Losing the Lag

Rob Claar’s quest to bring lifesaving innovations to Japan

Rob Claar became interested in healthcare at an early age. Watching his father work on the government-program side of insurance and talking to him about the industry, Claar came to understand some of the issues surrounding public and private systems. But as he entered Yale University to study art history, he did not envision a career helping healthcare innovators from the United States and elsewhere bring their lifesaving drugs and devices to Japan. A twist of fate, however, led Claar to become a champion of Japanese doctors, working to connect them with international peers and innovation.

Ahead of his presentation at a March 13 luncheon hosted by the American Chamber of Commerce in Japan Independent Business and Healthcare Committees, the HekaBio K.K. founder shares his journey from childhood in Detroit to Tokyo, where he helps companies gain regulatory approval for healthcare innovations.

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An extended version of this interview is available on The ACCJ Journal Podcast or by streaming from the audio player above.

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How did you get involved in healthcare innovation in Japan?

Claar: I came to Japan basically out of cultural interest. This was in 1987. I was 23, had just graduated from college, and decided that I wanted to see Asia. I was interested in the culture, art, and language, particularly of Japan.

I forced myself not to come to Tokyo to begin with. I thought Tokyo would be an easier place to survive with English, and I wanted to push myself to learn Japanese as quickly as possible. So, I landed in Nagoya and immersed myself in studying the language. I thought I was going to be good enough at Japanese after one year to move on to my next destination and call my Japan experience a success. That didn’t happen.

I was studying Japanese at the YWCA in Nagoya, and it was going very well. But, as you know, it takes a lot of time. After one year, I was still not where I wanted to be. I gave myself another half a year, and I started really enjoying being in Japan and speaking Japanese.

Then I got a job as a Japanese-to-English translator for Brother Industries and moved into their dormitory in Nagoya. They were setting up manufacturing operations in Malaysia and elsewhere, and I was translating manufacturing and line instructions. That was interesting and a good experience but, once I got good enough at Japanese, I decided it was time to either go home to America and start the rest of my academic career or go up to Tokyo and see what I could do. I decided to move to Tokyo and was lucky enough to get hired by a think tank called Sanwa Soken.

They were essentially a research arm for the government. The day after I joined, a huge project came in from the Ministry of Health. I was put on that project and got to learn all about the healthcare system. I traveled around Japan, met doctors, and began to understand how serious they are about patient care. I really started to fall in love with the idea of the Japanese healthcare system [and] how a national single-payer system can work wonderfully.

What did you discover that led you to want to help innovators?

Claar: As I met doctors, I began to understand their struggles. They wanted to be considered among their international peers as studying, researching, and being able to speak in an international forum on the greatest innovations worldwide. But their frustration was that their research was one generation too late in many areas. I became aware of the innovation lag and wanted to see what I could do to make an impact.

I realized that Japanese doctors struggle to get their hands on up-to-date innovations from around the world. There’s a lot of talk about drug lag and loss, and the same thing is happening on the device side, where innovations that are getting approved in the United States and Europe are not making it to Japan.

There are a few reasons for this, but I thought that if I could focus on how to help these very sincere, wonderful doctors in Japan, then that was going to be a way for me to potentially make a career here and have an impact on society.

So, I left Sanwa Soken to start my own company, Junicon. We would go around and interview doctors, and we found a way to sell those results to large pharmaceutical and medical device companies in Japan, Europe, and the United States.

I also started spending my spare time helping doctors translate their papers from Japanese into English so that they were better able to speak at international conferences. It was a minor thing, but being helpful to Japanese doctors is a way that I got into things and maintained those relationships.

What’s stopping overseas companies from entering the Japanese market?

Claar: Small companies are doing more and more of the true innovation around the world, and they have no bandwidth to start thinking about Japan. So, how do we get more innovative companies to think about Japan? That’s what we’re really focused on at HekaBio, and that’s my personal interest.

Japan is far away, and these companies don’t really know what goes on here. They have this outdated image that Japan is very hard to get into and the regulatory process is super opaque. They’re never going to get regulatory approval on their own, or they’re never going to form the right commercial relationship. I think this is a really outdated image of Japan that many companies have. We’re trying to help solve that. Our doctors and their patients are waiting for these innovations. We want to see if we can bring them in and arrange the capital.

The Japanese government is doing a great job right now with new programs that they’re introducing. They’re making clinical trials easier to get started and operate in Japan, both on the drug and the device sides. They’re welcoming first-in-human studies to be done in Japan, which has not been the case until recently. They’ve eliminated the requirement to have a Japanese principal investigator on international studies. And they’re also offering pricing incentives for programs that get submitted in Japan within a certain number of days or months of the submission in the United States. In some cases, we’ve had an approval in Japan before the United States, even though we started at the same time.

How many companies have you helped get regulatory approvals in Japan?

Claar: More than 50, including at our former subsidiary unit, which was a clinical research organization called Vorpal Technologies. We’re very proud to have been involved in getting those launched and into the market.

What is that process like?

Claar: At the beginning, we do market research. We want to confirm that the doctors who we want to be behind the program are really behind it. We’ll find out who has done the presentations and who has published how many papers in that area. Who’s in the medical society? Who’s on the board? All these different things. The worst thing we could do is partner with an overseas company that doesn’t have the health economics and an appreciation for the Japan system in mind.

Once we do that, and we understand the strength of the clinical data that the company has produced overseas—and whether the Pharmaceuticals and Medical Devices Agency (PMDA) will accept it as valid in Japan—then we start talking with the PMDA to understand the regulatory process [for the specific innovation]. Once we get buy-in from the regulators, then we go forward with the clinical trial. If no in-Japan clinical trial is required, which is often the case for devices, then we can just go forward to the submission and review period, which typically takes 12 months.

Sounds straightforward. Is there something else holding back innovation from overseas?

Claar: What remains is the question of reimbursement price. If companies have no idea until the very end what the reimbursement price is going to be, then it becomes difficult for them to want to invest the time and money. So, that’s part of the upfront market research that we do. What does a comparative product look like in terms of reimbursement? What can you expect, based on your experience in overseas markets, in terms of the ability for the Japanese health insurance system to pay?

If there’s no comparative product, if it’s a new category, then you submit your cost accounting information. The PMDA really wants to see everything in a very transparent way.

What we would like to see in Japan is more clarity. New categories, where nobody knows what the pricing is going to be, is a situation in the market that most people have to deal with. I think that if the government were able to give better guidelines up front, in a consultative process, and you could go to the Ministry of Health, Labour and Welfare and tell them what you are thinking about, more of the issues around the drug and device lag and loss could be solved. But they won’t give you anything in terms of a response with any responsibility associated with it. They’ll listen and tell you yes or no, but their answer is not a promise.

Japan’s healthcare system is the best in the world. I fully believe that. And we all have the responsibility to make sure that Japan’s great healthcare system can survive. We know that the government is fearful of healthcare costs growing. They’re looking for ways to cut the costs of [things such as] long-selling drugs, devices, and in vitro diagnostic tests. But we would like to encourage them to think more long term about some of the things that can be done in terms of digital health solutions for early diagnosis of particular conditions.

What opportunities do you see for ACCJ member companies? Can they replicate the success you’ve had?

Claar: Absolutely. And I hope so. I think we’ve come up with a great business model, and we’re happy for anyone to copy it, because we think it really works for bringing innovations into Japan.

HekaBio is focused, for the most part, on pharmaceutical and device interventions for acute illnesses, hospital treatments, and serious diseases. What we’re not working on are things such as chronic diseases, which are a huge burden on the healthcare system. [Monitoring] chronic diseases with at-home digital health [tech] would also work in our business model.

If somebody wanted to exactly copy our model and go right into exactly what HekaBio is doing in serious acute disease identification and treatment drugs and devices, then be my guest. We’ll be happy to have them [replicate] our business model with no worry.

But there are so many opportunities. For example, if they want to do something different, there are many new molecular entities, particularly for rare diseases. The PMDA has a list showing the status of those that are [only] available elsewhere. So, there’s no development risk, really, because you know that it works. It’s been approved in either the European Union or the United States, but it’s not available in Japan yet. Take one of those for a rare disease, buy the rights for Japan, and get it developed. You wouldn’t even have to build a big organization with your own infrastructure here. You could be a one-person company, get the rights, and then have a contract research organization do the clinical trial and be the in-country clinical caretaker on your behalf. Get it all through and then sell it to a pharmaceutical company once it’s done. That’s another business that could be not only very lucrative, but interesting and of societal benefit for Japan.

Healthy Makeover

How are digital transformation tools changing healthcare in Japan?

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ChatGPT, that large language model that is stealing the headlines these days, may be all the buzz, but it’s just one example of how technology is rapidly changing the way we work and do business. And while the artificial intelligence (AI) bot may represent a leap forward, the deployment of digital technology across an organization’s operations has been on the rise in all industries since the advent of the World Wide Web in 1989.

Today, we call it digital transformation (DX), and it is bringing computation, Big Data, AI, other digital applications, as well as connected devices, to bear on how products and services are made and/or delivered, in industries as diverse as education, finance, and logistics.

Healthcare could also greatly benefit from these incredible advances, and the industry is undergoing its own DX revolution—including in Japan. Here, healthcare DX is gaining traction in part due to the advocacy efforts of the American Chamber of Commerce in Japan (ACCJ).

However, speaking to The ACCJ Journal, industry insiders—including members of the chamber’s Healthcare Committee—note that adoption of healthcare DX in Japan lags that of other countries, especially those in North America and Europe.

“I think the current situation is that [Japan is far behind] compared with countries such as Denmark or the United States,” said Makoto Kawai, director of government affairs at Zimmer Biomet G.K., a global medical technology company. Kawai is also co-chair of the ACCJ Healthcare Committee.

Maya Mamiya and Diogo Rau share similar sentiments. Mamiya is an associate director of global public policy for Asia at Eli Lilly Japan K.K. and a Healthcare Committee vice-chair, while Rau serves as Eli Lilly’s chief information and digital officer.

Also sympathetic to Kawai’s view are healthcare industry expert and committee Vice-Chair Eiji Sasahara, and Go Ikeda, a senior manager in the Healthcare Economics and Government Affairs Division of medical devices maker Medtronic Japan Co., Ltd.

Data Utilization

Dr. Sasahara noted that healthcare DX in Japan—especially optimal utilization of Big Data—is still low. Why? It is in large part because “operations heavily depend on manual and paper-based processes,” he explained. “It’s not easy to utilize [the] merits of digital technologies, such as accessibility, scaling, and automation.”

However, optimizing Big Data use in healthcare is important for a variety of reasons. One area where its effective deployment is critical is in determining the health outcomes of patients, the experts pointed out.

Rau identified even more areas where optimal use of DX tools can make a difference. In the case of Eli Lilly, Big Data, AI, and machine learning can be used to:

• Develop digital connectivity for clinical trials and therapeutics
• Deploy solutions to manage patient-specific digital information
• Speed up the discovery of new life-changing medicines
• Design and implement clinical trials
• Increase accessibility to and diversity of medicines
• Obtain more accurate efficacy/safety data
• Improve patient experience
• Improve the safety and effectiveness of medicines
• Manage and interpret patient data from connected therapeutic devices

Medtronic’s Ikeda agrees. “In order to link personal health records [(PHRs)] and medical information, it is necessary to build a platform and take measures to shift data ownership and management to individuals,” he explained.

“By connecting and sharing data such as PHRs and medical information, the value of medical care will be improved, allowing for early diagnosis and prevention of disease progression.”

“By connecting and sharing data such as PHRs and medical information, the value of medical care will be improved, allowing for early diagnosis and prevention of disease progression.”

To provide better healthcare while maintaining universal access, the current fee-for-service health insurance system should be shifted to value-based healthcare (VBHC), Ikeda suggested. “DX of healthcare is an important precondition for VBHC.”

