Emerald Group Publishing Limited
Copyright © 2004, Emerald Group Publishing Limited
Medical robotics – opportunities and obstacles
Medical robotics – opportunities and obstacles
Keywords: Medical robotics, Healthcare, Legislation
Patrick A. Finlay is based at Armstrong Healthcare Limited, Knaves Beech Business Centre, High Wycombe, UK.
After some 15 years, there are probably about 1,000 surgical robots installed worldwide. They are no longer strangers in hospitals, and there is a general recognition of their strengths and weaknesses. Suppliers recognise the standards of safety expected, and we have a better understanding of the twin needs for clinical efficacy and cost effectiveness. And we have even set-up an ANSI committee to resolve that most vexed question, how to define and measure system accuracy.
The range of clinical applications is increasing rapidly, as advances in imaging, sensing and micromanipulation stretch the boundaries of the possible. Each day patients are treated minimally invasively with surgical robots, allowing faster recovery times, reduced morbidity and more consistent outcomes. There are operations performed regularly which cannot be attempted without the use of a robot.
Future medical students will listen with incredulity to accounts of how the norm in 2004 was to cut patients open, stick your hands inside and pull out vital structures. They will expect to operate with image-guided manipulators that are driven to surgical targets through tiny incisions to deliver therapy and remove diseased tissue. The questions are how do we get from here to there, how long will it take, and what can be done to make it happen faster?
Today's image-guided surgery robots rely on pre-operative CT or MRI scans. These are suitable for rigid structures such as bones and brains, but useless for soft tissues that deform and move when touched. So the only image-guided robots now available are for orthopaedic surgery and neurosurgery. However, change is on the way: the newest split-magnet MRI machines allow intraoperative (realtime) imaging – but present the challenging requirement of a non-magnetic robot. More usefully, high-resolution intraoperative 3D ultrasound is almost here, and will soon allow new soft-tissue procedures to be performed robotically, with the robot adopting its trajectory dynamically to accommodate displacement of the target.
The other major class of robotic surgical devices are master-slave telemanipulators, currently used for endoscopic abdominal and cardiac surgery. Today these are restricted to operations on passive organs, but as sensor feedback develops, the slave devices will be able to track the motion of pulsing structures, so that a beating heart will appear static on the surgeon's 3D monitor at the master console.
In the longer term, telemanipulator and image guidance technologies will fuse to provide a family of interventional robots that can operate interactively on tissues anywhere in the body. At this point, surgical robots will truly be universal, and in a rational world every operating theatre would be equipped with one as standard.
Unfortunately, clinical evidence of better results is not sufficient to ensure the spread of new technology in medicine. There are barriers to overcome including a multiplicity of regulatory requirements, the need for demonstrable cost effectiveness and, in the UK, a Byzantine procurement procedure.
Regulatory requirements and supposedly international standards are inconsistent between countries. Even within the EU where a harmonised CE mark supposedly sets a common approval, there are national differences of interpretation. Attempts to achieve mutual recognition of EU and US requirements (together representing 75 per cent of the world medical device market) have been going on for a decade without agreement. Entry into global markets is delayed by years through the need to obtain individual approval in each territory. Consumer political pressure is the best hope for a resolution: when it becomes clear that the public is being denied effective treatments through bureaucratic territorialism, the mountain is likely to move.
When introducing a robotic procedure, a comparison of clinical efficacy and economic cost is sometimes a rude awakening for robot developers. It is generally recognised, for example, that orthopaedic robots can consistently match the accuracy of a good surgeon in joint replacement. This is technically impressive, but it offers no clinical or financial benefit – the robot operation takes longer and costs more for the same clinical result. Successful surgical robots are those that offer the patient something which cannot be done manually, and offer the hospital an economic benefit at the same time. Many examples do exist today, and they are set to multiply.
But achieving regulatory approval and demonstrating clinical and financial benefits are not enough: the final hurdle is to negotiate the hospital purchasing process. Usually, there is no alternative, but to follow the maze from one committee and official to another. Vast amounts of supplier's time are taken up with stating and restating the case to correspondingly huge numbers of supernumerary administrators at each site, each wanting their own bespoke justification. We have in the UK a body called NICE, the National Institute for Clinical Excellence, charged with advising hospitals on sensible procurements. But NICE considers robotics too new and too small to be worthy of consideration: it intends to wait until robots are widely in use, and it will then issue its guidance. But what use will that be? By then the die will be cast, and meanwhile shedloads of suppliers' and taxpayers' money will be consumed in repeating appraisals at every hospital in the land.
So, here is a rare opportunity for an enlightened initiative: the UK has a powerful international position in medical robot development, and UK hospitals are in the midst of an intensive investment programme designed to correct years of under funding. How about a centralised appraisal of the clinical and financial benefits of various medical robots – followed by a procurement programme where benefits are proven. This will give UK hospitals access to cost- effective robotics, provide a showcase for British technology and boost our manufacturing sector – and all while saving money. This is a simple idea: it is not brain surgery – though in another sense it certainly could be.