What You Need To Know About Manufacturing Robot-Assisted Surgery Systems

Remember the 1960s television series, ‘Lost in Space’, ‘Astro Boy’ and ‘Fantastic Voyage’? Robots, adventure and unfathomable medical science were all pure science fiction back then. Today cutting edge technology and medical science has made using robots in medical procedures a reality – this is no longer make-believe! Today, the global Surgical Robots market is estimated to grow at a phenomenal rate of 21.6% (CAGR) from 2021 to 2028.

2021 has been a year full of advances and new entrants in the field of robotic surgery. Even during the pandemic, the surgical robots market clocked USD 2.3 billion. The reasons for the rapid adoption of Robot-assisted surgical systems are quite obvious, having application in almost all kinds of surgery such as: Urology, Orthopedics, Neurology, Gynecology, and others. Let’s discuss some of the amazing benefits and daunting challenges that manufacturers face.

Benefits of Robotic Surgery

Greater dexterity

If a surgeon had to use his hands to remove a tiny blood clot or remove a small kidney stone, he knows that he cannot maneuver his hands as he may need to – owing to the size of his hands and the lack of space to maneuver around in. This is also a disadvantage that surgeons have lived with ever since surgery came into use.

The next generation in surgery was the computer assisted arms that were not as advanced as robotic devices. These computer assisted arms require that doctors think completely differently. For example: they had to move the controls left to go right and move up to go down and so on, which made surgery quite difficult and had much potential to result in errors.

Today’s robot-assisted surgical devices, are incidentally quite small in comparison to preceding models. The surgeon now has the capability to maneuver at any angle he wishes without even having to rethink the way he needs to move the controls. Dexterity with surgical robots is virtually limitless. This also means that surgeons are now able to reach the innermost and most intricate parts of the human body, including the brain and other internal organs, with precision and with minimal damage to surrounding tissues.

Minimally Invasive Technology

Since open surgery involves larger surgical cuts, longer hospital stays, long recovery periods owing to comparatively higher damage to surrounding tissues, and of the apparent higher risk, minimally invasive procedures have become the most sought after by patients and the healthcare fraternity alike.

Robot-assisted surgery is an advanced form of minimally invasive surgery suited for complex surgeries that require greater skill, dexterity, and precision. All of which are hard to come by with alternative procedures.    

The pandemic created a sensitivity towards procedures that could result in any kind of infection. Minimally invasive procedures carry the lowest risk of infection, and are thus a preferred method worldwide.

Challenges with Manufacture of surgical robots

When designing a robot-assisted surgical system, there are an exponential number of considerations to be made. For example:

  • The design of wristed instruments
  • Building seven or more degrees of freedom
  • Overcoming factors such as abdominal wall torque
  • 3D visualization design
  • Ergonomic design at the patient cart and also at the control station for the surgeon
  • Elimination of counter-intuitive movements and more.

These requirements necessitates superior design engineering and production expertise to be applied when designing and manufacturing the RAS system. Let’s examine a few of the practical challenges that OEMs and manufacturers face:

Cost Effectiveness

Surgical robot systems are complex to build and to install at a healthcare facility. The hospital will need to assign an operating room specifically for this system, since it is not a mobile set-up. The high cost of manufacture, which is on average about a million dollars (USD), together with the set-up costs leaves patients with a bill that’s on average $2000-$5000 more than a traditional laparoscopic procedure.

Today, tremendous technological advances, use of breakthrough designs and improved manufacturing processes in the design and manufacturing process, are helping lower prices to as much as a quarter of what it originally cost. Meanwhile, precision, safety and improved patient outcomes are playing their part as major drivers, in favor of RAS systems. There is still a long way to go, but the good news is that despite the cost, the number of robot-assisted surgeries being performed in the United States are steadily on the rise.

Biocompatibility

Since the most important parts of the RAS system will come into direct contact with tissues, it is essential that they are crafted from biocompatible materials. While some manufacturers prefer advanced polymers such as PPSU, PEEK and PARA; some prefer specialized alloys like Titanium alloys like Nitinol, Cobalt-Chromium alloys or stainless steel alloys. Their relative weights, hardness and compatibility determine their specific use in the RAS system. The surgical site (soft tissue or hard tissue) also determines the suitability of the material.

Without biocompatibility, the body may not handle the procedure as well as it should. Materials chosen must also be heat resistant and be able to withstand multiple rounds of sterilization and disinfection after each use.

Advanced 3D Imaging

Traditional surgery has limited surgeons, especially on the visual front. With robot-assisted surgery, visualization is vastly better. The robotic arm is equipped with a light source and camera that is able to provide a 3600 view of its location. Visuals of fine anatomical structures, such as the miniature structures within the kidney, liver or brain, which could not be obtained clearly, even with MRI or computer-assisted tomography are now available to surgeons, for their assessment and precise surgical intervention. The cameras need to be so advanced that they are stable even to minor tremors or movements in the body.

Visual navigation is replaced by electromagnetic navigation, which can guide surgeons into hard-to-reach places. Not only should the RAS images and feed be stabilized, but they are also able to provide infrared, fluorescence imaging that can detect Indocyanine green or other dyes that are typically used to detect tissue perfusion, identify lymphatic structures or distinguish between healthy and tumor cells.

Miniaturization and Actuation Methods

RAS systems are specifically suited for complex surgical procedures that are particularly difficult to perform. This is why miniaturization is so important. In order to reach the inner parts of an organ, the robotic arm must come in miniature sizes that are less than a millimeter in diameter. These miniature parts must also be necessarily free to move about without limitations. This kind of mechanism has multiple joints to facilitate movement, which are usually powered by actuators. This is commonly called a Continuum Robot.

Striking the right balance between manipulation force and flexibility is critical to ensure precise control at the surgical site. In order to manufacture such a robot, the actuator mechanism must be perfected by the designer and manufactured using specialized manufacturing technology that can overcome adhesive forces, Van der Waals forces and electrostatic forces.

ITI’s Manufacturing Difference

At ITI we pride ourselves on our half-century of in-depth experience in developing imaging technologies and medical devices. Our facilities are equipped with top-in-class manufacturing equipment with dedicated production lines for miniature parts and large parts. To top that off, we have the best production and medical device design engineers on staff who are able to provide you with the right insight you need in designing and manufacturing your own Robot-Assisted Surgery System.

If you’re looking for an established medical device contract manufacturer to partner with or would simply like to consult our experts, drop us a note and we can schedule a free consultation today!