医疗器械如何开发On Medical Device Development

作为一家由社区驱动的研究实验室，我们希望采用不同于惯例的方式。我们会定期发布进展，让社区知道我们正在做什么——即使这意味着公开产品开发流程和监管分类的技术深度文章。我们希望社区尽可能充分知情，并获得尽可能多的反馈与批评机会。最好的方式，就是把一切完全公开。As a community-driven research lab we want to do things a little differently than usual. We want to post regular updates showing the community what we’re up to, even if that means publishing technical deep-dives about our product development processes and regulatory classifications. We also want our community to be maximally informed and provide as many opportunities for feedback and criticism as possible. The best way to do that is completely out in the open.

我们希望，这类文章能让大家看到一段有趣的幕后过程。We hope that blog posts like this will offer an interesting look behind the scenes.

第一天，我们能做到什么？What can we do on day one?

超声 CT 技术的长期潜力令人难以置信，但我们的起点仍然朴素。当前最难拿捏的，是在不牺牲安全的前提下，平衡用户需求与上市速度。The long-term potential for ultrasound CT technology is incredible, but we’re starting from humble beginnings. The biggest needle to thread is balancing user needs against time-to-market without compromising on safety.

经过长时间思考，我们在去年确定了一项简单策略：首先推出一款面向一般健康用途的高端身体成分分析仪，让人们能持续查看自己身体成分极其细致的三维地图。第一台设备不进行任何诊断或治疗，因此我们能更快地把安全产品带给社区。这不仅让我们有机会获得数十万人的反馈，也会为后续阶段积累更多时间和数据。After a great deal of thought and consideration, we landed on a simple strategy last year: launch a high-end body composition analyzer intended for general wellness use that lets people see an amazingly detailed 3D map of their body composition over time. By not performing any diagnosis or treatment with the first device, we can get a safe product out to the community much faster. This also enables feedback from hundreds of thousands of people and gives us more time and data for what comes next.

仅凭这项能力，我们相信已经能帮助许多人更好地理解身体内部正在发生什么。原本只能缓慢、间接地反映在外观上的生活方式变化，现在可以在更细的颗粒度上被观察，也更容易得到正向鼓励。我们认为，这从一开始就能帮助人们生活得更快乐、更健康。With this functionality, we believe that we can already help a lot of people better understand what’s happening inside their bodies. Lifestyle changes that would only slowly and visibly affect our bodies over time can suddenly be monitored and encouraged at a much more granular level. We think this can immediately help us live happier, healthier lives.

右小腿 · 扫描区域Right lower leg · scanned region

1月Jan2月Feb3月Mar4月Apr5月May6月Jun7月Jul8月Aug

肌肉Muscle1,308 cm³ ▲ +151

脂肪组织Fat tissue294 cm³ ▼ −176

骨骼Bone363 cm³ ▲ +1

第一代扫描仪的体验Here’s what to expect with our first-gen scanner

• 换上泳装、淋浴，然后进入一台完全自动运行的私密扫描仪。You change into swimwear, shower, and step into a private scanner that runs fully automatically.
• 站上扫描平台后，你会被轻柔地降入温暖的水中，感觉就像进入热水浴池。Once you step on the scanner platform, you will be gently lowered into water, which is warm, like a hot tub.
• 身体穿过设备时，一圈超声传感器会对身体成分进行成像。目前一次扫描需要 20 多分钟；第二代会快得多，而我们的最终目标是 60 秒。A ring of ultrasound sensors images your body composition as you pass through. Today a scan takes 20+ minutes; Gen 2 will be much faster, and our final goal is 60 seconds.
• 扫描结束后，详细的身体成分地图会上传到你的账户，可在 GBB全身超声 App 和网站中查看。没有针头，没有电离辐射，也没有任何侵入性操作。Afterward, you’ll get a detailed map of your body composition uploaded to your account. It will be visible in the GBB全身超声 app and on the website. No needles, no ionizing radiation and nothing invasive.

为什么要如此谨慎地限定范围？以较窄的产品功能起步，并不是胆怯，而是一项长期策略。先做身体成分分析，而不做诊断或治疗，能让安全产品更快发布，也为我们收集未来所需证据留下足够的时间和经验。Why are we being so careful with scope? Starting with a narrow set of product features isn’t us being timid. It’s a long-term strategy. Starting with body composition, not diagnosis or treatment, lets us ship a safe product much faster and gives us the time and experience needed to collect evidence for everything that might come after.

