Sakura Seiki. One thing we were grateful fordata), B3 (time-limited improvement premium) came

was that Kenichi Matsumoto, who spent half his time inalong, though from the government. Then, in 2016,

the US on business, was a veteran and always there to put

during Hiiro-san’s term, a trial of cost-effective analysis

in a word for us in Japan when we consulted with him.

began. In each term, there were big challenges. Can you

Kodama: How were things at the Chuikyo at that time?

all give us your opinions on them?

I heard you were bombarded with questions at the start.

AMDD

21

Medical device innovation and device lag

However, those circumstances didn’t stop the march

Matsumoto: After the Plaza Accord on September 22,

of innovation, which contributed to patients and manu-

1985, the exchange rate at the time of 240 yen to the US

facturers, especially foreign manufacturers that enjoyeddollar fell to 150 yen in one year due to the appreciation

tremendous growth. Then, a slowdown of innovationof the yen. For foreign companies in Japan, the price wasfollowed. The device lag was almost resolved. But, thecheaper because they were importing products. Anotherensuing economic downturn in Japan increased burden

thing was the innovation, that started around 1990. If you

on social security and price issues were hardly solved.

compare medical devices from around 1980 with those

Kodama: Tamura-san, tell us about your term, whicharound 1990 and 2000, they are completely different.

came after the very lucky and blessed term ofHirose: That’s very true.

Matsumoto-san.

Matsumoto: Innovations over the last 30 years changed

Tamura: During my time at Chuikyo, there were specificmost of healthcare to become minimally invasive one.

debates on what to do with innovation evaluation. I joined

However, the biggest problem Japan was facing in those

the ACCJ Subcommittee in 2004, and six months later I

days was the economic downturn, especially after the end

became Chairman of the insurance committee. I was told inof the Cold War in 1990, and rising medical expenses. This

2005 that the drastic relief measures in repricing would be

prompted the necessity to reduce the length of hospitaltightened. So Matsumoto-san, who was with Chuikyo at thestays. The most effective way is to make medical treat-time, told them on my behalf that if that happened wements minimally invasive. So most innovations have been

would be squeezed. A physician in Group 2 was infuriated,based on minimally invasiveness.

yelling that it was out of the question especially since

I remember, laparoscopy started in 1989; now, laparos-

people in Japan regard the price differences between Japan

copy is mainstream, with more than half of all operations

and overseas as a big issue. I really felt that Chuikyo was abeing conducted laparoscopically. And intervention

scary place. When the meeting was over, Matsumoto-sanbegan in the mid-1980s at first it was the balloon, but

said to me in an easy-going manner, “That was tough, butduring Hirose-san’s term, we saw the arrival of thethey are just making a big fuss about it.”

Palmaz-Schatz stent (Japan’s first coronary artery stent).

In the end the government agencies didn’t squeeze

Following that, Cypher gained tremendous popularity.

things that much. Just a soft squeeze. But recently,

That’s a drug-eluting stent, which is a stent coated with a

medicine is being squeezed a little too much, making

drug to prevent restenosis of the coronary artery. Then wethings difficult. In Hirose-san’s time, things were toughsaw the arrival of the robot, da Vinci. So to be honest, my

at Chuikyo, though in Matsumoto-san’s era, things got

term was most eventful; the appreciation of the yen and theeasier probably due to Matsumoto-san’s skilled way ofdevelopment of innovations continued. The market signifi-

dealing with things.

cantly expanded in that era, from 1990 to around 2000.

Hirose: It’s true. Their attitude was completely different.

Hirose: Yes, that was when the market was booming.

In my case, physicians in Group 2 just told me all I did

Matsumoto: So the real problem during my time atwas sophistry. You had to fight in those days. With a little

Chuikyo was device lag. Even though new products wereadvancement of innovation later on, things began todeveloped, Japan was slow to give them approval. In achange, especially in the case of stents and minimal

similar sense, a device gap was also an issue.

invasive procedures. Physicians then had to learn newtechnology. When Matsumoto-san was President of J&J,
he focused on training and invested heavily in it.
The good thing about working with devices is that
unlike pharmaceuticals, there is training before the sale,and assistance after the sale. Physicians come to the
manufacturing company to receive training and that’s
why they come to know the hard work on our part.
Kodama: Yes, that is the big difference between medical
devices and pharmaceuticals. The ACCJ has always
appealed through the AMDD that medical devices are

Akira Matsumoto

22

AMDD

different from pharmaceuticals. Do you have any

opinions on that?
Hiiro: Well, just as Hirose-san said, when I went to the
medical associations and spoke to physicians in Group 2,
I always told them that pharmaceuticals were different
from medical devices and that medical devices came withtechnology and had a learning curve. When I was there,
there were discussions about cost effectiveness, so I
asked them to not evaluate the devices merely as objects
and to remember that the technology is an integral part ofthem. That is the characteristic that sets them apart.
Kodama: Did that understanding deepen within Chuikyo?

Makoto Tamura

Hiiro: I would say that Chuikyo was the place for

immediately before the revision, Chuikyo didn’t hold adebates in the times of Hirose-san and Matsumoto-san,meeting. In mid-November, Chuikyo finally resumed

while in my and Tamura-san’s time groundwork was

operations. As an industry group, I was very worriedlaid outside of Chuikyo at meetings called “Hiraba”

about a possibility of decisions being made by somewhere(level ground). During “Hiraba” meetings, we bargained

else, so I escalated my concern to the Insurance Bureau,with a view to form consensus rather than debating. As

begging for the resumption of Chuikyo. Although I’ve

Matsumoto-san said, medical devices were last on the

been counter-attacked for my opinions expressed duringlist; medical fees, drug prices, and then medical devic-“Hiraba” meetings, if you don’t assert your opinions on

es. As such, public interest was not so high. I didn’t

that field, the checking system won’t work.

mention it much during “Hiraba”, but I strived to send

Hiiro: The assertion was rather for warning than forour messages outside Chuikyo.

discussion.

In fact, we asked the Group 1 (payer) members to

Matsumoto: Everything is recorded at Chuikyo. Everything

come over to our Tokyo Science Center. We showed

you say is jotted down. So I wrote everything down inthem a tremendous number of orthopedic instruments

polite terms before speaking at Chuikyo.

and explained that they are lent and returned. Also, we

Tamura: It’s a bit technical but when we debated about

actually demonstrated physicians’ training. Thesetransfer prices, Matsumoto-san explained it really well,experiences eventually made them grasp that theand those members on the payer side agreed with his

technology and products are inseparable.

point, keeping us on the right track.

Matsumoto: As long as we had a fair argument, no intense

Matsumoto: What was particularly good in my term was

rebuttal would come. So, we felt there was nothing we

support from those on the medical side, as I had quite a

could do but to correctly say the right things. Everyfew medical professional acquaintances. Dr. Takamasa

company pursues the profit, but what’s different about

Kayama made some radical remarks, but when I explained

the healthcare business is that their priority is thewell, he understood. You know I resigned as President ofpatients. Next comes the healthcare workers. Training

J&J and created an association to increase surgeons

was really for physicians to learn the correct way to use(NPO: The Committee to Encourage New Surgeons).

the devices.

Even at that time, if it were not for Chuikyo, medical fees

Kodama: It boils down to our wholehearted purpose towould not have increased. For companies affiliated withensure that physicians use the devices safely on thethe AMDD, the material price was a very serious issue,

patients.

but medical fees were more important. If medical fees

Matsumoto: We know our devices better than anyone else.

drastically decrease, drug and material prices will be

Therefore, I gave thorough training for our employees.

affected. So in a sense, logical explanation can convince

Tamura: I was reminded how important Chuikyo was inboth Group 1 and Group 2. During my tenure, surgeon

2009 when there was a change in government and thefees increased by 30 - 50%. That was when Akira Nagatsu-

Democratic Party of Japan became the ruling party, andma was the Minister for Health, Labor and Welfare in the

Chuikyo didn’t hold a meeting for a month. The

Democratic Party Administration.

Democratic Party that took power in September wanted

Hiiro: The estimation method of Gaihoren (Japanese

to make big changes to Chuikyo. In October, despite being

Health Insurance Federation for Surgery) was very good.

AMDD

23

committee in the process. Large-scale devices joined
Chuikyo around 2008, but IVD officially joined in 2016. Halfof the cases that passed C1 and C2 over the past year were
technical fee inclusive. The ratio of STM is decreasing.
Going forward, medical device programs and digital
items for the most part will be technical fee inclusive, so
I think the big issue for the AMDD and Chuikyo is how todeal with that.
Hiiro: Yes, that’s very important.
Tamotsu Hiiro

Technical fee inclusive or by function?

Debate of in-vitro diagnostics (IVD)

Matsumoto: Although it’s not written anywhere, techni-

Hayashi: By the way, diagnostics are part of AMDD’s

cal fees basically don’t decrease. They may increase on

portfolio. When Tamura-san was an expert member,occasion. There is no logic that material fees increase.

he said he’d like to express opinions on IVD at Chuikyo.

Therefore, the technical fee evaluations are not neces-This made it possible to input IVD in the framework

sarily bad even if recent cases are subject to technicalwithin the materials section.

fee evaluation after applying for C1 / C2.

Hirose: At the beginning of the ACCJ era, diagnostics were

Kodama: You have changed. You used to say no to

not included.

technical fee inclusive, didn’t you?

Kodama: Is that so?

Matsumoto: Frankly speaking, I have changed.

Hirose: A company called Ortho-Clinical Diagnostics

Hirose: Now they say technical fee inclusive is getting(OCD), a subsidiary of J&J, had paired devices andbetter.

diagnostics. The headache for them was that they had to

Matsumoto: Going back to 1998 during Hirose-san’s

file approval application for reagents as pharmaceuticals

tenure. Hirose-san made sutures technical fee inclusive.

and devices as devices. So IVD was added in the ACCJ

Hayashi: It was 1996.

era. And the name was changed to ACCJ Medical Device

Matsumoto: It wasn’t good to make it technical fee inclu-

and IVD Subcommittee.

sive at that time. Though, it’s better that way now.

Hiiro: I joined the ACCJ Medical Device and IVD

Tamura: There are discussions as to whether technical

Subcommittee and formed a consortium.

fee inclusive is good or STM is good, but in fact there are

Tamura: The Japanese Promotion Council for Laboratory

many materials that don’t fall into STM but only fall into

Testing.

the technical fee inclusive option. However, because the

Hiiro: Tadashi Suzuki and Kunikazu Teraoka from therules for inclusiveness are not so clear, I think a little

OCD were involved in the establishment of the consor-

more predictability is needed.

tium. It was truly groundbreaking in that the consortium

Hiiro: I think technical fee discussion as to whether

incorporated academia including the Japanese Society

technical fee inclusive or STM is increasingly import-of Laboratory Medicine and the Japan Registeredant. It boils down to a discussion of what to do with

Clinical Laboratories Association that include the SRL

the functional category. Some prefer category by brands,

and the BML to which tests were outsourced. If you
made a proposal through the consortium, they (MHLW)
listened to you. As a result, the downward revisions of
medical fees for tests stopped. Similarly, a consortiumwith academia was created for large-scale medical
devices, and then, medical fees increased.
Kodama: Staying silent doesn’t help after all.
Hiiro: We learned that it’s better to include academia in
addition to the industry to facilitate talks with the MHLW.
Tamura: Since tests and large-scale devices involve
technical fees, it was difficult to engage the materials

24

AMDD

Toshifumi Hayashi

and others prefer category by function. Realistically,
considering the number of medical devices, it would
be difficult to classify by brand.
Going forward, there will be cost-effectivenessevaluation, with ever more complicated FAP, it may bebetter to leave the current functional category as it is. Or
I personally think that while making certain things technical fee inclusive, the industry must steer toward the
direction of innovation evaluated in more highly fragmented functional categories. However, no consensus has
been reached and it’s going to be difficult.
On the premise that technical fees and the evaluation

Kodama: The AMDD also have prepared to take a hit andof medical materials are inseparable, what the industry

started a value-based healthcare project.

wants to do with the system of functional category overMatsumoto: On the other hand, there may be too muchthe next 5 to 10 years will be very important. I think thatprice erosion, depending on the product. This will kill us

the industry must debate this based on Hirose-san’s andall, and will be a particular blow to the hospitals.

Matsumoto-san’s past experiences and what they have

Hirose: Product creation with an aim to reduce hospitallearned.

costs is now underway. If hospital costs are down, one

Tamura: The functional category now has a special case,physician can do the work of six to seven physicians

and now we have B3, so functional category is gradually

because the rest will be handled by AI medical devices.

changing.

That kind of product creation is ongoing.

Hiiro: At the time of the most recent revision when I was an

Tamura: That sort of effort is also in line with work-style

expert member, that was a much debated topic. Medical

reforms, but there is debate on whether medical fees

devices are improved as we fine-tune it along the way, andshould be lowered as costs are lowered due to less work-

this fine tuning process has been recognized to date toload of the healthcare workers. If medical fees are low-some extent. But from the standpoint of those who madeered, we, the provider of technology, will be also affected.

the functional category, they don’t welcome the request for

How to address this is going to be extremely important

premiums for such minor improvement. But we say that

discussion in the future. When the MHLW officials came toincremental innovation is important for medical devices,

the AMDD for a lecture the other day, we asked that ques-

and it’s unlikely that something like Opdivo becomestion, and their answer was that it would be a fixed pay-suddenly available. We negotiated how to make themment or value-based healthcare or that sort of direction.

evaluate incremental innovation. So at this time, there wasa trade-off; the replacement addition (B3) was introduced
while C1 challenge application was available.

What is important in the future debates with
Chuikyo

At Chuikyo, I showed them an old pacemaker and the

Kodama: Now, how do we go about working withcurrent leadless pacemaker, and explained that it wasn’t a

Chuikyo? Would you advise Hayashi-san, the newest

giant leap from the old to the new but rather incremental

member of Chuikyo?

improvement that led to gradual miniaturization.

Matsumoto: Superficial measures would go unheard. It’s

Matsumoto: The miniaturization and the price are two

important not to lose sight of the bigger picture and keep

different stories. Innovation is advancing, but costs areon asserting what really matters. I served as a member atbasically going down. So it’s unreasonable to ask to raise

Chuikyo for 6 years, but I’ve never touched on anything

the price. It is needless to say that for the top management

other than bigger issues. I only talked about the fundamen-

at every company prioritizes the interest of their own

tals. In most cases such fundamental stuff went through.

company, but egotistically arguing for their own inter-

Sometimes I’ve had to lay the groundwork in advance.

ests gets them nowhere. So in a sense you have no choice

Kodama: And we must continue that stance.

but to take the greatest common denominator. Then,

Matsumoto: We are not real estate agents or land

when a decision is made, some may suffer a loss, but

speculators. Our work exists because of the presence

overall that will not be the case.

of patients, so we must not forget the fundamentals.

AMDD

25

on chemical compounds, then on biologics, and now on
genes. Since the base has changed, people in theindustry also must change. Then we’ll see new products
coming about.
Kodama: So ultimately, the more AMDD member
companies develop new products, the more theirposition is strengthened.
Tamura: The fields of structural heart diseases andneuromodulation are steadily but surely expanding.
Kosuke Kato

Hirose: Autologous cell sheets regenerated from
cells, and autologous knee cartilage in orthopedics

Kodama: Yes, if that fails to be communicated, no one

were developed through the partnership of alistens to us.

machine manufacturer and a biotechnology company.

Tamura: The Government credited us with proactive

Collaboration among sectors may significantly change

proposals of new ideas in value-based healthcare. And

the medical device field.

some are now realized. For pharmaceuticals, we made a

Kodama: We’re now in an era where it is difficult for one

balanced proposal of new drug innovation premium, andcompany to complete the whole process.

that was also very positive.

