Unique challenges to adopting laparoscopic approaches included bleeding/hemostasis, ischemia (speed on laparoscopic partial nephrectomy), excision, and repair. Improving on all of these factors was key for skill development, but the ultimate solution to these challenges was robotic surgery. The short history of robotic surgery is that it started in the military with DARPA funding in the 1980s and early 1990s. In 1995, Dr. Frederic Moll licensed an IP from the Stanford Research Institute to form Intuitive Surgical in 1995. The refined prototype of their first robotic system (called “Lenny”) was tested in 1997 and in 1999 the final version of the prototype was named da Vinci surgical system. The initial target organ for approval for this new robotic platform was cardiac surgery, but the first FDA approval came in 2000 for radical prostatectomy. Subsequently, Intuitive Surgical acquired a competitor Computer Motion in 2003. As of December 2019, Intuitive Surgical had an installed base of 5,582 da Vinci Surgical Systems, including 3,531 in the US, 977 in Europe, 780 in Asia, and 294 in the rest of the world.
The benefits of robotic surgery include improved dexterity secondary to degrees of freedom (equated to wrists), as well as stereo vision, and extra working arms. The journey of Intuitive Surgical becoming a $70 billion robotic surgery giant is clear based on the uptick in price starting around 2015:
New recent emerging trends include the single port systems, which reduce entry number and size of incision – based partly on these advances, there has been an increase in utilization by our General Surgery colleagues as depicted in the following figure:
Ultimately, the question is whether anyone can challenge Intuitive Surgical. The company had a 20-year head start, and as the first mover has a clear advantage. However, they have recently lost several over their patents, including the degree of freedom ‘wrist’, but they still have 300+ patents and the benefit of deep market penetration. Titan Medical is a Canadian company founded in 2008 and a potential competitor for the single port platform, however, they have yet to hit any metrics with the FDA and in early 2020 had a working capital deficit of $9.7 million and still no FDA application. Another company is Transenterix, based in the research triangle of North Carolina, which has a prototype called the SurgiBot, which was an attempt at the single port system based on the manual Spider platform. Dr. Herrell notes that they attempted to “robotize” this platform and take it to the FDA, but it failed FDA approval:
In 2015, Transenterix was acquired by SOFAR (an Italian robotics company) for $99 million and is attempting to run on a platform of a broad reusable instrument offering, however, in 2020 they only had a reported $10.6 million cash on hand and were seeking “strategic partners”. Cambridge Medical out of the UK has developed the Versius Surgical Robotic System, having raised over #350 million in capital and was approved by CE Mark in 2019, but is yet to be FDA approved. Furthermore, in Asia, there have been several “da Vinci-like” systems, including the Revo robot in Korea and Kang Duo robot in China.
In 2015, there appeared to be a legitimate competitor in the US market with Google (under the name Verily) and Johnson & Johnson forming Verb Surgical with plans to design a ‘smarter robot’. However, in December 2019, Johnson & Johnson acquired full control of Verb Surgical (effectively Google exiting) and Johnson & Johnson bought Auris Health for $3.4 billion created by Frederic Moll, the founder of Intuitive Surgical. Medtronic is also a potential competitor in the US market. Their new CEO has stated that robotic surgery is the #1 priority for the company and in 2019 they announced that Hugo was a legitimate competitor to da Vinci. Medtronic has deep pockets, already moving forward with an orthopedic robot called Mazor for $1.6 billion, however, their launch of a plan to move forward as a direct competitor to da Vinci has been delayed secondary to COVID till perhaps 2022.
Dr. Herrell also has a big interest in emerging access-specific robots, such as “intraluminal” natural orifice surgery and endoscopy including the robotically controlled flexible bronchoscope. Auris Medical started a company called Hansen Medical, which focused on robotic heart catheters, but this avenue never gained traction. At that point, they looked at possibly robotic ureteroscopy but eventually settled on the flexible bronchoscope prototype called Monarch, with robotic bronchoscopy being approved by the FDA in 2017. Since then Auris robotic flexible ureteroscopy has gained traction with first experimental trials starting in 2019, noting improved ergonomics and reduced radiation to the surgeon. Another avenue Auris is looking at is the advent of robotic-assisted percutaneous access.
Dr. Herrell’s greatest interest is in potential robotic applications of rigid endoscopy. The concept of robotic rigid endoscopy centers around concentric tube robots, which may have several potential applications such as for ureteroscopy. Dr. Herrell’s group subsequently formed a company called Virtuoso Surgical in 2016 on the platform of “Our solution: Two Needle-Sized Robotic Arms”
Currently, they are taking a robotic approach to the HoLEP procedure, allowing for better dexterity and precision, in addition to improving TURBT with an en-bloc resection removing the entire tumor in one piece with adequate muscle in the specimen. These two procedures are difficult with the present tools of a single fiber given that there is no ability to retract, poor exposure, and difficulty control the depth of resection, which would conceivably be easier with a second working arm available. The 2021 goals for Virtuoso Surgical are to (i) expand to 8 full-time engineers, (ii) develop their next-generation prototype (“Beethoven”), (iii) continue to raise capital, and (iv) expand on clinical advisory groups, including Drs. Miller, Krambeck, and Humphries for BPH enucleation and Dr. Sam Chang for bladder cancer.
Dr. Herrell concluded with several thoughts/quotes on change:
- Charles Kettering “If you have always done it that way, it is probably wrong”
- Woodrow Wilson “If you want to make enemies, try to change something”
Written by: Zachary Klaassen, MD, MSc – Assistant Professor of Urology, Georgia Cancer Center, Augusta University/Medical College of Georgia Twitter: @zklaassen_md at the 21st Annual Meeting of the Society of Urologic Oncology (SUO), December 3-5, Virtual Conference