Table of Contents
1. Purpose of the Vision of Medical Device Industry P4
1-1 Medical Device is P4
1-2 Purpose of the Vision of Medical Device Industry P4
2. Background surrounding Medical Device Industry P6
2-1 Advancement of Medical Care Engineering and Progress of the Application to the Most Advanced Medical Care P6
(1) Introduction of Innovative Medical Devices P6
(2) Introduction of IT into Medical Institutions and Progress of Remote Medicine, etc. P7
2-2 Intensification of Global Competition P8
(1) Globally Increasing Research and Development expenditure P8
(2) Strengthening Coordination in Research and Development P8
(3) Changes in Environment Surrounding Clinical Research P10
(4) Intensification of Competition with Patent Acquisition P10
(5) Reinforcement of the flow for International Harmonization P10
2-3 Increasing Demand to Cope with Safety for Patients P11
(1) Measures of assuring Safety for Medical Care and Medical Devices
(2) Coping with Organism-derived Products and Advanced Controlling Medical Devices P12
2-4 Influence of Assessment of Medical Devices on Medical Insurance P13
(1) Increase of Health Expenditures due to the Rapid Aging P13
(2) Problem of Domestic and Foreign Price Differences P13
(3) Appropriate Assessment on New Medical Devices, etc. P13
2-5 Changes in Way of Thinking of People for Medical Care P14
(1) Increasing Needs for Home Medical Care P14
(2) Increasing National Concern with Health Information P14
3. Current Conditions and Problems of our Medical Device Industry P15
3-1 Market Features P15
(1) Market Scale P15
(2) Market Structure P16
3-2 Features of the Industry P17
(1) Industrial Structure P17
(2) International Competitiveness P18
(3) Scale of the Companies P19
(4) Present Situation of Technology and Research and Development P20
(5) Distribution and Maintenance P26
(6) Others P29
4. Fundamental Idea of the Policy for Medical Device Industry P31
4-1 Strategic Development of Business Operation by the Companies themselves P31
4-2 Role of the Country P31
4-3 Establishment of Intensive Period to Promote Innovation and Implementation of the Policy P33
5. Concrete Measures to take during Intensive Period for Promoting InnovationE(within 5 years) P34
5-1 Strengthening Efforts and Promotion by the Government P34
(1) Comprehensive Measures by the entire Government P34
(2) Active efforts by Ministries and Offices concerned P35
5-2 Ideal Support with priority in Specified Field P38
(1) Necessity to give Priority for Support P38
(2) Idea of selecting Area with Priority P38
5-3 Action Plan for Strengthening International Competitiveness P40
(1) Support for Research and Development P40
(2) Promotion of Clinical Research, etc. after Clinical Trials P42
(3) Improvement of the System of Pharmaceutical Affairs P44
(4) Appropriate Assessment on Medical Insurance P45
(5) Appropriate Information and Services Offerings concerning Post-marketing P46
(6) Introduction IT into Medical Care P48
(7) Others P49
1. Purpose of the Vision of Medical Device Industry
1-1 Medical device is
Medical devices (Medical instrumentEin the current Pharmaceutical Affairs Law) is defined under the Pharmaceutical Affairs Law as an instrument intended for use in the diagnosis, cure or prevention of disease in humans or animals.
Recently however, role of medical devices is expanding more and more, for example, IT introduction into remote medicine or diagnosis is not merely improvement in handling the medical devices, but hints a possibility to alter medical care itself.
In light of these conditions, the promotion measures in this Vision are established, considering these devices are deeply associated with medical care.
1-2 Purpose of the Vision of Medical Device Industry
It is important to promote research and development of medical devices involving most advanced technology and introduce promptly the results to clinical site, as well as respond the demand for highly advancing medical care, in order to level up the national health and medical care standard. Indeed, medical device industry, known as knowledge- intensive industry with high value added, is expected one of the leading future industries in advanced countries, in terms of activating industry.
However, medical device industry in our country has not responded enough to the expectations, what is worse, recent bad influence of deteriorated medical insurance financial situation may possibly weaken more international competitiveness of the medical device industry which has not been tough so far. While improvement of the consciousness, represented by the recent organism-derived products, etc. as the industry contributing medical care is requested more than ever.
To meet the demand, the Vision of Medical Device Industry was established through analyzing present conditions and prospective problems surrounding our medical device industry, and sharing recognition with the persons concerned, as well as asking active strategic action towards strengthening international competitiveness for each device companies, and at the same time aiming at better understandings by the people for medical device.
In this context, the concrete measures to support medical device industry has been agreed with showing Action Plan as our country, in order to realize the improvement of the Quality of Life (QOL) and prognosis for not only domestic but world patients, through the development of innovative medical devices of our original, which is Emore superior and Esafer E
Additionally, as already referred in the Pharmaceutical Industrial Vision (Ministry of Welfare and Labor, 2002), this Vision claims also that 1. Together with our market itself has international competitiveness so that companies in the world, regardless of the capital whether domestic or foreign, should competitively perform research and development, manufacture, and sell the medical devices in our country. 2. Medical device companies themselves with domestic capital have real international competitiveness.
2. Background surrounding medical device industry
2-1 Advancement of medical care engineering and progress of the application to the most advanced medical care
(1) Introduction of innovative medical devices (Fig. (1))
Medical devices have had great influences on the development of medical care so far. Thanks to the discovery of X ray by Rtgen in 1895 followed by the development of X ray device system for medical use, remarkable progress has been made in medical technology, which is one of the examples. For another example, in the case of artificial kidney, succeeded in clinical experiment in 1943, then reformed into disposable type in 1956, enabled easier handling in clinical use, thus made a substantial contribution to such an extent that during the Korean War when the death rate of patients with kidney troubleincurable disease at that time, not only reduced the death rate of acute patients by 40%, but made over half of the patients return safe to the society.
Furthermore, after the latter half of the previous century, medical devices for treatment, diagnosis, etc. have made a remarkable progress mainly in US, and promotion of the development of advanced devices for medical use, such as pacemaker, or catheter for Percutaneous Transluminal Coronary Angioplasty (so called PTCA), enabled to offer medical care with little stress for the patients, as a result improved drastically QOL of the patients. While introduction of advanced diagnostic devices such as CT or MRI, etc. enabled early diagnosis with stroke, cancer, etc., then contributed for the betterment of prognosis and prevented the relapse with patients.
Today, the development of functional MRI (fMRI), equipped with more advanced additional functions or Positron Emission Tomography (PET), etc. allowed to diagnose more minute changes by diseases at earlier stage. Furthermore, thanks to the progress of cellular biology and embryology, so called regeneration utilizing regeneration of human cells is available, further development of new medical treatment has been expected, which so far having been impossible to avail.
(2) Introduction of IT into medical institutions and progress of the remote medicine, etc.
Even the products not so recognized as medical devices in the past began to make medical spots change drastically.