我们的监管路径Our regulatory pathway

很多人已经在问：从监管角度看，GBB全身超声扫描仪究竟是什么？在美国，医疗器械分为三类：I 类（例如绷带）、II 类（例如大多数影像设备）和 III 类（例如外科植入物）。器械所属类别决定了产品上市必须遵循的流程。We’re already getting a lot of questions about what the GBB Full-Body Ultrasound Scanner is from a regulatory standpoint. In the United States, medical devices fall into one of three classes: Class I, Class II and Class III. The class determines the processes required to bring a device to market.

今年 2 月，我们直接与 FDA 沟通，采用的机制称为“513(g) 信息请求”。简单来说，就是向 FDA 提交一份详细说明产品是什么、能做什么的文件，由 FDA 给出分类和监管方式的判断。FDA 于 2026 年 6 月 4 日回复了我们的 513(g) 请求。Back in February we engaged directly with the FDA through a 513(g) Request for Information. You send the FDA a detailed document describing the product and the agency responds with its assessment of the classification and how it should be regulated. FDA responded to our 513(g) on June 4, 2026.

这正是我们所期待的结果。GBB全身超声扫描仪是一款 II 类医疗器械；鉴于技术性质及其有限的一般健康用途，该设备可豁免 FDA 上市前审查。This is exactly what we hoped for. The GBB Full-Body Ultrasound Scanner is a Class II medical device, but given the nature of the technology and its limited general-wellness use, it is exempt from FDA’s premarket review process.

虽然免于上市前审查，FDA 医疗器械监管的许多其他要求仍然适用，包括：Though we are exempt from premarket review, many aspects of FDA medical-device regulation still apply to us, including:

• 机构注册与器械列名（21 CFR Part 807）Establishment registration & device listing (21 CFR Part 807)
• 医疗器械报告：报告不良事件（Part 803）Medical Device Reporting — adverse-event reporting (Part 803)
• 标签要求（Part 801）Labeling requirements (Part 801)
• 附加流程（QMSR 820.180 与 820.198，对应 ISO 13485 第 8.2.2 条）Additional processes (QMSR 820.180 & 820.198, tied to ISO 13485 Clause 8.2.2)
• 唯一器械标识（21 CFR Part 830）Unique Device Identification (21 CFR Part 830)
• 纠正与移除（21 CFR Part 806）Corrections and Removals (21 CFR Part 806)

FDA 对 513(g) 申报的回复并不是一枚“批准印章”，但它让我们确认：只要 GBB全身超声扫描仪严格用于一般健康目的，FDA 就不会要求上市前审查。This response to our 513(g) submission isn’t a stamp of approval, but it does give us comfort that the FDA will not require premarket review for the GBB Full-Body Ultrasound Scanner when used for general-wellness purposes.

监管阶梯如何运作How the regulatory ladder works

未来要增加任何超出一般健康用途的新能力——包括所有诊断或治疗功能——都必须沿监管阶梯向上，进入更严格的 FDA 上市前审查程序。证据负担也会根据功能的不同而增加。Every new capability beyond general wellness, including any diagnosis or treatment, will require moving up this regulatory ladder with more rigorous FDA premarket-review processes. The burden of evidence may also increase depending on the features.

我们如何开展研究与开发How we do research and development

医疗器械不能像普通消费产品那样，先发布，再随意在生产环境中迭代功能。它们必须在严格的设计控制下开发。所谓设计控制，本质上是一套高度严谨的产品开发与维护流程：每一项用户需求、产品要求、风险和测试都必须能够追踪、记录并评审。Medical devices aren’t built like a typical consumer product where you ship and iterate on any features you want in production. They are built with strict design controls: a highly disciplined development and maintenance process in which every user need, requirement, risk and test is traced, tracked and reviewed.

