Interview

Do you know a medical condition that afflicts more than 10 million people a year across the world? It is premature birth where the baby is born before 37 weeks of gestation. Ultrasound (echo) has long been used as a means to monitor the condition of a fetus between 24 and 30 weeks of pregnancy. Echo monitoring, however, is primarily intended to see the shape of the fetus and cannot determine whether the functional development of the fetus is going normally. Professor Yoshitaka Kimura of the Graduate School of Medicine, Disability Science, International Disciplinary Biomedical Engineering and Professor Nobuo Yaegashi, the Director of Tohoku University Hospital, have worked devotedly for over 10 years to develop a fetal electrocardiogram device for the functional monitoring of the condition of a fetus. On April 12, 2016, Professor Kimura and Professor Yaegashi received the Commendation for Science and Technology from the Minister of Education, Culture, Sports, Science and Technology (Prize for Science and Technology, Development Category) in recognition of the development of this fetal electrocardiogram device that enables fetal monitoring in a hospital room. We interviewed these two professors about how the development got started and progressed as well as about the future prospects of the device.

PR Office:
Could you give us an outline of the research for which you have been commended by the MEXT?

Prof. Kimura:
Do you know a medical condition that afflicts more than 10 million people a year across the world? It is premature birth. Premature birth is likely to lead to perinatal death and is therefore the most common cause of neonatal death. Premature birth can also result in disorders of the eyes and ears and cerebral palsy. It is said that a majority of premature newborns will be affected with higher brain dysfunction (impairment of social adjustment) by the time they reach five years of age. The worldwide increase in premature births is now a huge social problem. Surprisingly, however, not only do we have no established method to prevent premature birth, but no means is available for premature birth monitoring. Control of premature birth is entirely left to the experience and discretion of individual doctors. We have developed a fetal electrocardiogram device, which was formerly believed to be impossible to develop, and proven through clinical trials for the first time that fetal monitoring is possible for fetuses between 24 and 30 weeks of gestation. Currently, this fetal electrocardiogram device is the only method in the world to monitor fetuses between 24 and 30 weeks of gestation.

PR Office:
What aspects of your research were appreciated?Prof. Kimura:
I think there are two things. The first thing is the fact that we have opened up new possibilities for fetal evaluation by developing the fetal electrocardiogram device. Secondly, we have fully proven the potential of the device to become a commercial product that can be used in clinical trials. No matter how far the research advances in the lab, you never know how useful it actually is in the real world. We have verified whether the developed device really helps, by bringing it into practical use at the hospital. I think that is what was appreciated most.

Prof. Yaegashi:
I think that the R&D project for which we received the prize is a good model of so-called bridging research where results of basic research are applied to clinical use. Unlike in ordinary development projects, the ideas that are generated in the basic research stage are tested in clinical trials to ensure that they are useful in clinical use. That is what we demonstrated.

PR Office:
How do you feel about being awarded for your research?

Prof. Kimura:
Frankly, I am pleased. I think it gave us a good opportunity to bring a new medical device to society. I am very glad that our R&D effort was highly regarded, but the important thing is what happens after this device is introduced for clinical use. The device will be put to the test when its use is being in the real world. We have to see whether our research will actually help save many babies. Anyway, I think that we received a very good prize for us because it gave a push to our hands-on approach. Now I feel that I need to brace myself up to work even harder.

Prof. Yaegashi:
It was the first time that the prize was awarded to a department of obstetrics and gynecology not only for Tohoku University but nationwide as well. A research achievement like the one we made had never come from an obstetrics and gynecology department until then. I think that the great originality and high-level work of our research were acknowledged. More importantly, it is Tohoku University Hospital that accomplished this feat. All the work, from the initial idea and development to the final clinical trials, was done within Tohoku University Hospital. I am grateful that they considered our research to be excellent.

PR Office:
Could you tell us about the challenges you had to overcome in developing the device?

Prof. Kimura:
I came up with the idea of the principle when I was lecturing my students. I thought, “We fail because we try to separate out signals from noise. If we take out all the noise instead of signals, then we will be left with the signals alone. Noise is larger than the signals and therefore easier to measure accurately. It’s reversal thinking. So the principle and the prototype of the device were ready 10 years ago. But it was tremendously difficult to improve on them so that they could be used in clinical use and conduct clinical trials in the department of obstetrics and gynecology where high confidentiality is always required. We had a number of other challenges to overcome. The research did not progress as planned, and we couldn’t get enough budget. Also, because of a shortage of manpower, we had to do the work on our own. Thanks to the cooperation of many people, though, we have made it this far. Building on these challenges, we intend to promote the device on a global scale.