Sasahara refers to this new paradigm as “citizen-centered care”—a form of healthcare that not only makes use of digital tools such as Big Data, but also puts patient outcomes at the core of the industry.

Healthy Prices

The upside of deploying healthcare DX can be enjoyed not only by patients and the private sector, but the public sector, too, the experts noted.

Government ministries and agencies—as well as the hospitals and other healthcare institutions and research and development (R&D) centers they fund—will be able to reduce costs through the effective deployment of DX strategies.

Ikeda noted: “DX will promote R&D and enable outcome-based reimbursement evaluation, supporting a reduction of medical and nursing care costs. It can also support the healthcare workforce shortage [to] benefit patients overall.”

Data Security

Improving data security is another benefit the DX revolution will confer on the healthcare industry, according to the experts. This is especially the case when securing the privacy of patient records, an area of concern many of them highlighted.

Healthcare DX, they said, should adhere to international standards of security. These standards are based on interoperability of systems and use of platforms such as cloud computing. In Japan, however, patient data is usually stored on premises and in stand-alone systems, which are not necessarily secure.

“With regard to data storage, the current mainstream on-premises, stand-alone system has increased security risks, and it should be considered that an open mechanism using the public cloud paradoxically improves security,” explained Ikeda.

Lilly’s Rau added: “Some of the key concerns include ensuring the confidentiality of this data when tied to a patient and the integrity of the data when billing and making care decisions.”

Sasahara agrees. He also noted that, in Japan, there is a lack of in-house security expertise. “It is usual that there is no [chief information security officer] at Japanese hospitals.” Kawai held a similar view.

However, this opens up an opportunity not only to acquire the necessary human resources but also to “develop and utilize emerging privacy-enhancing technologies,” Sasahara and Kawai agreed.

Securely digitizing patient records will be key to realizing the potential of healthcare DX.

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Prevent and Cure

The reach of healthcare is broad. It includes the prevention, diagnosis, and treatment of diseases, injuries, and ailments, and encompasses a wide area of professions and fields—from doctors to nurses to medical researchers—as well as facilities such as hospitals, clinics, and research institutions.

In the healthcare technology space, a few themes are emerging at the forefront. For Ikeda, three areas of particular note are:

• Grand design
• Value assessment
• Private–public partnership (PPP)

Regarding the path to implementation, Ikeda shared: “We believe that it is necessary to first illustrate a grand design for the overall picture of what the platform should be in order to realize medical DX, and then the process for building that overall picture should be presented.” It is the remit of the government, working with stakeholders across society, to provide that grand design or vision, he added.

“DX will promote R&D and enable outcome-based reimbursement evaluation, supporting a reduction of medical and nursing care costs. It can also support the healthcare workforce shortage [to] benefit patients overall.”

As for value assessment of digital health technology, Ikeda noted that this is difficult to properly assess under existing medical service reimbursement systems.

“To reduce the burden on medical professionals, as a new evaluation perspective unique to digital health technology [emerges], to equalize and improve the efficiency of technology, and to evaluate products that match the speed of product development and improvement, it is necessary to build a new evaluation system by referring to overseas cases and the utilization of non-insurance combined medical care systems,” he explained. Here, stakeholders in Japan and abroad can learn from each other.

And what of private–public partnerships? To enhance PPP, Ikeda added, it is also necessary to set up new forums for information sharing and discussion among the public and cross-cutting private sectors. “I am expecting that the ACCJ could be the hub of PPP.”

Sasahara mentioned three more trends to keep an eye on as paradigms change in the healthcare industry:

• Citizen engagement
• A shift from reactive treatment to data-driven prevention
• Utilization of gamification tech for patient care

The ACCJ Healthcare x Digital program focused on empowering elderly patients through digital health in 2022.

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Advocating for Change

To keep abreast of fast-changing developments in the industry, the ACCJ Healthcare Committee was invited in March to an event hosted by the American Medical Devices and Diagnostics Manufacturers’ Association (AMDD).

Led by Ikeda, who is chair of the AMDD’s Digital Health Committee, the event featured Dr. Kengo Miyo of the National Center for Global Health and Medicine, a hospital and international medical research and healthcare training facility located across Tokyo. Miyo is the director of the institute’s Department of Planning Information and Management.

Ikeda explained that the event was organized to realize medical DX in a situation where the environment is changing, and technology is progressing rapidly. “Cooperation among stakeholders toward a shared goal, and understanding of medical DX as a whole, are indispensable,” he stated.

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Healthy Ideas

Innovators empower elderly patients at ACCJ Healthcare x Digital Ideathon

Started in 2020, the Healthcare x Digital (HxD) initiative of the American Chamber of Commerce in Japan (ACCJ) has grown to become a key platform for collaboration among innovators, startups, entrepreneurs, and top pharma executives.

After hosting pitch events for the first two years, the first ever HxD Ideathon took place late last fall with a hybrid in-person and online kickoff at the Hilton Osaka on October 29. This was followed by two virtual sessions on November 5 and 12, then finalized by the hybrid pitch event on November 19 at the Hilton Osaka. The four-day event was inspired by the tagline “empowering elderly patients through digital health.”

Participants included university students from the United States and Japan as well as healthcare professionals and a panel of judges from healthcare fields. Their aim? To forge new partnerships and create solutions for some of Japan’s most critical challenges in community healthcare and individual patient care.

Ideathon

The 2022 HxD event was modeled on the concept of ideathons, or workshop-like gatherings of groups tasked with challenges for which they are to propose solutions. Through this model, a total of 86 ideators, facilitators, and mentors worked together through a cyclic ideation process to identify root causes and develop the next big project in healthcare.

Day one began with opening remarks by Simone Thomsen, president and representative director of Eli Lilly Japan K.K. as well as ACCJ governor-Kansai, and continued with a panel discussion and ideation in groups to define problem statements and the healthcare challenges to be tackled. Ideation continued on days two and three, when teams focused on initial designs and worked to find agreement on a solution—one per group—that was to be presented on pitch day.

The event culminated on November 19 with a pitch contest in which nine teams presented their concepts, and engaged in question and answers sessions with judges, who then selected the best ideas. The winning teams will move forward to the next phase of the competition—a hackathon—to be held in 2023.

Pitch Day

The final day was divided into two rounds during which each group had five minutes to pitch their solution to a panel of judges.

Perhaps the biggest draw of HxD is the opportunity to present ideas directly to—and receive invaluable feedback from—industry leaders. There’s also the possibility of entering into a joint venture with, or receiving investment from, an industry player.

Winners also receive cash prizes and, this time, will have the chance to present their ideas at the 2025 Osaka Kansai Expo and as part of the Japanese government’s Super City Initiative.

Let’s take a look at this year’s pitches.

Kyocare

Presented by Hiba Abulgasim, Kyocare is a digital customer-to-customer and business-to-business platform that provides flexible, personalized, quality care.

In the pitch, Abulgasim noted that 28.9 percent of Japan’s population is over the age of 65 —a record number that is growing. But the workforce tasked with caring for them is understaffed and overworked, and about 70 percent want to leave the profession.

This means care services are poorly coordinated. Many elderly people feel lonely and disconnected as a result, and family members tasked with their care feel stressed out.

The solution? Kyocare provides on-demand caregiving services for the elderly through an app that matches those who need long-term home care with nearby care workers.

Hi-Real System

A digital ecosystem pitched by Masato Suzuki and Sachiko Nakatsuka, Hi-Real System allows emergency-patient health records to be accessed by healthcare professionals even before emergency care is provided.

In their problem statement, Suzuki and Nakatsuka asked, “How do we support emergency triage when medical resources, such as medical staff, are limited?” Their solution involves a blockchain emergency information transmission service that instantly shares patient information to the hospital before patient arrival, which can then be used for smoother emergency treatment diagnosis.

Maya Mind

Osaka University Assistant Professor Gajanan Revankar presented Maya Mind, a web platform accessible via smartphones, tablets, or personal computers that targets patients who suffer from dementia. Revankar noted that, during early onset of dementia, diagnosis is time consuming and costly, while accuracy is low. Maya Mind seeks to tackle all these challenges.

The app uses eye tracking, speech processing, artificial intelligence (AI)-based analytics, and machine learning algorithms to create an index score for classifying different kinds of dementia, among other provisions.

AI Assistant

Ajinkya Takawale and Tomoko Mitsuoka pitched a voice-controlled AI assistant with a focus on early diagnosis of chronic kidney disease (CKD) and diabetes. The challenge before Takawale and Mitsuoko included how to leverage digital technologies to make the elderly more aware of their health risks through early diagnosis. Their voice-controlled robot uses non-invasive methods such as retinal imaging to track, record, and analyze an elderly person’s healthcare data. Using the results, they provide a diagnosis and help the person plan their lifestyle based on the insights.

Toilet Light Sensor for CKD

Chisato Banno and Reiko Tsubaki, both third-year students at Tokyo Medical and Dental University, also pitched a digital solution for patients at risk of CKD. Their solution offers a low-cost yet accurate Internet of Things device that samples, analyzes, and visualizes a person’s real-time health data, helping them to diagnose the onset of CKD early.

Their first prototype will use toilet-based light sensors that can analyze urine. The data gathered can be visualized via a smartphone app, which also can share data with a relevant healthcare provider, such as a hospital.

Helper-san

An avatar bot that identifies and neutralizes triggers that cause aggression in dementia patients, Helper-san is a digital platform that was presented by students and researchers Shobha Dasari, Allison Jia, Kanon Mori, Aarushi Patil, and Tsubasa Tanabe.

The students and researchers are part of a collaboration involving universities in Japan and the United States brought about by the Japan-American Innovators of Medicine, a four-month program in which medical innovators from both countries join to tackle a global healthcare issue related to dementia, such as aggression.

Their bot, which is embedded in a small, television-like device, can track a patient’s behavior, identify aggression triggers, and defuse them. An example would be dimming or turning off a light source that has been identified as the trigger.

Parapul

A web app presented by Kasper Watanabe, Parapul helps caregivers obtain the information they need, build relationships with like-minded people, and support their caregiving lives.

As the portion of society classified as elderly increases, Watanabe noted, the physical, mental, and financial burden on family members will grow, and yet such caregivers often lack the information necessary to provide care.

The Parapul platform is based on three pillars:

• Providing customized information, such as nursing care, educational materials, or local service listings to family members who are caregivers
• Connecting caregivers so they can share their challenges on bulletin boards, question-and-answer boards, or via direct messaging
• Offering a caregiving management system that, for instance, allows users to schedule nursing care support

Mobile Health

Pitched by Jingwen Zhang and Nondo Jacob Sikazwe, Mobile Health (mHealth) is a community platform that allows those at risk of CKD to be inspired to connect and receive information that can help them manage the condition.

During their presentation, the ideators noted that there are few digital tools on the market to help patients prevent or manage CKD. Why is this? First, individuals at risk, or who have early onset, of CKD have no or only slight symptoms that cause them inconvenience in daily life.

What’s more, those with middle-to-low incomes often struggle with daily living, which leaves little time and few resources to access primary healthcare.

Lastly, current biomarkers used to screen for CKD are affected by many factors, so there is a need for regular checkups.

Their community platform solves these challenges by incentivizing elderly people and their caregivers in three key areas:

• Motivation: where you can collaborate with the local community and receive community rewards for positive lifestyle changes
• Connection: where you can communicate directly with a healthcare provider
• Education: participate in customized, immersive games, quizzes, audio guides, and more that shed light on the issues of CKD

Coupon Kun

The final pitch, by Zechen Zeng and Keita Tsuyuguchi, addressed loneliness among elderly, which has reached epidemic levels. Zechen and Tsuyuguchi’s solution is a social network being developed in four phases. Phase one is to create a “Groupon experience,” through coupons for groups, that incentivizes elderly individuals to experience new things—such as hobbies, lessons, or traveling—with new social connections.

