Jan, 2021 Vol.34

Unified Efforts Ensure Stable Supply of Medical Devices
Akira Yokoyama, Chairperson, AMDD Distribution & IT Committee
AMDD has been conducting surveys with member companies to understand the pandemic’s impact on operations and ways toensure a stable supply of medical devices during this time.
Of the 34 companies that responded, 26 said that “Imports from overseas were affected,” while 14 said that “The quantity arriving
continues to be less than desired.” However, it is clear that at this stage the overall stable supply of products has been maintained
thanks to companies’ considerable combined efforts, including fully utilizing global networks, and finding online solutions for handlingorders and alternative ocean freight transport options.

Member Companies Step Up CSR Activities
in Response to Pandemic
AMDD member companies are operating in an emergency situation and making every effort to ensure a stable supply of medical
devices and IVDs that need to be imported from outside of Japan. And yet many member companies (particularly those with U.S.
headquarters) are also actively working to develop additional products and technologies related to COVID-19 countermeasures. These
include developing vaccines and drugs used in testing, as well as a remote patient monitoring system, and increasing the productionof artificial respirators. Moreover, member companies that manufacture medical protective equipment are also engaging in an
impressive variety of CSR initiatives, including providing PPE to medical practitioners at no charge, and providing monetary support tovarious groups involved in the global fight against COVID-19.

AMDD’s New Office Structure Starts in January 2021
AMDD held an extraordinary general meeting on Nov. 26, 2020, during which measures were approved to partially change articles andrules of association to enable the introduction of a new office structure that began on January 1, 2021.
These revisions to the office structure aim to strengthen AMDD’s activities as an industry group and improve the sustainability of theorganization. Key changes include replacing the previous Staff Director position with Senior Managing Director, Managing Director, andAdministrative Assistant positions established as new full-time positions. The role of the new Senior Managing Director is to assist the
Chairperson and Vice-chairs, carry out office work, and lead strategic planning. Upon these changes, Shigeyuki Masukawa assumed thepost of Senior Managing Director on January 1, 2021. The existing committees and active working groups remain unchanged.

【AMDD Organization with New Secretariat】
Chairperson
Vice Chairperson (x2)
Board of Directors (ExCom)
Senior Managing Director (new)Managing Director (new)AA to Senior Managing Director (new)MTPICommittee Chairs and
SMO Staff are selected fromeach member companies (no changes)

The Secretariat
Chairperson
Vice Chairperson
Staff
Directorabolished

Senior Managing
Director

Administrative
Assistant (AA) to MD

Managing
Director
Strategic Management Office(SMO)

Executive Committee (ExCom)

By Function

By Specialty

OverallSpecial Treatment
Material (STM)

Capital Equipment(CE)

Membership

Regulatory Affairs &Quality Assurance(RAQA)

Orthopedics

Advocacy
Public Affairs (PA)Distribution & IT

In-Vitro
Diagnostics (IVDs)

Legal &
Compliance

WG
AMDD
Medical Technology
Policy Institute(MTPI)

Re-processed
Single-use
Device (R-SUD)
Cardiovascular
Diseases (CVD)
Contact Lens
Regenerative
medicine (RM)

C O N T E N T S

AMDDVol.34

Striving to Provide
Optimal Healthcare in Japan

01

Expert Interview:
The Role of Medical Manufacturers
02
at Medical Facilities

NEWSLETTER

Minimizing the Indirect Impactsof COVID-19

03

Unified Efforts Ensure Stable
Supply of Medical Devices

04

Member Companies Step Up
CSR Activities in Response
to Pandemic

04

AMDD’s New Office Structure
Starts in January 2021

04

Striving to Provide Optimal Healthcare in JapanOn behalf of the American Medical Devices and Diagnostics
Manufacturers’ Association (AMDD), I would like to extend my New
Year’s greetings to each of you for 2021.
These are undoubtedly challenging times with COVID-19 touching
all of our lives in some way. I would like to offer my heartfelt sympathy
to all those who have suffered directly and indirectly from the virus. I
would like to also express my sincere respect and gratitude to the medical
practitioners that continue to risk their own safety in order to treat
patients, and all those struggling as we continue to fight the spread of
infections.

