Chen Levin, CEO, XACT Robotics05.03.21
In recent years, the use of highly precise robotic technologies in a range of medical procedures has grown substantially.1,2 Robotic devices can lead to higher accuracy levels in surgery, less invasive procedures with shorter recovery times, reduce post-procedure pain, and lower the risk of infection for patients.3 There are also a number of potential benefits for the physician, including the ability to complete more procedures in less time and reduce strain and other risks associated with some procedures.4
To deliver these and other benefits, robotic medical devices must also provide surgeons and other healthcare providers with the assurance they will deliver the highest achievable levels of accuracy and reliability, especially for use in percutaneous procedures. To ensure that robotic technologies are engineered to deliver these results, attention to detail must begin in the earliest stages of the manufacturing process and be supported by rigorous standards in production, testing, and distribution.
Percutaneous procedures are used to reach areas of interest in the body for biopsies, ablations, site-specific drug delivery, and other local treatments. In recent years, engineers have developed a robotic device that surgeons can use to perform these procedures “hands free.” The XACT ACE Robotic System—cleared by the FDA in July 2020—uses an advanced image-based navigation system that includes robotic insertion and steering capabilities to insert and guide instruments into the human body. The device is designed and engineered to be able to consistently deliver an instrument to a target within 1.7-mm average accuracy on the first instrument insertion, representing a major advance in both timing and accuracy in percutaneous procedures. This level of performance means the technology may support earlier diagnosis and treatment for many patients, lower the risk of complications from surgery, lead to shorter recovery times, and support more efficient use of radiology services and resources. Without the highest levels of precision in design and production, achieving these results would not be possible. To support this level of precision, the XACT Robotics team developed a unique multiple-step manufacturing process of the XACT ACE System.
The first step involved the use of the highest quality materials sourced from suppliers around the world to ensure each uniquely engineered element in the device functions was structurally sound, and was able to support the highest levels of performance. The next step was a detailed assembly and testing procedure.
The XACT ACE System has two main parts: the robot and the console. The console is used to help plan a procedure and steer the instrument. The steering mechanism is based on a highly advanced proprietary algorithm that is used to keep the robot on the planned trajectory. The robot is placed on a patient’s body and steers the instrument to reach a target in the body. These two parts are first tested separately to ensure all components function perfectly on their own before they are integrated and tested together. While this may increase production timelines, this level of testing is essential for precision medical equipment.
The robot is then tested as a whole using a coordinate measuring machine (CMM)—a piece of equipment used to precisely and intricately measure an object’s geometry. The CMM system evaluates the insertion process and provides accurate and automated measurements to ensure the device does not deviate from the projected trajectory of the instrument and can repeatedly reach a target in the body within 1.7 mm. This special testing process helps to confirm every device can efficiently and accurately reach very small targets, even in hard-to-reach locations in the body.
In addition to the CMM system, production teams also use a custom-designed phantom of an abdomen to confirm device performance. The dummy abdomen reflects the same range of tissue density found in the human body. This process, used by many companies in the robotics space, helps to confirm a robot will perform accurately during a real-life procedure. These mock procedures are also required to certify the robot has met all mechanical accuracy and procedural checks before it is shipped to customers.
Another critical aspect of the manufacturing process for robotic medical devices is the shipping process. While it is true most medical devices must be shipped carefully, XACT Robotics takes extra precautions to guarantee each system arrives in perfect condition and no element of the shipping process can have an impact on the system’s accuracy or performance. The XACT ACE Robotic System is exposed to vibration testing and is then tested again for durability and to see if transport can cause any damage. This process is designed to confirm the safety and quality of distribution from the production center in Israel to locations around the world.
In robotic technologies, production also often includes a companion console or control panel used by the surgeon to operate the device. The same levels of quality and precision must be reflected in the design and performance of these control devices. With the XACT ACE system, the physician plans the procedure and confirms the trajectory of the instrument using the navigation console. The robot inserts the instrument into a patient’s body following the planning stage performed by the radiologist. If the console is not able to perform this function precisely, the procedure could be at risk. The console where the radiologist plans the procedure has a foot pedal that enables the robot to execute the procedure. Once the radiologist determines the optimal route to a target, the foot pedal is used to initiate the procedure and enable all subsequent steps performed by the robot during a procedure.