In phase two, the platform aims to introduce digital literacy to the elderly, including adoption of smart devices, while they undertake the group experiences.

In phase three, apps are used to monitor, collect, and share the health data of users with healthcare professionals following strict data privacy and security protocols.

And in phase four, insights gleaned from healthcare data are used to help users follow a healthy lifestyle.

Winners

With so many innovative ideas to consider, selecting the winners was not easy for the panel of industry professionals tasked with judging the 2022 HxD Ideathon.

Pitches were scored based on scientific innovation, relevance and timeliness, business feasibility, and how well they addressed the core issue.

Three ideas were selected to advance to the HxD hackathon in 2023:

• Maya Mind
• Hi-Real System
• Toilet Light Sensor for CKD

One other, Kyocare, was given special recognition and will also be part of the hackathon.

Overall, 119 ideators, facilitators, and students participated in at least one day of the ideathon, and connections were made with more than 22 universities for future events.

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Judges

Kozo Mori
Director, Medical Industry City, Medical and New Industry Division, Planning and Coordination Bureau, Kobe City Hall

Masayoshi Yamada
Deputy director, Department of Smart City Strategy, Strategy Promotion Office, Regional Strategy Promotion Division, Osaka Prefecture

Torsten Kanisch
Executive officer and vice president, commercial excellence, AstraZeneca K.K.

Christian Boettcher
Consulting partner, health sciences and wellness, EY Strategy & Consulting

Francisco Proano
Head of strategy and digital transformation, Bayer Yakuin

Yasuhiko Iida
Senior director, Consumer Experience Team and Next Generation Customer Engagement Strategy, Eli Lilly Japan

Hiroki Kayama
Strategic partnership development manager, AI for Japan, Google G.K.

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Digitizing Women’s Health

Startups and entrepreneurs leverage tech to improve care and equality for women in Japan

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In recent years, Japan has seen a boost in femtech. The portmanteau of female and technology refers to services using tech and products that help improve women’s health. Government support and media coverage have enabled femtech business offerings to move from niche to mainstream. But how soon might the fledgling industry take off as it has in the United States and Europe? The ACCJ Journal spoke with experts to explore prospects for femtech in Japan.

In 2021, the word femtech was nominated for publisher Jiyu Kokumin Sha Co., Ltd.’s Word of the Year, an annual award for language best representing life in Japan over the previous 12 months. The word eventually lost out to phrases related to US-based baseball superstar Shohei Ohtani, who made a splash in 2021. Yet the nomination alone is significant.

Awareness of femtech has remained low in Japan since the term was first coined in 2016 by Danish entrepreneur Ida Tin, founder of period- and fertility-tracking app Clue. But 2022 might see that change.

A February 2021 survey by Sompo Himawari Life Insurance Inc. shows that only 1.9 percent of its 1,000 working female respondents recognized the term. Once it was explained to them, however, more than half said they were “interested in” or “hopeful” about the concept.

Fast-forward to year-end, and 47.5 percent of respondents said they were aware of the word femtech. Though this is positive for the market, a Statista survey of 3,068 girls and women carried out in December 2021 and January 2022 also shows a long way to go, as just 15.3 percent of those polled report knowing the meaning.

Raising Awareness

Still, the increase is welcome for industry players. They say the market can grow only with an uptick in public awareness of, and willingness to talk about, women’s health—a topic that remains taboo in Japan. Progress over the past 12 months has been attributed to the launch of new products and services, exposure in media and social media, events, and other activities that support conversations about women’s health.

In March 2022, awareness-raising events Femtech Japan and Femcare Japan were held in Tokyo, while Japan Sports Week 2022, an industry event held in May, saw an area dedicated to femtech products and services supporting women in sports.

Promotion has already begun for Femtech Tokyo, an inaugural event to be held October 20–22 at Tokyo Big Sight, Japan’s largest international exhibition center. It will usher in what are expected to be annual trade fairs, designed to welcome the general public and businesses interested in “solving various problems in women’s life stages,” according to organizers.

“The term femtech is getting more recognition among women in Japan than ever before,” said Yoko Fukata, investment director at Sony Innovation Fund, which supports femtech startups in Japan. “Women want to know how their body works, such as its rhythms and hormones, and [want] to live better lives … exposure of the word and its different solutions will catch women’s attention.”

Indeed, consumers have been quick to notice femtech offerings entering the market. Almost 80 percent of some 10,000 working-age women in Japan said they knew of at least one femtech product or service, according to a 2021 Statista poll. Most familiar were sanitary shorts (48 percent), cloth sanitary pads (47.9 percent), ovulation test kits (40.9 percent), period tracker apps (40 percent), and sleep bras (38.3 percent).

These products are the result of several early stage femtech startups that emerged in 2019 and went on to release products and services in 2020 and 2021 in what can be considered “the first movement of the femtech industry,” according to Tomoko Minagawa, founder of industry association Femtech Community Japan and a leading investor in the femtech domain.

Improving Gender Equality

Now many players in Japan, including enterprise companies, are starting to launch new femtech businesses, Minagawa explained. Their motivation has been boosted by policies from a national government that sees the femtech industry as one method of addressing the country’s poor record in gender equality.

Japan ranks 120th among 156 nations in the World Economic Forum’s 2021 Global Gender Gap Report, far behind its G7 counterparts (which place between 11th and 63rd) as well as many of its Asian neighbors. The study, which tracks gender equality in four areas, evaluated Japan highly in health and education, but very low in economic participation and opportunity, as well as political empowerment.

Minagawa said the main reasons for Japan’s ranking are the lack of:

• Support for women in balancing their professional and private lives
• Consciousness of the very deep chasm between the experiences of men and women

She added that femtech can empower women by exposing the gap between the need for, and availability of, femtech products and services, and by leading discussions on femtech’s necessity and advantages for society.

Indeed, Minister of State for Gender Equality Seiko Noda, in her message on International Women’s Day 2022, listed “promoting femtech” as a government measure to improve Japan’s gender equality performance. Boosting women’s health by supporting the femtech industry is part of its efforts for “the realization of a society in which women live with dignity and pride,” one of the Japanese government’s four pillars in its Fifth Basic Plan for Gender Equality.

Government support includes the Subsidy Project for Demonstration Projects for Femtech and Similar Support Services that distributed a combined subsidy of ¥150 million to 20 femtech companies in 2021. According to the Ministry of Economy, Trade and Industry, which runs the program, the goal is to prevent events, such as the unwanted turnover of working women (triggered by life turning points, including pregnancy, childbirth, and menopause); to improve the well-being of individuals; and to increase the diversity of human resources at companies.

A healthy femtech industry, therefore, supports not only a societal need, but an economic one.

Business Cost

Loss of productivity, resulting from improperly treated health issues experienced by women working in Japan, is estimated at ¥2.7 trillion ($20 billion). According to Minagawa, the figure includes ¥323 billion ($2.4 billion) from menstruation, ¥672 billion ($5 billion) from fertility, and ¥1.75 trillion ($13 billion) from menopause.

With employees’ physical and mental health front of mind due to the acceleration of new work styles stemming from the pandemic, many companies are looking to the femtech industry for solutions to some of Japan’s long-running problems.

Kathy Matsui, general partner of MPower Partners, Japan’s first global venture capital fund focused on environmental, social, and corporate governance, told The ACCJ Journal that health and well-being has “become the priority” for more companies, particularly during the pandemic.

Startups have responded well. For example, lots of them have emerged that measure employee stress—now a legal requirement for companies in Japan. In the area of mental health support, companies are offering services, such as the outsourcing of care for children and elderly parents, she added.

Yuko Kidoguchi, operating officer and head of communications at life science company Bayer Holding Ltd. (Japan), which is active in women’s health policy advocacy, is also seeing more companies supporting the health and well-being of staff. Some are providing education on women’s health topics, including infertility treatment for women and men. Others are connecting female employees with gynecological care or providing financial support for women’s health treatments.

It’s all part of improving productivity and carrying out healthy management, Kidoguchi said.

Gradual Growth

With the needs and demand for femtech in Japan firmly established, what does the future hold? Japan’s femcare and femtech market grew from ¥57.5 billion ($428 million) in 2019 to almost ¥60 billion ($448 million) in 2020, and further development of the market is projected to generate an economic impact of about ¥2 trillion ($14.9 billion) in 2025, according to Statista.

In global terms, though, Japan’s market is tiny, with Asia accounting for only eight percent of the world’s femtech companies. Compare that with North America, which is home to 55 percent.

Sony Innovation Fund’s Fukata predicts that Japan’s femtech market will “grow gradually, not exponentially,” in part due to there being fewer female founders and investors than in the United States and some other countries.

Still, the industry consensus is that women femtech founders can make a big impact in both this industry and the wider healthtech domain.

“Women are often key decision-makers when it comes to household spending, and this is especially true in Japan,” according to Nuala Connolly, co-chair of the American Chamber of Commerce in Japan (ACCJ) Women in Business Committee and an ACCJ governor, as well as being head of talent, and the regional diversity, equity, and inclusion lead at AIG Japan Holdings. “Having women in leadership positions in startups and in femtech—and in every other sphere of business—means having leadership who represent this important consumer base and can innovate directly to optimally meet the needs of women. This, in turn, leads to the development of new products and markets, and boosts and elevates the overall economy.”

Fukata also cites the general population’s lack of deep understanding and the early stage of the industry as dampers on femtech growth, alluding to the fact that most femtech companies are focused on femcare, such as period underwear, rather than the technology aspect. She suggests this may be due to data that shows women are most concerned about period-related issues when it comes to women’s health. Alternatively, it might be due to the ease with which consumers can see, touch, and use such products.

“I think [femcare is] the starting point. Once they get accustomed to using those products and get to know more about the industry and the solutions there are in the world, there will be more people who want to focus on using femtech in different stages of their life,” she said.

Femtech Community Japan’s Minagawa agrees that most companies are providing non-tech products and services, but she is seeing some movement in the tech space, such as apps to track period cycles or to chat remotely with medical experts, as well as expansion into fertility treatments and early detection and support of menopause symptoms.

E-MCH

One area of women’s healthcare in Japan that is getting digital attention is the maternal and child-health (MCH) handbook, a printed booklet that can be obtained from a ward office or city hall which is used by doctors to track the results of pregnancy and post-birth health checks.

Lanex Co., Ltd. has developed an electronic version of the process—the E-MCH—an innovation for which the company won the From Japan and Beyond Award at last year’s ACCJ Healthcare x Digital competition.

“We analyzed the actual trend of existing digital healthcare solutions and found that most were not directly applicable to maternal and child healthcare, so we came up with the idea to digitalize the Japanese MCH,” explained software developer and project manager Boubacar Sow. “The E-MCH can play a significant role in tackling public health issues in both urban and rural areas of Japan. Our digital maternal and child healthcare system can collect and manage data from checkups during pregnancy, track the baby’s development, and enable women to communicate efficiently with their doctors and monitor their pregnancies.”

Sow said that femtech and supporting female entrepreneurship contributes to women’s empowerment and helps to achieve gender equality. “Specifically in Japan, femtech will boost the role of women in bettering healthcare and related activities. Femtech can be seen as one of the pillars of achieving gender equality in healthcare and bringing equal opportunities to women.”

The Road Ahead

There remains a long way to go, however. A full-fledged femtech market includes all kinds of hardware and software, including:

• Medical devices
• Wearables
• Telehealth and digital platforms
• Therapeutic drugs
• Vitamins and supplements

These items support everything from menstrual and reproductive health to pelvic, uterine, and sexual health to wellness and longevity.

Reaching that stage might not be smooth sailing, though, according to Dr. Amina Sugimoto, CEO of Fermata Inc., a platform and ecosystem designed to help domestic and overseas femtech companies enter the Japanese market.

