Introduction: In recent decades, medical devices (MDs) have increasingly become an integral part of patient care. However, when it comes to designing and appraising economic models, researchers typically follow pharmaceutical templates (e.g. CHEERS) to assess their economic viability. This study evaluates the generalizability of four device-specific criteria, as recommended by the recent MedtechHTA project, of learning curve, incremental innovation, dynamic pricing, and organizational impact with a broader group of MDs including diagnostics and implantables. The purpose was to determine the applicability of these criteria to a broader range of MDs.Areas Covered: We determined the extent to which these criteria could be applied to each device type and attempted to identify common themes. We performed a literature search using PubMed and Google of a range of devices to understand the clinical significance, operation, and economic viability.Expert Opinion: Our findings suggest that the four characteristics are not applicable to all device types. Prior evaluation of a device's intrinsic properties (such as longevity and device location) and its FDA risk classification could help to indicate the applicability of the criteria. Documenting this process when assessing the additional four criteria on the CHEERS checklist would improve the transparency of future economic evaluations.

中文翻译：

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医疗设备的固有特性：经济评估的考虑因素。

简介：在最近的几十年中，医疗设备（MD）日益成为患者护理的组成部分。但是，在设计和评估经济模型时，研究人员通常会按照药物模板（例如CHEERS）来评估其经济可行性。这项研究评估了最近的MedtechHTA项目建议的四个特定于设备的标准的通用性，这些标准涉及学习曲线，增量创新，动态定价和组织影响，以及包括诊断和植入物在内的更广泛的MD。目的是确定这些标准对更广泛的MD的适用性。覆盖范围：我们确定了这些标准可以在每种设备类型上应用的程度，并尝试确定共同的主题。我们使用PubMed和Google对一系列设备进行了文献检索，以了解其临床意义，操作和经济可行性。专家意见：我们的发现表明，这四个特征不适用于所有设备类型。事先评估设备的固有属性（例如寿命和设备位置）及其FDA风险分类可能有助于表明该标准的适用性。在评估CHEERS清单上的其他四个标准时记录此过程将提高未来经济评估的透明度。的内在属性（例如寿命和设备位置）及其FDA风险分类可以帮助表明该标准的适用性。在评估CHEERS清单上的其他四个标准时记录此过程将提高未来经济评估的透明度。的内在属性（例如寿命和设备位置）及其FDA风险分类可以帮助表明该标准的适用性。在评估CHEERS清单上的其他四个标准时记录此过程将提高未来经济评估的透明度。