Points of View Acceleration of Digital Medicine Development in Japan -Human resources and places that embody clinical needs

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Junya Tsujii, Senior Researcher, National Institute of Biomedical Innovation Policy

1. Introduction

Digital health, which involves involvement in health from daily life, is gaining prominence as a new medical modality, as the traditional focus of medical care and healthcare expands from treatment to the entire life course, including prevention and prognosis. In Japan, various solutions are being developed and used, including not only digital health, which is a health promotion tool mainly for general consumers, but also digital medicine, which measures the effects of pharmaceutical treatment, and digital therapeutics (DTx), which provides therapeutic interventions. The development and use of various solutions such as digital medicine and digital therapy (DTx), which provide therapeutic intervention and measure the effectiveness of treatment through continuous collection of health care data, is progressing. However, the Council for Medical Device and Healthcare Development, which was established to promote and commercialize the development of new medical devices and healthcare, has pointed out Japan's low competitive advantage in wearable devices and sensing devices, which are closely related to digital ^health2). Furthermore, as mentioned by the author in Policy Research Institute News No. 64 (November 2021), Japan's development in terms of clinical trial trends for digital medicine is currently not in a leading position over other ^countries1).

Amidst these challenges, in May 2022, the "Basic Plan for the Promotion of Research, Development, and Dissemination of Medical Devices to Improve the Quality of Medical Care Received by the Public (hereinafter referred to as the "Basic Plan")" was reviewed with the aim of promoting the research and development and dissemination of innovative medical devices including digital ^devices3). This is Japan's first document dedicated to medical device policy, which was approved by the Cabinet in 2014. The Second National Basic Plan, which was recently revised in light of changes in the environment, such as the global spread of the new coronavirus and the emergence of Software as a Medical Devices (SaMD), provides the following three elements for the promotion of medical device R&D: attractive "human resources," "places (such as medical institutions that conduct R&D on medical devices)," and "funds" in order to promote R&D of medical devices in Japan. The Second National Strategy aims to create an environment in which Japan can secure attractive "human resources," "location (places and opportunities for medical institutions to conduct medical device R&D)," "funds," and "information" in order to promote medical device R&D. This paper focuses on "human resources" and "location," which are essential for accelerating the development of digital medicine in Japan and must be addressed from a medium- to long-term perspective, and discusses Japan's challenges and possible measures, taking into account the current situation in Japan and overseas. Please note that this article is written with digital health with clinical evidence (hereafter referred to as "digital medicine") in mind.

2. digital medicine development and start-ups

In Policy Research Institute News No. 64, the author reported on global clinical trial trends in digital medicine (mobile apps, games, and Virtual Reality/Augmented Reality). ¹⁾ This time, under the same search conditions, the author reported on global clinical trials of digital medicine (mobile apps, games, and Virtual Reality/Augmented Reality). This time, under the same search conditions, the data coverage was all the information listed in the International Clinical Trials Registry Platform (ICTRP) provided by the World Health Organization (WHO) as of April 15, 2022, and the primary sponsor (primary sponsor), secondary sponsor (secondary sponsor), and primary sponsor (primary sponsor) were included in the data. The ^results4) showed that 212 companies (duplicates) were involved (Fig. 1a)). Of these, 124 (approximately 60%) were companies that are involved in the development of digital medicine on their own (hereafter referred to as "digital medicine-related companies"), with a particularly high involvement as primary and secondary sponsors (Figure 1b)). In addition, when we looked only at digital medicine-related companies (124 companies) and surveyed the year of establishment and clinical trial registration, more than 80% of the companies were established in 2000 or later (Figure 1c), and approximately 60% of the clinical trials were registered within 5 years of establishment, and approximately 80% if the registration is expanded to within 10 years of establishment (Figure 1d)). (Figure 1d)). The U.S. accounted for half of the nationalities of digital medicine-related companies, while Japan accounted for 4% (Figure 2a)). In the U.S., in particular, many companies located in Silicon Valley/San Francisco Bay Area and Boston were involved, indicating that many innovations are being created from the two regions with a high presence in the life science area (Figure 2b)).

In addition, for the U.S. and Germany, which have the highest number of DTx approvals/licenses, we surveyed the year of establishment of DTx development companies and found that the majority of companies were established after 2000 (34/35 companies, Figure 3a)). The median (median) time from company establishment to approval/licensing was 5 years in the U.S. and 6 years in Germany (Figure 3b)).

Currently, there is no unambiguous definition of a start-up, but a research report published in July 2021 by the Japan Science and Technology Agency (JST) defines a start-up as "a company that was established in 2000 or ^later7). With this as a reference, it can be said that startups play a major role in the development of speedy digital medicine (including DTx).

