Review and Feedback

Feasibility Report on the use of Robotics in the Surgical Setting

Alex Lochlann,

ENGL 235, Technical Writing

February 25, 2021

APA Format

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Letter of Transmittal To: Professor Tobias Peterson

From: Alex Lochlann

Date: February 25th, 2021

Subject: Letter of Transmittal

Dear Professor Peterson,

Enclosed is my feasibility report on the use of robotics in surgery. This term has been an incredible opportunity for me to sharpen my technical writing skills. It may have been a bumpy ride, but your sense of humor and creativity has given me the tools I need to be a successful writer. I want to walk you through the Learning Mastery skills you’ve instilled in me.

The first Learning Mastery achievement that I’ve accomplished is editing with the highest standards. This is key to writing an ethical document that has specific purpose. Work-world ethical documents are an important part for any future career path. Therefore, these documents should be clear and concise because they represent our work efficacy.

The second Learning Mastery achievement grasped is the appropriate formatting of visual aids when creating technical documents. Visual aids are what tie any written work together. They are appealing to the eye and they represent a different way of addressing the topic.

The third Learning Mastery skill is the location and proper citation of credible sources that supports our written work. The lesson of this Learning Mastery is what builds the foundation of our work. The sources gathered would be the determining factor to how our document will be presented. It is also equally important that the research presented is cited correctly. This gives credit to work that is not our own, and provides respect to the information addressed in our written work.

The fourth and final Learning Mastery skill you have encouraged is how to contribute within a group setting, to create work-world documents of the highest ethical standards. Our work will not just represent ourselves in our professional careers. They will also represent people who contribute to the process, and the Organization we represent. It is highly unlikely that we would provide work-world documents solely on our own. Our best work is compiled through a team effort, and that is what produces documents of the highest ethical standard.

These mastery skills that you’ve taught me will carry into my future. This class has allowed me the chance to self-reflect on the work I produce and contribute to. It has given my work a higher purpose and standard to adhere to. As a teacher, you have been clear and supportive of the direction of this course. You have encouraged your students, and given us the tools necessary to produce quality work. This class was not easy, but the teachings will move us forward in any direction we set.

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My only regret was that my time, as a student, was split between other core classes. I know many students are also sharing this difficult burden. If I could have been given the opportunity to solely focus on this class, my quality of work would have felt less rushed.

Despite a full-time workload and full-time course load, I have managed to be successful in this class. Your teaching style has entertained and encouraged me to understand the lessons you provided. I know that this personal growth and newfound skill will benefit me in the future, and I could not be more grateful for the opportunity.

I hope you enjoy your teachings coming to fruition with the report attached below. You will find that all four Learning Mastery skills have been applied with fulfillment. It has been my pleasure studying from you Mr. Tobias Peterson.

Sincerely,

-Alex Lochlann

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Table of Contents Letter of Transmittal ............................................................................................................. ii

Table of Contents ................................................................................................................. iv

Abstract ................................................................................................................................. v

Introduction .......................................................................................................................... 1

Collected Data ....................................................................................................................... 5

Conclusion ............................................................................................................................. 7

Reference ............................................................................................................................... 8

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Abstract

The presented investment feasibility report investigates the use of robotics in the healthcare systems to perform surgery. The robotic industry has reached milestones with technology advancements. Today’s operative robots offer surgeons 360 degrees of operative field visualization in high-definition 3D. They also offer real-time data, tactile dexterity and high quality precision of movements. Although, initial investment and start up costs are high, the robotic industry has been deemed successful in steadied growth of profit, with the market valued at 6.7 billion. The industry is also likely to reach 11.8 billion in value by 2025 (Perez & Schwaitzberg, 2019). Two different meta-analyses were studied on this topic. The first report supports the success in the operating room, and the second report opposes the use of robotics in surgery. The supportive meta-analyses provided in-depth data on the cancer patients who underwent robotic surgery for treatment. The results found that robotic surgery provided shorter hospital stay, quicker recovery time, lower blood loss, and complication rates (Liu et.al, 2017). The results of the second meta-analyses produced data of robotic malfunctions during surgery. There were 18 were randomized controlled studies and 30 were prospective comparative studies. The results found that the overall complication rate of the robotic arm was around 16.1%, which was higher than the traditional approach (Tan et. al, 2016). After careful consideration, it was concluded that there is not yet enough evidence supporting that robotic surgery was far superior to the traditional approach. It was clear that the robotic industry still has a lot to prove and more data needs to be collected from proper clinical trials to support meta-analyses article findings. However, the robotic industry’s technical advances and financial growth is promising for the future. Initech would benefit from investment of the surgical robots in the surgical setting. Their innovation will evolve patient care across the world.