这意味着我们需要建立一份设计与开发文件（DDF）。它包含数百页文档，从项目启动时开始创建，并贯穿产品开发、测试和发布的所有阶段。产品上线后，每个被制造和交付的零件也要受到严格控制与测试。哪怕只修改 GBB全身超声扫描仪的一个功能，也必须充分测试并完整追踪这项变更。This involves developing a design and development file with hundreds of pages of documentation created at project kickoff and carried through every phase of development, test and release. Similar procedures keep every manufactured and shipped part controlled and tested after launch. Changing even one Scanner feature requires thorough testing and traceability.

我们把产品进入市场的过程拆分为七个阶段。We break the process of releasing things into the market into seven distinct phases.

项目的每一个阶段结束后，都要由跨学科团队进行正式、详细的设计评审。只有通过并记录这一道关卡，我们才会进入下一阶段。A detailed, formal design review with the cross-disciplinary team is required after every phase. We do not move to the next phase until that gate is passed and documented.

这些阶段形成的路径被称为 V 模型。我们沿 V 的左侧向下，把广义的人类需求拆解为详细规格，并最终构建设备；再沿右侧向上，通过一层层测试返回。右侧每一级都用来证明左侧对应层级，所有实线和虚线共同提供可追溯性。The shape these phases trace is known as the V-model. You travel down the left side, breaking broad human needs into detailed specifications and building the device, then climb the right side by testing back up. Each level on the right proves the corresponding level on the left, with solid and dashed lines providing traceability.

V 模型与螺旋式开发The V-model vs. the spiral development method

开发此类产品时始终存在一种张力。V 模型是线性的，边界清晰；如果所有事情都能提前确定，它就是打造安全、有效产品的方式。但把数 TB 混乱声波转换成尽可能准确的图像，是真正的研究，不会遵循这样的线性过程。为此，我们还需要一套更像螺旋的迭代方法。There is a tension whenever teams build something like this. The V-model is linear and well defined — how you build a safe and effective product when everything is known ahead of time. But turning terabytes of messy sound waves into the most accurate possible images is genuine research that does not follow such a process. For that, we need an iterative method that looks like a spiral.

因此，我们有意识地同时使用两种开发模式。研究、软件和硬件在螺旋中逐渐成熟；当一项能力准备进入用户可以依赖的正式产品时，它就进入 V 模型，被固定为要求，接受验证、确认并形成文档。We use both development modes on purpose. Research, software and hardware mature on the spiral. When a capability is ready to become part of a product people can rely on, it enters the V-model, where it is pinned to requirements, verified, validated and documented.

螺旋帮助我们研究并在开发中发现问题；V 模型确保最终产品安全可靠。清楚自己当前处于哪种模式，并在两者之间取得平衡，是这项工作的重要部分。The spiral is how we research and discover issues during development; the V-model is how we make sure the final product is safe and reliable. Knowing which mode we are in and how to balance the two is a big part of the job.

严肃对待风险Risk, taken seriously

每一个可信的医疗器械项目，都建立在正式的风险管理之上。对每一件可能出错的事情，我们都会把后果严重程度与发生概率结合评分，结果决定需要采取多大力度的控制。绿色代表良好，红色代表危险；红色区域的风险在通过控制降至更低等级前，绝不会随产品发布。黄色和橙色区域同样会得到高度关注，其中许多也会继续降低到绿色。Every credible medical-device program runs on formal risk management. For each thing that could go wrong, we score severity against probability, and the result tells us how hard we must work to control it. Green is good; red is bad. Nothing in the red zone is released without a control that lowers the risk, and yellow or orange risks receive close attention, with many brought into the green.

GBB全身超声扫描仪的常见风险包括湿滑表面、皮肤刺激和水中不适等物理危险。我们会通过产品设计和操作方式，把每一项已识别风险降下来。产品不使用电离辐射，不包含侵入性操作；超声输出也被设计为符合 FDA 对诊断超声安全限值的指导。最后，软件所呈现的信息同样必须安全，尽量避免引发焦虑或误导用户。Common Scanner risks include physical hazards such as slippery surfaces, skin irritation and discomfort in the water. We engineer each identified risk down through product design and operation. There is no ionizing radiation or anything invasive, and the ultrasound output is designed to remain consistent with FDA guidance on diagnostic-ultrasound safety limits. The information presented in software must also minimize the risk of anxiety or misinformation.

