Custom automation equipment · Medical devices非标自动化设备 · 医疗器械

Precision automation for medical device production 医疗器械
精密自动化解决方案

VastSun Biotech designs and builds custom assembly, inspection and test equipment for medical device makers, from process development and equipment design to validation and complete production lines. 九胜生物专注医疗器械领域的精密非标自动化设备定制，从产品工艺、设备设计、验证测试到整条产线搭建，提供端到端的制造解决方案。

Explore our equipment查看设备与案例 Discuss your project咨询项目

Automated production lines delivered by the VastSun core team, at a customer cleanroom — Automated lines delivered by our core team · customer cleanroom核心团队交付的自动化产线 · 客户洁净车间实拍

±0.02mmVision-guided assembly accuracy视觉引导组装精度

≥99.8%Visual defect detection rate视觉缺陷检出率

4–6wk周Prototype delivery样机交付

200+Automation projects by our core team核心团队自动化项目

About us关于我们

Designed in Shenzhen, delivered worldwide深圳研发制造，全球交付落地

Shenzhen VastSun Biotech Co., Ltd. is an engineering-led intelligent manufacturing company in Shenzhen, China. Our core business is custom precision automation equipment for medical devices. We have also built our own medical device assembly line, so our equipment is designed for real production demands. The core team has delivered equipment to international medical device companies, including an insulin pump manufacturer.深圳九胜生物科技有限公司（VastSun Biotech）是一家以工程技术为核心的智能制造企业，核心业务是医疗器械精密非标自动化设备。九胜同时自建医疗器械组装产线，设备设计以真实量产需求为标准。核心团队曾为国际医疗器械企业交付设备，其中包括国际知名胰岛素泵企业。

VastSun has received strategic investment from Tonly Technology, a subsidiary of TCL Group, giving our customers access to large-scale electronics manufacturing, precision molding and supply chain resources.公司获 TCL 集团旗下通力技术股份有限公司战略入股，可为客户协同电子制造、精密注塑与供应链资源。

Automated lines delivered by the VastSun core team, installed at a customer site — Delivered lines running at a customer site核心团队交付的产线 · 客户现场

15+Years of core team experience in medical devices核心成员医疗器械项目经验（年）

70%Key technical staff with 10+ years' experience技术骨干拥有 10 年以上经验

>38%Staff in R&D研发人员占比

≥15%Of annual revenue reinvested in R&D年研发投入占比

TCLStrategic investment from Tonly (TCL Group)TCL 集团旗下通力战略入股

5,500 m²+Facility in Shenzhen深圳厂房面积

Industries服务领域

Industries we serve我们服务的领域

CGM连续血糖监测View equipment →查看设备 →

Insulin pumps胰岛素泵View equipment →查看设备 →

Balloon catheters球囊导管View equipment →查看设备 →

Dental implants口腔种植体View equipment →查看设备 →

Core team experience also includes:核心团队过往经验还包括： Automotive汽车 New energy新能源 Semiconductor半导体 Consumer electronics消费电子 View projects →查看项目 →

Custom automation equipment非标自动化设备

Equipment built around your product围绕客户产品定制的自动化设备

Single stations, complete lines and turnkey projects for medical devices and precision products.可承接医疗器械及精密产品的单机工位、整线及交钥匙项目。

Automated assembly lines自动化组装线

Vision-guided assembly of sensors, needles, housings and other precision parts.传感器、针头、壳体等精密部件的视觉引导自动组装。

AOI and AI vision inspectionAOI 与 AI 视觉检测

Inline defect detection and dimensional measurement to replace manual inspection.在线缺陷检测与尺寸测量，替代人工目检。

Electrochemical and functional testing电化学与功能测试

Multi-channel biosensor test systems that measure signals down to the picoampere (pA) level.面向生物传感器的多通道测试系统，可测 pA 级微弱信号。

UDI and MES integrationUDI 与 MES 集成

Unit-level records from each station, ready for medical device audits.各工位数据按单品记录，满足医疗器械追溯要求。

Flexible packaging lines柔性包装线

Carton forming, filling, labeling, weighing and palletizing with quick changeover.彩盒成型、填充、贴标、称重到码垛，快速换型。

Line upgrades产线改造升级

Add automation, inspection or traceability to your existing lines.为现有产线增加自动化、检测或追溯功能。

