AMDD Vol.25
NEWSLETTER

Jun 2017

English translation of the Japanese newsletter

CONTENTS- A Global Threat; Antimicrobial Resistance (AMR): The Importance of Clinical Testing
to Protect Japan- Direction of Policies for Medical Devices- Patient’s Voice: Treatment Methods and Future Challenges for Pediatric Brain Tumors- Voice from the Local Government: Expectations for the Medical Device Industry— For
Creation of Innovation —- AMDD Co-Sponsored the Japan Medical Association/AdvaMed Joint Symposium- AMDD Held the General Meeting- Value of Medical Technology<Diagnosis and Treatment of Cancer>: Evolution of
Laparoscopic Surgery: Cancer Surgery Without Opening the Abdomen- AMDD Held 6th Joint Media Seminar with JACRIA Global Threat; Antimicrobial Resistance (AMR):-The Importance of Clinical Testing to Protect JapanGrowing Awareness of Antimicrobial Resistance
Antimicrobial resistance refers to a resistance to antibiotics that results in a lack of efficacy
or difficulty in achieving efficacy. In 2010, several patients contracted and died in a university
hospital from an infection with multiple drug-resistant bacteria. This incident was widely
publicized, making the general public more aware of antimicrobial resistance.
In 2013, the U.S. Centers for Disease Control and Prevention (CDC) announced that drugresistant bacteria are a threat to humans. In the U.S., more than 2 million people are infectedwith drug-resistant bacteria annually and around 23,000 of these cases result in death. In
2015, a national action plan that aimed to provide a direction for resolving the issue of drugresistant bacteria was released. The World Health Organization (WHO) advocated theconcept of “One Health (living in one world)” in 2014, stating that the existence of drugresistant bacteria is not only a problem in the limited space of hospitals, but also an issue
that should be considered from perspectives that include the whole external environment,
including humans and animals (domesticated animals, poultry, pets, etc.).
Because of this global trend, academic societies, administration, and companies in Japan
collaborated to set up a committee called the Drug Discovery Promotion Council to provide
necessary advice to citizens, the administration, research institutes, and other bodies.
At the 42nd G7 Summit (Ise-Shima Summit), the Council of Cabinet Ministers forCountermeasures Against Infectious Diseases announced an action plan to enable Japan toexercise leadership, which had a great impact. The plan provided directions for six areas,1including enlightenment/education, surveillance, enhanced countermeasures against
infection, proper use of antibiotics, promotion of drug discovery, and international
cooperation. It also set numerical targets for each area. Based on this, Japan emphasized at
the Ise-Shima Summit held in May that it would exercise leadership on the issue of
antimicrobial resistance domestically and internationally, especially within Asia.
Emergence of a “Nightmarish” Drug-Resistant Bacteria
Drug-resistant bacteria are constantly evolving and new bacteria are emerging. Carbapenemresistant enterobacteria (CRE), which the CDC calls a “nightmare bacteria,” is becoming
increasingly problematic. CRE is difficult to eradicate because even the most powerfulantibiotics do not work for CRE infections. Patients infected with CRE have already been
identified in Japan, and in 2014, it became mandatory to notify public health centers if a CRE
infection occurs. It is said that this infection is expanding mainly in nursing facilities.
Another recently controversial issue is Clostridium difficile infection. This infection is caused
by a bacterium called Clostridium difficile in the intestines that abnormally propagates in
response to antibiotic treatment and induces symptoms such as diarrhea. It is considereddifficult to treat this infection because most antibiotics do not work on it.
The action plan also set a numerical target to reduce the usage of antibiotics. What we mustnote here is that the numerical target should not be used on its own. Patient status should be
carefully examined to decide on antibiotic use.
Diagnostic techniques are also advancing. Immunochromatography, which can diagnosediseases in as fast as 15 minutes, genetic diagnostic techniques such as multiplex, LAMP andGene Xpert, and various other diagnostic methods have been developed. In particular, the
LAMP method was developed in Japan and is attracting attention as an innovative techniquethat can visually judge bacteria. However, these methods still have some cost and other issues
that need to be resolved. Further development is anticipated.
The incidence of infectious diseases in Japan is much lower than that of other Asian
countries. In other words, drug-resistant bacteria are successfully controlled in our country,
so we should share our experience and skills with Asia and the rest of the world for the
future.
Department of Microbiology and Infectious Diseases, Facultyof Medicine, Toho University
Professor
Dr. Kazuhiro Tateda
Graduated from Nagasaki University School of Medicine in 1985. Joined
the Second Department of Internal Medicine, Nagasaki University Schoolof Medicine in 1985. Studied in the Department of Pulmonary andCritical Care Medicine at the University of Michigan in the U.S. in 1999.
Worked as Associate Professor in the Department of Microbiology and Infectious Diseases, Faculty of
Medicine, Toho University in 2005 before assuming his current post in 2011. President of the Japanese
Association for Infectious Diseases since April 2017.

