Objective We present examples of laboratory and remote studies, with a focus on studies appropriate for medical device design and evaluation. From this review and description of extant options for remote testing, we provide methods and tools to achieve research goals remotely. Background The FDA mandates human factors evaluation of medical devices. Studies show similarities and differences in results collected in laboratories compared to data collected remotely in non-laboratory settings. Remote studies show promise, though many of these are behavioral studies related to cognitive or experimental psychology. Remote usability studies are rare but increasing, as technologies allow for synchronous and asynchronous data collection. Method We reviewed methods of remote evaluation of medical devices, from testing labels and instruction to usability testing and simulated use. Each method was coded for the attributes (e.g., supported media) that need consideration in usability studies. Results We present examples of how published usability studies of medical devices could be moved to remote data collection. We also present novel systems for creating such tests, such as the use of 3D printed or virtual prototypes. Finally, we advise on targeted participant recruitment. Conclusion Remote testing will bring opportunities and challenges to the field of medical device testing. Current methods are adequate for most purposes, excepting the validation of Class III devices. Application The tools we provide enable the remote evaluation of medical devices. Evaluations have specific research goals, and our framework of attributes helps to select or combine tools for valid testing of medical devices.

中文翻译：

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远程评估医疗设备：当前方法和潜在创新。

目标 我们展示了实验室和远程研究的例子，重点是适合医疗器械设计和评估的研究。通过对现有远程测试选项的审查和描述，我们提供了远程实现研究目标的方法和工具。背景 FDA 强制要求对医疗器械进行人为因素评估。研究表明，与在非实验室环境中远程收集的数据相比，实验室收集的结果有异同。远程研究显示出希望，尽管其中许多是与认知或实验心理学相关的行为研究。远程可用性研究很少见，但正在增加，因为技术允许同步和异步数据收集。方法 我们回顾了医疗器械远程评估的方法，从测试标签和说明到可用性测试和模拟使用。每种方法都针对可用性研究中需要考虑的属性（例如，支持的媒体）进行编码。结果 我们展示了如何将已发布的医疗设备可用性研究转移到远程数据收集的示例。我们还展示了用于创建此类测试的新系统，例如使用 3D 打印或虚拟原型。最后，我们建议有针对性的参与者招募。结论远程检测将为医疗器械检测领域带来机遇和挑战。目前的方法适用于大多数目的，除了 III 类设备的验证。应用 我们提供的工具可实现医疗设备的远程评估。评估有特定的研究目标，