Pointing to a lack of understanding, she explained: “People think there is nothing in the market and try to come up with their own services. But the problem is the market is not there.” She added that it is unlikely the 90 percent of women in Japan who choose sanitary pads during their period would be interested in a device to predict fertility if it requires insertion.

Consumers are also largely unaware of, or uncomfortable discussing, what their personal health issues might be, Sugimoto added. But she aims to change that with Fermata’s mission “to turn taboos into triumphs” by facilitating more openness on women’s health.

“If people could talk about [women’s issues] more freely, the market would slowly start to grow—companies and startups would get ideas to come up with new products,” she believes.

The public would also benefit from understanding women’s bodies better, said Kidoguchi, a vice-chair of the ACCJ Healthcare Committee and the brainchild behind Bayer’s gynecological health education program in Japan. Inspired by the country’s limited female health literacy and access to gynecological care compared with what is available in other nations, the program has been delivered to more than 50,000 students in 200 high schools, from Hokkaido to Okinawa, over the past seven years. Such schemes that educate both men and women can act as seeds for the future growth of Japan’s femtech market by creating more individuals who are open about, and understand, women’s health issues.

Minagawa said the current lack of understanding and cultural non-acceptance by investors, mainly dominated by men, is the structural impediment for investment in the femtech domain in Japan.

This was one driver for her to establish Femtech Community Japan, which connects investors, startups, enterprises, research institutions, government, and media for networking and discussion.

With the growth of such forums that support the development of an open conversation around femtech in Japan, it surely won’t be long before the term graduates from its current status as a year-end listing on language trends to being a topic of everyday conversation.

State of Mind

How artificial intelligence is helping identify mental health concerns for better treatment

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For millions of people around the world who were already struggling with mental health issues, the past two-and-a-half years of the coronavirus pandemic have been a further trial. Isolation, a sudden shortage of opportunities to interact with friends or family in person, additional stresses in the workplace or the home, new financial worries, and difficulty in accessing appropriate mental healthcare have taken their toll, experts in the field told The ACCJ Journal.

However, in the battle against mental health complaints, this time of adversity has also served to fast-track development and adoption of a new tool: artificial intelligence (AI). While the technology may be relatively new to the sector, the potential is huge, according to companies that are applying it to assist physicians with diagnosis and treatment.

A Tool for Our Time

AI has come a very long way since the first chatbots appeared back in the 1990s, and early mental health monitoring apps became available, explained Vickie Skorji, Lifeline services director at the Tokyo-based TELL Lifeline and counseling service. And it is urgently needed, she added.

“When we have something such as Covid-19 come along on a global scale, there is inevitably a sharp increase in anxiety, stress, and depression. The mental healthcare systems that were in place were simply flooded,” she said.

“A lot of companies were already playing around in the area of AI and mental healthcare, but the pandemic has really pushed these opportunities to the forefront,” she explained. “If, for example, a physician is not able to meet a client in person, there are now ways to get around that, and there has been an explosion in those options.”

Not every purported tool is effective, she cautions, and there are going to be questions around client confidentiality and keeping data current. The clinician must also become sufficiently adept at interpreting a client’s genuine state of mind, which might be different from the feelings that are communicated through the technology. On the whole, however, Skorji sees AI as an extremely useful weapon in the clinician’s armory.

Voice Matters

One of the most innovative solutions has recently been launched by Kintsugi, a collaboration between Grace Chang and Rima Seiilova-Olson, engineers who met at the 2019 OpenAI Hackathon in San Francisco. In just a couple of years, the company has gone from a startup to being named in the Forbes list of North America’s top 50 AI companies.

Kintsugi has developed an application programming interface called Kintsugi Voice which can be integrated into clinical call centers, telehealth platforms, and remote patient monitoring applications. It enables a provider who is not a mental health expert to support someone whose speech indicates they may require assistance.

Instead of using natural language processing (NLP), Kintsugi’s unique machine learning models focus on signals from voice biomarkers that are indicative of symptoms of clinical depression and anxiety. Producing speech involves the coordination of various cognitive and motor processes, which can be used to provide insight into the state of a person’s physical and mental health.

In the view of Prentice Tom, chief medical officer of the Berkeley, California-based company, passive signals derived from voice biomarkers in clinical calls can greatly improve speed to triage, enhance behavioral health metadata capture, and benefit the patient.

“Real-time data that augments the clinician’s ability to improve care—and that can be easily embedded in current clinical workflows, such as Kintsugi’s voice biomarker tool—is a critical component necessary for us to move to a more efficient, quality-driven, value-based healthcare system,” he explained. The technology is already in use in the United States, and Japan is on the waiting list for expansion in the near future.

Chang, the company’s chief executive officer, is confident that they are just scratching the surface of what is possible with AI, with one estimate suggesting that AI could help reduce the time between the appearance of initial symptoms and intervention by as much as 10 years.

“Our work in voice biomarkers to detect signs of clinical depression and anxiety from short clips of speech is just the beginning,” she said. “Our team is looking forward to a future where we can look back and say, ‘Wow, I can’t believe there was a time when we couldn’t get people access to mental healthcare and deliver help to people at their time of need.’

“My dream and goal as the CEO of Kintsugi is that we can create opportunities for everyone to access mental health in an equitable way that is both timely and transformational,” she added.

The Power of Data

Maria Liakata, a professor of NLP at Queen Mary University of London, is also the joint lead on NLP and data science for mental health groups at the UK’s Alan Turing Institute. She has studied the use and effectiveness of AI in communicating with the public during a pandemic.

Liakata’s own work has focused on developing NLP methods to automatically capture changes in individuals’ mood and cognition over time, as manifested through their language and other digital content. This information can be used to construct new monitoring tools for clinicians and individuals.

But, she said, a couple of other projects have caught her eye.

One is Ieso Digital Health, a UK-based company that offers online cognitive behavioral therapy for the National Health Service, utilizing NLP technology to analyze sessions and provide data to physicians. And last October, US-based mental and behavioral health company SonderMind Inc. acquired Qntfy, which builds tools powered by AI and machine learning that analyze online behavioral data to help people find the most appropriate mental health treatment.

“There has definitely been a boom over the past few years in terms of the development of AI solutions for mental health,” Liakata said. “The availability of large fora in the past 10 years where individuals share experiences about mental health-related issues has certainly helped in this respect. The first work that came to my attention and sparked my interest in this domain was a paper in 2011 by the Cincinnati Children’s Hospital. It was about constructing a corpus of suicide notes for use in training machine learning models.”

Yet, as is the case during the early stages of any technology being implemented, there are issues that need to be ironed out.

“One big hurdle is the availability of good quality data, especially data over time,” she continued. “Such datasets are hard to collect and annotate. Another hurdle is the personalization of AI models and transferring across domains. What works well, let’s say, for identifying a low mood for one person may not work as well for other people. And there is also the challenge of moving across different domains and platforms, such as Reddit versus Twitter.

“I think there is also some reluctance on the part of clinicians to adopt solutions, and this is why it is very important that AI solutions are created in consultation with clinical experts.”

Over the longer term, however, the outlook is positive, and Liakata anticipates the deployment of AI-based tools to help with the early diagnosis of a range of mental health and neurological conditions, including depression, schizophrenia, and dementia. These tools would also be able to justify and provide evidence for their diagnosis, she suggested.

To Assist, Not Replace

Elsewhere, AI tools will be deployed to monitor the progression of mental health conditions, summarize these with appropriate evidence, and suggest interventions likely to be of benefit. These would be used by both individuals, to self-manage their conditions, and clinicians.

Despite all the potential positives, Skorji emphasizes that AI needs to be applied in conjunction with in-person treatment for mental health complaints, rather than as a replacement.

“The biggest problem we are seeing around the world at the moment is loneliness,” she said. “Technology is useful, but it does not give people access to people. How we deal with problems, what the causes of our stress are, how can we have healthy relationships with other people—we are not going to get that from AI. We need to be there as well.”

HxD Winners

Five finalists in the ACCJ’s digital healthcare competition show that innovation is alive and well in Japan

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As we enter the third year of the coronavirus pandemic, two societal needs have become crystal clear: healthcare and digitalization. These could be seen as distinct domains, and in some respects they are. But the combination of the two could bring some of the most impactful changes to Japan and the world by improving the quality of life, reducing the cost of care, and allowing society to better cope with future crises.

Bringing them together is exactly what the American Chamber of Commerce in Japan (ACCJ) has done with its Healthcare x Digital (HxD) initiative, which began in 2020 and reached new heights in its second year. HxD leaders Torsten Kanisch, Francisco Proaño, Christian Boettcher, and Yasuhiko Iida, with the support of the ACCJ’s Kansai chapter, followed up the very successful inaugural competition by boosting submissions 30 percent.

Ideas Day 2.0

Forty companies submitted entries and 10 were selected to participate in the Pitch Day virtual event on October 14. Five finalists then took part in the HxD Ideas Day on November 11, a hybrid in-person and virtual event with a panel of leading healthcare and pharmaceutical executives—all empowered to initiate business deals and new relationships on behalf of their global brands.

Opening remarks were delivered by AstraZeneca K.K. Representative Director and President Stefan Woxström, who welcomed the more than 300 online attendees and many others who attended in person.

After thanking the healthcare professionals and companies working to develop solutions and care for patients during the pandemic, he shared a bit of Innovation Infusion Japan’s background.

Known as i2.JP, the open innovation initiative connects healthcare professionals, local governments, academia, and private companies, helping them jointly work out collective, practical, and optimal answers to issues in the field of healthcare. The initiative was founded in 2020 and has rapidly grown from seven participants to 130.

“I want to emphasize that this is an open innovation network: anyone can join, it doesn’t matter where you are,” Woxström said. “You don’t have to collaborate with those who started the network, you can collaborate with anyone. That’s the beauty of it, and that’s why it is also starting to produce a lot of solutions for patients.”

He also noted that i2.JP has become a gateway through which startups are entering Japan. “Because they don’t know where to go, who to connect with, they contact i2.JP and find partners who help them come to Japan with their solutions.” He hopes it will flow the other way as well, with i2.JP assisting Japanese startups as they branch out globally.

Setting the stage for the finalist presentations, Woxström said: “What we are going to experience today is what happens when startups, academia, the private sector, and policymakers come together and start working, because that is what is going to create new solutions for the future of healthcare in Japan.”

Goals

Then-ACCJ President Jenifer Rogers spoke next, noting that HxD Ideas Day is “the culmination of a months-long efforts by healthcare leaders and innovators with a shared mission: to solve critical healthcare challenges and improve the lives of patients.”

HxD 2021, she explained, advances the goal of driving innovation in Japan’s healthcare ecosystem by focusing on three areas:

• Overcoming the urban–rural healthcare divide
• Reimagining the hospital of the future
• Empowering patients to own their healthcare

“These areas tie into the digital transformation of society and can help Japan continue to take care of—and provide even better care for—all its citizens,” she added. “Digital transformation [along with] sustainable society and healthcare were two of the ACCJ’s main strategic goals even before the onset of the Covid-19 pandemic, which has accelerated the need for digital and healthcare plans around the world.”

Professor Hiroaki Miyata, of the Keio University School of Medicine’s Department of Health Policy and Management, echoed the belief that the pandemic has driven greater understanding of the need for digital transformation and sustainable healthcare. Speaking after Rogers, he wore a shirt that mirrored the colors of the i2.JP logo, which he said was his way of honoring the diversity championed by the group.

“The pandemic is a turning point for civilization,” he proclaimed. “Particularly in Japan, in terms of digital, the country had ranked 27th or 28th in competitiveness around the world and had to face this situation.”

Noting that Japan, as an island nation, was long isolated from the world, he said that facing these challenges and being forced to embrace a connected world and digital transformation—to grow together in this ecosystem—is important. “In that sense, i2.JP and HxD [represent] growing together in the global environment, so these opportunities are very important for us,” he explained. “And all of you here are going to take a new step that is going to be important for Japan and the world.”

