Diversity Must Improve In Medical Device Testing

The current approach to medical device trials systematically excludes large segments of the population. Women, ethnic minorities, elderly patients, and those with rare conditions are routinely underrepresented in clinical trials. This isn't just an issue of fairness – it's a matter of life and death.

Approximately 3,000–4,000 clinical trials involving medical devices are registered globally each year – many of these are conducted in the US, the EU and Asia. Unfortunately, according to the International Consortium of Investigative Journalists' "Implant Files" investigation 83,000 deaths and 1.7 million injuries globally have been linked to inadequate medical device testing.

Consider the experience of Dr Michelle Tarver, now director of the Center for Devices and Radiological Health, part of the US’s Food and Drug Administration (FDA). Despite her medical knowledge and privileged position within the healthcare system, she nearly died during childbirth when a pulse oximeter failed to accurately read her oxygen levels due to her darker skin tone. Her story illustrates a fundamental flaw in medical device development: devices are often not adequately tested across the full spectrum of patients who will ultimately use them.

Diversity is crucial

When devices aren't tested on diverse populations, potentially fatal design flaws can go undetected until after the device reaches the market. It is highly likely that many of the reported adverse events occurred in patient groups that were underrepresented in pre-market clinical trials.

Recent analysis by the US National Academies of Sciences, Engineering, and Medicine reveals that a lack of diversity in clinical trials comes with an enormous economic cost. Looking at lack of representation in drug trials in particular, hundreds of billions of dollars will be lost over the next 25 years due to reduced life expectancy, shortened disability-free lives, and fewer working years among populations not proportionately represented in trials. The impact is particularly stark when examining specific conditions: even a modest 1% improvement in health disparities through better trial diversity could yield over £32 billion in gains for diabetes and £48 billion for heart disease alone.

These economic costs stem from multiple sources. When drugs and devices aren't optimised for diverse populations, patients often require additional treatments, experience more complications, and face longer recovery times. This leads to increased healthcare costs, reduced workforce participation, and diminished quality of life. The burden falls disproportionately on underserved communities, further exacerbating existing health inequities.

Furthermore, device manufacturers themselves face significant financial risks from a lack of consideration of diversity in device development. When devices fail or perform poorly in underrepresented populations after-market release, companies face costly recalls, litigation, and damage to their reputation. The resources required to address these issues post-market far exceed the cost of more inclusive testing during development.

Virtual solution

Amid this crisis, a revolutionary solution is emerging – virtual patients. Advanced computational techniques can now create digital, diverse, and representative virtual patient populations that capture the full spectrum of human anatomical and physiological variation. This approach, known as in silico trials (ISTs), offers a way to test medical devices across a much broader range of patient characteristics than traditional clinical trials allow.

The initial wave of virtual patient innovation has focused on creating digital twins of individual patients. While this represented an important step forward, achieving true diversity at scale requires a more sophisticated approach.

A pioneering new computational medicine company in the UK, adsilico, has recently been founded to drive the use of synthetic patients for use in ISTs. Recent advances in technology are now enabling the creation of fully synthetic virtual patients that combine characteristics from multiple real patients, which adsilico calls virtual “chimeras”. This novel approach enables the creation of much larger, truly diverse virtual populations that better reflect the full spectrum of future users of a given medical device.

The scale possible with this advanced synthetic patient approach is unprecedented. In the cardiovascular domain alone, a UK academic group processed 40,000 patient MRI images across 50 timepoints of the cardiac cycle, creating 2 million image volumes that serve as the foundation for building diverse virtual synthetic populations. This massive dataset allows for testing of devices across a wide range of anatomical variations, helping identify potential complications in previously underrepresented populations before devices reach real patients.

Moving forward

While digital twins offer some benefits, the future lies in more advanced synthetic data techniques that can generate unlimited, diverse patient populations efficiently and ethically. These new approaches enable early identification of design flaws that might affect specific populations. They allow systematic exploration of anatomical and physiological variations, ethical testing of high-risk scenarios without putting patients at risk, rapid evaluation of device performance in rare patient populations, and cost-effective testing across multiple demographic groups – all without the risk of direct patient harm.

Industry forecasts predict that by 2025, 50% of new medical devices will utilise in silico methods in their development process, with the global market for in silico-developed medical products reaching almost £90 billion. This isn't just a trend, it's a transformation in how we ensure medical devices are safe and effective for everyone who needs them.

We must do better

The evidence is clear: our current approach to medical device testing is not fit for purpose. We cannot continue to accept a system that has led to tens of thousands of deaths and more than one and a half million injuries. We have the technology to do better. Just because current approaches are considered “gold-standard”, it doesn’t mean that they are without limitations. Virtual patients, particularly through advanced approaches that can generate diverse, synthetic populations at scale, offers a path to more inclusive, comprehensive device testing that could save countless lives and prevent untold suffering.

Our health should not be determined by whether we happened to be represented in a clinical trial. With virtual patients, it doesn't have to be.

Anthony Holmes

Sheena Macpherson

Sheena Macpherson is CEO of adsilico and Anthony Holmes is the company’s Chief Product Officer. Adsilico is a University of Leeds (UK) spin-out company at the forefront of computational medicine. By leveraging advanced modelling and simulation techniques, adsilico is working to revolutionize the way medical devices are developed, tested, and brought to market. https://www.adsilico.uk/