Following on from my last article which delved into the key players within the Minimal Access Robotics sector, whereby I wrote about Intuitive, JnJ, Medtronic, CMR Surgical and Verb Surgical. I wanted to shine a light on some of the fantastic emerging companies in this sector. There has been a plethora of companies operating in stealth mode, developing technology, and preparing for rapid commercialisation over the past decade and in this article I sat down with some of the most innovative, niche and dynamic organisations within this bubble. This included Medicaroid and Quantum Surgical, who are on the cusp of FDA & CE approval and also Stereotaxis, who are hitting new gears in their global growth.

Tetsuya Nakanishi – Managing Director Europe – Medicaroid

I was very pleased to talk with Tetsuya Nakanishi, Managing Director of Medicaroid Europe, a subsidiary of Medicaroid Japan. Medicaroid is an organisation born from the joint venture of robotics powerhouse Kawasaki Heavy Industries and Sysmex, a leading diagnostic and life sciences company. The system utilises the combination of a highly adaptable robot and highly developed software to deliver a best-in-class RAS which has capabilities for urology, and will apply to general, gynaecology and cardiothoracic surgeries.

Whilst developing the hinotori™ system, Medicaroid has leveraged their deep-rooted robotics knowledge and has been designed to offer unrivalled manoeuvrability with each arm having 12 joints, and 4 joints just for each instrument. This allows greater flexibility for the surgeon and leads to less invasive procedures. This coupled with complex and highly developed software which is optimised with an emphasis on collision avoidance results in a highly advanced system which works in collaboration with the surgeon as an assistive robot.

I started by asking what was the situation when you came into the position, and how does it look now?

“After I first joined Kawasaki, I was engaged in developing robot systems for several industries and in 2012 Kawasaki decided to join the medical devices field. In 2015 the company finalized the market research and business plan for a surgical robot and I started as a Project Manager for the actual development for our surgical robot system. In 2020 we launched hinotori™ Surgical Robot System, with approval in Japan in August 2020 and the first case being completed in December 2020. The first case was in the field of urology but since that we will expand our capability to include general, gynaecology and, cardiothoracic.”

I then asked Tetsuya to explain the technology to me and why a surgeon would choose to use Medicaroid’s robot over systems with similar capabilities.

“The main reason for a surgeon using hinotori™ is the excellent technical specification of the robot. Each arm has 12 joints, as well as 4 joints for the instrument. This allows a much greater range of motion compared to other comparable systems. This coupled with complex and highly developed software means that motion is optimised but also a large emphasis on collision avoidance.”

So, what does this all mean for the patient?

“It means that there can be a smaller port of entry, leading to a less invasive procedure and quicker recovery times, whilst reducing the risk of human error.”

Where do you see as the key geographies?

“Clearly Europe and US are our key geographies. As per today we are working on CE mark for Europe. In addition, we are working on FDA approval to enter US market and we already have subsidiary in San Jose”

How has Covid-19 affected the adoption of your system?

“In Japan, it has not affected the business, it is still ongoing as planned. Similarly in Europe no big impact as we are still in the business development stage.”

What do you find as the biggest barrier to adoption of your technology?

“We are sure that device portfolio and new technologies like Artificial intelligence are key factors for us. Therefore, the important thing is to build an open platform structure with the government, academia, medical institutions, and companies leveraging their expertise.”

I finished the conversation by finding out what Tetsuya sees as the key trends moving forward in the surgical robotics sector?

“In robotics Tetsuya saw 5G as a big trend which will create more connectivity between surgeons. Artificial Intelligence & Machine Learning will also become more prevalent.”

Steffen Wuttke – VP EMEA & ROW Stereotaxis

Stereotaxis is the next organisation I was able to sit down and speak to, Steffen Wuttke who joined 7 years ago in the position of Vice President for EMEA and Rest of the World and has been instrumental in their global expansion. Prior to this, he held various positions in the cardiovascular space with Medtronic, Abbott & BSCI/Guidant. The Stereotaxis robot is used in the treatment of cardiac ablation however, unlike a lot of other robotic systems which has the proprietary emphasis placed on the patient outcome, Stereotaxis actually also has huge benefit to the physician’s health and wellbeing. In a traditional cardiac ablation procedure, the electrophysiologist has to wear a heavy lead apron to protect from the exposure to radiation, they can be stood up 8-12 hours a day, 5 days a week which places a lot of strain on the physician’s spine. With the Stereotaxis robot, the operator is able to be behind a safety barrier, meaning no need to wear the apron and can operate remotely, whilst seated and comfortable in the adjacent, protected control room.

Tell me about how you joined Stereotaxis and a bit more about your role within the organisation?

“I joined almost 7 years ago and have always been fascinated about robotics. The general feeling following the success of Intuitive, was that this area is very promising, for MedTech in general. Stereotaxis´ offering was intriguing technology, a very different and elegant robotic system. A lot of medial robots are based on a robotic arm extension, what I liked about Stereotaxis is that the movements are fully computer-controlled with its intriguing potential for semi- or full automation.”

What was the situation when you came into the position, and how does it look now?