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Direction of Policies for Medical Devices
Proper Usage After Approval
One of the major roles of the Ministry of Health, Labour, and Welfare is regulatory
administration. We tend to imagine from the term “regulation” that free and fluid industrial
growth may be hindered, but in fact, a healthy industry is fostered by appropriate regulation.
I believe that regulatory administration is essential for developing a strong Japanese industry.
However, regulatory administration also has various problems. Approval reviews in Japan aresaid to be rigorous for both medical devices and drugs, but once approved, subsequent
regulation is pretty loose. Drugs can be used by anyone and can be used in large amounts,
and all this usage is covered by insurance. This is because decisions after approval are basicallyleft to the discretion of clinics.
Recently, there was a TV program that could have misled viewers into believing that sleep
medicines work for diabetes. Misleading programs like this one are problematic. Also,
addictive drugs, such as sleep medicines, should be used carefully. We must further think
about proper regulation after approval, especially regarding proper usage, in the future andwe must work on this issue promptly.
Optimization of Regulation Before and After Launch
We sometimes receive criticism that Japanese drugs and medical devices are expensive, andthat companies profit too much. However, this is not the result of unfair profits made bycompanies, but often the result of the enormous costs spent on development. To lower
prices, development costs should be cut and reviews should be accelerated. At the same time,
innovation must be promoted. You may doubt that this is really possible, but we believe thatit can be done.
We have various methods for this. The first step may be to strengthen support at thedevelopment stage. At the last stage of approval, companies complete clinical studies andfinalize data. If their accomplishments are overturned on the brink of approval, companies
face a lot of trouble. It would be better to have communication between the authorities andcompanies from an early stage before approval in order for better products to be developed.
With this new idea, we are making efforts to enhance our consultation service.
The balance of regulation before and after marketing must also be reconsidered. If data canbe collected after marketing, requirements before marketing may be minimized to lessen
burdens. We think that development costs can be reduced by collecting post-marketing data
adequately.
We also aim to further streamline the review process for medical devices. Whether or notclinical studies are necessary is controversial, but it is also true that this puts a heavy burdenboth on the healthcare side and the patient side. We would like to make an attempt to boldly
overhaul this process and turn it into a more reasonable one.

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Aiming to Become a Reference Country
In 2016, a basic plan aiming at the promotion of research and development, or thewidespread use of medical devices to improve the quality of healthcare was approved in acabinet meeting. Some of the main elements of this plan are introduced below.
The first is to develop advanced medical devices based on advanced technologies. This aims
to develop medical devices that utilize genomic medicine or artificial intelligence (AI). The
situation of AI is still unpredictable because a large gap still exists between the expectations
and reality.
The second is to help the growth of venture firms involved in development. Venture firms
have professionals in management and finance, but they often lack skilled personnel inpharmaceutical affairs and insurance. This leads to difficulties in obtaining approval. We
would like to establish an organization that can alleviate this situation.
The third is to manage medical device regulation smoothly. Guidance on the number ofsubjects required in clinical studies will be drawn up early in the next fiscal year.
The fourth is to improve the environment to promote global business development.
Currently, we are accepting applications for Sakigake designation.
What is worthy of attention in the budgets for the next fiscal year is the budget related to
global strategies. As it is believed that review and evaluation methodologies for medical
devices in Japan can become global standards, a council secretariat was set up in the ministry.
A budget was approved for this project, allowing us to attend and make proposals ininternational conferences in the future. Even though the future of the health administrationis unpredictable partly due to the inauguration of the Trump administration in the U.S., wealways keep an eye on global strategies. Ultimately, our country will aim to become a reference
nation.
Owing to the postponement of the consumption tax hike from 2017 to 2019, financial
resources are limited. However, the healthcare system must be maintained regardless of theenvironment. The situation will remain uncertain for the next few years. Nevertheless, cutting
development costs, avoiding excessive burdens on health insurance, promoting innovation,and putting the priority on patients are unalterable themes that we have to honor, regardlessof whether or not we have the funds.
Director-General, Pharmaceutical Safety and Environmental
Health Bureau, Ministry of Health, Labour and Welfare
Mr. Toshihiko Takeda
Graduated from The University of Tokyo Faculty of Law in 1983.
Joined the Ministry of Health, Labour and Welfare in the same year.
Appointed as a planner in the Health Policy Bureau in 2000 to takecharge of the healthcare area.
Worked as a councilor for the integrated reform of social security andtax system. Worked as a minister’s secretariat, director-general, etc. in
the Ministry of Health, Labour and Welfare before assuming his
current post in June 2016.

