No matter the field – economics, politics, or technology – Japan continues to be awash in enormous changes. These waves of change are now clearly sweeping into both the healthcare field and the medical device industry. Specifically, we are being influenced by first, innovative developments in fields related to medical devices and second, by changes in the social environment surrounding medical devices.
Against this background, the Cabinet Office approved on June 18, 2010 a “New Growth Strategy” in its “Blueprint for Revitalizing Japan.” In referring to “growth areas driven by Japan’s strengths” one area mentioned was “life innovation to make Japan a healthcare superpower.” It was further declared that the country must “foster industry growth to meet the demand for medical, nursing care, and other health-related services and create jobs.” This landmark positioning of the healthcare industry is something that gives us high hopes. We further appreciate the fact that in the government’s “platforms to support growth” IT strategies related to healthcare were included in its list of “projects related to science-and-technology and an IT-oriented nation.”
Underlying all of this is the fact that Japan has not yet fully recovered from the shock brought on by the fall of Lehman Brothers, the ensuing appreciation of the yen and political ferment. I believe that in order for the medical imaging systems industry to thrive in the years ahead it will need to further develop its core diagnostic imaging modalities and expand development of medical imaging systems that use IT innovatively. Developments such as these will hold the key to any re-energization of the domestic market and expansion into emerging markets overseas.
As part of its “Future Concept Project,” JIRA clarified four action plans that it believes will help “create a new dynamism in the medical imaging systems industry.” Since last year JIRA activities have focused on these four plans:
(1) Implement swift decision-making in order to respond to a rapidly changing world
(2) Submit policy proposals to the government and strengthen government-industry partnerships in order to develop the industry and ensure its proper evaluation
(3) Promote the growth of the Medical Imaging IT industry
(4) Optimize JIRA’s organization
We believe the action plans set as part of JIRA’s “Future Concept Project” can play a role in the government’s New Growth Strategy and plan to follow through on these this year. We hope that by stimulating the medical imaging systems industry we will contribute to the development of the healthcare device industry and, consequently, contribute to the betterment of people’s QOL (Quality of Life). Below I explain, in turn, our plans for “promoting the growth of the medical imaging systems industry” and the “strengthening of JIRA’s basic activities” which support that goal.
1. Growth Stimulation of the Medical Imaging Systems Industry
I believe there are three points involved in expanding the medical imaging systems industry.
First, since the healthcare field is a regulated industry and, as such, greatly influenced by the Pharmaceutical Affairs Law (in terms of safety) and the Fee-for-Service Reimbursement System (in terms of economic potential), we must respond responsibly to efforts to restrict its growth and vitality and make sincere efforts to enact reform.
Second, in order to “grow” the medical imaging systems industry, we need to evaluate the economic viability and efficacy of innovations in an appropriate and predictable fashion in order to ensure fitting incentives (returns).
Third, we need to promote small and medium-sized businesses since 70% of our members are from such enterprises.
(1) Appropriate actions to promote safety and peace of mind
Under the Pharmaceutical Affairs Law, ensuring product safety is, along with ensuring product quality and effectiveness, of utmost importance. In this regard, JIRA has thus far taken appropriate actions with related organizations to strengthen post-sale safety measures by creating and updating items such as a model “Device Handover Guideline” and “Guideline for appropriately implementing the GPSP (Good Post-marketing Surveillance Practice) Directive.”
Going forward, we will promote even more content improvement and information sharing. From JIRA’s annual survey on the “State of Medical Imaging System Installation and Safety” we have also seen that in recent years the importance of daily safety inspections and regular maintenance of devices in continuous long-term use has gained prominent attention.
Also, in terms of x-ray diagnostic imaging, member companies have worked to develop devices which allow for a diagnosis with a low dose of x-rays. JIRA has worked with related organizations on standardization issues involved with dose reduction such as requiring dosage output before a CT scan (predictive value) and after (actual value.) Along with continuing these efforts, we will work toward ensuring each device operates at an appropriate dosage level and provide customer-users with information about the daily and periodic maintenance of devices.
Furthermore, in terms of “promoting the growth of the medical imaging systems IT industry,” we will work together with the government to draw up guidelines for the development of CAD (Computer Aided Detection) devices. These devices are noted in the government’s (Ministry of Economy, Trade and Ministry of Industry and Ministry of Health, Labour, and Welfare) “Project to Design Guidelines for Medical Device Development.” We will also collaborate with related organizations on “instrumentation in healthcare devices of healthcare application software.”
(2) Appropriate evaluation of economic potential and usability
Considering the important place innovative diagnostic imaging has in the healthcare field and the fact that economic and social evaluation methods have been established, since 2008 JIRA has continually stressed the importance of properly assessing diagnostic imaging. We will continue to make this case this year, as well.
In particular, as we prepare for the next revision to reimbursement, we will make the following specific recommendations to the government in the hopes that they take into consideration the fact that since the “security,” “accuracy,” and “operation” of diagnostic imaging devices can be comprehensively guaranteed there should be fair and predictable evaluations of treatment fees.
