Apr, 2020 Vol.33

AMDD 2020 New Year’s Celebration and Annual General Meeting
AMDD held a New Year’s celebration on January 10 at the Palace Hotel Tokyo. In his greeting, Chairperson Kosuke Kato (President andDirector of Edwards Lifesciences Ltd.) looked back on 2019 as the 10th anniversary since AMDD’s founding, and ahead to 2020’s prospects.
Congratulatory speeches were offered by Toshifumi Kojima (Parliamentary Vice-Minister of Health, Labor, and Welfare and Liberal Democratic
Party Member of the House of Representatives), Hanako Jimi (Parliamentary Vice-Minister of Health, Labor, and Welfare and Liberal Democratic
Party Member of the House of Councillors), Yasuhiro Fujiwara (Chief Executive of the Pharmaceuticals and Medical Devices Agency (PMDA)),
Kazumi Nishikawa (Director, IT Industry Division, Commerce and Information Policy Bureau, Ministry of Economy, Trade, and Industry), and Steve
Knode (Deputy Senior Commercial Officer, the U.S. Embassy in Japan). Kenichi Matsumoto (Chairman, Japan Federation of Medical Devices
Associations (JFMDA)) then gave the toast, inviting all guests to network and get to know each other’s fields.
On March 10, AMDD held its annual general meeting. Proposals for the 2020 and new members of the boardof directors were submitted and unanimously approved. At the subsequent special board of directors meeting,Kazuya Ogawa (Chairman and President of Zimmer Biomet G.K.) was appointed as the new chairperson effectivethat same day, as successor to Chairperson Kosuke Kato who is retiring. See page 1 for a greeting message fromthe new chairperson.

AMDD 28th Media Lecture

Mr. T. Kojima

Dr. H. Jimi

AMDD held its 28th media lecture on January 27 in Tokyo, under the title of “Practicing Shared Decision Making (SDM) in Medical Facilities.”
Japan SDM pioneer, Dr. Yasuhiro Komatsu (Professor and Chairman at Department of Healthcare Quality and Safety, Gunma University,
Graduate School of Medicine) spoke on the importance of SDM, in which medical professionals and patients
discuss and jointly decide treatment methods, as well as how it has recently become more prevalent in Japan.
With regard to the patient perspective, Ms. Mamiko Matsumura, President of the Kidney Support Association(non-profit organization), and a patient who chose to use insulin pumps for diabetic treatment were invited,and each were asked to share their views on SDM from the patients' perspective respectively. See page 2 fora summary of Dr. Komatsu’s lecture.

Value of Medical Technology〈Diagnosing and Treating Heart Conditions〉

Global Longitudinal Strain (GLS)’s Role in Evaluating
Cardiac Functions in Heart Failure and Anti-Cancer
Drug Cardiotoxicity in Echocardiography Tests
Echocardiography tests are a useful and safe way to observe and diagnose heart
condition in fine detail simply by placing a probe device on the body. Global
Longitudinal Strain (GLS) is an echocardiograph that is mainly used to identify
ischemic areas, detect areas with delayed contractions, and evaluate dyssynchrony.
GLS is an index of the systolic function of the cardiac muscle in the longitudinal
direction that was developed in the 2000s and was installed in commercially-soldmachines. However, GLS has gained attention in recent years as an index that cancomplement the Left Ventricular Ejection Fraction (LVEF), which has been the standard
index for evaluating cardiac functions. GLS has been listed in the American Society of
Echocardiography’s expert consensus and the European Society of Cardiology’s
position papers as a more incisive index. As a method for evaluating cardiac functions
for heart failures in which the LVEF is maintained, or as a method for evaluating the
cardiotoxicity of anti-cancer drugs, GLS showed more of a tendency to decrease thanthe decrease in LVEF. There remain issues of differing values between manufacturers
echocardiograph tests errors made by those performing the tests. However, humanerror can be minimized by using machinelearning for the automatic analysis function
to show an objective index that does notdepend on those performing the tests. The
graph shows waveforms of multiple
cross-sections on one screen, and showsabnormal areas on the bullseye screen(bottom right) so that they are easy tounderstand.
Graph: Waveform analysis of multiple cross-sections on(Wording: Katsushi Ogihara, GE Healthcare Japan Corporation)

the same screen; abnormal areas shown on the bullseye
screen (bottom right).