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Patient’s Voice
Treatment Methods and Future Challenges for Pediatric Brain Tumors
Pediatric Brain Tumor Network
Ms. Yuko Moue, Representative

Pediatric brain tumors have the highest mortality among pediatric cancer, which is theleading cause of childhood disease death in Japan. Of about 2,500 estimated pediatriccancer cases per year, around 500 are said to be brain tumors, which makes them thesecond-most common cancer after leukemia. As more than 100 types exist for pediatricbrain tumors, this disease can be considered as a group of many rare diseases.
Chemotherapy and radiation therapy are more effective for children than for adults, and sotreatment of pediatric brain tumors has significantly advanced in the past decade for somediseases, such as medulloblastoma. In contrast, some diseases including pediatric diffuse
intrinsic pontine glioma still have no definitive treatment, and unfortunately, the prognosis
of such diseases worsens a short time after onset. Widely different treatment methods are
selected for pediatric tumors according to the age, tumor site, and grade. For example,
high-dose chemotherapy is used rather than radiation therapy because it has become
known that children who receive radiation therapy at the age of 3 years or younger are left
with an intellectual disability. This means that multidisciplinary treatment in related clinicaldepartments is in high demand. Brain surgeries, strong drug therapies, and radiation
therapies for children in the growth and development period cause motor, endocrine, andpsychiatric disorders, and many other problems, as well as a number of sequelae and latecomplications. More than a few patients are forced to spend their whole life having
difficulties in daily life.
It is also difficult to make a differential diagnosis from symptoms of common pediatricdiseases, such as nausea, headache and double vision, and in some cases, patient families
visit various departments including pediatrics, ophthalmology, otolaryngology, andpsychiatry, but the disease is still not diagnosed until it has progressed. There is a strong
need to enlighten primary care physicians through education on pediatric brain tumors,development of innovative diagnostic devices or tools, and healthcare collaboration, so thatdiseases can be detected early.
Isolating a brain tumor damages the brain, but recently a large number of new medical
devices and technologies, such as navigation systems, mapping, awake surgery,intraoperative fluorescence diagnosis, and intraoperative MRI, have been put to use toisolate the necessary sites accurately and minimize damage. Proton beam therapy forpediatric solid tumors was covered by insurance last year. Functions to improve treatment,
and reduce sequelae and complications are strongly desired in the development of various
radiotherapy devices and new medical devices.
Patients cannot readily know what kind of advanced medical devices are required for theirdisease and where they can find them. I strongly hope that future advances in medical
devices and diagnostic technologies will become more understandable and quickly
5selectable by patient families, which will help to make a significant improvement to the curerate and QOL of children.
Pediatric Brain Tumor Network : http://www2.pbtn.jp/

Voice from the Local Government
Expectations for the Medical Device Industry— For Creation of Innovation — Chiba Prefecture
Director of Healthcare Division
Dr. Shigekazu Komoto