(1) Clarifying and clearly stating “maintenance and preservation management costs” and expanding the application of “medical device safety management fees”
(2) Introducing a “fee for managing image resolution” for digital images involved in acquisition modality systems
(3) In terms of a new evaluation scheme for filming fees for CRT and MRI cross-sectional imaging, we propose that the calculation be the basic points for the “cross-sectional filming fee” + added values
On the other hand, if this way of thinking is not reflected in an industry-wide evaluation system, it will not only be difficult to gain a proper evaluation of specific devices, it will not help create an environment conducive to the development of the medical device industry. In October 2009, The Medical Engineering Technology Industrial Strategy Consortium (METIS) decided its Fourth Term Activities and Strategy Council and began to take up the matter of “the proper evaluation of medical devices.” Along with coordinating with METIS activities to form a consensus regarding the three guarantees noted above, JIRA will also seek to build a framework corresponding to the digitalization of diagnostic imaging that leads to incorporating “evaluation of image maintenance,” “evaluation of devices based on diagnostic purpose,” and “evaluation of the clinical value of innovation.”
(3) Initiatives for business promotion
70% of the medical imaging systems industry membership comes from small and medium-sized enterprises that handle a related variety of products and technologies. In particular, with recent IT developments in medical imaging systems, many firms dealing with healthcare IT have become JIRA members; such member firms dealing with IT now make up over half our membership.
Given the composition of our membership and to promote a variety of firms which including healthcare IT venture companies, last year we expansively reorganized the Related Devices Committee and launched the Enterprise Promotion Committee. This committee is made up of specialists and has begun taking up such matters as “corporate management,” “trainings on related laws and regulations,” “cooperation with related scientific societies,” and “the promotion of IT venture firms.”
We will strive this year to firmly entrench these activities. Specifically, we will proactively hold presentation meetings and workshops and trainings on themes such as “Government Policy and Measures,” “Overseas Support Measures, such as JETRO,” and “The Pharmaceutical Affairs Law.” Also, by managing these activities with membership participation, we will be able to consolidate requests and opinions to not only share information, but use it in proposals made to the government. Since it is imperative for this kind of activity that the membership participate positively, we will actively support such self-reliance.
2. Reinforcement basic JIRA activities
To move JIRA forward into new growth, I would like to look at three approaches to strengthening basic JIRA activities that involve the organization as a whole.
First - international activities that take into consideration global markets. From the point of view of developing healthcare IT with cross-border healthcare services and global products, the need for global consistency in technical criteria and mechanisms has become increasingly necessary. Further, the emerging markets of China and S. Korea are seeing a rapid development in their healthcare quality and quantity and this is, in turn, has become a great business opportunity.
Second - activities related to standardization, the starting point for all industry activities. As the number of products and technologies JIRA deals with expands, it is important to create guidelines, performance standards, and voluntary standards/JESRA that help the industry operate smoothly.
Third - activities to make policy proposals. Thus far, JIRA has been committed to responding responsibly to regulations such as the Pharmaceutical Affairs Law in a way that ensures the industry’s smooth operation. Going forward, we believe it will be important to do not only that but to also make both recommendations about each policy and enhance our performance in each area.
Having all areas of JIRA acting in accordance with these three points will serve to strengthen JIRA’s overall power (foundation).
(1) International activities which take into consideration global markets
Last year, JIRA intensified its activities with China. We received a visit by Chinese dignitaries, gave a keynote presentation at the CHINA HOSPEQ 2010 Forum in Beijing, and delivered a lecture about the Pharmaceutical Affairs Law’s basic compatibility checklist at CIMDR (China International Medical Device Regulatory Forum), also in Beijing. We have intensified our efforts to introduce Japan’s healthcare system in Asia by supporting, for example, seminars in S. Korea on healthcare devices. Meanwhile, JIRA has presented on regulatory coordination in APEC’s LSIF (Life Science Innovation Forum) and the Chairman has lectured and given demonstrations on how JIRA sees Healthcare IT’s role in the New Growth Strategy. Furthermore, by participating in GHTF (Global Harmonization Task Force) and AHWP (Asian Harmonization Working Party) and acting as chair of DITTA (International Congress of the Diagnostic Imaging and Therapy Systems Trade Associations) we have expanded our global activities. Also, JIRA is more active in GHTF than in the past. We are involved in steering committees and are dispatching members to be on expert committees. This year is also Japan’s turn to host GHTF. Going forward we will continue these activities.
1. The global harmonization of regulations and technical standards that relate to medical imaging systems and other related activities
With its broad connections with overseas industry associations, JIRA seeks to promptly collect information about and advocate for JIRA requests regarding such matters as societal issues related to medical imaging systems, international standards, international conformity to and relaxation of regulations, trade negotiations, and environmental controls. Specifically, we collect information about problems related to the irradiance level of x-rays and environmental controls. We also seek information about the revised European MDD (Medical Devices Directive), changes in screening in the USA, GMDN (Global Medical Device Nomenclature) and UDI (Unique Device Identification) in GHTF (Global Harmonization Task Force), Chinese medical-device legislation, the CCC (China Compulsory Certificate) Safety Certification System, and medical device legislation in S. Korea. We will also continue regular exchanges of information with overseas industry associations and conduct public relations activities such as releasing joint declarations.
