Patient input into medical device development: A missed opportunity

Steven Bourke
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Abstract

The delivery of care to people who are patients has, beyond doubt, reached the digital age. This is never more striking than in the area of medical devices and in vitro diagnostic medical devices. Patients’ standard of care has risen exponentially in light of the technological and innovative advances in the medical device field. Yet, in many instances, medical device development is undertaken without patient input. This article discusses why it is important to include patients’ perspective in the process of developing medical devices. In addition, it addresses several related topics, such as the issue of access to medical devices and the need for transparency with regards to the data collected by medical devices. It also provides an example of a research project aimed to better understand and promote patient engagement in medical device development.
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患者对医疗设备开发的投入:一个错失的机会
毫无疑问,向病人提供护理已经进入了数字时代。这在医疗设备和体外诊断医疗设备领域是最引人注目的。由于医疗器械领域的技术和创新进步,患者的护理标准呈指数级上升。然而,在许多情况下,医疗设备的开发是在没有患者投入的情况下进行的。本文讨论了在医疗器械开发过程中纳入患者观点的重要性。此外,它还讨论了若干相关主题,例如获取医疗设备的问题以及医疗设备收集数据的透明度的必要性。它还提供了一个研究项目的例子,该项目旨在更好地了解和促进患者参与医疗设备开发。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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The PES-SLEEP project: A practical approach to the categorisation challenge for studies with medical devices Challenges facing Switzerland’s medical technology industry following the 2021 changes to medical device legislation Swissmedic’s experience with the regulatory changes for clinical investigations with medical devices implemented in 2021 Patient input into medical device development: A missed opportunity Regulatory developments in the medical devices sector: A long and difficult journey
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