In addition, it should not be forgotten that innovative technologies originating from academia play an important role in the creation of startups. In the aforementioned DTx development companies in the U.S., 13 out of 19 companies had academia-created technologies as the starting point for their ^startups8). For example, Welldoc, which received regulatory approval from the U.S. Food and Drug Administration (FDA) in 2010 as the world's first DTx, originated at the University of ^Maryland7), and Akili Interactive Labs, which received FDA regulatory approval as the world's first game-based digital therapy, was ⁹⁾ Akili Interactive Labs, which was the first in the world to obtain FDA approval for a game-based digital therapy, was founded based on research results at the University of California, San Francisco. HelloBetter, a German company with multiple DiGA (German for digital health app) approvals outside the U.S., conducted research at Leufana University ^Lüneburg10), and Australian company ResApp Health, an Australian company that partners with a number of pharmaceutical companies, including Janssen Pharma and AstraZeneca, originated from research at the University of ^{Queensland11)}, suggesting that academia is contributing as a source of new technologies.

3. efforts of each country to accelerate the development of digital medicine

3-1. human resources

As start-ups play a major role in the development of digital medicine, it is important to develop the "human resources" that will play a central role. To begin with, we surveyed the efforts in each country to develop human resources that contribute to innovation in digital medicine. The human resources required for start-ups vary depending on the stage of development, but this paper focuses on "human resources who can identify clinical needs and lead from R&D to commercialization," which is mentioned in the second basic ^{plan3), 12)}.

1) Academia-led initiatives

In the development of medical devices, including digital medicine, the "Bedside to Bench to Bedside" approach is mainly used, starting from the needs of the medical field and ^patients13). In this process, "design thinking" is used as a thinking method to quickly explore needs and create optimal solutions. Design Thinking is an approach that identifies the essential issues facing a product or user, develops a solution in a short period of time, and then proceeds to solve the issue through repeated revisions based on feedback from the ^user14).

Biodesign, a program to develop human resources for innovation based on design thinking, was launched at Stanford University in 2001, and programs specific to digital health (Biodesign for digital health and Building for digital health) have been prepared15). Stanford Biodesign targets students and working professionals, and the "Biodesign Innovation Fellowship" for working professionals provides a 10-month curriculum that includes a needs assessment and screening (IDENTIFY) concept. The "Biodesign Innovation Fellowship" for working professionals is a practical, project-based program that teaches a series of processes from needs identification and screening (IDENTIFY), concept generation and screening (INVENT), strategy development, and business planning (IMPLEMENT) through a 10-month curriculum (Figure 4). The program is characterized by its emphasis on innovation generated from "diversity," with members of different specialties (medicine, engineering, computer science, business, etc.) and attributes (race, gender, etc.) forming ^{teams16), 17)}.

Many innovations have emerged from this one-stop program, and 53 health tech companies have already been ^{established18)}. Major examples are shown in Table 1. For example, iRhythm Technologies, founded by a 2005 student, is developing a wearable system to assist in the diagnosis of ^{arrhythmia19)} and has grown to a company with a market capitalization of approximately US$4 ^billion20). CALA Health, founded by a 2012 student, is working on a wristband medical device that offers a new treatment for essential tremor, and has received FDA ^approval21).

In addition to Stanford University, the University of California, San Francisco offers a global entrepreneurship program that has welcomed more than 300 diverse students from five ^{continents22).} In addition, Harvard University offers a project-based program (Healthtech Fellowship) for graduate students and working professionals, from observation of clinical needs to innovation ^{implementation23)}. Although this program was launched as recently as 2020, it has attracted participants from a variety of backgrounds, including physicians, engineers, and business development managers from medical technology manufacturers.

Thus, many universities in the U.S. offer their own human resource development programs. However, what they all have in common is that they emphasize diverse specialties (medicine, engineering, etc.) and attributes (race, nationality, gender, academia/company, etc.) in their efforts to develop innovative human resources. The creation of innovative innovations requires ideas and technological applications that are not an extension of the present, and diversity of human resources will be an important factor in attracting such innovations.

In the U.K., each university has been focusing on human resource development to accelerate digital health innovation in recent years. The University of Oxford has established a graduate course called "Applied Digital Health" from the 2022 academic year, offering early- and mid-career professionals, including those from overseas, the opportunity to learn the knowledge and skills that will contribute to digital health development from the ground ^up24). In addition, several other universities offer their own full-time programs, including the University of St. ^{Andrews25) and the} University of ^Bristol26). Many of these programs are long-term, lasting one year or more, and are distinctive efforts to develop human resources specialized in digital health development.

2) Government-led initiatives

On the other hand, there are also cases where the national government takes the lead in human resource development. In Singapore, government agencies such as the Economic Development Board and the Agency for Science, Technology and Research (A*STAR) play a central role in the establishment and operation of the program. Since its inception in 2010, 59 projects have been funded and an additional 16 start-ups have been established ^. In a small nation like Singapore, human resources are regarded as a source of national growth (human capital), and the government is actively involved in their development.

