The Mantra surgical robot system. (Image credit: News9/Aditya Madanapalle)
SS Innovations has its office in a suitably modern building in Gurugram, which seems like a looming ship with its chamfered edges. Entering the office seems like stepping a bit into the future. In a room technicians are working with the hero product in the company's lineup, the Mantra surgical platform. Indigenously developed to provide low-cast access to robotic surgery, the Mantra surgical system cuts no corners in its high-quality components. Using polarised 3D glasses, an engineer can be seen gently manipulating rubber bands on a testbed, using strong, powerful robotic arms that end in small, delicate and sharp surgical instruments. The technician is sitting comfortably, with his spine erect, instead of hunched over and peering into a narrow viewfinder, as seen in some other similar systems. This is the future of surgery.
This is a state-of-the-art system, with no corners being just because it is a 'low-cost' initiative. Instead of going along the lines of already established robotic surgery systems, Mantra has been designed from scratch, with local conditions and needs in mind, which makes it suitable for any advanced medical facility in the world at the same time. Instead of all the surgical arms emerging from one monolithic post, each of the arms have their own mast, which is mounted on a cart, which the team refers to as "scooters". This is because they can be manoeuvred around much like two wheelers, with a throttle, clutch and brake. Having independent arms allows for a versatile, modular system with between three and five arms, that can be individually set up according to the requirements of the procedure.
There are two monitors for the doctor, a 3D one where the doctor can see a magnified view of the surgery, and a touchscreen control panel. There is another 3D monitor for the other healthcare workers in the operating theatre as well. On top of the primary monitor is a row of cameras, which is a safety feature that makes sure that the arms stop moving when the doctor is not looking directly at the screen. For the safety feature, SS Innovations tried using eye tracking, but that was not very accurate, so they opted for head tracking instead.
The most common surgical robot system used in the world today is da Vinci by Intuitive Surgical. The question for any emerging robotic surgery platform is its capability to take on the monopoly enjoyed by da Vinci. There are a number of other systems in development, that are also modular, or have arms mounted on carts, or allow for better postures. With Mantra, SS Innovations has hit upon a unique and unmatched combinations of features, safety and cost that is a very particularly considered mix, informed by decades of experience and a deep knowledge of the local requirements, and it is ready to hit the market. Sure, Mantra is a 'made-in-India' robotic surgery system, but it is made for the world.
What makes Mantra even more impressive is that it was developed in under three years, which would have been further accelerated if it were not for delays caused by the pandemic. However, the techniques developed for the novel procedures extend beyond the development of the robot itself. To understand more about the development of Mantra, we spoke to Sudhir P Srivastava, CEO and founder of SS Innovations, in an office right next to the room where the surgical robot was housed.
To start with, we asked Srivastava about the promise and benefits of robotic surgery. Srivastava tells us, "If the stay in the hospital is minimised for the patients, then the same bed can be used for other patients. So from the business side, it is great for the hospital, and from the patient's side there is nothing better than to just get back home soon, return to their lives. If you take the conventional surgical approaches which have been around for a long time, they have large incisions. Endoscopic and laparoscopic surgery came in the 80s. Although you have small incisions with laparoscopic surgeries, and patients get to go home early, there are certain complex operations, and cardiac surgeries definitely cannot be done laparoscopically. The robotic surgery technology has attributes such as 3D vision, magnified up to 10 times, with a true high-definition 1080p resolution, which provides absolute, very precise depth. Then the machine filters any tremors the surgeon may have. It is basically very precise. The number of complications are significantly reduced. Patients do not have to be readmitted for all kinds of things. There is less trauma. Because the incisions are small, they heal very quickly. There is no disruption of the muscles or the thoracic cage. So the patients recover very quickly. Blood loss is less. There are specific benefits based on the specialties. A conventional prostrate operation results in a loss of blood between 1 and 2 litres. In a robotic procedure, it is only 100 millilitres. None of this was possible with other approaches."