AMDD’s Role Brought into Sharper Focus

Reflecting on the past year, COVID-19 seemingly spread across theworld in the blink of an eye. As infection numbers rose in every
continent, remarkable efforts were made in every country and region toprevent and minimize the spread.
Of course, prevention is just one step in a much larger global
undertaking. 2020 was also the year when governments and the public
became acutely aware of the challenges facing healthcare systems andthe importance of public health. Japan was no exception. Having longunderstood the academic importance of healthcare, AMDD’s member
companies quickly gained a deeper awareness of the practical role weplay, including the enormity and significance of the social responsibility
we hold for ensuring a stable supply of medical devices and in-vitro
diagnostics (IVDs), developing personnel, and providing the informationnecessary to support these.

Now is the Time for Healthcare Innovation

The pandemic is not something one country alone can deal with. Theinternational frameworks that make it possible to quickly and efficiently
leverage global resources are extremely important. Maintaining the stableproduction and supply of goods that support healthcare during both
emergencies and ordinary times, and building a system that ensures
optimal healthcare for all patients in Japan has arisen as a critical issue.
It was with this in mind that AMDD submitted a proposal last year to
the Ministry of Health, Labour, and Welfare with a goal of setting
reasonable healthcare costs and creating value-based healthcare that
improves outcomes for anyone receiving treatment. The proposal

consists of five key aims: (1) to maintain an environment in which
medical facilities can comprehensively propose options to patients forhigh-quality medical technology, (2) to create structures that make itpossible for medical institutions to provide high-quality medical
technology, (3) to evaluate outcomes, (4) to flexibly utilize diverse
evidence, and (5) to revise the framework for evaluating technology.
Even times of crisis have the power to accelerate innovation. There
has never been a better time to introduce cutting-edge technology and forJapan to assume its place at the forefront of global healthcare innovation
through teamwork between companies and groups beyond the limitationsof the current framework. AMDD has a long record of working toward
appropriately evaluating and reflecting the value of innovative medical
technology and achieving a healthcare system that makes society
healthier, and we are strengthening our resolve to continue these efforts.

Office Restructure to Encourage Innovation

Taking the principles of our value-based healthcare proposal andapplying them to our own organization, we implemented an office
restructure in January this year. Aligned with our slogan of “Enabling ahealthier Japan,” these changes will make it easier to put proposals andnew thinking first. AMDD aims to contribute to healthcare in Japan byproactively proposing policies, while cooperating with the Japanese
government, related industry groups, and academic societies, andcontinuing to coordinate with the U.S. government and the Advanced
Medical Technology Association (AdvaMed), headquartered in the U.S.
We thank you for your continued support and guidance this year, as
together we strive toward a safer, healthier 2021 and ultimately providing
optimal healthcare in Japan.

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: American Medical Devices and Diagnostics Manufacturers’ Association. (AMDD)
Shiodome City Center 5F, 1-5-2 Higashi Shimbashi, Minato-ku, Tokyo 105-7105 (Secretariat office)Tel: +81(0)3-6734-0382 Fax: +81(0)3-6679-2644
Website: http://www.amdd.jp

04 AMDD NEWSLETTER Vol.34

AMDD NEWSLETTER Vol.34 01

Expert Interview:

Achieving Sustainable Healthcare through Regulatory Reforms
and Faster Adoption of Remote Healthcare

The Role of Medical Manufacturers at Medical Facilities
Advanced technology is required in order to use many medical devices such as intracardiac catheters andpacemakers. Clinical use of such devices in actual patients requires extensive training to master techniques,
while those providing the training must have deep knowledge of treatment options.
It’s within this context that we met online with Dr. Kyoko Soejima (Professor and Chief of Cardiology, Kyorin University Hospital)
for this interview to discuss the roles and significance of medical device manufacturers,
the support manufacturers are expected to provide even during the COVID-19 crisis when face-to-face contact is limited,and other issues that should be resolved.

Manufacturers and Physicians Improving Healthcare
Together as “One Team”

Dr. Soejima: Manufacturers usually provide training
when a new medical device is introduced, but it helps if
they can also be available to give advice should problems
occur, such as malfunctions during treatment. If there are
multiple treatment options, I am grateful whenmanufacturers can give me their professional opinion
based on specialist knowledge.

