Views: 0 Author: Kevin Publish Time: 2026-02-24 Origin: Jinan Chensheng Medical Technology Co., Ltd.
In the rapidly evolving medical device industry, "off-the-shelf" components rarely meet the specific needs of modern innovation. Whether it’s a complex seal for a minimally invasive surgical robot or a biocompatible skin patch for a wearable monitor, the solution often lies in Custom Medical Silicone Rubber Products.
For medical device engineers and procurement managers, customization offers the freedom to optimize performance, safety, and aesthetics. However, moving from a CAD drawing to a finished part requires navigating a maze of material choices and molding techniques.
This guide explores how to leverage custom silicone manufacturing to solve complex design challenges.
The demand for custom silicone solutions is driven by the need for precision and integration. Standard O-rings or tubes often fail when:
Space is limited: Miniaturized devices require micro-molded parts with thin walls (<0.5mm).
Complex Geometries: Features like undercuts or variable wall thicknesses cannot be achieved with standard extrusion.
Material Integration: Overmolding (bonding silicone directly to metal or plastic) eliminates assembly steps and creates a seamless, hygienic bond.
To get the best result from your manufacturer, you need to define three key parameters for your Medical Silicone Rubber Products:
Customization allows you to dial in the exact physical properties:
Hardness: Do you need a soft, skin-like feel (20-30 Shore A) for a mask, or a rigid, durable grip (70-80 Shore A) for a handle?
Surface Finish: You can request a matte finish (to reduce friction and tackiness) or a glossy finish (for clarity and visibility).
Color Coding: Custom colors aren't just for looks; they are vital for safety (e.g., red for "hot" or "danger," blue for "oxygen"). We can match any Pantone color while maintaining biocompatibility.
Choosing the right process affects cost and quality:
Compression Molding: Ideal for low-to-medium volume production and simple shapes. It has lower tooling costs.
LSR (Liquid Silicone Rubber) Injection Molding: The gold standard for high-volume, high-precision parts. It offers the tightest tolerances and fastest cycle times, perfect for complex medical silicone rubber products.
Medical devices require exact fits.
Standard: ISO 3302 Class M2 is common.
Precision: For critical seals, specify Class M1. Be aware that tighter tolerances require more expensive, high-precision steel molds.
Investing in a custom solution brings tangible ROI:
Risk Reduction: A custom-designed seal fits perfectly, eliminating leakage risks that come with forcing a standard O-ring into a non-standard groove.
Assembly Efficiency: By combining multiple parts into one custom silicone component (e.g., a keypad with integrated seals), you reduce assembly time and potential failure points.
Brand Identity: Unique shapes and colors make your medical device instantly recognizable in the market.
The Challenge: A MedTech startup was developing a continuous glucose monitor. They needed a housing that was soft enough to be worn on the skin for 14 days but durable enough to protect the electronics from water (IP67 rated).
The Custom Solution:
Material: We formulated a specialized Low-Tack, Biocompatible Silicone (40 Shore A) to prevent lint buildup and skin irritation.
Process: We used LSR Overmolding to bond the soft silicone directly onto the rigid polycarbonate casing of the sensor.
The Result: The overmolded design eliminated the need for adhesives (which can cause allergies) and provided a perfect waterproof seal. The product passed FDA validation on the first try.
Customization is not just about buying a part; it's about partnering with a manufacturer who understands Design for Manufacturability (DFM).
At JNGXJ, we don't just mold rubber; we help you engineer solutions. From material selection to mold flow analysis, our team ensures your Medical Silicone Rubber Products meet the rigorous demands of the medical industry.
Q: What is the minimum order quantity (MOQ) for custom medical silicone parts?
A: MOQ depends on the manufacturing process. Compression molding allows for lower MOQs (e.g., 500-1000 units), while LSR injection molding is typically suited for higher volumes (5,000+ units) due to higher tooling costs.
Q: How long does it take to develop a custom mold?
A: Typically, prototype molds can be ready in 1-2 weeks. Production molds for high-precision medical silicone rubber products usually take 3-5 weeks to design, machine, and test.
Q: Can you help with the design of my silicone part?
A: Yes. We offer DFM (Design for Manufacturability) support. We can review your 3D files and suggest modifications to improve moldability, reduce costs, and ensure the part functions as intended.
Q: Is custom silicone expensive?
A: While there is an upfront cost for the mold (tooling), the unit price of custom parts can be very competitive, especially when "overmolding" reduces your assembly labor costs.