Matsumoto: Many great products have been developed

This isn’t just the work of the expert members, but

in 10, 15, 20 years prior to the last decade that was quite

it’s important to make positive and sensible proposals

uneventful. For example, stents later evolved into

as an industry group. Some people will poke holes indrug-eluting stents. And laparoscopy came about.

what you suggest, but Hayashi-san should persevere on

Kodama: We also had transcatheter aortic valve

the “Hiraba” of Chuikyo.

implantation (TAVI).

Hiiro: It may be a bit technical, but I have two points to

Hayashi: The revisions over the past few years

make. First, in the past, discussions on medical devices

comprised of two parts; evaluation of innovation andwere limited to those precisely on devices, but thesefinancial issues. Listening to what’s being said, the mech-days the drug product movement is so rapid andanism for evaluating innovation enabled a number ofcost-effectiveness of medical devices is also discussed

things. So, as an organization we need to clearly convey

along with pharmaceuticals. So, I think we must makethe value of innovative medical devices, to send out our

medical device claims based on how the policy on

messages what must be evaluated, and to make thepharmaceuticals works out, and how the technical fee

message understood at Chuikyo. Even with smaller

debate mentioned earlier works out. So, as Matsumoto-sanchanges, there must be a value proposition for patients.

said, with the whole picture in mind, it is necessary to

Hirose: That is what we must continue.

see how to position medical devices within it. In that

Matsumoto: Decades ago, the Premium for innovative-sense I think the current committee members have a lot

ness was established, but has there been any otherof work to do with a full knowledge of all of these things.

system in place since Cypher?

My second point is related to advocacy. They say,Hayashi: Nothing. The Premium for innovativeness was“Make friends before you need them.” It’s too late to start

applied for Cypher for the first time, and that’s it.

making friends when you need them. So making friends

Matsumoto: That was 15 years ago in 2004.

before you need them is very important. You must have
happens, which need to be discussed.

Making more people understand medical
devices and IVD is key to the future

Kodama: Hirose-san, any advice for Hayashi-san?

Tamura: However, for very innovative products, theHirose: I think it’s true that we scarcely see the advent of

reimbursement price may be determined by the cost

breakthrough technology in recent years. The less break-calculation method. Thus, we can’t simply say that it isthrough technology, the weaker our position in Chuikyo

problematic if we do not have the Premium forbecomes and so does the position of the industry. The

innovativeness. Another thing I’d like to point out tobase for drug research has changed. Initially it was based

Hayashi-san is that it’s the government that makes thea framework for discussion ready before something

26

AMDD

final decisions after all, so it’s extremely importantto have someone in the government offices who isknowledgeable about medical devices.
For example, a medical officer had been in the medical
division prior to moving to the economics division where
he stayed until last year. He is concerned about medical
devices. During his tenure in the medical and economics
divisions, he was tough on us time to time, but his approach
was balanced as he did a lot of positive things based on
his deep understanding of medical devices. What’s more,
he held study groups for young people at the Japan

Junko Kodama

Association for the Advancement of Medical Equipment

Even today, surgical medical fees are not that good,(JAAME) when he was in Japan. Even after studying

but much better than back then. Just because we areabroad, he regularly participates in the study groups by

medical device manufacturers does not mean we should

Skype. He tries to understand and support the medical

only consider medical device issues. We have to take thedevice industry. I’d like to see more people like him.

entire industry into consideration.

Hirose: That’s great. That’s the kind of people we need.

Kodama: And finally, Chairman Kato, could you give us

Hayashi: During discussions at Chuikyo, I must speak

your thoughts?

carefully while considering advice from everyone. In the

Kato: I don’t know about Hirose-san’s era, but

meantime, we deliver our message to stakeholders with

Matsumoto-san used some interesting caricatures tothe help of all our experienced predecessors. I suppose

impress Chuikyo. It was amazing. Tamura-san took athat is one of the goals for the AMDD.

theoretical approach, while Hiiro-san was like a sales-

Matsumoto: In my experience, payers were not necessarilyman, dealing with both Group 1 and Group 2 as histrying to make everything cheaper, and medical

customers. So it remains to be seen how Hayashi-san

professionals were not necessarily trying to raise only

will work to make further improvement on their legacies.

medical fees while reducing material costs. If things were

I hope he can even outplay his predecessors.

explained properly, they understood. That’s why, when the

As Hirose-san mentioned, the drug development stage

number of surgeons decreased and something needed to be

is changing, and in recent years there’s been no innova-

done, I thought about devising a way to raise medical fees.

tion in medical devices. Increased change means that theAt that time, Dr. Kayama, Dr. Itsumi and I asked thedevelopment stage may be also changing. AI isn’t fully

President and the Vice President of the Gaihoren to makedeveloped and it is not something you actually realize,

a statement for us at Chuikyo. It was a great statement.

hence the concept of STM is wearing thin. How to keep

Afterwards they (including public labor committee mem-holding discussions on technical fee at the STM commit-bers) said they didn’t realize that things were so bad.

tee is a very important mission in a mid to long-term.

Despite their busy schedule, the Gaihoren used theHirose: Let’s leave it there.

National Clinical Database (NCD) to classify surgery into

Kodama: I would like to thank all of you for taking time

A, B, C, D, and E depending on its level of difficulty.

out of your day to participate in the discussion today.

Medical fees were raised to 50% for E and 30% for D.

(Recorded in Tokyo on April 17, 2019)

AMDD

27

10 Years of Innovation Saving
Patients

Cerebrovascular Disease
The third leading cause of death in Japan: Finding theanswers to the treatment of cerebrovascular disease
Cerebrovascular disease (stroke) kills approximately 110,000 people each year, making it the third leading cause of death in Japan*.
* MHLW, 2017 demographic statistics (determinate number)

Stroke can be roughly divided into hemorrhagic cases
including subarachnoid hemorrhage which is caused by ruptureof the cerebral aneurysm, and ischemic cases causing cerebral
infarction due to a thrombus. Both hemorrhagic and ischemic
cases may cause paralysis, language disorder, and motor
dysfunction, which results in long-term nursing care, becoming
bedridden, or death.
Minimally invasive advanced medical care has developed
over the past decade. This contributes to reduced physicaland mental burden for a wider range of stroke patients andimproves their QOL after recovery.

The age of post-platinum coils
The first treatment developed and introduced as a minimallyinvasive procedure for cerebrovascular disease was cerebral
aneurysm coil embolization (endovascular treatment) thattreats or prevents ruptured cerebral aneurysms. Unlike conventional craniotomy, endovascular treatment uses a catheter thatis inserted into the blood vessel and guides a thin, soft spiralplatinum coil to the cerebral aneurysm. This treatment fills the
cerebral aneurysm with the coil to stop the blood inflow into
the aneurysm and prevent bleeding from the rupture of aneurysm. This treatment introduced to Japan in 1997 became aforerunner of minimally invasive treatment.
However, performing coil embolization on an aneurysm
which has a wide entrance (neck) was very difficult. To that end,
adjunctive stents were introduced in Japan in 2008. Adjunctive
stents were developed for the purpose of preventing protrusion
or deviation of the coil mass from the parent artery during coilembolization, even when the aneurysm entrance is wide.
In 2015, flow diverters, the first stent-like device for treating
cerebral aneurysms, were introduced in Japan. These devices made it possible to treat large and giant aneurysms (only for
aneurysms with a maximum 10mm diameter and 4mm neck,and excluding rupture acute phase aneurysms), which had
been defined as difficult-to-treat cerebral aneurysms. Such difficult-to-treat cases are as follows: even with treatment, bloodflow into the cerebral aneurysm cannot be fully blocked, andhence cannot be completely cured; and re-treatments are necessary because measures to prevent cerebral aneurysm are noteffective. Flow diversion is a new treatment method; while preserving the original blood flow of arteries, blocking the blood
inflow to the cerebral aneurysm, proliferating endothelial cells
at the neck of the blocked cerebral
aneurysm to induce the formationof a new tunica intima, and reducing

Flow diverters for cerebral aneurysm treatment

28

AMDD

the risk of cerebral aneurysm ruptures. However, its placement
is limited to sites from petrous part of internal carotid arteryto the upper and lower petrous part, and the treatment is very
difficult. Therefore, as of June 2019, the treatment with flow
diverters is performed at limited facilities in Japan.

New treatment options for cerebral infarction
For acute cerebral infarction, which is the most common type ofstroke, there are two therapies: internal therapy of intravenous t-PA
treatment, and thrombus collection therapy which uses a thrombectomy device. Thrombectomy therapy was first introduced inJapan in 2008. Since then, we have seen a decade of innovationin thrombectomy. In general, acute cerebral infarction develops in
the middle of the night or in the morning, and the onset timing isoften not clear. The t-PA cannot be used in some cases because of
the body constitution and treatment of other diseases.
In 2010, as a new treatment option for acute cerebral infarction, a soft, wire thrombectomy device with a spiral tip waslaunched for the first time in Japan. This enabled treatment of
those patients who were unresponsive to t-PA (internal treatment) within 8 hours of the onset of acute cerebral infarction,or those who were not eligible for internal treatment. The
results of clinical studies showed that 70% to 80% of occluded
blood vessels are reopened with endovascular treatment for
acute cerebral infarction using this device.
In 2011, approval was given to a device that collects thrombi
while breaking them down with a catheter equipped with a powerfulaspiration pump. Then in 2014, a stent-type thrombectomy device
was introduced, and this improved reopening rate and safety.
In 2019, more than 10 years after the introduction of the firstthrombectomy device, the indication of the device was expanded; treatment within 8 hours after the onset was expanded totreatment within 24 hours after the onset for some stent-type
thrombectomy devices. This also allowed the expansion of treatment options to include those patients who might have sufferedserious sequelae as they had not been eligible for this device,
such as those with unknown onset times or those who presented
with cerebral infarction symptoms upon arising in the morning.

Thrombectomy devices for the treatment of acute cerebral infarction

The next 10 years
In the last 10 years, endovascular treatment for cerebrovascular disease has evolved and allowed patients to have moretreatment options. According to Stroke Treatment Guidelines 2015 (Supplement 2017), it is highly recommended thatpatients diagnosed with acute cerebral infarction be treatedwith mechanical thrombectomy within 6 hours of the onset
in addition to the conventional medical treatment (Grade A).
Going forward, endovascular treatment is expected to become
the standard treatment for an increasing number of patients.

10 Years of Innovation Saving
Patients

Diagnostic Imaging
Products for diagnostic imaging use can be roughly categorized into X-ray equipment,
CT, MRI, ultrasonic diagnostic equipment, and nuclear
medicine equipment1). Amongthese, ultrasonic diagnostic
equipment showed a dramatic
Pocket-sized ultrasonic diagnostic
improvement as pocket-sized equipment
devices were marketed in 2010.
Thereafter, several improvements have been made. Taking thisproduct as an example from the perspective of innovation in
medical devices, we hereby discuss its significance.
Ultrasound diagnostic devices in the size of a conventional
laptop have been available; however, the best feature of thisproduct is its small size that can fit in a shirt pocket and can be
operated intuitively with a single thumb. A probe is connected to the main body that has a 3.5-inch LCD panel. Since its
launch, it has been presumed that the device is used in home
medical care, emergency / disaster medical care, and remote
medical care2), and its usage scenes and users are expected to
expand. Product feature is not limited to its compact size. One
user comments its clear image and 20 seconds to start up as
excellent features of the device3). The fast start-up time is one of
the needs in emergency outpatient calls, where speed is everything. Apart from its size, the product feature factors in actual
use in the medical field.
This product continues to be improved. In 2014, a 2-in-1 probe
model was launched; the model has a probe at each end and can
depict deep organs and superficial organs. With built-in probethat can depict superficial organs, visualization of superficial
blood vessels, prostate, thyroid gland, and lung echo (pneumothorax) is possible4).
The model eliminated theneed to replace probes.
This time-saving feature
was useful for home careand emergency outpatient
calls and disasters.
2-in-1 probe (processed image)In 2017, a new model was
launched. It realized operability similar to a smartphone, andwas equipped with a touch screen function, a 5-inch LCD display, and a Wi-Fi function. The start-up time was further shortened to one second, addressing the need for a quick diagnosis
in life-saving emergencies 5). In a clinical setting where a user
may need to perform breathing and circulation assessments ina short time (in emergencies), the user listens to the patient’s
chest with a stethoscope with the right hand, while starting
the product with the left hand 6). Further shortening of start-up
times was prompted by such needs from users. Smartphone use
was not spreading widely in 2010 when the first model became
available, but in 2016, smartphone usage rate exceeded 70% 7).
With the incorporation of smartphone-level operability into thedevice at that time, users could use the device intuitively. Thismodel had a built-in measurement application for residual urine
volume. It had been in high demand in the primary care field
where patients have no or fading sensation of residual urine.
Residual urine volume can be measured semi-automatically 8).
These elements are also seen as improvements from the user’s
perspective.
Moreover, a new model launched in 2018 was equipped withnew functions useful for diagnosis, and quantitative measurement and analysis applications. Output function to an externalmonitor allowed test images to be displayed on a large-screen,and patients, family members and medical staff can view thescreen together. Function to create and register proceduresfor surgeons, and function to adjust images and assist various
users were also added 9). The improvements for usability ofusers were achieved this time using software.
At the time of the launch, the device attracted attention for its
potential usage environments, enabled by its pocket size. As
it turned out, various improvements continue to be made inorder to keep reflecting the needs of users, suitable for their
method and purpose of use other than the expected usage
environments. “Innovation” is a status deemed where a new or
improved technology has become prevalent. It is only after thetechnology is prevalent that it begins to contribute to the needsof medical sites, and is called innovation. Since its first launch
in 2010, over 5,200 of the devices have been sold in Japan (as ofApril 2017) 10). Going forward, we must continue to understandmedical needs and play a role in innovation that underpins
medical setting.

Reference1)	Trends in diagnostic imaging equipment in recent years, Special Feature
Trends in medical equipment in recent years and electrical equipment
2, Academic Journal of the Institute of Electrical Installation Engineersof Japan, May 2005,Vol. 25 No. 5, P313 - 3162)	Nikkei Digital Health: https://tech.nikkeibp.co.jp/dm/article/
NEWS/20100708/184067/?ST=health3)	RadFan ONLINE
http://www.e-radfan.com/column/5150/
4)	Nikkei Digital Health: https://tech.nikkeibp.co.jp/dm/article/
NEWS/20140613/358380/?ST=health5)	Nikkei Digital Health: https://tech.nikkeibp.co.jp/dm/atcl/
news/16/070608265/?ST=health6)	Users’Voice, Doctors’Voice
http://gecommunity.on.arena.ne.jp/Vscan/dp/user.html
7)	2016 Survey on Information Communication Media Usage Time andInformation Behavior <Summary>, July 2017, Ministry of Internal Affairs
and Communications Policy Institute8)	CNET Japan: https://japan.cnet.com/release/30198832/
9)	Nikkei Digital Healthhttps://tech.nikkeibp.co.jp/dm/atcl/news/16/111611700/?ST=health10) Website of manufacturer: http://www3.gehealthcare.co.jp/ja-jp/event_
and_news/news_and_initiatives/2017/press05

AMDD

29

Chapter3
Cooperation and Collaboration
with the MHLW and the PMDA that led to thePharmaceuticals and Medical Devices Act
1. Introduction
Before the 10th anniversary of the American Medical Devices
and Diagnostics Manufacturers’ Association (hereinafterreferred to as “AMDD”), there was a revision of the Pharmaceutical Affairs Law (PAL, now the Pharmaceuticals andMedical Devices Act). At the time of revision, the Regulatory
Affairs and Quality Assurance Committee (hereinafterreferred to as RAQA Committee) of the AMDD made active
policy recommendations to the MHLW/PMDA, and carriedout activities to achieve its recommendations.

