Invitation to “Communities, People and Work Creation Conference” held at Prime
Minister’s Office
Approval of super downsized mobile CTG (Petit CTG) as medical device
Kazuhiro Hara
Professor emeritus of Kagawa University
Specially Appointed Professor of Kagawa University,
Seto Inland Sea Regional Research Center
Chairperson of NPO e-HCIK
Chairman emeritus of the Japanese Telemedicine and Telecare Association
Introduction
On November 21, 2018, Ms. Ogata, CEO of Melody International Ltd. and I
were invited to “Communities, People and Work Creation Conference” held at Prime
Minister’s Office. We were given an opportunity to present ultra-small-sized mobile
CTG called Petit CTG, its approval as medical device, and its global development at theconference. It was very honorable that we could directly speak with Prime Minister
Abe about our development plan not only in Japan but also in ASEAN nations, African
nations, South and Central American nations, and other parts of the world. We also
took commemorative photos (Fig. 1).

(Fig.1) Commemorative photo with Prime Minister Abe at “Communities, People andWork Creation Conference” held at Prime Minister’s Office(Fig.2) Commemorative photo with Mr. Suga, the Chief Cabinet Secretary and Ms.
Ogata, CEO of Melody International Ltd.
This paper reports the purpose and direction of “Communities, People and Work
Creation Conference”, which is one of the most important national policies that thenational government is promoting. It also discusses how telemedicine, perinatal
control, medical IT innovation especially on medical device development, and its global
expansion draw particular attention.
1. What is “Communities, People and Work Creation Conference”?
“Communities, People and Work Creation Conference” is held by “Communities,
People and Work Creation Conference Headquarter”. The headquarter was organizedunder the second Abe administration on Sep. 3, 2014, with aims to generate sustainable
and autonomous society utilizing each region’s unique features. It addresses
significant issues of rapid population decline and extreme aging society that Japan iscurrently facing and to tackle those problems with the entire government members
united as one team. It is a legal organization directly established under the cabinet.
The conference was held 17 times between September 2014 and December 2018,
and the results were presented as “Communities, People and Work Creation Conferencecomprehensive strategy” every year.
https://www.kantei.go.jp/jp/singi/sousei/info/pdf/h30-06-15-kihonhousin2018hontai.pdf
Its fundamental missions are as follow;

(1) Overcoming population decline and revitalizing shrinking regional economy(2) Establishment of favorable circulation among communities, people and jobs
・Creation of jobs
・Creation of people
・Creation of communities
In short, its main tasks are to halt population decline, correct population
concentration in metropolitan area, secure work-life balance in regional areas, and tosustain energetic Japanese society for the future. In order for that to happen, thecentral government, regional municipalities, educational institutions such as university,and private companies should work together as one team to vitalize regional areas,
nurture energetic companies and human resources, and secure worksites where young
people can work with hope and provide places for them to safely give birth and raisechildren.
For the above purposes, basic policies for revitalization of regional areas weresettled as follows.
(1) Fulfillment and reinforcement of regional area for each stage of life(2) Implementation of “Realization policy of exciting life in regional area”- Fundamental reinforcement measures to promote transferring young people toregional areas- Finding new manpower through active participation of females and elderly- Utilization of foreign labor force in regional areas- Effective and strategic advertisement to draw people’s attention
The followings are listed as particularly important policies.
- Reinforcing competitiveness of regional industry (cross-industrial measures)- Creation of environment to promote start-ups by females- Promotion of start-up companies’ entry into public sector projects- Bringing in foreign and exterior demands into regional areas for revitalization ofregional economy- Supporting top companies/top global companies in niche industry by public
offices’ cooperation- Formulating regional comprehensive strategy policy for each municipality
Kagawa Prefecture already established “Kagawa Prefecture Industry Growth
Strategy” in 2013, one year prior to national “Communities, People and Work Creation
Comprehensive Strategy”. Later, “Kagawa Prefecture Industry Growth Strategy” wasrevised to be “Kagawa Generation Comprehensive Strategy” as Kagawa Prefecture
version of regional comprehensive strategy.
https://www.pref.kagawa.lg.jp/content/etc/web/upfiles/wsb3bt151030115001_f03.pdf
The followings are the list of specific measures of “Kagawa Prefecture Industry
Growth Strategy” and “Kagawa Generation Comprehensive Strategy.”1) Growth/accumulation of growing industry- Promotion of manufacturing project “Studying the past to learn new things”- Promotion of “Kagawa rare sugar white valley” project- Promotion of olive industry reinforcement project- Promotion of K-MIX related industry development project- Promotion of attractive agricultural and fishery products into sixth industry
2) Support companies with unique features and reinforce their competitiveness- Accelerating promotion of start-ups and secondary business- Reinforcement of R&D/fundamental technology- Support companies for overseas development- Development and securing human resources to support industry development- Reinforcement of enterprise location and industry foundation
National government’s “Communities, People, Work Creation Comprehensive
Strategy” stated the following three.
- Finding new manpower through active participation of females and elderly- Promotion of start-up companies’ entry into public sector projects- Bringing in foreign and exterior demands into regional areas for revitalization ofregional economy“Kagawa Prefecture Industry Growth Strategy” and “Kagawa Generation
Comprehensive Strategy” stated the followings.
- Promotion of K-MIX related industry development project- Support companies for overseas development
The above items of national policies match with our long-term work of thefollowings.
- Development of ultra-small-sized mobile CTG (Petit CTG)
- Approval as university originated start-up company- Approval as a medical device- Our oversea projects in Thailand, Laos, Myanmar, South Africa supported by
Ministry of Internal Affairs and Communication (MIC), Ministry of Economy,

