2024-08-01

Q: How can surgical robotics influence the outcomes in complex surgeries like cardiac and thoracic surgery and how is SS Innovations products impacting the medical device industry?

Dr. Sudhir Srivastava: The advent of robotic surgery has been a pivotal development in the field of medicine, revolutionizing the way complex surgical procedures are approached and executed. The integration of robotic surgical systems, particularly in cardiac and thoracic surgeries, has provided surgeons with an unprecedented level of support, enhancing precision and accessibility during operations. These sophisticated systems are equipped with robotic arms, capable of performing precise movements, thereby significantly reducing the margin for human error. This precision is crucial when performing intricate tasks that demand higher accuracy.

Moreover, the assistance of robotics in surgery allows for easier access to anatomical regions that are typically challenging to reach. Hand tremors are filtered, ensuring greater stability and contributing to the overall safety of the surgical procedure. The state-of-the-art 3D 4K visualization technology that comes with the robotic systems further augment the surgeon’s ability to navigate through intricate anatomical structures. This is particularly beneficial in managing adult congenital heart complications, where in-depth perception is vital for successful navigation and intervention.

In addition to the enhanced visual capabilities, robotic surgeries leverage minimally invasive techniques that have shown improved post-operative results. These include a marked reduction in blood loss and a lower risk of infection, both of which contribute to improved patient outcomes. Patients who undergo robotic surgeries often experience less post-operative pain, enjoy shorter hospital stays, and benefit from a quicker return to their daily activities. The cumulative effect of these advantages is a more efficient healthcare system, where patient recovery is expedited, and the quality of care is elevated.

The implementation of Surgical Robotic systems signifies a transformative step forward in surgical practices. It not only refines the technical aspects of surgery but also has a profound impact on patient care. As the technology continues to advance, it is anticipated that robotic surgery will become even more integral to modern surgeries, further improving surgical outcomes and patient experiences.

Q: What are the main challenges in designing surgical robotics for multi-specialty applications leveraged by SS Innovations and explain the role of 3D 4K vision technology in robotic surgery systems?

Dr. Sudhir Srivastava: The development of surgical robotics tailored to various specialties presents a multitude of challenges, the foremost being the assurance that the robotic system is versatile enough to accommodate the diverse array of surgeries, each with its distinct medical requirements and constraints. Ensuring the safety, precision, and reliability of these systems is paramount to safeguard patient health and maintain the confidence of healthcare providers in the technology. Rigorous testing, validation, and adherence to regulatory standards are imperative to address these concerns and mitigate risks associated with complex multi-specialty applications.

The integration of cutting-edge technologies such as artificial intelligence (AI) and augmented reality (AR) is essential, yet it is equally important to maintain user-friendly interfaces for surgeons. Moreover, fostering collaboration among engineers, surgeons, and healthcare professionals is critical. Such interdisciplinary cooperation is instrumental in comprehending the multifaceted needs of the medical community, refining system designs, and catalysing innovation for the application of surgical robots in a variety of specialties.

The implementation of 3D 4K vision technology represents a significant advancement for surgical robotic systems, providing surgeons with an immersive, high-resolution view of the operative field enhancing their hand-eye coordination, depth perception, and ability to discern complex anatomical structures with greater accuracy. This technological leap forward enables surgeons to execute procedures with heightened precision, thereby reducing the likelihood of complications and improving patient outcomes. Furthermore, the superior visualization offered by 3D 4K technology allows surgeons to identify minute anatomical details with ease, resulting in more precise manoeuvres and superior surgical results.

Q: Explain the regulatory approval process for medical devices in India and how does it compare to the process in the United States and the European Union?

Dr. Sudhir Srivastava: The regulatory approval process for medical devices is a critical component of healthcare governance, ensuring the safety and efficacy of devices before they reach the market. In India, this process is administered by the Central Drugs Standard Control Organization (CDSCO), which oversees the evaluation of medical devices based on a comprehensive set of guidelines to ensure they meet the required safety and performance standards. The timeline for approval in India is variable, and contingent upon the device’s classification and complexity, and can extend from several months to a few years.

In US, the regulatory framework is more stringent, with the Food and Drug Administration (FDA) at the helm of the approval process. The FDA’s approach is renowned for its meticulous scrutiny of safety and efficacy data, which encompasses a detailed review of clinical trial results and other pertinent information. This rigorous process is designed to ensure that only medical devices that meet the highest standards of safety and effectiveness are authorized for use. Hence, the timeline for approval can be protracted, due to the thoroughness of the FDA’s approach to assessment.

The European Union’s regulatory process is governed by the Medical Devices Regulation (MDR) and the In-vitro Diagnostic Regulation (IVDR), which mandates a conformity assessment conducted by a notified body. This assessment is a systematic evaluation of whether a product meets the necessary regulatory requirements or not. Upon successful evaluation, the device is awarded a CE mark, signifying its compliance with EU standards and permitting its free movement within the European market. The regulatory system of EU is structured to harmonize the standards across the member states, thereby ensuring a high level of protection for public health and facilitating the accessibility of medical devices across the EU.