1,000 UPH · 1 pA

Balloon vision inspection球囊视觉检测设备

See equipment for each of our four fields, our core technologies and how a project is delivered week by week.查看四大领域的设备、五大核心技术，以及项目的逐周交付安排。

Automation equipment in detail →非标自动化详情 →

Why VastSun为什么选择九胜

What our customers get九胜能为客户带来什么

Medical device focus专注医疗器械

CGM, insulin pumps, balloon catheters and dental implants.深耕连续血糖监测、胰岛素泵、球囊导管与口腔种植体。

Quality backed by data品质有数据支撑

Inline AOI inspection, real-time process monitoring and unit-level UDI traceability, so every part has a quality record.在线 AOI 全检、关键工序实时监控、UDI 单品级追溯，每件产品的质量都有记录可查。

Built for volume production按量产标准设计

We have built our own medical device assembly line, so we design equipment around takt time, yield and maintainability.九胜自建医疗器械组装产线，设备按量产节拍、良率与维护需求设计。

Fast, global delivery快速交付，覆盖海外

Prototypes in 4–6 weeks, lines in 2–4 months, with on-site support overseas.样机 4–6 周，整线 2–4 个月，支持海外现场服务。

Quality & customers质量与客户

Quality system and customers质量体系与合作客户

ISO 13485 medical device quality managementISO 13485 医疗器械质量管理体系

Certification in progress认证进行中

Equipment commissioning产线设备调试Production line installed and being commissioned产线设备进厂调试In progress进行中
Quality system体系建设Quality management system documented and implemented建立并完善质量管理体系文件
System operation体系运行System operated in daily production ahead of the audit体系在日常生产中运行
Certification认证取证ISO 13485 certification expected预计取得 ISO 13485 证书Q1 20272027 Q1

Customers合作客户

SiBionics GS series CGM systems硅基仿生 GS 系列连续血糖监测产品

More customers will be listed with their approval更多客户经授权后展示

Manufacturing services制造服务

Medical device contract manufacturing医疗器械组装制造

For customers who want us to build the product as well as the equipment.客户如需同时委托产品制造，九胜可提供组装测试与交付服务。

CGM assembly line in place and ramping up to volume productionCGM 组装产线已建成，即将量产交付
Automated lines built by our own equipment team产线由九胜自有设备团队搭建
UDI traceability from incoming material to shipment从来料到出货的 UDI 全程追溯
PCBA and injection-molded parts via TCL TonlyPCBA 与注塑件依托 TCL 通力协同

	VastSun	TCL Tonly通力协同
Engineering工程	Process design, automation, NPI工艺设计、自动化、NPI 导入	—
Production制造	Medical device assembly and testing医疗器械组装与测试	SMT / PCBA, tooling, injection moldingSMT / PCBA、模具与注塑
Quality质量	Medical device quality system and release医疗器械质量体系与放行	Failure analysis, reliability testing失效分析、可靠性测试
Scale扩展	Project management and delivery项目管理与交付	Supply chain, overseas bases供应链、海外基地

TCL Group operates in 160+ countries and regions. Tonly has manufacturing bases in China and Vietnam, with Mexico planned for 2027.TCL 集团业务覆盖 160+ 个国家和地区；通力在中国、越南设有生产基地，墨西哥基地计划 2027 年投产。

Culture企业文化

Mission使命

Make manufacturing more reliable and more efficient.让制造更可靠、更高效

Medical device manufacturing leaves no room for error. With automation and disciplined engineering, we make every product consistent and traceable, while lowering costs and shortening lead times.医疗器械制造容不得差错。我们用自动化和严谨的工程方法，让每一件产品稳定、可追溯，同时帮客户降低成本、缩短交付周期。

Vision愿景

Become a trusted precision manufacturing partner in medical devices.成为医疗器械领域值得信赖的精密制造伙伴

We focus on medical devices and aim to earn long-term trust through precision, quality and on-time delivery.专注医疗器械领域，以精度、质量和准时交付赢得客户的长期信任。

Help others succeed成就他人We measure our value by the success of our customers, partners and colleagues.帮助客户、伙伴和同事取得成功，我们的价值体现在他人的成功里。