AMDD’s 10th Anniversary Activities—Patient Essays, Volume 3—

To celebrate 2019 marking the 10th
anniversary since its founding, AMDD
published “I’m Glad I Chose This Treatment!
III―Essays by patients who chose advanced
treatment,” a collection of essays recording
the benefits patients received, how their lives were saved, andhow the quality of their lives improved thanks to testing andtreatments using advanced medical technology.
AMDD published Volume 1 of “I’m Glad I Chose This
Treatment!” in 2009 and Volume 2 in 2014 in order tostrengthen understanding of the value of advanced medical
technology and the contributions that AMDD member
companies have made to healthcare in Japan. In the ten years
since Volume 1 was published, advanced medical technology
such as medical devices and in-vitro diagnostics (IVDs) havebecome more compact with developments in surgical
techniques and the use of technologies such as ICT all
evolving significantly. Volume 3 delves into the newtechnologies and fields not mentioned in Volumes 1 and 2, as
well as the progress that has been made over a decade oftechnological development. Overseen by Dr. Tatsuya Kondo(Chief Executive Officer of Medical Excellence Japan/Chief
Executive of the PMDA), the volume covers real patient stories
and an interview with Mr. Tsutomu Sekine, a famous Japanese
comedian, regarding a heart examination introduced througha TV show that revealed his coronary artery stenosis, as wellas the impact on his life before and after surgery.
The essays are also available to download from theAMDD website.
*To receive a copy of the essays, please get in touch via the AMDD
website or email AMDD PR representative at: amdd@cosmopr.co.jp

AMDDVol.33

NEWSLETTERC O N T E N T S
Greetings from the New Chairperson 01
Patient Participation in Healthcare
and Shared Decision Making (SDM) 02
Patient’s Voice
Understanding Dystonia and its
Optimal Treatments

03

Supporting patients with a clinical team
03
Radiological Technologists
AMDD 2020 New Year’s Celebration
04
and Annual General Meeting
AMDD 28th Media Lecture04

AMDD’s 10th Anniversary Activities
04—Patient Essays, Volume 3—
Value of Medical Technology
Global Longitudinal Strain (GLS)’s Role in Evaluating
Cardiac Functions in Heart Failure and Anti-Cancer
04
Drug Cardiotoxicity in Echocardiography Tests

Greetings from the New Chairperson
It is an honor to have recently been appointed the 5th Chairperson of
the American Medical Devices and Diagnostics Manufacturers’
Association, an industrial organization composed of about 70
Japanese companies headquartered in the US that provide advanced
medical technology such as medical devices and in-vitro diagnostics(IVDs). Since our founding in April 2009, our activities strive tomeet the needs of patients in Japanese medical facilities and deliver
the latest treatments, diagnostic technologies, and information undera theme of improving citizens’ health and quality of life. Speaking
personally, AMDD’s social responsibility is a source of great
motivation and lies at the heart of what we do.

Working Toward Good Health for Your Loved Ones

It is important for patients in Japan to have access to the sameinnovative medical devices used around the world. A long-standing
focus for AMDD has been the “device lag” issue. Working closelywith the Ministry of Health, Labor, and Welfare (MHLW), thePharmaceuticals and Medical Devices Agency (PMDA), and otherorganizations, we have been able to reduce approval times for
medical devices, resolving most of the device lag. The
Pharmaceuticals and Medical Device Act (passed in November 2013
and implemented the following year), separated regulations forpharmaceuticals and medical devices, and has paved the way for amajor leap forward in the medical devices industry from theperspective of building a regulatory framework to better meet thecharacteristics of medical devices.
AMDD became a general incorporated association in 2016 inrecognition of its social responsibility. To mark this change, weestablished a new mission statement: “Providing valuable medical
technology and information to your loved ones today, so that they
may live in good health.” Medical devices and IVDs are used in awide variety of ways that extend beyond treating illnesses, including
preventive care and improving post-treatment conditions. In order tobe an industrial organization that delivers such medical devices and
IVDs to Japanese patients as promptly as possible, we have beenfurther expanding the scope of our activities in line with this mission.
In order to promote the value of innovation in medical devices
and IVDs, we have been recommending a policy of “value-based

healthcare” since 2017. Part of this recommendation has alreadybeen registered as a “Challenge Application.” We have now
established the AMDD Medical Technology Policy Institutethink-tank within our organization in order to research ways for
medical technologies such as medical devices and IVDs tocontribute further to healthcare in Japan from the medium tolong-term perspective, and to recommend policies based on this.

Contributing to Healthcare for Japan’s
Super-aging Society

Japan continues to become a super-aged society. The quick
introduction and appropriate use of advanced medical technologies
that are standard overseas will prevent the progression of illnesses
and improve patients’ quality of life, which will result in a longer life
expectancy. A healthcare system that improves the health of society
by appropriately evaluating and reflecting the value of innovative
medical technologies will be important to achieve this. We need toconsider the management and distribution of medical devices andIVDs, as well as the use of digital technologies in healthcare.
AMDD will continue to leverage its unique strengths as anindustrial organization in the healthcare field to drive policy
recommendations and make other efforts to support the positive
development of Japan’s healthcare system by collaborating with theJapanese government, medical societies, and associated industry
associations, while also maintaining close relationships with the US
government and the US-based Advanced Medical Technology
Association (AdvaMed).

