Biomaterials


The simple, handheld STEM device might not come with the bells and whistles of other medtech gadgets, but sometimes simple is most effective.


factors. What we’re saying is, if you give the synovium a good brushing at the end of the procedure, you’re effectively doing an orthopaedic rain dance. Swallows will find their way to Africa if you let them out of a cage in August, you don’t have to tag them; likewise, as we demonstrated in the lab, fluid stem cells will migrate into clots and find their way to sites of injury.”


A simple tool


The concept is promising, the device and procedure simple and affordable, and yet the reality so far has proved challenging. Back in 2014, while the device was still in its early stages of development, the team at Leeds lost Stuart Calder, one of its most enthusiastic members, in a tragic coastal accident. “That knocked us back,” McGonagle shares. Five years later, the team were preparing to conduct their first nationwide study, led by Hemant Pandit, professor of orthopaedic surgery at the University of Leeds and consultant orthopaedic surgeon at Leeds Teaching Hospitals’ NHS Trust. Looking at knee joint distraction as a means of spontaneously repairing cartilage, the study would put the synovial brush to the test – but research was stymied by the onset of the Covid-19 pandemic. As McGonagle explains, “12 centres in the UK were involved, but only Leeds recruited. Our limited data is now undergoing analysis.” Despite these setbacks, the device itself continued to undergo a series of iterative tests. Once the team were happy with the shape, size and material of their synovial brush, the device was patented and then sold to Yorkshire-based medtech solutions company XIROS. Uptake, however, has been slow. In part, McGonagle suggests, this may be because the brush is devoid of high-tech bells and whistles. “The device is very simple, and it’s handheld,” he says. “One of the things [we] realised in hindsight is that surgeons like gadgets. A device that was battery operated and that spontaneously


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spun and rotated would be more attractive.” McGonagle’s comment might sound flippant, but the fact remains: many in the field expect more pizzazz from contemporary medical devices. Yet, as McGonagle stresses, the device remains merely a means to end.


Using what we’ve got


While the team at Leeds are confident that their synovial brush is the best tool for the job, they’re also prepared to consider the possibility that existing surgical implements might produce the same outcome – albeit with more abrasive effect and with greater risk of tissue loss. Ultimately, “there is a mindset that needs to change” McGonagle admits. “Even without our device, if surgeons appreciated this they could, in theory, use other [tools] for scraping and preparing surfaces in order to rough up the synovium.” Will we see a STEM-device 2.0, something with more tech appeal? That’s certainly an option, McGonagle says, but the key message remains paramount: “Joints do repair from the top down with the stem cells in the fluid that comes from the synovium, and augmentation of that process in the context of proper mechanical alignment is likely to be very beneficial.”


The work of McGonagle et al. signals an exciting development in the field of osteoarthritic therapy, and one that could have widespread and lasting impact – if surgeons could only be persuaded to start adopting the device under procedural conditions. Of course, there remains work to be done to turn this theory into a reality as more trials and further studies will need to be carried out before we can be sure of the efficacy of this approach. But one thing that seems certain, our expectations about medical technology need to change. Putting the cart before the horse may work in other tech environments, but when it comes to medical science, the right tool for the job might just be as simple as a toothbrush. ●


Medical Device Developments / www.nsmedicaldevices.com


Dennis McGonagle


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