The benefits of robotic surgery though, extend well beyond the hospital, and are systemic. Srivastava tells us "The technological attributes of the robotic surgery allows us to perform complex operations with least trauma and the most benefits, which ultimately then filter through to beyond the hospital. The employer gets the employee back, the employee is able to return to work and earn money again, faster. Families do not have to make arrangements or take holidays to be with parents et cetera. It ultimately translates to lower healthcare costs. When you look at the bigger picture, that is, if you lose let us say a week of work, and you take the number of procedures that are performed annually, and you translate that loss of income, or loss of employee time for the employer time, who has to now hire somebody else, and the experience of somebody is irreplicable. These benefits are kind of intangible, but they are enormous. Also, we see progress in every field with technology. Everything in the technology world is constantly changing, such as phones, cars and planes, to make it better and cheaper. In medicine, things have been the same since the last 50 years. We are not making any progress at all. The status quo is today going backwards."
At SS Innovations, the mission is to advance new approaches and therapies that will be performed in a novel manner. This mission is driven by years of experience that Srivastava has using the most cutting edge surgical robotic systems, and developing new procedures. We asked Srivastava about his journey as a heart surgeon, who specialised in robotic surgeries that minimised hospital stay time and scarring. Srivastava told us, "I was born in Jodhpur, went to medical college in Ajmer and left for the United States in 1972 to pursue postgraduation in general surgery and then specialise in cardiothoracic surgery, and was certified by the American Board of Surgery for general surgery as well as thoracic surgery. I started practicing in Texas, and around the year 2000, we had developed some minimally invasive procedures. As heart surgeons, we were trained at splitting the sternum, which is how most surgeons even today perform the operations. At that time, the idea was to avoid splitting of the sternum to perform heart surgeries. So we developed some procedures, and in 2002, the surgical robot was going to become available in the US. I was the founding chairman of Alliance Hospital in Odessa, Texas. It was a small 75 bed hospital but a 57 million dollar project that we were going to do from scratch. We raised 16 million dollars from doctors, financed the rest and we built the hospital and launched the robotic programme."
The Alliance hospital offers a range of treatments, with a focus on cardiac care. It was at this hospital where several innovative robotic surgeries were conducted for the first time, including the world's first totally endoscopic coronary artery bypass (TECAB) procedure. Srivastava continues, "So I ran the hospital for the next four years, and it became known as the robotic cardiac surgery centre of the world. We had the maximum number of cases in a relatively small town, and patients were coming from all over. Here we saw the huge benefits of robotic surgery, whereby almost 50 per cent of my patients went home in 24 hours or less. The average length of the stay was about 3.2 days. It was tremendously inspiring to see patients getting back very quickly to their functional status even after complex heart surgeries. It was almost unheard of."
Srivastava was then invited to the University of Chicago, performing complex minimally invasive surgical procedures, without the use of a heart-lung bypass machine. "In 2007, I moved joined the faculty in the University of Chicago, and served as director of the cardiac surgery programme. In 2009, an invitation came from Fortis group in India. In fact, I used to come to India to operate and train a lot of teams from here (India), during my stay in US. In fact, back in 2002, I performed the first ever robotic surgery in the country. Fortis Escorts Heart Institute had purchased a robot, so I launched the programme. In fact, President Abdul Kalam had come in the room and he watched it for ten minutes or so. When the invitation came, I left the United States completely, and in 2011, I came to India with family, bags and baggage."
Despite being director of a hospital he had built, Srivastava moved to Chicago to provide the academic validation for the robotic surgeries, and performed a large number of them. The move to India was similarly motivated by a desire to popularise, advocate and train teams to use surgical robots. "The idea was to really launch programmes in the country", explains Srivastava, "because of the benefits. At that time there were only seven or eight robotic systems, because it was expensive. We in fact, purchased a robotic system ourselves, with our personal funds, almost 8 crores or something. Very quickly, I found that it was very expensive. For patients to pay personally, was very difficult. Insurance was almost non-existent, and also there wasn't a familiarity with the procedures. There was a lot of struggle and the business culture was quite challenging."