2. F rom the Pharmaceutical Affairs Law to thePharmaceuticals and Medical Devices Act
The PAL had been amended since it was enacted in 1960.
However, the promulgation of the 2013 revision and theenforcement of the revision in 2014 were extremely important turning points.
The revision came at a time when the AMDD moved fromaction programs to collaborative plans, and AMDD pinned
great expectations on the revision. The RAQA Committee
Leadership Team compiled expectations in their proposals on the revision of the PAL for medical devices (including in-vitro diagnostics) titled, “Medical Device Regulation
Issues in Japan and their Solutions” 1).
In accordance with the PAL then, the MHLW imposed
various regulations in the approval review process of medical devices: design and development stages, approval application and review, approval by the Minister of the MHLW,
and market launch. The issues at each stage were classified
into seven areas (design / risk management, quality management system (QMS), software / IT, clinical studies, pre-marketing review, Good Vigilance Practice (GVP) and businesscategory), as shown in Figure 1, and then analyzed.
The results of the analysis led to the recommendations
summarized to the right.
Some issues have been resolved, and some are midway
through their journey, but it is safe to say we are now steadily approaching the ideal status of the AMDD as recommended by the RAQA Committee back then.
Of particular note is the recommendation written in the
proposal related to overall PAL, to divide the descriptions in

30

AMDD

Recommendations concerning the revision of
the Pharmaceutical Affairs Law for medical devices(including in-vitro diagnostic devices) 1)
Proposals for the Pharmaceutical Affairs Law as a whole•	Divide the descriptions of Articles in the Pharmaceutical
Affairs Law into “pharmaceuticals, quasi-drugs, andcosmetics”, and “medical devices”• Apply the content of ISO 13485 without changing it
Proposals on individual matters
Article 1 of the Act (Objective)• Add “Accelerated introduction” of medical devices and a
viewpoint “to contribute to the health of the public.”•	The term “efficacy” is associated with pharmaceuticals, andthus, it should be changed to “performance” for medical
devices.
Article 12-2 of the Act (Permission Criteria)•	Integrate GVP / GQP because ensuring quality and safety are
two sides of the same coin
Article 13 of the Act (Permission for Manufacturing)
Article 13-3 of the Act (Certification of Foreign Manufacturer)•	Regardless of domestic and overseas products, make QMS
a requirement, and change the manufacturer's permission /certification to the registration system.
Article 14 of the Act (Manufacturing and Marketing Approval)•	Expand the current concept of “one item”, and build amechanism for obtaining approval and certification for eachprinciple of the medical device.
•	Likewise, instead of reviewing to “identify” devices as inpharmaceuticals, introduce an evaluation method withminimum necessary data from the design management (leastburdensome approach)•	Replace “by item” QMS compliance inspection withappropriate maintenance and management of QMS(especially design management portion), to expand theunnecessary scope of a partial change application and totimely perform improvement.
•	Abolish review other than GCP and GLP as it is redundantwith QMS design management.
Article 23-2 of the Act (Certification of Manufacturing andMarketing Designated Controlled Medical Devices)•	Entrust the review of low-risk items (equivalent to general
medical devices) to a registered third party certification bodyalong with a QMS compliance inspection.
Article 63-2 of the Act (descriptions in package inserts, etc.)•	Introduce package insert system from the users’ point of view(e.g. provision of electronic files on Internet, substitution by
instruction manuals)

Figure 1. Analysis of issues on medical device regulationeach Article of PAL into “pharmaceuticals, quasi-drugs, andrequests have been prepared and disseminated by a joint teamcosmetics”, and “medical devices (including IVD)”. This hasof the IVD 3 groups (AMDD, JACRI, and EBC). Through thisbeen the long-held vision of the medical device industry sincecommunication, awareness of industry issues is shared withthe time when medical devices were called medical tools.

the government. More than a few issues have been resolved or

Medical devices and pharmaceuticals are of complete-resolving through past and ongoing legal revisions and collab-

ly different nature in the first place. Medical devices haveorative plans. The main recommendations are shown below.

evolved from tools used in treatment and diagnosis. They are• Position paper “Thoughts on the Handling of In-vitro Diag-

designed and evaluated based on their purpose of use (devel-

nostics”, August 4, 2010

opment concept). With feedback obtained from healthcare• “Proposal on Infrastructure Building for Companion Diag-

professionals in the clinical setting, medical devices need to

nostics for the Promotion of Personalized Medicine”,

be placed in a continuous cycle of improvements.

October 21, 2011

This cycle has failed to operate because the regulations forpharmaceuticals (whose approval does not or should not change)• Legal Revision Request “Proposal for Revision to the Pharmaceutical Affairs Law for IVDs”, July 20, 2011were applied to medical devices (which must be continuously• “Proposals on the Appropriate Provision of In-vitro Diag-

improved), and this was a part of the reason for the device lag.

nostics” based on Diversifying Medical Needs, June 17, 2014

The enactment of regulations suitable for the characteristics of medical devices, envisaged by the entire medical• Law Revision Request, “IVD Industry Request for a Revision of the PMD Act”, July 5, 2018device industry including the AMDD, took a major step for-In particular, the advent of companion diagnostics was award when the revision of PAL stipulated that medical devices

milestone in the IVD field in the past 10 years, as described

be in a separate chapter. The name was also changed fromin the article, “10 Years of Innovation Saving Patients” on

the Pharmaceutical Affairs Law to “Act on Securing Quality,

page 36 of this journal.

Efficacy and Safety of Products Including Pharmaceuticals andMedical Devices (Pharmaceuticals and Medical Devices Act)”.
This was a great result that the entire medical device

3. The Collaborative plan for accelerating
the review of medical devices and IVD

industry has finally managed to achieve. For a long time, we

The Collaborative Plan for Accelerating the Review of Medical

have been trying to enlighten people about the differences

Devices was initiated after the Accelerated Review Action Pro-

between pharmaceuticals and medical devices at various

gram for medical devices. The Action Program and its excel-

venues. We owe a great deal to those at the MHLW and thelent results are described in Chapter 2. Here, we introduce

PMDA who listened sincerely to the industry recommenda-

some of the major achievements of the medical device andtions and worked towards the realization of our vision. We

IVD collaborative plan that was started in order to acceleratewould like to take this opportunity to express our gratitude

the review on the heels of the success of the Action Program.

again. We also believe that the trusting relationship with the
MHLW and the PMDA, cultivated through action programs
and collaborative plans, has helped us press forward.

3-1. Collaborative Plan for Accelerating the
Review of Medical Devices

Moreover, the 2013 revision added regulations for single

The Action Program described in Chapter 2 significantly con-programs and regenerative medicine, and set the stage fortributed to eliminating device lag. To further accelerate thethe development of an area which did not exist in the past,review process, both government and industry agreed to for-and where regulations did not keep up with the speed ofmulate a collaborative plan with a view to accelerate reviews

development.

by improving the quality of reviews and applications.

With regards to IVD, a number of proposals and revision

The target review period was set at the 80th percentile

AMDD

31

value of the application cohort, which is higher than the 50th

tion of regulations and review” as a goal. While maintain-

percentile value of the conventionally approved cohort. Set-

ing the current review period target, we seek to optimize

ting the target values for both the reviewer and the applicant

the medical device development process and regulations.

and debating who is responsible for delays is an unproductive discussion. Thus, instead of their individual holding
time, the target value for the total review period was set.

3-3. Collaborative Plan for Accelerating the
Review of IVD

In the discussion of how to name this initiative after the

IVD had been still out of scope when the review acceleration

Action Program, it was impressive that we named it “collabo-

action program was to be started in the medical device field.

ration”; hard work from both the government and industry to

As a result of discussions between the then ACCJ Medical

achieve their goals.

Device and IVD Subcommittee’s RAQA Committee Chairperson (Junko Kodama) and the IVD Chairperson (Isao Ikeda), theCollaborative Plan for Accelerating the Review ofMedical Devices (FY 2014 - 2018)

IVD-TF was newly established under the RAQA Committee, andImprove training of reviewers and quality of applicants
Review consultation system
Summarize ideas on clinical evaluations
Have a timeline in the standard process
Have a review checklist
Achieve a goal of total review period based on 80th
percentile value of application cohort

following the advocacy activities to the MHLW. It was in 2007

the regulatory system task force IVD-TF was then newly set up
when participants from the ACCJ and JACRI came to the negotiating table at IVD-TF as representatives of industry groups,
to set the stage for constructive discussions concerning IVD.
Until then, the IVD industry had mainly functioned asa bridge to conduct industry research and gather opinions
upon request from the government. At the regular opinion

3-2. R esults of the Collaborative Plan for
Accelerating the Review of Medical Devices

exchange meetings on regulatory affairs between the medi-

The collaborative plan was successfully completed at theed for the IVD industry, allowing the industry to voice theirend of March 2018. Activities and results for five years will

demands in public. However, people in the IVD industry

be summarized. Figure 2 shows the achievement of the target

group were not skilled at communicating their requests andreview period, which was one of the most fruitful results.

discussing issues with the MHLW / PMDA; they were seen as

cal device association and the government, time was allocat-

The AMDD, the Japan Federation of Medical Devices

a rather “sheepish industry group” (according to the MHLW).

Association (JFMDA), and the EBC jointly carry out Time

Looking at the preceding medical device industry as their

Clock Surveys every year. Figure 2 compares the results ofrole model, the IVD industry group became capable of creat-

the survey at the start of the collaborative plan and theing materials that logically explained their views and having

final fiscal year. The review period was shortened in allheated discussions within the industry.

application categories, and the target value was achievedin almost all categories in the final fiscal year.
The biggest goal for both the Action Program and theIn the Collaborative Plan for Accelerating the Review of IVD(2014-2018), dated March 31, 2014, the collaborative plan

Collaborative Plan was acceleration of the review. A newproceeded on the following matters:

Collaborative Plan, started in April 2019, set “optimiza-• Improve quality in the approval review process

2015 Survey (April 1, 2014 - March 31, 2015)2018 Survey (April 1, 2017 - March 31, 2018)* The value indicated by
the arrow in the graph isthe 80th percentile valueof the total review period.
However, the blue letters
indicate a processing
rate of less than 80%

Figure 2. Results of Time Clock Survey (AMDD, JFMDA, EBC joint survey), application cohort 80th percentile value

32

AMDD

Words from the Chairman

Former Chairman on
10 Years of the AMDD

Takashi Shimada, Third Chairman (2012 - 2015)
There were three major issues that I worked on during mytenure as the AMDD Chairman (2012 - 2015). Device lag, foreign average pricing (FAP), and revisions of the Pharmaceutical Affairs Law.
Based on the recommendations from the 2008 Device
Lag Survey presented by the ACCJ, device lag improved dramatically through the 2009 MHLW Action Program for accelerating reviews at the PMDA. The issue of slow reviews had
been discussed at the AMDD since the times of Chairman
Wang and Chairman Powell. The data from the Time Clock
Survey conducted by the ECB and the JFMDA, particularly helped them to objectively grasp the issue and to takeactions for the resolution of issues.
The AMDD continues to call for the abolition of FAP, but
it still remains a challenge. As a result of the implementation of FAP, Japan’s reimbursement prices have gone down
so low that Japan has become the least favored investment
market. This “Japan passing” has created a device gap rather
than a device lag, which calls for our attention.
Lastly, with regard to the revision of the Pharmaceutical
Affairs Law, the Law had been regulating medical devices
using the same legal framework as with pharmaceuticals. Medical devices are completely different from pharmaceuticals.
For example, a drug has a compound which is something thatis discovered. Approved compounds must remain unchanged.
Whereas a medical device is something that is designed, used
for treatment, and are to be improved over a short cycle.
Subjecting medical devices to the same restrictions and regulations as pharmaceuticals was not logical in many way, andhampered innovation. We at the AMDD had had discussion
after discussion with the MHLW almost every month, andwere eventually successful in making them understand thedifferences between pharmaceuticals and medical devices. In
November 2013, we were finally able to see the current Pharmaceuticals and Medical Devices Act (PMD Act).
I give credit for this success to enthusiastic cooperation of the committees set up within the AMDD. This is
the strength and characteristic of the AMDD, which also
impressed the staff at the US embassy.
Aside from those external issues, I also worked hard on
internal group management. During my tenure, we saw M&A
between member companies (J&J with Synthes, Medtronic
with Covidien, Zimmer with Biomet, etc.), which raised the riskof decreasing membership fees. As this may have significantly impacted finances of the AMDD, which relies on membership fees, the membership fee system was overhauled during
my tenure. We visited member companies and asked the top
management to increase their contributions. That’s one of thememories I recall. In addition, for compliance purposes, wemade a rule that the AMDD comprehensively undertakes Foreign Corrupt Practices Act (FCPA) training with wholesalers.
Our members and agencies welcomed this move.
I was extremely busy as I was representing my company
both externally and internally while serving as Chairman of
the AMDD. However, I was grateful for my position back thenas it gave me the opportunity to think about patients deeply,
not just from the perspective of a company but from that ofhealthcare public policy.
I hope the AMDD continues to make policy recommendations and work hard for the benefit of medical care andpatients in Japan.
(AMDD adviser, former President of Medtronic Japan Co., Ltd.)• Set a standard review period• Reliability assurance of application dossiers• Increase reviewers• Clinical performance testing guidelines• Manage progress• Review of classifications

The collaborative plan for accelerating review was a fiveset during that time. As a result of the review, almost all unre-

3-4. Results of Collaborative Plan for
Accelerating Review of IVD

solved issues; the regulatory system task force, proposals

The final results of FY 2014 - 2018 collaborative plan will be

and discussions on law revision requests, are included in thereleased after the completion of analysis in 2019 - 2020. Pre-

collaborative plan. It is currently used as a history manage-liminary figures compiled by the PMDA as of July 2019 are as

ment tool for resolving issues of regulatory affairs. Examples

shown in Figure 3. The review periods for the two categories

of issues included during that period are as follows:(items for special review discussion, regular items) with set• Discussions on streamlining operations and approaches ofgoals, were shortened year by year, and goals set for eachpre-approval testing by the National Institute of Infectious

year were met. With the understanding and cooperation of

Diseases (NIID).

both applicants and reviewers, the data for the final year, FY

year plan, but a period for reviewing issues and goals was• Global harmonization of review requirements and standards

2018 application cohort, is also expected to meet its goal.