Kazuya Ogawa
Chairperson, American Medical Devices
and Diagnostics Manufacturers’
Association (AMDD)
Chairman and President,
Zimmer Biomet G.K.

All opinions in the newsletter are the views of the authorsand do not represent the views of AMDD or its activities.

Contact: Public Relations, American Medical Devices and Diagnostics Manufacturers’ Association (AMDD)
C/O Cosmo Public Relations Corporation, 1-8-10 Azabudai, Minato-ku, Tokyo, Japan 〒106-0041
Tel: +81(0)3-5561-2915
Website: https://www.amdd.jp/en/

04 AMDD NEWSLETTER Vol.33

AMDD NEWSLETTER Vol.33 01

Patient’s Voice

Patient Participation in Healthcare andShared Decision Making (SDM)
A New Doctor-Patient RelationshipThe relationship between doctors and patients is as much an
old issue as it is new. Conventionally it has followed theinformed model and paternalism, in which patients do what
the doctors decide. Dating back to the 1980s, this model saw
widely adoption as a precursor to informed consent (IC),whereby doctors provide information but leave the final
decision on treatment method to patients. However, this iscan be problematic for patients with limited medical
knowledge.
Thus, the concept of Shared Decision Making (SDM)
was born. SDM is a process in which medical professionals
and patients collaborate to determine the best treatment
method. In this model, both the doctors and the patientsprovide information about issues and concerns that areimportant to them. They then discuss the issues and decide
the treatment method together.
The main advantages of this approach are better patientsatisfaction with their experience, improved quality of life
and treatment results, shorter hospitalization periods, andreduced healthcare costs. For medical professionals too,
SDM brings advantages in reduced levels of burnout andfewer people quitting their medical jobs.

Shared Decision Making (SDM)• A communication process in which medical
professionals and patients collaborate to determine
the best treatment methods for the patients in linewith what is most important to the patients.
• SDM’s three requirements:–Clear, accurate, and unbiased medical informationon the available options (including not treating thecondition), and the benefits and risks of these
options–Medical professionals with specialist skill forcommunicating this evidence to individual patients–Information on patients’ values, objectives,
intentions, and concerns (including the burden oftreatment)
Developed by the NQP (National Quality Partners) Shared Decision Making Action Team.

Working Toward Patient Well-being

I specialize in kidney disease, for which it is important thatpatients play an active role in deciding their treatment
method. These decisions, such as whether to perform akidney transplant or have dialysis treatment at home or thehospital have very real consequences for the patient’s
quality of life.
For example, let’s consider patients with end-stage renal
failure who have chosen hemodialysis. Patients often go
down this route because it’s the most common option.
However, a variety of issues may arise once dialysis starts.
There are cases when patients can’t handle the needles, or

02 AMDD NEWSLETTER Vol.33

going into hospital three times a week is not compatible
with their work. A patient good at operating machinery andmanaging themselves may be better suited to peritoneal
dialysis. SDM allows patients and doctors to have moredetailed discussions beforehand to prevent such scenarios
where the treatment method doesn’t match the patient’s
needs.
SDM is not only necessary at the stage of choosing
treatment, but also when reviewing the resulting impact onlife and potential recovery – particularly for treatments thatplace burden on the patient, and diseases such as cancer,
chronic diseases, and renal replacement treatments.
Promoting SDM in the first instance must also involve
patients. It is important we change the awareness andbehavior of those patients who want to leave everything up
to the doctor. In return, doctors must precisely convey the
information patients most need out of a huge array of
medical information. An honest approach is required in thediscussion process to draw out the patient’s true feelings.
In this approach, there is a limit to what doctors alone
can do, so it is important to use team healthcare. There aredecision-making support tools for promoting SDM, and theJapan Shared Decision Making Collaborative for Chronic
Kidney Disease also conducts SDM training that uses
role-playing in which medical professionals play the roles ofpatients and families.
Atul Gawande, a professor at Harvard University
Medical School, has stated that the objective of medicine is
to make well-being possible. He says that well-being means
health and happiness (philosophically, “being well”), butthat the ultimate objective of medicine is to support patientsso they can live the life they want to live. SDM is truly aconcept that makes well-being possible, and I would
sincerely like to promote the adoption of SDM to help
patients achieve well-being.

Yasuhiro Komatsu
Doctor, Master of Public Health (MPH), Doctor of Medicine
Professor and Chairman at Department
of Healthcare Quality and Safety, Gunma University,
Graduate School of Medicine

Graduated from the Chiba University
School of Medicine in 1984 andgraduated from the University of North
Carolina at Chapel Hill School of Public
Health in the US in 2010. Has worked
at St. Luke’s International Hospital since2017 as the Vice President and Head of
Nephrology, and is involved with thequality and safety in healthcare andtraining at the university overall. He
specializes in the dialysis field.

