Battelle User Interface Design for Generic vs. RLD Combination Products

通用与 RLD 组合产品的 Battelle 用户界面设计

• 批准号: 10377279
• 负责人: Jessica Sanford
• 金额: $ 20万
• 依托单位: BATTELLE CENTERS/PUB HLTH RES & EVALUATN
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10377279
• 关键词: Battelle; User; Interface; Design; Generic

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.

项目总结/摘要 2019年，美国食品药品监督管理局批准了仿制药组合产品，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 如果不仔细评估用户界面，这些可能会对患者或用户造成伤害 确保通用产品的用户界面与所列参考产品的用户界面相比具有可替代性 药物（RLD）。在评估时，了解可能影响安全有效使用的因素至关重要 通用组合产品，因为用户的预处理导致使用错误的可能性更高， 现有的心理模型，基于RLD的使用经验。此外，对缩写的依赖 新药申请（ANDA）对FDA的调查结果，即RLD是安全有效的前提依赖于 不存在会破坏治疗等效性的用户界面差异， 对RLD通用。Battelle将基于风险的以人为中心的设计（HCD）方法应用于医疗 早于FDA指南的器械开发。巴特尔将修改这一方法， 开发针对RLD有效评估通用器械的方法。巴特尔将与 联邦研究小组完成以下两个目标： 目标1：开发用于用户界面阈值分析和分类的增强方法 差异巴特尔将利用广泛的设备开发和人为因素的专业知识， 与FDA合作，开发基于风险的方法，以支持差异分类 在用户界面的设计中。Battelle将选择特定的代表性组合产品， 分析. Battelle将实施或修改其现有的可用性工程（UE）方法， 使用所选器械关键要素的风险分析，以支持适当的分类 用户界面。 目标2：建立有效的方法来评估“其他”设计差异。巴特尔将利用其在- 提供专门知识，以制定评价和数据收集定制方法。结合 Battelle为各种人体组织类型开发创造性建模解决方案的经验， 巴特尔将产生的方法，将准确地评估是否“其他”的差异，在用户 接口引入可能影响仿制药-器械临床效果或安全性的风险 与RLD相比，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 参与仿制药-器械组合产品开发的利益相关者。这一努力将 导致一组改进的工具，用于评估所提出的 与RLD相比，通用组合产品可能会影响产品的总体使用。