In the UK, Health Education England (HEE), part of the National Health Service (NHS), is playing a central role in a program (Topol Digital Fellowship) for medical professionals (doctors, pharmacists, nurses, etc.) to develop digital solutions to solve organizational issues (clinical needs). The program (Topol Digital Fellowship) is offered to healthcare professionals (doctors, pharmacists, nurses, etc.) to develop digital solutions to organizational problems (clinical needs ⁾²⁸⁾. This program was born out of a document on building a healthcare workforce strategy in the UK (The Topol Review: Preparing the healthcare workforce to deliver the digital future, published in February 2019), which was compiled on behalf of the Minister of Health and Social Care. More than 100 people have been selected since the start of 2019, and through specific ^{project-based30)} support, the workforce is being developed to embody digital innovation.

3) Public-private partnerships

France has been implementing a policy called French Tech since 2013, which aims to create innovations originating from France by bringing in talented human resources and investors not only from their own country but also from around the world through cooperation between the public and private ^sectors31). In 2021, France will also publish a "Digital Health Acceleration Strategy" to strengthen national support for the creation of innovative digital health from ^France32). Here, we would like to mention "STATION F" as a distinctive public-private partnership ^{initiative33)}.

STATION F is the world's largest startup campus located in Paris, and was established in 2017 with private funds from Xavier Niel, founder of Iliad, a major French telecommunications ^company34). In addition to approximately 1,000 startups, venture capitalists, and partner companies, the campus is home to the French Tech Mission, a team of representatives from the French government and a diverse group of public and private sector players. ³⁵⁾ STATION F's human resource development STATION F's human resource development measures include the FOUNDERS PROGRAM for early-stage startups, the FIGHTERS PROGRAM for entrepreneurs from difficult backgrounds such as immigrants/refugees and low-income people (free one-year training), the Female Founders Fellowship for female entrepreneurs, and the FemTech Fellowship. Fellowship" for female entrepreneurs, and the "FemTech Program" dedicated to FemTech ^{entrepreneurs36)}, and more than 30 unique entrepreneurship programs.

STATION F has set "building diversity" as one of its values, and as described above, it is promoting measures to foster a variety of human resources. The active support for foreign talents and female entrepreneurs has been successful, with 1/3 of STATION F residents coming from outside ^France37) and 45% of the startups being female-led. In addition, residential facilities have been established for these entrepreneurs (over 4,500 people in total), and the aim is to create innovation through the chemical reaction of diverse human resources.

In Australia, efforts are also underway to promote digital health services based on Australia's National Digital Health Strategy, which was approved in ^201738). The document sets seven strategic priorities to be achieved by 2022, one of which is "a thriving digital health industry that delivers world-class innovation." As the entire nation promotes the use of digital health, the public and private sectors are working together to develop the human resources that will play a central role in its development.

As in the United States and other countries, Biodesign Australia provides practical, project-based programs for entrepreneurs and researchers of various specialties who are seeking to innovate in digital medicine and other areas of innovation. ³⁹⁾ Biodesign Australia networks five programs across Australia ⁽ Perth, Melbourne, Sydney, Adelaide, and Brisbane ⁾ to share resources, instructors, and best practices. Australia is unique in that it networks five programs across Australia (Perth, Melbourne, Sydney, Adelaide, and Brisbane) to share resources, instructors, and best practices to provide a high quality experience for participants. Academia (University of Western Australia, University of Sydney, etc.) plays a central role in the operation of the program, while business, medical institutions, government agencies, etc. are also named as partners, which can be said to be a collaborative effort between the public and private sectors to develop human resources. In the iPREP (Industry and PhD Research Engagement Program) Biodesign for PhD students, academia and industry collaborate to provide training based on ^biodesign40). Industry can benefit from the employment opportunities for talented students who have learned various skills in this program, and it also serves as a source of innovative human resources for companies.

On the other hand, there are also multi-country initiatives. The European Institute of Innovation and Technology Health (EIT Health), an agency of the European Union (EU), connects more than 150 business, research, and education organizations (academia, companies, government agencies, etc.) across the EU with startups. The EIT Health supports the realization of digital innovation in ^{healthcare41)}. In the area of education, EIT Health provides educational programs for entrepreneurs, medical professionals, and others in cooperation with various players in industry, government, and academia in response to activities designed by EIT Health. Entrepreneurship education as well as practical programs based on issues raised by pharmaceutical ^companies42), and in the four years since 2016, more than 40 products have already been put on the market. In addition, the company has hubs in eight EU regions, including Germany, and each hub offers its own educational programs. This is a distinctive measure that aims at both "starting a business" and "creating high value-added solutions.