At this point Srivastava realised that there had to be a way to make the surgeries more accessible, and the surgical robots cheaper. "In 2012, I had a turning point in my life, where a 22 year old lady came. Her brother brought her. She had a congenital defect in the heart, with a hole between the two chambers of the heart. The brother was saying that if she has an incision in front of her chest, she will never get married. She was a perfect candidate for a robotic surgery, where there would be no incision seen at all, with only a small incision on the side of the chest. Except, they did not have money. We offered our services for free, but the hospital wanted to charge, which would have amounted to several lakh rupees. The lady had no insurance. The brother said that they would try to raise money, and called me a month later to inform me that they were still struggling. After that, I never heard from them again. It really pained me, that patients could not get the best care because of money."
When the companies that built robotic systems showed disinterest in developing more accessible systems, Srivastava decided to use his years of experience to do it himself. Srivastava says, "I used to talk to Intuitive Surgical (manufacturers of the da Vinci robot) at that time. They were enjoying their monopoly and there was no other robotic surgery company in the world. I used to tell them, why don't you develop something for the emerging economies, but they were basically just not interested. They were enjoying their monopoly and doing great for the shareholders. At that point, I said, 'I am going to develop it'. So I used up a lot of my personal resources, almost close to four and a half million dollars of my personal savings. Initially, I went to Germany, and worked with some German scientists, and then put a team of engineers together in Gurugram."
At this point, Srivastava had to switch out his doctors hat for the founders, "We started to develop, and I literally ran out of money. I was not practicing because I was completely focused on development. I sold my car, sold my furniture, borrowed money from friends to support the team, while trying to raise money. I went to the government also, the Make In India initiative had started, but there was no infrastructure set up to even support the scheme. Finally, we got overseas funding in 2017. We developed the system which we are not calling Mantra. I wanted a Sanskrit name. We literally moved very fast, with a relatively small amount of money. By 2019, we had raised almost 33 million dollars. Our team also grew. Initially we had our facility in Andhra Pradesh Medtech Zone in Vishakhapatnam, which was under Modiji's Make in India initiative. We did the first clinical trial in India, at the Rajiv Gandhi Cancer Institute. It was a very complex operation with our first generation Mantra. It went very well, and was very successful. The patient did very well and there was no device related issue.
After that came the process of product iterations, clinical trials, and regulatory clearances required for any medical device. "At that point, we observed certain things in the system, we do the trials mainly to see how it will function with the live patients, so that is generally never the final product. So we made certain modifications and we created the second generation Mantra very rapidly, we made all the changes. Now, Mantra 2 is absolutely ready, and we are going to be going for a short animal and a clinical trial. Basically, it is market ready. Various very prominent surgeons have tested out the system, and all of them, without exception have said that the system is ready for clinical use and going to the market. Currently we have ISO 13485 certification, which is an international certificate, given by a third party, required for medical devices. We are also registered with Central Drugs Standard Control Organisation (CDSCO)."
CDSCO is the national regulatory body for cosmetics, pharmaceuticals and medical devices. The Mantra system is on the verge of hitting the market. Srivastava says, "We have tremendous interest among doctors and hospitals. My vision was always that in terms of quality and performance, the Mantra system should be very similar to the da Vinci surgical system. Not only have we achieved that, but we have better features and more uses. Including da Vinci, no one is doing cardiac surgeries. There is a huge volume of cardiac surgery patients, not only adults, but children also. Almost 99 per cent of these have their sternums split, leading to long recoveries and complications. We have added the cardiac specialty with our system, and no one in the world has this ability at the level we are offering. Our Mantra system is designed to address all specialties, general surgery, neurology, gynecology, thoracic, at the neck, and cardiac on top of all these things."
The realised platform is provided at a significantly lower cost to doctors and hospitals, allowing the patients to pay less for the procedures as well. Srivastava says, "Apart from being comparable, if not better (to the da Vinci system), the other consideration was that it should be very price effective. The top model of the da Vinci system sells today for between 15 and 18 crores or so. Our Mantra system for somewhere between four and five crores. The per procedure cost will generally be somewhere between Rs 30,000 to Rs 50,000 for non-cardiac operations. The maintenance contract will be one-third that of other systems. The whole idea was to create a system which will be made in India and will be cost effective."
