The Human Cost of Medical Device Testing

The Human Cost of Medical Device Testing. Hello everyone, I hope you are well. In today’s post, I will be sharing a guest post from Sheena Macpherson and Anthony Holmes, Directors of adsilico. Both directors will be exploring the human cost (in terms of death and injury) of unrepresentative medical device testing and why diversity, at scale, is essential—for example, heart valve replacement studies. In one major trial, women made up only about a third of participants despite being equally affected by heart valve disease. Dr Michelle Tarver, despite her medical knowledge and privileged position within the healthcare system, nearly died during childbirth when a pulse oximeter failed to accurately read her oxygen levels due to her darker skin tone.

The Human Cost of Medical Device Testing

Every year, thousands of patients put their trust in medical devices that weren’t tested on people like them. The consequences are devastating: 83,000 deaths and 1.7 million injuries globally have been linked to inadequate medical device testing, according to the International Consortium of Investigative Journalists’ “Implant Files” investigation.

Behind these stark numbers lie countless personal tragedies, some of which could have been prevented through more inclusive 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.

A System That Leaves Too Many Behind

The current approach to medical device trials systematically excludes large segments of the population. Despite recent attempts to address the equality gap, 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. 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.

Heart valve replacement studies provide a striking example. In one major trial, women made up only about a third of participants despite being equally affected by heart valve disease. In a separate trial of a similar device, researchers found women experienced higher rates of serious complications than men, including irregular heartbeat, heart wall damage, and dangerous fluid buildup around the heart. The same study raised questions about whether the device sizes used might have been suboptimal for women, as only larger valve sizes were used.

Economic and Health Consequences of Inequity in Clinical Trials

A subsequent trial, specifically designed for women, included smaller sizes to better match female anatomy. These cases exemplify how underrepresentation in clinical trials can mask important sex-specific differences in device performance and complications, potentially affecting treatment decisions and patient outcomes.

Recent analysis by the US National Academies of Sciences, Engineering, and Medicine reveals that this 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.

The scale of this economic impact becomes clearer when examining recent FDA data. From 2014 to 2021, fewer than 20% of FDA-approved drugs had clinical trial data regarding treatment benefits or side effects for black patients. This gap in understanding means that billions are spent annually treating preventable complications and managing suboptimal outcomes in underrepresented populations. Healthcare systems bear the cost of readmissions and extended care, while employers face productivity losses from extended employee absences. Insurance companies pass these costs on to all policyholders, creating a hidden tax on the entire healthcare system.

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.

The Promise of Virtual Patients

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.

A Path Forward

The FDA is increasingly recognising the potential of synthetic data approaches. As Dr Tarver emphasises, diversity in device trials isn’t just a regulatory requirement – it’s a crucial opportunity to develop better products that serve wider populations. 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.

A Call to Action

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 83,000 deaths and 1.7 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.

The time has come for device manufacturers, regulators, and healthcare stakeholders to embrace this technological revolution. By combining traditional clinical trials with advanced virtual patient approaches, we can ensure that the next generation of medical devices is truly tested for and effective in all populations they serve. The cost of maintaining the status quo—in both human lives and economic terms—is simply too high to ignore.

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.

I hope you enjoyed that.

Talk soon.

ABOUT THE AUTHOR

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.

website: https://www.adsilico.uk/