Another unique aspect of XACT ACE made possible through the manufacturing process is the robot’s capabilities in non-linear steering. During percutaneous procedures, a target in the body can often move due to soft tissue movement or when a patient moves or breathes. When an instrument does not reach a target that has moved, it is often necessary to repeat the insertion or even the procedure, increasing risk for both the patient and healthcare providers. With an advanced, non-linear steering capability, the radiologist can plan the trajectory and the instrument will reach the target on the first attempt—even if it moves. If the target does move, the radiologist can use the console navigation system to update the trajectory. Advanced engineering that supports three-dimensional movement based on an advanced software algorithm allows the instrument to move in five degrees of freedom: x and y axes, left and right angulations, and insertion. The level of flexibility in steering technology is a more recent advance in engineering that will become a standard in robotics in the years ahead.
As the use of robotics in healthcare continues to grow, it will be important for manufacturers to continue to focus on access to the highest quality materials and precision engineering. Every step of the engineering and manufacturing process must support the level of accuracy and performance that surgeons and other medical specialists demand. They must apply these rigorous standards to every phase of product development and production from early design to final distribution. Meeting these standards will provide surgeons with the confidence they need to adopt new technologies faster and use them more widely to support optimal patient outcomes.
References
Chen Levin is a seasoned leader in the healthcare space with vast experience in management and operational positions. Throughout her career, Chen contributed to, and played an instrumental part of, the Israeli biomed industry’s continuous growth. Prior to leading XACT Robotics, Chen served as the executive director of BioJerusalem, an initiative of the Prime Minister’s Office of the government of Israel to foster the biomed industry in Jerusalem, where she established numerous ventures and collaborations. Before BioJerusalem, Chen served as the CEO of Biomagnesium Systems Ltd., an early-stage medical device company. Prior to this, Chen played a key role in the establishment of BioLineRx, Israel’s first Biomed Incubator (now a TASE publicly traded company).
To deliver these and other benefits, robotic medical devices must also provide surgeons and other healthcare providers with the assurance they will deliver the highest achievable levels of accuracy and reliability, especially for use in percutaneous procedures. To ensure that robotic technologies are engineered to deliver these results, attention to detail must begin in the earliest stages of the manufacturing process and be supported by rigorous standards in production, testing, and distribution.
Percutaneous procedures are used to reach areas of interest in the body for biopsies, ablations, site-specific drug delivery, and other local treatments. In recent years, engineers have developed a robotic device that surgeons can use to perform these procedures “hands free.” The XACT ACE Robotic System—cleared by the FDA in July 2020—uses an advanced image-based navigation system that includes robotic insertion and steering capabilities to insert and guide instruments into the human body. The device is designed and engineered to be able to consistently deliver an instrument to a target within 1.7-mm average accuracy on the first instrument insertion, representing a major advance in both timing and accuracy in percutaneous procedures. This level of performance means the technology may support earlier diagnosis and treatment for many patients, lower the risk of complications from surgery, lead to shorter recovery times, and support more efficient use of radiology services and resources. Without the highest levels of precision in design and production, achieving these results would not be possible. To support this level of precision, the XACT Robotics team developed a unique multiple-step manufacturing process of the XACT ACE System.
The first step involved the use of the highest quality materials sourced from suppliers around the world to ensure each uniquely engineered element in the device functions was structurally sound, and was able to support the highest levels of performance. The next step was a detailed assembly and testing procedure.
The XACT ACE System has two main parts: the robot and the console. The console is used to help plan a procedure and steer the instrument. The steering mechanism is based on a highly advanced proprietary algorithm that is used to keep the robot on the planned trajectory. The robot is placed on a patient’s body and steers the instrument to reach a target in the body. These two parts are first tested separately to ensure all components function perfectly on their own before they are integrated and tested together. While this may increase production timelines, this level of testing is essential for precision medical equipment.