4) Summary of efforts in each country

Table 2 summarizes each country's initiatives for human resource development. While various initiatives are underway in each country, the author would like to highlight "securing diverse human resources," "practical project-based support," "providing specialized programs for female entrepreneurs, medical specialists, etc.," and "human resource development through collaboration (networking) throughout the country/region" as key points.

3-2. location

As with pharmaceuticals, in the development of digital medicine, it is necessary for various players to collaborate with each other to nurture the seeds of innovation. Figure 5 shows an example of the development flow of digital medicine. The author believes that the establishment of "a place for matching clinical needs and technology seeds" and "a place for verification and validation" is indispensable to ensure that this flow can proceed quickly and reliably. Next, I would like to take a bird's-eye view of efforts in each country related to these "places.

1) Matching of clinical needs and technology seeds

As Paul Yock, founder of Stanford Biodesign, states, "A well-characterized need is the DNA of a great invention," a clear understanding of clinical needs is the starting point for the creation of superior digital medicine. Matching clinical needs with technology seeds is the most important process in development. Clinical needs are most effectively obtained through observation of medical sites, and Stanford Biodesign spends as much as 30% of its time in the entire program observing medical sites, identifying unmet clinical needs, and then developing technology ^seeds43). The Earl E. Bakken Medical Devices Center at the University of Minnesota in the U.S. coordinates the development of technology seeds that match clinical needs by identifying clinical needs through collaboration between medical institutions and companies, and by providing prototyping facilities to promote the verification and development of technology seeds. ^44).

In addition, ^{in the ecosystem46)} formed in various parts of the world, the matching of clinical needs and technology seeds through interdisciplinary collaboration among academia, companies, and medical institutions is accelerating.

In the "Medical Alley" in Minnesota, the "Silicon Valley of Healthcare," more than 1,000 medical-related companies, including top medical device manufacturers, as well as industry, academia, and government players such as the Mayo Clinic, one of the best hospitals in the US, the aforementioned University of Minnesota, and government agencies, have started up start-ups based on clinical needs. are supporting the development of startup seeds based on clinical ^needs47).

Germany also has a digital hub (de:hub), an initiative of the German Federal Ministry of Economics and Climate ^{Protection48)}. This is an ecosystem in which 12 selected regional hubs across Germany work together to accelerate digital innovation through technical/business support for startups beyond geographical constraints. Nuremberg/Erlangen and Mannheim/Ludwigshafen play a central role in the development of digital ^health49). Nuremberg/Erlangen is home to Germany's largest medical technology cluster, the Medical Valley EMN, which supports the development of technology seeds in line with clinical needs through interdisciplinary cooperation among more than 500 medical-related companies, 65 medical institutions, 80 academia, etc. ^50).

On the other hand, there are efforts to visualize the technologies held by academia. The American Association of University Technology Transfer Managers (AUTM) has created a database (AUTM Innovation Marketplace) that matches companies with available technologies created by academia, and currently lists over 28,000 ^{technologies51)}. Although this database is not a measure aimed at matching clinical needs with technology seeds, the visualization of technology seeds may be a helpful approach in terms of effective matching with clinical needs (medical institutions).

(2) Place for verification and validation

As shown in Figure 5, rapid verification of technology seeds at medical institutions is necessary to materialize clinical needs. Therefore, the development of appropriate demonstration and verification sites is an important factor that will accelerate the development of digital medicine.

Mass Digital Health, a comprehensive public-private partnership launched in January 2016 in the U.S. state of Massachusetts, is an ecosystem of about 350 digital health companies, 79 medical institutions, academia, and research institutes, etc. One of Mass Digital Health's signature initiatives is the Sandbox Program, which provides a "place" to support the validation of new products and services ^. Nine sandboxes, including medical institutions and living labs, are widely publicized along with the characteristics of the facilities, allowing companies and others to access the appropriate demonstration and verification sites according to their ^{objectives53)}.

In addition, the Medical Valley Digital Health Application Center (dmac), part of the Medical Valley EMN in Germany, coordinates the design and conduct of clinical trials at medical institutions and validation in living labs in order to bring innovative ideas and technologies to market faster and more effectively54) ⁵⁴⁾.

In addition, although not a measure specific to digital medicine, Sweden has developed an environment called "Swedish testbeds" to promote empirical verification of digital ^solutions55). In this environment, information on testbeds (12 locations) classified into three categories (laboratory environment, simulated environment, and actual environment) is available to the public, allowing companies, etc. to easily access each testbed based on their verification objectives.

3) Summary of initiatives in each country

Table 3 summarizes each country's efforts to build a place. Various efforts are underway in each country, but the author would like to highlight "visualization of information on technology and verification environment," "extensive collaboration among industry, government, academia, and physicians," and "a coordinating function to support matching of clinical needs and technology seeds as well as implementation of verification and validation" as key points.

