The HAL (Hybrid Assistive Limb) robot suit that I developed at a university research center can amplify, extend, and supplement the bodily movements of the wearer. The suit, in the form of a robotic exoskeleton, is equipped with sensors that pick up on the weak bioelectrical signals that are detectable when a person is about to move an arm or leg, and a mechanism allows the suit to assist whatever movement a person intends to make. The robot suit can assist walking and rehabilitation of those whose bodies are too weak to move about freely or those with physical disabilities. There are high expectations for this device, which has been the focus of attention as the world’s first cyborg robot.
In the years to come, with the aging of Japan’s population, the role played by technology will become even more important. Recognizing this, I wanted to come up with a way to help people counteract declining physical abilities so they can live more active lives. With this goal in mind, I have been focusing on commercialization of the HAL prototype that I developed at the University of Tsukuba. Based on my work there, in 2004 I established a start-up called Cyberdyne Inc. in order to advance basic research on the robot suit through use in the practical field. Cyberdyne has been moving forward with research and development aimed at commercialization, and it has established a system for mass production. Aiming for mass production has also made it possible to reduce costs for the end user of the robot suit. In order for as many people as possible to have access to HAL, a full-fledged rental system was put in place in 2010. So far 60 facilities have introduced the system, with around 160 suits now in use.
In the fall of 2010, Cyberdyne entered into agency contracts with businesses in the regions of Kyūshū, Chūgoku-Shikoku, Kansai, Kantō, and Kita Kantō, thereby launching cooperative efforts with firms in each of these regions that have the best track records in sales of equipment to medical and nursing facilities.
Six years have already passed since Cyberdyne was launched. Numerous hurdles have to be overcome to have a new product equipped with innovative technology take root within society, particularly when it involves the human body. In the case of an existing type of product or one that is similar to an existing product, the process tends to be relatively smooth because a route has already been established leading from research and development through the receipt of necessary government approvals to actual production and sales. In contrast, the hurdles are quite high when seeking to commercialize an unprecedented innovative technology.
Japan quite some time ago raised the goal of again becoming a “science-and-technology based nation,” but the goal of becoming a leader in this area is unlikely to be reached if the focus is only on generating innovative technologies. In addition to promoting research and development, it is essential to establish the sort of environment necessary to foster newly created technologies. Policies need to be devised for systems that take into consideration the development of human resources and the formation of international hubs for fostering technologies.
In this article I want to examine some of Japan’s blind spots that became apparent to me in the process of commercializing HAL.
HAL is now being sold for nursing care purposes. Government approval for it as a medical device is required in order for it to be used in therapy assisting the rehabilitation of the sick or injured at hospitals and other institutions. The path for an innovative device to receive this permission is by no means easy.
Makers of medical devices are required to carry out production and management in compliance with ISO 13485, an international standard for such devices. This includes a number of strict requirements, including the presence of an expert in the field of medical device management. In order to get our operations underway, we have had to start from square one to undertake numerous procedures, such as securing human resources, establishing internal rules, and preparing documentation.
Once we had reached the stage of applying for a permit as a medical device, after completing each of the requirements, I was startled to discover that the normal approval process centered on providing comparisons between the new product and existing ones and pointing out the differences and improvements.
In the case of a completely unprecedented type of device like ours, the approval process takes place within a separate framework under the category of “new medical device.” The Pharmaceuticals and Medical Devices Agency cannot decide to approve such a device on its own judgment; the application must be reviewed by the Ministry of Health, Labor, and Welfare and officially approved by its minister. It would be a good idea to reform this set of arrangements and speed up the process for the sake of Japan’s global strategy.
A single example serves to illustrate the situation: Japan leads the world when it comes to its electronics technologies, but it does not have a single domestic producer of cardiac pacemakers. It would not be particularly difficult to produce a pacemaker in Japan, given its high technological level. What seems to have been lacking is a combined public-private setup based on a “social business” perspective to promote domestic diffusion of these sorts of innovative products with an impact on human life premised on the analysis of potential risks and benefits.
There are countless products that appear on the market in Japan that one could easily live without, but when it comes to products upon which a person’s life or therapy may depend, the hurdles suddenly become so high that even determined entrepreneurs and companies can be unable to surmount them. It is always necessary to go through a certain commercialization process in the case of technologies that meet a social need. This involves passing through an initial pioneering period and then in the early stages making continual improvements that lead in an upward spiral toward a better product. If a major obstacle is dropped in the middle of this process, a potential social business–an undertaking aimed at addressing a social issue through an ongoing business–will be nipped in the bud. It is time for us to break away from the idea that businesses only exist to seek profits.
