Group 1 - Business Development (BD) is a significant trend in the domestic medical device industry, with a notable increase in BD transactions for innovative drugs, reaching a total of $60.8 billion in the first half of the year, surpassing the total for 2024 [1] - The Chinese government is promoting the development of domestic medical devices, with a focus on high-end medical equipment and technologies such as medical robots and AI medical devices, as outlined in the announcement released in July 2025 [2] - There is a fundamental difference in the evaluation systems and investment models between innovative drugs and medical devices, with medical devices requiring more extensive market and academic investment for recognition in different markets [3] Group 2 - The current BD model for medical devices is not suitable for a simple license-out approach due to the high dependency on usage scenarios and the experience of practitioners, which complicates the management and control of subsequent clinical trials and registrations [4] - Although the current BD model for innovative drugs may not fit medical devices, there are still BD transactions occurring in the medical device sector, such as the joint venture established between China Medical Device Co., Ltd. and GE Healthcare China [5] - The recently published "Medical Device BD White Paper 2025" indicates that BD in the medical device sector encompasses various transaction activities, including technology licensing, joint development, and strategic investments, with a focus on the actual product deployment [6] Group 3 - The trend in medical device BD is shifting from single transactions to a more structured resource allocation system, with an increasing willingness among investors and partners to engage in the early stages of product development and registration [7]

Core Viewpoint - The article emphasizes the importance of Business Development (BD) in the medical device industry, highlighting that success often relies on strategic transactions rather than solely on product success [1][2]. Group 1: Importance of BD - BD is not merely an additional capability but a structural advantage that should be integrated from product design, registration strategy, and market validation [2]. - The medical device industry's rules are changing, necessitating a readiness to engage in transactions [2]. Group 2: Key Scenarios for Medical Device Companies - The white paper aims to provide practical guidance for medical device companies on how to accelerate growth and navigate challenges [1]. - It addresses various scenarios such as finding the first business through licensing, designing cooperation structures for international expansion, and integrating investment with sales during financing [3]. Group 3: Structure of the White Paper - The white paper is divided into six chapters covering topics from product authorization, strategic partnerships, overall mergers and acquisitions, to enhancing a company's "tradeability" and future trends [2].

在过去几年里，思宇MedTech接触过无数医疗器械企业。 有些企业技术先进、团队优秀，却始终卡在"第一笔交易"； 白皮书写了什么？ 这是思宇MedTech为 器械企业、投资人、产业生态参与者 写的一份实战型知识手册，聚焦 商务合作、产品授权、战略投资、并购退出 等关键场景 。 你将看到： 这不是一份"给投资人看的包装材料"，而是站在企业实操一线写的参考文档。 每一章都围绕实际问题写：怎么谈、谈什么、准备什么、容易踩什么坑。 为什么要做这件事？ 有些公司已经上市，依然在反复试错"该不该投、该怎么谈"； 还有更多的创业者，在注册快结束的时候突然发现—— "光有产品不够，我还要知道怎么合作。" 于是思宇决定写这样一份白皮书。 不是从药企套公式、也不是堆概念，而是回到器械行业自己的语境，去回答一个朴素但关键的问题： 医疗器械行业里的BD，到底是怎么一回事？ 因为思宇发现， 太多优秀的器械企业卡在了"不会被交易"的关口 。 思宇MedTech想告诉你： 在医疗器械行业， 交易本身就是一种能力 。 能不能被合作，决定了你能不能走得快、走得远。 什么时候发布？ 《医疗器械BD白皮书》将于7月17日第二届全球医疗科技大会上正 ...