The market and potential demand for the device is huge, "If you look at the market size globally, on average there are more than 350 million operations done. Last year, there were only 1.6 million robotic operations globally. This is a very small percentage. The main reason is the cost of the system. There are roughly around 6,500 da Vinci systems today globally, of those, 87 per cent are between the United States, Europe and Japan. That means, the rest of the world with a population of 6 billion has only a 13 per cent penetration. India, with it's population of almost 1.4 billion, has 70,000 hospitals, close to 500 medical colleges, and we have less than 100 robotic systems in the country today. Last year, there were around 10,000 procedures, which is again, less than 1 per cent of the global procedures. There is a huge gap between what can be done, versus what we have."
When asked how much of the system is manufactured in India, using components made here, Srivastava says, "The system is designed by the team in India, manufactured in India, assembled and tested here. Almost 80 per cent of the hardware is manufactured in India. There are certain electronic components, such as certain specialised motors, drives and sensors, which we import from European countries such as Germany, Switzerland, as well as Israel, US and Japan. On one side we are talking about made in India and Aatmanirbhar Bharat, so hopefully someday... (we can source components entirely from India). I know there is a lot of emphasis on medical technologies in the country. We can produce a lot of things, India has tremendous talent at ISRO, DRDO and AEC. We have very bright minds. Investment in medical devices does not occur here. We are importing almost 80 per cent of the sophisticated medical devices, which means there is a foreign exchange drain. We will never develop actually, or become independent of it. Our idea was to really manufacture Mantra in India, so we also have the Make in India certification, based on the process and audit report, they look at how much of the device is being manufactured in India. Literally all the hardware is done in India. This also allows us to compete with other companies. So all the central government hospitals, military hospitals, the railway hospitals all have to purchase our system as a preference."
Srivastava hopes to replicate the academic validation of the da Vinci system using the large population of India as a platform, Srivastava says, "I have performed over 1,400 robotic cardiac surgeries when I was in the US, and it was the largest experience in the world at one time. And I still hold the world record for TECAB surgeries, have trained over 350 surgical teams, and launched programs all over the world. So the whole idea was to really use India as a platform. With our population base and tremendous enthusiasm among the surgical professionals, who really want to use the latest and the best technologies, the cost is a barrier. We are addressing that, while including more features, better ergonomics, more ease-of-use, resulting in a system that is very different system."
When it comes to the design of the system itself, there are a number of differentiating factors of Mantra. Srivastava explains, "Since the Mantra system is completely developed, it is technologically very different from the da Vinci system. All the arms are separate, mounted on separate carts. They can be placed wherever required, as opposed to the da Vinci system, where all the four arms are mounted on one central beam. The robotic arms can be placed anywhere, and the surgeon has the flexibility of using between three to five arms. The da Vinci system is locked in with four arms. In cardiac cases for instance, we can use five arms. The surgeon command centre is very different. With da Vinci, you are sitting hunched over and you do not know where your hands and feet are. People have a lot of difficulties because of this thing. They have small 8 inch screens, so open console is ergonomic, the surgeon can sit straight, there is a large 32 inch primary monitor, that provides 3D vision. The bigger the magnification, the better it is for the surgeon. With a 3D endoscope, we bring the view directly on the screen. It is a truly remote operation, where using the hand and foot controls, we are controlling the robotic arms and instruments that are going into the patient's body. The other very advantageous feature we have is 3D vision for the tableside assisting team, the nurses and assistants. They have the same 3D 32 inch monitor view, as the surgeon. No other company offers that today. This allows the team to be safer, they know exactly where to go so they are not accidentally hitting something, because in 2D, you cannot see how deep you are. Also, it becomes efficient because it allows for precision, and it shortens the learning curve, ultimately translating to better quality outcomes for the patients."
Srivastava then goes on to explain the inception of the da Vinci system, and the different path followed by SS Innovations, "Although the da Vinci system is great, and I am grateful to them for having started over twenty five years now, they never actually changed the core technology. In our case, we had to develop everything from scratch. In their case, they had the intellectual property, or patents, which came from Stanford Research Institute, which was funded by NASA and the US defence department in the 1980s. At that time, the idea was to be able to perform telesurgeries in space, as well as in battlefields. But the technology was not ripe for that, the bandwidth was just not there. So they shelved it. This group raised money and licensed the technology. They essentially stayed with the core technology, and did not make any changes other than cosmetic changes, and every time they changed, the price went up. In our case, we developed everything very quickly, with a relatively small budget, compared to Medtronic and J&J. They have spend between 300 and 350 million dollars, we had a tenth of that budget. Medtronic has just brought out the system after 8-9 years, while J&J has been struggling for almost the last 8 years or so, they haven't brought out a system yet."