Key words: Investment, Precision, Operating Room, Surgery, Robotics,

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Introduction Technology is an area under constant evolution. With all these advancements, it was only a matter of time before robots would find themselves in the operating room. Since the 1970s, mankind has been working on the technology to incorporate robotics in surgery. The concepts of robotic surgery or “remote surgery” was actually first explored by the U.S. National Aeronautics and Space Administration (NASA). This idea was entertained because NASA believed surgeons could one day be able to perform surgical procedures in space, remotely, and safely from the comfort of Earth (Moore, 2018).

NASA may have had high dreams for robotic technology during that time period, but their ideas weren’t too far fetched. In fact, the very first robot used in a clinical setting was just a little later on in 1985. The PUMA 560 or Programmable Universal Manipulation Arm was the very first robot used in surgery. Victor Scheinman, who was a Mechanical Engineer and a pioneer of robotics, developed its technology. It was created to perform biopsies on the human brain in Neurosurgery. Since the PUMA 560, progression of robotics used in surgery has continued to skyrocket! The benefits of continuing innovation have lead to high performance accuracy in surgery, enhanced surgical outcomes for patients being treated, and a wealthy healthcare revenue stream (Tan et.al, 2016).

Figure 1 Robotic Metamorphoses from 1985-2013

Historical robotic events in the medical history provided by Tan et.al (2016).

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Today in Robotics As of 2021, there has been significant headway in the medical field for the robotic industry. There are many advantages to using robotics to perform surgical procedures. Surgeons operating with robotics are able to have a high definition, 3 dimensional, 360-degree view of their operative site. They operate on a console, away from the field, through the use of minimally invasive techniques. The robotic arms, which hold the instruments, offer full articulating motions that mimic the hands of the surgeon operating, giving them full control. Operating through robotics brings a whole new meaning to steady hands, removing a high percentage of errors that occur due to unsteady hand-eye coordination. There are many key companies competing in this industry such as Stryker, Mazor Robotics, Smith & Nephew, Hansen Medical, Medrobotics, TransEnterix, and THINK SURGICAL. The largest and most successful robotics company by far, however, is Intuitive

Surgical. Intuitive Surgical was established in 1995 and its most prized robot, the da Vinci system, is the most widely used robot in the hospital systems today (Perez & Schwaitzberg, 2019). These robotic systems are used for a wide variety of surgical procedures such as General, GYN, Cardio- Thoracic, Urology, Orthopedic, and Oncology related surgery. It is incredible to think that robotic technology has advanced so much since the first PUMA 560. It is now one of the leading treatment options for Oncology cancer patients because surgeons are able to visualize cancer tumors in real time 3D during removal. There is a robotic system called the MAKO, which aids in doing total knee replacements on patients. Cardio-Thoracic surgeons are able to repair their patient’s heart valves with the utmost precision. These are only a fraction of procedures that can be preformed using robotic technology. This industry is clearly here to stay.

How it Works: da Vinci System by Intuitive Surgical There are three main working parts to the da Vinci robotic system: The surgeon’s console, the robotic computer module, and the robotic surgical arms. The surgeon’s console is away from the operative field, usually placed in a corner of the operating room, where there is little to no distraction. Here, the surgeon sits and looks into a VR type lens that shows the operative field in real-time 3D. From the surgeon’s console, they are able to control the robotic arms with extreme precision, using joysticks and foot pedals.