Essential progress of introducing IT into medical facilities made an image of ideal medicine change, contributing to improve the standard of national health and medical care. For example, by sharing medical treatment information of patients with introduction of electronic charts, team medical care and cooperation among mutual medical institutions got easier, as a result, it helped preventing medical accidents beforehand, and improved the quality of medical care. Further, in terms of improving efficiency and service for patients some effects such as betterment of cost analysis of medical care through accumulated management data, and shortening of waiting time, etc. have been shown.
In the mean time, research and development for medical devices made a progress for doing so called remote medicine where medical affairs or medical related affairs such as diagnosis and instruction are performing based on the data sent from remote area including imaging. A model business intending to aim at sharing know-how of special medical doctors, establishing remote imaging diagnosis support system and transmitting images mutually among hospitals, including between hospitals and clinics. The role of remote medicine is assumed to grow bigger in the future, helping the situation that remote medicine is admitted even at the first medical examination where face-to-face medical treatment is impossible (remote area, isolated island, etc.).
2-2 Intensification of the global competition
Medical devices are classified in many ways by the area of products, in the low matured product area with short development cycle (such as products for cardiovascular surgery, etc., ex: coronary artery stent, etc.), main competition is with research and development, invested large amount of research money, while in the relatively matured product area (ex: siringe or catheter), price competition is the main. (Fig.(2) )
(1) Globally increasing research and development expenditure
Incessant technical innovation has taken place in the medical device industry, as a result, continuous efforts to improve existent products and development of new products has become important theme, the research and development is now recognized as a key for the industrial promotion (Fig. (3) ).
It is said that competition for the development of research and development will globally intensify, in the area of cultured skin etc. utilizing advanced engineering technology such as regenerative medicine, etc. The importance of research and development will increase more and more in the future to win the race in the area of medical devices.
(2) Strengthening coordination in research and development
With advancing medical devices, more sophisticated integration in respective fields of scientific engineering such as machine, electricity, physics, and chemistry, etc. as well as medicine is needed. In addition to these new developments, improvement based on the clinical experiences by the doctor is meaningful for technical innovation for the post marketing of the products, which is characteristic of research and development for medical devices.
In the U.S, creation of environment (so called coordination of medicine and technology) is proceeding in the form that researchers with knowledge of doctor and engineer are permanently stationed in the medical institutions and are jointly developing medical devices in order to meet the needs of medical places by applying the advanced engineering seeds. As a background, it is pointed out that the position of clinical engineer in hospital is higher than that of our country, and coordination (control and management concerning the use of facilities in the institutions by the companies) for research and development is actively promoted, through the application of the seeds of the most advanced technology and development of medical devices to meet the demand of the need of the medical site.
Tying up with private companies, so called coordination between company and academic, as well as advanced research and development institutions is also needed in order to realize to accumulate these technologies, and manufacture and marketing the products. In addition, through participation of pharmacy in the cooperation between medicine and engineering, development of medical devices in many field of research such as bio imaging, DDS (drug delivery system) and regenerative medicine is expected to break through.
(3) Changes in environment surrounding clinical research
In the pharmaceutical companies and medical device companies in US, in performing research including clinical trials, the of number organizations outsourcing partial job, to Site Management Organization (SMO), or Clinical Research Organization (CRO), etc., has increased, enabled to relieve the burden of job in the medical institutions and other companies.
Further more, there are some medical institutions performing intensive care on specified disease in US, which offers easier environment in collecting applicants for clinical trials, as well as secures the persons necessary for doing clinical trials. While functional diversification of medical device companies has not been succeeded yet in our country, which is said to be one of the causes for inefficient clinical trials.
(4) Intensification of competitions in patent acquisition
Recently, patent strategy is a major management strategy, even in the medical device industry, copy products may be allowed to participate in the market, without proper blocking patent strategy, now resulting in failure in realizing advantages from new products.
In Europe and US, they are trying to secure the priors advantage by the investment to patent strategy, like investment to research and development. As a result, the number of patent applications with medical related devices in tripartite or Japan, US, Europe, are only 8% in Japan, comparing 64% in US, 27% in Europe, respectively. (Fig.(4) ).
(5) Reinforcement of the flow of international harmonization
Incessant introduction of new products to the market with relatively short cycle is important for research and development of medical device, in terms of its characteristics. In order to achieve, time consuming clinical trials with large amount of expenditure and application procedure for approval, etc. are inevitable. Thus more global market strategy has become important, then standardization of examination criteria has been asked. Global Harmonization Task Force of which members are composed of the regulatory authority staffs from Japan, the US, EU, Canada and Australia and representatives of industries was held in 1993, since then discussions with the harmonization of the criteria in the examination procedure for approval, report of adverse event, and quality control, etc. have been continuing so far.
Then, to do examination for approval with medical devices utilizing most advanced technology, which is assumed to increase, promptly and properly, the necessity for regulatory science has increased.
2-3 Increasing demand to cope with safety for patients
(1) Measures of assuring safety for medical care and medical devices
According to the Incident Report by FDA concerning medical devices, more than one thirds of incidents of 80 thousand incidents a year in the report were pointed out caused by unexpected ways or inappropriate handling, etc. so called EUse ErrorE
To prevent Use Error and secure Safety for UseE it is required that the design (human factor engineering) involving characteristic of human behavior and its limit at the stage of developing products, and active improvement of products including simplification of structure, function as well as the way of handling as much as possible and grade up of the contents in attached instruction which offers appropriate information to medical institutions. (Fig. (5) (6) )
And accompanied by advancement and complication of medical devices, more instruction and information offerings to the user with usage are needed for now using medical devices.
On the other hand, as many medical devices are used repeatedly for fixed terms, maintenance and control is important, more information offerings, etc. including utilizing the specialist, such as clinical engineer, etc., and instruction for maintenance controller, as well as establishing standard for service life, is needed in order to enhance the efficiency of maintenance control in medical institutions.
Specialists offering information of medical device are required to be fostered so that effective information offerings are given to the medical stuffs.
With some medical instruments, bar code check is utilized, but study is needed for further spread.
Pharmaceutical Affairs Law Reform including major theme to review the safety measures in medical devices and upgrade of safety measures of post- marketing was established in July. 2002. Concerning medical devices, Good Vigilance Practice (GVP, tentative name) of post-marketing is to be enforced in 2005, companies without enough safety measures to secure the national safety for post-marketing can not be admitted to business.
(2) Coping with the organismderived products and advanced controlling medical devices
Recently, organismderived products used materials derived from organism have been in the market to enhance the performance of medical devices are expected high efficacy, but can not necessarily avoid all infectious risks in its nature.
Accordingly, under the amended Pharmaceutical Affairs Law, enforcement of safety measures to cope with respective risks concerning organism-derived products, and advanced administrative medical devices having high risks for human body, was included, and also asked to be surely achieved.
2-4 Effects of assessment of medical devices on medical insurance
(1) Increase of health expenditures due to the rapid aging
Under the circumstances that further increase of national health expenditures caused by the progress of rapid aging, etc. is anticipated, and environment surrounding medical care is drastically changing, medical system reform is proceeding to secure good and efficient medical care (Fig.7).
