Medical devices
Conclusion The current approach to medical device testing has created unacceptable risks for many patients, with the toll of 83,000 deaths and 1.7 million injuries demanding immediate action.2
While achieving health equity requires
far more than just equitable representation in clinical research, failure to achieve equity in this dimension leaves health disparities unaddressed and reinforces inequities.8 Clinical services have a unique opportunity
to shape this transformation. Healthcare professionals must actively participate in documenting device performance across diverse populations, contributing to post-market surveillance studies, advocating for more inclusive testing protocols, and implementing enhanced monitoring for at-risk patients. The emergence of in silico trials and virtual
patient technology offers a path toward more comprehensive device testing that could transform clinical practice. By 2025, the UK will export at least £800 million of pharmaceuticals underpinned by in silico methods annually.12
Plan, Black Patients Remain Inadequately Represented In Clinical Trials For Drugs. Health Aff. (Millwood) 41, 368–374 (2022).
This
technological revolution is beginning to translate into promising safer devices, more predictable outcomes, and better value for healthcare systems. The cost of maintaining the status quo
– in both human lives and economic terms – is simply too high to ignore. As Dr. Tarver emphasises, “It’s important to the agency because a lot of people just like me across this country and across the globe also want the benefits of medical products that work for them. Our initiative is making sure no person is left behind in healthcare, that everybody has an opportunity to realise the maximum benefits for the devices that are intended to be used by them.”1
6. Popma, J. J. et al. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N. Engl. J. Med. 380, 1706–1715 (2019).
7. Mieghem, N. M. V. et al. Clinical outcomes of TAVI or SAVR in men and women with aortic stenosis at intermediate operative risk: a post hoc analysis of the randomised SURTAVI trial.
https://eurointervention.pcronline.com/ article/clinical-outcomes-of-tavi-or-savr- in-men-and-women-with-aortic-stenosis- at-intermediate-operative-risk-a-post-hoc- analysis-of-the-randomized-surtavi-trial doi:10.4244/EIJ-D-20-00303.
CSJ
References 1. Al-Faruque, F. [Regulatory News] Tarver says clinical trial diversity action plans are a marketing opportunity.
https://www.raps.org/ news-and-articles/news-articles/2024/10/ tarver-says-clinical-trial-diversity-action-plans (2024).
2. International Consortium of Investigative Journalists (ICIJ). Implant Files - ICIJ. https://
www.icij.org/investigations/implant-files/ (2018).
3. FDA. 2015-2019 Drug Trials Snapshots Summary Report. (2020).
4. US population by year, race, age, ethnicity, & more. USAFacts
https://usafacts.org/ data/topics/people-society/population-and- demographics/our-changing-population/ (2024).
5. Green, A. K. et al. Despite The FDA’s Five-Year 22
www.clinicalservicesjournal.com I February 2025
8. National Academies of Sciences, Engineering, and Medicine; Policy and Global Affairs; Committee on Women in Science, Engineering, and Medicine. Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups. (National Academies Press (US), Washington (DC), 2022).
9. Al-Halawani, R., Charlton, P. H., Qassem, M. & Kyriacou, P. A. A review of the effect of skin pigmentation on pulse oximeter accuracy. Physiol. Meas. 44, 05TR01 (2023).
10. Walsh, B., Macfarlane, P. W., Prutkin, J. M. & Smith, S. W. Distinctive ECG patterns in healthy black adults. J. Electrocardiol. 56, 15–23 (2019).
11. Wedlund, L. & Kvedar, J. Simulated trials: in silico approach adds depth and nuance to the RCT gold-standard. Npj Digit. Med. 4, 1–2 (2021).
12. Frangi, A., Denison, T. & Lincoln, J. The Economic Impact of In-silico Technology on the UK and its Lifesciences Sector. (2023) doi:10.5281/ zenodo.7558649.
13. Xia, Y. et al. Automatic 3D+t four-chamber CMR quantification of the UK biobank: integrating imaging and non-imaging data priors at scale.
Med. Image Anal. 80, 102498 (2022).
14. Kaye, J. B. et al. Warfarin Pharmacogenomics in Diverse Populations. Pharmacother. J. Hum. Pharmacol. Drug Ther. 37, 1150–1163 (2017).
About the Authors
Stuart Grant is an Academic Clinical Lecturer in Cardiothoracic Surgery at the University of Manchester, a Consultant Cardiac and Aortic Surgeon, Manchester
University NHS Foundation Trust, and a clinical advisor to adsilico. His research focuses on improving cardiac surgery outcomes for patients, publishing widely on clinical risk prediction models, clinical outcome analyses, cardiopulmonary exercise testing and clinical registries. Stuart is a member of the European Association of Cardiothoracic Surgery Research Task Force and the Clinical Lead for Manchester on the Cardiovascular Health Informatics Collaborative. He is a clinical advisor to adsilico.
Sheena Macpherson is CEO of adsilico, a University of Leeds spin-out company at the forefront of computational medicine. With extensive experience in commercialisation of
healthcare technology, she leads efforts to revolutionise medical device development through advanced modelling and simulation techniques. adsilico’s mission focuses on improving patient outcomes through more comprehensive and inclusive device testing methodologies.
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