Pharma Industrial India Magazine - May-June 2024

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 regulato- ry requirements or not. Upon successful evaluation, the device is awarded a CE mark, signifying its compliance with EU stan - dards 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 ac- cessibility 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 regula- tory approval process, for ensuring the safety and efficacy of medical devices. Indian regulatory approval process, is equal - ly 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 sur- gical robotic systems necessitates the involvement of highly skilled healthcare professionals who possess a comprehensive blend of medical and technological knowledge. These pro- fessionals 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 un - derstanding. 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 surgi- cal procedures that can be execute using the system. Health- care 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, en - abling them to adeptly handle a range of surgeries, from minor to overly complex procedures, using the surgical robotic sys - tem. 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 opera - tion 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 profession - als are not only proficient in the use of surgical robotics but also in the holistic management of the system, ensuring opti - mal patient outcomes. Q How do you foresee the integration of AI and machine learning in future versions of the SSi Mantra and kind - ly 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 revo - PHARMA INDUSTRIALINDIA · MAY-JUN 24 23 INTERVIEW