Patient safety


also be ‘finely balanced in order to support and not stifle innovation.’5


There is a delicate


equilibrium between extending the scope of regulations to promote patient safety and discouraging manufacturers from bringing ground-breaking new products to market, or putting existing products through the regulatory process. Understanding this and getting the balance right is critical to the future of UK healthcare. There is a lot at stake. We can see evidence of the impact regulatory is currently having on medical device


changes6


innovation in Europe. The intention behind Regulation (EU) 2017/745 might be to ‘ensure greater safety and health protection for consumers,’6


but it’s proving to be a challenge


for manufacturers, many of which are small and medium-sized enterprises (SMEs).6


This suggests


we need to create a system that is ‘stringent enough to safeguard the patient but flexible enough to allow for novel approaches that foster innovation.’7


What we don’t want to see, as an unintended consequence of the new framework, are fewer specialist options for clinicians. This could happen if the new MRHA regulations require manufacturers to generate greater volumes of data over a longer timescale than previously required, to provide clinical evidence of the safety and efficiency of their products. If this is the case, the commercial reality is that it might be too expensive and time- consuming for manufacturers to secure approval for their smaller volume devices, such as specialist joint replacements, so they remove them from the market altogether. This would leave clinicians with more limited


options for treatment and could see patients not receiving the most appropriate implant, which could compromise the final functional outcome and might prove life-changing for the patient. Surgeons will have to learn how to use what for them would be a “new” device. This will mean that their next patient would have an operation the surgeon has not previously performed.


Other orthopaedic surgeons have echoed this concern, including John Skinner, Consultant Orthopaedic Surgeon, who states, “Low volume implants for complex revision surgery could


be the most under threat from stringent regulations.”8 He believes, “While exacting regulations are important for all types of medical implant, if manufacturers have to provide as much data on an implant, which is only used a couple of thousand times a year, compared with one that is used 100,000 times, they might decide it is too costly to continue producing that implant.” In addition to concern about reducing


innovation in the sector, the new regulations could also result in successful products being lost to the market. Under the new framework, they will be required to be regularly reviewed. If the demand for data becomes too onerous, it could lead to some successful and effective devices, which have performed well for several years, being removed from the market. This is certainly the view of the British Orthopaedic Association (BOA) who have gone on record to state that “legacy devices will struggle to demonstrate compliance with the new requirements”’5


the steps to tighten the regulatory framework should be welcomed. However, it may be necessary to find a way to allow existing devices that work well to stay on the market, even when their usage may not be high enough to allow the manufacturer to justify the expense involved in going through the entire process repeatedly.”8 So, how can we find a way to safeguard patient care without stifling innovation or jeopardising the availability in the market of existing devices that work well, even when their usage might not be high enough to allow the manufacturer to justify the expense of going through the process repeatedly?


and that “introducing higher


requirements than currently exist for legacy devices could potentially have serious implications for creating patient harm either through removal of well-established devices, or significant cost implication for their continued use.”5 Take a well tried and successful hip


replacement that’s been available for 15 years or more, for example. Under the new regulations, manufacturers are likely to be required to collect extensive clinical data to ensure its continued availability to surgeons. But if they must pay vast sums to collect this data, so they can demonstrate the effectiveness of an established device, at worst it could result in the implant being withdrawn and at best it would be more expensive. It is a question of balance, as Tim Wilton, Orthopaedic Surgeon and Medical Director of the National Joint Registry, explains: “Many of


36 www.clinicalservicesjournal.com I May 2024


Supporting the UK to remain a hub of innovation If the regulations become too demanding, they may deter manufacturers from operating in the UK and lead them to focus on other countries instead. This would result in less new products being developed in the UK, which would seriously undermine our reputation as an innovative country. The NHS has a longstanding tradition of


innovation. Hip replacements, eye lenses and medical imaging technology were all pioneered in the NHS. These innovations, among others, have made a massive difference to healthcare in the UK and globally. The concerns are that future innovations like these are under threat. It goes without saying that there will always


be room for improvement in medicine and that relies on a strong culture of research and innovation. For instance, we need advances such as new materials for implants, joint replacements which will last the life of a patient, and such advances as augmented reality to optimise the way these implants are put in. Since we don’t want to close the door on


innovation, there is a tightrope to be walked between extending the scope of regulations to


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