Trade and Industry (METI), and Japan International Cooperation Agency(JICA.)
Therefore, it is considered that we were given an opportunity to present our work in“Communities, People and Work Creation Conference”.

(Fig.3) “Kagawa Prefecture Industry Growth Strategy”
To promote K-MIX related industry growth project, the followings are clearly
described.
2. Spreading the wonderful Japanese prenatal (fetus/neonate) management todeveloping nations
As I already reported in the past article (December 2014 and January 2017), we
have been working on development of fetal monitor known as cardiotocomonitor forover 40 years. Our fetal heart rate detecting method is incorporated in the most fetalmonitor currently used in the world. Fetal monitor is used for most pregnancy anddelivery management in developed nations, and prenatal mortality rate declined
significantly. Especially, Japan has the lowest prenatal mortality rate in the world.
(Reference 1 and 2)
On the other hand, prenatal mortality rates in ASEAN nations, African and SouthAmerican nations are several ten times higher than that of Japan. Therefore, prenatal
medical situation in those nations needed immediate attention. (Fig.4)

Prenatal medical issues in those developing nations are due to insufficient number offoundation and core hospital to implement prenatal care. In addition to that,obstetrician/gynecologist and midwife are significantly insufficient, making it difficult
to systematically and continuously manage pregnancy, delivery and newborn infants.

(Fig.4) Kagawa Prefecture, the safest place for pregnant women in the world
Prenatal mortality rate in Japan is the lowest in the world. Kagawa has the lowest ratein Japan.
Prime Minister Abe visited all the ASEAN nations and strengthened supports
for them. Support for medical field is especially emphasized, and various projects
such as hospital construction and medical device implementation by official
development aid (ODA) and JICA fund were implemented.
Kagawa Prefecture and Kagawa University also worked on prenatal projects
using mobile CTG in Thailand, Laos, Myanmar, Indonesia, and South Africa withsupports from Asia-Pacific Telecommunity (APT) of MIC and JICA. It has been very
successful, yielding many positive results. (Reference 3-6)
As seen above, our overseas prenatal projects were highly evaluated, but
demands for further light-weighted and downsized mobile CTG were very high.
3. The history of ultra-small sized mobile CTG development

As mentioned previously, fetal monitor was developed in 1970s. However,equipment was quite large and heavy back then, weighing over 10 kg. Therefore, it
was unavoidable for it to become a stationary type installed in hospitals. It was also
extremely expensive. (Fig. 5)(Fig. 5) History of fetal monitor development
Large-sized installed type CTG to mobile CTG, and to super downsized Petit CTG
Nearly fifty years passed since then, and fetal monitor was gradually improved.
Main unit was downsized, and connection between main unit and two probes,
ultrasound transducer and uterine contraction monitor, became wireless. Pregnant
women can now move around in hospital with transducer attached on their body.
By connecting the equipment to central monitor, it is now possible to monitor
multiple pregnant women simultaneously. Recently, fetal heart rate pattern can be sentto physicians through internet. However, the equipment is still installed and used onlyin the hospital.
Therefore, mobile fetal monitors which can be used at home drew attention.
We have been working on mobile CTG development for over twenty years since 1990s.
In 1990s, we used system with telephone line and acoustic coupler for high risk
pregnant women in Shodo Island. (Fig 6) Later, we used ISDN and modem for PC
network. Following that, we developed downsized portable system (weight: 2.0 kg) in
response to popularization of internet, cellphone and smartphone. With this device,pregnant women and physicians can monitor fetal heart rate in or outside of hospitals.
(Fig.7) (Reference 7-11)(Fig.6) Fetal monitor at home at the initial stage of development
It was prohibited to transmit digital signal on telephone line then, and acoustic coupler
was used to transmit fetal heart rate.