There are many cases we can see where practices long accepted in economically advanced countries are not introduced to Japan for many years. Why is it that those other countries are able to swiftly introduce new things in their societies? In Japan’s case, in most cases the responsibility for granting approval lies with government agencies. This leads to a tendency to vacillate because the agencies are reluctant to take responsibility in the face of harsh media scrutiny. The limitation of leaving everything in the hands of the government is becoming clear in this age where global competition is becoming more intense.
Europe, by contrast, has already entered an age of “certification branding”: Partly because each country has its own strategic outlook, there are hundreds of private certification bodies competing against each other. Users are interested in whether a given product has received this or that particular certification. Moreover, because the certification is in the private sector, the response is more flexible and dynamic when it comes to pioneering new fields. This is because the international business of a certification body will benefit from having a proven track record of offering certification that is prompter and more globally competitive than that of rivals.
Across the globe we are entering an era in which international standards and certification are directly linked to industrial development. My hope for Japan, with its declining birthrate and graying population, is that the national government will get involved in the effort to develop an international certification business with brand power for the world-class certification of new technologies.
If Japan is positioned as an international hub that helps pioneer dynamic new fields, it will come to play a key role within the world. This was the idea that led me to establish Cyberdyne as a company to undertake the challenge of pioneering unexplored fields. Six years have passed since then and we have finally reached the stage of applying for certification domestically and overseas. During this time, our progress in European countries has been surprisingly fast and dynamic.
For example, the Karolinska Institutet in Sweden, which is responsible for selection of laureates for the Nobel Prize in Physiology or Medicine, offered to provide us with all the support we need for clinical testing and the obtaining of certification in Europe. Another organization that is showing an active interest in HAL is the German certification body TÜV Rheinland, one of the most prestigious in Europe, whose president visited us personally. Such organizations have tried to get involved as soon as possible, recognizing that helping to pioneer a new field is a way to raise their own brand power and enhance their own appeal.
If our emphasis were on forming overseas partnerships, we probably would have had HAL certified as a medical device outside of Japan first. But our aim is to help build up the strength of Japan and its personnel so as to make it a country whose value the world recognizes; we are thus focusing our effort on the domestic front initially. The required scenario is for companies and researchers with the technologies that can lead to next-generation industries to be attracted to Japan, rather than flowing out to other countries. Our initiative, embodied in Cyberdyne, is the expression of a passionate desire to truly do something about Japan’s future.
Japan’s growth rate has dropped sharply. I wonder how many people are aware that around 180 new companies were listed on the stock market annually back in 2005 or 2006 but that in 2009–following the onset of the crisis marked by the collapse of Lehmann Brothers–only 19 new companies were listed. Offices of foreign investment firms are also beginning to be closed or transferred to neighboring countries. If Japan hopes to foster next-generation industries, now is the time for it to shed its old ways. Cyberdyne is doing everything it can to play a pioneering role in this endeavor. Our effort to provide society with cutting-edge medical devices equipped with robot technology still faces many hurdles, but we are continuing to focus mainly on the domestic side because we are able to sketch out a vision of a vigorous future for Japan.
Branding is important to the success of an international certification business. At the core of branding is having a system that unites the public and private sectors, as well as the necessary human resources. The quality that Japan has to offer comes down to the quality of its human resources. Specialized knowledge is important, but it is essential to also offer well-rounded education that can cultivate people with a high degree of ethics, a social consciousness, and a humanistic outlook. Japan’s precious resource of youth is shrinking. Almost no junior or senior high schools in the country have incorporated into their curricula well-rounded education that can help improve the power of human beings with strong aspirations. In order to make Japan the envy of the world with respect to the commercialization of sophisticated and innovative technologies, we must get a firm grasp on the current state of affairs and promptly undertake reforms to turn our country into a global leader that can help lead the way to the future.
The impression I get from the Japanese government and administrative bodies is that they are valiantly striving to make improvements. Even though sectionalism between government agencies poses some difficulties, I expect bolder initiatives will be taken from the perspective of overall reform. A vision for a new Japan will come into view if an international hub for fostering and developing brand-new technologies can be forged by putting in place an environment that is oriented toward making it easier for new technologies to emerge, incubating those that are created and carefully tending their youthful growth, attracting innovative technologies from other countries, and fostering the necessary human resources. What is necessary, in other words, is a process for cultivating both people and technologies. This is precisely why I established Cyberdyne in the first place.