AMDD

33

Figure 3. Total review period for in-vitro diagnostics (application cohort) (Source: Meeting of Collaborative Plan Practitioners, March 20, 2019)

4. Expectations for future revisions to thePharmaceuticals and Medical Devices Act• Requests to streamline QMS compliance inspection

As of July 2019, a bill on revisions to the Pharmaceuticals• Promote the use of package inserts for electronic media

eligibility requirements of administrators, etc.

and Medical Devices Act has been submitted to the NationalDiet, pending deliberation. In April 2018, an industry groupAs outlined above, in the previous revision of the Act, we

including the AMDD, JFMDA and EBC jointly submitted aenacted provisions for medical devices that are different

proposal for revisions.

from pharmaceuticals, with regard to marketing authoriza-• Provide all provisions related to medical devices in a sep-tion and manufacturing of medical devices. In this recom-

arate chapter.
• Further streamline QMS compliance inspection and international harmonization• Promote the use of package inserts on electronic media

mendation for revision submitted by the medical device /IVD industry, a completely separate chapter for medical
device provisions was requested as part of efforts to formulate a medical device act in the future. The recommendation
included the establishment of a review system that can deal

Additionally, after discussions with the government, matterswith new technologies such as AI. The AMDD would like torelated to the review system and traceability were also included.

contribute by actively involving itself in the discussion and• Early introduction of the approval review system tailored

eventually realizing its requests.

to the characteristics of medical devices• Improve traceability of medical devices

5. Closing remarks

The IVD industry also submitted proposals / revisionDuring the 10 years since the AMDD’s inception, there haverequests from a joint team of the three IVD organizations (AMDD,

been significant changes in the relationships between the

JACRI, and EBC). “Request from the IVD Industry for a Revisionindustry and the MHLW/PMDA.

of the Pharmaceuticals and Medical Devices Act,” July 5, 2018

At the time of inception, it was normal that approval was• Review of the definition of IVDs

delayed by a year in comparison with Europe and the US•
Review of licensing requirement for business category

because of regulations unique to Japan. And the AMDD, mak-(marketing authorization, manufacturing, sales), anding efforts to improve the situation, was often accused of acting like an outsider pressuring Japan. However, we believe that
our relationship changed to that of a collaborative stakeholder.
As our Association is increasingly globalized, real world
and technological progress including big data and AI, continue to become more complex, and challenges will be
more difficult to resolve. When we arrive at a juncture, we
hope that our efforts over the past decade and the results
we accumulated, together with the activities of our next 10
years can greatly contribute to tackling such challenges.
Reference1)	RAQA Committee Leadership Team, AMDD,“Medical Device Regulation
Issues in Japan and their Solution”, Pharmaceutical Medical Device Regulatory Science.Vol. 42 No. 11-12 (2011),Vol. 43 No. 1 (2012)

34

AMDD

Contribution

What I have Witnessed in
10 Years of the AMDD
Yasushi Takahashi, Acting Chairman, Japan
Association of Cardiac Pacemaker Friends (JACPF)
Congratulations to the American Medical Devices and Diagnostics Manufacturers’ Association on your 10th anniversary.
Allow me to express my heartfelt respect to the AMDD. As a
medical device industry association within a diversified society, the AMDD has made a major contribution to the development of the medical industry and comprehensive management
over the past decade through the dissemination and sharing of
information to related parties.
JACPF’s history begins in 1963 when the first domestic cardiac
pacemaker (hereinafter, “PM”) was implanted at the University ofTokyo Hospital. The establishment of our association was prompted by necessity to share patient information. The activities of
JACPF got under way through the efforts of Dr. Kansai Hayakawa,
our first president and the first doctor to have a PM implanted. In
1993, he received the Health Culture Award for his contribution
and was admitted to be in the presence of the Emperor.
We PM wearers benefit greatly from the development of
medical devices and we pin our hopes on their further progress.
Association members have PMs/ICDs under their collarbones and in their abdomens, and these devices send electricalsignals for symptoms associated with bradyarrhythmia.
The first implanted PM had a built-in mercury battery of
8 centimeters in diameter. It started out as an external systemwith a battery-life of only one to two years; it placed a heavy
burden on the patients. PMs fall under the medical device class
IV, “specially controlled medical devices, they may be linked toa life-threatening crisis in the event of malfunction”.
However, thanks to the remarkable research and development in medical devices since then, significant progress has
been made in PM compared with the one we first implanted
41 years previously. Downsizing of PM with batteries changing
from mercury to lithium enabled MRI imaging and home monitoring with a transmission system. In 2016, the successful development of a leadless PM was announced, and battery life is now
over 12 years. Such PMs are being implanted for those patients
indicated for the devices.
Approximately 520,000 to 560,000 PM wearers are now inJapan. Of which, JACPF members account for 3,600 members
across 29 chapters around the country. Above all, JACPF, as apatient group representing sufferers of the same disease, values
mental care. Our fundamental principles are “appreciation, gratitude, and service.” We are not a demanding organization. We
shared information with the Japan Association of ICD Friends
and the National Association for the Protection of Children with
Heart Disease and promoted our activities.
We would like to thank you for your warm support. We
would not be here today were it not for support from the AMDD,
government, academic societies, universities, hospitals, andmedical device companies.
Amid the recent progress in medical care and medical

devices, PM patients now have a sense of security/QOL intheir lives and are able to participate in society just as they did
before the implantation of the devices.
That said, PM patients get older and their declining
physical strength is inevitable although they look healthy. To
address the anxiety of infections, when a PM or old batteries
are replaced, we hope that one day implanted PM batteries canbe charged from outside the body to prolong battery-life.
Medical development is a critical concern for patients.
Many people suffer from various intractable conditions, sudden
heart and brain diseases, and malignant tumors that develop
one in every two persons. Such a status led us to consider thefollowing points:
1) Increase the chances of early detection with preventive medicine.
	Correct diagnosis and early treatment initiation are vital toa patient’s survival. I have been admitted to the hospital 10
times and experienced a series of painful tests and operations.
	Public health checkups offered by municipalities are often
simple and may fall short from early detection of problems.
We hope that the burden on patients will be reduced by thedevelopment of medical devices that allow more tests andless pain for patients.
2) No healthcare disparities among medical institutions and byregion.
	This is a university hospital-oriented issue, but the family doctor system must be improved. It is still difficult forpatients to ask for a second opinion. Elderly patients express
their discontent in the way doctors address their complaints
as doctors tend to blame everything on aging.
3) Reforms are under way to review clinical issues and promoteacceleration of approval process for treatment drugs. We
would like to realize a system that provides patients withgreat healthcare.
	Meanwhile, patients should be proactive in their own treatment, not totally dependent on medical professionals. They
should ask their doctors questions to deepen their understanding and to their circumstances as patients, and fightand live with their illnesses.
Healthcare is the most important aspect for human beings as itis related to the dignity of life. On a personal note, I would liketo express my heartfelt respect to those who work day-in-dayout in research and development, as I would not have survived
if PM had not been developed.
Finally, we would like to express our deep appreciation for the
regular and valuable dissemination of information by the AMDD
that performs an important role in the medical industry in developed countries, and we look forward to your continued guidance.
I end my note by wishing you the best for your futureendeavors.

AMDD

35

10 Years of Innovation Saving
Patients

In-vitro Diagnostics (IVD)
IVD were first defined in 1985 under the Pharmaceutical Affairs
Law. Since then, laws and regulations for IVD and insurance coverage rules for medical fees have been developed. Along with
progress in testing technology and shifts in social and medical
environments, the value and positioning of clinical testing havesignificantly changed. IVD are not only used for disease prevention, diagnosis, decision on treatment policy and clinical monitoring of prognosis, but also for various clinical settings forpurposes other than diagnosis, such as companion diagnostics(CoDx) to stratify patients for drug administration.
Looking back over the past decade, as innovations in the
IVD field that have made significant contributions to improving
patient outcomes, we introduce CoDx and tests before medical
examination.

The advent of CoDx
CoDx is a biomarker testing IVD used mainly for predicting theefficacy and safety of a drug and optimizing the dose of a drug inpharmacotherapy including anticancer drugs. It is expected to
be widely used in future medical care, and to be indispensablefor personalized medicine, enabling selection of treatments andmedications suited to individual patients.
Pharmaceutical companies and diagnostics manufacturers
develop a drug and CoDx concurrently, and market them almost
simultaneously after PMDA review. This requires unprecedented
innovative development process, review process, and insurance
coverage based on a new idea. Thus, diagnostic manufacturers
created a new process in collaboration with pharmaceutical companies, and the PMDA / MHLW. Since 2012 when the first CoDx
was approved as an IVD, several CoDxs have been approved andcovered by insurance.

The introduction of testing before medical
examinations

societies related to clinical testing. In 2006, a new calculation was
implemented. Initially, one point was added for each item, up to
5 items. However, test-related academic societies, manufacturers, and industry groups pressured the government, and the calculation was changed to the addition of 5 points for each item in
2008, and the addition of 10 points for each item in 2010. We werealso successful in our policy guidance to implement tests before
medical examinations for medical institutions.
The two examples above were achieved through a combinationof innovation in the regulatory system related to clinical testingand innovation in testing technology. Above all, innovation of
the regulatory system could not have been achieved without
collaboration between industry groups such as the AMDD andstakeholders.
To contribute to a prolonged healthy life span, we continue
with our activities to improve testing technology and design andoptimization of the regulatory system including the introductionof a specimen measurement room (2014), and addition of an item
for OTC IVD for the first time in 25 years (2016).
The role played by clinical testing will be more diversified
and its continued contribution to the healthy lives of the public
is expected as shown in: the Global Action Plan on Antimicrobial
Resistance (AMR), which was adopted at the 2015 World Health
Assembly and further mentioned at the 2018 G20 held in
Argentina; the contribution from Japan’s action plan; early
detection of cancer with microRNA testing; and the promotionof testing information management using ICT. In December 2018,cancer-related multigene panel testing obtained the first regulatory approval in Japan as a combination medical device, and its
insurance coverage began in June, 2019. Multigene panel testing
has the potential to significantly change the future of medicalcare and people’s lives. Thus, while hoping and anticipating its
future development and prevalence, we will watch closely the
insurance coverage of panel testing and the possibility of recalculation upon its
market expansion.

Testing before medical examination is clinical testing performed
prior to medical examination by doctors for outpatients. The
patient sees the doctor after the test results are obtained. With theintroduction of this testing, test results are available in a timely
manner, and patients can receive appropriate treatment without
revisiting the hospital to verify
the test results or take additional tests. This resulted in changes
in patient behavior and daily living since social activities are not
restricted due to hospital visits.
Testing before medical examinations was introduced in theclinical setting more than 10 years
ago. Diagnostics manufacturers
not only pursued the automationand shortening of testing time,
but also requested Chuikyo to add
points of outpatient rapid clinicaltesting within medical fees, incooperation with academic
A page, set up on the PMDA website for the companion
diagnostics WG

36

AMDD

Paper on a Joint Position of three IVD
organizations: Proposal on Infrastructure
Development for Companion Diagnostics toPromote Personalized Medical Care

10 Years of Innovation Saving
Patients

Diabetes (A New Era of Glucose Monitoring)
In recent years, survey results showed that 10 million adults inJapan are strongly suspected of having an diabetes, an alarming statistic where diabetes is a national disease. Various
drugs are used for treatment; however it is important to knowa patient’s glucose level in detail before selecting medication /determining effects or giving guidance on medical treatment.
The Japan Diabetes Society (JDS) says that not only medical
professionals but also patients themselves should understandin detail their own glucose fluctuations, especially those who
are taking insulin.
Glucose monitoring technology development started withthe advent of urinary sugar test strip in the early 1900s. Now,
glucose levels can easily be measured with a simple self-monitoring blood glucose meter. Blood glucose must be measured
frequently at appropriate timing to grasp glucose fluctuations indetail. However, self-measurement of blood glucose presented
issues including pain due to fingertip pricks and the inability toobtain glucose levels other than measured points in time.
In 2009, a Continuous Glucose Monitoring (CGM) systemthat continuously measures the glucose concentration ininterstitial fluid became available. The CGM captured in detailglucose fluctuations that had been difficult to grasp. Thereafter,
the concept of “quality of glucose control” attracted more
attention. Treatment to avoid hypoglycemia and minimize
glucose fluctuations has been sought. The CGM back thenwas designed for professional use; medical professionals
used it to obtain detailed data and it required specialized
knowledge to analyze data. Its specifications did not allow
patients to check data in real-time by themselves. Then, asystem that allowed patients to check their glucose fluctuations
in real-time was marketed, but such functions were accompaniedby the insulin pump, and its use was limited to few patients.
In January 2017, a Flash Glucose Monitoring system* waslaunched in Japan. It was a system that allowed patients for the
first time to check their glucose fluctuations in detail. Unlike other
CGM systems, it did not require daily calibration, saving time forhealthcare workers and patients alike. It has been clinicallyadopted as a monitoring system that allows both healthcare
professionals and patients to quickly and easily grasp glucose
fluctuations. In December 2018, clinical application of real-time
CGM** started. This enabled real-time monitoring of glucose
for non-insulin pump users. With real-time CGM, patientscan check their glucose fluctuations, and be alerted for
hypoglycemia or hyperglycemia, thereby allowing them to takeearly actions against hypoglycemia and hyperglycemia.
These systems make glucose fluctuations visible,
enabling strategic treatment planning, medical guidance, andchanges in patient behavior. This is expected to bring better
glucose control. The waves of digital transformation are also
affecting the field of diabetes; as we move into the future,with the expansion of the eco-system and further incorporationof AI, the distance between patients, healthcare professionals
and caregivers will be considerably narrowed, and the levelof diabetes treatment will be further enhanced.

* Flash Glucose Monitoring system
A sensor the size of a 500-yen coin is attached to the back of theupper arm, and the data stored in the sensor is read by scanning it with the reader (main unit). Scanning the sensor, a patient
can check and confirm their current glucose level, changes intheir glucose level over the preceding 8 hours, and future glucose trends. The sensor can be easily attached, and it measures
glucose levels continuously for up to 14 days without the needfor calibration that requires the fingertip prick. (A device for
medical professionals is also available. A patient wears only thesensor and has no reader, and the medical institution reads thedata.)

Flash Glucose Monitoring system** Real-time CGM
In real-time CGM, a sensor electrode that is as fine as a hair isplaced under the skin and connected to a transmitter forcontinuous measurement of subcutaneous glucose, and thedata is then continuously sent to a monitor. Patients canmonitor their own glucose fluctuations in real-time, and canreceive alerts should hypoglycemia occur. In 2015, an insulin
pump that can display real-time CGM on screen became
available in Japan, and in 2018, a pump that automaticallysuspends and resumes insulin administration based on those
CGM values was also rolled out. At the end of 2018, a device
was launched, which allowed even patients receiving insulin
pen injections to check real-time CGM on a mobile device oron a dedicated monitor, and share data with family members
and medical professionals.

Real-time CGM

AMDD

37

Chapter

4
Changes in the Insurance Reimbursement System
for Medical Devices and In-vitro Diagnostics (IVD)over 10 Years and AMDD’s Response
The following describes the changes in the special treatment

The Chuikyo Committee on Medical Materials is anmaterial system since the AMDD was founded in 2009, andadvisory body for medical fees, a place for practical

how the AMDD has addressed those changes, and toucheddecision-making, and the main battlefield of the medical

on future issues.

devices reimbursement system. The items targeted were
fundamentally special treatment materials, and the focal

1. Changes in the insured special treatment
material system and AMDD’s response

areas were the evaluation of innovation and the

The insured special treatment material system was createdin recent years, technical fee inclusive systems including

based on the recommendations of the Central Social

large-scale medical devices and IVD are also covered by

Insurance Medical Council (Chuikyo) in 1993, and by

the expert group. In this article, these elements are

2002, the framework of the current system was in place.

described sequentially.

correction of domestic and foreign price gaps. However,Subsequently, the system was reformed in line withrevisions of medical fees.

Figure 1. The premium rate and the foreign average price ratio have been decreasing over the past 10 years

38

AMDD

1) Evaluation of innovation3) Special cases of function classification

The reimbursement price for Japanese medical devices(specially insured medical materials) is reduced by the mar-

The AMDD’s awareness of issues and response

ket price and the foreign average price once every two years

Although these systems have played a certain role in pro-when it is revised 1). For medical devices that are not list-

moting innovation, AMDD has been aware since 2015 thated by brand but are listed by a function classification thatconventional evaluation of innovation is insufficient toshare similar structure and indications, the price is reduced

secure the spiraling costs of R&D.

not only by the company’s market price or foreign average

Looking at the average premium rate of the similar

price but also by the market price of competitors’ products.

function classification comparison method, the decrease to

It is extremely important that appropriate evaluation of

10.4% in 2008 - 2010, 6.5% in 2010 - 2012, and 5.1% in 2012 -innovation is made when new products are introduced in2014 can be seen. When compared in foreign prices, prices

order to secure funds for future R&D.

in Japan are lower. (See Figure 1.)
As a result of heated discussions within the AMDD, val-Enhancements and improvements of the premium methodue-based healthcare was proposed in 2017 (see Figure 2.)

