H E A L T H I N S I G H T S
Women , ethnic minorities , elderly patients and those with rare conditions are routinely underrepresented in medical device trials . Excluding large segments of the population is both an issue of fairness and a matter of life and death . 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 Dr Michelle Tarver , who holds a senior post at the US ’ s Food and Drug Administration ( FDA ). Despite her medical knowledge and 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 .
Sheena Macpherson , CEO of adsilico , and Anthony Holmes , Chief Product Officer at adsilico , explore the urgent need for diversity in medical device testing . With underrepresented patient groups at higher risk of device failure , they highlight the potential of in silico trials – virtual patients designed to ensure safer , more inclusive healthcare solutions . As technology advances , could synthetic populations transform the future of medical innovation ?
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
EXCLUSION IS DEADLY : THE CASE FOR INCLUSIVE MEDICAL DEVICE TESTING
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