真实的人：我们的第一次 IRB 研究Real people: our first IRB study

有一个重要事实需要说明：发布公告中的扫描图并非 AI 生成，它们来自真实的志愿者。只要研究涉及真人——哪怕只是为了产品发布采集图像——合乎伦理、也正确的做法，就是接受独立监督。我们正是这样做的。Here’s an important fact: the scan images in our announcement were not AI-generated. They came from real volunteers. Whenever research involves real people — even just to collect images for a product reveal — the ethical and correct thing is to put it under independent oversight. So we did.

我们的图像采集研究经过 WCG IRB 审查并获批。WCG IRB 是一个独立的机构审查委员会，按照 FDA、HHS 和 ICH 临床试验质量管理规范运作。IRB 的存在，是为了独立于研究执行方，保护研究参与者。Our image-collection study was reviewed and approved by WCG IRB, an independent Institutional Review Board operating under FDA, HHS and ICH good-clinical-practice standards. An IRB exists to protect the people in a study, independently of the people running it.

研究方案Protocol

为 GBB全身超声扫描仪产品发布采集身体成分图像Collection of Body Composition Images for the GBB Full-Body Ultrasound Scanner Product Announcement

监督机构Oversight

WCG IRB——独立审查委员会（符合 FDA / HHS / ICH GCP 标准）WCG IRB — independent review board (FDA / HHS / ICH GCP compliant)

IRB 方案编号IRB protocol

20260427 · 研究 1406472#20260427 · Study 1406472

发起方Sponsor

安徽梗必爆技术有限公司GBBAI

状态Status

有条件批准（2026 年 2 月 26 日）· 知情同意书于 2026 年 3 月 10 日获批Approved with conditions (Feb 26, 2026) · consent form IRB approved Mar 10, 2026

研究目的Purpose of the Study

采集真实身体成分图像，以便公开展示该设备Collect real body-composition imagery in order to demonstrate the device publicly

我们通过以下方式保护研究志愿者：Here are some of the ways in which we protect the people who volunteer for studies:

• 每位参与者都会在研究开始前了解流程、风险和自身权利，并签署知情同意书。Everyone learns about what will happen, the risks, and their rights, and signs consent before anything begins.
• 任何人都可以拒绝参加或随时退出，不会受到任何处罚；员工的工作绝不会因其选择而受到影响。Anyone can decline or stop at any moment with no penalty. Employees’ jobs are never affected by their choice.
• 我们把安全放在首位：低功率超声、头部始终露出水面、温暖洁净的水、一名受训操作员在设备上方值守、另一名操作员在附近协助，并可随时退出。We keep it safe: low-power ultrasound, the head stays above warm clean water, a trained operator remains up top, a second operator is nearby, and participants can exit at any time.
• 当前研究仅面向成年人，并对体重上限、开放性伤口和活动性感染等情况设有明确排除标准。The current study is for adults only, with documented exclusions for weight limits, open wounds and active infections.
• 公开扫描图不包含姓名等身份信息。每位志愿者都会签署专门的图像授权书，也可以就其数据改变决定。Published scans contain no identifying information such as names. Every volunteer signs an explicit image release and can change their mind regarding their data.
• 未来任何为监管申报生成数据的研究，都将依据独立 IRB 方案开展；适用时，还会根据 21 CFR Part 812 评估研究器械豁免（IDE）要求。Future studies generating data for regulatory submissions will use separate IRB protocols and, where applicable, be assessed for IDE requirements under 21 CFR Part 812.

公告中的人体横截面并非 AI 生成。它们来自真实的人——这些人自愿参加了 GBB全身超声扫描仪第一项经 IRB 批准的研究。Those cross-sections of the human body in our announcement were not AI generated. They were scans of real people who volunteered for our first IRB-approved study with the GBB Full-Body Ultrasound Scanner.

谈谈你的数据Let’s talk about your data

上文的 IRB 管理研究本身，以及从志愿者采集扫描数据时涉及的伦理问题。IRB 审查保护研究参与者；而 HIPAA 及“受保护健康信息”（PHI）的概念，则约束医院、保险公司和向患者收费的临床医生等实体如何存储、共享和保护健康数据。The IRB above governs research and the ethics of collecting scan data from volunteers. IRB review protects research participants, while HIPAA and Protected Health Information govern how entities such as hospitals, insurers and billing clinicians store, share and safeguard health data.

