Until surprisingly late, medical devices were fearsome things. Look for instance at the implements used by surgeons during the world wars: scalpels were like daggers and scissors familiar to the sort used by butchers and cooks. In large part, this distinct lack of elegance can be understood in terms of how twentieth-century factories were organised. In an age before digital production lines, surgical equipment was typically manufactured in a similar way to aircrafts or tanks. In fact, production of military and medical equipment sometimes blurred.
During the Second World War, surgical supplies for the US Army were pumped out by firms like Standard Oil – which also helped develop synthetic rubber for the war effort. This rugged approach to manufacturing impacted the way devices could be used. Subtlety was often in short supply, instead requiring doctors to cut deep into their unfortunate charges. Naturally, this also impacted patient outcomes. Relatively minor surgery could lead to stays in hospital lasting several weeks at a time, leaving patients with a cavalcade of pain-points and scars.
To an extent, these problems still persist even today. According to one recent study by doctors in Changsha, China, invasive surgery of children with congenital heart disease led some to worry about their post-op physical appearance. Naturally, all this can have knock-on economic effects too, with patients unable to work for extended periods and hospitals obliged to spend valuable resources caring for them.
However, that landscape is quickly changing; over the last 15 years, so-called minimally invasive surgery has become increasingly accepted by patients and doctors alike. As so often, this transformation is clear from the statistics. According to work by Allied Market Research, the global market for minimally invasive surgery is expected to reach $94bn by 2030. All the same, the industry can only thrive if medical professionals actually have the tools for the job – and that’s by no means a given.
As revolutionary as they may be, some businesses do not have the machines or expertise to build intricate devices like endoscopic cameras. Not that the situation is hopeless. By partnering with specialised contract manufacturers and leaning on technologies like big data, insiders can be sure to keep their production lines flowing all while supporting patient care along the way.
“We’ve seen an increase in the number of manufacturers of minimally invasive devices in recent years and as far as we’re aware they have kept up with the demand.”
Several benefits
As the headline growth implies, minimally invasive surgery is an increasingly common sight across emergency rooms. Paula Gomes, British Standards Institution’s (BSI) global head of active medical devices, goes as far as to suggest it’s becoming “the standard practice for most surgical procedures”. Certainly, disciplines as varied as traumatology, orthopaedics and urology all benefit from lighttouch technology, especially when it comes to sophisticated machines like bronchoscopes and endoscopes, which can peer into the human body without leaving a scratch. If, moreover, minimally invasive surgery can dramatically improve operations themselves, some devices also reside in the bodies of patients for extended periods. Consider, for example, the case of implants for spine surgery, which measure force changes across joints, or the remarkable work being done at firms like Medtronic that allow doctors to replace heart valves via miniature catheters.
The consequences of all this are being vividly felt across medical life. “There are a number of benefits to using minimally invasive surgery,” Gomes stresses, “including faster recovery, better pain relief and improved cosmetics – smaller or no visible scars.” As work by doctors in New Orleans has found, minimally invasive colectomies can result in patients returning home two days sooner than if they had undergone traditional alternatives. The socioeconomic advantages here are clear, too, not least given a single night stay at an NHS hospital can cost over £450. There’s even some evidence that minimally invasive surgery can reduce anxiety among patients, potentially leading them to search for treatment faster.
Despite these manifold advantages, however, the path to a minimally invasive future isn’t necessarily certain – a problem that arguably begins long before devices can be deployed in the operating theatre. Gomes, for her part, brings up the issue of manufacturing. As she puts it, start-ups and small businesses “may not have the approved facilities” to manufacture minimally invasive products. Though specific statistics are scarce, one 2018 study by Jabil found that 95% of companies face manufacturing challenges, with 98% reporting that industry hurdles impact the development of sophisticated new healthcare solutions. Meanwhile, it’s hardly helpful that manufacturing costs of imaging systems and robots are often high – a price only elevated further by the training needed for end users.
Robotic enhancement
How has the device sector responded to these challenges? Listen to Gomes and the simple answer seems to be reasonably well. “The industry has been a positive driving force in the development of minimally invasive surgery,” she says. “We’ve seen an increase in the number of manufacturers of minimally invasive devices in recent years and as far as we’re aware they have kept up with the demand.” Certainly, this optimism is amply supported by several practical examples. Apart from the sector’s impressive growth, industry mammoths have been busy snapping up specialist manufacturers. In 2018, Stryker acquired K2M, a builder of minimally invasive spine solutions, while Johnson & Johnson bought Abiomed last year, which builds innovative heart pumps.
Past these varied purchases, however, Gomes suggests that another pillar of the minimally invasive revolution involves external partners. “Contract manufacturers can be an effective route for medical device manufacturers,” she emphasises, adding that firms boasting robust quality management systems are especially useful. Taking a step back, moreover, this enthusiasm makes sense far beyond the specifics of ISOs. Typically offering fully customisable products, contract manufacturers can craft machines expressly suited to the most technical of surgeries – hardly irrelevant when devices sometimes encompass 60 wires smaller than the diameter of human hair. Just as crucially, contract manufacturers can make machines more cheaply, especially when so-called ‘full service’ options allow R&D teams to focus exclusively on developing new products. In short, it’s no wonder that contract manufacturing is going from strength to strength. Research and Markets recently found the global medical devices contract manufacturing sector is due to enjoy CAGR of 10% from 2020 to 2026. This booming market is reflected elsewhere too; there are currently around 6,000 contract manufacturers to choose from, while individual firms are confident enough in the future to invest millions in new production facilities.
And if contract manufacturing is proving a major boon to minimally invasive devices, Gomes is no less excited by the arrival of new technology. “Robotics are revolutionising the way that minimally invasive surgery is carried out,” she says. “The introduction of robotic systems has made previously complicated operations or procedures – that were unsuitable for minimally invasive surgery – possible. The technology used for minimally invasive surgery continues to advance and this offers the potential to make optics and imaging more accurate and efficient.” Once again, her point is being dramatically reflected in the real world. To give one example, Pennsylvania company Globus Medical created ExcelsiusGPS, a product that allows doctors to complete complex spine surgery using a robot, with each miniscule cut guided using a similar technology to GPS.
Data-led surgery
Despite the clear advantages in terms of accuracy, robot-led surgery is far from perfect. For one thing, surgical instruments risk damaging nearby nerves and tissues. For another, training remains expensive, even as human error can turn robots into death traps. In both these cases, however, ones-and-zeros could soon come to the rescue. Fundamentally, this can be understood in terms of how medical robots have traditionally operated. As Gomes explains, most have typically performed as “master-slave” systems, whereby robots only follow the movements carried out by an attendant doctor. But in future, the BSI expert suggests “these robotic systems have the potential to perform autonomous actions with the use of AI, big data and machine learning”.
The implications here are obvious. Rather than relying on fallible human interventions, robots could instead learn from previous operations exactly where to inject or how hard to slice. Big data may eventually even presage a world where robots can complete certain operations without any human intervention whatsoever, at least when it comes to simple procedures like closing port sites or tying sutures. There’s also evidence that AI can help in more subtle ways. In minimally invasive colonoscopies, for instance, machine learning could help surgeons identify potential polyps. If only the workers on those twentieth-century production lines could come back and see that.
