B is for Benefit

Benefit is key to clinical safety and medical device regulation. If a patient (or clinician) doesn’t stand to benefit from a device being brought to market, then what is the point in developing it? However, this point is often lost in the excitement to utilise new technology, particularly artificial intelligence.

First of all, what do we mean by benefit? The Oxford dictionary defines benefit as “an advantage or profit gained from something”. In the context of patients, benefit is generally understood as improving their wellbeing. This could be through improving the symptoms of their disease through pharmacological management, or by empowering them to manage their condition through technology. However, if a patient experiences side effects from a medication, they may stop taking it despite its benefits in controlling their disease, just as if a health app is poorly designed, they may choose not to use it and therefore not benefit from its support.

In clinical benefit, there is a balance to be achieved between benefitting an individual patient and benefitting the patient population. For example, an individual may not see the direct benefit from a vaccination (although they are less likely to contract or suffer badly from the disease), whist the population overall will benefit, through ultimate eradication of the disease in some cases. Conversely, an individual may directly benefit from an antibiotic, but if over-used, this may have a negative impact on the population by contributing to anti-microbial resistance.

This leads us into risk-benefit, which is a key aspect of medical device compliance. Part of the clinical evaluation involves establishing what the current situation, or “state-of-the-art” for the given condition or disease being treated by the device. For example, if a manufacturer wants to bring a new health check device to market, they must establish what the current landscape is for this area and demonstrate that their product has additional benefits or is at least as good as those products already available. They must provide evidence regarding the safety and performance of their device and ensure that it does not introduce unacceptable risk, such as informing a patient that their measurements are within range when in fact they are not.

The UK clinical safety standards, DCB0129 and DCB0160 also require a clinical risk benefit analysis to be undertaken. If a residual clinical risk is deemed unacceptable and further risk reduction is not possible, then the manufacturer must determine if the clinical benefits of the intended use outweigh the risks.