Ten years ago, Medicaroid was born from an ambitious collaboration between Kawasaki Heavy Industries and Sysmex. The joint venture was launched by Yasuhiko Hashimoto and Kaoru Asano, the current presidents of the two companies, to combine Kawasaki’s expertise in robotics with Sysmex’s medical innovations. The result: significant advances in the field of surgical robotics in Japan. Medicaroid is currently preparing to launch its first model, “hinotori” (Japanese for ‘phoenix’ or ‘firebird’). A surgical robot system that takes its name from the legendary manga by Osamu Tezuka. J-BIG had the opportunity to talk to Tetsuya Nakanishi, Managing Director of Medicaroid Europe, about the origins of the company, the development of hinotori and the differences between the Japanese and European markets.
J-BIG: Last year marked the tenth anniversary of Medicaroid. Could you tell us how the company began?
Tetsuya Nakanishi: Medicaroid was born out of our founder Yasuhiko Hashimoto’s vision to use robotics to make a meaningful impact on people’s lives. Mr. Hashimoto, now the President of Kawasaki Heavy Industries, has always valued human life deeply, influenced by his Christian beliefs. His career at Kawasaki focused on industrial robots, and after reaching a top management position, he saw an opportunity to bring his dream to life. He reached out to his friend and former Kawasaki Heavy Industries colleague Kaoru Asano, now the President of Sysmex, a leading Japanese medical company, and said, “The time has come. Our dream can become a reality.”
Together, they formed a research group between Kawasaki Heavy Industries and Sysmex Corporation to explore the potential of surgical robots. I was part of this group from the Kawasaki side. Japanese companies are often cautious, focusing more on diagnostics than treatment. But we asked ourselves, “Why not utilize our technology to save lives?” This question led to the creation of the Medicaroid Corporation, with the aim of developing surgical robots.
J-BIG: Kawasaki and Sysmex are well-known companies. How do their activities align within the Medicaroid project?
Tetsuya Nakanishi: Kawasaki is widely known in the general public for its motorcycles, but it is also a technological powerhouse with a 150-year history, particularly in robotics. With 50 years of experience in industrial robots, Kawasaki is a pioneer in this field in Japan. Their extensive experience in meeting customer needs, even in challenging situations, has been invaluable.
Sysmex, on the other hand, is a leader in blood cell counters and healthcare systems, with a presence in over 190 countries, not only in Europe and America, but also in Africa. Their expertise in customer support, especially through IoT, complements Kawasaki’s robotics.
Medicaroid brings together the strengths of both companies, blending healthcare and robotics to create innovative medical solutions.
J-BIG: What has been your personal journey with Kawasaki and Medicaroid?
Tetsuya Nakanishi: I began my career at Kawasaki as a motorcycle engineer. Later, I transitioned to the robotics division, which was expanding rapidly at the time. I worked on special robot development projects for automotive companies in Japan and the US, and later in the food and pharmaceutical industries. Although I made mistakes along the way, these experiences helped me grow and better meet customer needs. Mr. Hashimoto recognized my evolving expertise and assigned me to help establish Medicaroid.
I spent a year in the research group, learning medical device terminology and attending nearly 200 surgeries. This hands-on experience was crucial in developing the specifications for what would become Medicaroid Corporation. In 2015, I was appointed project manager for surgical robots. My team and I rapidly prototyped a system that impressed surgeons. After three years, in October 2018, I was transferred to Germany because I was assigned to the European business establishment. We received approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), which allowed us to establish Medicaroid Europe in 2020.
J-BIG: Could you tell us about the size and structure of Medicaroid?
Tetsuya Nakanishi: Globally, Medicaroid has 200 employees, and Kawasaki Heavy Industries has dedicated 100 people to work exclusively on our product called “hinotori”. In total, 300 people are focused on this one product. Kawasaki handles engineering, production, and service parts related to robot technology, while Medicaroid is responsible for clinical and medical affairs, sales, training, and system development. The instruments used in surgeries are at the core of our medical device, and our development team is continuously refining them.
J-BIG: Why did the company choose Dusseldorf for its European operations?
Tetsuya Nakanishi: The Japanese headquarter deeply thought about what location has similarities with Japan. We chose Germany for its cultural similarities to Japan, particularly in craftsmanship, and because Germany is a global leader in medical and operational fields. From Germany we are able to extend our system to the whole of Europe and then to the whole of the EMEA region.
Dusseldorf, specifically, was chosen for several reasons. First, it has a large Japanese community, which offers networking opportunities and support. Second, its central location in Europe makes it an ideal base for reaching customers across the continent. Third, Dusseldorf’s global business environment is conducive to networking and recruiting talent.