Under such severe financial conditions of medical insurance, severe rationalization and review of the corporate strategy is required.
(2) Problem of the domestic and foreign price differences
In the product group having a big market share with imported products, there are actually domestic and foreign price differences by dozens percent to several times, which have been asked to correct (Fig. 8).
(3) Appropriate assessment on new medical devices, etc.
Medical device industry, playing a major role to support national medical care, may be the one playing an official role, in terms of developing medical devices with good quality and safety, resulting in contributing to grade up the national health and medical standard, and expected to reduce health expenditures. However, many companies are pointed out that they are staying only selling existing products or products with minor change, so epoch-making or innovative efforts for developing medical devices is strongly demanded, in view of strengthening international competitiveness, amid the further global expansion of the industry. In addition, appropriate assessment on medical insurance system of medical devices covered by insurance, as well as medical devices which may be epoch-making and innovative diagnosis or treatment, has also become issues.
2-5 Changes in way of thinking of people for medical care
(1) Increasing needs for home medical care
Recently, due to the changes of the needs for medical care, needs for home medical care by the people have increased. The revision of the Medical Service Law in 2002 where home medical service was introduced and placed in medical care, and home medical service technique and instruments was evaluated on medical insurance treatment, was said to help promoting home medical service. Thanks to this revision, chances to use related medical devices by patients or
their families are increasing in performing such as expectorant aspiration, tube feedings, peritoneal dialysis, and home oxygen therapy, as a result, the development of research and development of medical devices easy for user is requested.
(2) Increasing concern with health care information
Through increasing amount of information caused by the changes of disease structure such as an increase of life style related disease under the influence of increasing number of aged population, spread of informed consent, pursuit of QOL, and mass media, those who have great concern with their own health and medicine and treatment as well as prevention of diseases have increased. The idea of self-care is spreading. In this situation, sphygmomanometer and pulse meter, etc. play certain roles of checking own health condition. (Fig. (9) (10) (11) ).
In consideration of these backgrounds, it is anticipated that people will select medical service with their own will in the future, so more appropriate information offerings with efficacy, safety, and usage for medical devices based on evidence and diagnosis are required than ever. In the field of medical check, etc. demand for products will increase in parallel with growing national needs.
3. Current Conditions and Problems of our Medical Device Industry
3-1 Market Features
(1) Market Scale
World market scale of medical device industry is around \1.6 trillion, having around share 41% of America, 25% of Europe, 15% of Japan respectively (Fig. (1)).
The scale of the market for medical device industry in our country was around \2 trillion in 2000. The market scale has grown to \2.286 trillion in 1998 at the speed of 5.2% a year on average, which was \1.2901 trillion in 1989. Nevertheless, it marked minus 3.5 percent of growth in 1999, and minus 1.2 percent in 2000 showing the first consecutive negative growth for these ten years (Fig. (2)), this trend is conspicuous in the area of diagnosis-related devices. On the other hand, European and US market are continuing to expand the market (Fig. (3)).
(2) Market Structure
The items with large market scale are for example: Treatment-related devices and Imaging Diagnostic Devices, including Operating Equipment and Supplies, Artificial Internal Organ Apparatus and Assist Device, Operative Products, Surgical and Plastic Surgical Products and Related Products, X Ray Related Devices for Medical Use and Other Products (Fig. (4)).
If medical devices are classified roughly two categories, where one is treatment-related medical devicesEincluding PTCA catheter, pace maker, and in-plant of plastic surgery, the other is diagnosis-related medical devicesEincluding endoscope, CT and MRI, etc., foreign products have got a large share in the market for treatment-related medical devices. While in the diagnosis-related medical device market, Japanese companies maintain strong competitiveness, but its share has been only on the decline (Fig.5).
Reviewing the breakdown of the growth rate from 1989 to 1998, sales increase on treatment-related devices was \ 506.2 billion of total sales increase of \738.5 billion from 1989 to 1998, the growth of treatment-related devices are assumed to have largely contributed to the growth of total medical device market (Fig. (6)).
And as to the rate of introduction for medical information system into medical institutions as of 2001, the rate of order entry system was 31.1%, and electronics medical chart system was 1.1% respectively, showing inefficient penetration, but rapidly prevailing of late (Fig. (7)).
3-2 Features of the Industry
(1) Industrial Structure
Companies including large, medium and small size have participated widely in manufacturers and importers and sellers of medical devices, the number of companies reached 1580, according to the investigation with the actual conditions of medical device industry. The number of the companies capitalized at from 10 million to 50 million yen shares nearly half of them, while those capitalized at over 20 billion yen are keeping only 2.9% (Fig. (8)).
Products vary according to the company scales, the companies capitalized at over 10 billion yen usually deal with diagnostic-related imaging devices, while generally some trends to deal with steal product for medical use and medical apparatus for home use are seen, as the scale of the capital decreases (Fig. (9)).
And as to the companies having domestic capital, many large scale companies applying high technology of another industry manufacturing such as textile and pottery have participated in medical device industry. Nevertheless the sales in the medical device are only small portion of total sales for these companies. Which is said to be one of the reasons for slow investment to the field with high risk high return of medical device in light of avoid bad affects on parent companies.
The number of employees engaged in medical device manufacturers amount to around 68 thousand, having a 0.1% share of all industries (Fig. (10)).
(2) International Competitiveness
General trade balance showed deficit of around 500 billion yen, the spread of deficit is now growing in this industry (Fig. (11)). As to import, the share of treatmentrelated devices is around 70%, major importer is Us, sharing about 80% (Fig. (12)). Then index of international competitiveness (=(balance of import and export) /(amount of export + amount of import) marked a slight plus in 2000 exceptionally, but in another years, it has continued to decline these 10 years. Reviewing the breakdown, though the index has been on the decline, has showed consistent plus in the area of diagnostic-related devices, on the other hand, the index with the treatment-related devices marked continuous minus these ten years, the spread of minus is substantially increasing in recent years (Fig. (13) (14)).
As the items manufactured by domestic medical device companies whose items are highly ranked in terms of sales, there are general-purpose items including syringe and catheter, etc., medical devices for use of hemocatheresis such as dialyzer, and diagnostic devices and endoscope including CT and MRI, etc. No dialyzer existed except for imported one at first, in the mean time, domestic fiber companies having advantages in developing filter materials for use of hemocatharsis, such as dialyzer, almost monopolized in the domestic market, and certain competitiveness has been kept in foreign market. Referring to endoscope, Olympus corp. that brought their technology of their own into the medical field, has got the share of around 70% in the world endoscope market (Fig. (15)). Thus, the basic technology of our industries was verified to be globally acceptable. In the future, with sufficient development of global strategic management by companies themselves, improvement for international competitiveness can be expected.