Ownership主动担当We tackle problems proactively and take responsibility for results.发现问题主动解决，对结果负责，不推诿、不等待。

Professional rigor专业求真We rely on data and facts, and work to standards that stand up to validation and audits.尊重数据和事实，按专业标准做事，经得起验证与审核。

Lean innovation精益创新We continuously eliminate waste and find new ways to work better, faster and at lower cost.持续消除浪费，用新方法把事情做得更好、更快、更省。

Home首页 / Automation equipment非标自动化

Custom automation equipment非标自动化设备

From process development to a running line从产品工艺到整线量产

We handle process development, equipment design and validation together, then build and commission complete lines for medical devices.九胜把产品工艺、设备设计与验证测试放在一起完成，为医疗器械客户搭建并调试整条产线。

4–6wk周Prototype样机交付

2–4mo个月Production line产线交付

19Medical device equipment solutions套医疗器械设备方案

5Core in-house technologies自研核心技术

Equipment by industry领域设备 Technologies核心技术 Strengths核心优势 Delivery交付流程 FAQ常见问题

Equipment by industry领域设备

Choose your industry按领域查看设备

Each page lists our equipment for that field, with photos, key specifications and process steps.每个领域页面列出对应设备，包含设备图片、关键参数与工艺流程。

Continuous glucose monitoring连续血糖监测7 equipment solutions7 套设备方案

Insulin pumps胰岛素泵7 equipment solutions7 套设备方案

Balloon catheters球囊导管3 equipment solutions3 套设备方案

Dental implants口腔种植体2 equipment solutions2 套设备方案

Other industry experience其他行业经验7 past team projects7 个团队过往项目

Core technologies五大核心技术

In-house hardware and software软硬件自主研发

2D / 3D

Machine vision高效机器视觉

In-house vision inspection system自研机器视觉检测系统
Custom optics and algorithms定制光学成像硬件与算法
2D / 3D inspection accuracy ±0.01 mm2D/3D 视觉检测精度 ±0.01 mm
High-resolution recognition with adaptive learning高分辨率识别 + 学习自适应

±5 µm

Motion control智能运动控制

Closed-loop multi-axis synchronization自研闭环驱动，多轴同步、高速启停
Hardware and software developed together软硬件一体化定制开发
Picoampere-level sensitivity for CGM electrochemical testingCGM 电化学测试，皮安级灵敏度
Motion control accuracy ±5 µm智能运动控制精度 ±5 µm

Modular模块化

Modular design模块化设计

Standardized module units标准化模块单元
Shorter delivery cycles缩短交付周期
Swap modules to keep pace with product changes模块替换，快速跟进产品迭代

+50%

Production visibility生产可视化

In-house HMI that raises operator efficiency by 50%自研人机界面 HMI，操作效率提升 50%
Line data refreshed every second全线数据实时可视化，秒级刷新
Output, yield, uptime and material loss in one view产能、良率、稼动、物料损耗集中呈现

≥98%

Data analytics数据分析

Full-cycle production data capture全周期采集生产数据
Automatic yield, capacity and failure-mode reports自动生成良率、产能、故障模式与根因分析
MES integration with ≥98% data integration rateMES 系统对接，数据整合率 98% 以上

Core strengths核心优势

Why our equipment performs九胜设备的底气

200+Projects delivered by the core team核心团队项目交付经验

1,000+Precision molds designed精密模具设计

±3 µmMachining accuracy加工精度

≥99.8%Defect detection rate缺陷检测率

R&D strength研发技术优势

In-house senior R&D team; core members bring 15+ years of hands-on project experience自有资深研发团队，核心成员拥有 15 年以上实战项目经验
Dedicated R&D lab and test platform for early-stage development and continuous iteration配套专项研发实验室与测试平台，前沿技术预研、持续产品迭代
R&D staff over 38% of headcount; at least 15% of annual revenue reinvested in R&D研发人员占比 >38%，年研发投入比例 ≥15%

Precision manufacturing & quality精密制造与品质优势

In-house machine building and debugging workshop with standardized assembly SOPs自有标准化机械设备生产与调试车间，装配 SOP 标准化管理
100% inspection, from incoming materials through in-process checks to final shipment从原材料入厂检、制程巡检到成品出厂全流程检验
Standard parts kept in stock; 24-hour technical support and fast on-site service标准件常备库存快速响应；24 小时技术咨询，故障快速上门处置

