Medical devices
outcomes, improving diversity in device testing is the ultimate solution. A revolutionary approach to device testing is emerging that could transform clinical practice. In silico trials (ISTs) use advanced computational techniques to create virtual patient populations, enabling more comprehensive device testing across diverse populations before real-world implementation. This technology promises to address many of the current limitations in device testing while potentially reducing the risks to real patients during the development process.12 Recent technological advances have made it possible to create synthetic “virtual patients” that combine characteristics from multiple real patients. A groundbreaking example comes from the UK biobank, where researchers processed 40,000 cardiac 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.13
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. The healthcare industry is rapidly
embracing these new approaches. Market projections indicate that by 2025, 50% of all new medical devices will utilise in silico methods in their development process, while 25% of new pharmaceuticals will incorporate virtual testing. The global market for in silico developed products is expected to reach £109 billion, growing at 16% annually.12
Future implications for healthcare The evolution in device testing methodologies promises significant improvements in patient care delivery. Industry forecasts suggest that by 2025, in silico methods will enable 30% more new drugs and medical devices to be brought to market annually, with this figure rising to 60% for drugs by 2030.12
For clinical
services, this acceleration in development must be matched with rigorous attention to performance across diverse populations. Healthcare professionals will play a
crucial role in this transformation through enhanced post-market surveillance. The FDA’s experience with warfarin offers a cautionary tale. Despite being approved for human use since 1951, it wasn’t until 2013 that researchers fully understood how genetic variants affected dosing requirements across different populations. Populations with greater genetic African ancestry typically require higher average daily doses (about 5.7
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The limitations in device testing create daily challenges for healthcare professionals across all clinical settings. A stark example emerges from recent FDA data showing that fewer than 20% of approved medical products have clinical trial data regarding treatment benefits or side effects for Black patients.
mg per day), whereas populations with greater genetic Asian ancestry require lower doses (about 3.4 mg per day).14 The impact on clinical decision-making will be particularly significant in specialised areas. The device trial mentioned earlier demonstrated that functional status improvement was more
pronounced after TAVI in females than in males, with women showing greater improvement in six- minute walk tests at both 30 days and one-year post-procedure.7
Such sex-specific differences
in outcomes highlight the importance of considering demographic factors when selecting treatment approaches.7
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