Q. What has been most difficult during the
COVID-19 crisis, and has this impacted
your expectations of manufacturers at all?
Dr. Soejima: In order to prevent infections at medical
facilities, in-person activities have been regulated, andface-to-face support from manufacturers has been
limited. There may have been cases when this caused ahindrance in hospitals struggling with insufficientpersonnel.
However, experiencing the COVID-19 crisis has
allowed me to better understand the different ways inwhich manufacturers can support. With in-person
activities restricted, I have found ways to access detailed
advice and efficient support even remotely. In the past, it
wasn’t uncommon for a manufacturer staff member tospend all day with the hospital, but now I don’t thinkthat’s necessary. Having staff members from several
manufacturers constantly on standby in hospital hallways
or waiting in their cars for a long time probably affects
their motivation. I’m also against that from theperspective of achieving sustainable healthcare that
doesn’t waste personnel or add unnecessary personnel
costs by cutting that which can. I have always liked
healthcare setups like the U.S. where the manufacturers
are on equal ground with the physicians. I would like toimprove awareness and create an environment where
both manufacturers and physicians can deal with patientsas one team, and the manufacturer’s side can also focus
on developing their personnel. COVID-19 has simply
made me feel that even more strongly now.

02 AMDD NEWSLETTER Vol.34

Q. Please tell us more of what you mean by
the concept of “one team”?
Dr. Soejima: Compared to the U.S., people in Japan tend
to be hesitant when talking to physicians, and there is aculture of not speaking up. Manufacturers share the same
goal as physicians do - to achieve the best treatment forpatients. I want manufacturers to be able to speak up
without hesitating as an equal. For that to happen, I
would also like manufacturers to ensure they have athorough knowledge of our devices and systems, so that
we can rely on them. So when I say “one team,” I’mimagining taking pride and joy in the areas we areresponsible for and being able to share a sense of unitythat we are doing our best for the patients. I think it’s
important to have an awareness of and take pride in
healthcare in which our efforts and knowledge always
lead to positive outcomes. This is what I tell students
every day.

Q. How do you reconcile the concept of“one team” with competition between
manufacturers?
Dr. Soejima: I think competition and friendly rivalry arenecessary ingredients for things to progress. For example,
at this hospital, we are using three types of heart mapping
systems. It’s useful for difficult cases as we can increase
the range of treatment options by looking at informationfrom systems made by three different companies.
Those with a thorough knowledge of their products
can fairly judge the appropriateness of their use,
including cases when they may not be appropriate. By
addressing concerns over such devices in an objective
way, they may also spot the advantages of competitor
products and share that important information with teammembers when needed most. If everyone first andforemost has a shared goal of consistently doing what's inthe best interests of patients, I don’t think there will be
unnecessary competition and emphasis will be placed on
improving the technology through friendly rivalry.

→

Q. What role do medical device
manufacturers normally play in medical
facilities?

Q. How has your experience of COVID-19
shaped your view of issues for the future?
Dr. Soejima: My impression is that Japan’s efforts toincrease the adoption of remote healthcare have beenslower than Europe, North America, and China. Remotehealthcare had not progressed that much in the U.S.
either, but really started to gain momentum during the
pandemic. Japan still needs to address the issue of patientawareness, but frustratingly the government response has
been slow.
The year 2025, when baby boomers will be at least
75, is just around the corner. If we don’t establish
simpler, lower-cost healthcare, we can’t hope forsustainable healthcare to continue at the same level we’reaccustomed to. This is why it’s so critical that digital
healthcare makes progress. The Digital Administration
was created and the idea of permanently enabling online
diagnosis was raised, but Japan’s healthcare is lagging
behind the world. I strongly hope that Japan’s

government will make drastic regulatory reforms andswift progress of digital measures needed for Japan’s
healthcare system to survive.

Dr. Kyoko Soejima, M.D.
Professor/Chief of Cardiology, Kyorin University Hospital
Graduated from Keio University
School of Medicine, Tokyo, Japan in
1989, and attended internship andresidency at Keio University Hospital.
Clinical electrophysiology fellowshipat Brigham and Women's Hospital,
U.S. and Assistant Professor there in
2003. Associate Professor at
Cardiovascular Medicine of Miami
University, U.S. Currently Professor
and Chief of Cardiology at Kyorin
University Hospital in Tokyo.