Generally, as majority of treatmentrelated devices such as PTCA catheter, etc. are imported, the existence of domestic and foreign price differences or price fixing at high level is criticized. To correct this situation, reassessment rule to deflate the price level was introduced to the Revision of Medical Fees in April 2002, with reference to the foreign price level of a part of materials prices.
(3) Scale of the Companies
International competitiveness of the company is not necessary determined by the scale such as sales, but it is true that certain amount of sales (or scale of the company) is necessary to continue large amount of research and development investment.
Medical device manufacturers and importers or sellers in our country are characterized as requiring large items small-scale production with medical devices, consequently majority of our companies are small in size. The sales of Johnson ＆ Johnson, No.1 among the companies engaging in medical device and diagnostic devise in 2002, reached over 1.35 trillion yen (11 billion dollars), while the sales of Toshiba corp. with the biggest sales in Japan in terms of the above, showed only 260 billion yen. As to the field of medical treatment-related devices, Terumo corp., the top company having the sales of a little less than 150 billion yen, while medical treatment-related medical device companies highly ranked on sales in US, got the sales ranging from700 to 900 billion yen (Fig. (16)).
M＆A, which seems to be one of the effective measures for the companies to expand company scale in Europe and US, has not taken place significantly in our medical device industry. In our traditional case of merger and reorganization of the companies, many cases have taken place casing by the critical feeling of the companies themselves, which was assumed by some people the proof of having been guaranteed some benefits to such an extent that M＆A was not so needed so far.
(4) Present situation of technology and research and developing
1. Conditions of research and development investment, etc.
The period required for the development of medical device varies largely by type of products, and also the form of the development varies ranging from self-development to purchasing of product technology, research and development expenditures by each companies are generally increasing.
While in the medical device and diagnostic device industry in US, research and development expenditure was $ 8.9 billion, 12.9 percent share on sales (Fig. (17)). On the other hand, according to the actual investigation for medical device industry, though companies with more than \ 50 thousand on sales in our country have the differences of several times through several decade times smaller on sales than US, research and development expenditures stay only 5.8 percent of total sales.
The difference between tax system for research and development of Japan and the US. is pointed out as one of the reasons, thus essential review of the research and development for medical devices has been introduced to the EScheme of Tax ReformEsummarized in Dec. last year in Japan, to strongly support research and development for medical devices, including tax deduction system reform enabling 8~10 percent of total research and development expenditure, or equivalent to that of about 3~4 times higher than in US. (temporarily 10~12 percent for 3 years), as well as accelerated depreciation system where almost all the amount of asset used for research and development can be deducted from the tax at the first year. In the future, this effect is expected that companies for themselves will make active efforts for the research and development under the support of these tax merits.
By scale of the companies in US, the ratio for the research and development expenditure of the companies with sales less than $ 5 million, reached 252 percent (Fig. (21)), suggesting that these small companies played substantial role for the development of innovative medical devices. while the companies with sales between more than￥50 million and￥100 million are staying only 19.3 percent in our country (Fig.20). Though the companies with sales less than $ 100 million share only 10 percent of all the sales of medical industries in US, share a bit less than 30 percent of the total research and development expenditure, which suggest the roles of the companies are changing to two categories, or Esmall companies doing research and developmentEand large companies having know-how for commercializationE(Fig. (22)).
Some people insist that one of the reasons for slow speed of the development for innovative medical devices attributes cultural and social factors in our country. Namely, the culture where they prefer demerit system to the merit system and are afraid of failure substantially exist. As the background, it is said that one is the social attitude strict for the failure, often seen on the repot of mass communication, as well as the legal environment forcing them unable to revive either financially or substantially. Creation of the social environment enabling to challenge again and encourage challenge is required for not only medical device industry but for the development of whole industries in Japan.
In addition, the differences between the amount of research and development expenditures of large medical device companies in US and Japan was six times as of 1997, have grown almost ten times as of 2001, differences of developing power of both countries are to be spreading further, as far as substantial change in the efforts to tackle with the research and development by the companies are not shown, there may be possible to lose completely international competitiveness with our medical device companies in the future (Fig. (19))
2. Conditions of technology and standard of research and development
Generally, the number of acquired patents with treatment-related devices in our country seriously fell behind Europe and US (Fig. (23), (24)), but concerning the diagnostic devices, our companies acquired many patents have lead to shorten the differences between the companies in Japan and Europe and US. (Fig.25).
And in the medical device industry of our country, some examples companies succeeded in getting the share after improving conventional products by applying high core technology of parent company like dialyzer of textile-related company (Fig.26), but it was very rare that original medical devices of our country to have made big hit.
Recently, thanks to the progress of cell biology and development biology, so called regeneration medicine using human cultured tissues became available. In US, several items such as self or similar cultured skin and regeneration of self cartilage cell are already distributing in the market after getting approval, while in Japan, cultured skin narrowly reached the stage of commercializing after completion of research and development, no approved products exist.
3. Present conditions of technology transfer and academic, business, and government alliances
Fruits from research supported by the government used to belong to the intellectual property of the government in US before 1980, but after the establishment of administration system for patents such as Bydoll Law, etc. in university (1980), the fruits of research were altered to attribute to the universities concerned, then partially they were to be returned to the inventors. In addition, by means of the measures to encourage medium and small companies including the program for medium and small companies technology transfer (STTR) through enhancing partnership, combining medium and small companies being good at utilizing technology with the nonprofit institutions being good at theoretical research, the idea is planned and commercialized into the products. While in Japan, deregulation of the national research institutes was implemented through establishment of the Law for the Promotion of Technology Transfer of University, etc. (in 1998), including subsidy system (10 million yen a year for 5 years) for the business of Technology Licensing Organization (TLO), and deregulation for use of national site of the institutions by private companies (Revision of the Promotion for Research Cooperation Law, in 1998), etc., there are 28 approved TLO as of Jan, 2003 (Fig.(27)).
Thus, the environmental considerations around technology transfer in our country are proceeding now, but the actual achievement is far inferior to that of the US, (the number of approved TLO came to 3295 in single year of 1999 in US, in contrast, aggregated number from 1998 to 2001 was 223 in Japan), effective commercialization of products and commercialization of hidden technological seeds are expected through promoting TLO in the future (Fig. (28)).
And then, with the upgrading of medical devices, both industry-university alliance and medicine-engineering alliance are required to promote the development for the medical devices with high novelty, unfortunately either of them seems to be insufficiently in our country. While in US, clinical engineer (ME or CE) who has advanced professional knowledge serves as bridge between clinician and researcher at clinical trials and research and development in the medical institutes, consequently facilitates their communication, and promotes medicine-engineering alliance. Now in the US, medical device engineering and clinical engineering has been already established as a field of engineering, many hospitals have established the integrated clinical engineering department, which is doing maintenance, purchasing of medical devices and also controlling clinical trials, being inevitable for hospital management.
In contrast, clinical doctors could not participate in the medicine-engineering cooperation because of being busy for routine work or having inadequate channel with manufacturer.