“I took a calculated risk. Stereotaxis was in a prolonged start-up phase which did not seem to end. While the technology was very elegant with huge potential it was commercially launched in the market too early. The expectations in this new technology created initially a big hype, but technology could not meet the expectations at this point. After a first hype in the market, there was a disappointment in this phase. However, 3 years ago, the company changed significantly and re-invented itself. Some new investors noticed the company and recognised the potential of its technology. They invested and got actively involved on the board of directors. The company became debt free overnight and was able to re-direct its expenses towards much higher investments into R&D initiatives. Also, David Fischel a very dynamic CEO took charge, developed a clearly defined innovation strategy with focus on execution and customer focus based on a solid financial foundation for long-term success.”

Why would a surgeon or health system choose to use a robotic procedure over traditional cardiac ablation?

“Major reasons are all around safety and efficacy, for both patient and physician. There are more than 400 peer-reviewed publications to confirm the significant clinical advantages. For conventional, non-robotic procedures the operator must stand every day, 5 days a week, in a heavy lead apron. The orthopaedic burden is accumulating over the years and taking its toll on the spine. In comparison the physician in a robotic lab is seated comfortable in a cockpit-like environment, relaxed and fully focused on the patient, navigating the catheter remotely with a computer mouse. Plus, there is no exposure to radiation during the ablation, the physician does not need an apron sitting well protected in the control room. For the patient the robot has a much higher level of precision and stability when positioning the catheter to the right location within the heart. As the catheter is navigated by a magnetic field there is also no need for a pull wire construction to steer a rather stiff, conventional catheter manually. As a consequence, the specific catheter used for a robotic procedure is remarkably soft, almost like a Spaghetti – reduceing the risk for major complications. The catheter is basically so soft that it is almost impossible to accidentally damage the cardiac tissue, which could lead to a life-threatening cardiac perforation.”

What do you find as the biggest barrier to adoption of your technology?

“Financially the capital equipment requires additional investment although we offer ROI calculations to demonstrate that the innovation will pay off. In Europe especially public tenders and complex buying cycles can take a long time. Additionally, like with every disruptive technology, change takes time. Traditionally clinicians have done ablation procedures for many years by hand, now they need to transform their craftmanship to the control of a robot integrated with 3D imaging via a computer mouse and keyboard. Stereotaxis itself has also changed big time and we need to make everybody aware how we have transformed – and this is just the start of an exciting journey and a new beginning for us. This is also why we called our new robotic system Genesis. Clinicians and hospital administrators are usually very surprised to learn about the rebirth of Stereotaxis.”

How has Covid-19 affected the adoption of your system?

“Understandably hospitals had to shift their attention to manage the pandemic outbreak. Elective procedures were reduced which also impacted a part of our business, like many other medical device companies. The hospitals´ focus on the management of Covid-19 patients with some budget decisions for capital equipment being stalled, but we are optimistic for the future. With all its challenges there came also new opportunities. We realized a big additional advantage of remote robotic navigation: Our technology allows physicians to perform or monitor procedures even if they are far away, not even in the hospital. Our clinical specialists can provide clinical support and training remotely without physically being in the hospital. We can provide physicians with the capabilities to interact peer-to peer remotely, like exchanging experience or discussing individual patient cases.“

Where do you see as the key geographies?

“Even within Europe, we are selective in which markets we want to operate. We have limited resources and want to focus on quality and sustainability instead of quantity. It is much more important for us to have active and satisfied users who are well trained and supported by us than just trying to sell as much as possible in the short-term.

That´s why we put a lot of efforts into training and education, we also offer a training program for fellows who are interested in robotics.”

Are there any plans for diversification of the product range?

“Yes, our new platform, the Genesis Robotic EP system, will allow us to look at other endovascular applications beyond electrophysiology. We are planning to share more about our future plans around the end of this year.”

What do you think some of the key trends will be in the robotic surgery sector?

“I think this is just the beginning and we have an exciting journey ahead of us. The pace of innovation will accelerate, as more companies are entering this market. Machine learning, artificial intelligence, automation, 3D-imaging integration are just a few key areas that will drive innovation. Simulation is another interesting area, to allow the training of physicians in a safe environment before they approach the patient. For the rather complex procedures you usually need experts with also a very high level of manual skills, but these top-experts are not always easy to find in each hospital and city. The safety and precision of a robotic system could allow the treatment of more patients, without jeopardizing safety and efficacy. Robots will never replace the physician, but will become a more and more essential tool and aid. And with more and more compelling clinical evidence, I strongly believe this is the pathway towards standard of care over time. Economies of scale will also make robotics more affordable for every hospital.”

Do you have any final comments?

“Whenever disruptive technology comes to market it is all about change – especially when it comes to medicine and patient lives you want to be cautious with the adoption of any new technology. It took a while, but the pace has picked up and I’ve never seen such an interest in robotics before. Senior clinicians and administrators have become more receptive. Especially the new generation of physicians are very keen to learn more about robotics. Young clinicians are keen and often able to use our simulator intuitively without much training needed. They can experience our technology online even from home. It is also always remarkable for me how much they think ahead. Often they are very health conscious and want to make sure that they are at the beginning of a long career without any health issues later.”