Expert Insight

Saving the finalist presentations—the highlight of the day—for last, the middle section featured a wide range of presentations from experts. Five keynotes followed Professor Miyata’s comments:

• Yoshihiko Izumida—a professor in the Saitama Medical Center’s Department of Endocrinology and Diabetes, as well as representative director of Saitama Medical and chairman of the Life Course Design Association—gave a presentation entitled Global Standardized IoT Platform for Promoting Open Science
• Ryosuke Fukuda—deputy director of the Health Policy Bureau’s Medical Professions Division and director of the bureau’s Planning and Coordination Office for Physician Training in the Medical Professions Division—talked about recent topics in online medical care guidelines
• Jun Miyagawa—general manager of Kansai growth strategy in the Growth Business Development Department of Sumitomo Mitsui Banking Corporation—shared a presentation entitled Accelerating the Formation of a Venture Ecosystem in the Kansai Area: Trends in Innovation in the Run-up to the Osaka-Kansai Expo
• Takeru Yamamoto—board director and chief operating officer at Welby Inc., talked about the current and future prospects for personal health record platforms
• Lei Liu, PhD—innovation partnerships and i2.JP director of commercial excellence at AstraZeneca K.K., recapped the open innovation initiative’s successes in its first year, looked ahead to the future, and introduced HxD and its achievements

After the keynotes, a panel discussion involving the keynote speakers, moderated by Liu, covered current trends in, and future prospects for, digital innovation in healthcare.

Next, the five finalists made their last pitches.

Medii, Inc

First to present was Medii, Inc Chief Executive Officer Hiroki Yamada, a rheumatologist who is himself a patient coping with an intractable disease. His own experience led him to become a specialist treating arthritis and other musculoskeletal conditions and systemic autoimmune diseases, and to search for a way to bring better care to patients and support local doctors across Japan.

Specialist doctors in his field, he explained, may be difficult to find outside of the largest cities. While there are 759 in Tokyo, 32 of Japan’s 47 prefectures have fewer than 75. “In terms of the population, there is a 50-fold difference in the distribution of specialist doctors. We have to do something about this,” he said.

“There are so many undiagnosed patients who are not receiving proper treatment—they are simply overcoming their symptoms. This is the challenge we are facing and that we must overcome.”

Medii would like to create a National Intractable Disease Center so that the latest and most effective treatments can be delivered to patients. About five percent of the people in Japan suffer from such ailments.

The company’s focus is on the issue of doctor’s knowledge about intractable diseases, because supporting local physicians is one of the best ways to help patients.

Medii is offering a service called E-Consult, a digital resource powered by artificial intelligence (AI) that enables the sharing of expertise about rare diseases with doctors who are not specialists.

Doctors in the local community who are trying to diagnose a problem, but who do not possess knowledge of these rare diseases, can be matched with an expert through E-Consult. More than 500 specialists are working with Medii to provide assistance through the service that is a bit like the LINE messaging platform, which is dominant in Japan.

Doctors can be matched on a real-time basis for one-on-one chats and images can be exchanged securely. A response is received within 42 minutes and the level of satisfaction has been as high as 93 percent.

“For instance, in the remote islands, the doctor may be working all on his own, and he has to take care of patients with many diseases,” Yamada explained. “And yet, by using our platform, even though he may be working on a solo basis, all these specialists can support him, and better diagnoses and treatments can be offered to his patients.

“We cannot do this alone, so together with the support of the pharma companies—and for the benefit of the patients and the doctors and the specialists—I would like to further grow this platform,” he continued. “Our team is putting all its efforts into this, and I hope you will all join hands together for this endeavor.”

Immunosens Co., Ltd.

Next, Hirokazu Sugihara, CEO, representative director, and president of Immunosens Co., Ltd., shared his vision for more efficient testing that can close the time gap between diagnosis and treatment.

“Our first target is cardiovascular diseases,” Sugihara said. “As the Japanese population ages, the number of patients with such diseases is on the rise, and treatment accounts for 20 percent of national medical costs.

“When your condition is poor, you go to a primary care physician to find out what is wrong and if there is a risk of disease,” he continued. “Various exams may be performed, and right now tests are outsourced.”

That time lag—typically one to three days—can make a big difference in the outcome for patients. At a minimum, it requires them to make an additional trip to the hospital or clinic and, in some cases, it may prevent the doctor from providing proper treatment.

Immunosens’s solution is a high-performance point-of-care testing (POCT) system that utilizes a technology that the company calls GLEIA, an acronym for gold-linked electrochemical immunoassay.

This lateral flow test technology uses a printed electrode to trap disease markers in the sample by immunoreaction and then sandwich the markers with gold nanoparticles. If a disease marker exists, it will gather near the printed electrode. Ultra-sensitive detection of gold nanoparticles on the printed electrode is achieved through an oxidation and reduction process. This electrochemical measurement can be completed with a single cartridge, enabling quick and efficient measurement with results in just 10 minutes. The easy-to-use, disposable GLEIA sensor is much smaller and cheaper than existing equipment, but detection sensitivity is equal to, or higher than, that of current processes.

The product weighs just 0.1 kilograms and costs between ¥10,000 for a model designed for home use and ¥50,000 for one aimed at clinics. Compare this with existing equipment, which weighs 10–100 kilograms, costs between ¥3 and ¥10 million, and takes as long as two hours to read a sample. Also, current equipment requires a 100–200 microliter sample whereas the GLEIA solution needs just 2–20 microliters.

The device for home use allows patients to measure their condition every four days if they are unstable, or every 23 days if stable. Currently, new measurements are taken once every six months, on average, at a hospital.

Steady development has been underway since 2018 and the first product is scheduled to be launched in the second half of this year. Mass production is targeted for 2025.

Oishii kenko Inc.

With a name meaning “tasty health,” Oishii kenko’s goal is “to contribute to health and healthcare issues through delicious solutions and dietary management,” explained Chief Executive Officer Tetsuya Nojiri.

Scientific evidence has shown that an optimized diet is key to reducing healthcare costs, preventing diseases, and supporting the treatment of existing ailments.

But, as Nojiri noted, controlling one’s diet is easier said than done. He explained that, while 80 percent of Japanese households prepare their own meals every day, it is challenging to plan a nutritionally balanced menu. And if you have dietary restrictions due to illness, doing so becomes even more difficult.

“To whom do you turn for help?” he asked. According to the company’s research, 85 percent of physicians say that they are consulted about diet by their patients, and 90 percent of that group admit that they lack the knowledge and time to provide such guidance. This is where Nojiri feels Oishii kenko can make a difference.

“There is a position called certified dietitian, but 84.4 percent of hospitals in Japan do not have anyone in this role. So, while patients want to improve their dietary life, there is no one whom they can consult,” he explained.

Oishii kenko believes that dietary management is possible in the home, and you don’t need a dietary specialist sitting next to you to make it happen.

“We need to trigger the understanding and desire to eat healthily, and that is what we want to provide through our personalized recipe and nutrition management app, supervised by a registered dietitian,” Nojiri said.

The AI-powered recommendations provide nutritionally balanced meal options, and a shopping list is created automatically. More than 60 health issues can be managed through the 10,000 recipes found on the app.

In addition, the app offers previously unavailable insight into the habits and preferences of people with similar health challenges. This is thanks to Big Data from more than 40,000 users that allows nutritional trends to be surfaced.

As an example, Nojiri shared that, according to the data, female diabetics may have a tendency to like spicy food, while male diabetics eat a lot of meat and dislike fish.

“This is different from the expected behavior of diabetics,
so using real-life data … and based on the preference of the individual, we can suggest good dietary management tailored to each person,” he explained. “Through the app, we hope to change behavior that helps pharmaceuticals to work their best.”

Lanex Co., Ltd.

One example of a traditional practice in Japan that could benefit from digitalization is the maternal and child-health (MCH) handbook. This printed booklet is used to track the results of pregnancy and post-birth health checks.

Lanex software developer and project manager Boubacar Sow shared the company’s electronic version of the process—the E-MCH—explaining that “we empower doctors to manage data generated during pregnancy through virtual consultation, interoperability, and maternal decision support.”

Under the current system, a woman who is expecting visits the doctor and receives a document which certifies that she is pregnant. She then takes this paper to the health center at the ward office and receives the MCH.

Using Lanex’s E-MCH system, she would register during her first visit to the hospital and receive a unique identification number issued by the local government. Login credentials are also provided so that she can download and begin using the system immediately.

At every checkup, data is added to the E-MCH and is accessible via the web portal and smartphone app.

“We believe we have a special system, because it is not simply a pregnancy tracker, but also an ecosystem to digitize maternal and child healthcare,” Sow explained. “We help the local government provide a unique identification number to better track those who are pregnant. It’s special because we have a knowledge base, the contents of which are provided by maternal and healthcare experts from Miyagi University.”

Lanex, founded in 1993, has offices in Japan, the Philippines, Australia, and the United States, and has been developing high-quality software for more than 28 years. It is targeting countries that are unable to meet United Nations Sustainable Development Goal 3: ensure healthy lives and promote well-being for all at all ages, as well as every medical institution that provides maternal and child healthcare in both developed and developing countries.

In May 2021, the E-MCH was adopted by the Japan International Cooperation Agency (JICA) as an innovative product to solve a public problem, and Lanex received financial support from JICA to conduct a survey in African countries.

The web system requires a small payment by the hospital, while the mobile app is free for mothers.

CardioCouple

The final presenter was Ayush Balaji, an 18-year-old from Japan, who is a first-year medical student at the University of York in the United Kingdom. He came up with the idea for a pulsatile percutaneous circulatory assist device for those with heart failure during his last year of high school in Japan.

“I’ve taken inspiration from nature—with animals, such as octopi, which have branchial hearts—and I looked at adopting a resilient network-based solution to heart failure,” he explained.

Cephalopods have two branchial hearts, one located at the base of each gill. The two branchial hearts push oxygen-depleted blood through the gills, thereby supplementing the function of the systematic heart, which pumps the oxygenated blood throughout the body. Similar systems are found in insects and other animal species.

“The biggest issue we have at the moment is heart failure, or cardiovascular-related diseases. There are 64 million cases of heart failure per year [worldwide], and cardiovascular disease is the most common cause of death,” he continued. “The only treatment available at the moment for heart failure is a heart transplant. Between diagnosis and transplant there is an extended waiting period, and during this time the quality of life for patients is significantly reduced.”

Balaji has designed a device called the CardioCouple that focuses on forestalling a reduction in the quality of life between diagnosis and transplant. The aim is to allow patients to lead lives that are as close to normalcy as possible.

He noted five problems with current surgical approaches:

• High rates of infection and complications
• Reduced patient mobility and access
• Hemolysis complications (destruction of red blood cells)
• Lack of resilience
• Foreign material contact and proximity to the heart

How does CardioCouple fix this?

A network-based approach uses small pumps in multiple location around the body to reduce fail rates, provide resilience, and increase mobility. No components come in direct contact with blood, which increases longevity of the devices and reduces the risk of hemolysis-related complications. And, while some surgery is required to implant the devices, major open heart surgery is not needed.

The result is improved quality of life and outlook, more time for physicians to plan further intervention, reduced cardiac afterload and stroke risk, and the ability of patients to resume normal life without the need to manage bulky external apparatus.

In terms of digital healthcare, dedicated software allows data from the device to be utilized, and physicians and patients to control the device in real time. The pump rate can be managed remotely, and physicians can set operational limits so that the patient can adjust the pump rate themselves when needed. Plus, physician access to real-time data on pump performance and patient parameters ensures the maintenance of the device and patient health.

“All these things come together to provide a more reliable, efficient, convenient, and cost-effective device, as it does not rely on significantly new advances in technology and the complication rate is not as high as what exists today,” said Balaji.