作为一款直接面向消费者、仅用于一般健康、不诊断疾病也不向保险公司收费的产品，GBB全身超声扫描仪首次发布时通常不属于 HIPAA 严格法律范围，这一点类似智能体重秤或运动手环。As a direct-to-consumer product intended for general wellness that does not diagnose disease or bill insurance, the initial release of the GBB Full-Body Ultrasound Scanner will generally sit outside HIPAA’s strict legal scope, much like a smart scale or fitness band.

随着产品能力沿监管阶梯走向临床用途，正式的 HIPAA 与 PHI 义务也会随之出现。因此，我们选择在产品规模尚小、处于早期时，就按照这一标准建设，而不是日后再勉强补上。基本原则包括：As our capabilities climb the regulatory ladder toward clinical use, formal HIPAA and PHI obligations will begin. We are building to that standard now, while the product is small and early, rather than wedging it in later. The general principles include:

• 你的扫描图，以及由此生成的身体成分数据，都属于你。你可以随时获取副本，也可以要求我们删除。Your scans and the body-composition data generated from them are yours. You can get a copy or ask us to delete it at any time.
• 数据存储在加密并实施访问控制的系统中，配有管理、技术和物理防护措施，仅授权人员可以访问。Data lives in encrypted, access-controlled systems with administrative, technical and physical safeguards, reachable only by authorized personnel.
• 用于研究、演示或此类博客文章的图像，都会移除能够识别个人身份的信息。Images used in research, demos or blog posts like this one are stripped of information that identifies you.

隐私不是事后补救。我们现在就为此投入精力，因为这项事业的意义，正是创造一个让数十亿人都能放心把最私密数据交给我们的未来。Privacy isn’t an afterthought. We are putting effort into it now because the whole point is creating a future where billions of people can trust us with the most personal data there is.

我们目前的开发进度Where we are in development

扫描仪与中心是两个紧密相连、同步建设的项目。下面是 GBB全身超声扫描仪和中心当前的目标时间表，也标出了我们今天所在的位置。我们甚至正在下注，看看哪一个会先准备好发布。We’re building the scanner and the center together as two closely linked projects. Below is our current target timeline for both the GBB Full-Body Ultrasound Scanner and the center, including where we are today. We’re taking bets on which will be ready to release first!

为什么要告诉你这一切Why we’re telling you all of this stuff

大多数公司会把这部分开发过程隐藏起来。分类、矩阵、审查委员会，以及所有关于产品的谨慎措辞，往往像官僚文件一样被锁进后台。那些本应受到这些信息保护的人看不到它，只能选择相信流程。Most companies keep this part of development hidden away. Classifications, matrices, review boards and careful product language are filed in a back office like bureaucratic paperwork. The information is kept from the people it is designed to protect, who are simply asked to trust the process.

但我们的运作方式不同。对我们来说，这个过程也是应该与社区分享的内容。一次值得信任的 GBB全身超声扫描，建立在上千个谨慎决定之上；你完全有权看到这些决定是如何做出的。开放工作也是我们对自己负责的方式，让我们能在开发仍在进行时就听到大家的反馈。We don’t operate like a typical company. To us, the process is one of many things we want to share with the community. A GBB full-body ultrasound scan you can trust is built on a thousand careful decisions, and you have every right to see how those decisions are made. Working openly also keeps us accountable and lets us take feedback while development is still underway.

作为一家由社区驱动的研究实验室，我们向你负责，而不是向任何投资人负责。因此，除了那些美好、鼓舞人心的内容，我们还会继续发布像这样的更新。知道一件产品被多么谨慎地打造，本身就是一种安心。As a community-driven research lab, we answer to you, not to investors. We’ll keep publishing updates like this alongside the beautiful and inspirational ones. Knowing how carefully something is being built is its own kind of reassurance.

在一个越来越快、快到难以跟上的未来，GBB全身超声甚至可能成为一种透明工作的范本。我们会以正确的方式、公开地、共同地把它建设起来——因为我们是 GBBAI。GBB Full-Body Ultrasound might even become a template for transparent work in a future that increasingly moves too fast to follow. We’re building this the right way, in the open, together — because we are GBBAI.