4. Environment around clinical trials
In our country, clinical trials have not increased because of the difficulties of collecting patients, inefficiency of environmental considerations and costly clinical trials for the companies. Under the influence caused by the system revision of 1997 regulating the results from clinical trials performed in foreign countries shall be accepted as approved application data in Japan, such cases have been observed that not only foreign companies but even Japanese companies once implemented clinical trials in Europe where regulations were not so strict with tripolar countries, or Japan, the US and European countries (Fig. (29)), then they got approval in the US, finally got approval in Japan utilizing the clinical data already acquired in the US. These inactive performance of clinical trials may adversely lead to 1. Delay in access to the most advanced medical technology (treatment already implemented in foreign countries ) for the patients in Japan. 2. Adverse effects on the level, etc. of research and development of our companies, and creation of new business and new job. 3.Technical level down with the doctors, which consequently may give adverse effects on the standard of Japanese public health and medical care and international competitiveness in our industries. It might be a real loss for us that rapid commercializing in our country is not implemented because of the lack of environmental considerations.
� The reason why rapid collection of data on clinical trials in our country is difficult is caused from poor incentive for the person being tested (patients) or practical researcher, in addition to the differences on such as medical care environment and custom. For another reason, it is pointed out the medical devices with novelty and high risk where especially many case are required clinical trials, being lack of experiences in Japan, would take many times to evaluate the design before the implementation of clinical trials.
� As to the problems of clinical trialsEcost, the companies have been relieved the burden of clinical trialsEcost of the companies, by introducing the system of Special Healthcare Expenditure in April 2002.
� The problems of the time and quality required for clinical trials, effective performance system for clinical trials and consideration of the GCP standard is said to be the problems.
(5) Distribution and Maintenance
The companies selling medical devices are 2500 in number, about the same as those of drugs. Market scale of drug manufacturers is about \6 trillion, and the number of products is 17000, in contrast, considering that the market scale of medical device industry is \2 trillion with hundreds of thousand of products, each sellers seem to be relatively small scale dealing with many items.
Medical institutions in our country usually purchase medical devices by way of wholesalers except for expensive diagnostic devices, etc., stead of direct deal with the manufacturers which are usual practice for the medical institutions in the US. With the medical care materials such as catheter, etc., about 70% of the medical institutions deal with more than 10 wholesalers, consequently distribution process is complicated (Fig. (30)).
The medical institutions making a bid when purchasing is less than half of them in number, price competition in the market is inefficient in function now, which is criticized by some people to be the causes of spiraling medical device cost (Fig. (31)).
In the US, upgrading the purchasing power by dint of the merger among a number of hospitals as well as group purchasing by Group Purchasing Organization called GPO are proceeding, while such movement is not seen except for some groups of hospitals in Japan. Administration of medical care materials in many medical institutions where no administrative department consolidating all products like in the case of drugs, they have to procure and make an inventory control with respect to each medical treatment service at present, leading to complicated and ineffective process of distribution.
� To solve these problems, the delivery services have begun to make contract with a number of medical institutions, price negotiations with wholesalers, manufacturers, and importers, in behalf of medical institutions, as well as to deliver products with more inexpensive prices than ever and in small amount in response to the demand of the medical institutions. This is to meet the detailed needs of medical institutes desiring to relieve the complexity of delivery, and inventory control in the medical institutions, such a new movement is expected to have a possibility of promoting efficiency in the distribution of medical devices.
� Environment surrounding the delivery of medical devices has continued to change. To enhance the existing value of sellers, under the circumstances that management environment is anticipated to become severer in future, and amidst the demand of promoting efficiency, further efforts to create more value added in the delivery-related field are expected. For example, function like a platform of information offering the information to the manufacturer of medical devices for commercializing is assumed to play a roll of comprehending surely new ideas at medical site, as well as the idea for remodeling existent products.
� As to the Universal Product Code and bar code requiring for communication, government and industry group have made efforts to diffuse so far, the stances of handling these problems differ from company to company, and have not been coped with so much (Fig. (32)). And in the Revision of Pharmaceutical Affairs Law in 2002, sales records, precise comprehension etc. of organism-derived products was required, in addition, in light of increasing needs to utilize communication technology are, urgent and firm measures must be taken towards enforcement of July 2003.
� Fair trade conference for medical instrument was organized restraining unfair business inducement by forcing to fully observe EFair competition rulesE In concrete, Business standard for rent industryEmade in 2001, subsequently Business standard for the presenceEis to be planned with a prospective goal in 2002, movement aiming at establishing normal business practice has been just started. In the future, further minute analysis for the current conditions and problems how the changes of distribution give effect on the medical care offerings systems.
� Maintenance of medical devices in medical institutions is defined in the Medical Service Law as a responsibility for the medical institutions. But it is reported that some medical institutions do not properly maintenance in practice, and others are forcing sellers of medical devices to serve as an additional service (Fig. (33)). As the background, it is said that there are some situations being hard to allow expense for maintenance depending upon the companies, comprehending current status and coping with the problems based on it must be necessary.
�Thus, fix-it of medical devices was clearly described in the revised Pharmaceutical affairs Law, further improvement of the quality of maintenance for medical devices are required.
1. Medical information technology
In the field of medical information devices, international standardization is rapidly proceeding and international standards such as ISO/TC215, HL7, etc have been establishing now. And also in the field of remote medicine, in a part of the field such as imaging for use of medicine, there are already standardization of the system and component-orientation having enabled reciprocal connections between different manufacturers.
�Under the circumstances that electronics medical charts standardized and systematized component system and information system using remote medicine, better medical services are expected to offer through more improved reciprocal information exchange in more upgraded cooperation.
Further, as standardization and systematization of components proceed, venture business which has partly good technology but can not develop large scale system become easier to participate in the field, resulting in being available for the medical institutions to utilize the most advanced function rapidly and with lowered price.
While introduction rate of order entry system into the large medical institutions with more than 500 beds is 4~5% in the US, and 2~3% in Germany, that of Japan is about 50% which may be proud as worlds leading technologies of medical information system. To offer the most advanced medical service to the people in our country, further efforts to strengthen international competitiveness of medical devices in future as well as strategic action for this technology to be accepted as international standards is requested, and the government support is also asked.
2. Home Medical Care
��Home medical care is characterized by the long period for cure and the place using devices is general household. Consequently, support system for use of devices is generally consigned to the device rentals, instead of direct maintenance by the medical institutes, with not only hardware but also software including installation, maintenance, emergency response, and taking back of devices (Fig. (34)).
� But as to the service offerings, there is a service manual with no clear regulations, so maintaining the quality of the offering services has become issues.
4. Fundamental idea of industrial policy for medical device industry
4-1 Strategic development of business operation by the companies themselves
��� The development of industries proceeds through the free competitions based on the market principle by each company, in which these ideas should be fundamentally observed in future.
