Future of diagnostics: a utopia or dystopia?

Some of these ambitions, while sounding futuristic, are in fact within reach or have made it to the market already. A few years ago, Aktiia worked with Team Consulting to develop a 24/7 blood pressure monitor wearable device, that has since been used for over 30 million readings. Next generation sequencing providers, such as Oxford Nanopore Technologies, who to-date have predominantly served the scientific research community, are now increasingly investigating diagnostic and healthcare applications for their technologies. The UK’s most powerful supercomputer, Cambridge-1, was also launched by NVIDIA a couple of years ago, with the purpose of advancing healthcare by “unlocking clues to disease and treatments at a scale and speed previously impossible”.

These advancements in diagnostics and monitoring are not anomalies. According to some estimates, the global market for wearable medical devices will reach $19.4 billion USD by 2029, expanding at a compound annual growth rate of 16.4% from 2022. Similarly, the molecular diagnostics market is estimated to be worth $30.2 billion in terms of revenue by 2027, up from $23.2 billion in 2022.

Of course, you’d be forgiven for thinking these advancements sound too good to be true and are mere ‘wishful thinking’. We must also consider that there could be unintended consequences from each of these technological advances. These advances could rapidly repaint our image of a utopian future of diagnostics into a dystopian one. For example:

• Getting rapid diagnostic capabilities to the masses could mean far more efficient treatment for everyone. However, could it also mean a lot of diagnosis for diagnosis’ sake, creating a population of the ‘worried well’?
• Will ‘big data’ unlock whole new strategies for prevention and treatment? Or will data breaches create a privacy nightmare, or worse, place great new powers into the hands of oppressive regimes?
• Can we expect truly personalised medicine or just selective medicine? Will limited access to expensive genetics screening further exacerbate the inequalities in our societies?
• Could machine learning and AI mean we no longer need to rely on fallible humans? Or will the systems we create be just as, or possibly even more, biased than us?

So, what will the future of diagnostics look like, a utopia or dystopia? Of course, much like the nature vs nurture debate, this is not an either/or situation at all – the answer is somewhere in between. The good news is that we have control over which end of the spectrum we move towards.

Regulating the future of diagnostics

Throughout history, every world changing technology has had its upsides and downsides. Cars allowed for faster transportation (and less horse muck on the streets) but created new types of air pollution and high-speed crashes. When Jennifer Doudna discovered CRISPR-Cas9 she almost simultaneously realised the unfathomable potential for good, such as curing awful, otherwise incurable diseases, alongside the unthinkable potential for evil, for example, genetically engineering soldiers and eugenics.

What all emerging technologies have in common is that once they have been invented or discovered, it becomes incredibly difficult to stop their momentum and revert to a world in which they don’t exist. In order to move towards a positive future for diagnostics, it is essential that we take a pragmatic, yet pro-active approach to identify risks and mitigate them from the start. Enforced licensing, regulations and international laws, while not removing all potential problems, can go a long way to improving the implementation of new technologies.

Luckily, this framework is already in place for diagnostics, in the form of the IVDR, MDR and their harmonised standards, (particularly ISO 14971:2019), along with similar regulations around the world. Are the regulations perfect and will they prevent all catastrophes? Absolutely not. However, as we endeavour to continuously improve upon them, we can strive to make the future of diagnostics as safe as possible.

It’s important to note that medical regulations don’t aim to remove all possible risks before a technology enters the market. This is not possible in practice and we wouldn’t have the modern medicines we use today if that was the bar we had to reach. The underpinning concept behind the regulations is that we aim to mitigate risks during the design process as much as is reasonably possible. We then need to assess whether the benefits the diagnostic brings sufficiently outweigh the risks from a clinical perspective, followed by continuous post-market analysis and improvements.