Minimizing the Indirect Impactsof COVID-19
I would like to thank all the healthcare providers who arerising to the challenge of helping COVID-19 patients. I
would also like to express my respect to the staff of
AMDD member companies who are facing challenges
such as restrictions to our normal working practices andinsufficient distribution from production countries,
continue to oversee the supply chain, deliver needed
devices and provide vital information to medical facilities.
Concerns over new infections continue tosignificantly impact the ability to deliver normal
healthcare. Medical institutions and patients alike arechoosing to postpone consultations, tests and scheduled
surgeries. While holistic data on this issue remains hard
to come by, the U.S. recently announced that treatments
such as PCI by cardiovascular medicine departments
have fallen by almost 50%.*1 Another report indicatedthat the pandemic has resulted in a significant reduction
in surgeries on patients with serious life-threatening
illnesses.*2 According to the Japan Surgical Society andrelated societies, even if things return to normal capacity,
it would take almost a year to perform the surgeriescanceled during April and May of last year alone. Thissuggests there are lives that could have been saved bynormal treatments during ordinary times, and patients
who have progressive diseases are being exposed tohigher risks.

Everyone is hoping that the situation will return tonormal as soon as possible and that treatments will returnto pre-pandemic levels. In the meantime, AMDD member
companies continue to provide much-needed diagnosis
and treatment devices, and will take measures to prevent
infection equivalent to those of medical practitioners in
hospitals. It is my wish to continue working closely withall of you in supporting the healthcare system toovercome these challenges.
*1: https://www.ajconline.org/article/
S0002-9149(20)30565-8/fulltext*2: https://www.ahajournals.org/doi/abs/10.1161/
circ.142.suppl_3.15347

Kosuke Kato
AdvisorAmerican Medical Devices and Diagnostics
Manufacturers’ Association (AMDD)

AMDD NEWSLETTER Vol.34 03

Expert Interview:

Achieving Sustainable Healthcare through Regulatory Reforms
and Faster Adoption of Remote Healthcare

The Role of Medical Manufacturers at Medical Facilities
Advanced technology is required in order to use many medical devices such as intracardiac catheters andpacemakers. Clinical use of such devices in actual patients requires extensive training to master techniques,
while those providing the training must have deep knowledge of treatment options.
It’s within this context that we met online with Dr. Kyoko Soejima (Professor and Chief of Cardiology, Kyorin University Hospital)
for this interview to discuss the roles and significance of medical device manufacturers,
the support manufacturers are expected to provide even during the COVID-19 crisis when face-to-face contact is limited,and other issues that should be resolved.

Manufacturers and Physicians Improving Healthcare
Together as “One Team”

Dr. Soejima: Manufacturers usually provide training
when a new medical device is introduced, but it helps if
they can also be available to give advice should problems
occur, such as malfunctions during treatment. If there are
multiple treatment options, I am grateful whenmanufacturers can give me their professional opinion
based on specialist knowledge.

Q. What has been most difficult during the
COVID-19 crisis, and has this impacted
your expectations of manufacturers at all?
Dr. Soejima: In order to prevent infections at medical
facilities, in-person activities have been regulated, andface-to-face support from manufacturers has been
limited. There may have been cases when this caused ahindrance in hospitals struggling with insufficientpersonnel.
However, experiencing the COVID-19 crisis has
allowed me to better understand the different ways inwhich manufacturers can support. With in-person
activities restricted, I have found ways to access detailed
advice and efficient support even remotely. In the past, it
wasn’t uncommon for a manufacturer staff member tospend all day with the hospital, but now I don’t thinkthat’s necessary. Having staff members from several
manufacturers constantly on standby in hospital hallways
or waiting in their cars for a long time probably affects
their motivation. I’m also against that from theperspective of achieving sustainable healthcare that
doesn’t waste personnel or add unnecessary personnel
costs by cutting that which can. I have always liked
healthcare setups like the U.S. where the manufacturers
are on equal ground with the physicians. I would like toimprove awareness and create an environment where
both manufacturers and physicians can deal with patientsas one team, and the manufacturer’s side can also focus
on developing their personnel. COVID-19 has simply
made me feel that even more strongly now.