Kazutaka Mochizuki

Dystonian Friends Association (non-profit organization)
Director and IT Division Manager

Understanding Dystonia andits Optimal Treatments

Dystonia is a refractory disease in which muscles continuously or involuntarily
contract and harden. Patients become stiff in unnatural postures, and they may
become unable to stop muscles moving by themselves, restricting everyday lifeand bringing psychological distress. The cause is believed to be impairments inthe brain or nervous system, but the disease does not affect intelligence orthreaten the patient’s life.
According to the Japan Intractable Diseases Information Center, there areapproximately 20,000 dystonia patients in Japan. Due to its rarity and low rate ofprevalence (only a few people out of every 10,000), there is a lack of medical
specialists and information on the disease. Doctors often see cases where patients
have had no choice but to travel long distances in order to find a hospital.
Patients and doctors established the Dystonian Friends Association in 2005 todeepen the understanding of this lesser-known disease, and have been working
with related facilities to improve patients’ experience with opportunities tocooperate and exchange information with each other. After putting requests to the
Ministry of Health, Labor, and Welfare since 2008, a major win came in 2015
when hereditary dystonia became eligible for healthcare cost assistance fordesignated intractable diseases.
Common treatment methods for dystonia are drugs taken internally, localized
injection treatments of botulinum toxin, and surgical treatments (stereotactic
neurosurgery such as deep-brain stimulation (DBS) treatment and deep-brain
lesioning procedures). Treatment with drugs taken internally and localized
injection treatments are symptomatic treatments. There is a relatively highnumber of doctors that can perform DBS, which is a type of stereotactic

neurosurgery, and is said to have a high level of safety. However, as a treatment
method that implants a device into the body, DBS may require periodic surgery to
fix device degradation or replace batteries, bringing about significant physical andfinancial burden on patients.
Similarly, lesioning (coagulation) procedures are a type of stereotactic
neurosurgery. These can be the fundamental treatment because they directly
destroy the brain tissue that is producing the abnormalities. There are someexamples in which coagulation procedures significantly improve symptoms, butthere are few doctors or medical institutions that can perform the surgery, andrecently the medical instruments necessary for the coagulation procedures havestopped being sold. This creates a serious issue for patients who are eager for a
fundamental treatment but may not be able to access it. Similarly, although it’s notnecessary to cut a hole in the skull as some coagulation procedures use ultrasonicwaves, the only area possible for lesioning is the thalamus, which depending on
the shape of the individual’s skull may make the treatment unsuitable.
The optimal treatment method could be symptomatic, DBS, or coagulation as
a fundamental treatment, but ultimately depends on the patient’s symptoms andlifestyle. We will continue to work on activities in the future that enable patients
to choose their preferred treatment.
Dystonian Friends Association(non-profit organization)
https://www.dystonia2005.com/

No. 4

Supporting patients with aclinical teamRadiological Technologists
Mikio Sano
Vice President, Japan Association of Radiological Technologists

Healthcare is becoming more sophisticated and complex.
Team healthcare is collaborative healthcare that leverages
diverse occupations with high levels of specialization, shares
objectives and information, and provides safe healthcare. By
dividing work roles and encouraging workers to cooperate,
members can complement each other. With patient needs
also diversifying, there is a move toward emphasizing patient
quality of life and creating a system that can provide ongoing,
comprehensive care for the physical and mental health ofpatients, not just improved knowledge and technology forspecialist occupations. We are truly facing an aging society,and healthcare is rapidly changing from diagnosing andtreating illnesses to preventative medicine. As a specialist
occupation that involves radiological imaging diagnosis andtreatment, it is important to provide accurate and precise
information to patients about less-invasive procedures.
In recent years, IT for healthcare has continued to evolve.
Many healthcare facilities have digitalized their medical
records and have introduced Picture Archiving and Communication Systems (PACS), which has made it possible tomanage medical images in a centralized manner, and this hascompletely changed the content of work in clinical facilities. In

radiology departments, the digitalization of radiologicaldevices has brought about technological innovations and led
to the development of sophisticated medical devices. As a
specialist occupation for new imaging information, newmethods of managing images inside hospitals and cuttingedge testing technology continue to emerge, and new types
of work have begun to develop in clinical facilities, such asbuilding 3D images and navigation to support surgery.
Since radiologic technologists are the only ones who
conduct X-rays, I felt it may have been too narrow a specialty
to join team healthcare. However, in the routine testing work,
there are many areas where doctors, nurses, and othermedical staff members collaborate, and the staff members
need to communicate with each other. For things like angiography tests and X-ray TV tests in particular, it is important tomanage the medical radiation that patients and medical
practitioners are exposed to from radiologic technologists.
It is predicted that clinical facilities will adopt AI and robots
in the future, changing the way we work. But doctors and staff
from other specialist disciplines will still need to collaborate. It
is my hope that integrating my specialism in team healthcare
will improve the safety and quality of healthcare for patients.

