Associations with Cooperative Relationships

The Advanced Medical Technology Association (AdvaMed)AdvaMed, headquartered in Washington D.C. is the world’s largest medical technology trade association. Its member companies produce close to 90% of the medical devices, diagnostics, and systems sold in the U.S., and more than 50% of those sold worldwide. Most parent companies of AMDD member companies belong to AdvaMed. AMDD and AdvaMed have a close cooperative relationship.Website: www.advamed.org

AMDD Public Relations ActivitiesAMDD engages in a variety of activities to inform the importance of advanced medical technologies such as medical device and IVDs, to a wide range of people, including the media, government officials, politicians, medical professionals, and the general public.In 2002, AMDD initiated the “Value of Medical Technology” awareness campaign, and have given more than 25 media lectures to date, which are intended to improve awareness and understanding of advanced medical technologies to the media, and have held many media seminars in collaboration with other organizations.

The results of these efforts have been taken up by many newspapers, magazines, and TVs, contributing to increasing awareness about advanced medical technologies. The documents and KOL presentations used at each event can be viewed on the AMDD website.

Additionally, in order to communicate how advanced medical technology is helpful to patients, we have published two books with compilations of essays from patients who chose to use such advanced technology, “I’m glad I chose this treatment” (2009), and “I’m glad I chose this treatment II” (2014).

These essay compilations can also be viewed on the AMDD website.Website: www.amdd.jp

January 2016

American Medical Devices and Diagnostics Manufacturers’ Association. (AMDD)Central Park South 15F, 4-10-2 Nakano, Nakano-ku, 164-0001 Tokyo (Secretariat office)Website: www.amdd.jp

Organization Profile

The History of AMDD1980s Medical devices task force within the American

Chamber of Commerce in Japan (ACCJ), for negotiations including MOSS conferences established

1990s Medical Devices and Diagnostics Subcommittee within the ACCJ healthcare committee established

1997 Proposal titled “The Role of Medical Equipment and Supplies in Improving the Efficiency and Quality of the Japanese Healthcare System” released

1999 Proposal titled “A Turning Point of the Japanese Healthcare System” released

2002 Revised Pharmaceutical Affairs Law (effective April 2005) enacted, and the ACCJ Medical Device and Diagnostics Subcommittee began a public awareness campaign titled “Value of Medical Technology program” (Chairman: Dr. Yasuhisa Sakurai, Professor Emeritus, Tokyo Women’s Medical University)

2004 Symposium titled“Patient-Centered Medical Care” symposium held

2007 The term “device lag” comes into useOctober, 2008 “Device Lag Report” releasedDecember, 2008 The Council on Economic and Fiscal Policy instructs

that “device lag” be eliminated in an action program

April, 2009 The American Medical Devices and Diagnostics Manufacturers’ Association spins off from ACCJ; Dr. Huimin Wang (President of Edwards Lifesciences Ltd.) appointed as first chairman

May, 2009 Book titled “I’m glad I chose this treatment”—a compilation of patients’ essays, published

July, 2009 Research paper “Comparison of Medical Device Supply Costs in Japan and Europe” released

November, 2009 Request proposal “Opportunities for Revisions of Reimbursement System on Medical Device” submitted to the government

April, 2010 Mr. David W. Powell (President of Johnson and Johnson K. K.) appointed as second chairman.

“A Proposal from the Medical Device Industry with Regard to the New Growth Strategy ‘A Healthy Country through Life Innovation’” submitted to the government

August, 2010 Position paper “Thoughts on the Handling of In-vitro diagnostics” submitted to the government

November, 2010 Proposal “Medical Device Maintenance Compliance as an Issue of Medical Safety” submitted to the government

July, 2011 “Proposal for Revisions to the Pharmaceutical Affairs Law for Medical Devices” and “Proposal for Revision to the Pharmaceutical Affairs Law for IVDs” submitted to the government

August, 2011 “Opinion Survey of Japanese Healthcare and Advanced Medical Technology” report released

September, 2011 “Comparison Survey of Market Environment for Medical Devices in Japan, China, and Korea” released

November, 2011 “Proposal on Infrastructure Building for Companion Diagnostics for the Promotion of Personalized Medicine” submitted to the government

April, 2012 Mr. Takashi Shimada (President of Medtronic Japan Co., Ltd.) appointed as third chairman

June, 2012 “Proposal on Healthcare Associated Infections (HAIs) and Healthcare Worker Safety” released

November, 2013 “Pharmaceutical and Medical Device Act” enacted (Executed in October 2014)

April, 2014 Book titled “I’m glad I chose this treatment II”, the second compilation of patients’ essays published

June, 2014 “Proposals on the Appropriate Provision of In-vitro Diagnostics” submitted to the government

August, 2015 Mr. Kousuke Kato (Managing director of Edwards Lifesciences Ltd.) is appointed as fourth Chairman

January, 2016 Change of organization status to general incorporated association

Facility locations associated with AMDD member companies

Manufacturing facilities

Labeling facilities

Training facilities

Repair and maintenance facilities

Branch offices

•Medical and diagnostic devices for the heart, brain and vascular systemMany AMDD member companies offer medical devices in this area, such as pacemakers, and ICDs (implantable cardioverter defibrillators), as well as stents and coils used for treating coronary, carotid, and brain arteries. These devices greatly contribute to preventing sudden cardiac death, cardiac infarctions, and stroke, the major causes of brain and heart diseases, which are among the three top causes of death in Japan today. Furthermore, AMDD’s advanced medical technologies are also employed in the cardiac hemodynamic monitoring and intravascular diagnosis used in such treatments.