Especially, in the medical device industry where they are competing internationally, it is inevitable for the companies to strengthen international competitiveness including doing selection and concentrationEof human resources, resource and capital under the strong leadership of the management stuffs, as well as doing restructuring consciousness including reform of mind, and developing strategic management utilizing technology of their own.
� Then, needless to say, all related Laws including Pharmaceutical Affairs Law, etc. shall be complied with (compliance), in addition, corporate activities must be done with the mind of corporate ethics together with being aware that medical device industry is really one supporting medical service saving human life.
4-2 Role of the country (Refer to Fig. (1))
��� Role of the country is summarized generally as follows
1. To eliminate the conditions and causes which block improvement of national systems as well as performing effectively the principle of market competitions.
2. To advance research and development in the field of private companies being hard to deal with because of unprofitability.
3.� To give priority to support by the country in view of national strategy.
�� Country should play a certain role for the medical device industry base on these ideas, the following close attention with medical devices must be paid in that case.
(1) Medical devices vary substantially with the maturity of products and growth potential of the market depending on the field involved, consequently, the necessity and orientation of research and development vary, accordingly the technical field of research and development diversify variously including chemistry, engineering and biology, etc.
(2)�As medical devices require clinical trials before marketing, understandings and co-operations of not only medical institutes and medical stuffs but also the people in general are inevitable.
(3) Medical devices often have a great influence on the life and health of the people, it is essential to be regulated by the Pharmaceutical Affaires Law, etc. so as to secure its quality, efficacy, and security, as well as stable supply and information offerings.
(4)�Further, it is necessary to take measures of constructing new regulatory systems in view of not only securing the safety for products but the Esafety for useE
(5)�As medical devices are assessed in the framework of medical treatment fee system, market does not necessarily mean complete free competition.
(6) For the proper use of medical devices, unification of information offerings by package insert, and standardization of instruction are necessary, in addition, sometimes training of usage for the doctor, nurse and clinical engineer, etc. are requested including maintenance for repeated use.
(7) Thanks to the recent progress of science technology, research and development using human tissues and cells has made a progress, consequently more considerations on confirming the donors intention and ethics have been requested.
These characteristics are indispensable hurdle to contribute upgrade of national health and medical care, it is true that these hurdles are heavy burdens on each company. Especially various regulations by the government itself should be always fully paid attention whether these regulations are minimum one to attain the goal. In the future, it is important to make an effort to get over these hurdles together with effective cooperation between the government and industry and to make use of the merits at their stances, regardless of the scale of the companies.
4-3 Establishment of Intensive Period to Promote Innovation and Implementation of the Policy
� The measures assumed to be taken by the country based on these arrangements, while promoting innovation which is driving force of the industrial development, on the other hand, emphasizing an Intensive Period for Promoting InnovationEfor the next 5 years, in view of promoting proper use of medical devices, necessary measures are to be taken according the plan by steps.
As conditions and problems of the medical device industry have not been analyzed so far, basic data are not sufficient. Thus, the Welfare and Labor Ministry should continue to make an effort to comprehend and analyze the problems from now on, and revise the Vision of Medical Device Industry based on the results, as well as take the measures to strengthen international competitiveness.
5. Concrete Measures to take during Intensive Period for Promoting InnovationE(within 5 years)
5-1 Strengthening Efforts and Promotion by the government
(1) Comprehensive Measures by the entire government
To improve the standards of public health and medical care, environmental considerations for developing the most advanced medical devices, as well as development of the system for accessing these devices by the people are needed.
In addition, the government role to play is essentially important for strengthening international competitiveness of the medical device industry, so it is important to strengthen and promote comprehensive and strategic efforts by the government.
The system for promoting Science and Technology Administration in a comprehensive manner has been established, including establishment of general council on Science and Technology through the reorganization of central government ministries in Jan. 2001.and biotechnology including medical device related technology is the one which gives great impact on the national life and economy, accordingly its industrialization has become an urgent issue in our country in light of many foreign countries having made national efforts vigorously. In response to this, BT Strategy ConferenceEwas established in July. 2002, under the control of the prime minister to design comprehensive strategy and help biotechnology contribute to the society as well as strengthen industrial competitiveness. Thus scheme for the Biotechnology Strategy was wrapped up in Dec. 6, in the same year.
In addition, Strategy Conference of Intellectual propertyEwas established in Feb. 2002 under the control of prime minister, outline of the scheme for improving intellectual property system was put together in July, which may seriously affects on the development of medical devices, in response to this, fundamental law for intellectual property came into effect Dec. in the same year, thus strategic head office for intellectual property was to be established.
Further comprehensive and flexible countermeasures by the government are demanded so as to implement the rapid and firm support in response to the drastically changing international environment. Ministry of Health, Labor and Welfare wishes to tie up and cooperate with other competent administrations such as ministries and offices concerned, as one of the members of the government, together with making utmost efforts to focus on the concrete measures actively in the presiding authorities as follows.
(2) Active efforts in ministries and offices concerned
1. Protection for intellectual property
As the patent system protecting intellectual property is vitally important for the medical device manufactures, it may have great influences on the development of medical devices, depending upon how it works.
At present, invention of medical practice such as cultured skin in regenerative medicine can not be patented because it is the invention of methodEin interpretation of patent law. Under such circumstances, it is requested that patent right should be given and protected in light of promoting research and development and industry, as intellectual property, further discussions are required.
2. Environmental considerations for promoting research and development of the companies
Supporting budget for national research and development is arranged by the Council for Science and Technology at budgetary request with a view to avoid an overlap of each budget of ministry, many people criticize that the county does not perform consistent suitable support (supplementary service) for research and development, and also commented each ministry should have an opportunity to tie up each other.
In light of these criticisms, strategy consortium of medical technology industry was established in Mar. 2001, (Head office belongs the Council of Japan Medical Device related Group Association), and related three ministries (Ministry of Labor, Health and Welfare, Ministry of Economy, Trade and Industry and Minister of Education, Culture, Sports, Science and Technology) participated in as the observers, with concrete active items of proposal on project including 1. Enlightening social recognition about the role of medical device industry. 2. Deepening the technological strategy for fostering venture business, etc. 3.Selection of the field desirable to tie up between industry, government, university and medicine. To support these activities and strengthen the measures for the development of medical device industry, together with the cooperation of ministries and offices concerned are required from now on (Fig. (1)).
3. Upgrading education and fostering staffs
Needless to say, research and development should be done subjectively by individual companies according to their strategy, on the other hand, the role of administration to improve research and development basis is not small. Though either knowledge of medicine and engineering is necessary for developing medical devices, progress of fostering medical and engineering staffs are inefficient in our country comparing that of the US where medical device engineering and clinical engineering have been established already as one of the field of engineering. In addition, distinguished specialist on statistics and immunology are needed so as to commercialize the developed medical devices rapidly. In the future, fostering staffs at each stage of under graduate school, graduate school and society is a big theme, but also enhancing flexibility of person-to-person exchange so that new idea should be brought more easily into this industry is important.
