PDF(Pubmed)
Abstract：
There has been a surge in academic and business interest in software as a medical device (SaMD). SaMD enables medical professionals to streamline existing medical practices and make innovative medical processes such as digital therapeutics a reality. Furthermore, SaMD is a billion-dollar market. However, SaMD is not clearly understood as a technological change and emerging industry.
This study aims to review the landscape of SaMD in response to increasing interest in SaMD within health systems and regulation. The objectives of the study are to (1) clarify the innovation process of SaMD, (2) identify the prevailing typology of such innovation, and (3) elucidate the underlying mechanisms driving the SaMD innovation process.
We collected product information on 581 US Food and Drug Administration-approved SaMDs from the OpenFDA website and 268 company profiles of the corresponding manufacturers from Crunchbase, Bloomberg, PichBook.com, and other company websites. In addition to assessing the metadata of SaMD, we used correspondence and business process analysis to assess the distribution of intended use and how SaMDs interact with other devices in the medical process.
The current SaMD industry is highly concentrated in medical image processing and radiological analysis. Incumbents in the medical device industry currently lead the market and focus on incremental innovation, whereas new entrants, particularly startups, produce more disruptive innovation. We found that hardware medical device functions as a complementary asset for SaMD, whereas how SaMD interacts with the complementary asset differs according to its intended use. Based on these findings, we propose a regime map that illustrates the SaMD innovation process.
SaMD, as an industry, is nascent and dominated by incremental innovation. The innovation process of the present SaMD industry is shaped by data accessibility, which is key to building disruptive innovation.
This study aims to review the landscape of SaMD in response to increasing interest in SaMD within health systems and regulation. The objectives of the study are to (1) clarify the innovation process of SaMD, (2) identify the prevailing typology of such innovation, and (3) elucidate the underlying mechanisms driving the SaMD innovation process.
We collected product information on 581 US Food and Drug Administration-approved SaMDs from the OpenFDA website and 268 company profiles of the corresponding manufacturers from Crunchbase, Bloomberg, PichBook.com, and other company websites. In addition to assessing the metadata of SaMD, we used correspondence and business process analysis to assess the distribution of intended use and how SaMDs interact with other devices in the medical process.
The current SaMD industry is highly concentrated in medical image processing and radiological analysis. Incumbents in the medical device industry currently lead the market and focus on incremental innovation, whereas new entrants, particularly startups, produce more disruptive innovation. We found that hardware medical device functions as a complementary asset for SaMD, whereas how SaMD interacts with the complementary asset differs according to its intended use. Based on these findings, we propose a regime map that illustrates the SaMD innovation process.
SaMD, as an industry, is nascent and dominated by incremental innovation. The innovation process of the present SaMD industry is shaped by data accessibility, which is key to building disruptive innovation.
摘要：
背景：对软件作为医疗设备（SaMD）的学术和商业兴趣激增。SaMD使医疗专业人员能够简化现有的医疗实践，并使数字治疗等创新医疗流程成为现实。此外，SaMD是一个十亿美元的市场。然而,SaMD并没有被清楚地理解为技术变革和新兴产业。
目的：本研究旨在回顾SaMD的情况，以应对卫生系统和法规中对SaMD日益增长的兴趣。本研究的目标是(1)阐明SaMD的创新过程，(2)确定这种创新的流行类型，(3)阐明驱动SaMD创新过程的潜在机制。
方法：我们从OpenFDA网站收集了581个美国食品和药物管理局批准的SaMD的产品信息，并从Crunchbase收集了268个相应制造商的公司简介，彭博社,PichBook.com,和其他公司网站。除了评估SaMD的元数据之外，我们使用通信和业务流程分析来评估预期用途的分布以及SaMD在医疗流程中如何与其他设备进行交互.
结果：当前的SaMD行业高度集中于医学图像处理和放射学分析。目前医疗器械行业的现有企业引领市场，注重增量创新，而新进入者，特别是初创公司，产生更具颠覆性的创新。我们发现硬件医疗设备是SaMD的补充资产，而SaMD与互补资产的互动方式根据其预期用途而有所不同。基于这些发现,我们提出了一个说明SaMD创新过程的政权图。
结论：SaMD，作为一个行业,是新生的，由增量创新主导。当前SaMD行业的创新过程是由数据可访问性塑造的，这是建立颠覆性创新的关键。
目的：本研究旨在回顾SaMD的情况，以应对卫生系统和法规中对SaMD日益增长的兴趣。本研究的目标是(1)阐明SaMD的创新过程，(2)确定这种创新的流行类型，(3)阐明驱动SaMD创新过程的潜在机制。
方法：我们从OpenFDA网站收集了581个美国食品和药物管理局批准的SaMD的产品信息，并从Crunchbase收集了268个相应制造商的公司简介，彭博社,PichBook.com,和其他公司网站。除了评估SaMD的元数据之外，我们使用通信和业务流程分析来评估预期用途的分布以及SaMD在医疗流程中如何与其他设备进行交互.
结果：当前的SaMD行业高度集中于医学图像处理和放射学分析。目前医疗器械行业的现有企业引领市场，注重增量创新，而新进入者，特别是初创公司，产生更具颠覆性的创新。我们发现硬件医疗设备是SaMD的补充资产，而SaMD与互补资产的互动方式根据其预期用途而有所不同。基于这些发现,我们提出了一个说明SaMD创新过程的政权图。
结论：SaMD，作为一个行业,是新生的，由增量创新主导。当前SaMD行业的创新过程是由数据可访问性塑造的，这是建立颠覆性创新的关键。
