Materials
Richard Hall, next to an artificial joint simulation machine.
needing primary operations. That’s all in addition to increased demand driven by an ageing population. “Given the changing patient demographic, implants need to survive longer and be more robust against the variability encountered in vivo,” says Bryant. The recorded failure rate is about 5% at ten years, according to Bryant. But there are significant differences in performance as a function of, for example, prosthesis type and surgeon skill. “Issues relating to early failure in metal-on-metal total hip and resurfacing replacements have been defined as
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a significant public health issue,” he says, adding that there is ongoing debate within the scientific and clinical communities that focuses on alternative materials and designs for replacement systems and orthopaedic implants. Hall points out that device failures also put the regulatory spotlight on authorities, which need to determine how to effectively test new devices preclinically. “[There is] significant potential in finding solutions through the rise of computational techniques, such as the use of digital twin and in silico clinical trials, which will augment clinical trials data, if not completely replace it,” he explains. “These and similar technologies will revolutionise regulatory science and affairs over the next 20 years, but there are challenges in terms of, for instance, validating these models.” BioTrib believes improved testing should be a major focus, either computationally, experimentally, or both. “However, these methods are currently limited in both capacity and capability,” says Hall. “Failure to implement adequate preclinical testing leads to poor outcomes, including the loss of quality of life and continued disability for the patient. These high-profile failures also diminish trust in the healthcare system.” With this in mind, Bryant says the BioTrib project will build on research done in the sector in the past five or ten years. “There have been significant developments in the materials used in joint replacement bearings, in particular the widespread use of XLPE (cross-linked polyethylene). This has reduced the wear in some devices considerably and, therefore, reduced the potential for osteolytic failure.” Other innovations, such as coatings for bearing surfaces, have not had the same success, he says, with significant evidence of delamination in real-world situations. Looking ahead, regulatory science remains a worthwhile domain for research and innovation. Hall says interest in this area has been driven by multiple factors, including the pull of the industry trying to reduce costs while improving the effectiveness of implants and the fact that the public is now more vocal about their expectations. Researchers continue to push science forward, particularly in the computational domain. Hall says outstanding areas of investigation include how to maximise the synergy between traditional clinical trials and in silico versions. The relationship between computational tools and experiments, and the role of real-world data in the preclinical process will also help identify the possible design or implementation issues, and inform future assessment methods. “This needs to be underpinned by improved capacity within the workforce through the deployment of the appropriate masters and PhD programmes,” he says. “The USA has a lead in this domain – driven by the industry and the FDA – and Europe needs to follow suit.” ●
Medical Device Developments /
www.nsmedicaldevices.com
BioTrib
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