“This translates to a lower strain on healthcare budgets, improves profit margins for pharmaceutical companies due to lower complication rates, and provides patients with better control over their health.”

Impressive Breadth of Ideas

Following the presentations, Deloitte Touche Tohmatsu LLC Senior Partner Christian Boettcher moderated a panel discussion during which the five finalists talked with AstraZeneca’s Woxström and Eli Lilly Japan K.K. President and Representative Director Simone Thomsen.

“This year it was very impressive to see the breadth of ideas,” said Thomsen, congratulating the finalists. “I feel the true patient-centric passion is coming through, really making sure that [the focus is on] just one problem and how we can make it better. I think we are seeing an even greater breadth of what digital technology can do to support Japanese patients.

“As always, I continue to applaud you,” she added. “I know there is a lot of entrepreneurship needed, a lot of courage, to make it work. I assume all of you have faced multiple challenges so, by bringing it this far, you continue to impress me.”

Prizes

Ideas Day ended with recognition of the incredible innovation brought forth by the finalists.

Six honors were given:

• Empowering Patients Award and People’s Choice Award: Oishii kenko Inc.
• Hospital of the Future Award: Immunosens Co., Ltd.
• Bridging Urban Health Award: Medii, Inc
• From Japan and Beyond Award: Lanex, Co., Ltd.
• Moonshot Award: Ayush Balaji

The winners received monetary prizes and the chance to meet with senior executives from the organizing sponsors. They will also receive mentoring and support from healthcare professionals and executives of organizing sponsors.

All who took part in the HxD competition benefited from having their ideas reviewed, and the ACCJ thanks everyone who submitted pitches. Yet again, HxD proved that there is boundless healthcare innovation in Japan, and the 2022 competition is sure to reach new heights once more.

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Sponsors

President’s Circle Sponsors
Cisco Systems G.K.
Eli Lilly Japan K.K.
Google Japan G.K.

Organizing Sponsors
AstraZeneca K.K. | Bayer Yakuhin, Ltd. | Deloitte Touche Tohmatsu LLC | i2.JP (Innovation Infusion Japan)

Contributing Sponsors
Dentsu | Johnson & Johnson | K&L Gates LLP | Motorola Solutions | NRW Global Business | Omron Corporation | Trilations G.K. | Real Life Sciences | SoftBank Corp.

Supporting Organizations
City of Kobe | Embassy of the United States, Tokyo | Foundation for Biomedical Research and Innovation at Kobe | Global Venture Habitat | LINK-J | Osaka Innovation Hub

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Have an idea to pitch? Want to become a sponsor?
Get ready for the 2022 competition with an info packet: www.accj.or.jp/hxd

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Leveraging Lessons Learned

Building an innovation ecosystem for a healthier, more secure future

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Since the onset of the Covid-19 pandemic, the biopharmaceutical industry has come together in unprecedented ways to attack the virus, and we have achieved incredible progress in just two years. Working across the global healthcare ecosystem, biopharmaceutical companies, academia, and the public sector have harnessed decades of investment, research, and past discovery to deliver safe and effective vaccines and treatments to patients. As a result, the industry was able to develop vaccines in just 12 to 18 months, and almost 11 billion doses have been administered worldwide.

To put this success in perspective, it typically takes eight to 10 years to develop a vaccine, and the overall success rate is only 5 to 10 percent.

But our work is far from over. Today, there are more than 1,700 clinical trials underway globally for treatments and vaccines to combat the virus. Across the industry, companies are continuing clinical research to assess whether modifications or boosters are warranted, and to identify further treatments. We also continue to scale up production facilities and manufacturing capacity, while working collaboratively on manufacturing to increase the supply of vaccines and treatments.

Enhance the Innovation Ecosystem

As the pandemic continues, we must build on lessons learned and prepare for challenges ahead. This begins with strengthening the innovation ecosystem that led to the discovery and development of Covid-19 vaccines and treatments, and ensuring that the healthcare system is more resilient in the future.

Given the Japanese government’s desire to be better prepared for future healthcare challenges, enhance domestic biopharmaceutical research and development (R&D), and promote economic growth, now is the time for Japan to take concrete steps to enhance its innovation ecosystem. This will help the government achieve its important domestic goals, including safeguarding patients’ early access to innovative medicines and treatments as well as ensuring that Japan remains a world leader in advancing public health.

Regulatory and reimbursement policies that incentivize innovation are needed to develop an innovation ecosystem that expands R&D and drives economic growth in Japan. However, in recent years, the policy environment in Japan has become increasingly difficult for the biopharmaceutical industry.

Since 2015, more than 50 new drug pricing rules have been introduced, and we are starting to see the results of these policies that disincentivize investment and undermine early access to innovative medicines. For example:

• Between 2015 and 2020, biopharmaceutical industry R&D investment grew 33 percent on average globally, while in Japan it declined 9 percent
• The number of medicines in clinical trials in Japan grew 8 percent annually between 2009 and 2016. However, following the implementation of harmful policy changes, growth in clinical trial activity has fallen to 3 percent annually
• In 2016, 51 percent of global new medicines from the prior five years were available in Japan, but by 2020 had declined to 43 percent

Strengthen US–Japan Collaboration

It is clear that the Covid-19 pandemic has provoked some important reflection in Japan on the policy environment for innovative medicines, and there is growing recognition of the need for Japan to improve its innovation ecosystem.

The government must ensure greater transparency in both its healthcare policy decision-making and its application of new policies. More focused bilateral engagement could help achieve progress in these areas. A US–Japan healthcare dialogue under mechanisms such as the Competitiveness and Resilience Partnership or Economic Policy Consultative Committee could help ensure that both countries remain global leaders in driving innovation in the life sciences and promoting global health security.

Having joined the Pharmaceutical Research and Manufacturers of America in January as the new Japan representative, I am honored to speak on behalf of the biopharmaceutical industry at this critical time. I look forward to working with the ACCJ and policymakers in Japan and the United States to advance strong economic and health ties between our countries, and to ensuring that Japanese patients continue to have early access to lifesaving and life-enhancing medicines.

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The Case of the Missing Startups

Why biotechs find it hard to get going in Japan

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University and government venture funds play a much larger role in Japan than they do in Western countries. Yet we see fewer biotechnology startups here compared with, say, the United States, which is home to eight of the top 10 highest-funded ventures. Why?

I explored this with Dr. Hiroaki Suga, co-founder of biotech company PeptiDream Inc., in a recent episode of my podcast Disrupting Japan. A professor at the University of Tokyo, Suga did his post-doctoral study under Nobel Prize-winning biologist Jack Szostak at Harvard Medical School. As an academic and a researcher, Suga knows well the dynamics at play in biotech development and application in Japan.

With PeptiDream, which has created a platform for the discovery of highly diverse, non-standard peptide libraries that can be developed into peptide-based therapeutics, Suga has taken a different approach to funding. And it has paid off.

Founded in 2006, PeptiDream is now worth more than $3 billion and collaborates with many of the world’s largest pharmaceutical companies, including American Chamber of Commerce in Japan (ACCJ) members Eli Lilly Japan K.K., Bayer Yakuhin, Ltd., AstraZeneca K.K., and Novartis.

Less is More

What I learned from our discussion is that, in this situation, smaller investments may lead to better results.

“If you have $10 million, you will just burn through it,” Suga said, adding that less capital will keep you focused and get results that can lead to bigger things.

In PeptiDream’s seed round, it received $1 million from The University of Tokyo Edge Capital Partners Co., Ltd., a Japan-based seed- and early-stage deep-tech venture capital firm.

With limited funds, “You need to really develop technology that will allow you to collaborate with big pharmaceutical companies,” Suga explained. These companies set criteria, and don’t give you money immediately. “Once you reach [one set of] criteria, you can get money. Then you get to another stage and you get more money,” he said.

This approach carries less risk for pharmaceutical companies, and Suga sees little risk for PeptiDream, because he is confident that they can meet the criteria.

Obstacles

This unusual approach has worked well for PeptiDream, so why don’t we see more biotech startups succeeding this way in Japan?

Suga said there are several reasons.

“Venture capitalists are not investing in risky companies, and biopharmaceutical companies are high risk,” he explained. “If you are developing business software, after six months, you know if it isn’t working. But drug development is a long-term commitment.”

“The first is that venture capitalists are not investing in risky companies, and biopharmaceutical companies are high risk,” he explained. “If you are developing business software, after six months, you know if it isn’t working. But drug development is a long-term commitment. Venture capitalists have to wait, and they may not be able to do so. They may need to wait 10 years to realize the potential, but they are looking for five.”

“The second reason is that Japanese society prefers to go with what’s known,” he continued. In this case, it means that talent heads for the largest pharmaceutical companies, which are seen as stronger and a safe harbor. “For example, all my students go to big pharma. They don’t go to PeptiDream.”

But this isn’t so much a case of risk aversion—often cited as an obstacle to success in Japan—as one of familiarity. Their parents know the names of the big players, but not of small ones such as PeptiDream.

Large Japanese companies tend to have little interest in helping smaller ones. This chasm is one that the ACCJ is attempting to bridge with its Healthcare x Digital initiative, which completed its second annual competition in November.

Spin-off vs. Startup

The third obstacle that Suga cited is the fact that many startups in Japan are research units that have been spun off from large companies that chose to leave Japan. “They had a very good team here, so they decided to spin off. They already have a background from big pharma and continue doing [what they were doing],” he explained. “That means that they aren’t hugely different from the big companies.”

In the end, Suga said that the biggest change that needs to take place for Japan to become more fertile ground for biotech startups must be made at the university level.

“Professors really need to work hard to get technology to be very practical, to be very robust. You really have to put forth effort to get to the end,” he said. “Then, the Japanese government needs to support this type of research. That’s very critical.”

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D&I Hiring in Healthcare

Titan Consulting helps companies put diversity policies into action

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Presented in partnership with Titan Consulting K.K.

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It has been two decades since the Japanese government set its target of having women in 30 percent of management positions by 2020. The country has fallen far short of that goal, which the government has pushed off to 2030.

Titan Consulting K.K. Business Development Manager Sophia Plessier certainly noticed the imbalance on her arrival in Japan. Coming from San Francisco, where discussion of diversity and inclusion (D&I) and support for women in business are a part of everyday life, she found it striking how few Japanese companies were promoting these important issues.

At Titan, she helps clients increase the diversity of their leadership. It’s a natural progression of her career in executive recruitment for the pharmaceutical, biotechnology, medical devices, and technology industries. She began that journey in 2015 in the United States, where she partnered with top healthcare companies to fill key spots in their management.

Focus on Diversity

Filling those positions is about more than just reaching a percentage. It’s about benefiting society through the innovation and solutions that emerge from teams built on diverse views, experiences, and backgrounds. And Titan’s area of focus—healthcare and life science—requires a little extra attention.

As Business Operations Manager Sean Lindley noted: “The benefits of having a more diverse leadership team are well established, but building that team can be more of a challenge in healthcare—especially in Japan—due to the somewhat conservative nature of the industry.” The way in which these companies approach screening adds an extra layer that must be overcome, he explained, “but with this challenge come opportunities, and if you’ve got something which can potentially remedy that, then the most conservative industry is probably where you want to try and apply the solution.”

The solution he speaks of is the D&I Spotlight Package, which Titan has created, inspired by another product they offer to clients which focuses on medical-doctor hiring. The package helps clients who wish to start putting their D&I policies into action through talent acquisition do so in the most effective way possible.

“Titan takes the time to understand the areas on which the client is aiming to focus their D&I hiring and the foreseeable challenges.”

The D&I Spotlight Package is a 12-month commitment from Titan Consulting which starts with an in-depth discussion to understand the client’s current situation and business needs. Titan takes the time to understand the areas on which the client is aiming to focus their D&I hiring and the foreseeable challenges. This offers a close partnership in which Titan provides detailed market analysis, access to an extensive network of professionals, a market map that identifies candidates, and ongoing, proactive support. Whether the client just wants a market map, needs to hire for key positions, or has extensive hiring needs, Titan is ready with a tailored service.