02 AMDD NEWSLETTER Vol.34

Q. Please tell us more of what you mean by
the concept of “one team”?
Dr. Soejima: Compared to the U.S., people in Japan tend
to be hesitant when talking to physicians, and there is aculture of not speaking up. Manufacturers share the same
goal as physicians do - to achieve the best treatment forpatients. I want manufacturers to be able to speak up
without hesitating as an equal. For that to happen, I
would also like manufacturers to ensure they have athorough knowledge of our devices and systems, so that
we can rely on them. So when I say “one team,” I’mimagining taking pride and joy in the areas we areresponsible for and being able to share a sense of unitythat we are doing our best for the patients. I think it’s
important to have an awareness of and take pride in
healthcare in which our efforts and knowledge always
lead to positive outcomes. This is what I tell students
every day.

Q. How do you reconcile the concept of“one team” with competition between
manufacturers?
Dr. Soejima: I think competition and friendly rivalry arenecessary ingredients for things to progress. For example,
at this hospital, we are using three types of heart mapping
systems. It’s useful for difficult cases as we can increase
the range of treatment options by looking at informationfrom systems made by three different companies.
Those with a thorough knowledge of their products
can fairly judge the appropriateness of their use,
including cases when they may not be appropriate. By
addressing concerns over such devices in an objective
way, they may also spot the advantages of competitor
products and share that important information with teammembers when needed most. If everyone first andforemost has a shared goal of consistently doing what's inthe best interests of patients, I don’t think there will be
unnecessary competition and emphasis will be placed on
improving the technology through friendly rivalry.

→

Q. What role do medical device
manufacturers normally play in medical
facilities?

Q. How has your experience of COVID-19
shaped your view of issues for the future?
Dr. Soejima: My impression is that Japan’s efforts toincrease the adoption of remote healthcare have beenslower than Europe, North America, and China. Remotehealthcare had not progressed that much in the U.S.
either, but really started to gain momentum during the
pandemic. Japan still needs to address the issue of patientawareness, but frustratingly the government response has
been slow.
The year 2025, when baby boomers will be at least
75, is just around the corner. If we don’t establish
simpler, lower-cost healthcare, we can’t hope forsustainable healthcare to continue at the same level we’reaccustomed to. This is why it’s so critical that digital
healthcare makes progress. The Digital Administration
was created and the idea of permanently enabling online
diagnosis was raised, but Japan’s healthcare is lagging
behind the world. I strongly hope that Japan’s

government will make drastic regulatory reforms andswift progress of digital measures needed for Japan’s
healthcare system to survive.

Dr. Kyoko Soejima, M.D.
Professor/Chief of Cardiology, Kyorin University Hospital
Graduated from Keio University
School of Medicine, Tokyo, Japan in
1989, and attended internship andresidency at Keio University Hospital.
Clinical electrophysiology fellowshipat Brigham and Women's Hospital,
U.S. and Assistant Professor there in
2003. Associate Professor at
Cardiovascular Medicine of Miami
University, U.S. Currently Professor
and Chief of Cardiology at Kyorin
University Hospital in Tokyo.

Minimizing the Indirect Impactsof COVID-19
I would like to thank all the healthcare providers who arerising to the challenge of helping COVID-19 patients. I
would also like to express my respect to the staff of
AMDD member companies who are facing challenges
such as restrictions to our normal working practices andinsufficient distribution from production countries,
continue to oversee the supply chain, deliver needed
devices and provide vital information to medical facilities.
Concerns over new infections continue tosignificantly impact the ability to deliver normal
healthcare. Medical institutions and patients alike arechoosing to postpone consultations, tests and scheduled
surgeries. While holistic data on this issue remains hard
to come by, the U.S. recently announced that treatments
such as PCI by cardiovascular medicine departments
have fallen by almost 50%.*1 Another report indicatedthat the pandemic has resulted in a significant reduction
in surgeries on patients with serious life-threatening
illnesses.*2 According to the Japan Surgical Society andrelated societies, even if things return to normal capacity,
it would take almost a year to perform the surgeriescanceled during April and May of last year alone. Thissuggests there are lives that could have been saved bynormal treatments during ordinary times, and patients
who have progressive diseases are being exposed tohigher risks.

