Customized medical silicone tubes by Ruixiang: Empowering the compliance and implementation of long-term implantable medical products
Implantable Medical Devices: Why Custom Silicone Tubes Are Make-or-Break
2025-12-29
In the field of implantable medical devices, the customization of medical-grade silicone tubes directly determines the safety, effectiveness and regulatory compliance of products. A global medical device enterprise focusing on hormonal implant products once faced huge challenges in finding a suitable silicone tube supplier: the product needs long-term subcutaneous implantation (more than 28 days, target 12 months), which has extremely strict requirements on material biocompatibility, dimensional precision and regulatory documents. Finally, through in-depth cooperation with Dongguan Ruixiang Precision Silicone Products Co., Ltd., the customized demand of high-standard implantable silicone tubes was successfully realized. This case will detail how Ruixiang's professional customization capabilities solve the core pain points of medical enterprises.
Customer Background & Core Customization Pain Points
The customer is a well-known medical device company engaged in the R&D and production of hormonal implant products, with business covering major markets such as Brazil. Its core demand is to customize a finished implantable silicone tube for long-term subcutaneous use. In the process of looking for suppliers, it has encountered three core pain points: First, the material safety is difficult to guarantee. The silicone tube needs to be implanted in the human body for a long time, and the risk of rejection or tissue stimulation must be minimized; Second, the dimensional precision requirements are high. The product has strict specifications for inner diameter, outer diameter and length, and the error range must be controlled within a small range to ensure the matching with subsequent implantation instruments; Third, the regulatory compliance documents are incomplete. The products need to pass the ANVISA certification in Brazil, and a complete set of compliance documents such as biocompatibility reports and quality certificates are required.
Detailed Customization Requirements of Implantable Silicone Tubes
Based on the application scenario of long-term subcutaneous implantation, the customer put forward clear and detailed customization requirements for silicone tubes:
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Material Requirements: Medical/implant-grade platinum-cured silicone, which must have excellent biocompatibility and stability to ensure no harmful substances are precipitated during long-term implantation.
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Application Scenario: Long-term subcutaneous implantation (more than 28 days, the ideal service life is up to 12 months), used for hormonal implant products (silicone only, no drug loading).
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Product Form: Finished extruded and cut tubes, no need for secondary processing by customers.
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Dimensional Parameters: Inner diameter about 1.8mm, outer diameter about 2.4mm, length 38mm, and the dimensional tolerance must be controlled within the range of medical grade.
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Appearance & Hardness: Transparent/translucent appearance, hardness about 38 Shore A, to meet the needs of product visualization and implantation operation.
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Regulatory Documents: Provide a formal declaration of suitability for long-term implantation, Certificate of Analysis (CoA) per production lot, biocompatibility report in line with ISO 10993, and Certificate of Conformity (CoC) as well as evidence of production in line with ISO 13485 to support ANVISA registration in Brazil.
Ruixiang's Professional Customization Solution
After in-depth communication with the customer, Ruixiang quickly set up a professional customization team, combining its own technical advantages and compliance system, to provide a one-stop customization solution for the customer:
1. Material Selection & Formula Optimization: The Foundation of Safety
In view of the long-term implantation demand, Ruixiang selected imported high-purity platinum-cured medical implant-grade silicone as the raw material, which has the characteristics of low extractables, no harmful additives and excellent biocompatibility. The R&D team optimized the formula according to the 38 Shore A hardness requirement, ensuring that the silicone tube has appropriate flexibility and toughness, which can adapt to the human body's subcutaneous environment and avoid deformation or degradation within 12 months. At the same time, the raw material suppliers are strictly audited, and the traceability of each batch of raw materials is realized to ensure the stability of the material foundation.
2. Precision Production & Process Control: Guarantee of Dimensional Accuracy
Ruixiang has a 2,000-square-meter factory and a professional clean workshop, equipped with advanced extrusion and cutting equipment, which can realize high-precision control of silicone tube dimensions. For the customer's requirements of inner diameter 1.8mm, outer diameter 2.4mm and length 38mm, the production team adjusted the extrusion parameters and optimized the cutting process, controlling the dimensional tolerance within ±0.02mm, which is far higher than the industry average level. In the production process, full-process quality inspection is implemented, including online dimensional detection and offline sampling inspection, to ensure that each finished product meets the customer's specifications. The transparent/translucent appearance requirement is achieved by optimizing the raw material purity and extrusion temperature, avoiding impurities and color differences.
3. Comprehensive Compliance Support: Escort for Regulatory Registration
As a professional medical silicone product manufacturer, Ruixiang has a complete compliance system. For the customer's regulatory needs, it provides a full set of authoritative documents: First, a formal declaration of suitability for long-term implantation (more than 12 months) issued by the technical department, which clearly states the product's compliance with implantable use requirements; Second, Certificate of Analysis (CoA) for each production lot, including detailed test data such as dimensional accuracy, hardness and purity; Third, biocompatibility test report in line with ISO 10993, covering cytotoxicity, sensitization, irritation and other key indicators, fully meeting the requirements of implantable materials; Fourth, Certificate of Conformity (CoC) and ISO 13485 quality management system certification certificate, proving that the production process is strictly in line with international medical device standards. These documents provide solid support for the customer's ANVISA certification in Brazil.
4. Sample Provision & Flexible Delivery: Guarantee of Cooperation Smoothness
In order to facilitate the customer's initial evaluation, Ruixiang provided customized samples within 7 working days, and attached a detailed sample test report to help the customer complete the performance verification quickly. For the batch delivery demand, Ruixiang formulated a flexible production plan according to the customer's order quantity, realizing the minimum order quantity (MOQ) of 500 pieces and the delivery cycle of 15-20 working days. At the same time, it provides both non-sterile and sterile supply options (sterile products are processed by ethylene oxide sterilization in line with ISO 11135), fully meeting the customer's different use scenarios.
Cooperation Achievements & Customer Recognition
The customized medical silicone tubes provided by Ruixiang have passed the customer's strict performance test and clinical trial verification. The product's biocompatibility, dimensional stability and long-term implantation safety have been fully recognized. With the complete compliance documents provided by Ruixiang, the customer successfully passed the ANVISA regulatory registration in Brazil, and the product was put on the market smoothly. Up to now, the two sides have maintained long-term stable cooperative relations. The customer said: "Ruixiang's professional customization ability and comprehensive compliance support have solved our core pain points in product R&D and registration, and their product quality and service level are among the top in the industry."
Why Choose Ruixiang for Medical Silicone Tube Customization?
1. Professional Customization Capability: Focus on precision silicone products since 2012, with rich experience in customizing medical silicone tubes for different implantation scenarios, which can meet the personalized needs of customers such as special dimensions, hardness and appearance.
2. Strict Quality & Compliance System: The products have passed multiple international certifications such as FDA, USP Class VI, ISO 10993 and ISO 13485, and can provide a full set of compliance documents to support the regulatory registration of global markets.
3. Advanced Production & Inspection Equipment: Equipped with professional clean workshops and high-precision production and inspection equipment, ensuring the stability and precision of products.
4. Efficient Service Response: Provide one-stop service from sample customization to batch delivery, with fast sample delivery and flexible delivery cycle, which can quickly respond to customer needs.
Whether you are engaged in the R&D of hormonal implants, minimally invasive interventional instruments or other medical devices, Ruixiang can provide you with professional medical silicone tube customization solutions. Contact us today to get your exclusive customization plan!
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