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Summary of JIRA Future Concept Project
(Abstract)

Wani Hidenobu, Project Leader
(JIRA Executive Director and Policy Planning Council Chairman)

1. Background and Purpose

In 2000, JIRA established its “21st Century Vision” and has since conducted activities with this as its imperative. Given the dramatic changes which have occurred in the environment surrounding JIRA over the past ten years, however, it was time for the “Future Concept Project” to not only review and assess its work, but to also put together action proposals regarding the direction of its future activities in terms of “re-evaluating the value of medical devices” and “new value creation.” Also, taking into consideration that there will be further changes in the environment, The Project listed up the issues JIRA faces, and proposed ways to implement a framework that will help us create solutions.

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2. JIRA Mission and Priority Topics

We reacknowledged the following as JIRA’s Mission:

JIRA's Mission, Vision, and Priority Topics
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Through diagnostic imaging devices・system technology, JIRA will seek to contribute to society in the following ways:

  • Improve the quality of healthcare; optimize national medical care expenses and streamline medical service management
  • Make valuable proposals from the point of view of the medical device industry that contribute to the reform of medical-care systems here and abroad
  • Ensure the medical device industry promotes the economic development of Japan and the safety of its citizens

JIRA also has the following Vision: To lead the way in the promotion of the radiological systems industry and in the generation of new projects, to become a platform able to adjust to changes in the environment, to rebuild・strengthen basic fields, and to create and nurture new medical device businesses, such as diagnostic imaging IT solutions.

Taking into consideration present issues and changes in the environment, we also selected the following topics to receive priority. Specifically, our strategy is to place priority on these four areas: “realization of swift decision-making,” “strengthening of collaboration with governmental authorities at home and abroad,” “promotion of the growth of medical imaging IT,” and “overall optimization of the JIRA organization.”

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3. JIRA Organizational Reform

Organizational Reform Points
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The name of the group previously called the “Policy Planning Working Meeting” was changed to the “Policy Planning Council.” This new Policy Planning Council was created to be the main place within JIRA where matters pertaining to issues affecting JIRA overall were to be discussed. The Council is to make plans related to JIRA’s overall strategy.

At the same time, in order to ensure that issues are covered in an appropriate manner, we created a new Division Chairman’s Meeting to encourage the exchange of information between the chairman of the various Divisions and Committees. Also, in line with the changes in the decision-making process noted above, we newly created the Industry Strategy Planning Office directly linked to the Policy Planning Council and the Standing Board of Directors.

We further separated the Divisions, Committees, and Working Groups that do substantive work into the Sections Specialized field and Sections Cross-related field.

The core groups to focus on specialized activities are the Medical Imaging System Division, the Standardization Division, the Regulation and Safety Division, the Economy Division, and the International Division. These five Divisions are the core places for activity within JIRA and undertake activities which harness the specialties of its area. A Division Chairman’s Meeting is also occasionally convened to both promote information sharing between Divisions and to work as a group that takes action to see that JIRA’s strategy is translated into actual tactics.

In contrast, the Future Concept Project made major changes to committees which form the core of cross-related fields by creating five committees.

By taking into consideration the characteristics of their individual activities, the previously independent “Related Devices Committee,” “Academic Committee,” and “Training Committee” were constructively reorganized as the “Enterprise Promotion Committee.”

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The mission of this Committee is to ensure JIRA supports all of its member companies. More specifically, this Committee has within it a “JIRA-IT Zone” and a “Business Management Zone” which provide support that will meet the needs of member companies. The functions of the previous “Academic Committee” and “Training Committee” are taken care of by committee members in charge of Academics and Training, respectively.

The previous Chapters have now been incorporated into the newly established Regional Committee which has four blocks – Kanto, Chubu, Kansai, and Kyushu. Each Block works to gather and disseminate information in its respective area.

With regard to the Public Relations Committee, with the establishment of the JIRA Industry Strategy Planning Office, we were able to clarify the division of responsibilities. The Strategy Planning Office and Divisions are now responsible for creating specialized external communications aimed at governmental authorities (specific external parties).

In this regard, the Public Relations Committee now concentrates on communications to JIRA members and the general public. It will seek to raise its communication planning ability and thus deliver strategic public relations communications. We will also close the JIRA Virtual Museum.

The Exhibition Committee and Survey and Research Committee will continue their present activities. The Survey and Research Committee, however, will now receive support from the Industry Strategy Planning Office.

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4. Value of Participating in JIRA

We considered the value of participation in JIRA activities and came up with the following:

1) Promoting and nurturing JIRA related industries becomes easier
The voice of just one company speaking about the industry or making a proposal does not carry much weight externally and it is easy to be influenced by outside forces. This is especially pronounced in our regulated medical device industry where there are almost no opportunities to negotiate or make requests to related industries or government authorities.
There is, thus, a need for collaboration and information exchange with related industries through interaction and cooperation between companies.

2) Able to participate in creating specifications, guidelines, and standards; able to work favorably on behalf of one’s company (the industry)
 In the highly-regulated medical device industry, the most important task is creating JIS, specifications, and guideline proposals. This work is difficult for just one company to do.

3) Access to information, transmission of information, and exchange of information is easier
A reduction in the workload related to acquiring information needed for industry activities. In the medical device industry, especially, where “Government Advisories” related to PAL regulations are important, unless one is a member of a related medical devices organization, one does not automatically receive advisories. It is a burden to independently acquire this information. The same also holds true for acquiring governmental information within Japan and from abroad. In conclusion, it is difficult for a company on its own to know where it stands “within the industry,” “within Japan,” and “globally.”

4) Participation in various training sessions, study sessions, and briefing sessions
Companies are not only able to get current information concerning laws and regulations relevant to the medical device industry (Pharmaceutical Affairs Act, Compliance, Fair-Trade), but can also participate in ongoing study related to the Pharmaceutical Affairs Act.

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5. Summary

Through the Future Concept Project we have been able both to organize those matters we needed to tackle and to develop an organizational structure to support these activities. There are issues, however, we have yet to address.

In terms of topics which relate to all areas, there is the matter of “visualizing the value of JIRA activities and making this transparent.”

Also, considering such topics as “Strategy Planning for the Medical Device Industry,” “Implementing Strategic Public Relations for the General Public,” “Handling of Global Harmonization in Specialist Fields such as the Pharmaceutical Affairs Act・Standards” it will be necessary going forward for JIRA to have highly professional staff working on these activities.

Finally, along with checking on whether the action plans formulated in the project are steadily being implemented and producing the expected results, we will need to evaluate them and make any needed adjustments.

 
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