(Fig.7) Mobile fetal monitor at home (mobile CTG) development
Cellular network has spread nationwide, enabling development of mobile CTG.

As for transmission of fetal heart rate, data standardization is important.
Therefore, The Japan Association of Obstetricians and Gynecologists specified the data
format for fetal heart rate information file (1999). (Reference 12)
http://www.jaog.or.jp/sep2012/JAPANESE/jigyo/JOUHOU/H10/shinpaku.htm
4. The developmental concept of super downsized CTG (Petit CTG)
As for development of super downsized CTG (Petit CTG), we designed it
based on totally new concepts without adhesion to conventional technology.
1) It is be portable and operates on Cloud, and fetal heart rate can be transmitted fromanywhere both domestically and internationally.
2) Fetal heart rate is to be recorded on a server of data center.
3) Complete paperless is to be realized. No recording paper is used.
4) Electrical circuit of fetal heart monitor is to be downsized and mounted in the caseof ultrasound transducer and contraction transducer.
5) Commercial tablets are to be used for display of fetal heart rate and uterine
contraction, and internet connection.
6) Tablet’s Bluetooth connection is to be used between ultrasound transducer andcontraction transducer.
7) Li-ion battery is to be used as a power source, enabling cable-free usage. (Thisallows it to be used in developing countries where power supply is unstable.)
Of these goals, the most challenging technological obstacle was downsizing andintegrating the electronic circuit (circuit for emitting and receiving ultrasound wave, andcircuit for detecting fetal heart rate, hence analog circuit and digital circuit), and putting
them into small transducer casing.
5. Establishing “Melody International Ltd.”, Kagawa University originated Start-up
Company
It tends to be difficult for existing enterprises to develop medical equipment
based on a totally new concept due to high risks they need to take. Therefore, weestablished a start-up company called “Melody International Ltd.” whose president is
Ms. Yuko Ogata, in partnership with Kagawa University (July, 2015). From Kagawa
University, visiting professor Yasuto Takeuchi and I became advisers of the company.
By the way, professor Takeuchi and I are the founders of the basic principle of fetal
heart monitor (1974), which is now universal standard.
The basic policy of establishment of “Melody International Ltd.” was in linewith “Kagawa Industrial Growth Strategy.” The goal was to conduct everything fromdesigning to manufacturing in Kagawa prefecture, where the perinatal mortality rate is
the lowest in Japan and the world, and appeal the device as “Made in Kagawa” brand in
the world.

(Fig.8) “Melody International Ltd.” , a venture company originated in Kagawa
University
From Kagawa University, visiting professor Yasuto Takeuchi and I took office asadvisers of the company.

Launching business enterprise required a large amount of fund for research anddevelopment. Fortunately, we were able to obtain following subsidies to cover suchcosts.
- “Subsidy for creating fields to accelerate growth” from Kagawa prefecture- “ICT innovation creation challenge program (I-Challenge!)” from MIC- “Tobidase-Japan! Subsidy for development in growing markets in the world” from
METIThanks to the subsidies above, on May 2018, we obtained an approval for
production and distribution for medical equipment “Petit CTG,” and were officiallyapproved as Kagawa University-originated Startup Company (Fig.9)(Fig.9) Approved as a start-up company originated in Kagawa University
Commemorative picture with dean of Kagawa University
It is generally said that rural start up enterprises have difficulty obtaining suchapproval for medical devices, but Melody International Ltd. was able to obtain it only 2
years and 10 months after its establishment. We are grateful for the entire concerned
individual’s support in making this possible. It was also fortunate that the building
complex which Melody International Ltd. moved into (NEXT Kagawa, Kagawa
Industry Support Foundation) had its own radiowave darkroom, an essential facility inconfirming medical device’s safety.
6. Configuration of Petit CTG and actual usage
The official name of Petit CTG is Mobile Cardiotocomonitor “iCTG”, and it
comprises of an ultrasound transducer for detecting fetal heart rate, transducer for
detecting uterine contraction, data displaying tablet, and controlling software.
Controlling software is to be installed into the tablet (windows 10 device, iOS device).
The transducers and the tablet transfer data via Bluetooth. The data transferred to thetablet is transmitted to the internet through WiFi at medical institution or home, or 4G(LTE) mobile network system.

