Martjan Rahel Sophie, Weimar Sascha Noel, Terzidis Orestis
Institute for Entrepreneurship, Technology Management and Innovation (EnTechnon), Karlsruhe Institute of Technology (KIT), Karlsruhe, Germany.
J Med Internet Res. 2025 May 23;27:e67328. doi: 10.2196/67328.
With the introduction of Regulation (EU) 2017/745, also known as the Medical Device Regulation (MDR), startups aiming to develop software as a medical device (SaMD) in the European Union are confronted with stringent and complex regulations, and many of them struggle with them. Complying with the MDR is a costly, time-consuming endeavor requiring expertise and substantial financial resources. However, it opens the door for new revenue models, such as reimbursement pathways. Consequently, the MDR significantly shapes the business model of startups. Early on, the regulation needs to be considered for business modeling to survive the conformity assessment process financially. Business model frameworks are tools that reduce complexity by focusing on the key aspects of a business model. Thereby, the risk of overlooking essential elements can be minimized. A framework directly integrating the MDR could alleviate the intricate circumstances in which SaMD startups are entangled.
This study focused on deriving a business model framework for startups aiming to develop SaMD under the MDR. With the framework, we strived to facilitate business modeling for SaMD startups.
The study is based on a 3-step approach. First, a systematic literature review was carried out, resulting in a concept matrix and an overview of business model frameworks developed and applied in the digital health sector. Subsequently, 13 interviews were conducted with experts and startups in the SaMD industry. On the basis of the literature analysis and expert interviews, along with the MDR requirements for SaMD, we developed the SaMD business model framework.
The SaMD business model framework consists of 13 interrelated components, with the MDR being a pivotal component. The centerpiece of the framework is the "regulatory value arc," which is the trio of intended purpose, value propositions, and customer segments. For each component, valuable input is provided, making the framework tailored to startups aiming to develop SaMD.
The findings highlight the crucial role of regulations in business modeling. Notably, the MDR is a central regulation for startups aiming to develop SaMD. The study uncovers the impact of the MDR on business modeling for SaMD startups. Our research provides a framework that integrates this regulation, thereby reducing its complexity and facilitating startups in deriving a sustainable business model. Concurrently, this research integrates the domains of business modeling and the MDR. Therefore, it contributes to the academic discourse in both fields and addresses a notable gap in the existing literature.
随着欧盟第2017/745号法规（即《医疗器械法规》，简称MDR）的出台，旨在在欧盟开发作为医疗器械的软件（SaMD）的初创企业面临着严格而复杂的法规，许多企业在应对这些法规时遇到困难。遵守MDR是一项成本高昂、耗时的工作，需要专业知识和大量资金。然而，它为新的收入模式（如报销途径）打开了大门。因此，MDR显著塑造了初创企业的商业模式。在早期，为了在财务上挺过合格评定过程，在进行商业模式构建时就需要考虑该法规。商业模式框架是通过关注商业模式的关键方面来降低复杂性的工具。由此，可以将忽略关键要素的风险降至最低。一个直接整合MDR的框架可以缓解SaMD初创企业所陷入的复杂局面。
本研究聚焦于为旨在依据MDR开发SaMD的初创企业推导一个商业模式框架。借助该框架，我们努力为SaMD初创企业的商业模式构建提供便利。
本研究基于一种三步法。首先，进行了系统的文献综述，得出了一个概念矩阵以及数字健康领域已开发和应用的商业模式框架概述。随后，对SaMD行业的专家和初创企业进行了13次访谈。基于文献分析、专家访谈以及MDR对SaMD的要求，我们开发了SaMD商业模式框架。
SaMD商业模式框架由13个相互关联的组件组成，其中MDR是关键组件。该框架的核心是“监管价值弧”，即预期目的、价值主张和客户细分这三者。针对每个组件都提供了有价值的输入，使得该框架是为旨在开发SaMD的初创企业量身定制的。
研究结果凸显了法规在商业模式构建中的关键作用。值得注意的是，MDR是旨在开发SaMD的初创企业的核心法规。该研究揭示了MDR对SaMD初创企业商业模式构建的影响。我们的研究提供了一个整合该法规的框架，从而降低其复杂性，并帮助初创企业推导可持续的商业模式。同时，本研究整合了商业模式构建和MDR这两个领域。因此，它为这两个领域的学术讨论做出了贡献，并弥补了现有文献中一个显著的空白。