Let me first say a word about human-resource development. The fostering of personnel in the area of monozukuri (literally “making things,” meaning skilled manufacturing and artisanship), including system development, is handled mainly at university engineering departments. There is a need to improve the level of instruction so that students can learn about highly practical product design and management of development and quality. One possible scenario would involve cooperation between industry and academia. The situation for the teaching of monozukuri is a bit troubling when compared to the medical field, where all medical professors have experience with clinical therapy. There are few opportunities for university professors, including me, to be involved with sophisticated manufacturing processes. Honestly, I have some qualms about such professors teaching courses on manufacturing in which they tell students about how they will play a leading role in “making things” in the future. Unless 20%-30% of the professors are capable of conveying highly practical information to their students, the training of the next generation of advanced technicians will be inadequate.
A crucial task with regard to the human-resource training that sustains Japanese industry is to rapidly develop training that cultivates personnel capable of opening up new paths to the future. Important to this effort is putting in place the sort of lively and stimulating environment in which these young pioneers can passionately dedicate themselves to conducting substantial research.
On top of this, if Japan aims to be a world leader in the realm of intellectual assets, rather than focus energy only on the acquisition of domestic patents, it will need to strongly advance an intellectual property strategy on the global stage, bringing together the private and public sectors, for the sake of strong patents that can definitely be utilized.
Incidentally, the international patent for HAL was recognized for its excellence by the World Intellectual Property Organization in 2005 and the Japan Institute of Invention and Innovation (21st Century Invention Award) in 2009. Moreover, because the research and development for HAL could not rely solely on engineering knowledge, we established a new scholarly field called cybernics, which combines a number of areas of study, including behavioral science, neuroscience, biology, psychology, social science, ethics, and law. Our attitude has been that if something is lacking, we will create it ourselves.
In the field of medicine there are university-affiliated hospitals. This allows medical professors and others to team up with medical students to research the causes of and treatments for a variety of illnesses, including intractable and rare diseases, and focus on developing world-class treatments and elucidations of causes. University-affiliated hospitals function as practical centers of pioneering cutting-edge medical treatments by bringing together fundamental knowledge, real-life situations, and the cultivation of human resources.
Unfortunately, university engineering departments lack the sort of access to practical fields that university-affiliated hospitals provide for medical faculties. One reason for founding Cyberdyne was my awareness that the engineering field needs to have a place where cutting-edge research can be pioneered at the same time as human resources are cultivated, while also truly contributing to society–as in the case of university-affiliated hospitals. If there is place where truly needed technologies can be developed, it is likely to generate the sort of meaningful research themes and personnel that the real world requires.
Becoming a “Foster Parent”I think that Japan has entered an era where its aim must shift from being a “birth parent” to being a “foster parent.” What I mean is that the key point is not merely the creation of technologies but the fostering of those technologies as well. Given its low birthrate and graying population, our country literally has fewer mothers to give birth to the future creators of technologies. For Japan to make great strides forward, it will thus need to not only foster the technologies that have emerged domestically, but also gather the seeds of new technologies that arise overseas and cultivate them in Japan. This will make it possible for Japan to continually gather brilliant new technologies from overseas and foster them along with domestic technologies, while at the same time steadily creating peripheral technologies. This might be described as a modern-day Cambrian period. Forging an international hub to help open up the future signifies a great transformation from a “birth parent” to a “foster parent.”
Although its approach is somewhat different, Europe has been very ambitious in creating this sort of hub. In return for the preparation of funds and provision of the necessary environment for our operations, they required us to set up a European subsidiary. The reason for this approach is that if a European country is lacking innovative technologies, it can have them introduced through the subsidiary whose creation is mandated, thereby accumulating know-how regarding necessary peripheral technologies. And by the time the relevant patents have expired, it will probably have built up a level of know-how sufficient to allow it to pursue the development of additional technologies in the same field.
An additional point that I have found surprising about the civil servants in European countries like Denmark, Sweden, Germany, and France is that they visit us in the capacity of international businessmen or -women representing their respective countries. The visiting teams have included members specializing in a variety of areas, ranging from public administration to technology, medicine, finance, and insurance. They have energetically explained to us the merits of their own country’s tax systems, comparing them to the system in Japan. And they have attempted to convince us that it would be more efficient to establish a subsidiary in Europe than to undertake research and development within Japan. There are many things to be learned from the dynamism of European countries’ initiatives based on unified efforts by the public and private sectors.