4. efforts in Japan to accelerate the development of digital medicine

Now that we have introduced the efforts in each country to develop human resources and establish a place for the realization of clinical needs, we would like to look at the current situation in Japan.

4-1. human resources 4-2. location

In Japan, Osaka University, the University of Tokyo, and Tohoku University have taken the lead in launching a practical innovation human resource development program (Japan Biodesign) in collaboration with Stanford University in ^201556). Several members with different specialties, such as medicine, engineering, and business, form a team and work to materialize clinical needs through externships (short-term practical work experience) at local companies in Silicon Valley and other regions, in addition to practical work from the search for clinical needs to commercialization. To date, the program has achieved a certain level of success, with eight startup companies having been established. In addition, 14 universities and medical institutions across Japan have been selected for the "Next Generation Medical Device Collaboration Center Development Project," which began in FY 1991, with the aim of developing a center for human resource development for medical device development to meet medical ^needs57). For example, at Kyoto University, corporate personnel enter the medical field and human resource development is conducted based on the practice of specific ^projects58).

In terms of fostering entrepreneurial human resources, the Ministry of Education, Culture, Sports, Science and Technology (MEXT) is taking the lead in entrepreneurship education for young researchers, working adults, etc. The Next Generation Entrepreneurship Development Project (EDGE-NEXT), which began in 2017, aims to develop human resources who can take on the challenge of starting a business or creating new businesses based on research results at universities, etc. The project has been adopted by five consortiums (24 universities) with the aim of fostering human resources to take on the challenges of entrepreneurship and creating a venture ecosystem, and more than 130 startups have been launched to ^date59). Currently, as a successor to this project, the "University-Ecosystem Promotion Type Startup Ecosystem Formation Support," which provides practical entrepreneurship education and support for entrepreneurial activities in startup ecosystem base cities (selected by the Cabinet Office in July 2020), has been launched. ⁶⁰⁾ In 2021 In October 2021, three platforms were selected in Keihanshin (lead institution: Kyoto University), Tokyo (lead institutions: University of Tokyo, Waseda University, and Tokyo Institute of Technology), and Tokai (lead institution: Nagoya University), and human resource development by providing unique entrepreneurship education is being ^promoted61).

4-2. location

1) Matching of clinical needs and technology seeds

The "Next Generation Medical Device Collaboration Center Development Project," discussed in section 4-1, also provides opportunities for matching clinical needs and technology seeds, which are key to development, in order to build an environment for medical device development. For example, the National Cancer Center Hospital East and Kyoto University have made the needs of the medical field available on their websites (Kyoto University requires user registration to view the needs), and are promoting collaboration with companies and academia that possess technological ^{seeds62), 63).} In addition, the University of Tsukuba collects problems at clinical sites and coordinates matching with corporate seeds based on clinical ^needs64). In addition, Oita University launched CENSNET in 2017 to provide a forum for the exchange of information between needs in medical and welfare settings and seeds from academia, companies, etc. ⁶⁵⁾ As of May 31, 2022, 527 needs and 42 seeds had been registered, with 21 specific In 21 cases, concrete efforts are underway.

On the other hand, the Venture Total Support Project (MEDISO) by the Ministry of Health, Labour and Welfare (MHLW) has been releasing technology seeds of startups and academia as a "Seeds Treasure Box " ⁶⁶⁾. However, it is open to members only, and its main purpose is to match startups with venture capital and existing companies.

(2) Place for verification and validation

The "Kobe Medical Industry Development Project" is probably the most advanced environment for the verification of digital medicine in Japan. As the largest medical cluster in Japan, the Kobe Medical Industry Development Project is driving innovation in the life science field in Japan, and is also providing extensive support for the commercialization of the digital health ^field67). In terms of verification and validation, eight highly specialized medical hospitals in Kobe are collaborating with companies to enable verification and validation of medical services and technologies. In particular, for companies based in the Kobe Medical Industry Development Project, the "Medical Field Innovation Program" is offered to further deepen collaboration with medical fields. In addition, the demonstration and verification is not limited to medical institutions, but also promotes monitoring and demonstration tests using more than 2,000 citizen supporters, and various other venues have been established based on the characteristics of digital health, which is closely related to daily life.

In 2020, Tohoku University Hospital will launch the "OPEN BED Lab," which will provide its former hospital bed functions to companies as an R&D demonstration field, with the aim of "demonstrating the concept in the closest proximity to medical practice with medical professionals. " ⁴⁵⁾ The Tohoku University Hospital has originally launched a program called the "Academic Science Unit," in which companies enter the medical field to search for medical needs through on-site observation, and in combination with the OPEN BED Lab, aims to create a unique development environment that seamlessly links the search for medical needs to the demonstration of medical products. The program aims to create a unique development environment that seamlessly links the exploration of medical needs to the demonstration of the technology.