Supply chain cost advantage供应链成本优势

Long-term partnerships with original manufacturers; capacity and pricing secured in advance与原厂长期战略合作，提前锁定产能配额与最优采购价
Key precision parts designed and made in house, cutting outsourcing costs关键精密零部件自主设计生产，减少外协费用
Mature inventory and production planning keep pricing competitive without compromising quality成熟的库存与排产管控，在保证品质的前提下提供高性价比

Delivery交付流程

How a project runs项目如何推进

Each stage ends with a deliverable you can review.每个阶段都有明确的交付文件，客户可逐项确认。

Pre-contract合同签订前

Requirements需求交流URS / RFP
Technical review技术沟通Feasibility技术可行性
Specification规格确认Spec sign-off规格书确认
Concept design方案设计Preliminary design概要设计说明
Quotation配置报价Quote / cost breakdown (CBD)报价单 / CBD
Contract合同审批PO / Contract合同

After kick-off: a typical 10-week line project项目启动后：以 10 周产线项目为例

Prototypes take 4–6 weeks; lines take 2–4 months depending on scope.样机 4–6 周；产线视范围 2–4 个月。

Design and prototyping设计与原型开发

Process study, concept, detailed design and prototypes.工艺研究、方案、详细设计与样机。

Machine build设备整机制造

Machining, assembly and debugging in our own workshop under standardized SOPs.自有机械生产与调试车间，装配 SOP 标准化管理。

Process validation全方位工艺验证

Validation runs in parallel with the build to shorten lead time.验证流程与制造并行，缩短周期。

Installation and commissioning安装调试与验证

On-site installation, SAT and acceptance documents, in China and overseas.国内及海外现场安装、SAT 验收与验收文件。

Training and support培训与售后

Operator training, fast technical response and lifecycle follow-up.操作培训、快速技术响应与全周期跟进。

Multi-site replication多站点复制部署

Proven lines replicated at new sites, with local support.成熟产线复制到新工厂，本地化服务。

FAQ

Common questions常见问题

How long does a project take?项目周期多长？

A prototype usually takes 4–6 weeks. A complete production line takes 2–4 months, depending on process complexity and scope.样机一般 4–6 周，整条产线 2–4 个月，具体取决于工艺复杂度和项目范围。

What do you need from us to quote?报价需要我们提供什么？

Product drawings or samples, the process steps, target output (UPH or annual volume), quality requirements and your timeline. A URS is ideal but not required to start.产品图纸或样品、工艺步骤、目标产能（UPH 或年产量）、质量要求和时间计划。有 URS 最好，没有也可以先沟通。

Can you test our parts before we commit?能先用我们的工件打样验证吗？

Yes. For inspection and measurement projects we run sample tests on your parts to confirm detectable defects, accuracy and cycle time before finalizing the configuration.可以。检测与测量类项目会先用客户工件打样，确认可检出项、精度和节拍，再确定最终配置。

Can the equipment connect to our MES?设备能对接我们的 MES 吗？

Yes. Our equipment supports MES integration, Modbus TCP and UDI tracking, with local data storage where needed.可以。设备支持 MES 对接、Modbus TCP 协议与 UDI 追溯，也支持数据本地存储。

Can one line handle several product models?一条线能兼容多个型号吗？

Yes. Modular design and quick-change tooling let lines switch models; our flexible packaging line changes over in about 15 minutes.可以。模块化设计与快换工装支持多型号切换，例如柔性包装线约 15 分钟完成换型。

Do you deliver outside China?能交付到中国以外吗？

Yes. We design and build in Shenzhen and deliver to customers overseas, including on-site installation, commissioning, SAT and training. Our core team has delivered equipment for an international insulin pump manufacturer.可以。九胜在深圳研发制造，具备海外交付能力，可提供海外现场安装、调试、SAT 验收与培训。核心团队曾为国际知名胰岛素泵企业交付设备。

Home首页 / Industries服务领域

Includes past projects by VastSun, its core team and partners. Customer names are disclosed only with authorization. Actual performance depends on equipment design, validation scope and site conditions.含九胜、核心团队及合作伙伴过往项目；客户名称经授权后披露；实际性能以设备设计、验证范围及现场工况为准。