4. Environmental considerations for supporting venture business
In the medical device industry with high risk on development of research and development, the role of venture business is important, especially at the beginning stage of research and development. In the US, venture businesses bear the burden of risk for research and development, playing an important role in commercializing the medical devices. While in Japan, venture businesses have not enough performed because many venture business are coming from finance or security related companies with the attitude avoiding investment with high risk, and seems to be insufficient fostering of angel (individual investors) in spite of the environmental considerations including angel tax system. And then, the risk when the venture business goes bankruptcy is quite different between Japan and the US, living house and cost of bringing up family members are to be guaranteed in the US, on the other hand, the risk accompanied with challenge is very high to the extent that entrepreneurs shrink from challenge, are pointed out in Japan. It seems that if high risk of business promotion can be reduced a little, venture business will play more important role in Japan.
Upgrading the system is now proceeding through learning the environmental considerations of venture finance in the US, being prepared all the menus of the systems (Fig. (2)). Nevertheless, it is designated that enforcement period was 20 years behind the US, including operation and the contents such as supporting scale, etc. is not efficient. Needless to say, it is true that venture business itself should make an effort to become more attractive as an investment grade corporate, environment where the venture business can run the business expected to be considered by the administration.
5-2 Ideal Support with priority in Specified Field
(1) Necessity to give priority for support
Necessity for Support with overriding priority here are a large variety with medical devices, even among similar medical device manufacturers, environment around the companies is different each other. Consequently, it is true that implementation of improving common basis is necessary, so support with overriding priority in specified restricted field is necessary to utilize the limited resource and capital effectively, as well as realizing to develop innovative medical devices.
(2) Idea of selecting area with priority
Following 3 items are defined as the field with priority
1.Research is to be at the stage of utilizing the results from fundamental research to practical application
2.Products belong to the field of low maturity
3.The field is to be expected to expand in future
The reason for these standards is as follows.
Though the object of research expenditures with medical devices by the Ministry of Health, Labor and Welfare is focused on basic research so far, recently they concentrate the study of application including
To promote basic research which forms the basis of the development of medical devices is important, in the long run, in light of the use by people in general through medical institutions to support research, etc. with priority is required for the research to lead to practical application.
And in the field where product maturity is low and also technological innovation is still hard and rapid, extending the market share is possible through substantial technological innovation to enhance the effect of treatment, it is thought that participation in the competition of research and development is possible to some extent in the future.
In addition, now that the country supports, more focused support should be given to the field where necessity for medical care and medical needs for the patients are high. And as this industry, there is a possibility to expand the market share drastically by new technology and management strategy in the field where increasing needs are expected including the market for medical devices or instruments for the old and medical devices with little stress for the patients.
The field satisfying the above conditions in concrete is considered to be the devices including the ones using medical technology of regeneration medicine, cardiovascular medical devices and treatment devices with low stress and bio-imaging devices and automatic diagnostic appliances for helping medical checkup
Accordingly, it does not mean that strengthening international competitiveness ca be achieved not only by limited national investment for research as a matter of course, but also by an influx of money such as private money, etc. is indispensable, involving planning and promoting the field with priority together with the cooperation between industry, university and the government, is required.
5-3 Action plan for Strengthening International competitiveness
(1) Support for Research and Development
To aim at developing innovative medical devices by promoting efficient and effective use of national subsidy for research and development together with considering to enhance the motivations for the system of research and development of the researcher and companies.
Additionally, to aim at developing products with high international competitiveness by promoting to apply basic technology being rated highly in the world to medical field, together with our excellent engineers from engineering field engage in the research and development of medical field.
1.Discussion on an effective allocation of the subsidy for research and development, such as national welfare, labor, scientific development.
To discuss an effective allocation on the selected field is to be focused from the standpoint of supporting industrializing.
2.Promotion for technology transfer and industry-university-government alliance.
Establishing Technology Licensing Organization (TLO) which transfers the results from research and development of national experiment and research institute, etc. to the industries.
Utilizing the consigned research business on Byedoll System.
Utilizing the research expenditure on condition of the cooperation between industry, university and the government.
3. Clarification of the treatment of medical related patent
To Clarify the treatment under the patent law concerning new technology including method of skin culture regarding regeneration medicine and gene therapy and the way of dealing with cells.
4. Intensifying cooperation between medicine, engineering, and pharmacy.
In the national highly specialized medical care center, etc presided by the Ministry of Health, Labor and welfare, measures to establish the department for cooperation between the specialists of medicine, engineering and pharmacy have been discussed and played a role as model hospital which promote the research and development of advanced medical devices as well as clinical applications.
To promote establishing ME department (Medical Engineering) in the medical institutes, as the bases of the bridge between industry and medicine in the medical institutes, including education, research, treatment support for medical devices through matching seeds and needs in the daily cooperation.
To examine on the allocation with priority with of subsidy for Welfare, Labor, Research Expenditure on the research and development carried out by the alliances between medicine, engineering or medicine, engineering and pharmacy.
5. Promotion for introducing advanced technology of other industries to the field of medicine.
To hold periodical exchange forums aiming at exchanging information between the industries including other industries (electronics industry, etc.) and medical staffs.
6. Support for the research and development of treatment devices with high risks
��� To study with clarification of the scope of liability with the company supplying accessories under the Product Liability Law, concerning the treatment devices with high risks, being slow in developing speed in our country.
7. Promotion for the development of eco-friendly medical devices
To promote the development of eco-friendly medical devices on the occasion of disposing.
(2) Promotion of clinical research, etc. after clinical trials
��� To promote rapid commercialization in our country by establishing the executive system of clinical trials, in consideration of the environment surrounding medical devices such as characteristics of large items small scale production, and Good Clinical Practice which is different from drugs.
To deepen national understanding with clinical trials, after securing the safety of medical devices through upgrading consulting function of clinical trials, together with enabling rapid marketing with innovative medical devices.
1. Organizing large-scale net work for clinical trials
� To organize large-scale net work for clinical trials consisting of national highly specialized medical center, advanced treatment hospital and designated clinical training hospitals, etc. by type of diseases in the coming 3 years, then to promote industrializing and putting medical devices to practical use.
2.Promotion for upgrading executive systems of clinical trials in the medical institutions.
Environmental considerations for promoting utilizing Site Management Organization (SMO) and Clinical Research Organization (CRO).
Referring to the Clinical Related Coordinator (CRC) contributing to the betterment of quality for clinical trials, to foster CRC who is able to cope with clinical trials of medical devices more efficiently.
To promote expansion or enlightenment and instruction for the staffs in charge of clinical trials such as staffs in the medical institutes.
To realize further integration of the source in doing clinical trials, such as facilities and members for performing clinical trials, by establishing Clinical Trials CenterEso as to enhance executive function of department of clinical trials.
� To review reducing documents related to Good Clinical Practice.
3.Establishing comprehensive counseling windows concerning regulations from clinical trials to pharmaceutical application for approval.