Furthermore, in Japan, the use of the Living Lab as a place for verification and validation is beginning to make progress. Living Labs are open innovation activities that seek solutions to issues faced by local communities through experiments in everyday environments, and in the healthcare field, there are an increasing number of cases where citizens, governments, companies, and others are collaborating on verification ^.68) For example, in the Kanagawa ME-BYO Living Lab, the public and private sectors are collaborating to verify mental health applications and lifestyle improvement ^{applications69)}.

5. the future of digital medicine development in japan

5-1. challenges and measures in japan

As described in section 4, various measures have been taken in Japan to accelerate the development of digital medicine, and certain results have already begun to emerge. However, in order for Japan to become one of the global centers of innovation in digital medicine, there are still issues to be overcome in the areas of "human resource development" and "establishment of places" respectively. Based on domestic and international efforts, the author discusses Japan's challenges and countermeasures (see Table 4 for a summary).

Human resource development" to accelerate the development of digital medicine

As a result of various human resource development measures, the number of start-ups in Japan is expanding both in quality and quantity. However, looking at the clinical trial trends in digital medicine (Figure 2a)) and DTx development, the number of start-ups driving the digital medicine field in Japan is still insufficient compared to those in Europe and the United States. Entrepreneurship education, which supports entrepreneurship, is also currently provided to only 1% of university students (undergraduate and master's students) ⁵⁹⁾. According to a global survey on entrepreneurship (Global Entrepreneurship Monitor (GEM) (2021/2022)), Japan's entrepreneurial activity (TEA: Total Early-stage Entrepreneurial Activity) ⁷⁰ ) and entrepreneurial intentions (plans to start a business within 3 years) are low (Figure 6) ⁷¹⁾. To address these issues, the public and private sectors must work together to come up with effective measures.

First, there will be an expansion of human resource development programs related to innovation in digital medicine, such as biodesign and entrepreneurship education. In the U.S. and the U.K., each university offers its own program, but in Japan, where digital medicine is in its infancy, systematic human resource development measures are needed to expand the scope of these educational programs, which are currently limited to a few universities and institutions, and to broaden the base (number of startups). ⁷²⁾ In this regard, Australia's policy should be taken as a reference. In this case, it is important to take a cue from Australia and have leading universities and institutions play a central role in human resource development and share instructors and training processes among implementing institutions, thereby raising the level of the human resource development infrastructure in Japan as a whole, even with limited resources. In particular, it is desirable for medical and engineering faculties that are deeply involved in digital medicine development to make digital medicine development (and entrepreneurship) an option as a career path for young researchers by expanding curricula related to biodesign and entrepreneurship education.

Furthermore, it is important to provide opportunities to be exposed to entrepreneurship from primary and secondary education. In Finland, which was cited in the aforementioned GEM report as the country with the most advanced entrepreneurship education, the curriculum guidelines include entrepreneurship as one of the skills to be developed in elementary and junior high ^schools73). Japan is also aiming to nurture entrepreneurial human resources from an early stage through entrepreneurship experiences in elementary and junior high ^{schools74) and} an international entrepreneurship contest for high school ^students75), but the level of education is still the lowest among Level A countries (see Figure 6), ⁷¹⁾ and efforts must be strengthened.

In addition, in order to secure high-quality human resources, it is desirable for human resources with experience in entrepreneurship to contribute to the development of new innovative human resources in an autonomous cycle. Currently, however, Japan does not have an abundance of entrepreneurs and innovative human resources who can play such roles. Therefore, from a short-term perspective, it is important to increase the number of people who can contribute to the development of innovative human resources in Japan by actively sending human resources to excellent human resource development centers overseas. In order to promote this, it will be necessary to take measures to encourage the growth of motivated human resources overseas, such as financial support from the public and private sectors.

On the other hand, from a medium- to long-term perspective, it is essential for Japan itself to become a source of excellent innovative human resources in order to accelerate the development of digital medicine in Japan, and it is necessary to establish a center that provides more advanced and practical human resource development programs. As a base for such a center, a "start-up village" should be established, where selected promising human resources and start-ups are concentrated, based on the French policy of public-private partnership, and human resource development should be strengthened through the provision of various educational programs by senior entrepreneurs and experts from the public and private sectors. （The "Startup Village" is intended to be a complex environment that includes offices, laboratories, and residences, in addition to a place for education.) Furthermore, it is desirable to accelerate the development of digital medicine in Japan by bringing together companies, venture capitalists, government agencies, and others to promote technical and business support for the commercialization of startups' concrete ideas, thereby promoting both human resource development and commercialization of startups.