Each of these regulatory environments reflects a commitment to patient safety and product quality, albeit through different procedural avenues. Manufacturers seeking to navigate these processes must be well-versed in the respective regulations and prepared for the varying timelines and requirements they entail. The ultimate goal of these regulatory bodies is to ensure that medical devices are safe for patient use and effective in their intended applications, thereby upholding the integrity of healthcare systems globally. Each country has its own regulatory approval process, for ensuring the safety and efficacy of medical devices. Indian regulatory approval process, is equally stringent than the US FDA and EU CE.

Q: How does SS Innovations approach the development of its training programs for surgical robotics?

Dr. Sudhir Srivastava: The successful implementation of surgical robotic systems necessitates the involvement of highly skilled healthcare professionals who possess a comprehensive blend of medical and technological knowledge. These professionals ensure that the sophisticated machinery operates seamlessly within the clinical setting. Surgical robotics training programs are meticulously designed to impart knowledge on the intricacies of surgical robotic systems, encompassing both theoretical and practical aspects, to guarantee a thorough understanding.

These training sessions are structured to provide a progressive learning experience, starting with the foundational principles of the robotic system and gradually advancing to complex surgical procedures that can be execute using the system. Healthcare professionals are equipped with the necessary skills to operate the robotic system through hands-on training, which includes tasks such as configuring the console, manipulating the controls, practicing on organ models, suturing on suture pads, pick and place for hand-eye coordination and controlling the robotic arms with precision. Since most of these surgeons are adept with laparoscopic techniques, the learning curve is not very steep, and the surgeons transition to robotic platform with much ease.

As practitioners progress through the training, they develop a deep-seated expertise in various surgical techniques, enabling them to adeptly handle a range of surgeries, from minor to overly complex procedures, using the surgical robotic system. This expertise is not only technical but also procedural, as they learn to navigate through the intricacies of different surgical scenarios.

Furthermore, the training curriculum extends beyond operation to include comprehensive guidance on maintenance and troubleshooting. Participants receive detailed instruction on system upkeep, identifying and resolving common technical issues, and ensuring the consistent functionality of the robotic equipment. This aspect of the training is crucial for minimizing downtime and maintaining the reliability of the system.

By the end of these training programs, healthcare professionals are not only proficient in the use of surgical robotics but also in the holistic management of the system, ensuring optimal patient outcomes.

Q: How do you foresee the integration of AI and machine learning in future versions of the SSi Mantra and kindly discuss about the maintenance and after sales services the company employs to ensure customer satisfaction?

Dr. Sudhir Srivastava: The integration of AI and machine learning into future versions of the SSi Mantra, the innovative surgical robotic system from SS Innovations, promises to revolutionize surgical procedures and enhance the overall efficiency and effectiveness of medical operations. Here are some key areas where AI and machine learning are being and will be increasingly integrated into SSi Mantra:

AI and Machine Learning Integration in SSi Mantra

1. Medical Imaging and 3D DICOM Visualization:
   • Automated Organ and Vessel Segmentation: AI-driven software enhances 3D DICOM visualization by automating the segmentation of organs and blood vessels. This provides surgeons with detailed pre-operative and intra-operative insights into the patient's anatomy, facilitating more precise and informed surgical decisions.
2. Surgeon Ergonomics Analysis:
   • Ergonomics and Efficiency: AI is used to analyze and improve the ergonomics of surgeons using the SSi Mantra. By studying the movements and postures of surgeons, AI can recommend best practices to enhance ergonomic well-being, reduce fatigue, and improve overall surgical efficiency.
3. Data Anonymization for Security and Training:
   • Patient Data Protection: AI algorithms anonymize patient data to ensure security and privacy. This anonymized data, with patient consent, can then be utilized to train the surgical robots for performing basic automated tasks such as irrigation and camera positioning. Over time, this training can be extended to more complex tasks like suturing and ablation.

Future Prospects

The foreseeable future of SSi Mantra includes:

• Enhanced Automated Tasks: AI will enable the robots to handle increasingly complex surgical tasks autonomously, improving surgical precision and reducing the workload on human surgeons.
• Personalized Surgical Training: Continuous AI-driven analysis will allow for highly personalized training programs for surgeons, ensuring that each surgeon can achieve optimal performance with the robotic system.

Maintenance and After-Sales Services

SS Innovations is dedicated to ensuring customer satisfaction through comprehensive maintenance and after-sales services. These services are designed to maximize the uptime of the SSi Mantra system and provide ongoing support to medical teams.