AMDD NEWSLETTER Vol.33 03

Patient’s Voice

Patient Participation in Healthcare andShared Decision Making (SDM)
A New Doctor-Patient RelationshipThe relationship between doctors and patients is as much an
old issue as it is new. Conventionally it has followed theinformed model and paternalism, in which patients do what
the doctors decide. Dating back to the 1980s, this model saw
widely adoption as a precursor to informed consent (IC),whereby doctors provide information but leave the final
decision on treatment method to patients. However, this iscan be problematic for patients with limited medical
knowledge.
Thus, the concept of Shared Decision Making (SDM)
was born. SDM is a process in which medical professionals
and patients collaborate to determine the best treatment
method. In this model, both the doctors and the patientsprovide information about issues and concerns that areimportant to them. They then discuss the issues and decide
the treatment method together.
The main advantages of this approach are better patientsatisfaction with their experience, improved quality of life
and treatment results, shorter hospitalization periods, andreduced healthcare costs. For medical professionals too,
SDM brings advantages in reduced levels of burnout andfewer people quitting their medical jobs.

Shared Decision Making (SDM)• A communication process in which medical
professionals and patients collaborate to determine
the best treatment methods for the patients in linewith what is most important to the patients.
• SDM’s three requirements:–Clear, accurate, and unbiased medical informationon the available options (including not treating thecondition), and the benefits and risks of these
options–Medical professionals with specialist skill forcommunicating this evidence to individual patients–Information on patients’ values, objectives,
intentions, and concerns (including the burden oftreatment)
Developed by the NQP (National Quality Partners) Shared Decision Making Action Team.

Working Toward Patient Well-being

I specialize in kidney disease, for which it is important thatpatients play an active role in deciding their treatment
method. These decisions, such as whether to perform akidney transplant or have dialysis treatment at home or thehospital have very real consequences for the patient’s
quality of life.
For example, let’s consider patients with end-stage renal
failure who have chosen hemodialysis. Patients often go
down this route because it’s the most common option.
However, a variety of issues may arise once dialysis starts.
There are cases when patients can’t handle the needles, or

02 AMDD NEWSLETTER Vol.33

going into hospital three times a week is not compatible
with their work. A patient good at operating machinery andmanaging themselves may be better suited to peritoneal
dialysis. SDM allows patients and doctors to have moredetailed discussions beforehand to prevent such scenarios
where the treatment method doesn’t match the patient’s
needs.
SDM is not only necessary at the stage of choosing
treatment, but also when reviewing the resulting impact onlife and potential recovery – particularly for treatments thatplace burden on the patient, and diseases such as cancer,
chronic diseases, and renal replacement treatments.
Promoting SDM in the first instance must also involve
patients. It is important we change the awareness andbehavior of those patients who want to leave everything up
to the doctor. In return, doctors must precisely convey the
information patients most need out of a huge array of
medical information. An honest approach is required in thediscussion process to draw out the patient’s true feelings.
In this approach, there is a limit to what doctors alone
can do, so it is important to use team healthcare. There aredecision-making support tools for promoting SDM, and theJapan Shared Decision Making Collaborative for Chronic
Kidney Disease also conducts SDM training that uses
role-playing in which medical professionals play the roles ofpatients and families.
Atul Gawande, a professor at Harvard University
Medical School, has stated that the objective of medicine is
to make well-being possible. He says that well-being means
health and happiness (philosophically, “being well”), butthat the ultimate objective of medicine is to support patientsso they can live the life they want to live. SDM is truly aconcept that makes well-being possible, and I would
sincerely like to promote the adoption of SDM to help
patients achieve well-being.

Yasuhiro Komatsu
Doctor, Master of Public Health (MPH), Doctor of Medicine
Professor and Chairman at Department
of Healthcare Quality and Safety, Gunma University,
Graduate School of Medicine

Graduated from the Chiba University
School of Medicine in 1984 andgraduated from the University of North
Carolina at Chapel Hill School of Public
Health in the US in 2010. Has worked
at St. Luke’s International Hospital since2017 as the Vice President and Head of
Nephrology, and is involved with thequality and safety in healthcare andtraining at the university overall. He
specializes in the dialysis field.

Kazutaka Mochizuki

Dystonian Friends Association (non-profit organization)
Director and IT Division Manager