In addition, it is important to ensure "diversity of human resources" in digital medicine development, which is emphasized in many countries. However, for example, in Japan Biodesign, although a wide range of personnel with expertise, such as doctors and engineers affiliated with companies and academia, have participated, the number of women (about 17% of total participants) and overseas personnel (about 9% of total participants) ^{76), 77) is} still not large. Specific measures to create diversity include providing free office space, laboratories, and housing in start-up villages, improving the living environment for family members, and other measures to attract excellent human resources from overseas, and enhancing specialized training programs for female entrepreneurs and medical professionals. In particular, in order to increase the number of startups that are looking to expand globally, it is important to bring together a diverse range of human resources, including those from overseas, and in-person networking should be used to promote encounters between various types of human resources. We believe that intentionally creating diversity, including attributes in addition to skill specialties, will help promote the creation of innovative innovations.

Building a "place" to accelerate the development of digital medicine

In this paper, "places for matching clinical needs and technological seeds" and "places for verification and validation" were identified as important "places" for the development of digital medicine. In Japan, while there are excellent individual efforts being promoted, each activity is not necessarily closely coordinated, and startups may not be able to access the appropriate "place" due to the community to which they belong or geographical limitations.

The first step toward reducing this risk would be to expand matching opportunities through "visualization of clinical needs and technology seeds. In addition to the importance of expanding opportunities for companies to actually enter the medical field and link identified clinical needs to development, it would be possible to expand matching opportunities between clinical needs and technology seeds in Japan as a whole by registering, centralizing, and disclosing clinical needs and technology seeds held by academia and startups. This would expand opportunities for matching clinical needs and technology seeds in Japan as a whole. Although several organizations are already collecting and disclosing clinical needs and technology seeds individually, it is necessary to establish a mechanism to increase the probability of matching by linking the efforts of Japan as a whole as an ecosystem, referring to the measures taken in Germany (de:hub). (In addition, from the perspective of protecting intellectual property rights, it is desirable to establish a certain level of eligibility for access to technology seeds.)

Second, it is important to establish a system that allows domestic and foreign start-ups to easily access appropriate demonstration/verification sites that match their concepts by visualizing information through centralized management. As indicated in section 4-2, in Japan, medical institutions and living laboratories provide unique opportunities for verification and validation that take advantage of the characteristics of their own organizations and regions. On the other hand, such information is scattered, and it is expected to take a considerable amount of time and effort for a startup to find an appropriate demonstration and verification site that fits its concept. Therefore, based on examples from Europe and the U.S. (Mass Digital Health, Swedish testbeds) and Japan (Kobe Medical Industry Development Project, etc.), we believe that it is necessary to establish a system that enables startups to more efficiently and effectively encounter verification sites by centrally visualizing the information of verification sites in Japan, along with their characteristics. We believe that it is necessary to develop a system that enables startups to more efficiently and effectively meet with verification and testing sites. In addition, Japan, which is said to be the world's leading country in issues in the healthcare field due to its declining birthrate and aging and declining population, can turn the tables and create a globally attractive environment for demonstration and verification. The centralization of information will not only accelerate the practical application of technological seeds originating in Japan, but will also widely publicize Japan's attractive development environment to the world and attract excellent human resources and technologies from overseas to Japan as a place for demonstration and verification. In the future, it will be important to utilize Japan's high-quality medical technology and diverse medical environment to further expand and enhance attractive venues for demonstration and verification.

In order for the two "places" described so far to function effectively, we believe that an expert organization (assuming a government agency or a private organization accredited by a government agency) with a coordinating function is necessary. It is desirable for an organization composed of experts familiar with technology, regulations, business, etc. to appropriately coordinate the matching of clinical needs and technology seeds with a view to future prospects up to commercialization, and the bridging between startups and medical institutions/living labs based on demonstration objectives.

5-2. possible role of the pharmaceutical industry

Having discussed the development of digital medicine in Japan from a broad perspective, we would like to consider what contribution the pharmaceutical industry can make.

Acceleration of innovation by fostering corporate human resources

The most important reason for the lack of entrepreneurship in Japan is "fear of failure ^.) This is due to the fact that there is a great deal of psychological anxiety about the financial and social repercussions of entrepreneurial failure. Furthermore, considering the situation in Japan, where low mobility of human resources has also been pointed out, support for challenges while still belonging to the company, such as "in-house start-ups" and "start-ups on loan," may be one way to accelerate innovative innovation.

In April 2020, Rohto launched "Ashinniha," a project to support in-house entrepreneurs, and is supporting new ways of working that transcend organizational ^{boundaries79)}. Under the "Niha Tomorrow" program, businesses that lead to wellbeing are encouraged, and four companies have already achieved results in starting their own businesses, such as craft beer sales and online cooking classes.

