A region on the forefront of dialysis treatment: Nikkiso automation gathering attention in Europe

Nikkiso has been a leader in dialysis therapy for more than fifty years with its original technology and know-how. Nikkiso's share of the domestic market for hemodialysis machines (hereinafter referred to as "dialysis machines") exceeds 50%. In the 1990s, Nikkiso developed a dialysis machine that conformed to European standards. Since then, Nikkiso products have been used in Europe and other countries as well.

In the series "For Patients Around the World," which begins with this article, Nikkiso, a pioneer in dialysis machine manufacturing, will introduce its efforts to meet the needs for dialysis therapy not only in Japan but also around the world.

In this first installment, we interviewed Yuki Matsubara, who works at Nikkiso Medical Europe GmbH (Nikkiso Medical Europe) in Germany, where Nikkiso established its first overseas office. We spoke with him about the differences between Japan and Europe regarding dialysis treatment and the reasons why Nikkiso's products are highly regarded overseas.

Nikkiso can meet the needs of Europe, where technical requirements are high

—— First of all, can you please tell us how Nikkiso made inroads into Europe, a market where there are many major competitors present?

Matsubara: Originally, in Europe, major local dialysis machine manufacturers led the market and had established the standard for dialysis machines. One strategy was to enter an untapped section of the market rather than compete in the highly competitive ones. In order to enhance Nikkiso's brand power and reliability, however, we needed to demonstrate a track record in Europe. The reason for that is because success in Germany and France end up being a major factor when expanding sales to other countries.

Also, Europe is characterized by strict standards and high technical requirements. Nikkiso is also a company with confidence in its technological capabilities, so we thought that what we have to offer would match the needs of the market. Moreover, our decision to aim at entry into the European market was also related to our desire to develop new high-end models, since it's easier to capture demand in that market for higher functionality.

——  What are the differences between Japan and Europe regarding hemodialysis treatment?

Matsubara: First of all, the system by which dialysate is supplied, differs in Japan and Europe. There are thus differences in the devices used themselves. In Japan, dialysate is supplied by a method known as the "central dialysis fluid delivery system," while in Europe, a method known as the "individualized method" is used, with the "Personalized method" involving the usage of "personalized dialysis machines."

The central method is a method in which dialysate is prepared in batches by the dialysate regulator located in the machine room and is then distributed to the dialysis machines of multiple patients in the treatment room. This method is characterized by the ability to efficiently supply dialysate.

The individualized method used in Europe, on the other hand, is a method in which dialysate is made individually by each patient's dialysis machine, with the composition and concentration of the dialysate varying according to the patient. Since Nikkiso has traditionally possessed the technology for both systems, we have delivered equipment with the method best suited to the local treatment environment and the needs present.

—— So, the supply systems differ from country to country. Are there any other points that are unique to Europe?

Matsubara: Europe is also characterized by a demand for high-end models. However, there are slight differences among countries even though all those countries are located in Europe. In France, for example, dialysis treatment is provided at general hospitals rather than at specialized dialysis clinics. As such, equipment with a full range of optional functions is required so that the various physicians treating the patient can ascertain the patient's situation and respond quickly.

Specifically, we often install four types of equipment: blood pressure monitors to measure blood pressure during dialysis treatment, dialysis dose monitors which can measure dialysis dose in real time, blood volume monitors to monitor relative changes in blood volumes, and Central concentrate mechanisms which allow for the systematic supply of Acid concentrate to devices.

—— Can you shed some light on the areas of culture and value sets?

Matsubara: Sometimes we feel as though there are gaps in terms of needs due to cultural differences. As for equipment design, for instance, Japan requires flexibility in terms of treatment, so we incorporate features that allow for flexible operation to take place at the discretion of medical professionals.

In Europe, however, manufacturers are required to fully determine the procedures and rules. This means that Nikkiso is required to have a clear approach established in that regard, with equipment being designed so that it cannot be used unless usage complies by procedures along with the established approach. Specifications in demand in Japan that allow for flexible handling to be undertaken by medical professionals can also serve as a disadvantage.