The procedure is performed at the surgeon’s console by the surgeon controlling the robotic arms at the surgical field. The scrubbed in Physician Assistant and Surgical Technologist monitor the robotic arms and assist the surgeon to perform surgery. The da Vinci is capable of a wide variety of surgical procedures. The robotic technology of the arms is designed for complex

Figure 2 da Vinci system XI

Original photograph of the robotic system at Providence Portland Medical Center.

Image Copyright

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maneuvers. These arms, allow the surgeon’s hand movements to become smaller and more precise. While the surgeon is working, the computer module translates the movements at the operative field using these multi-armed instruments inside the patient’s body (Compton, 2020).

How it Works: MAKO SmartRobotics by Stryker The da Vinci may be the most popular option for General, GYN, Urological, and Cardio- Thoracic surgical procedures, but it has not been successful in the Orthopedic field. The MAKO robot by Stryker, has answered the call for Orthopedic surgeons. This is especially true for total joint surgeons. The MAKO system is a single robotic arm with the technology to accomplish total knee replacements, partial knee replacements, and total hip replacements.

The technology is based on a virtual 3D model that is specifically made for each individual patient. Before the surgery even begins, there is extensive planning that takes affect in order to ensure proper placement of the patient’s new joint. During the procedure, the MAKO robotic arm provides real-time tactile and auditory feed back to the surgeon. The system works autonomously to perform precisely planned femoral and tibial bone resections, allowing accurate patient limb alignment (Kayani et.al, 2019).

Unlike the da Vinci, surgeons are able to operate the robotic MAKO arm directly from the operative field. This is able to happen because the personalized patient information is pre- registered into the software of the MAKO system. The surgeon dissects down to the joint, and places the robotic arm at the pre-registered markers of the patient’s anatomy. Then the surgeon starts the bone resection process, allowing the personalized bone cuts to be made, and the new prosthetic joint to be implanted.

Figure 3 MAKO Robotic System by Stryker

This photograph shows the MAKO robotic arm with its computer software system. Copyright of South Carolina Sports Medicine & Orthopedic Center (2020).

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Cost vs. Profit Margins Even with all the advancements the robotic industry has made throughout the years, there are a few unconventional aspects. The initial upfront costs can be overwhelming to smaller healthcare systems. Depending on the type of robot purchased, one unit can cost anywhere from $1.5 to $3 million. This does not include the purchase of specialized instruments, drapes, utilities, and maintenance costs. The da Vinci system requires an upfront capital investment, ranging in price from $0.5 to $2.5 million. This cost depends on the model, configuration, and geographic location. Recurring costs include: annual service contracts, ranging in price from $80,000– 170,000 based on model and services desired. Instrument and accessory costs can range anywhere from $700–$3,500 per procedure (Perez & Schwaitzberg, 2019).

According to a press release from ReportnReports on OpenPR Worldwide Public Relations, the market is currently

reported to be worth over 6.7 billion dollars and it is projected to reach over 11.8 billion dollars by 2025 (2020). Expected growth is likely to reach 15% per year. It is clear the robotic surgery is here to stay. Intuitive Surgical has successfully marketed the benefits of robotic surgery. State-of-the-art technology, improved visualization, maneuverability, ergonomics and outcomes has all allowed the da Vinci system to be installed in over 2,800 hospitals (Perez & Schwaitzberg, 2019).

The foreseeable future looks hopeful for robots in the surgical setting with its evolving technology. Even with its aggressive marketing and advanced robotic surgery system however, the industry still has a lot to prove. Current research suggests that robotic surgery has not definitively proven itself superior to conventional surgery in terms of cost and outcome (Perez & Schwaitzberg, 2019).

0

5,000

10,000

15,000

20,000

25,000

Cost of Traditional Surgery (US$)

Cost of Robotic Surgery (US$)

Figure 4 Cost Comparison Analysis

Self-made Cost Comparison Chart of Traditional vs. Robotic Surgery. Data was provided by Perez & Schwaitzberg (2019).

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Collected Data Clinical Trials Supporting Robotic Surgery in Cancer Patients The advancements of caring for cancer patients, still needs improvement. In the surgical setting there are higher inherent risks associated with cancer patients. This is because the demographic of these patients is really sick. They undergo chemotherapy regimens and their immune systems are compromised. When bringing these sick patients into the operating room, they are at risk for negative outcomes.