Back in the 70s, cardiotocomonitor weighed more than 15kg (including
carrying cart), but our Petit CTG system weighs only 300g (weight of 2 transducers).
That is up to 1/40~1/50 downsizing.
As for actual use of the device, heart-shaped ultrasound transducer is placed on
the abdomen of a pregnant woman. Stabilize it once you found an optimal location for
detecting fetal heart sound. This makes it easier to extract fetal heart rate. The
transducer itself only weighs like an average smartphone and it is complete cable-free,enabling expectant mothers to easily move around. (fig.10)(Fig. 10) Further downsizing was enabled. Petit CTG
Ultrasound transducer is placed on the abdomen of a pregnant woman to search for a
spot where fetal heart rate can be heard. Significantly easy detection of fetal heart ratechange is enabled.
If you are connected to an internet, not only you can use it in medical facilities
and at home, but also within vehicles, trains, and inside an ambulance for emergency
transfer. Oversea tests have been done already in ASEAN countries like Thailand andIndonesia, and also in African nations like South Africa and Zambia. Basically, as
long as you are connected to an internet, you can use this system from anywhere in theworld.
7. Achieving complete paperless cloud system, suitable for an era of electronic medical
recordAn electronic medical record system is quickly adopted in today’s medical field,
making a shift towards paperless environment. Another recent trend is to accept cloudserver instead of placing data server within a medical facility.
Traditionally, cardiotocomonitor required recording paper, and recent devices
still have built in instrument for recording paper. It takes a lot of space to keep andstore past recording papers, becoming a burden for medical facilities. It was also timeand energy consuming to find necessary fetal heart rate from a bundle of paper record.
Since its initial designing, Petit CTG aimed to get rid of paper recording anduse cloud server to save and store information semi-permanently. This would decreasea burden of medical facilities to maintain physical storage space for recording paper,and enables easy referencing of past fetal heart records. It can be said that Petit CTG
is one step ahead of trend of the era.
8. The 2nd Phase “JICA Grassroot Technical Corporation Project” in Chiang Mai,
Thailand and a research project in Myanmar
An overview of our oversea projects was mentioned in the previous article(January, 2017), and recently we newly working with Asia-Pacific Telecommunity(APT-CI, MIC) project in Kayin, Myanmar. The national government of Myanmar
and Yangon First University of Medicine showed high interests in this project.
“A Collaboration Project for ICT Telemedicine for Perinatal Care andDiabetes in Thailand - JICA Grass roots Cooperation Project –“ in Chiang Mai,
Thailand was particularly highly evaluated, and from this year, the second term (for 3
years) was approved. The scope is expanded from the region around Chiang Mai
University (3 medical institutions) to the entire region of Chiang Mai Prefecture (25medical institutions). It is a grand project to improve prenatal mortality rate.
Petit CTG is already introduced in 15 facilities and they are operating well.
10 remaining facilities (out of the total 25 facilities) will receive the device next year,
and fruitful result is expected. (Fig.11)

(Fig.11) The 2nd Phase “JICA Grassroot Technology Corporation Project” in Chiang
Mai in Thailand
The scope is expanded from the region around Chiang Mai University (3 medical
institutions) to the entire region of Chiang Mai Prefecture (25 medical institutions).
Grand project to improve prenatal mortality rate has started.

Conclusion
In the present article, purposes and concepts of “Communities, People andWork Creation Conference” which is promoted as the most important national policy
was reported. An importance of innovation in telemedicine and medical device inrelated to the conference was also discussed. In such a social framework, we launcheda university originated start-up company, and developed super downsized mobile CTG(Petit CTG) and gained approval as a medical device.
Outstanding features of Petit CTG are that it is Cloud-based, and usable inanywhere in the world if internet connection is available. It is technically possible tomanage fetus in the whole world by Petit CTG in the future. In such case, the volumeof CTG data will be significantly large, and it will be necessary to implement automatic
diagnosis function by AI on a server. It will be an optimal model to collect medical
big data.

Internet of Thing (IOT) is often mentioned recently. We would like to makeInternet of Fetuses (IOF) into a reality in order to monitor fetuses in the entire world
through internet network. (Fig.12) (Reference 13-16)(Fig.12)Internet of Thing (IOT) is often mentioned recently. We would like to make Internetof Fetuses (IOF) into a reality in order to monitor fetuses in the entire world throughinternet network.

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