The robot is then tested as a whole using a coordinate measuring machine (CMM)—a piece of equipment used to precisely and intricately measure an object’s geometry. The CMM system evaluates the insertion process and provides accurate and automated measurements to ensure the device does not deviate from the projected trajectory of the instrument and can repeatedly reach a target in the body within 1.7 mm. This special testing process helps to confirm every device can efficiently and accurately reach very small targets, even in hard-to-reach locations in the body.
In addition to the CMM system, production teams also use a custom-designed phantom of an abdomen to confirm device performance. The dummy abdomen reflects the same range of tissue density found in the human body. This process, used by many companies in the robotics space, helps to confirm a robot will perform accurately during a real-life procedure. These mock procedures are also required to certify the robot has met all mechanical accuracy and procedural checks before it is shipped to customers.
Another critical aspect of the manufacturing process for robotic medical devices is the shipping process. While it is true most medical devices must be shipped carefully, XACT Robotics takes extra precautions to guarantee each system arrives in perfect condition and no element of the shipping process can have an impact on the system’s accuracy or performance. The XACT ACE Robotic System is exposed to vibration testing and is then tested again for durability and to see if transport can cause any damage. This process is designed to confirm the safety and quality of distribution from the production center in Israel to locations around the world.
In robotic technologies, production also often includes a companion console or control panel used by the surgeon to operate the device. The same levels of quality and precision must be reflected in the design and performance of these control devices. With the XACT ACE system, the physician plans the procedure and confirms the trajectory of the instrument using the navigation console. The robot inserts the instrument into a patient’s body following the planning stage performed by the radiologist. If the console is not able to perform this function precisely, the procedure could be at risk. The console where the radiologist plans the procedure has a foot pedal that enables the robot to execute the procedure. Once the radiologist determines the optimal route to a target, the foot pedal is used to initiate the procedure and enable all subsequent steps performed by the robot during a procedure.
Another unique aspect of XACT ACE made possible through the manufacturing process is the robot’s capabilities in non-linear steering. During percutaneous procedures, a target in the body can often move due to soft tissue movement or when a patient moves or breathes. When an instrument does not reach a target that has moved, it is often necessary to repeat the insertion or even the procedure, increasing risk for both the patient and healthcare providers. With an advanced, non-linear steering capability, the radiologist can plan the trajectory and the instrument will reach the target on the first attempt—even if it moves. If the target does move, the radiologist can use the console navigation system to update the trajectory. Advanced engineering that supports three-dimensional movement based on an advanced software algorithm allows the instrument to move in five degrees of freedom: x and y axes, left and right angulations, and insertion. The level of flexibility in steering technology is a more recent advance in engineering that will become a standard in robotics in the years ahead.
As the use of robotics in healthcare continues to grow, it will be important for manufacturers to continue to focus on access to the highest quality materials and precision engineering. Every step of the engineering and manufacturing process must support the level of accuracy and performance that surgeons and other medical specialists demand. They must apply these rigorous standards to every phase of product development and production from early design to final distribution. Meeting these standards will provide surgeons with the confidence they need to adopt new technologies faster and use them more widely to support optimal patient outcomes.
References
Chen Levin is a seasoned leader in the healthcare space with vast experience in management and operational positions. Throughout her career, Chen contributed to, and played an instrumental part of, the Israeli biomed industry’s continuous growth. Prior to leading XACT Robotics, Chen served as the executive director of BioJerusalem, an initiative of the Prime Minister’s Office of the government of Israel to foster the biomed industry in Jerusalem, where she established numerous ventures and collaborations. Before BioJerusalem, Chen served as the CEO of Biomagnesium Systems Ltd., an early-stage medical device company. Prior to this, Chen played a key role in the establishment of BioLineRx, Israel’s first Biomed Incubator (now a TASE publicly traded company).