Methods for evaluating new products are 1) the similar

with the support of external organizations.

function classification comparison method and 2) the cost

Specifically, the AMDD proposed to introduce economic

accounting method. The similar function classification com-

evaluation as the fourth supplementary premium require-parison method includes a premium for innovativeness, use-

ment, and the establishment of a novelty leading evaluation

fulness, and marketability, and a premium for improvement

system. The idea was to make both “promotion of innova-

which has been included since 2008.

tion and ensuring medical access for patients”, and “soundSince 2009, the Government’s policy to promote themedical device industry has also introduced the following

medical and nursing care finance” possible.
The AMDD had made various recommendations on sys-

matters sequentially for innovation evaluation:

tem reform up to that point, but it had never made a com-

1) Evaluation for expedited insurance coverage

prehensive proposal with a view on financial soundness.

2) Review of premium for improvements (evaluation of highThis proposal was well received by various stakeholders.

probability, additional requirements, etc.)

Figure 2. Value-based healthcare

AMDD

39

Subsequent introduction of the new system

in Japan and Europe that the implementation bodies forThis led to the “challenge application” which was intro-

product distribution and proper usage support for the sup-duced in 2018, and the “price hike” rule in the cost-effec-

ply and distribution of medical devices are different in Japan

tiveness evaluation system, which was introduced in 2019.

and Europe; and that the differences in the number of med-

The “Challenge application” is a system for long-term

ical institutions in Japan and Europe, the intensity of cases

implantable devices, which allows applicants to apply forand the structure of medical institutions, were addressed bya new function classification after it is covered by insur-

manufacturers and distributors 4).

ance based on clinical use records if sufficient clinical data

The evidence which the AMDD submitted was positively

cannot be ready for the insurance coverage. “Price hike” inreceived by Chuikyo bodies and government officials as it is

the cost-effectiveness evaluation system means to raise theuseful to understand the actual state of the medical device

reimbursement price if the result of analyzing the cost-effec-

market and the provision system. There used to be an emo-

tiveness evaluation shows that the incremental cost-effec-

tional repulsion to the foreign and domestic price gaps, but

tiveness ratio (ICER) is less than 2 million yen, or if effective-

the current environment allows evidence-based discussion.

ness is equal or higher and cost goes down. Both cases arein line with AMDD’s recommendations.

The volatile fluctuation of foreign exchange from the second half of 2000 to the first half of 2010 triggered concerns

As these two cases are not sufficient for the evaluation

over a major impact on reimbursement prices. Then, theof innovation, the AMDD should continue to make recom-

MHLW and Chuikyo showed a certain level of understand-mendations in line with value-based healthcare, and makeing of how to mitigate radical changes from the impact, andthese new systems more desirable.

came up with a specific measure to extend the target period
for calculating exchange rates.

2) Domestic and foreign price gap

On the other hand, the prices of medical devices in

It was pointed out in the 1990s that medical devices in Japan

Japan sequentially fell due to not only the FAP system but

seemed to be priced higher than overseas. In order to cor-also the so-called R-zone system, in which prices are cut inrect this gap, a system for lowering prices, FAP, when Japa-

accordance with the market prices. Some product prices

nese prices are higher than the FAP by a certain ratio (thehave fallen by 10 - 15% at every revision. As outlined ear-upper limit of the foreign price rate) was introduced in 2002

lier, the price of new products in Japan is lower than over-(foreign price adjustment for new products and recalcula-seas prices on average, and Chuikyo has pointed out thattion system for existing listed products). Since then, eventhe price gap between domestic and foreign countries hasstricter rules for remedying differences between domestic

shrunk considerably.

and foreign prices have been in place, such as lowering theupper limit of the foreign price rate and introducing outlier

3) Technical fee inclusive products

rules.

The treatment material system and the expert committee
on special treatment materials at Chuikyo have been posi-

AMDD’s awareness of issues and response

tioned as a forum for the discussion of special treatment

With AdvaMed, the AMDD has consistently presented a vari-material.

ety of evidence to Chuikyo to oppose the uniform price cut

Meanwhile, the medical device industry and IVD indus-

that does not factor in differing market environments which

try groups, including the AMDD, have requested that theresult in differing prices from country to country.

evaluation process and the methods used for evaluations of

In 2009, the AMDD entrusted the research to Mitsubishi

new products, such as diagnostic imaging and IVD (includ-

Research Institute. Results showed that cardiovascular

ing those other than special treatment material) should be

medical devices cost 2.2 times higher in Japan than in Euro-

clearly defined, and the groups requested opportunities topean countries, and orthopedic devices cost 2.5 times high-state their opinions at Chuikyo 5).

er .

Against this backdrop, it was gradually becoming clear2)

In 2011, the AMDD announced “Comparison Survey

that: C2 applications for technical fee inclusive productsof Market Environment for Medical Devices in Japan,

would be possible; companies can request the applied tech-

China, and Korea”. The results indicated that a device lag andnical fees from 2016; organizations dedicated to treatment

device gap between Japan and China/Korea had emerged,

material can propose the applied technical fees to Chuikyo;

not to mention such gaps between Japan and Europe / US.

IVD can be included in the discussion of new product eval-

We argued that the abolition of the FAP adjustment systemuation at dedicated treatment material organizations; andwas necessary to resolve this gap .

opinions can be stated at the expert committee on special

3)

In 2015, the AMDD revealed in cooperation with theJapan Medical Device Sales Association and organizations

40

AMDD

treatment materials at Chuikyo.
While technical fee inclusive products are increasing,underpinned by the medical device program established bymore and more advanced medical devices, including those

the Pharmaceuticals and Medical Device Act (PMD Act) ofrelated to heart failure and orthopedics which contribute2014, there is a need for further clarification of the insurance

to improved QOL of elderly, are developed and introduced.

reimbursement process related to technical fee inclusive
products.

Improved productivity is expected to reduce physical and psychological burdens of healthcare professionals
through technologies including robots, IoT, monitoring, and2. The establishment of the Medical
Technology Policy Institute (MTPI)AI.

In October 2017, the AMDD established the MTPI. In a press

bution to Japan’s two major policy issues. To allow medical

release, Kosuke Kato, Chairman of the AMDD, said, “Thedevices an even greater role to play, the AMDD must antic-

AMDD’s earnest wish is to see the high-quality, advanced

ipate changes in Japan’s medical policies and markets, andmedical technologies of AMDD member companies makeaddress those changes.

Japanese healthier. However, with tight financial positionsin Japan, it is not easy to introduce the latest technologies

Medical devices are expected to make a major contri-

There are currently three changes in the future of healthcare policy / market access.

in a timely manner to please everyone. Under such difficult
circumstances, the AMDD established MTPI to carry out

Value-based healthcare

research from a mid- to long-term perspective on how medi-

First change is the trend toward value-based healthcare

cal devices and IVD can contribute to Japanese medical carethat was proposed by the AMDD. Value-based healthcare

and to make policy proposals based on the research.”includes the introduction of cost-effectiveness assessment,

The AMDD had experienced that evidence-based policy

which is not only based on medical technology sophistica-

proposals and comprehensive proposals in consideration

tion, but also on the reimbursement of medical expensesof sound financial positioning (value-based healthcare)according to the results achieved, instead of the treatment

had been well received by related parties, and consideredgiven (shifting from a quantitative basis to a qualitative

it necessary to accumulate more discussions from a public

basis); and the reimbursement based on medical expenses

perspective over the medium- to long-term. This led to therequired for a series of treatments per patient in addition toestablishment of MTPI.

the medical expenses required at individual medical institu-

Since its establishment, MTPI has been providing infor-tions (bundle payment).

and supporting research

Even if a medical device that can reduce the burdengroups with academia 10) in relation to the Japan Association

on healthcare professionals is introduced, if the medical

for the Advancement of Medical Equipment (JAAME) and

expenses are paid based on performance, the income of thevarious AMDD committees.

medical institution will not decrease. If bundle payments

mation through research papers

6)-9)

In May 2019, as part of an effort to promote collabora-

prevail as a payment method, even if the initial medicaltion with external experts and to enhance functionality, theexpenses are relatively high, products that can reduce med-

AMDD invited Kohei Onozaki, director of the Japan Healthical expenses for readmission will be more valued in theand Global Policy Institute, on board as a special advisor,

clinical setting.

and Kosuke Iwasaki, Actuary and Milliman Tokyo OfficeDirector, on board as a senior researcher.

Digital health / IoT
Second change is a trend of digital health / IoT. Digitization

3. Challenges that lie ahead of us

related to our daily lives is now inevitable, and of course,

Japan has an unprecedented declining birthrate and aging

the digitization of medical technology will also progress. It

population. According to “the Social Security Toward 2040”

has been more than 10 years since the introduction of tech-

depicted by the MHLW, it is important for us to somehow

nology that enabled the remote monitoring of pacemakers.

manage the current situation until 2040 when the number

In that sense, it can be said that digital health started a longof elderly people levels off or slightly decreases. To thattime ago in the medical device industry.

end, the two major policy issues are to curtail increases

With the revision of medical fees in 2018, the remotein medical expenses by prolonging healthy life spans, andmonitoring premium of the pacemaker guidance management

to maintain social vitality and secure medical and nursing

fee is now nearly three times what it was in the past, and thecare services through improved productivity amid a rapidly

evaluation of remote monitoring for other technologies

shrinking workforce.

including CPAP has also evolved. If such evaluations continue

When the AMDD considers the relationship between

and digital health and IoT are further implemented, longer

these policy issues and medical devices, it can be expected

healthy life spans and improved productivity can bethat the extension of a healthy life span will be seen if

expected to be seen.

AMDD

41

Expansion of the shared billing scheme

4. Afterword

Third change is the expansion of the shared billing scheme.

When the AMDD looks back at the past decade of the

A research group at the Institute for Health Economics andreimbursement system for medical devices and IVD in

Policy (IHEP) in Japan published the report, “Review of theJapan, the AMDD has played a leading role in cooperation

scope of coverage for public medical insurance,” in Junewith Japanese and European organizations. Going forward,

2019. Within the report, IHEP recommended the expansion

the AMDD looks forward to lead the industry together withof the shared billing scheme, which may expand the use of

the administrative authorities to contribute to the social

medical devices.

security and healthcare system in Japan amid declining

For example, the report states that if the scope of applica-

birthrates and an aging population.

ble medical insurance is narrower than the scope approvedby the PMD Act, then it should be clearly positioned under
the shared billing scheme. Self-monitoring blood glucose
meters and implantable cardioverter defibrillators are mentioned as examples of such cases. Such new coverage may
expand options for more use of medical devices in medical
settings.

Reference1)	There are exceptional cases where prices were raised, such as when products are unprofitable, or in the case of “challenge application” introduced in 2018.
2)	AMDD:“Comparison of Medical Device Supply Costs in Japan and Europe”, July 2009, https://amdd.jp/pdf/activities/recommen/report090724.pdf
3)	AMDD: “Comparison Survey of Market Environment for Medical Devices in Japan, China, and Korea” , August 2011, https://amdd.jp/pdf/activities/recommen/
report110921.pdf
4)	Chuikyo Opinion Statement:“Survey on Differences in Supply and Distribution of Medical Devices in Japan and Europe”, September 9, 2015, https://www.mhlw.
go.jp/file/05-Shingikai-12404000-Hokenkyoku-Iryouka/0000096891.pdf
5)	Request for IVD (from AMDD) - Chuikyo Insured Special Treatment Materials Expert Committee Statement , November 11, 2015, https://www.mhlw.go.jp/file/
05-Shingikai-12404000-Hokenkyoku-Iryouka/0000103783.pdf6)	“What is meant by value-based healthcare (value-based healthcare)” Social insurance periodic report, 2700: 34-40, 20187)	Reimbursement pricing for new medical devices in Japan: Is the evaluation of innovation appropriate? International Journal of Health Planning and Management, 2018 Dec 14. https: //doi.org/10.1002/hpm.2719
8)	“Analysis of the relationship between the number of CT devices and MRI devices installed, the number of images taken, and medical costs, https://amdd.jp/about/mtpi.html
9) “Evidence of Digital Health”, Beyond Health (Nikkei BP)10)	
JAAME: “Announcement of the launch of the Medical Devices and Socioeconomic Research Group”, http://www.jaame.or.jp/mdsi/other-files/
mdse_press_release_20171031.pdf

42

AMDD

History of main pricing rules set in the system of special treatment materials
PeriodPeriodOctober
1958

Main measures• Notification of film redemption prices (classified by function)• Reimbursement of municipal purchase price of splints as a
special treatment material
November • 
Dialyzer (then named “cellophane for dialysis”) insurance
coverage (purchase price reimbursement)
1967
March
•
Pacemaker insurance coverage (purchase price reimbursement)
1968
February • Dialyzer was included in artificial kidney procedure fees

April
2006

1978
June
1981

• Dialyzer was separated from artificial kidney procedure fees
• Notice of dialyzer reimbursement prices (classified by function)
April• Some special treatment materials including automatic suturing devices were included in procedure fee
1990
April
• Notice of brand-based reimbursement prices of pacemaker1992• Intraocular lens insurance application (evaluated by including procedural fees from start )September • Chuikyo proposals (hereinafter “pricing based on proposal”)
1993Problems pointed out for treatment materials reimbursed at
the purchase price: medical institutions are less likely to becost conscious; competition principle is less likely to work inmarket price formation; and the same treatment materials havedifferent redemption prices depending on medical institutions.
April• Notice of reimbursement prices for 7 items* such as artificial
joints (classified by function)
1994

April
2008

April
2010

April
2012

*Artificial joints (knee joints, hip joints), artificial heart valves (mechanicalvalves, bio-valves), disposable artificial heart-lung, balloon catheters for balloon pumping, percutaneous coronary angioplasty catheters

April
1996

• Notice of reimbursement prices for 16 items* such as angiography guide-wire (classified by function)*Guide-wire for angiography, sheath introducer set / dilators for angiography,
catheter for angiography, catheter guide-wire for percutaneous coronary angioplasty, disposable catheter for bladder indwelling, optional components
for artificial hip and knee joints, inner splints for fixing, esophageal varices
sclerotherapy set, endoscopic esophageal varices ligation sets, cannulas
extracorporeal circulation, guiding catheters for percutaneous coronary
angioplasty catheters

April
1998
April
2000

October
2000

April
2002

April
2004

• Review of dialyzer grouping• Special sutures and back support belts are included in procedure fees
• Review of a certain range in the revision of reference treatment material price• Addition of facility standards for pacemakers, PTCA, etc.
• Special provisions limited to FY 2000 in association with the
reduction of a certain range (range adjustment)• Measures for international price fluctuations of precious metalmaterial for dental use (range correction)• Review of function classifications for pacemakers, PTCA catheters, and artificial joints• Abolition of municipal purchase price system (actual purchase price system)• Outline of procedures for determining new product classifications (including provisional price of C1)• Outline of procedures for setting new function classifications
upon material price revisions• Establishment of an organization dedicated to treatment materials• Formulated the calculation method for the reimbursement priceof special treatment materials for new function classifications(C1 and C2) when reviewing the definition of existing functionalclassifications and when setting up new function classifications.
• When a new function classifications is set up, in principle thesimilar function classification comparison method is used. If
there is no similar function classification, then use the costcalculation method.
• If the calculated price is significantly different from actual
market prices of other countries, certain price adjustments
will be implemented• Recalculate fields that meet certain requirements with an aim
to optimize the price of existing treatment materials• Review existing function classifications when material prices
are revised• Review price adjustment criteria in the calculation of material
prices for special treatment materials that require the setting of
new function classifications (C1 and C2)• Insurance coverage for special treatment materials classified
as C1 four times a year
(Note) C2 (new function / new technology) insurance coverage, timed for the introduction of new medical technology
insurance coverage• Review recalculation price adjustment rules• Review a certain range of reference material price revision

Main measures• Insurance applied four times a year for classification C2 (newfunction / new technology)• Specified range review of reference material price revisions• Expanded scope of special treatment materials for which validity of recalculation conditions are discussed• Review measure to mitigate radical changes during recalculation• Review supplementary premium• Review new medical materials and recalculation price adjustment rules• Review a certain range of reference material price revisions• Raise objections• Review new medical materials and recalculation price adjustment rules• Handling of product cost within the cost accounting method• Review of statement on improved premium requirements• Review of a certain range of reference material price revisions• Clarification of rules for withdrawal of insurance coverage• Clarification of procedures for materials that are not fully reimbursed due to extremely difficult supply• Review of as-needed revision rules of the prices of precious
metal for dental use• Review of new medical materials and recalculation price adjustment rules• Australia was added to foreign price reference system• Handling of post-marketing surveillance (PMS) costs within
the cost accounting method• Review of supplementary premium requirements (clarificationof target materials of premium, etc.)