Both Medtronic and J&J are developing their own modular robotic systems to take on da Vinci. Medtronic's Hugo system is in the process of a global rollout, with the first surgery in India taking place at Appolo Hospitals in Greams Road Chennai, in September 2021, while J&J's Ottava system has been delayed by two years. Both Hugo and Ottava are designed as low-cost alternatives to the da Vinci system. The underlying problem that companies are taking a crack at, including Medtronic and J&J is a global one. SS Innovation's solution, Mantra, stands to benefit all nations, and not just India. Srivastava says, "One thing I want to emphasise is that Mantra is made by Indians for the world. This problem of cost, of not having access everywhere, is universal."
The development of the Mantra system is just the beginning for SS Innovations, which has ambitious plans to push the technology further than it has ever been, realising the initial vision behind the inception of robotic surgeries. Srivastava explains, "So the term that I use for our vision is to 'decentralise excellence'. Whereby, all the advanced technologies can be made accessible to smaller communities, smaller towns and various remote locations, for the army and so on. We have partnered with Airtel to develop telesurgeries. We are going to use the technology for proctoring people, and do a variety of long distance things with remote control, including being able to operate long distance. The whole idea is to literally use India as a platform, with our population base, as well as tremendous interest among doctors, to literally become a model for the rest of the world, where even in emerging economies, we can demonstrate that it is possible to develop these highly sophisticated technologies. Hopefully, it will inspire others, and the Government of India, to invest in medical technologies. We can produce every single thing."
Srivastava intends to disrupt the entire medical device manufacturing sector in India, "When ISRO sent these missions to the Moon and Mars, everything was indigenous, which was absolutely remarkable. It can be done here for medical devices as well. Hopefully, we can change the scene, it will help with medical tourism. India will be very proud (of having such capabilities), and we will export all of these devices. With a lot of issues that can occur, such as the pandemic, we can completely lose control (as a country), especially if we are bringing things from outside." Srivastava is advocating self-reliance in the medical technology sector because of a number of potential disruptions in a country heavily reliant on imports, including geopolitical issues that may crop up. Srivastava says, "We must develop everything, and now we have a great opportunity. In terms of going to the market, we are actually ready, and we are raising somewhere between 50 and 100 million dollars right now to transition from a research and development phase to the manufacturing and assembly phase. We are promising people that we will be delivering our systems within three months in India. We already have about 100 letters of interest from various hospitals."
Srivastava is also very appreciative of the engineering team, that worked through the disruptions caused by the pandemic "People who have come (to our labs) are very appreciative that we have developed Mantra in India. I am working with a highly talented team of Indian engineers. When we started, nobody knew anything about robotic surgeries, but now they have become so good, that they can teach robotics at IITs. The team is very talented, and very hard working. People come and work even over the weekends. This is part of the reason we have been able to move very fast, despite pandemic challenges. We lost the entire 2020 because of the lockdowns, and again there were issues last year and this year. Despite all the challenges, we have been very successful, mainly due to the unitary vision that we must produce something that will help humanity at large, because it is a universal problem."
We asked to know more about the engineering team, as that is something that readers who are engineering students would be interested in. Srivastava tells us, "We have engineers from all over the country. We also have some very senior engineers at a global level. With robotics, these are some of the best scientists in the world that are working with us. We have currently 85 people working, and with funding, we hope to grow to around 200 this year. We have essentially almost 70 people that are in the technical team, the rest are administrative, finance, marketing, regulatory et cetera. The rest are all engineers. We have mechanical engineers, software engineers, electronic engineers as well as quality assurance engineers. We have all these areas completely covered at this point in time."