Everyone is hoping that the situation will return tonormal as soon as possible and that treatments will returnto pre-pandemic levels. In the meantime, AMDD member
companies continue to provide much-needed diagnosis
and treatment devices, and will take measures to prevent
infection equivalent to those of medical practitioners in
hospitals. It is my wish to continue working closely withall of you in supporting the healthcare system toovercome these challenges.
*1: https://www.ajconline.org/article/
S0002-9149(20)30565-8/fulltext*2: https://www.ahajournals.org/doi/abs/10.1161/
circ.142.suppl_3.15347

Kosuke Kato
AdvisorAmerican Medical Devices and Diagnostics
Manufacturers’ Association (AMDD)

AMDD NEWSLETTER Vol.34 03

Jan, 2021 Vol.34

Unified Efforts Ensure Stable Supply of Medical Devices
Akira Yokoyama, Chairperson, AMDD Distribution & IT Committee
AMDD has been conducting surveys with member companies to understand the pandemic’s impact on operations and ways toensure a stable supply of medical devices during this time.
Of the 34 companies that responded, 26 said that “Imports from overseas were affected,” while 14 said that “The quantity arriving
continues to be less than desired.” However, it is clear that at this stage the overall stable supply of products has been maintained
thanks to companies’ considerable combined efforts, including fully utilizing global networks, and finding online solutions for handlingorders and alternative ocean freight transport options.

Member Companies Step Up CSR Activities
in Response to Pandemic
AMDD member companies are operating in an emergency situation and making every effort to ensure a stable supply of medical
devices and IVDs that need to be imported from outside of Japan. And yet many member companies (particularly those with U.S.
headquarters) are also actively working to develop additional products and technologies related to COVID-19 countermeasures. These
include developing vaccines and drugs used in testing, as well as a remote patient monitoring system, and increasing the productionof artificial respirators. Moreover, member companies that manufacture medical protective equipment are also engaging in an
impressive variety of CSR initiatives, including providing PPE to medical practitioners at no charge, and providing monetary support tovarious groups involved in the global fight against COVID-19.

AMDD’s New Office Structure Starts in January 2021
AMDD held an extraordinary general meeting on Nov. 26, 2020, during which measures were approved to partially change articles andrules of association to enable the introduction of a new office structure that began on January 1, 2021.
These revisions to the office structure aim to strengthen AMDD’s activities as an industry group and improve the sustainability of theorganization. Key changes include replacing the previous Staff Director position with Senior Managing Director, Managing Director, andAdministrative Assistant positions established as new full-time positions. The role of the new Senior Managing Director is to assist the
Chairperson and Vice-chairs, carry out office work, and lead strategic planning. Upon these changes, Shigeyuki Masukawa assumed thepost of Senior Managing Director on January 1, 2021. The existing committees and active working groups remain unchanged.

【AMDD Organization with New Secretariat】
Chairperson
Vice Chairperson (x2)
Board of Directors (ExCom)
Senior Managing Director (new)Managing Director (new)AA to Senior Managing Director (new)MTPICommittee Chairs and
SMO Staff are selected fromeach member companies (no changes)

The Secretariat
Chairperson
Vice Chairperson
Staff
Directorabolished

Senior Managing
Director

Administrative
Assistant (AA) to MD

Managing
Director
Strategic Management Office(SMO)

Executive Committee (ExCom)

By Function

By Specialty

OverallSpecial Treatment
Material (STM)

Capital Equipment(CE)

Membership

Regulatory Affairs &Quality Assurance(RAQA)

Orthopedics

Advocacy
Public Affairs (PA)Distribution & IT

In-Vitro
Diagnostics (IVDs)

Legal &
Compliance

WG
AMDD
Medical Technology
Policy Institute(MTPI)

Re-processed
Single-use
Device (R-SUD)
Cardiovascular
Diseases (CVD)
Contact Lens
Regenerative
medicine (RM)