April
2014

• Establishment of evaluations for expedited insurance coverage• Response to volatile foreign exchange rates• Review of price adjustments related to new function classifications (FAP calculation method, measures for products with verya low FAP ratio)• Review of the evaluation of innovation related to new function
classifications (continue evaluation for expedited introduction of
insurance, operating profit ratio in cost accounting method, special
exceptions for function classifications, added additional requirements for supplementary premium)• Matters related to recalculation of existing function classifications (review of recalculation ratio, response to changes in consumption tax rate)

April
2016

• Review of reference material prices• Review of function classification• Measures for ensuring stable supply• Review of price adjustments in new function classifications(review of comparison levels, refinement of measures for productswith a very low FAP ratio)• Review of evaluation of innovation in new function categories(evaluation of medical devices with high medical needs, continued
evaluation and review requirements of expedited insurance introduction, continuation of special exceptions for function classifications, addition of approach to re-calculation by similar function classificationcomparison method, clarification of approach to C2 classification)• Review of recalculation of existing function classifications (revision of comparison levels, review of FAP calculation method)

April
2018

• Accelerated insurance coverage• Review of price adjustments related to new function classifications (FAP calculation method)• Measures for products that require evaluation based on actual
usage, (operation of premium for replacement products, measuresfor new products that have been more simplified than existing products, continued evaluation and review of requirements for expedited
introduction of insurance, continuation and expansion of special exceptions for function classifications)• Review of recalculation of existing function classifications(review of FAP calculation method)

April
2019

• Price adjustments premised on evaluation results in trial introduction of cost-effectiveness evaluations• Establishment of new insurance coverage classifications andsimplified procedures• Introduction of cost-effectiveness evaluation (inclusion criteria
for items covered, analysis process, price adjustments)

Source: FY 2016 “Guidebook on Insurance Coverage of Medical Device”, a project commissioned by Economic Affairs Division, Health Policy Bureau,
MHLW (March 2017, Mitsubishi UFJ Research & Consulting)
Data in the guidebook was simplified as needed and the change in thesystem from 2018 onward was added. Notation of years changed to the
Gregorian calendar (CE).

AMDD

43

10 Years of Innovation Saving
Patients

Dialysis
Kidney disease
The kidneys are a pair of bean-shaped organs, located in theupper abdominal area of the human body. The kidney is an
essential organ for maintaining the health of the body. Its mainfunctions are to: 1) remove waste from the body, 2) maintainoverall fluid and salt balance, 3) control blood pressure, 4)adjust the amount of red blood cells, and 5) maintain healthybones.
In this way, the kidneys play an important role in human life.
However, should the function of the kidneys gradually decrease
due to aging, diabetes, high blood pressure, and arteriosclerosis, a patient may be diagnosed with chronic kidney disease(CKD), and require treatment depending on the condition of disease progression. Currently, approximately 13.3 million patients
suffer from CKD, which is said to be a new national disease.
Treatment of CKD involves the combination of numerous
methods, including lifestyle improvements, diet, treatment forhigh blood pressure, and pharmacotherapy. In serious cases,
kidney function drops to 15% or less and renal replacement
therapy including dialysis or renal transplant must be initiated.

dialysate via catheter and the blood is purified in the body. As
this can be performed at home, patients have to visit hospitals
only about once a month. As such, patients can undergo dialysis treatment while continuing working without major lifestylechanges.
There are two different types of peritoneal dialysis. The firstis continuous ambulatory peritoneal dialysis (CAPD), in which
the bag containing dialysate is manually changed 3-5 times aday. The other is automatic peritoneal dialysis (APD) whichmechanically changes dialysate at night. APD can reduce theburden of replacing dialysate during the day and allow patients
more freedom of action.
The most recent technological innovations in APD allow
medical staff to remotely monitor a patient’s status at theirhome using mobile communications functions, and allow doctors to change prescriptions from hospitals.

Dialysis treatment
One renal replacement therapy is hemodialysis. This therapy
circulates blood outside the body through an artificial filter toremove waste and excess water accumulated in the blood due
to renal failure.
The prototype of the dialysis membrane used in treatment
was invented by Thomas Graham in the mid-19th century.
Doctor John Abel first applied the membrane as a substitutefor the kidney in 1913, and successfully performed extracorporeal hemodialysis on animals. Initially, blood coagulation during
extracorporeal circulation was a major challenge. However,anticoagulants have been developed subsequently, and the procedure could be performed on the human body.
Since the end of World War II, dialysis technology dramatically improved. Downsizing of devices prompted the enlargement of
the dialysis membrane area. During the process, multilayer dialyzers and hollow fiber dialyzers were developed. After a numberof improvements, this became the standard therapy up to now.

Principles of hemodialysis
The principle of dialysis is to place a semipermeable membrane
between the blood and a dialysate to remove toxins in the bloodby diffusing them into the dialysate. In doing so, water andother substances are moved to adjust the amount of water andreplenish deficiencies in the blood. A medical device equippedwith this dialysis membrane is called a dialyzer. It substitutes
the kidney’s filtration function, and acts as a substitute kidney
for patients with decreased kidney function. Dialysis that used
this mechanism is called hemodialysis, and it is performed at
medical institutions including clinics.

Peritoneal dialysis and remote monitoring
Another renal replacement therapy is peritoneal dialysis thatuses the peritoneum lining of the organs in the abdomen as adialysis membrane. In this procedure, the abdomen is filled with

44

AMDD

Automatic peritoneal dialysis (APD) at home enables remote monitoring by
medical staff

Paradigm shift in therapy selection
The number of dialysis patients in Japan is said to be about
330,000, and continues to increase, largely due to an aging population and increasing incidence of diabetes, which is one of themain causes for dialysis. Technological progress has improved
prognosis and reduced complications such as infections. Moreover, increased treatment options such as CAPD and APD, in
addition to hemodialysis, have allowed patients to choose
treatments that best fit their lifestyles.
And, in Japan, the ratio of patients receiving hemodialysis
to peritoneal dialysis is 97:3, which is showing the significant
imbalance. This is attributed to the fact that peritoneal dialysis
was not fully explained to patients because medical staff were
uneasy about the procedure due to a lack of experience, andpatients were concerned about self-management at home.
In recent years, there has been a call for “shared decision
making” in which patients and their families fully participate
in therapy selection, and we are shifting into an era where weselect treatments that suit our lives and values.** Japan Society for Peritoneal Dialysis: Symposium in October 2017

Technological innovation that applies digital technology is set
to continue in the dialysis field, such as APD remote monitoring.
It is expected that medical fees and devices that offer innovative treatment will be evaluated in light of the values they offer.

10 Years of Innovation Saving
Patients

Ophthalmology
The joy of seeing
Visual disturbances significantly reduces a person’s quality oflife. These conditions include cataracts that affect many as theyage; glaucoma, which develops in about one in 20 Japanese
aged over 40; and ametropia, including myopia which has been
increasingly noticed in younger aged individuals. The evolutionof medical devices has given many patients the joy of seeing
again with their own eyes. Here we introduce medical devices,which continue to innovate and advance the field of Japanese
ophthalmology.

Cataracts:
Evolving multifocal intraocular lenses
Cataracts are a condition in which the lens becomes turbid,
largely due to aging. Even with modern medicine, cloudy lenscannot be restored to their original condition. Now the common method is to surgically remove lens and insert an intraocular lens. Cataracts, which were once the number one cause ofblindness, are now more or less a disease which can be avoided through surgery owing to the emergence and subsequent
improvements of intraocular lenses, and the development oflens reconstruction techniques for lens insertion.
The intraocular lens was introduced in 1949 by British
ophthalmologist Harold Ridley. The idea of creating an intraocular lens with polymethyl methacrylate (PMMA) was inspired
from pilots who sustained eye injuries from fighter jet PMMA
windshield fragments, and did not show signs of foreign bodyreaction. It was 1985, some 36 years later, when Japan approved
intraocular lenses.
The evolution of intraocular lenses overthe past decade, especially multifocal intraocular lenses, have allowed not only lenses
that offer far and near focus, but also diversified selection of lenses according to individual lifestyles. It is possible to select the lenses
that best suit our needs after consultation
with our optician; such as reading, crafting,using a computer, and improving astigmaMultifocal
tism.
intraocular lenses
Cataract surgery is no longer just the
replacement of a cloudy lens with a clear lens. It would be no
exaggeration to say that the surgery is now an opportunity tothink about how to improve one’s quality of life. The multifocal intraocular lens will continue to evolve as a device with thepotential to expand the joy of living and seeing.

Glaucoma:
Implants that expand surgical treatment options
Glaucoma may develop due to increased intraocular pressure,or in normal intraocular pressure. But in both cases, the visual
field narrows due to damage to the optic disk where the optic
nerve gathers. If it progresses, vision may eventually be lost.
As the optic nerve is not restored to its original condition, themost important thing is to delay progression of the condition
through early detection and early treatment. Recent advancesin diagnosis and treatment have made it possible to reduce therisk of blindness.
Guidelines for diagnosis and treatment have been published by the Japan Glaucoma Society. The basis of treatment
is continuous pharmacotherapy with eye drops. However,should the condition continue to worsen, then various surgicaloperations are approved as indications. In 2011, a device calleda tube shunt (implant) for draining aqueous humor from theeye and prevent an increase in intraocular pressure was introduced from overseas and approved. The tube shunt is a gift forpatients with problematic conditions that cannot be treatedwith conventional glaucoma surgery.

Silicone plate (left) and tube (right) used for tube shunt surgery.
The area of the oval plate is 350 mm2, and the tube is an extremely small device
with an outer diameter of 0.38 mm and an inner diameter of 0.05 mm.

The evolution of contact lenses
Contact lenses (CL) are designated as highly controlled medical devices. They are defined as “medical devices that require
proper management as they may materially affect health andlife in the event of adverse reactions or malfunction of devices.”
The market for silicone hydrogel CL has been growing inrecent years. Silicone is a material with a very high oxygen permeability, but essentially hydrophobic. For CL, in which highhydrophilicity is essential for comfort, developing products
using silicone was deemed problematic. However, progress insurface treatment technology at CL manufacturers allowed thelaunch of products that combine high oxygen permeability andhydrophilicity on the lens surface, and they are now the mainstream. Over the past decade, an array of products that leverage these new materials and better manufacturing technologies
have been developed in those technologically high-value-added
products including CL for astigmatism and CL for presbyopia.
Particularly in Japan, the world’s most aged society, the importance of CL for presbyopia is expected to increase in the future.
Meanwhile, colored CL, which make the pupils look larger,
are popular among women. In this field, products made of materials in the former generation using older coloring technology
are still available on the market. The challenge now is to raiseawareness, encourage correct usage, promote the use of highly
safe products, and ensure eye safety among colored CL users.

Reference
The Japan Glaucoma Society Guidelines for Glaucoma (3rd Edition) addendum: Guidelines for Glaucoma Tube Shunt Surgery
http://www.nichigan.or.jp/member/guideline/glaucoma3_1.pdf

AMDD

45

Chapter

5
The Road Ahead
Prologue

Immediately after reception at the medical center, her

In 203X, in a village in Akita Prefecture, lives alone an 87-year-

examination begins. She takes a blood test and diagnostic

old widow, Ms. Yoshino. Her husband passed away 10 years

imaging tests with the help of a coordinator. Ms. Yoshino’s sec-

earlier. The number of private farmers is decreasing, andond daughter, who lives in Morioka, also arrives. Meanwhile,

agricultural corporations are becoming larger and franchised.

her eldest son living in Tokyo also participates online. The

Mechanized farming and user interfaces continue to evolve,

results of each test and Holmes’ findings are handed in to theand elderly people who are not good at picking up new things

attending physician. The 80-year-old doctor looks over them

are working as long as they have physical strength and cancarefully and shows Ms. Yoshino her treatment options. Unlike

ride on the waves of mechanization. Ms. Yoshino also intends

the past, now the doctor looks at her in the eyes when speak-

to work until she can’t anymore.

ing to her. Her eldest son comments that he’s happy to see

In recent days, her chest pain and shortness of breath havethe AI recognizes the contents of the conversation and display

grown worse. She has not quite fainted, but she sometimes

them with pictures on the screen. Seeing is believing, especial-feels like she’s descending in an elevator. A general healthly for Ms. Yoshino, who has become hard of hearing.

check that she took several years ago showed mild calcifica-

After a brief explanation, data and treatment courses oftion and regurgitation in her heart valve, and she was told topast patients with similar heart lesions are presented to Ms.

see a doctor immediately if such symptoms arose. Ms. Yoshino,

Yoshino for each treatment option. They are data accumulated

who had never been ill until the age of 80, had an artificialfrom the past three years up to the previous month in Japan.

joint replacement about 5 years ago because her hip joint

Laymen can’t understand it. But Ms. Yoshino feels relieved

was degenerating and she found walking difficult. She foundto hear that the probability of complications is just as low as

the artificial joint convenient. Ms. Yoshino did not hesitate inwhen she underwent the artificial joint replacement. No matterbooking a medical examination because she knew from past

which treatment Ms. Yoshino chooses, the co-payment will be

experience that preventative treatment led to a better quality

about the same (Note: the amount of co-payment in the nation-of life.

al health insurance system. The total expense of follow-up med-

She is off to the Akita Medical Center in an autonomously

ical treatment and hospital admission expenses are shown todriven pod. The center is 30 km, around 40 minutes away. She

the patient). Upon that advice, Ms. Yoshino decides to havesafely arrives soon. Autonomous driving is not fully approved,a smart implant (self-diagnosing artificial organ with a sen-but its use is allowed in areas where there is little public trans-

sor connected to the hospital) embedded in the heart throughportation. Multifaceted benefits of the pod are being acknowl-a minimally invasive procedure, which allows for early dis-edged; addressing the driver shortage, the withdrawal of thecharge. Although a patient can go home on the following day,aged into their homes, and a lack of infrastructure, as well

preparation is required. Ms. Yoshino reserves her operation

as improved convenience. The area has been designated as

three days later when an experienced doctor in his fifties isa “Special zone for social infrastructure safeguard”. The pod

available for the operation. After her reservation is complete,is a means of transport for local residents, and a pod-type

Ms. Yoshino is finished with her pre-operative examination.

unmanned convenience store circulates so that the aged are
not locked out from their necessary daily shopping.