Understanding Dystonia andits Optimal Treatments

Dystonia is a refractory disease in which muscles continuously or involuntarily
contract and harden. Patients become stiff in unnatural postures, and they may
become unable to stop muscles moving by themselves, restricting everyday lifeand bringing psychological distress. The cause is believed to be impairments inthe brain or nervous system, but the disease does not affect intelligence orthreaten the patient’s life.
According to the Japan Intractable Diseases Information Center, there areapproximately 20,000 dystonia patients in Japan. Due to its rarity and low rate ofprevalence (only a few people out of every 10,000), there is a lack of medical
specialists and information on the disease. Doctors often see cases where patients
have had no choice but to travel long distances in order to find a hospital.
Patients and doctors established the Dystonian Friends Association in 2005 todeepen the understanding of this lesser-known disease, and have been working
with related facilities to improve patients’ experience with opportunities tocooperate and exchange information with each other. After putting requests to the
Ministry of Health, Labor, and Welfare since 2008, a major win came in 2015
when hereditary dystonia became eligible for healthcare cost assistance fordesignated intractable diseases.
Common treatment methods for dystonia are drugs taken internally, localized
injection treatments of botulinum toxin, and surgical treatments (stereotactic
neurosurgery such as deep-brain stimulation (DBS) treatment and deep-brain
lesioning procedures). Treatment with drugs taken internally and localized
injection treatments are symptomatic treatments. There is a relatively highnumber of doctors that can perform DBS, which is a type of stereotactic

neurosurgery, and is said to have a high level of safety. However, as a treatment
method that implants a device into the body, DBS may require periodic surgery to
fix device degradation or replace batteries, bringing about significant physical andfinancial burden on patients.
Similarly, lesioning (coagulation) procedures are a type of stereotactic
neurosurgery. These can be the fundamental treatment because they directly
destroy the brain tissue that is producing the abnormalities. There are someexamples in which coagulation procedures significantly improve symptoms, butthere are few doctors or medical institutions that can perform the surgery, andrecently the medical instruments necessary for the coagulation procedures havestopped being sold. This creates a serious issue for patients who are eager for a
fundamental treatment but may not be able to access it. Similarly, although it’s notnecessary to cut a hole in the skull as some coagulation procedures use ultrasonicwaves, the only area possible for lesioning is the thalamus, which depending on
the shape of the individual’s skull may make the treatment unsuitable.
The optimal treatment method could be symptomatic, DBS, or coagulation as
a fundamental treatment, but ultimately depends on the patient’s symptoms andlifestyle. We will continue to work on activities in the future that enable patients
to choose their preferred treatment.
Dystonian Friends Association(non-profit organization)
https://www.dystonia2005.com/

No. 4

Supporting patients with aclinical teamRadiological Technologists
Mikio Sano
Vice President, Japan Association of Radiological Technologists

Healthcare is becoming more sophisticated and complex.
Team healthcare is collaborative healthcare that leverages
diverse occupations with high levels of specialization, shares
objectives and information, and provides safe healthcare. By
dividing work roles and encouraging workers to cooperate,
members can complement each other. With patient needs
also diversifying, there is a move toward emphasizing patient
quality of life and creating a system that can provide ongoing,
comprehensive care for the physical and mental health ofpatients, not just improved knowledge and technology forspecialist occupations. We are truly facing an aging society,and healthcare is rapidly changing from diagnosing andtreating illnesses to preventative medicine. As a specialist
occupation that involves radiological imaging diagnosis andtreatment, it is important to provide accurate and precise
information to patients about less-invasive procedures.
In recent years, IT for healthcare has continued to evolve.
Many healthcare facilities have digitalized their medical
records and have introduced Picture Archiving and Communication Systems (PACS), which has made it possible tomanage medical images in a centralized manner, and this hascompletely changed the content of work in clinical facilities. In

radiology departments, the digitalization of radiologicaldevices has brought about technological innovations and led
to the development of sophisticated medical devices. As a
specialist occupation for new imaging information, newmethods of managing images inside hospitals and cuttingedge testing technology continue to emerge, and new types
of work have begun to develop in clinical facilities, such asbuilding 3D images and navigation to support surgery.
Since radiologic technologists are the only ones who
conduct X-rays, I felt it may have been too narrow a specialty
to join team healthcare. However, in the routine testing work,
there are many areas where doctors, nurses, and othermedical staff members collaborate, and the staff members
need to communicate with each other. For things like angiography tests and X-ray TV tests in particular, it is important tomanage the medical radiation that patients and medical
practitioners are exposed to from radiologic technologists.
It is predicted that clinical facilities will adopt AI and robots
in the future, changing the way we work. But doctors and staff
from other specialist disciplines will still need to collaborate. It
is my hope that integrating my specialism in team healthcare
will improve the safety and quality of healthcare for patients.