C O N T E N T S

AMDDVol.34

Striving to Provide
Optimal Healthcare in Japan

01

Expert Interview:
The Role of Medical Manufacturers
02
at Medical Facilities

NEWSLETTER

Minimizing the Indirect Impactsof COVID-19

03

Unified Efforts Ensure Stable
Supply of Medical Devices

04

Member Companies Step Up
CSR Activities in Response
to Pandemic

04

AMDD’s New Office Structure
Starts in January 2021

04

Striving to Provide Optimal Healthcare in JapanOn behalf of the American Medical Devices and Diagnostics
Manufacturers’ Association (AMDD), I would like to extend my New
Year’s greetings to each of you for 2021.
These are undoubtedly challenging times with COVID-19 touching
all of our lives in some way. I would like to offer my heartfelt sympathy
to all those who have suffered directly and indirectly from the virus. I
would like to also express my sincere respect and gratitude to the medical
practitioners that continue to risk their own safety in order to treat
patients, and all those struggling as we continue to fight the spread of
infections.

AMDD’s Role Brought into Sharper Focus

Reflecting on the past year, COVID-19 seemingly spread across theworld in the blink of an eye. As infection numbers rose in every
continent, remarkable efforts were made in every country and region toprevent and minimize the spread.
Of course, prevention is just one step in a much larger global
undertaking. 2020 was also the year when governments and the public
became acutely aware of the challenges facing healthcare systems andthe importance of public health. Japan was no exception. Having longunderstood the academic importance of healthcare, AMDD’s member
companies quickly gained a deeper awareness of the practical role weplay, including the enormity and significance of the social responsibility
we hold for ensuring a stable supply of medical devices and in-vitro
diagnostics (IVDs), developing personnel, and providing the informationnecessary to support these.

Now is the Time for Healthcare Innovation

The pandemic is not something one country alone can deal with. Theinternational frameworks that make it possible to quickly and efficiently
leverage global resources are extremely important. Maintaining the stableproduction and supply of goods that support healthcare during both
emergencies and ordinary times, and building a system that ensures
optimal healthcare for all patients in Japan has arisen as a critical issue.
It was with this in mind that AMDD submitted a proposal last year to
the Ministry of Health, Labour, and Welfare with a goal of setting
reasonable healthcare costs and creating value-based healthcare that
improves outcomes for anyone receiving treatment. The proposal

consists of five key aims: (1) to maintain an environment in which
medical facilities can comprehensively propose options to patients forhigh-quality medical technology, (2) to create structures that make itpossible for medical institutions to provide high-quality medical
technology, (3) to evaluate outcomes, (4) to flexibly utilize diverse
evidence, and (5) to revise the framework for evaluating technology.
Even times of crisis have the power to accelerate innovation. There
has never been a better time to introduce cutting-edge technology and forJapan to assume its place at the forefront of global healthcare innovation
through teamwork between companies and groups beyond the limitationsof the current framework. AMDD has a long record of working toward
appropriately evaluating and reflecting the value of innovative medical
technology and achieving a healthcare system that makes society
healthier, and we are strengthening our resolve to continue these efforts.

Office Restructure to Encourage Innovation

Taking the principles of our value-based healthcare proposal andapplying them to our own organization, we implemented an office
restructure in January this year. Aligned with our slogan of “Enabling ahealthier Japan,” these changes will make it easier to put proposals andnew thinking first. AMDD aims to contribute to healthcare in Japan byproactively proposing policies, while cooperating with the Japanese
government, related industry groups, and academic societies, andcontinuing to coordinate with the U.S. government and the Advanced
Medical Technology Association (AdvaMed), headquartered in the U.S.
We thank you for your continued support and guidance this year, as
together we strive toward a safer, healthier 2021 and ultimately providing
optimal healthcare in Japan.

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: American Medical Devices and Diagnostics Manufacturers’ Association. (AMDD)
Shiodome City Center 5F, 1-5-2 Higashi Shimbashi, Minato-ku, Tokyo 105-7105 (Secretariat office)Tel: +81(0)3-6734-0382 Fax: +81(0)3-6679-2644
Website: http://www.amdd.jp

04 AMDD NEWSLETTER Vol.34

AMDD NEWSLETTER Vol.34 01