2. Activities aimed at business expansion in emerging markets like China
We will conduct research regarding trends in legislative control over medical devices in the emerging markets showing marked growth and seek to inform member companies promptly through the JIRA website, bulletin, and lecture presentations.
In terms of China and S. Korea, JIRA has been particularly out in front of other organizations with interactions and the dispatch of survey teams. We have maintained active exchanges with both key Chinese administrative agencies, such as the Health Ministry, and with industry groups. We have held seminars concerning the regulations in Japan’s Pharmaceutical Affairs Law and, through regular meetings of the China Working Group, helped both sides obtain and share specific information concerning regulations in each other’s country.
3. International exhibitions and overseas communications
JIRA has sought to increase its international presence. Since 2006, we have set up a booth at CHINA HOSPEQ and CMEF (China), and had booths at RSNA (Radiological Society of North America) and ECR (European Congress of Radiology) conventions. With the aid of JETRO, we also played a leading role in setting up the Japan Pavilion at CMEF (China International Medical Equipment Fair). This year we plan to evaluate the results of these activities and clarify our goals for future activities. We will also further enhance JIRA’s English-language news brochure “JIRA Report” which is found on our website. This publication plays a central role in providing information about JIRA to those overseas.
(2) Standardization Activities
We have the following three key issues to attend to this year.
1. Handling the transition to the third edition of IEC (International Electrotechnical Commission Safety Standards (IEC 60601-1)
In 2012, we want to apprehend changes in global and international activities with precision. We will strengthen our relations with JEITA (Japan Electronics and Information Technology Industries Association), the body responsible for deliberating about general principles and collateral standards, and seek to reflect JIRA’s views in international discussions. Also, we will dispatch a member to discussions about individual IEC Standards to make the case for Japan.
2. Responding to the rapidly-expanding field of medical imaging IT systems
To ensure development of an industry in the IT area of medical imaging systems, it is critical that we secure “a high degree of interoperability regarding medical imaging information.” More specifically, we must lay a foundational infrastructure for medical imaging information such that patients, healthcare professionals, governmental bodies, and businesses will each be able to support a high-level of healthcare service which hen results in a world where safety and simplicity occur anywhere, for anyone, at any time. This system will not be one that exists simply within one individual medical institution; interoperability will need to extend across space to cooperating with medical organizations in a wider medical region, at the national level, and finally, at the global level. Furthermore, interoperability will need to extend across time such that medical information is used from the time a person is born until the time they die (and even after their death).
For these reasons, we will promote creation of an “effective” standard for medical imaging information that has a high degree of interoperability. Furthermore, to ensure that the introduction and application of these standards within the industry is smooth, we will promote efforts to develop products and systems compliant with standards such as IHE (Integrating the Health-care Enterprise) Connectathon events, compliance certification, and the formulation of guidelines on how products and systems should be operated in medical practice.
3. Toward international standards for Japan’s dominant heavy-ion radiotherapy technology
Within the international standardization strategy included in Japan’s “2010 Intellectual Property Promotion Program” there is mention of the specialized field of cutting-edge medical devices. Since JIRA member companies manufacture heavy-ion radiotherapy devices, a technology in which Japan has a competitive edge, we will proactively conduct activities to promote the international standardization of these devices and seek to link this to the development of a competitive medical imaging systems industry.
(3) Policy Proposals and Coordinated Activities
To nimbly capitalize on changes in the economic, political, and technological landscape, it is necessary for JIRA to clarify its vision and proactively give suggestions on countermeasures to the government. Accordingly, we created the “JIRA Industry Strategy Planning Office” within JIRA to work full-time on promoting this. To understand better expectations for JIRA regarding the government’s New Growth Strategy, we conducted last year a “Questionnaire Survey of All Member Companies,” created a “Medical IT Strategy Map” to help with the establishment of our Medical Imaging IT Industry Vision and, as also noted in the New Growth Strategy, conducted a “Survey to Understand the Current State of Remote Diagnosis and Remote Medical Care.” We also convened study sessions and briefings with the government and initiated coordinated activities with them. Going forward, we aim to make the “Industry Strategy Planning Office” JIRA’s “think tank” – a place that complies studies and proposals in a timely manner and, through periodic meetings with the government, is able both to asses the expectations of the administration and offer opinions. Also, to achieve the best results, we will work together on recommendation activities with organizations involved in business-academia collaboration.
Especially in relation to the “New Growth Strategy” and its calls for “life innovation to make Japan a healthcare superpower” and a “science-and-technology IT oriented nation,” JIRA established a “Medical Imaging IT Industry Promotion Working Group (WG)” so that it can respond to the expectations of this growing industry. The group will work on creating a vision for the medical imaging IT industry and consider how to flesh out proposals regarding areas in the New Growth Strategy that JIRA can impact significantly such as remote medical treatment systems, the two-dimensional use of medical data, the “My Hospital Everywhere” concept, and seamless community-collaborated medical services. We plan to coordinate with JFMDA (The Japan Federation of Medical Devices Associations) and collectively make proposals to the government.