46

1. AMDD’s path

Ms. Yoshino saw her doctor yesterday afternoon. Thanks

The innovation in medical technology is amazing. Thus far,to the 5G communication network, she sees her doctor fromit has already contributed so much toward many aspects,

her home. For an hour and a half, including a break, nurses

such as patient outcomes and reduced workload of doc-(coordinators), and AI Doctor Holmes asked her questions, fol-

tors. The AMDD has worked hard under a mission to deliver

lowed by a physician’s confirmation inquiry. Ms. Yoshino isworld-class medical technology to Japanese patients.

asked about her daily routine and diet in detail, and her eldest

AMDD’s mission is “Enabling a Healthier Japan”. Thisdaughter time to time intercepts via the Internet. Ms. Yoshino isneeds some explanation. AMDD comprises of Japanesegrateful that Holmes’ questions were in audio and on a screen.

companies affiliated with large multinational players.

AMDDIn most cases, the scope of business operations of thosetechnology itself. The intention was to depict the onset ofcompanies is limited to Japan. Therefore, our mission is tothe disease to its treatment for the patient while consider-stably supply medical devices and technology to Japanese

ing the shared decision making between the patient and thepatients, and to deliver our member’s superior productdoctor. (Please read the epilogue for the path to recovery.)technology to Japanese patients ahead of other countries.

Although the technology is not omnipotent, we described

Our important role in pursuing these missions is to propose

what the technology may bring: correction of the working

to parent companies what is necessary to meet Japaneseenvironment of physicians, addressing the shortage of phy-healthcare needs and to get investments. And for sound cor-sicians, and task-shifting to AI. The evidence accumulated

porate activities, we cast a keen eye on Japan’s healthcare

in the clinical setting and from epidemiological surveys issystem, the soundness of social security finances, and theenormous. As we move forward, such clinical information,

sustainability of financial resources.

papers and big data will be increasingly enriched. The vast-

AMDD activities are concentrated on three axes. The

ness of the latest knowledge is beyond what a single physi-

first is to make recommendations for the accelerated andcian can handle in his/her daily interaction with patients.

appropriate introduction of medical devices and IVD into

Thus, collaboration between doctors and AI will be a major

Japan. Second is our role as a window to the government.

subject.

And third is to convey the value of advanced medical technologies.
Our major achievements over the last decade are wide-

2. What can the AMDD contribute to the
future?

ranged, including eliminating device lag and device gap,

Do you know how big innovators in the world now capture

contributing towards the formulation of the Pharmaceutical

opportunities for their innovation? Let us look at one

and Medical Device Act (Act on Securing Quality, Efficacy

example.

and Safety of Products Including Pharmaceuticals and Med-The world’s population is approximately 7.5 billion,

ical Devices), and raising awareness of medical devices.

increasing by about 70 million every year. For the sake ofAchievements of our member companies are also diversi-

clarity, let’s assume the population will be 7.7 billion in thefied, including safe and stable supply of medical devices,

near future, of which about 700 million people will enjoy

detailed information provision, enhancements, refinement

advanced living standards. To deliver advanced living stan-and improvements for more effective and safe products,

dards to the remaining 7 billion people, goods and services

introduction of innovative medical devices and IVD, domes-

must be offered at lower cost and scaled up 10 times. Yet,tic research and clinical development, production, and pro-on the other hand, CO2 emissions need to be reduced fromcurement.

the viewpoint of sustainability and energy consumption. To

Over the last decade, awareness of medical devices has

put it another way, big innovation must provide more thanbeen raised, yet it is far from sufficient. Differences between

10 times its current efficiency and added value. The existing

medical devices and pharmaceuticals have been dissem-

technology and industry paradigms will be replaced withinated among relevant parties, especially in terms of the

new ones. Although it is a painful process, declining indus-

background of development (development in which feed-

try and the disappearance of certain industrial segmentsback based on the opinions of the doctors and the results

will result. That’s why it is called “disruptive innovation.” Aof patients’ treatments are reflected in new versions of prod-frequently cited example is when in 2010, the US government

ucts, refinement, improvement, and the learning curve nec-

reported the number of electric vehicles that were estimat-

essary for physicians). Additionally information about how

ed to be produced in 2035, which was achieved by Tesla inthey contribute to medical care (minimally invasive early

2015, 20 years ahead of the estimate. For taxi drivers and thehospital discharge, early recovery, improvement of QOL),

existing automotive industry, coupled with Uber, this trend

and their characteristics (few in quantity but an array ofis leading to disruptive innovation. Big innovation targets

types, size, combined use, and fast innovation cycle) has

communication, transportation, energy, food, education,

also been disseminated. In that respect, there are more

and of course, healthcare. How can the healthcare system

active and fruitful discussions about the future directionthat is currently enjoyed by 700 million people worldwideof the medical device field among stakeholders such as theand the state-of-the-art medical technology enjoyed by an

MHLW, the PMDA, the Japan Medical Association (JMA),

even smaller number of people be delivered to the remain-

insurer organizations, and clinical academic societies.

ing 7 billion people on the planet? (and how can any solu-

The near-future depicted in this chapter’s prologue fac-tion to this question generate further innovation and added

tors in the aging society and regional responses to it, prog-

value to build a competitive edge in the markets of the 700

ress of AI/ICT/IoT, development of autonomous driving andmillion?) This is where big business opportunities lie andcommunication infrastructure, and innovation in medical

innovation competition is ongoing.

AMDD

47

Column

1

Aging population

People aged 65 or older are expected to be on the rise until 2045 1). From 2005, we entered a phase of population decrease inwhich the number of deaths surpassed the number of births. In 2016, the number of newborns was below 1 million 2) (Figure 1).
Figure 1.
Number of births and deaths(persons: left axis) and changes
in increase / decrease (persons: right axis) 2)

Additionally, the number of elderly living alone has increased, and 40% of elderly people are estimated to be living alone in2035 (Figure 2).
Figure 2.
Changes in the number of
elderly people living alone(thousands: left axis) andpercentage of all elderly people(right axis) 3)

Aging of healthcare providers
The decrease of the working generation due to aging will also affect medical professionals. Some suggest the era of elderly
patients being treated by elderly medical professionals (physicians, nurses, and paramedics) could be on its way out.
The age-based structure of hospital doctors in 2006 showed that a majority of physicians were over 40 years old and theaverage age in 2016 was 44.5 years old, revealing an aging trend among physicians (Figure 3).
Figure 3.
Age structure of hospital
doctors (persons: left axis) andaverage age (years: right axis) 4)

This trend is significant for those in clinics, where although the average age is 59.6 years, the number of those over 70 years
accounts for 22.8% 4).
Moreover, the number of young physicians (aged 39 or less) who take over the skills of experienced physicians hasleveled off. A lack of succeeding physicians has put the handing down of skills and technical know-how at risk. Amid suchchallenges, medical devices are expected to play a significant role in maintaining and improving clinical outcomes.

 Elderly people’s assets and reduced liquidity
The number of patients with cognitive decline due to aging is expected to increase. When a patient shows cognitive decline, theirassets are managed by a Guardian as per the adult guardian system. In most cases, such assets are managed as deposits not to
be damaged and this means they could not be invested in the market as there is risk (hence these assets become dead assets).
The total financial assets of elderly people with cognitive decline was estimated to be 127 trillion JPY in 2015 (Figure 4),
and will exceed 200 trillion JPY by 2030.

48

AMDD

Figure 4.
Financial assets held by
patients with cognitive decline(estimate and future pro forma
figure: trillion yen) 5)

When compared with Japan’s National Budget in FY 2019 (approx. 101 trillion) and the outstanding currency issued at the endof FY 2018 (110.4 trillion 6)), a considerable amount of money is lying dormant without underpinning the economic activity inJapan. Because of concerns over healthy life spans, those assets are hardly spent, thereby affecting the national economy.

What about the healthcare challenges in Japan? This is dis-innovation in Japan and to disseminate the value of innovation.

cussed in three key words; aging population, sustainability ofThis has been our role to date. Another important role for us

financial resources, and extension of healthy life span. (See thegoing forward is to keep the global innovation community post-columns for more details.) In other words, how to provide pre-ed on Japanese business opportunities in an easy-to-under-

vention, diagnosis, and treatment of diseases for healthy living

stand manner, together with the government and academia.

at minimum additional cost to those living in various parts of

Of course, it is important to commercialize and dissem-

Japan with limited economic power and declining mobility.

inate Japanese know-how and innovation as Japan’s popu-

An aging population results in decreased medical literacy.

lation becomes super-aged. An important point in finding

The number of elderly people living alone like Ms. Yoshino

a solution to the problem of Japanese healthcare provision

is increasing. The rapid development of technology and themust be to have innovation funded by mega-VC firms

onset and progression of dementia are testimonies to thetargeting 7 billion people, and to raise Japan-specificfact that medical literacy among the aged cannot keep up.

innovation as a solution for a global problem.

It is extremely difficult to find solutions for the three key
concepts in the current paradigm because they contradict one

3. All stakeholders unitedanother. Cash hidden away by the elderly lies outside the eco-

The AMDD is proud of its success in improving medical

nomic cycle. An important question is how to bring that money

technology and contributing to patient care in Japan. Thisback into the economy. Another pressing issue is whether asuccess is the result of the efforts of our member companies

mechanism to channel money into healthcare can be built.

and their introductions of innovative technologies, and theJapanese healthcare issues and the direction of big innovation are very similar. Providing the healthcare system,

understanding and cooperation of the MHLW, PMDA, JMA,
insurers, and clinical societies.

that Japan takes pride in, to the elderly population, which

As we head towards a society in which population

is aging and thus is becoming relatively less medically literate,

growth has peaked and medical health care can no longer be

is equivalent to delivering healthcare enjoyed by 700 mil-provided at prices offered to date, we face a question of howlion people to 7 billion people. There are different challeng-

to proceed. As in the development of medical devices, policy

es, but answers which are applicable to both issues may

will depend on revisions and improvements brought about

emerge. Such challenges include the following cases: med-by drastic and disruptive innovation for all concerned.

ical care in developing regions with poor social infrastruc-Our aim is brighten our future through the continued

ture; medical care for Japanese rural residents whose social

development of cooperative relationships that enableinfrastructure is dwindling; support for areas in which there

patient-centered sincere discussions in these areas so thatis no room for capital investment; and support for areas

Japan’s social security system can be improved.

where capital investment is made but nobody is using it.

The world depicted in the prologue and epilogue is drawn

These aspects elucidate the important role of the AMDD.

on the basis of a mechanism that is already feasible. With

How can we use big innovation that can solve global chal-

one eye on our changing world, I hope we can keep working

lenges to improve Japanese healthcare? AMDD members

hard so that a more advanced future will arrive soon.

must be keenly aware of such question and be a good judge
to carry out our mission to “Enabling a Healthier Japan”.

Epilogue

Individual member companies will undoubtedly obtain

While being drowsy from local anesthesia and sedatives, thesuch innovation. The role of the AMDD is to make recommenda-

surgery was over in no time. After being examined in thetions for the accelerated and appropriate introduction of suchrecovery room, Ms. Yoshino practices walking in the evening

AMDD

49

Column

2

Sustainability of financial resources

Financial outlook in Japan
General accounts for FY 2019 exceeded the 100 trillion yen for the first time. Social security expenses including medical
expenditure, ran to approximately 34 trillion yen, due to the aging population, accounting for the largest government expenditure (Figure 5).
The total new government bonds issued (approx. 32.7 trillion yen) exceeds the redemption amount (23.5 trillion yen),
and approximately 9.2 trillion yen outstanding bonds are expected. The debt at the end of FY2019 would be 896.7 trillion yen,which is 158.4% of GDP 7). Difficult financial circumstances are expected to continue (Figure 6).

Efforts toward optimized social security costs
Social security costs, especially optimized and sustainable medical costs, remain a major discussion point in Japan. Further discussions on our aging society is needed to secure medical access while looking for ways to contain the natural increase of costs.
There is room to look for more efficiency in fields such as surgery, which consumes a lot of medical resources. According to Berwick et al. 8), of the medical resources consumed in 2011, approximately 34% (US $910 billion) was inefficiently
consumed. Although advanced functions across hospitals and clinics are available, medical resources are inefficiently consumed. In Japan, further consideration for efficient medical operations (lean operations) should be considered.
More than 100 billion JPY in costs, combining medical devices and pharmaceuticals, have been cut at every revision.
However, we have come to a point where it is no longer possible to look for further reductions in the cost of medical devices/ pharmaceuticals. Guidelines on cost-effectiveness have already been issued, but there is a need for further discussion, notonly on the incremental cost-effectiveness ratio (ICER), but also on avoiding risks in nursing care, for which medical devices
are useful, and avoiding the risk of productivity loss in the future.
In the 2018 medical fees revision, a stepped reimbursement scheme was introduced for basic inpatient fees by the beds’
functional category depending upon actual accepted number of acute phase patients. However, in Japan, still the numberof beds for acute phase patients is significantly high and this does not well reflect for the future demand of distribution for
nursing or chronic phase beds due to the aging society (Figure 7).

Figure 5. General account for FY 2019 (trillion yen)
101 trillion 456.4 billion yen

Figure 7. Number of hospital beds by function (2016) 9), 10)

50

AMDD

Figure 6. Outstanding bond issues (trillion yen) after 2000 and as a percentage
of GDP 7)

without a problem. She is informed that the operation was ahome. The itemized expenses received by e-mail detail the

success, and she is to be discharged. Her second daughter, who

total amount in yen along with the amount she had to pay.

accompanied her, also feels relieved. As planned, Ms. Yoshino

This is part of the recent efforts to raise awareness of medical

stays overnight at a hotel she reserved with postoperative sup-expenses. Ms. Yoshino was surprised to see the total amount,

port service near the hospital because she is a little worried.

but remembers her eldest son telling her about the High-Cost

If something happens, there is a nurse on call so she can feel

Medical Expense Benefit. She is indeed grateful to the nation-safe and secure. The smartphone in the room has a monitoringal health insurance system. Ms. Yoshino is given a watch-likeapp and an AI doctor, which addresses voice inquiries othermonitor from the hospital for postoperative management.

than stressed or panic-stricken voices. The state of the implant

The monitor, which is connected to the medical center’s mon-and the patient’s body are also monitored.

itoring room via a smartphone app, is provided in case of the

Ms. Yoshino stayed overnight without incident, and went toneed for intervention. The monitor will be removed in a month,

the hospital the next morning. She received a final confirma-

but Ms. Yoshino wants to buy a similar monitor and continue

tory interview with the nurse, paid electronically, and returned

to focus on her farming work while self-managing her health.

Column3

Extension of healthy life spanC hanges in healthy life span
and average life expectancy
The length of unrestricted daily life (healthy lifespan) and average life expectancy are extending.
Since a 2001 survey, healthy life span has extended
by 2.74 years for men and 2.14 years for women 11).
In the 2011 survey by the OECD, numericalthinking and reading comprehension skills ofJapanese were above the international averages. There is growing expectation for seniorcitizens to continue their active participation
in society (Figure 8).

Figure 8. Changes in healthy life span and average life expectancy 11)

Older retirement ages
The regular retirement age is significantly shifting to a higher age. In 1986, efforts were madeto introduce a retirement age of 60, and thisbecame legally enacted in 1998. Simultaneously,
efforts to change the retirement age to 65 began.
In 2012, the Japanese government enacted aretirement age of 65 for workers to be entitledto benefits; but workers are permitted to work
beyond the retirement age (Figure 9).

Figure 9. Changes in the corporate retirement age 12)

Raising the elderly
employment rate
The elderly employment rate has increased byabout 5 points from 2008 (male: 19.7%, female: 12.8%)
to 2018 (male: 24.3%, female: 17.4%) (Figure 10).

