监管环境是成功推出创新医疗产品的关键因素之一，就像药物-设备组合产品，到市场。本文提供了有关在欧盟和美国获得药物-设备组合产品监管批准的人员的经验。
研究分为两个阶段，定性数据收集(通过半结构化访谈)和分析，其次是定量数据收集(通过在线调查)和分析。
开发了一个概念模型，描述了药物-设备组合产品获得监管批准的促进因素，与欧盟和美国系统相关，分别。
此模型提供，第一次,全面了解这些因素，提供一个可以适应反映特定药物-设备组合产品的基础。这项研究证明了在采访生命科学领域的思想领袖以及进行一项涵盖世界上两个最大的药物-设备组合产品司法管辖区的调查方面的方法的独创性。
The regulatory environment is one of the key factors in successfully bringing an innovative medical product, like a drug-device combination product, to market. This paper offers insight into the experiences of those involved in obtaining regulatory approval of drug-device combination products in the European Union and the United States.
The research consisted of two phases, qualitative data collection (through semi-structured interviews) and analysis, followed by quantitative data collection (through an online survey) and analysis.
A conceptual model was developed that depicted the facilitating factors for obtaining regulatory approval of a drug-device combination product, relevant to the European Union and United States systems, respectively.
This model provides, for the first time, a comprehensive understanding of these factors, providing a foundation that could be adapted to reflect specific drug-device combination products. This research demonstrated originality of approach in interviewing thought leaders in the life sciences sector as well as conducting a survey that spans two of the largest jurisdictions for drug-device combination products in the world.