Acclaim won in Europe starting with automation systems

——What led to Nikkiso's dialysis machines to become the subject of recognition in Europe?

Matsubara: The catalyst was DBB-EXA, which was launched in 2015. It was the first device for overseas markets to incorporate the D-FAS (Dialysis-Full Assist System) automation function that had been adopted in Japan, and it attracted attention as an innovative model.

Before hemodialysis treatment can be performed, consumables such as blood tubing lines and dialyzers must be attached to the equipment. Then, the tubing lines must be flushed and filled with physiological saline or highly purified dialysate solution. In addition, the blood remaining in the blood tubing lines must be returned to the body after treatment is completed. In the past, these pre-treatment and post-treatment tasks were all performed manually by medical professionals. However, with the DBB-EXA, you just set up the consumables and press a single button. The device will then automatically complete the series of tasks for you. By reducing the time required for treatment preparations undertaken by staff, more time can be spent on providing patients with care.

With the DBB-EXA, Nikkiso's technical capabilities were recognized in Europe and the number of devices being adopted had increased.

One of the reasons for this strong performance is the shortage of medical professionals in Europe. Dialysis machines depend in part on the ability and skill of the operator, but the reality is that there are not enough nurses, who also constitute the operators of these machines, working in the field. More and more situations called for the relatively easy-to-operate DBB-EXA. I have heard that Nikkiso's automation systems had such an impact on the market at the time that competitors felt a sense of crisis.

—— It seems that labor shortages constitute a pressing issue every country. What kind of initiatives is Nikkiso undertaking to confront this issue?

Training facility in Hamburg, GermanyMatsubara: Follow-ups on education is something that is important to us. Having nurses teach each person how to operate the dialysis machines would result in heavy burdens being shouldered at treatment sites. Therefore, Nikkiso's maintenance staff and dedicated nurses in Germany are actively providing basic training.

In addition, training is provided once a year to nurses, technicians, and distributors who are in charge of education at each hospital. We are also working to have them pass on what they learn to their local subordinates and junior staff. The rule is that no one can handle Nikkiso's dialysis machines without a certificate. This certificate is received after having taken a training course. This is how we are effectively supporting knowledge updates.

European Agent Meetings

—— What do you feel is necessary to continue to be recognized in Europe?

Matsubara: In recent years, environmental considerations have been particularly important. Hemodialysis treatment requires large amounts of water and electricity and involves waste products such as blood tubing lines. We are also focusing our efforts on the need provide data on all energy usage and CO2 emissions involved and present measures to reduce environmental impacts.

—— What specific initiatives are you working on?

Matsubara: We have, for example, installed solar panels at our Kanazawa Plant, where dialysis machines are manufactured, and we use liquefied natural gas (LNG), which results in less CO2 emissions than heavy oil, as boiler fuel to reduce CO2 emissions during product manufacturing.

In addition, blood tubing lines that are specifically for our devices are currently made in Vietnam and transported by container ship to Europe, then they are delivered by truck. We are considering the establishment of a backup manufacturing system within the European region to serve as a countermeasure against the risks created by the COVID-19 pandemic. This project is designed to reduce the supply-related risks involved with products that are essential for dialysis treatment, while at the same time reduce CO2 emissions by shortening transportation distances. The aim of the project thus consists both of the stable supply of products and transportation with low levels of environmental impact.

Providing the best treatment for local patients considering the needs of the field

—— Finally, what are your prospects with respect to Europe, where higher quality and higher-end models are in demand?

Matsubara: Just as Nikkiso is the market leader in Japan, our goal is to become the market leader in Europe as well. We want to be the partners that customers choose first. In order to create a next-generation flagship model which serves as a strong asset when it comes to achieving our goal , we would like to actively address the needs for higher functionality, environmental friendliness, and so on. We will continue to listen to feedback provided by health institutions and provide the best treatment to local patients.