J-BIG: When was hinotori launched in Japan?
Tetsuya Nakanishi: Hinotori was launched in Japan in December 2020. While we could have applied for European approval immediately after, we decided to optimize the system further based on feedback from surgeons who used it in hospitals. Japanese people tend to strive for perfection, and we wanted to ensure the system was fully optimized before expanding. Now, I’m confident that hinotori represents a significant medical innovation, and we are preparing to seek healthcare approval in Europe.
J-BIG: How many hinotori are already operational in the Japanese market?
Tetsuya Nakanishi: As of July 2024, we have installed hinotori in 61 hospitals in Japan, with over 5,200 procedures completed. In the first two to three years after its launch, we focused on optimizing the system and intentionally limited sales. Now that we’ve finalized the optimization, we’re moving forward. Although 61 installations might not seem like a large number, it represents our confidence in reaching key hospitals.
J-BIG: When do you expect to launch hinotori in Europe, and what needs to be done still?
Tetsuya Nakanishi: It’s difficult to predict exactly when we’ll receive approval, but we are confident in our system’s documentation. We aim to launch in mid-2025. In the meantime, we need to establish business operations, approach hospitals, and prepare for post-launch activities, including post-marketing surveillance (PMS). When we launch the system, the regulatory compliance requires us in the first six months to show real safety data. Although mid-2025 might seem far off, it feels like time is running out.
J-BIG: Let’s talk about the hinotori Robot System. Could you explain the components?
Tetsuya Nakanishi: The hinotori system consists of several key components. The surgeon sits in a cockpit, controlling the robot system, which operates beside the patient. When the surgeon is doing the procedure the actual robot system besides the patient is moving and two or three assistant surgeons are supporting this robot system. The surgeon just sits here in the controlling unit and the motion is transmitted to the robot system. The system has four arms, one of which holds a camera inserted into the body through a small incision. This minimally invasive approach reduces the burden on the patient. The surgeon sees inside the body through a 3D viewer and uses forceps. Another robot arm holds the forceps – that’s what we call this instrument that is both a cutting device and a gripping tool. The surgeon can see the body as well as his own hands through the camera, which allows him to move the forceps inside the body precisely.
It’s important to note that this system is a support tool, not a replacement for the surgeon. That’s why I don’t say “robot surgery”. “Robot assisted surgery” is the correct wording. We are not replacing people; we are just emphasizing people’s skills and capabilities.
J-BIG: The cockpit is physically independent of the robot unit. This means the surgeon can also work from somewhere else. The idea of a wireless operation isn’t just a dream but is something where you have already taken experiments in Japan, right?
Tetsuya Nakanishi: Yes, the cockpit can be placed anywhere, not necessarily in the same operating room. In the future, it’s possible to transmit a wireless connection, allowing a surgeon in Japan to operate on a patient in Europe. We’ve already conducted experiments connecting Japan and Singapore, but for now, the system is primarily used within the same operating room, with one surgeon placed on the cockpit and one robot unit.
J-BIG: What are the challenges for a globally connected system? Is it the speed of internet connection or is there a certain risk if the surgeon is not in the same room?
Tetsuya Nakanishi: Technologically, the capability exists, but the regulatory environment is the main challenge. If a surgeon performs a procedure remotely and something goes wrong, who is responsible? This is a question of legislation. Another challenge is cybersecurity. If the internet connection is disrupted, the surgery could be interrupted, raising questions about how to proceed in such a situation.
J-BIG: In the US, some surgeons only have a license to operate in certain areas, so they have a license to be a surgeon in New York, for example. But it’s not simply possible that they operate a patient that is in California at the same time. Is their license working for this or not?
Tetsuya Nakanishi: Licensing issues are indeed a barrier to remote surgery. It depends on the license. A surgeon licensed in New York, for example, may have the skills to operate on a patient in California, but legal and regulatory restrictions currently prevent this. While these regulations can be seen as a hindrance to innovation, they are necessary to ensure patient safety.
J-BIG: What steps have been taken in Europe since the product’s approval in Japan and what needs to be done to also get this approval for Europe?
Tetsuya Nakanishi: The first step is regulatory compliance, specifically the CE marking process. However, I believe the biggest challenge is setting up the business infrastructure. This includes establishing training, education, sales, service support, and logistics frameworks. Ensuring the safe transfer of safety information, known as vigilance, from hospitals to the Japanese manufacturer is also crucial.