1. Onsite and Offsite Training:
   • Comprehensive Training Programs: SS Innovations provides extensive training programs both onsite and offsite to ensure that surgical teams are fully proficient in using the SSi Mantra. This includes initial setup training and continuous education on advanced features and updates.
2. On-Call Service Checkups:
   • Performance Monitoring: Regular on-call service checkups are conducted to monitor the performance of the SSi Mantra systems. This proactive approach helps in identifying and resolving issues before they affect surgical operations.
3. Scheduled System Checkups:
   • Routine Maintenance: Scheduled system checkups ensure that all components of the SSi Mantra are functioning optimally. This routine maintenance is crucial for preventing unexpected downtimes and ensuring consistent performance.
4. Proctoring Provisions:
   • Expert Guidance: SS Innovations offers proctoring services where experienced surgeons provide guidance during initial surgeries using the SSi Mantra. This ensures that new users can perform surgeries with confidence and efficiency.
5. Launching Surgical Programs:
   • Robotic Cardiac Surgery: SS Innovations assists hospitals in launching new surgical programs, including robotic cardiac surgery. This support includes providing the necessary equipment, training, and expertise to establish successful robotic surgery programs.
6. Efficient Turnaround Time (TAT):
   • Made in India Advantage: Being a product made in India, the SSi Mantra benefits from rapid serviceability, especially for customers within the country. SS Innovations can quickly provide system updates and advancements with cost-effective solutions, ensuring minimal downtime and high affordability.

Through these comprehensive after-sales services, SS Innovations ensures that customers receive continuous support and that the SSi Mantra system remains at the cutting edge of surgical technology. This commitment to excellence not only enhances customer satisfaction but also solidifies SS Innovations' position as a leader in surgical robotics.

Q: What is the key software and hardware components of the SSi Mantra robotic system and how does SS Innovations ensure the compatibility of its surgical instruments with various surgical techniques?

Dr. Sudhir Srivastava: The SSi Mantra surgical robotic system from SS Innovations integrates advanced software and hardware to enhance surgical precision and efficiency. Here’s a detailed overview of its key components and how the system ensures the compatibility of its surgical instruments with various surgical techniques:

Key Software Components

1. Real-Time Operating System (RTOS)
   • High-Speed Communication: The system runs on RTOS, enabling the fastest possible device communication protocols to provide a real-time operating experience for surgeons and surgical staff.
2. Surgeon Command Center Software
   • 7 DOF Tracking Controllers: This software effectively translates the position and orientation of the surgeon’s movements to the robotic arms with high precision.
   • Ancillary Software: Includes pre-operative guidance, multimedia streaming, and recording platforms.
   • SSI Maya Suite:
     • 3D DICOM Viewing: Advanced imaging software for detailed pre-operative and intra-operative visualization.
     • Tele-Proctoring: Allows remote guidance and assistance.
     • Surgical Simulations: Uses XR technologies for training and simulation.
3. Data Transfer Protocols
   • Real-Time Data Transfer: Ensures seamless communication between the surgeon and the robotic instruments, enabling precise control and movement during surgeries.

Key Hardware Components

1. Surgeon Command Center
   • Ergonomic Design: Features 7 Degrees of Freedom (DOF) tracking controllers to accurately translate the surgeon’s hand movements to the robotic arms.
2. Robotic Arm Carts
   • Patient-Side Modules: These robotic arms hold and manipulate the surgical instruments within the patient. They execute the surgeon's commands in real-time, ensuring precision and control.
3. Vision Cart
   • Integrated Surgical Devices: Houses essential surgical devices such as cautery machines, power modules, and endoscope systems.
   • 3D Video Feed: Provides a high-definition, three-dimensional video feed to the entire surgical team, enhancing communication and coordination.

Ensuring Instrument Compatibility with Various Surgical Techniques

1. Mimicking Human Motion
   • Miniaturized Instruments: The robotic instruments are designed to replicate the motion of a surgeon’s hand and wrist. This miniaturization allows for familiar movements and techniques used in open surgeries to be adapted to robotic procedures.
2. Novel Instrumentation
   • Specialized Robotic Tools: SS Innovations has developed unique instruments only possible through robotic technology. These include tools for complex tasks such as stapling, ultrasonic vessel sealing, and anastomosis, which automate and enhance these procedures.
3. Pre-Operative Guidance and Simulation
   • 3D DICOM and XR Technologies: The use of 3D DICOM for detailed anatomical visualization and XR technologies for simulation ensures that surgical teams can plan and practice surgeries, ensuring that the instruments and techniques are optimized for each specific procedure.
4. Compatibility and Adaptability
   • Standardization and Customization: The instruments are built to be standard yet adaptable, ensuring they can be used across a wide range of surgical techniques. This versatility allows surgeons to apply familiar techniques while benefiting from the precision of robotic assistance.

Through these detailed software and hardware integrations, SS Innovations ensures that the SSi Mantra system remains a cutting-edge solution in the field of surgical robotics, meeting the evolving needs of surgeons and healthcare facilities.