The robotic industry has brought new light to the treatment of cancer patients in the surgical setting and there is data to back it up. According to Liu et al, robotic surgery for cancer patients provides a more advantageous position than traditional open surgery in terms of length of hospital stay, lower surgical complication rate, and volume of blood loss (2017).

Meta-analyses were conducted to compare surgical outcomes in cancer patients using the da Vinci robot to collect data on the subject. The primary recruitment of studies addressed over 852 articles, which were reviewed by qualified researchers. Of the 852 articles, only 19 articles and their studies were qualified to represent their data. From the 19 articles, 9 of them had significant findings to support robotic surgery in cancer patients. The results found that when using the da Vinci robot to perform surgical interventions on cervical cancer patients, there was significant blood loss reduction, lower risk of blood transfusions, lower complication rates, and lower length of stay in hospitals (Liu et.al, 2017). There are many studies that support these benefits exist for cancer patients, as well as all surgical patients.

Figure 5 Primary Surgical Findings from Meta-Analyses

Outcome Measure

Number of Studies

Total Sample

Size

Statistical Heterogeneity

Measures: I2, P-Value

MD or OR (95%CI)

Operative time (min)

11 603 99.0%, <0.001 39.71 (−6.69, 86.11)

Hospital stay (day)

9 544 94.0%, <0.001 −3.36 (−3.99, −2.73)

Blood loss (mL) 7 429 83.0%, <0.001 −1.50 (−1.73, −1.28)

Incidence of complications

10 565 0%, 0.60 0.34 (0.21, 0.56)

Incidence of transfusion

3 194 0, 0.84 0.10 (0.02,0.41)

Number of nodes(n)

4 196 88.9%, <0.001 −6.66 (−8.19,−5.13)

Primary Surgical Findings of Robotic V.S. Open Procedures in Cervical Cancer Patients provided by Liu et al (2017).

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Data Analysis Opposing Robotic Use in the Surgical Setting Although the use of robotics in surgery has its advantages, it is not without its faults. There are many complications associated with robotic surgery across the board. These complications include longer operation times and anesthesia times, inadvertent positioning injuries, and possibly even device malfunction. Intuitive Surgical claims that the surgeon operating the da Vinci has 100% control of the system at all times but there have been several adverse event reports claiming device malfunction with the robotic arm and software system (Compton, 2020).

According to Compton, over the last few years, Intuitive has issued several recalls for the malfunction of robotic instrument arms due to causing friction between the arms. This completely defeats the purpose of smooth, accurate movements during surgery. There were 1,400 da Vinci arms recalled and the FDA classified it as a II recall, meaning that the device was able to cause harm with potential serious complications (2020).

Tan et al, conducted their own meta-analyses study. This was in regards to robotic surgery vs minimally invasive (MIS) or laparoscopic surgery, and their results were less than favorable. Over 48 different studies were examined which investigated complications in the surgical setting. Of those 48 articles, 18 were randomized controlled studies and 30 were prospective comparative studies. The results found that the overall complication rate of the robotic arm was around 16.1%, which was higher than the MIS approach (2016).

Figure 6 Comparison Data of Findings

This Chart represents the clinical findings of Tan et al (2016) regarding Robotic vs open vs MIS

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Conclusion Robotics in the surgical setting is not a new concept by any means. The idea of robotics dates back over 50 years even though physical use of these devices doesn’t start until about the 1980’s. As technology has advanced, so has the robotic industry. It has become a standard of care for patients in the operating room. This is especially true for General, GYN, Colorectal, Cardiothoracic, Urological, Orthopedics, and Oncology related surgical procedures. With further advancements, the robotic surgical industry effectively generates about $3 billion in profit, is worth over 6.7 billion, and growing at about 15% per year (Perez & Schwaitzberg, 2019).

To say the least, the robotic industry is a major competitive market with sustainable billion-dollar profit. The growth potential is proving to be consistent. It is certain that technology has made a home in the healthcare system, and advancements for state-of-the-art equipment are continuous.

The software behind robotics will only continue to advance, but the future looks fruitful.

