Regulatory
technologies with rigorous evaluation in a robust but expedient manner to ensure the highest degree of safety, quality, efficacy and performance should be a multidisciplinary and multi-factorial approach – all taken while employing the principles of regulatory science. In this way, it is an all-hands- on-deck approach, focusing on the science of developing new tools, standards, and approaches. Lessons learned from the previous and current pandemics offer opportunities to adopt new regulatory strategies and change the way regulators manage medical device approval processes in a future pandemic.
The progress of research and clinical trials, including for vaccines, were hampered by a lack of diversity among participants. This has serious ethical and research consequences, including impeding our ability to generalise study results, preventing some populations from experiencing the benefits of research innovations and receiving high quality care.
In November 2021, the UK government announced that it has commissioned a review into the health impact of possible race and gender bias in medical devices, including pulse oximeters. The issues could be widespread in clinical research.
The result of this review should be quotas to govern the recruitment of participants in clinical trials, as well as other requirements that must be met to address diversity and inclusion. This can also be part of the remit of the EU Ethics Committee as per the provisions of Directive 2001/20/EC in the ethical approval process of any clinical trial application submission. Advancing regulation with regulatory science by building on the achievements of existing programmes, with the efforts to transform the way medical products are developed, evaluated, and manufactured is the key to a swifter response and more robust approach to regulatory practice. That said, it is encouraging to know that in coordinated efforts, the regulatory agencies and other related authorities are working hard to provide support for the medical device industry, to enhance the progression of new technologies to the point of use, while maintaining the strictness of the regulations. Credit should be given to the regulatory agencies and other related health authorities working diligently and taking the necessary measures to manage the pandemic and ultimately making products available for the management of the virus. ●
Gabriel Adusei, director, Triune Technologies (Consulting)
Gabriel Adusei has more than 32 years of experience in the medical technology industry. Adusei is a renowned medtech professional and an influential expert, having worked on many high-profile projects in the industry. His numerous publications have influenced some of the quality and regulatory developments in the industry.
Medical Device Developments /
www.nsmedicaldevices.com
23
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