AMDD NEWSLETTER Vol.33 03

Apr, 2020 Vol.33

AMDD 2020 New Year’s Celebration and Annual General Meeting
AMDD held a New Year’s celebration on January 10 at the Palace Hotel Tokyo. In his greeting, Chairperson Kosuke Kato (President andDirector of Edwards Lifesciences Ltd.) looked back on 2019 as the 10th anniversary since AMDD’s founding, and ahead to 2020’s prospects.
Congratulatory speeches were offered by Toshifumi Kojima (Parliamentary Vice-Minister of Health, Labor, and Welfare and Liberal Democratic
Party Member of the House of Representatives), Hanako Jimi (Parliamentary Vice-Minister of Health, Labor, and Welfare and Liberal Democratic
Party Member of the House of Councillors), Yasuhiro Fujiwara (Chief Executive of the Pharmaceuticals and Medical Devices Agency (PMDA)),
Kazumi Nishikawa (Director, IT Industry Division, Commerce and Information Policy Bureau, Ministry of Economy, Trade, and Industry), and Steve
Knode (Deputy Senior Commercial Officer, the U.S. Embassy in Japan). Kenichi Matsumoto (Chairman, Japan Federation of Medical Devices
Associations (JFMDA)) then gave the toast, inviting all guests to network and get to know each other’s fields.
On March 10, AMDD held its annual general meeting. Proposals for the 2020 and new members of the boardof directors were submitted and unanimously approved. At the subsequent special board of directors meeting,Kazuya Ogawa (Chairman and President of Zimmer Biomet G.K.) was appointed as the new chairperson effectivethat same day, as successor to Chairperson Kosuke Kato who is retiring. See page 1 for a greeting message fromthe new chairperson.

AMDD 28th Media Lecture

Mr. T. Kojima

Dr. H. Jimi

AMDD held its 28th media lecture on January 27 in Tokyo, under the title of “Practicing Shared Decision Making (SDM) in Medical Facilities.”
Japan SDM pioneer, Dr. Yasuhiro Komatsu (Professor and Chairman at Department of Healthcare Quality and Safety, Gunma University,
Graduate School of Medicine) spoke on the importance of SDM, in which medical professionals and patients
discuss and jointly decide treatment methods, as well as how it has recently become more prevalent in Japan.
With regard to the patient perspective, Ms. Mamiko Matsumura, President of the Kidney Support Association(non-profit organization), and a patient who chose to use insulin pumps for diabetic treatment were invited,and each were asked to share their views on SDM from the patients' perspective respectively. See page 2 fora summary of Dr. Komatsu’s lecture.

Value of Medical Technology〈Diagnosing and Treating Heart Conditions〉

Global Longitudinal Strain (GLS)’s Role in Evaluating
Cardiac Functions in Heart Failure and Anti-Cancer
Drug Cardiotoxicity in Echocardiography Tests
Echocardiography tests are a useful and safe way to observe and diagnose heart
condition in fine detail simply by placing a probe device on the body. Global
Longitudinal Strain (GLS) is an echocardiograph that is mainly used to identify
ischemic areas, detect areas with delayed contractions, and evaluate dyssynchrony.
GLS is an index of the systolic function of the cardiac muscle in the longitudinal
direction that was developed in the 2000s and was installed in commercially-soldmachines. However, GLS has gained attention in recent years as an index that cancomplement the Left Ventricular Ejection Fraction (LVEF), which has been the standard
index for evaluating cardiac functions. GLS has been listed in the American Society of
Echocardiography’s expert consensus and the European Society of Cardiology’s
position papers as a more incisive index. As a method for evaluating cardiac functions
for heart failures in which the LVEF is maintained, or as a method for evaluating the
cardiotoxicity of anti-cancer drugs, GLS showed more of a tendency to decrease thanthe decrease in LVEF. There remain issues of differing values between manufacturers
echocardiograph tests errors made by those performing the tests. However, humanerror can be minimized by using machinelearning for the automatic analysis function
to show an objective index that does notdepend on those performing the tests. The
graph shows waveforms of multiple
cross-sections on one screen, and showsabnormal areas on the bullseye screen(bottom right) so that they are easy tounderstand.
Graph: Waveform analysis of multiple cross-sections on(Wording: Katsushi Ogihara, GE Healthcare Japan Corporation)

the same screen; abnormal areas shown on the bullseye
screen (bottom right).

AMDD’s 10th Anniversary Activities—Patient Essays, Volume 3—

To celebrate 2019 marking the 10th
anniversary since its founding, AMDD
published “I’m Glad I Chose This Treatment!
III―Essays by patients who chose advanced
treatment,” a collection of essays recording
the benefits patients received, how their lives were saved, andhow the quality of their lives improved thanks to testing andtreatments using advanced medical technology.
AMDD published Volume 1 of “I’m Glad I Chose This
Treatment!” in 2009 and Volume 2 in 2014 in order tostrengthen understanding of the value of advanced medical
technology and the contributions that AMDD member
companies have made to healthcare in Japan. In the ten years
since Volume 1 was published, advanced medical technology
such as medical devices and in-vitro diagnostics (IVDs) havebecome more compact with developments in surgical
techniques and the use of technologies such as ICT all
evolving significantly. Volume 3 delves into the newtechnologies and fields not mentioned in Volumes 1 and 2, as
well as the progress that has been made over a decade oftechnological development. Overseen by Dr. Tatsuya Kondo(Chief Executive Officer of Medical Excellence Japan/Chief
Executive of the PMDA), the volume covers real patient stories
and an interview with Mr. Tsutomu Sekine, a famous Japanese
comedian, regarding a heart examination introduced througha TV show that revealed his coronary artery stenosis, as wellas the impact on his life before and after surgery.
The essays are also available to download from theAMDD website.
*To receive a copy of the essays, please get in touch via the AMDD
website or email AMDD PR representative at: amdd@cosmopr.co.jp