Lucien Blondel- Quantum Surgical

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For those who are involved in the sphere of medical robotic surgery, it is hard not to have met Lucien and his passion for sharing developments and information in this field. The company he recently co-founded, Quantum Surgical, has studied and selected a very specific application, and that is Minimally Invasive Treatment of Liver Cancer. The product combines a robotic system with an open platform, artificial intelligence, and a planning tool to create a complete technological ecosystem.

Tell me about how your path to Quantum Surgical and your role within the company.

“I am currently Co-Founder and CTO of Quantum Surgical. We founded the company in early 2017 after Zimmer Biomet acquired MedTech SA, Montpellier. Together with 3 other founders with a strong entrepreneurial spirit, we then decided to move on. We started from scratch and took the time to study the market. It took us about 6 months to really dig into all segments of the surgical and interventional medicine market, looking for the same equation that made the ROSA robot successful in epilepsy: a complex, operator-dependent procedure with clinically proven results that would benefit from pre-surgical planning and robotic execution. We took the time to look everywhere and found an underpenetrated area with no clinical fit, namely the liver cancer market and the percutaneous ablation technique.”

“In early summer 2017, we began developing the software, mechanics, robotics, and quickly built an initial prototype to demonstrate the vision to investors. For this new entrepreneurial venture, our plan is to go bigger much faster with more funding in the beginning. We are looking to target the three main medical device markets. Starting with Europe with CE Mark this year, and the US with FDA clearance in 2022. In addition, through a joint venture with our local partner in China, LifeTech Scientific, we hope to obtain regulatory approval from the NMPA in China in 2022. We are also in the process of building our sales teams and establishing a European sales force. We currently have a Sales Director in Europe, and we will soon be establishing a subsidiary in the United States.”

Why would a surgeon or health system choose to use a robotic procedure over traditional surgery?

“Our goal is to create a market to move from conventional procedures to robotic procedures. The situation was similar in cranial neurosurgery, and in knee surgery years ago, so this is a challenge we know how to meet. We are using a formula that has proven successful in other areas of surgery: preoperative planning, a robotic arm, instrumentation and navigation technologies. Because with soft tissues, you have to take into account organ movements due to patient movement and breathing, we have added a respiratory monitoring module to this. It tracks all the patient’s movements and can analyze the respiratory cycle. This allows the needle insertion to be synchronized with the appropriate phase of the breathing cycle.

Despite the Covid-19 situation, we were able to complete a 21-patient multicenter study in early 2021.”

How do you protect the intellectual property of your system?

“We identified IP as a strategic area to invest in for a startup like ours, so we started filing patents in the first year and hired an IP engineer early on. In 2019, we filed 7 new patent families, which led Quantum Surgical to be recognized as one of the top 15 applicants in our state by the French Patent Office. Today, we have 16 patent families.”

What do you see as Quantum Surgical’s competitive strengths?

“Our strength lies in combining product vision with physician needs. With 25 years of surgical robotics experience in various fields; knee, brain, spine, interventional radiology – we can understand the unmet needs and identify the right technology to provide a solution to end users. We believe that by putting a navigation component and a respiratory monitoring module into one platform with a collaborative robot and a powerful end-to-end software solution, we will address the challenges physicians face during percutaneous ablation.”

What impact has Covid-19 had on you?

“We’ve been pretty good about it. Since the start of the project in 2017, we have always intended to complete product development by the end of 2020. While it has been a challenging time and we have temporarily downsized to focus all of our resources on clinical study preparation and execution, we have continued at a steady pace and met that deadline.”

Is a diversification of the product line planned?

“My experience has taught me that before you diversify, you have to be successful in your first market. Today, we are focused on organs in the abdomen, including liver cancer and kidney cancer. The technology we have developed for interventional oncology allows physicians to plan their procedure and place the needle according to the plan, which is not specific to the abdomen. The most obvious next step would be to expand the indication to the lung and other areas of the body where percutaneous ablation is a clinically proven technique.”

What do you see as the key trends in the robotic surgery industry?

– The creation of a digital ecosystem around the robot

– Artificial intelligence and machine learning to transform pre-, intra- and postoperative data into actionable insights.

– Augmented reality and virtual reality to enhance the physician experience.

I then asked Lucien if he had any final comments…

“What strikes me today, after being in the surgical robotics field for all these years and developing a product in a market where there was no competition or no significant market, is the real momentum for robotics that we are seeing in oncology. We have had many clinical partners participate in our Epione® robot trials and they are all very enthusiastic about the technology and what it can do, whereas before we had to fight much harder to convince physicians of the potential benefits of robotics. It’s no longer a question of whether or not robotics is part of the future, it’s more a question of how it should be designed to meet clinical needs.”

Conclusion

It was a very interesting conversation with these individuals, and I really appreciate them sharing their views, knowledge and plans for their organisations. I think we can all agree that with only 3% of the worlds surgeries performed by robotic systems, there is a lot of growth still to be had, and as technology becomes more accessible, I can only predict stratospheric growth. The technology is mind blowing and the organisations in this article are all on a significant upward trajectory. I am really looking forward to following their movements in the market.