The counseling window necessary for the procedure from clinical trials design to pharmaceutical application for approval is to be established in the independent comprehensive organization of administrative agency for pharmaceutical products and medical devices in 2004.
4. Environmental considerations for participation in clinical trials by the people.
� To consider the environment to participate in clinical trials by the people at ease through clarification of compensation with the participated person when damaged, together with upgrading informed consent.
�To promote further understanding of the people concerning clinical trials through activities of diffusion, enlightenment and public relations (holding symposium by related organizations or groups) as well as offering the practical information of clinical trials through internet.
5. Promotion for early introduction of clinical trials with doctors leadership.
(3) Improvement of the system of Pharmaceutical Affairs��
To promote rapid marketing of innovative medical devices, after securing safety of medical devices, through upgrading regulatory science and promoting international harmonization with pharmaceutical examination together with upgrading examination system.
1. To secure quantitatively sufficient highly specialized examiner
��� In consideration of the characteristics of medical devices, to increase the number of engineering related examiner in examination, together with securing plentiful number of examiners with high specialty who can respond the application of new medical devices, such as regenerative medicine expected to increase the needs, then to promote securing and improving speed, quality of examination for approval.
2.Promoting Global Harmonization in Pharmaceutical Examination through Global Harmonization Task Force (GHTF).
To promote standardization of GCP and GLP, as well as introducing approval system for medical related software, etc. required pharmaceutical approval in the US.
3. Setting up the windows to receive objection and complaint on the examination.
To set up consulting windows in the administration to receive operational problems on the pharmaceutical examination, reflecting on establishment of examination system.
4.Upgrading consultation before the approval referring to the modular examination
Referring to the modular examination by FDA, to upgrade consultation before the application for approval, and establish the system where important point with priority at the time of actual application for approval can be examined.
5.�Introduction of fast truck consultation system
��To study preferential consulting system based on medical necessity.
6.Establishing examination standard and assessment standard on pharmaceutical approval.
To establish examination standard and assessment standard on pharmaceutical approval, for the purpose of clarifying standard in the advanced field or field with many applications for approval.
(4) Appropriate assessment on medical insurance
To promote farther and rapid introducing insurance system with the appropriate price of useful and novel medical devices, together with correcting domestic and foreign price differences, and enhancing the motivation for researcher and research and development of the companies.
1. Examining the way of assessment on new medical devices.
To promote introduction of proper assessment on medical devices with new and high novelty as well as rapid introduction of insurance.
2. Study the way of assessment on medical devices in consideration of safety for medicine.
To study the way of proper assessment on medical devices in consideration of safety for medicine.
(5) Appropriate Information and Services Offerings concerning post-marketing
Safety measures of the company for post-marketing as well as upgrading and strengthening securing needed members are inevitable for reliance of the people relating medical devices and promotion of safety use.
To promote proper use for medical devices by making rules for use of proper usage of medical devices, maintenance and disposal.
And to promote efficiency and upgrading of distribution of medical devices in and outside the medical institutions, and to offer the proper messages with medical devices to medical institutions. For this purpose, it needs to foster specialist dealing with information of medical instruments.
1. Observance of proper usage
�� Support for the training system of the instruction of devices for the doctor and medical staffs supporting doctor.
Observance of post-marketing safety measures in the companies to promote proper use of devices (collecting defect information, taking safety measures and offering information).
2. Observance of maintenance and control
� To checkup at certain intervals concerning the situation of maintenance of medical devices by the third party compulsorily by introducing maintenance and checkup system, together with the observance of maintenance and control in the medical institutions.
To do research for knowing present status of maintenance of medical devices including status of using used products and waste disposals.
� To promote establishing ME department (assuming the same function as pharmaceutical department, being the control section of pharmacies) as a universal window dealing with assessment, selection, maintenance and disposal of medical devices in the medical institutes.
To promote utilizing specialists of medical devices such as clinical engineer, etc, at ME department, etc.
��To promote clarification of durable time of medical devices in pharmaceutical approval.
3. Promoting information offerings for medical institutions and patients, etc.
To promote information offerings concerning proper use of medical devices as well as proper use in the medical institutions based on offered information, through normalization of the contents in package insert, together with information offerings using IT to the medical institutions.
4. Study for newly establishing qualified MR (private qualification) adapted to medical devices.
� To promote the development of innovative medical devices by reflecting the needs of clinical sites to the development, together with upgrading to offer information of the field where special consideration for safety is required, by establishing qualified medical representative (MR) having special knowledge of medicine and engineering.
5. Correcting inappropriate trade practice such as ancillary services, etc.
��� To practice the study for knowing more detailed status of distributions.
�� To support the efforts by the Fair Trade Council for Medical Instrument.
6. Development of the medical device data base (equivalent to Device List (classifiedⅠ～Ⅲ in uniformed product code) on the Food and Drug Administration, raw material, etc. and data base from medical device information).
(6) Introduction IT into medical care
��� To promote upgrading quality of medical care and efficiency of distribution by standardizing medical information.
��� To consider the regulation coping with new type of medical care using information devices such as remote medicine, etc.
1. Promoting standardization
To realize standardization of medical terms and code necessary for sharing medical information for the maintenance of computerizing basis.
��� To consider the environment to access the reserved information from any kind of systems, together with updating the function of necessary information system as needed, by the development of standard electronics medical charts.
2. Reviewing the point of concern with remote medicine
To study the possibility enabling remote medicine under specific conditions in case of being able to offer appropriate medical services, using remote medical systems, besides the case of being difficult to do face to face treatment (remote area, isolated island, etc.).
3. Promotion for developing and utilizing IT devices contributing to the safety for medicine.
To support development of devices contributing safety for medicine, by utilizing barcode, etc.
4. Component oriented information and coping with the global standard.
At present, the study for establishing specification of component oriented information system are proceeding, together with promoting standardization for medical information system with close cooperation between the Ministry of Education, Culture, Sports, Science and Technology and Ministry of Economy, Trade and Industry, and being intended to support its diffusion and practical application in the future.
1. Promotion of enlightening activity for the people.
��� To support information offerings regarding usefulness and safety of medical devices by industrial groups.
2. Support for overseas presence
��� To improve the system of collecting and offering information concerning pharmaceutical affairs and insurance systems overseas.
3. Upgrade of the qualification of clinical engineer.
�� To upgrade the specialty of clinical engineers through establishing specialty approval system by clinical engineering association, etc.
4. Upgrading evaluation on the developer of innovative medical devices.
��� To clarify the standard of recognition by the Minister of Health, Labor and Welfare for the developer of innovative medical devices.
5. Promotion of the activities of clinical engineer.
��� To promote proper use of medical devices by further promoting utilization of the specialists of medical devices such as clinical engineers, etc. in the medical institutes.
6. Securing stable employment under the business restructuring or corporate restructuring.
To promote making efforts to prevent unemployment, secure the stable employment and support for reemployment in case of business restructuring and corporate restructuring, together with the efforts to create the safety net work for employment by the administration.