AMDDVol.33

NEWSLETTERC O N T E N T S
Greetings from the New Chairperson 01
Patient Participation in Healthcare
and Shared Decision Making (SDM) 02
Patient’s Voice
Understanding Dystonia and its
Optimal Treatments

03

Supporting patients with a clinical team
03
Radiological Technologists
AMDD 2020 New Year’s Celebration
04
and Annual General Meeting
AMDD 28th Media Lecture04

AMDD’s 10th Anniversary Activities
04—Patient Essays, Volume 3—
Value of Medical Technology
Global Longitudinal Strain (GLS)’s Role in Evaluating
Cardiac Functions in Heart Failure and Anti-Cancer
04
Drug Cardiotoxicity in Echocardiography Tests

Greetings from the New Chairperson
It is an honor to have recently been appointed the 5th Chairperson of
the American Medical Devices and Diagnostics Manufacturers’
Association, an industrial organization composed of about 70
Japanese companies headquartered in the US that provide advanced
medical technology such as medical devices and in-vitro diagnostics(IVDs). Since our founding in April 2009, our activities strive tomeet the needs of patients in Japanese medical facilities and deliver
the latest treatments, diagnostic technologies, and information undera theme of improving citizens’ health and quality of life. Speaking
personally, AMDD’s social responsibility is a source of great
motivation and lies at the heart of what we do.

Working Toward Good Health for Your Loved Ones

It is important for patients in Japan to have access to the sameinnovative medical devices used around the world. A long-standing
focus for AMDD has been the “device lag” issue. Working closelywith the Ministry of Health, Labor, and Welfare (MHLW), thePharmaceuticals and Medical Devices Agency (PMDA), and otherorganizations, we have been able to reduce approval times for
medical devices, resolving most of the device lag. The
Pharmaceuticals and Medical Device Act (passed in November 2013
and implemented the following year), separated regulations forpharmaceuticals and medical devices, and has paved the way for amajor leap forward in the medical devices industry from theperspective of building a regulatory framework to better meet thecharacteristics of medical devices.
AMDD became a general incorporated association in 2016 inrecognition of its social responsibility. To mark this change, weestablished a new mission statement: “Providing valuable medical
technology and information to your loved ones today, so that they
may live in good health.” Medical devices and IVDs are used in awide variety of ways that extend beyond treating illnesses, including
preventive care and improving post-treatment conditions. In order tobe an industrial organization that delivers such medical devices and
IVDs to Japanese patients as promptly as possible, we have beenfurther expanding the scope of our activities in line with this mission.
In order to promote the value of innovation in medical devices
and IVDs, we have been recommending a policy of “value-based

healthcare” since 2017. Part of this recommendation has alreadybeen registered as a “Challenge Application.” We have now
established the AMDD Medical Technology Policy Institutethink-tank within our organization in order to research ways for
medical technologies such as medical devices and IVDs tocontribute further to healthcare in Japan from the medium tolong-term perspective, and to recommend policies based on this.

Contributing to Healthcare for Japan’s
Super-aging Society

Japan continues to become a super-aged society. The quick
introduction and appropriate use of advanced medical technologies
that are standard overseas will prevent the progression of illnesses
and improve patients’ quality of life, which will result in a longer life
expectancy. A healthcare system that improves the health of society
by appropriately evaluating and reflecting the value of innovative
medical technologies will be important to achieve this. We need toconsider the management and distribution of medical devices andIVDs, as well as the use of digital technologies in healthcare.
AMDD will continue to leverage its unique strengths as anindustrial organization in the healthcare field to drive policy
recommendations and make other efforts to support the positive
development of Japan’s healthcare system by collaborating with theJapanese government, medical societies, and associated industry
associations, while also maintaining close relationships with the US
government and the US-based Advanced Medical Technology
Association (AdvaMed).

Kazuya Ogawa
Chairperson, American Medical Devices
and Diagnostics Manufacturers’
Association (AMDD)
Chairman and President,
Zimmer Biomet G.K.

All opinions in the newsletter are the views of the authorsand do not represent the views of AMDD or its activities.

Contact: Public Relations, American Medical Devices and Diagnostics Manufacturers’ Association (AMDD)
C/O Cosmo Public Relations Corporation, 1-8-10 Azabudai, Minato-ku, Tokyo, Japan 〒106-0041
Tel: +81(0)3-5561-2915
Website: https://www.amdd.jp/en/

04 AMDD NEWSLETTER Vol.33

AMDD NEWSLETTER Vol.33 01