Having a dream and passion is important for research, but is insufficient on its own in the field of engineering. Another important element is to have a sense of compassion for other people. It is vital to always have in mind an image of new technology bringing happiness to people’s lives. This is the sort of mind-set that makes it possible to perceive how there are all sorts of potential research topics in one’s own surroundings. Researchers who lack a sense of compassion for others have difficulty coming up with ideas for the sort of research that can meet people’s needs. Instead, they tend simply to follow research trends on the basis of information provided by the mass media or government bodies. This approach of chasing after trends is not likely to result in pioneering research.
For much of the engineering research conducted up to now the tendency has been to start with the creation of general theories. That is to say, researchers engage in abstract thinking, where the emphasis is on theoretical elegance, and seek to put their ideas into the form of a theory. Practical problems, however, are complex, involving various intertwined issues; they cannot be handled with a single theory. In the field of engineering, which deals with systems that people use, the response to individual problems leads to general applications. Developing a technology that is suited to even just one particular user directly leads to the development of general-purpose technologies.
I will never forget my sense of surprise and joy upon seeing with my own eyes a person with a physical disability put on the HAL robot suit, which was the fruit of all our research and development, and move for the first time after a life of never being able to stand up or walk.
The number of people using the suit rose steadily, one person at a time. I was told by some that these people benefiting from the suit were exceptional cases, but even bringing happiness to a single person was of great significance. Moreover, I was certain it could become a general-purpose technology benefiting other people with similar disabilities. Currently we are earnestly cultivating the social and academic aspects of HAL under an appropriate system of administration and management through a cooperative effort that brings together university professors and government administrators, including doctors and physical therapists active in the fields of medicine and nursing.
People have long been talking about the need for links between industry, government, and academia, but I have proposed and implemented a new cooperative system in which the three sectors also interact with the end users. By having the product’s users involved at the stage of fundamental research, we can get them to test the results of our innovative efforts and use the feedback to make further improvements.
Throughout the research and development of HAL, which at all times involved input from people facing various problems, more than just technical prowess and knowledge were displayed: There was also a human power exerted that consisted of such elements as compassion for other people, a humanistic mind-set, a sense of responsibility, willpower, and the effort to assist each other in moving the project forward. The experience underlined how crucially important it is to have a set of arrangements for the balanced growth of technologies that involve a variety of fields in such a way as to serve society, along with a system for the development of human resources providing balanced growth through comprehensive, holistic education.
I would note that in the context of our effort to advance research and development, we have set up a cybernics ethics committee and have also received approvals from the ethics committees of various organizations.
On a somewhat different topic, I should also point out that in Japan, unfortunately, there are almost no examples of education that places an emphasis on the nation or the community. It is essential to have a system of education that fosters people’s sense of affection for others, their families, their communities, and their country so that they can understand how communities and nations can sort out their difficulties and get along with each other. Such education can foster the type of person able to act on the basis of a philosophy that recognizes how everyone exists and acts within some sort of organization.
In Japan, however, partly in reaction to the prewar and wartime national educational system that inculcated patriotism, people have shunned the idea of teaching children to love their country. Perhaps for this reason, there has been a tendency to jump from the idea of affection for the individual all the way up to talk of the importance of world peace. What has been lacking is an emphasis on the importance of considering the surrounding community. Valuing the community is a key part of beginning one’s research from a sense of affection for other people. Meaningful research is likely to increase when more researchers adopt this mind-set.
As for what fields may offer Japan’s researchers the chance to undertake cutting-edge work, assuming there is a future for Japanese scientific technology, I would say that the opportunities will be found in medicine and nursing, not military research, because Japan is one of the very few countries on the planet to have renounced war and committed itself to peace.
Today’s economically advanced countries are all more or less trending toward lower birthrates and a graying population. The era of mass production premised on increasing populations and social prosperity has come to an end. My view is that developing technologies specifically suited to the diseases or disabilities that individuals face is precisely how Japan will be able to open up a path toward being a true leader in scientific technology. Finally, it is worth emphasizing yet again how essential it is to build up a hub for human-resource education so that new-born technologies can be cultivated in Japan.
Translated from “Robotto sūtsu HAL: Kaihatsu jitsuyōka e no butaiura,” Chūō Kōron, March 2011, pp. 78-85. (Courtesy of Chūō Kōron Shinsha) [March 2011]