Figure 10. Changes in the total working population over the age of 65 (10,000 persons: leftaxis) and employment rate (right axis) 13) *: Estimated value

Reference
1) 2017 White Paper on Aging Society (Cabinet Office: Https://www8.cao.go.jp/kourei/whitepaper/w-2017/html/zenbun/s1_1_1.html)
2) 2018 Annual estimates of demographic statistics (MHLW: Https://www.mhlw.go.jp/toukei/saikin/hw/jinkou/suikei18/index.html)
3) 2016 White Paper on Aging Society (Cabinet Office: Https://www8.cao.go.jp/kourei/whitepaper/w-2016/html/zenbun/s1_2_1.html)
4) 2016 Doctor, dentist, pharmacist survey overview (MHLW: Https://www.mhlw.go.jp/toukei/saikin/hw/ishi/16/index.html)
5)	The future of dementia patient with financial assets worth 200 trillion yen (Dai-Ichi Life Research Institute Inc.: Http://group.dai-ichi-life.co.jp/dlri/pdf/macro/2018/hoshi180828.pdf)
6) Tell me! BOJ (Bank of Japan: Https://www.boj.or.jp/announcements/education/oshiete/money/c06.htm/)
7) Changes of post war government bond management policy (Ministry of Finance: Https://www.mof.go.jp/jgbs/reference/appendix/hakkou01.pdf)
8) Berwick D.M., Hackbarth A.D., Eliminating Waste in US Health Care, JAMA. 2012;307(14): doi: 10.1001/jama.2012.362
9) Results of 2016 report on the function of hospital beds (MHLW: https://www.mhlw.go.jp/file/05-Shingikai-10801000-Iseikyoku-Soumuka/0000164336.pdf),10)	Council on Economic and Fiscal Policy: Toward Steady Promotion of a New Economic and Fiscal Regeneration Plan - Social Security System Reform - (referencematerial): (https://www5.cao.go.jp/keizai-shimon/kaigi/minutes/2019/0410/shiryo_01-2.pdf)
11) 2018 White Paper on Aging Society (Cabinet Office: Https://www8.cao.go.jp/kourei/whitepaper/w-2018/zenbun/pdf/1s2s_02_01.pdf)
12) Employment management survey (MHLW: Http://www.mhlw.go.jp/toukei/list/39-16.html) and comprehensive survey of working conditions (MHLW)
13) Labor force survey (basic tabulation) (Statistic Bureau of Japan: Https://www.stat.go.jp/data/roudou/sokuhou/tsuki/index.html)

AMDD

51

The History of
the AMDD
2010• April 1, Mr. David Powell (President of Johnson & Johnson K. K.) is appointed as the second Chairman• April, “A Proposal from the Medical Device Industry with regard to the New Growth Strategy‘A Healthy Country through Life Innovation’” was released• August, Position paper “Thoughts on the Handling of Invitro diagnostics” was released• November, Proposal “Medical Device Maintenance Compliance as an Issue of Medical Safety” was released2009• April 1, The American Medical Devices and Diagnostics Manufacturers’ Association (AMDD) spins off from ACCJ;
Dr. Huimin Wang was appointed as first Chairman (President of Edwards Lifesciences Ltd.)(Masataka Toyota, the first Staff Director), and a press conference was held
• May, Book titled “I’m glad I chose this treatment,” a compilation of essays by patients who selected
the latest medical technology, was published• July, Research paper “Comparison of Medical Device Supply Costs in Japan and Europe” was released2008• October, “Device Lag Report” was released• December, Press conference for “Device Lag Report”
April 2009, press release on
the inception of the AMDD
July 2009, Comparison of
May 2009,
Essay Collection Medical Device Supply
Costs in Japan and Europe

2007• November, Media Forum titled, “Thinking about
the Future of Japanese Healthcare” was held

December 2008,
press conference for“Device Lag Report”

2009
2008
2007
December 2006, press
conference for the viewpoint
paper on patient access2007 November, Media Forum
titled “Thinking about the
Future of Japanese Healthcare”

2005

2002
• In October, the ACCJ Medical
Device and Diagnostics
Subcommittee began a publicawareness campaign titled“Value of Medical Technology”

1999

2004

• December, Viewpoint paper titled,“Improve Patient Access to Advanced
The term “device lag”
Medical Technology” was released
comes into use.
and press conference was held

2004

2003
2002

2006

2003

• Symposium titled “Patient-Centered
Medical Care” was held

• February, The first Media Lecture was held(subsequently held every other month)
Revised Pharmaceutical• July, Exhibition, titled “International Modern
Affairs Law (effective
April 2005) enacted.
Hospital Show 2003” was held

1999

1997
The
1990s

2006

1997

AMDD

Media lectures commenced
in 2003• Proposal titled “A Turning Point of the Japanese Healthcare System”
was released• Proposal titled “The Role of Medical Equipment and Supplies in Improving
the Efficiency and Quality of the Japanese Healthcare System” was released• Medical Devices and Diagnostics Subcommittee was established within
the ACCJ Healthcare Committee (later renamed the Medical Device / IVD Subcommittee)

52

December 2008,
MHLW launched“Medical Device Review
Acceleration Action Program”

International Modern
Hospital Show exhibitionin July 2003

2013

2019

• June, “Proposal on Healthcare• April 1, 10th anniversary
Associated Infections (HAIs) andof the AMDD
2018
Healthcare Worker Safety” was released• April, “Proposals from the Medical Device• October, Participation and exhibition
Industry for the 5th Year Revisionat Aomori Prefecture and AMDDof the Pharmaceuticals andCollaboration forum,
Medical Device Act” was released.
2018
2016
“Collaboration of Medicine andEngineering to Open up a New Future” • January, Change oforganization status to a general
2017
incorporated association

2019

2016
October 2013,
Courtesy Visit from the Aomori
Prefectural Governor at the
AMDD Collaboration Forum

2017
2014

• February, Proposed “Value-Based Reimbursement
System” that reflects the innovation value of
medical devices and held press conference• April, Symposium in collaboration with the Japan
Medical Association (JMA), National Federation of
Health Insurance Societies (KENPOREN),
and the AdvaMed, “Creating a Vibrant Nation andLife Purpose” (annually held hereafter)• October 1, Established the Medical Technology
Policy Institute (MTPI), (Mr. Makoto Tamura, Director)

2013
2012
2011
2010

January 2018,
Press conference by
Chairman to announce theestablishment of the MTPI

2015

November 2013,“Pharmaceutical andMedical Device Act”
(PMD Act) enacted(Executed in October
2014)

March 11,
2011,
Great EastJapan
Earthquake

2015
2014

October 2017, Public-private February 2017, Press
discussion
conference for a value-based
reimbursement system• August 1, Mr. Kosuke Kato (Managing director of Edwards
Lifesciences Ltd.) is appointed as the fourth Chairman of the AMDD

• April, Book titled “I’m glad I chose this treatment II,”
the second compilation of patients’ essays was published• June, “Proposals on the Appropriate Provision of
In-vitro Diagnostics” was released2012• April 1, Mr. Takashi Shimada (President of Medtronic Japan Co., Ltd.) is
April 2014,
appointed as the third Chairman (Hiroshi Ikeda, the second Staff Director)
secondcollection of• June, “Proposal on Healthcare Associated Infections (HAIs) andessaysHealthcare Worker Safety” was released• August, Participation in Children’s Government Offices Field Trip Day (annual participation hereafter)• November, “Medical Creation Fukushima 2012” exhibition• December, “Research on the Economic Evaluation of Large Medical Devices” report was released

2011• July, “Proposal for Revisions to thePharmaceutical Affairs Law for Medical Devices”
and “Proposal for Revision to the PharmaceuticalAugust 2012, booths at
Affairs Law for IVDs” were released
Children’s Government• August, “Opinion Survey of Japanese Healthcare Offices Field Trip Day
and Advanced Medical Technology” report was
released and press conference was held
• September, “Comparison Survey of Market Environmentfor Medical Devices in Japan, China, and Korea”
was released and press conference was held
• November, “Proposal on Infrastructure Building for
Companion Diagnostics for the Promotion of Personalized
Medicine” was released

October 2012, Courtesy
visit to the Fukushima
Prefectural Deputy
GovernorAugust 2011,“Opinion Surveyof Japanese
Healthcare andAdvanced Medical
Technology”

November 2012, Medical
Creation Fukushima 2012

September 2011,“Comparison Surveyof Market Environmentfor Medical Devices inJapan, China, and Korea”

AMDD

53

Profile of
the AMDD

The American Medical Devices and Diagnostics Manufacturers’ Association (AMDD) is an industry group founded in2009 consisting of approximately 70 Japanese corporations that handle medical devices and in-vitro diagnostics(IVD), with headquarters located mainly in the United States. At the AMDD we aim to deliver the latest medical
technology (treatment and diagnostic technology) and information to meet the needs of medical setting and patientsin Japan. Our member companies not only import and sell products, but also work closely with the Japanese medical
device industry in research and development and manufacturing, and actively use components developed andmanufactured in Japan in their products. Furthermore, our member companies account for about 70% (about 1.8
trillion yen) of domestic sales of medical devices, and have created approximately 27,000 jobs (as of 2019) as direct
employment in Japan. Their domestic bases, including repair and maintenance facilities, spread to almost all
prefectures and contribute to the development of the Japanese medical device industry.

AMDD’s Mission
To provide valuable medical technology and information for the healthy everyday lives of people.

Activities of the AMDD
1

Providing recommendations to facilitate fast and appropriate introduction of medical devices

AMDD offers recommendations to the Japanese government regarding regulatory systems for the fast and safe introductionof the world’s advanced medical technologies to Japan. Such recommendations are provided in cooperation with the US
government and the US-based Advanced Medical Technology Association (AdvaMed).

2

Serving as a contact to the government

In order to realize overall cut backs on medical costs and appropriate allocation of healthcare expenditures, AMDD serves
as a point of contact between member companies and government offices such as the Ministry of Health, Labour andWelfare, with regard to the reimbursement system and related regulatory revisions.

3

Communicating the value of advanced medical technology

AMDD undertakes a variety of activities intended to inform a wide range of people, including the media, government officials
and politicians, medical professionals, and the general public of the value and role of advanced medical technologies.

Executive Committee (as of April 1, 2019)
Chairman

Auditors

Kosuke Kato (Managing Director, Edwards Lifesciences Limited)

Shigeyuki Masukawa (Vice President, Boston Scientific Japan K. K.)
Koichi Higuchi (Koiichi Higuchi, CPA, Tax Counselor )Vice Chairman
Yusuke Naiki (Chairman, Boston Scientific Japan K.K.)
Tony Semedo (President of Medtronic Japan Co., Ltd.)

Directors
Tatsuo Achiwa (President & Representative Director,
Nippon Becton Dickinson Company, Ltd.)
Sotaro Amano (Representative Director and Chairman of theBoard and President, Abbott Japan Co., Ltd.)Samih Al Mawass (President & Representative Director, Abbott
Vascular Japan Co., Ltd.)Ryo Noda (President, Asia Pacific, Cardinal Health)Kazuya Ogawa (Chairman & President, Zimmer Biomet G.K.)
Danny Risberg (President, Representative Director,
Baxter Ltd.)
Hiroyuki Saeki (Representative Director and President,
Stryker Japan K.K.)
Soichiro Tada (President & CEO, GE Healthcare Japan Co.)
Takanao Tamai (President, Johnson & Johnson K.K.)
Masaaki Tsuchimoto (President, Abbott Medical Japan LLC,
Head of CAHF)

54

AMDD

Advisors
Takashi Shimada (Former President of Medtronic Japan Co., Ltd.)
Toshifumi Hayashi (Director, Government Affairs,
Edwards Lifesciences Limited)Marie Kissell (Senior Advisor, Government Affairs,
Abbott Japan Co., Ltd.)

Director, Medical Technology Policy Institute (MTPI)
Makoto Tamura (Representative Director and CEO,
Healthcare System Planning)

Staff Director
Hiroshi Ikeda

Member Companies (As of December 31, 2019)
3M Japan Limited Health Care Company

Japan Lifeline Co., Ltd.

Abbott Diagnostics Medical Co., Ltd.

Japan Medicalnext Co., Ltd.

Abbott Japan LLC

Johnson & Johnson K.K.

Abbott Vascular Japan Co., Ltd.

KYOCERA Co.

Abbott Medical Japan LLCLabPMM Japan G.K.

Abiomed Japan K.K.

Lumenis Japan Co., Ltd.

Accuray Japan K.K.

Masimo Japan Co.

Alcon Japan Ltd.

Medacta Japan Co.

Allergan Japan KK

Medicon Inc.

AMO Japan K.K.

Medline Japan G.K.

Arthrex Japan G.K.

Medtronic Japan Co., Ltd.

Asahi Kasei Zoll Medical Corp.

MicroPort Orthopedics Japan K.K.

Avanos Medical, Inc.

Murata Manufacturing Co., Ltd.

Bausch & Lomb Japan Co., Ltd.

Nova Biomedical K.K.

Baxter Ltd.

Nippon Becton Dickinson Company, Ltd.

Bayer Yakuhin, Ltd.

Nippon Covidien Ltd.

Biosensors Japan Co., Ltd.

O&M Halyard Japan G.K.

Biotronik Japan, Inc.

Ortho-Clinical Diagnostics K.K.

Boston Scientific Japan K.K.

Otsuka Medical Devices Co., Ltd.

Cardinal Health Japan G.K.

Philips Japan, Ltd.

Century Medical, Inc.

ResMed KK

Cook Japan, Inc.

Sakura Global Holding Co., Ltd.

Cooper Vision Japan, Inc.

Smith & Nephew KK

Edwards Lifesciences Ltd.

STERIS Japan Inc.

Exactech K.K.

Stryker Japan K.K.

GE Healthcare Japan Co.

Thermo Fisher Diagnostics K.K.

Haemonetics G.K.

TKB Co.

Hollister Co., Ltd.

Ultradent Japan K.K.

Hologic Japan Inc.

Varian Medical Systems K.K.

AMDD 10th Anniversary
Memorial Book Committee

InSightec Japan K.K.

Vorpal Technologies K.K.

Editing and production:

Intuitive Surgical G.K.

Zimmer Biomet G.K.

Cosmo Public Relations Corporation

Avery Dennison Japan K.K.

SATO HEALTHCARE CO., LTD.

Mars Tohken Solution Co., Ltd.

SEAOS, Inc.

[Authors]
Chapter 1: Ryuji Kondoh

Nippon Express Co., Ltd.

Sunmedix Co., Ltd.

Chapter 2: Junko Kodama

North American Science Associates Japan G.K.

Toppan Forms Co., Ltd.

NTT DATA Corporation

Yamato Logistics Co., Ltd.

Associate members

NTT Logisco Inc.

AMDD 10th Anniversary
Memorial Book:
AMDD 10-year
History and Beyond
Publication date:February 1, 2020

Planning and publication:© 2020 American Medical Devices
and Diagnostics Manufacturers’
Association (AMDD)

Chapter 3: Aya Saeki / Shinobu Sato
Chapter 4: Makoto Tamura
Chapter 5: Kosuke Kato
(Figures and graphs:
Katsunori Fujita)Among the articles in this book, thepiece s on 10 Year s of Innovation
S av i n g Pa t ie nt s r e ga r d i n g e ac hd i s e a s e fi e ld, we r e w r it te n a ndcontributed to by member companies that have medical technology
related to the relevant field, and bycommittees within the AMDD. We
would like to thank the authors ofeach chapter and the companie s
they represent. We would also like toex pre s s our sincere gr at it ude to
everyone who has been supporting
the AMDD since the time when it
w a s p a r t of t he AC C J M e d ic a l
Devices and IVD Subcommittee tothe present day, and all those who
took part in the round-table discussion.

Executive Committee (April 2019)

AMDD: 10-year History and Beyond

10-year History and Beyond

Nakano Central Park South 15F, 4-10-2 Nakano, Nakano-ku, Tokyo 164-0001