There are many benefits to performing surgery with robotics. It offers a high precision of accuracy, real-time guidance, data and analytics. These qualities offer a minimally invasive approach like no other. Patient care is increased because robotic surgery offers lower length of hospital stay, lowered complications, and less chance of blood loss.

Although there are a number of benefits to using robotics in surgery, there are some downsides. There is a huge learning curve for surgeons, which causes longer intra- operative cases where patients are under anesthesia for much longer than necessary. Because of this, patients are also at high risk for position injuries, such as nerve damage or pressure ulcers. There is also the risk of robotic malfunctions that could cause irreversible damage to the patients.

Personal Recommendation The clinical findings that support for or against arguments of the use of robotics to perform surgery were inadequate. I felt that there was not any evidence to truly and definitively say that robotic surgery was far superior to the traditional approach. There are both positive and negative qualities that should be weighed carefully. While studying the collective data, it was clear that the robotic industry still has a lot to prove and more data needs to be collected from proper clinical trials to support meta-analyses article findings.

That being said, it is my personal recommendation that the company of Initech highly considers the investment opportunity that robotics in surgery has to offer. Or at the very least, keeps the surgical robotic industry on Initech’s horizon. The robotic industry offers an impressive profit margin and steadied continuous growth. With predictions of its values reaching over 11.8 billon by 2025, it is clearly a financially feasible investment. We are only at the beginning stages of robotic popularity in the operating rooms and it is my belief that robotics will become the standard of care in the near future. More data will continue to present itself, and the advancements in technology will propel robotics forward to more success.

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Reference

Compton, K. (2020, April 20). Da Vinci Surgical System - FDA Warning, Injuries & Complications. Retrieved January 23, 2021, from https://www.drugwatch.com/davinci- surgery/

Kayani, B., Konan, S., Ayuob, A., Onochie, E., Al-Jabri, T., & Haddad, F. S. (2019). Robotic technology in total knee arthroplasty: a systematic review. EFORT open reviews, 4(10), 611–617. https://doi.org/10.1302/2058-5241.4.190022

Korsholm, M., Sørensen, J., Mogensen, O., Wu, C., Karlsen, K., & Jensen, P. T. (2018). A systematic review about costing methodology in robotic surgery: evidence for low quality in most of the studies. Health economics review, 8(1), 21. https://doi.org/10.1186/s13561- 018-0207-5

Liu, Z., Li, X., Tian, S., Zhu, T., Yao, Y., & Tao, Y. (2017). Superiority of robotic surgery for cervical cancer in comparison with traditional approaches: A systematic review and meta-analysis. International journal of surgery (London, England), 40, 145– 154. https://doi.org/10.1016/j.ijsu.2017.02.062

Mako robotic Surgery Charleston SC: Knee replacement surgery. (2020, December 22). Retrieved March 06, 2021, from https://scsportsmedicine.com/joint-replacement-surgery- charleston-sc/mako-robotic-surgery-charleston-sc

Moore, E. J. (2018, November 23). Robotic surgery. Encyclopedia Britannica. https://www.britannica.com/science/robotic-surgery

Perez, R., & Schwaitzberg, S. (2019, May 30). Robotic surgery: Finding value in 2019 and

beyond. Retrieved January 23, 2021, from https://ales.amegroups.com/article/view/5205/html

ReportsnReports. (2020, March 06). Surgical robots MARKET 2020 global Industry Extensive competitive landscape on size, Volume, Trends, share And Revenue: Regional forecast by 2025. Retrieved March 06, 2021, from https://www.openpr.com/news/1957768/surgical- robots-market-2020-global-industry-extensive

Sridhar, A., Briggs, T., Kelly, J., & Nathan, S. (2017, August). Training in Robotic Surgery-an Overview. Retrieved January 23, 2021, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5486586/

Tan, A., Ashrafian, H., Scott, A. J., Mason, S. E., Harling, L., Athanasiou, T., & Darzi, A. (2016). Robotic surgery: disruptive innovation or unfulfilled promise? A systematic review and meta-analysis of the first 30 years. Surgical endoscopy, 30(10), 4330– 4352. https://doi.org/10.1007/s00464-016-4752-x