1.
Challenges Faced by Local Governments
Shortage of physicians, nurses, care staff, and childcare workers.
The largest challenge faced by local governments in Japan is the shortage of humanresources. According to recently published vital statistics from the Ministry of Health,Labour and Welfare, about 977,000 children were born in 2016, falling below 1 million for
the first time since 1899 when the statistics were first collected. This news surprised me.
Amid a shrinking workforce, the number of hospitalized patients and home-care patients is
expected to increase 1.4-fold and 2-fold, respectively, in Chiba Prefecture. In the laborintensive industries of healthcare and nursing care, more human resources are required as
the services provided increase and become more sophisticated. As a result, the issue of ashortage of human resources remains unsolved, possibly bringing about obstacles in thesafety of healthcare, especially in rural areas. Construction of a safe and secure society
based on the rapidly declining and super-aging population is required.
2.
Innovation Wanted
I expect innovation for the medical device industry, including AMDD, to overcome thishardship. In other words, I would like to ask you to develop devices that can realize
healthcare and nursing care of higher quality, and a happier society despite fewer people in
the workforce.
Dr. Hiroshi Yoshikawa, Professor Emeritus at The University of Tokyo, said that, in the
postwar years of high-speed economic growth during which the Japanese economy grewby 10% per year in real terms, the workforce increased by only 1.3% per year, and thedifference of about 9% was due to higher labor productivity. Why don’t we aim to improvelabor productivity through innovation, not through selfless devotion, for our children’s
future?

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3.
An Eye on the Entire Community
Healthcare and nursing care will become increasingly borderless. Out of the total of about
1,700 municipal areas in Japan, a trial-and-error process is underway to shift from thetraditional hospital-centered healthcare to comprehensive local care in which the entire
community provides healthcare and nursing care. Efforts for prevention and early detection
are also important.
Why don’t you create innovation using your knowledge, skills, experience, and vitality in thefield of the world’s most advanced aging society, not only in operating rooms, laboratories,
and hospitals, but also with an eye on the entire community?
4.
Three Appealing Points of Chiba Prefecture
Chiba Prefecture, which encapsulates Japanese society, is the best environment for proof
of concept in medical device development. The prefecture is also promoting collaboration
between medicine and engineering, and will utilize the advantage of being designated as a
strategic special zone to support your business in medical device development. If you areinterested, please call the Investment Promotion Division, Commerce, Industry and Labor
Department (+81-43-223-2444).
[1] It has an enriched road network including the Tokyo Bay Aqua Line and Metropolitan
Intercity Expressway, and easy domestic and international access through Narita Airport
and Chiba Port.
[2] In addition to various industrial areas, including Kazusa Akademia Park and Chiba New
Town, new technoparks are being built in Sodegaura and Mobara. A variety of support
programs are available for new plants and laboratories.
[3] Advanced medical institutions in healthcare, AI, etc. including The University of Tokyo
Kashiwa Campus, National Cancer Center Hospital East, Chiba University, Chiba Instituteof Technology and Kazusa DNA Research Institute are located there.

AMDD Co-Sponsored the Japan Medical Association/AdvaMed Joint
Symposium
The American Medical Devices and Diagnostics Manufacturers’ Association (AMDD) cosponsored the joint symposium of the Japan Medical Association and Advanced Medical
Technology Association (AdvaMed) entitled “Vibrant Nation: Realizing the Fullness of“Ikigai” in Japan, The Role of Health Innovation in Delivering Growth, Productivity, andCost Savings.” held on April 26. The symposium was held to mark the publication of theJapanese version of a U.S. report on the economic effects of advanced medical devices.
After speeches by Dr. Yoshitake Yokokura, President of the Japan Medical Association, Mr.
Shuji Shirakawa, Deputy Chairman and Director of the National Federation of Health
Insurance Societies, Mr. Ichiro Kamoshita, Chairman of the Parliamentary Association for
Quick and Safe Access to Superior Medical Devices , and Mr. Kozo Yamamoto, Ministerof State for Regional Revitalization and Regulatory Reform in the Cabinet Office, Mr. Ross
DeVol, Chief Research Officer at the Milken Institute, U.S., who prepared the report,
provided a keynote lecture.

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In the subsequent panel discussion on current healthcare from the perspectives ofphysicians, the administration, and patients, the motivation in life beyond QOL from their
the different viewpoints was discussed.

