Since entering the medical mainstream over forty years ago, laparoscopic (or keyhole) surgery - which enables surgeons to access a patient’s abdomen and pelvis without having to make large incisions - has had a profound impact on clinical care: reducing pain, boosting recovery times and lowering the risk of infection.
And yet, of the estimated 12 million pelvic and abdomen procedures carried out every year, only around fifty per cent are actually performed using minimally invasive techniques.
There are a number of reasons for this. Not least the fact that operating inside a patient’s body with just a grainy 2D image to guide you is exceptionally difficult.
What’s more, whilst there are some technologies available that simplify the process - such as the da Vinci robot, launched almost twenty years ago by US firm Intuitive Surgical - the high cost of these systems and the specialist facilities they require has limited their uptake.
However, Cambridge-based medical technology start-up, CMR Surgical, is on a mission to change this and bring laparoscopic surgery to the masses with a surgical robot that’s portable, cost-effective, simple to use, and - its developers claim - coming to an NHS hospital near you soon.
Developed from scratch in just five years, the company’s technology, named Versius, is a modular system of robot arms that can be wheeled into an operating theatre and used to perform a range of minimally invasive procedures. A typical installation will see three or more robots used, with one arm holding an imaging probe and the others equipped with tools such as scalpels, graspers and suturing instruments.
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During use, the robot is operated from a console in the corner of the theatre – linked via a 1-gigabit ethernet cable - where the surgeon uses gaming style controllers and a 3D display screen to perform the procedure.
As The Engineer discovered during a recent demonstration, the technology has immediate and compelling advantages over traditional techniques, where hand-eye coordination is exceptionally tricky and instrument movements are counterintuitive (i.e. to move the tip of an instrument to the left, the surgeon has to move their hand to the right).
As well as providing a 3D view, Versius cancels out these counterintuitive aspects, enabling the surgeon – or in this case the surgically inept journalist – to comfortably move the tools around without having to override the brain’s instinctive commands.
To achieve all of this has required some exceptionally clever software, hardware, and electronics engineering, but as the firm’s head of clinical engineering Fiona Haig explained, the underpinning innovation for the system is actually an elegant bit of mechanical engineering: the robot’s wrist.
“The secret sauce really lies in the wrist of,” she said. “It means that the robot holds the arm end-on, more like a surgeon would hold the instrument. If you look at traditional surgical or industrial robots they hold the instrument like a dagger.”
The performance of this human-like wrist has, she added, been key to delivering a system that is compact and portable enough to fit into an existing operating theatre. Each arm is roughly one and a half times the size of a human arm and has a footprint of 38cm by 38cm. The system also draws on some of the collaborative robot (or co-bot) developments seen in other sectors.
“The advent of collaborative robotics has enabled us at CMR to leapfrog the incumbents,” said Haig, “we’re using the very best in the cutting edge in robotic tech and applying it to the medical field.” Just as production engineers are able to work alongside co-bots on the factory floor, nurses and clinical staff can work around Versius without fear of it crashing into them.
Despite the lessons learned from other sectors, the underpinning technology - the software, hardware and electronics at the heart of the system – is largely bespoke. And this, said Haig, has required the company’s suppliers to go on a bit of a journey. “Our innovations have really sparked the imaginations of some of the development teams in our suppliers. Sometimes there’s the inevitable red tape of being a startup….and trying to convince some cutting edge manufacturers to work with us on essentially nothing more than a prototype and a promise but once they’ve seen that potential they’ve engaged with us and they’ve come with us on that journey.”
Arguably the most important partner of all though is the clinical community, and the team has worked closely with hospital teams, including a group at Addenbrookes in Cambridge to ensure that the technology is compatible with the reality of an NHS hospital. This is not just about ensuring the system meets the surgeon’s requirements, but also that it fits into the workflow of the wider team. “The team [at Addenbrookes] have been involved from a very early stage,” said Haig, “and we’ve expanded that out to nursing teams, as a lot of what happens in an operating room is a manipulated set-up connected together and positioned by nurses.”
Hospital layout has also been a factor. “This can’t be something that gets craned in, where we cordon off part of the hospital and it gets used for special occasions. This needs to be something everybody can use – something you can wheel in when you need it.”
And of course, feedback from surgeons has been hugely important, particularly in terms of the system’s ergonomic design.
According to the company’s own research, around 76 per cent of surgeons in the UK experience muscular pain as a result of performing surgery, with many forced into retirement by the physical demands of the job. “A lot of surgeons retire early,” said Haig, “and yet their peak from a skill level is in their sixties. We’ve spent a lot of time focusing on how we can improve the ergonomics of surgery so you’re not standing with your arms up in the air with sharp instruments jabbed into the palm of your hands for eight hours a day with your neck twisted around looking at a screen on the opposite side of the room.”
As well as prolonging the careers of surgeons, the ability to gather and analyse data from systems in the field could be used to help drive up skills. “We can benchmark people and say, ‘OK this is where you are on the learning curve, these are the areas where comparatively you seem to be less efficient’.”
Technology aside, one of the most remarkable things about the Versius story is the speed with which the company has grown given that its target market is one of the most heavily regulated sectors there is. Founded just five years ago, the firm now employs almost 400 people, and – according to its head of marketing Patrick Pordage – is doubling in size every 12 months.
Even more significantly, the technology is now poised to have a real-world impact. Clinical trials - announced earlier last year (April / May 2019) are ongoing in hospitals in Pune, India. At the time of writing upwards of 30 successful procedures had been performed and, according to the team, the first UK sale to an NHS hospital is imminent.
Five years from concept to patient is a pretty impressive achievement. And Haig, who has been with the company since the very early stages, puts this success down to a clarity of vision. “We’ve been extremely focused, we came from an informed background, we knew where technology could help in surgery, we had worked in different environments ourselves and we knew that if we were going to make this work we had to be pragmatic.”
What’s more, the fact that the firm has one core product has helped maintain that focus: “When you’ve got 400 people all with the same goal it really helps you cut through some of the politics. Everyone has one goal in mind, and that makes it much more straightforward”.
It also makes for a pretty inspiring work culture. “There’s nothing more satisfying than seeing your product being used in surgery on a person knowing that you have transformed that person’s life,” said Haig. “I burst into tears the first time I saw a procedure being done with Versius. It really is quite a special moment.”
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