•Testing and diagnostic technologyTesting and diagnostic technologies have made striking progress in step with advances in biochemistry, molecular biology, and chemical analysis devices such as flow cytometers, blood sugar measuring devices, automatic bioanalytical devices, percutaneous blood gas analysis, genetic diagnosis, DNA chips, POCT, and companion diagnostics. It is now possible to automatically examine tens to hundreds of test items from even a minuscule blood sample. Moreover, development of technologies such as genetic diagnosis that allow physicians to arrive at treatments suited to each patient are underway.

•OtherRevolutionary diagnostic and treatment methods utilizing cutting-edge life sciences and advanced technology, such as surgical robots, CAS (computer assisted surgery), navigation, remote treatment, electronic health record systems, and nanotechnology, are now becoming practical. Technologies such as remote treatment, which virtually connects patients to a medical institution in a distant location, will allow doctors to provide advice to patients using surgical imagery with precise reproducibility. These technologies offer great promise.

•Biological diagnostic imaging Since X-ray examination methods came into use, diagnostic imaging technology has made remarkable progress, contributing a range of methods such as CT scanning, MRI scanning, and ultrasound diagnosis. In recent years, image data has become digital, enabling three-dimensional modeling, and further advancements have been made with technologies such as PET-CT. The PET-CT combines pictures of metabolic information made with PET with CT, which detects morphological aberration in affected areas.

•Minimally invasive treatmentsMinimally invasive treatments are surgical procedures such as endoscopic surgery, intravascular surgery, PCI (PTCA), microsurgery, laser treatment, gamma knife treatment, radiation treatment, and DDS, which involve the insertion of an endoscope or catheter through a small incision in the body which allows surgeons to view their procedures via monitors. These treatments obviate large incisions and allow for procedures using impulse waves and ultrasound which targets only the affected areas. Minimally invasive treatment improves patients’ QOL while reducing hospitalizations, which leads to reductions in medical costs.

•Artificial organs and regenerative medicineArtificial organs and regenerative medicine, such as ventricular assist devices, artificial heart valves, artificial lungs, artificial kidneys, artificial bones, artificial joints, intraocular lenses, cochlea implants, and cultured tissue, serve as replacements for damaged organs and improve patients’ QOL. While these technologies are not yet practical for all organs, as a result of biomedical engineering, they are widely used clinically, in hearts, lungs, joints, and eyes.

What is Advanced Medical Technology?Advanced medical technology not only plays a significant role in saving or extending patient lives and early detection of illness, but also helps reduce burdens on patient’s bodies with the use of minimally invasive technologies, allowing improvement of quality-of-life (QOL). Advanced medical technology helps improve the quality and efficiency of medical care, and allows patients to receive economic benefits such as lowered medical expenditures through shortened hospitalizations and increased overall productivity through improved QOL.

American Medical Devices and Diagnostics Manufacturers’ Association (AMDD)

The American Medical Devices and Diagnostics Manufacturers’ Association (AMDD) is an industry association established in 2009 comprising over 60 member companies, most of which are Japanese subsidiaries of U.S.-based corporations, that handle medical devices and in-vitro diagnostics. AMDD works to provide advanced medical technology (diagnostic and therapeutic technology) in response to the needs of both the Japanese medical field and its patients. AMDD member companies not only engage in product import and sales but also work in close cooperation with the Japanese medical device industry in R & D, and in promoting the use of Japanese-made parts and components in their products. Moreover, they account for approximately 70 percent of the medical devices sold in Japan (at an annual value of approximately 1.8 trillion yen) and for directly employing around 22,000 people (as of 2015) in the country. Member companies have bases such as repair and maintenance facilities in almost every prefecture in Japan, contributing greatly to the advancement of the Japanese medical device industry.

Our MissionProviding valuable medical technology and information to your loved ones today, so that they may live in good health.

Our Activities(1) Providing recommendations to facilitate rapid and

appropriate introduction of medical devicesAMDD offers recommendations to the Japanese government regarding regulatory systems for the fast and safe introduction of the world's advanced medical technologies to Japan. Such recommendations are provided in cooperation with the U.S. government and the U.S.-based Advanced Medical Technology Association (AdvaMed).

(2) Serving as a contact to the governmentIn order to realize overall containment and appropriate allocation of healthcare expenditures, AMDD serves as a point of contact between member companies and government offices such as the Ministry of Health, Labour and Welfare, with regard to the reimbursement system and related regulatory revisions.

(3) Communicating the value of advanced medical technologyAMDD undertakes a variety of activities intended to inform a wide range of people, including the media, government officials and politicians, medical professionals, and the general public, of the value and role of advanced medical technologies.

Activities in Cooperation with Affiliated OrganizationsAMDD pursues industry activities in cooperation with other industry organizations associated with medical devices that share the same mission and goal: to advance medical care in Japan. To date, we have written joint recommendations and held joint media seminars in cooperation with groups such as the Japan Federation of Medical Devices Association, the Medical Technology Association of Japan, the European Business Council in Japan, and the Japan Association of Clinical Reagents Industries.