(From left)(Moderator) Dr. Shuzo Nishimura, President, Institute for Health Economics and Policy
Dr. Yuichi Murayama, Chief Professor, Department of Neurosurgery, The Jikei University School of
Medicine
Dr. Yasuo Terauchi, Professor, Department of Endocrinology and Metabolism, Yokohama City University
School of Medicine
Dr. Yasuhiro Suzuki, Director-General, Health Insurance Bureau, Ministry of Health, Labour and Welfare
Ms. Yumi Kagawa, Chief Director, NPO Kanja Speaker Bank

AMDD Held the General Meeting
The American Medical Devices and Diagnostics Manufacturers’ Association (AMDD) held
the 8th General Meeting on March 15. After an opening speech by Chairman Kosuke Kato,Managing Director of Edwards Lifesciences Corporation, the settlement of account in2016 was closed and the budget for 2017 was unanimously approved. In a special lecture,
Mr. Toshihiko Takeda, Director-General of the Pharmaceutical Safety and Environmental
Health Bureau, Ministry of Health, Labour and Welfare was invited to make a speechentitled “Direction of Policies for Medical Devices.” The participants asked manyquestions about his passionate lecture, making for an invaluable time for both sides. (Seepage 2 for summaries of the lecture by Mr. Takeda)

The Value of Medical Technology<Diagnosis and Treatment of Cancer>
Evolution of Laparoscopic Surgery: Cancer Surgery Without Opening
the Abdomen
In recent years, laparoscopic surgery, which minimizes lesions, has become increasingly
common. Unlike a traditional laparotomy, laparoscopic surgery is a type that inserts acamera and operation device through a small hole opened in the abdomen and removes
lesions while the surgeon consults a monitor. Various devices have been developed toenable the surgeon to operate through a hole as small as 1 or 2 cm in diameter. In
particular, the evolution of energy devices that coagulate and cut tissues while suppressing
bleeding is astonishing. In 2016, an ultrasonic coagulotomy device that can treat bloodvessels no larger than 7 mm in diameter was developed and has been used by surgeons. The

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usage of automatic suture devices that automatically cut
lesion sites in the stomach or large intestine has also
been practiced by many people, and now, all procedures
including anastomosis (a procedure to connect tissues
after cancer removal) can be completed in the body
cavity.
We have high hopes that there will be continued
improvement of clinical values through new device
development and contributions to surgeons and patients
through the realization of less invasive procedures.
(Article written with full responsibility by Masakazu
Hirata, Ethicon Division, Johnson & Johnson K.K.)

AMDD Held 6th Joint Media Seminar with JACRI— A Global Threat; Antimicrobial Resistance (AMR): Importance ofClinical Testing to Protect Japan —The Japan Association of Clinical Reagents Industries (JACRI) andAmerican Medical Devices and Diagnostics Manufacturers’ Association(AMDD) held the 6th joint media seminar at the JA Building Conference inOtemachi, Tokyo on February 22, 2017.
Dr. Kazuhiro Tateda, Professor, Department of Microbiology and
Infectious Diseases, Faculty of Medicine, Toho University was invited toprovide a lecture on the current situation of AMR in the world andJapan, importance of clinical tests and future challenges to be addressed
under the theme of “A Global Threat, Antimicrobial Resistance (AMR):
Importance of Clinical Tests to Protect Japan.”

Dr. Kazuhirro Tateda

In the opening speech, Mr. Tetsuya Teramoto, President of JACRI, said
that a strategy against infectious diseases and antimicrobial resistance has
been recently focused on as an urgent issue. He mentioned that an action
plan against antimicrobial resistance was adopted also in Japan in April
Mr. Tetsuya Teramoto,2016, and in this action plan, a concept of “One Health” to implement President of JACRI
measures in a way that goes beyond the boundary of humans, animals
and the environment is especially important.
Materials on clinical reagents for antimicrobial resistance were exhibited at the back of thevenue which attracted the media’s attention.
(See page 1 for summaries of the lecture by Dr. Tateda)
Value of Medical Technology
Our mission is to make more people understand the unlimited potential of advanced medical
technology and its contribution to the reformation of the Japanese medical care system
Note: All opinions in this newsletter are the personal opinions of the authors, and do not necessarily
represent the opinions and activities of AMDD.

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