J-BIG: How does the medical market in Japan compare to that in Germany?
Tetsuya Nakanishi: Both countries have a good medical system. So basically the medical framework is the same. However, the health insurance systems, environments, and market dynamics are very different. In Japan, surgeons are often seen as almost inaccessible, which makes it difficult to have open discussions. In Germany, we have a more equal relationship with surgeons, which leads to more efficient communication.
There’s also a cultural difference in the philosophy of how robots are perceived. Normally, for Western people, robots are far from human and easily perceived as the enemy, maybe because of movies like “Terminator”. In Europe, there’s a feeling that robots can steal our jobs. However, the Japanese view is very different. There are a lot of anime where the robot is a friend. Robots can enhance your job, and our robot system is the same.
J-BIG: The surgeon is the user of your product. Who is the primary customer / buyer for the hinotori system?
Tetsuya Nakanishi: The surgeon is the key decision-maker. Once the surgeon is convinced of the system’s value, they can persuade hospital management to invest in it. While the surgeon is our primary customer, the hospital procurement and management teams are also important. Additionally, as the field of surgical robotics is still emerging, the medical community will play a crucial role in establishing regulations and licensing for different robotic systems.
J-BIG: If we look at the roles of the Düsseldorf side and the Japan side: how do the roles of the Düsseldorf and Japan teams differ? Will the products differ technologically between regions?
Tetsuya Nakanishi: All production is done in Japan. Globally, the most important requirement is safety, but some of the surgical procedures have a different approach in each country. That’s why we are responsible for communicating with surgeons and summarizing their requirements. Here in the European team, we translate the surgeon’s opinion into technological terminology and technological specifications. We’re also going to do some feasibility studies in Europe, so we have engineers here. Finally, we refresh the surgeon’s requirements and ask Japan to implement this function in our system. After that, the development production site in Japan officially produces and develops this system. Normally, many Japanese companies have a so-called “Hansha”, which means sales office. Medicaroid Europe is not only a “Hansha”, but we are also in charge of training, education, market requirement brushing up and regulatory things as well as business development.
J-BIG: Could you provide an example of a specific demand from European surgeons that differs from those in Japan?
Tetsuya Nakanishi: Certainly. One example is the type of trocar used in surgeries. A trocar is a shaft inserted into the patient’s body to facilitate the insertion of surgical instruments. In Japan, surgeons and the market generally prefer disposable trocars because they believe using a new one for each surgery ensures the highest level of safety. However, in Europe, sustainability is a key concern. European surgeons tend to favor reusable trocars, which align with their commitment to reducing waste and environmental impact.
J-BIG: Are there aspects or perspectives from Europe that are challenging to convey to the headquarters in Japan? What kinds of issues are difficult to communicate?
Tetsuya Nakanishi: One major challenge is the difference in how robotic surgery is integrated into the healthcare systems. In Japan, robotic surgeries are covered by insurance, which influences how surgeons use instruments like forceps. Japanese surgeons typically use both hands for holding a needle during suturing. In contrast, European surgeons often use one hand for the needle holder and the other for a different task, to minimize the use of costly instruments. This practice requires precise instruction on operating the suturing device, which differs significantly between the two regions. Communicating these nuances can be difficult without direct observation and interaction with European surgeons.
Another challenge is the emphasis on operation time in Europe. European hospitals often bill surgeries based on their duration, so there’s a strong focus on completing procedures quickly while maintaining safety. In Japan, the pressure to shorten operation time isn’t as intense, allowing for more relaxed scheduling. Typically, Japanese hospitals perform two to three robotic surgeries a day, whereas in Europe, it’s common to conduct five surgeries a day, every day. Conveying this difference to the Japanese headquarters, where the pace is slower, can be challenging.
J-BIG: Are there things you discovered later in the process that you wish you had known earlier? What advice would you give to a medical company just starting out?
Tetsuya Nakanishi: One crucial lesson is the importance of effective communication between the European and Japanese teams. Japanese culture tends to be indirect, while European communication is more direct. For example, during discussions, Japanese participants often avoid expressing disagreement openly, which can lead to misunderstandings. In contrast, Europeans are more likely to say, “I don’t think so,” which helps quickly identify and address issues.
This difference can result in delays, as Japanese team members might move forward with their own ideas without openly discussing disagreements, only to realize later that adjustments are needed. We’ve learned to ask direct yes-or-no questions to ensure everyone is on the same page. This approach has greatly improved our communication and efficiency, and it’s advice I would strongly recommend to any company navigating cross-cultural collaboration.