“We work with the client to pinpoint what type of professionals they want to engage with,” explained Partner Daniel McGrath. “Some clients have urgent and immediate needs while others are more focused on casual exploratory meetings for pipelining. Whatever their situation, Titan offers the opportunity to turn D&I hiring ambitions into reality for companies that are serious about evolving their business.”

Real World Results

Plessier shared an example of a successful placement. In another case, a medical device client, which was focused on Japan and had an entirely male executive team, was given a big incentive from the global executives to push for more diversity. They needed to replace their head of research and development, so decided to invest in diversity hiring and work with Titan. In just six weeks, the final candidate was selected from three finalists.

If you’re ready to strengthen your management team with more female leaders and greater diversity of voices and ideas, Titan Consulting is ready to help.

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Learn more about the D&I Spotlight Package:
titanconsulting.jp/diversity

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Innovation Destination

US-led platform to provide healthcare traceability and stability in Japan

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As a super-aging society with a population of more than 100 million, Japan has the potential to become a destination for healthcare innovation. Its citizens have easy and equal access to quality healthcare services, with pharmaceuticals and medical devices playing important roles in improving quality of life.

But there are technological obstacles to overcome. The US medical device industry is leading the effort to develop a data platform in Japan which will enable traceability in healthcare. The platform will allow the collection, storage, and sharing of information among stakeholders (e.g., manufactures, vendors, and hospitals). It will become a critical tool for improving the quality and efficiency of Japan’s healthcare system and will help ensure a stable supply of medical goods for healthcare providers.

Leveraging Tech

High-speed internet is nearly ubiquitous across Japan, but its benefit to healthcare is hampered by rules, systems, and business practices put in place before the internet era. Healthcare data is stored in a way that makes it difficult to share among stakeholders. This issue became obvious as the Covid-19 pandemic took hold and the country found it difficult to:

• Track medical supplies
• Monitor public health
• Analyze collected data

Medical devices in Japan now carry a unique device identifier and all products are labeled with a GS1-128 bar code that contains a Global Trade Item Number. Some products, such as those related to orthopedics, are even tagged with radio frequency identification (RFID) information so that every item can be tracked, traced, and reported on.

Currently, RFID is only used to improve productivity within an organization. But as more companies introduce RFID technologies, to minimize confusion and inconvenience, the industry has agreed to:

• Standardize the RFID format
• Develop a platform to store and share data

The platform will enable manufactures to offer products that allow stakeholders to use all associated information to improve the quality and productivity of the healthcare system and to stabilize the supply of medical products. Expected to be available in mid-2022, the platform is being developed under the Smart Logistics Service portion of the Japanese government’s Cross-ministerial Strategic Innovation Promotion Program.

Government Support

The US medical device industry is part of a study group supported by Japan’s Ministry of Health, Labour and Welfare (MHLW), which provides grants to help enable traceability of drugs and medical devices to improve safety and efficiency in hospitals. The goal of this study group is to set the basic feature requirements for electronic health-record systems used in hospitals. Guiding documents help hospitals and vendors introduce and use bar codes and RFID technology. With these two systems, traceability in the Japanese healthcare system can be dramatically improved.

Traceability in healthcare enables us to see the movement of prescription drugs and medical devices through the supply chain. We can trace the history of the transfers and locations of a product, starting from the point of manufacture. We can also look ahead to see the intended route of the product to the point of care. It also helps provide greater oversight of medical device performance for effective post-market surveillance in the event of adverse event reports or product recall alerts.

With increased traceability and productivity along the whole supply chain, the quality and efficiency of healthcare services provided in Japan will improve, and a stable supply of medical goods will be guaranteed. Data can also be collected automatically, and shared among stakeholders for analysis that will lead to improvements in care.

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Unsung Hero: Dr. Tatsuya Kondo

Remembering the former PMDA chief executive and how he changed medicine in Japan

One year ago, we featured Dr. Tatsuya Kondo on the cover of The ACCJ Journal. The American Chamber of Commerce in Japan (ACCJ) had recognized him for his contributions to the healthcare industry with the 2020 ACCJ Outstanding Achievement Award. Dr. Kondo played a key role in Japan’s healthcare efforts as chief executive of the Pharmaceuticals and Medical Devices Agency (PMDA) from 2008 to 2019. Sadly, he passed away on September 26 after a battle with prostate cancer. ACCJ members shared thoughts and memories with The ACCJ Journal about what Dr. Kondo meant to them and the industry.

Strong Supporter

“We are all deeply shocked and saddened to hear the news of Dr. Kondo’s passing and would like to extend our deepest condolences to his family,” said Zimmer Biomet G.K. Executive Officer and Chairman Kazuya Ogawa, who is also chairperson of the American Medical Devices and Diagnostics Manufacturers’ Association (AMDD), adding that the AMDD Executive Committee offered a silent prayer for his soul at its October meeting.

“Dr. Kondo was respected as a strong supporter of the need to resolve the medical device lag issues. His thoughtful, sharply focused actions, always led to a quick resolution of serious lag problems. I personally recall intense discussions with him about more than 300 files of outstanding orthopedic reviews on hand at the PMDA, just as some 100 new applications were coming in. He promptly organized a task force to tackle the issues and cleaned them up in a very short time frame. He demonstrated great leadership during his time at the PMDA, and we feel very honored to have had opportunities to work with him.”

Man of Results

ACCJ Governor James Feliciano, who serves as chair of the Japan-based Executive Committee of the Pharmaceutical Research and Manufacturers of America, highlighted some of the results.

“Dr. Kondo was nothing short of a Japanese hero. Through his untiring efforts over so many years, he transformed the PMDA into a premier regulatory review and approval body,” he said. “We can look at the results in terms of months of review, number of new products approved, or the elimination of the drug lag compared with Western countries. However, the real measurement should be the number of Japanese patients who received access to lifesaving and life-changing innovative pharmaceutical medicine. Kondo-san is the unsung hero for so many patients in Japan.”

Leader of Change

Simone Thomsen, president and general manager of Eli Lilly Japan K.K. and ACCJ governor–Kansai, praised his leadership.

“We would like to express our deepest sympathy on the passing of Dr. Tatsuya Kondo, chief executive emeritus of the PMDA. He was truly a great leader for Japan who advanced our efforts to eliminate the drug lag for Japanese patients,” she said.

“Under Dr. Kondo’s leadership, regulatory science was truly developed and incorporated into the PMDA’s review, which yielded greater transparency for the industry. We appreciate the opportunity to have had the chance to work with him.”

Warm and Supportive

ACCJ Vice President and former PhRMA Japan Representative Amy Jackson, who is APAC senior director of government affairs and policy at Janssen Pharmaceutical K.K., said: “Dr. Kondo had a powerful and long-term impact on the Japanese healthcare system. Countless Japanese patients got early access to needed, lifesaving medicines thanks to his vision and efforts to make the PMDA a truly world-class regulatory system. Not only was Dr. Kondo a great leader, he was also an excellent ambassador between the PMDA and international stakeholders. I so fondly remember the many times PhRMA had meetings with him and his team. Dr. Kondo would always walk into the PMDA conference room with a big smile on his face. He would greet his international visitors with great warmth and would earnestly urge them to share, without reservation, any comments or concerns they had about the Japanese regulatory system. He will be greatly missed.”

Thank You

ACCJ Healthcare Committee Co-chair John Carlson summed up Dr. Kondo’s support of the chamber. “He was no stranger at the ACCJ. During the course of his career at the PMDA, he visited the chamber on numerous occasions to share his thoughts on the future of the agency and exchange opinions with members of the Healthcare Committee," he recalled. “His commitment to public–private partnership was compelling. The ACCJ extends its deepest gratitude to Dr. Kondo and condolences to his family. He was a transformational healthcare leader.”

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The Power to Innovate

Covid-19, mRNA, and government and private sector roles in healthcare

The Japanese public is concerned that domestic pharmaceutical companies have yet to launch a single Covid-19 vaccine. Some may argue that this is due to a low rate of vaccine confidence, as is seen in the national tendency to avoid the human papillomavirus (HPV) vaccine, which has, in turn, caused a problem for vaccine development.

Although there may, indeed, be such a factor, this would not be the primary reason—especially not for the delay in the domestic development of a messenger ribonucleic acid (mRNA) vaccine.

It should be noted that Moderna, Inc., the US pharmaceutical and biotechnology company that has produced an mRNA vaccine to combat Covid-19, had been advancing cancer therapeutic vaccine development since well before the pandemic.

In Japan, however, initiation of development was delayed compared with other advanced countries, and efforts to develop products based on mRNA technology have failed to make significant progress. This is not because the environment surrounding a prophylactic vaccine is unfavorable but, rather, it is due to the lack of an environment in which companies can take risks and consider new modalities.

The Role of Government

The coronavirus pandemic has made me reconsider what the government should do to promote the development of innovative healthcare products. Among the various ideas I have come up with, I would like to conclude—even though this may be obvious—that the primary responsibility of the government is to create an environment in which innovative products are highly valued and the private sector can invest in a broad range of research and development (R&D).

I see that Operation Warp Speed—the public–private partnership backed by the US government to support rapid development of a Covid-19 vaccine—has had a huge impact. This underlines the fact that the Japanese government needs to invest directly in companies that can provide clinical research and manufacturing facilities, especially during a public health emergency.

Yet, under normal circumstances, it is fair to say that the private sector in Japan can make more efficient investments than can the government. It is extremely challenging for the government to pinpoint and invest in a promising company and product. Further, a massive direct investment by the Japanese government is unlikely, given the current budgetary issues.

By evaluating the history of mRNA technology, we can see how difficult it is to identify rising stars. Thanks to its wide use around the world to prevent Covid-19 infections, mRNA technology is now well known. Before the pandemic, however, only a few of us predicted such a quick, practical application. A researcher from Hungary, according to media reports, even struggled to have the merits of her research results recognized, despite years of studies.

Private Sector Stands Ready

I believe that Japanese and US companies in the private sector are willing to take risks and engage in R&D if they recognize innovative product candidates and can appropriately evaluate them under the right conditions.

But how can Japan create such an environment? I will be committed to accomplishing this once I complete my current assignment in the United States, and policymaking becomes my direct responsibility in the government.

US corporations are involved in the two mRNA vaccines currently in use, a fact that highlights US power to pursue innovation. The collaboration between Pfizer Inc. and BioNTech SE in Germany brought us a Covid-19 vaccine, thanks to the US pharmaceutical company’s attitude of aggressively seeking cooperation among companies beyond the borders that might restrain activity under normal circumstances. It has made me realize, once again, the importance of open innovation.

During the rest of my stay in the United States, I look forward to gaining further insight into what drives the US power to innovate.

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HxD 2021

ACCJ drives innovation by bringing together startups and big pharma

Last August, the American Chamber of Commerce in Japan (ACCJ) announced Healthcare x Digital, an XPRIZE-style competition meant to spur industry-changing technologies and connect Japan-based startups with major pharmaceutical companies and public officials.

Driven by the ACCJ Healthcare Committee—with support from the chamber’s Kansai Chapter—the initiative is led by ACCJ Corporate Sustaining Members AstraZeneca K.K., Bayer Yakuhin, Ltd., Deloitte Touche Tohmatsu LLC, and President’s Circle Member Eli Lilly Japan K.K.

The inaugural event was a huge success, with 28 companies submitting proposals. Three finalists were selected from this pool, and each emerged from the December 1 Pitch Event with awards and prize money to help them continue development of their ideas. Honors went to:

• Bisu, Inc.: Best Innovation; the Moonshot Prize
• MediFrame, Inc.: Best Value Proposition
• MICIN, Inc.: Best Product

Great Opportunity

In a follow-up interview, Bisu Chief Executive Officer Daniel Maggs told The ACCJ Journal that participation in the Healthcare x Digital competition was important to them because “it matters for us to have validation and recognition from the medical industry, because we care very deeply about quality.”