On the other hand, "secondment entrepreneurship" is an initiative in which corporate personnel launch start-ups and take on the challenge of creating new businesses without resigning from the company to which they belong, and the Ministry of Economy, Trade, and Industry provides financial ^support80). It differs from in-house entrepreneurship in that the employee is transferred from the company to which he or she belongs, and more than 80% of the capital must come from outside the company. Currently, 23 companies have been established, and this is attracting attention as a new form of entrepreneurship by corporate human resources.

In order to accelerate innovation by corporate human resources, it is essential to support entrepreneurship as described above and, at the same time, to develop new skills in response to the trends of the times, such as digital technology. However, it is difficult to say that Japanese companies are investing sufficiently in human resources (OFF-JT expenses, as a percentage of GDP), as it is low at one-tenth to one-twentieth the level of Europe and the United States, and has been declining further in recent ^years81). On the other hand, on the employee side, there is not a high sense of urgency on the part of employees to acquire new skills under the lifetime employment system or else they will fall behind in competition with other companies, including global companies, and both of these issues need improvement. Against this backdrop, in September 2020, the Ministry of Economy, Trade and Industry ⁽ METI) released the "Report of the Study Group on Sustainable Corporate Value Enhancement and Human Capital: Human Resources Version Ito Report" ⁸²⁾. The report considers "human resources" as a core intangible asset (capital) that influences corporate value, and calls for companies to provide employees with opportunities to autonomously reskill and relearn in order to respond to rapid technological evolution, etc. ^{83), 84).} For example, Sumitomo Pharma and Shionogi are promoting reskilling in the digital field, including in-house open data scientist training and DX training consisting of multiple ^{programs85), 86).}

One of the roles that the pharmaceutical industry can play in the future will be to develop corporate human resources who can generate innovation, not only through external support, but also by supporting employees' challenges through in-house entrepreneurship and providing reskilling opportunities for new expertise such as digital technology.

6. conclusion

In this paper, we discuss Japan's challenges and possible measures to develop human resources who can contribute to the realization of clinical needs and establish a place to accelerate the practical application of technological seeds, with reference to domestic and international efforts. It was confirmed that excellent individual efforts have been made in Japan and that they have already achieved a certain level of success. On the other hand, he stated that in order for Japan to become one of the global centers of innovation in digital medicine, the keys are to improve both the quality and quantity of human resource development, promote the matching of clinical needs and technological seeds, improve accessibility to appropriate demonstration and verification sites, and build globally attractive demonstration and verification sites. To achieve this, in addition to expanding individual measures, it is important to remove conventional barriers between universities, medical institutions, regions, etc., and organically link efforts throughout Japan. In addition, this development environment will induce Japan to attract the world's best human resources and technological seeds and strengthen ties with overseas ecosystems, which will enhance Japan's digital medicine competitiveness with a view to global expansion.

As described above, by viewing Japan as a whole as an ecosystem, and by steadily promoting the development of human resources and a development environment conducive to the development of digital medicine through strong collaboration among industry, government, academia, and medicine, it will be possible to create a powerful environment for innovation creation in Japan, comparable to that of the U.S. and Europe. However, with persistent efforts, Japan may be able to establish itself as one of the world's leading centers for digital medicine development and a hub for human resources and technology.

In addition, while this paper focuses on "human resources who can identify clinical needs and lead from R&D to commercialization," the development of digital medicine requires human resources with various knowledge and experience specific to the life science field, such as disease understanding, laws and regulations related to clinical trials, and business strategies, in accordance with the development stage. However, the company is still in need of personnel with limited development experience to start the project. However, for a startup with limited development experience to deal with these issues on its own would lead to loss of time and cost, and increase the risk of failure. Therefore, appropriate support for startups by various players from industry, government, academia, and medicine is essential at each stage of the development flow (Figure 5). The pharmaceutical industry's understanding of the disease and its network with clinical sites can contribute to startup support. On the other hand, the pharmaceutical industry can also benefit from the latest technological information and development know-how unique to digital medicine possessed by startups. As a player aiming for innovative innovation, it is important for the pharmaceutical industry to learn and grow together.

The rapid development of digital technology will bring unexpected new services and solutions to the medical and healthcare industries, and may change the way they operate. In order for Japan to lead the world in creating innovative digital medicine that will lead to higher quality medical and healthcare services, it will be necessary to identify unmet needs and quickly create effective seeds that capture the essence of those needs. The foundation for this is the "human resources" to create ideas and seeds, and the "location" to accelerate their realization. This is not a future that can be realized by a single player alone; it is essential that industry, government, academia, and medicine work in unison. In order for Japan as a whole to accelerate such efforts, it is important to establish a policy that defines a specific vision and goals, and to strongly promote such efforts under a clear national strategy. The "Second National Strategy" is one of the pathways to this goal, but the policy should be revised from time to time in light of various social changes and technological innovations that may occur in the future. We hope that all players will work in unison to further accelerate the development of digital medicine in Japan, and that various initiatives will be promoted.

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