PR Office:
What are the challenges you need to address in order to promote the device?

Prof. Kimura:
I think the biggest challenge is how we work with companies in joint development efforts. In the Japanese enterprise system, compared to those in foreign countries, venture companies do not grow or it is difficult for them to grow. So I think we are going to have to create a venture ourselves in order to supplement what the current system lacks. In today’s globalized society, even if you succeed in developing an excellent device in Japan, the rest of the world will soon catch up with you. It is urgent that we set up a university-based venture company and promote the device all over the world.

Prof. Yaegashi:
I agree that this is a tough challenge. When I went to the U.S., I saw people launch ventures quite easily and many funds invested in them. Compared to that, the situation in Japan is unfavorable.

PR Office:
Please tell us about the future prospects.

Prof. Kimura:
I think that what we need to do now is to create a system that allows the monitoring device to be attached in a simpler way and the monitoring to be done with ease. What we have in mind is a cloud-based system whereby the monitoring can be done by anyone anywhere.

Prof. Yaegashi:
Up until now, it was only the mother who could feel whether the baby was fine. Our monitoring system will enable us to obtain a fetal electrocardiogram and see in real time how the baby is doing.

PR Office:
What are the benefits of this system when compared with an echocardiogram?

Prof. Kimura:
To make a diagnosis with an echo, you need to use expensive equipment at the hospital. And what it does is not monitoring, because it only captures instantaneous images of the baby. In contrast, the system we are going to develop will enable us to monitor the baby for a long period of time not just in the hospital but when the mother is at home as well. Pregnant women in the obstetrics and gynecology department are special in the sense that there is no knowing what will happen to them or when it will happen. This system will provide patients with an extra layer of assurance. From the viewpoint of obstetrics and gynecology specialists, on the other hand, an enormous amount of data will be collected, making it possible to do big data analysis. Maybe that will reveal the differences in how individual obstetrics and gynecology specialists interpret the data, as well as the characteristics of each geographical region. Another benefit is that finding similar ECG waveforms will help predict the health condition of the fetus. I think it will be possible to offer a new kind of service that combines medical equipment with data analysis.

PR Office:
Is there anything that you do in your daily life to improve as a researcher?

Prof. Kimura:
I never cease to do three things: learn, train myself and be nice to people. This is what I always tell my colleagues and students. These three things are all I can think of doing. So whatever I can do, I do it with integrity.

Public Relations Office:
Could we have your messages to younger researchers and doctors?

Prof. Kimura:
I would like to see more young people venture into the field of obstetrics and gynecology.

Prof. Yaegashi:
In this research project, we are going to identify questions and needs in the field of clinical medicine. There are still unexploited areas in the realm of obstetrics and gynecology, particularly in obstetrics. The womb of a pregnant woman is a black box, so to speak, and, at the moment, it is difficult to act directly on the fetus. We are at a stage where seeing the shape of the fetus is barely possible using ultrasound. Since the fetus and placenta of humans are different from those of animals, effective animal experiments are difficult to do. So it can be said that many frontiers still remain in the science of obstetrics and gynecology.

Prof. Kimura:
The world is changing drastically. But a period of change means that there will be more opportunities for individuals to play active roles. Don’t feel at a loss what to do, but think that you have been given a chance to create new value yourself. I hear that what this drastically changing world now needs is smart creative people. According to the definition I’ve come across, smart creative people are those who are well versed in many fields and who are not only interested in their own environments and surrounding ones but also extensively interested in other fields and vast areas of knowledge. They also have highly practical expertise and experience and are capable of creating new things continuously.
Of course, it is very important to master the tradition that our predecessors have built over the years. But science and medicine are both changing so significantly that we can no longer settle for the existing tradition alone. Being born in an era of change is the greatest gift from heaven. It is young people who can initiate a new Renaissance. Think out of the box and create a new world. In the department of obstetrics and gynecology, you can take on a diverse range of challenges. I hope that many young people take interest in this field of medicine.

(2016.8.15)