There are a number of ambitious plans that SS Innovations has, and it moves beyond robotic surgery into realising the full potential of telemedicine. Srivastava says, "Many countries do not have even a single robotic surgeon. This will be the future. There is no reason for patients to have large incisions. Beyond the hospital, it has a very positive socioeconomic and emotional impact, which at times is not possible to quantify in money. The only reason patients come to doctors is to get better, so that they can go back to their functional lives. Any operation that prolongs the recovery, or has more complications, where families have to rearrange all kinds of things, and it is very expensive. The goal is to change all of this, and change the direction of surgery for generations to come. Where it gradually becomes less and less invasive, and goes beyond the 1 per cent type of numbers. So the plan and the vision of SSI is to address all of these things, and to literally remain as a science company. There is of course a business model, but there are a lot of things that are in the pipeline, that will really change the landscape."
One of the plans is to integrate telemedicine into the education system, to reduce the cost and time in training the surgeons after their education. Srivastava explains, "Telemedicine so far has been hyped up even though it is at this point as good as videoconferencing, and remote consultations et cetera. Our goal is to do teleeducation, telementoring, telediagnostics, and teletherepeutics. We can take these wonderful abilities wherever needed. It is not just for India, but all different countries. Even in the United States, with their economy and advanced medical system, the penetration of robotic surgeries is only 30 per cent among hospitals. The need is everywhere, but the cost and learning curve has been prohibitive. So our goal is to address all of these things in a very holistic way. One of the plans is to make robotic surgeries an integral part of the post-graduate curriculum. So you literally produce a pool or robotic surgeons, and the staff to support, and then you have a system that is affordable."
Right now, the surgeries are technically robot-assisted surgeries, and although performed remotely, the distance is less than a couple of metres. SS Innovations is working on technologies that will improve the existing systems, as well as push the boundaries even further, developing true telesurgieries, as well as intelligent overlays to act as visual aids for the surgeons, summoned on demand. That is all apart from developing new surgical procedures and instruments. Srivastava tells us, "We are developing certain automated enabling technologies that no one in the world has, which will revolutionise the heart bypass surgeries. We can push a button and within six seconds, the bypass is joined together. It will make the procedure safer, more efficient and provide a lifeline for the patients. Some of the science fiction stuff that we see, we are already looking at the metaverse, holograms and virtual operating theatres. We are working on all of these technologies in parallel. We will be doing telesurgeries. If the surgeons are unable to perform some complex operations, people with more experience will be able to strap in from wherever, for example a surgery in Delhi can be conducted from Mumbai, or takeover the machine and continue a procedure. There are huge, huge benefits. We can do remote surgeries in rural areas, on mobile units. Of course, we will need a lot of help from the government in terms of infrastructure, bandwidth, power et cetera, but all of this will become very feasible."
When asked if SS Innovations is working with augmented reality and artificial intelligence, Srivastava nods vehemently, "The vision is to change medicine, and how it is done. The next 10 to 20 years will be very different. We have already developed a virtual operating room. We can take the medical images, CAT scans or MRIs, and place it in the operating field. The surgeon can see everything inside, where the blood vessels are, and where the important structures are. We are working on all of these things in parallel. We are going to use AI and machine learning. We are also developing some single arm applications for tele diagnosis, where we can attach let us say an ultrasound probe onto a robotic arm. We have already experimented actually, whereby we use 5G and performed an ultrasound on a patient at a distance of 30 kilometres. In rural areas, patients have to travel long distances for healthcare, that has a high cost and is inconvenient. We can control a robotic arm remotely with a joystick, and with machine learning and AI, we can put libraries of images, and so the machine can provide the best possible image every time. Same thing with biopsies for instance, with 3D imaging coordinates, we can go in very precisely and biopsy a tumor. Right now, a radiologist does that under the guidance of fluoroscopy. Then there is the possibility of delivering targeted therapies, for cancer for instance, the drugs can be delivered directly to the tumour, instead of chemotherapy with systemic effects and hair loss and so on. All of these things are absolutely feasible with our robotic single arm applications, because we can automate the whole thing."
At SS Innovations, there are some procedures and capabilities being developed that no one really has globally. The idea is to develop specialty-specific robotic systems in the future, as well as self-assembling robotic platforms. Although it is bound to take time to hit the markets, SS Innovations is dedicated in the pursuit.
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