Battelle User Interface Design for Generic vs. RLD Combination Products

项目摘要/摘要 2019年，美国食品药品监督管理局发布了对仿制药组合产品的批准，包括 氟替卡松沙美特罗吸入粉和纳洛酮鼻喷雾剂。通用设备，如 如果没有仔细评估用户界面，这些问题可能会对患者或用户造成伤害 确保与所列参考产品的用户界面相比，通用产品的用户界面是可替代的 药物(RLD)。在评估时，了解可能影响安全和有效使用的因素至关重要 通用组合产品，因为有更高的可能性使用错误所导致的用户的预 现有的心理模型，基于RLD的使用经验。此外，对缩写的 新药申请(ANDA)依赖于FDA关于RLD安全有效的发现的前提 没有用户界面差异会破坏 RLD的通用型。巴特尔将基于风险的以人为本的设计(HCD)方法应用于医疗 早于FDA关于该主题的指导方针的设备开发。巴特尔将修改这一方法，以 制定针对RLD有效评估通用设备的方法。巴特尔将与 联邦研究团队将实现以下两(2)个目标： 目标1：开发改进的用户界面阈值分析和分类方法 不同之处。巴特尔将利用广泛的设备开发和人为因素专业知识来 与FDA合作开发基于风险的方法来支持差异分类 在用户界面的设计中。巴特尔将选择具有代表性的特定组合产品 分析。Battelle将实施或修改其现有的可用性工程(UE)方法以执行 使用对选定设备的关键要素的风险分析来支持适当的分类 用户界面。 目标2：建立评估“其他”设计差异的有效方法。巴特尔将利用他们在- 具备开发评估和数据收集的定制方法的专业知识。与 巴特尔为各种人体组织类型开发创造性建模解决方案的经验， 巴特尔将开发出能够准确评估用户是否存在其他差异的方法 接口引入了可能影响仿制药装置的临床效果或安全性的风险 与RLD相比的组合产品。 巴特尔和联邦研究小组开发的评估方法将适用于所有人 利益相关者参与了仿制药-装置组合产品的开发。这一努力将 结果产生了一组改进的工具，用于评估建议的 与RLD相比，仿制药组合产品可能会影响产品的整体使用。

PROJECT SUMMARY/ABSTRACT In 2019, the Food and Drug Administration issued approvals for generic combination products including the Fluticasone and Salmeterol Inhalation Powder and the Naloxone Nasal Spray. Generic devices like these have the potential to cause harm to a patient or user if the user interface is not carefully evaluated to ensure a generic product’s user interface is substitutable when compared to that of its reference listed drug (RLD). Understanding the factors that could impact safe and effective use is critical when evaluating a generic combination product as there is a higher likelihood for use error resulting from a user’s pre- existing mental model, based on use experience with the RLD. Additionally, the reliance of an abbreviated new drug application (ANDA) on FDA’s findings that the RLD is safe and effective relies on the premise that there are no user interface differences that would undermine the therapeutic equivalence of the generic to the RLD. Battelle applies a risk-based human-centric design (HCD) approach to medical device development that predates FDA guidance on the subject. Battelle will modify this approach to develop methods for effectively evaluating a generic device against an RLD. Battelle will collaborate with the federal research team to accomplish the following two (2) aims: Aim 1: Develop enhanced methods for threshold analysis and categorization of user interface differences. Battelle will leverage extensive device development and human factors expertise to collaborate with the FDA to develop a risk-based approach to support the categorization of differences in the design of a user interface. Battelle will select specific representative combination products for analysis. Battelle will implement or modify their existing usability engineering (UE) methods to perform use risk analyses of key elements of the selected devices to support the appropriate categorization of the user interfaces. Aim 2: Establish effective methods for assessing “other” design differences.” Battelle will utilize their in- house expertise to develop custom methods for evaluation and data collection. Combined with Battelle’s experience developing creative modeling solutions for a variety of human tissue types, Battelle will produce methods that will accurately assess whether "other" differences in the user interface introduce a risk that might impact the clinical effect or safety profile of the generic drug-device combination product as compared to the RLD. The evaluation methods developed by Battelle and the federal research team will be applicable for all stakeholders engaged in the development of generic drug-device combination products. This effort will result in an improved set of tools for evaluating how differences in the user interface of a proposed generic combination product as compared to the RLD may impact the overall use of a product.