Ryoichi Kusama, co-founder and senior vice president of MICIN, said that his company wants to help the medical industry change from within and become a player that can be trusted. Therefore, “the biggest plus is that it has expanded the collaboration with major pharmaceutical companies.”

And Mediframe CEO Atsushi Wada said that it meant a lot to him to be recognized by AstraZeneca, Bayer, and Lilly. “For them to see the potential in my company made me feel very pleased and encouraged.”

This year’s competition will once again bring together global healthcare leaders with top and emerging tech companies, entrepreneurs, and innovators in the search for new ideas.

Three Challenges

Healthcare x Digital 2021 will carry forth the goal of forging new partnerships and creating new solutions to solve Japan’s most critical community healthcare and individual patient challenges by focusing on three areas:

• Overcoming the urban vs. rural healthcare divide
• Reimagining the hospital of the future
• Empowering patients to own their healthcare

These areas tie into the digital transformation of society and can help Japan continue to take care of—and provide even better care for—all its citizens. Demographic and economic trends are creating a strong contrast between rural and urban regions, and these shifts will require Japan to adopt new healthcare approaches and solutions. One question being asked in this year’s competition is how digital technology can break down the boundaries of distance to provide great and uniform care for everyone, no matter where they live.

Of course, reform of the healthcare system puts great pressure on hospitals to transform themselves and make better use of tools and resources. Technology is certainly key to that makeover, but what are the most innovative digital levers that can open up those paths to greater efficiency?

Another important part of ensuring that the healthcare system remains sustainable is empowering individuals to monitor their own health. A great example of such a tool is Bisu’s home health lab, for which the startup won ¥1 million in funding at last year’s competition. The elegant and easy-to-use system supports a range of tests that anyone can perform at home, allowing early disease detection and providing a way for individuals to track their health and adjust their daily lifestyle habits and decisions.

Joining Forces

At the core of Healthcare x Digital is the goal of bringing together emerging players—who have healthcare ideas, but require partners—with established players looking for innovative ideas to solve healthcare challenges.

This is made possible through the Healthcare x Digital ecosystem, which comprises four groups:

• Innovators and startups
• Established companies
• Government organizations
• Academic and non-profit institutions

These public, private, and non-profit sector players join forces to deliver all the pieces required to envision and execute groundbreaking solutions.

In the private sector, startups often have innovative digital healthcare ideas, but they lack the partnerships to evolve them. Teaming up with established companies that have the resources to develop an idea and bring it to market can allow the startup not only to grow as a company, but to change the course of future healthcare.

In the public and non-profit sectors, government bodies are searching for solutions to long-term healthcare challenges, such as cost, quality, and access. They want to drive innovation, which can lead to economic growth, but how to drive that change is not always clear. Academics and research institutions have insights that can help effect change, and they need a way to translate this into real-impact non-profit organizations.

Pitch Your Idea

Healthcare x Digital 2021 began accepting submissions on July 1 and the deadline is October 1. Evaluation of submissions is set to start on October 5. Pitches will be evaluated according to the following criteria:

• Focus on patient and community needs
• Healthcare x Digital value proposition
• Need for an ecosystem to flourish

Everyone who participates in Healthcare x Digital will benefit from having their ideas reviewed by top executives from leading international healthcare and technology companies.

Those selected to participate in the Pitch Day will be invited to the full-day virtual event on October 14. Finalists will then take part in the HxD Ideas Day on November 11, a hybrid in-person and virtual event at which they will present to a panel of leading healthcare and pharmaceutical executives—all empowered to initiate business deals and new relationships on behalf of their global brands.

Monetary prizes will also be awarded, and the finalists will meet with senior executives from the organizing sponsors. Winning companies will receive mentoring and support from healthcare professionals and executives from organizing sponsors.

Join us to discover Japan’s most innovative healthcare ideas and develop partnerships to make them a reality.

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Sponsors

President’s Circle Sponsor

Eli Lilly Japan K.K.

Organizing Sponsors

AstraZeneca K.K. | Bayer Yakuhin, Ltd. | Deloitte Touche Tohmatsu LLC | i2.JP (Innovation Infusion Japan)

Contributing Sponsors

Dentsu | K&L Gates LLP | NRW Global Business | Omron Corporation | Trilations G.K. | Real Life Sciences

Supporting Organizations

City of Kobe | Embassy of the United States, Tokyo | Foundation for Biomedical Research and Innovation at Kobe | Global Venture Habitat | GVH#5 | LINK-J | Osaka Innovation Hub

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Impact of Engagement

Continuing our efforts to communicate the value of investing in health

Japan faces a very modern problem: its success in delivering universal health coverage and fostering longer life expectancy has led to demographic and social changes that are giving rise to a new set of interconnected healthcare challenges.

As the Japanese government moves to reform its healthcare system to address these challenges, new policy approaches will be necessary. Promoting innovation in all areas of the system will allow for increased healthy life expectancy and improved productivity, helping Japan move to the next phase of economic growth. And all this can be achieved while maintaining Japanese patients’ access to the most cutting-edge medicines, technologies, and treatments, while ensuring the security and stability of health and social care.

With the right approach and policies, Japan can continue to improve the health of its citizens and create a blueprint that aging societies around the world can follow.

More Agile Advocacy

On the back of our successful health and retirement work, the American Chamber of Commerce in Japan Healthcare Committee is now moving forward with our biennial health policy white paper. The upcoming report will look different compared with earlier reports. Previous white papers published by the Healthcare Committee have included topics ranging from the use of advance modeling and simulation in pandemic-related planning to improving cervical cancer screening. However, the wide range of topics made it difficult to maintain an up-to-date and compelling narrative in a single document.

Starting with our next white paper, we plan to create more succinct recommendations that fit with the overall messages of our committee viewpoints. The individual viewpoints will become the tools with which to dig deeper into issues featured in the white paper, thus creating a hybrid set of materials that can be updated regularly and used with greater agility in our advocacy. We are excited about the new format, and appreciate the ongoing contributions of member companies.

In the forthcoming white paper, we plan to explore a range of issues, focusing our recommendations across four key themes:

• Investing in prevention, early detection, and treatment of disease
• Maximizing healthcare quality and efficiency through digital and data innovation
• Developing innovation policy, exploring reimbursement models
• Ensuring the financial sustainability of Japan’s healthcare system

We believe that each theme will help Japan chart a path to more sustainable healthcare, and we encourage you to join upcoming Healthcare Committee meetings to learn more about our ongoing efforts and to help us finalize our recommendations.

To help you consider what form those final recommendations should take, here is more information about each of the key themes.

1. Prevention, early detection, treatment

In recent years, the Japanese government has shifted its focus from simply caring for disease to applying the practices of prevention, early detection, and earlier aggressive treatment to reduce overall healthcare expenditure and to sustain the productivity of its citizens. While significant progress has been made, much more could be done.

2. Digital and data innovation to boost quality, efficiency

Recognizing the need for better healthcare data management, the Japanese government has begun to centralize data platforms, accelerate data-driven innovation programs, and strengthen cybersecurity infrastructures to safeguard against external threats.

Yet, despite these efforts, Japan trails other developed countries in the implementation of a comprehensive healthcare data platform. Much more could be done to incentivize better collection and utilization of healthcare-related data.

3. Innovation policy, reimbursement models

In response to calls for the acceleration of healthcare innovation in Japan, the government launched a healthcare innovation initiative in 2014. Since then, the government has pursued several broad initiatives for research and development support, as well as the registration, authorization, commercialization, and evaluation of new healthcare technologies.

Despite this, reforms made to the pricing of, and reimbursement for, innovative medical technologies threaten to undo the progress made over recent years. With the clear purpose of delivering innovative healthcare to people in need, as soon and safely as possible, more could be done to allocate physical, human, and financial resources to maximize the potential for innovation.

4. The healthcare system’s financial sustainability

Japan’s healthcare system is respected around the world for its quality of care and contribution to long life expectancy. However, the aging society and low birthrate are straining a system designed, starting in 1868, primarily to control infectious and acute diseases in a different population structure. Improving the overall financial health of the system will be critical as more of the population ages and the workforce shrinks further.

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ACCJ Healthcare White Papers & Viewpoints

The ACCJ Healthcare Committee strives to stimulate multi-stakeholder partnerships and discussions that will drive healthcare transformation by identifying practical, tangible actions and providing innovative solutions that address patient needs and ensure the sustainability of Japan’s healthcare system. Read advocacy documents and get involved in the committee’s ongoing efforts at: www.accj.or.jp/healthcare-advocacy.

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Beyond the Pandemic

Digital health can guide the way for Japan’s post-virus evolution

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As the ACCJ is dedicated to ensuring a vibrant environment for global business in Japan, advocacy for improved health policy and initiatives is an important part of the chamber’s mission. One reason that foreign companies choose to invest in Japan is the nation’s high-quality manufacturing and services sectors, as well as its technological prowess and innovative workforce. Maintaining the health of the population—beyond the immediate challenges of Covid-19—is, therefore, critical to the future prosperity of the country and the viability of its business environment.

Recognizing this, the ACCJ has worked with the Institute for New Era Strategy (INES) to bring together key leaders in business, government, and academia to discuss the future shape of social security in Japan. The results can be found in the Healthcare Committee white paper Post Covid-19 Recommendations to Realize a Social Security System for All Generations.

Stronger Foundation

Our evolution as a data-based society has allowed us to grasp the impact of Covid-19 in real time, and digital tools have enabled the active cooperation of civil society as the government works to mitigate the threat and limit its damage. While this is an encouraging sign that bodes well for the future of Japanese society, the state of Japan’s infrastructure has been inadequate compared with other countries.

The ACCJ and INES provide ideas on how to build a stronger infrastructure through post-Covid-19 recommendations on how to realize a social security system for all generations, and to promote continued innovation and application of technology that can help Japan provide for the needs of its people in a way that is effective and fiscally sustainable.

The white paper discusses utilizing data technology, shifting financial resources to healthcare and retirement, and raising the health and financial literacy of society.

In terms of digital health and utilizing data technology, areas of focus include:

• Information usage rights
• Data collection
• Database integration
• Public–private collaboration
• Telehealth and virtual care

In the case of the last item, the Covid-19 pandemic has thrust this need to the forefront. As most people have been forced to stay home for extended periods, quarantine, or limit visits to clinics and hospitals, healthcare services at a distance has been the only way for many patients and doctors to interact. Particularly those in high-risk categories due to preexisting conditions, and those living in rural areas, have relied on telehealth services to minimize the risk of infection during the pandemic.

Stay the Course

One concern is that, once the coronavirus vaccine rollout is complete and a majority of the population has been inoculated, some digital initiatives that have been embraced might fall by the wayside as Japan fully returns to normal routines.

One recommendation from the joint ACCJ–INES team states: “It is essential to couple the support for telehealth with support for digital prescriptions, and to enable pharmacies to offer home delivery of important medications, all while expanding the overall role of digital technologies in delivering care. These measures will help support the aging population long after Covid-19, and enable new approaches to triaging, screening, and following up, customizing the patient experience, and improving the ability of doctors to monitor and communicate with their patients.”

Doing this will require a change in mindset and policy. While many forms of digital data exist in Japan, the individual’s consent is often not obtained at the time of collection, making it impossible to utilize the information. Even if the data is in the government’s possession, it is still difficult for it to be leveraged due to privacy considerations.

But with Japan’s fiscal strains exacerbated by the coronavirus, now is the time for the government to tackle these challenges. Strong political will and leadership are required to face reality, make the right choices, and share with the public a vision for a better future. And today’s digital tools and the power of data are making this possible and opening a door to a healthier, sustainable tomorrow.

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