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Comprehensive Professional Guide to Designing and Manufacturing Silicone Medical Devices1

Comprehensive Professional Guide to Designing and Manufacturing Silicone Medical Devices

In the ever-evolving field of healthcare, the demand for safe, reliable, and highly customizable materials continues to grow. Silicone rubber has emerged as a trusted material of choice for medical applications — prized for its heat resistance, biocompatibility, flexibility, and mechanical strength. From soft anatomical models and prosthetics to custom hearing aids and overmolded medical device handles, silicone’s versatility opens new doors for innovation.

At Neosilicone, we’re proud to offer a comprehensive ecosystem of silicone molding and production services that meet the demanding standards of the healthcare industry. In this guide, we’ll explore how advanced silicone processing methods — from direct 3D printing with silicone resins to precision molding using SLA-printed tooling — can streamline your prototyping and production workflows. If you have a project in mind or need technical guidance, don’t hesitate to contact our team today. We’re here to help turn your ideas into tangible, high-performance silicone solutions.

Comprehensive Professional Guide to Designing and Manufacturing Silicone Medical Devices2

Why Silicone Rubber is the Ideal Material for Healthcare Applications

Silicone elastomers offer a unique combination of performance properties that make them invaluable in healthcare settings:

Outstanding biocompatibility for skin-contact and implantable applications

Exceptional thermal stability, maintaining elasticity and integrity at high and low temperatures

Superior chemical and UV resistance, suitable for sterilization processes

Excellent flexibility and tear strength, perfect for soft, wearable devices

These properties allow silicone to be used in a broad range of healthcare products, including anatomical models, surgical training aids, prosthetics, seals, gaskets, and medical device housings. The material’s ability to conform to complex geometries while maintaining long-term durability makes it an industry standard.

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Modern Methods for Producing Silicone Medical Parts

At Neosilicone, we offer two primary approaches to manufacturing custom silicone parts:

1️⃣ Direct 3D Printing with Silicone 40A Resin

With advances in stereolithography (SLA) 3D printing, it’s now possible to print true silicone parts directly, without intermediate tooling. Using Silicone 40A Resin on high-resolution SLA printers, medical designers can create intricate geometries that would be challenging or impossible to achieve through conventional molding.

This process is ideal for rapid prototyping or producing functional parts with complex internal channels, undercuts, or customized surface textures. It’s also a faster route to market when time is critical, as it eliminates mold design and fabrication lead times.

2️⃣ Silicone Molding Using SLA-Printed Tooling

For projects requiring a wider selection of silicone grades, colors, or biocompatibility certifications, molding remains the preferred method. SLA 3D printers produce precise, high-quality molds that capture fine surface details, essential for medical-grade components.

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Silicone molding with printed tooling offers several techniques:

Persvorming of Silicone Putty: Fast-curing silicone putty is packed into a two-part mold and clamped in a vise. This method is ideal for prototyping gaskets and seals.

Liquid Silicone Injection Molding: Liquid RTV silicones are injected into a printed mold, filling the cavity by gravity or with pressure. This approach supports both platinum- and tin-catalyzed silicones, offering flexibility in biocompatibility and mechanical properties.

Overmolding: Hardware components are encapsulated partially or fully with liquid silicone within a printed mold, used for medical device grips, soft housings, and wearable electronics.

Eggshell Molding: A thin, sacrificial mold is printed around a cavity and cracked away after curing, suitable for producing one-off custom components like silicone ear molds.

Understanding the Types of Silicone for Healthcare Applications

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Different medical products call for specific silicone materials. Here’s a breakdown of the most common categories we use at Neosilicone:

Liquid Silicone Rubber (LSR): High-performance, injection-molded silicones for mass production of technical parts like seals and medical connectors.

High-Temperature Vulcanized (HTV) Silicone: Also known as Heat-Cured Rubber (HCR), ideal for cables and components requiring outstanding temperature resistance.

Room-Temperature Vulcanized (RTV) Silicone: User-friendly, versatile silicones processed by injection, compression, or gravity casting at room temperature. They’re well-suited for prototyping, small-batch runs, and medical mold-making.

Among RTV silicones:

Silicone 40A Resin: A one-part RTV silicone suitable for direct SLA 3D printing, offering excellent flexibility and chemical resistance.

RTV Liquid Silicone: Two-part systems available in platinum or tin-catalyzed variants, chosen based on required biocompatibility and dimensional stability.

Polydimethylsiloxane (PDMS): Known for its optical clarity and surface replication capabilities, commonly used in soft lithography and microfluidics.

Silicone Putty: A hand-mixed, two-part system ideal for creating quick, small molds or prototypes.

Pro tip: Always verify a material’s safety data sheet (MSDS) for skin contact or food safety applications. Platinum-catalyzed silicones are typically preferred for direct skin contact due to their superior biocompatibility.

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When to Print vs. When to Mold

Deciding whether to print or mold silicone parts depends on several project-specific factors:

Complexity: Direct printing accommodates intricate geometries difficult to achieve with molding.

Lead Time: Printing requires less preparation than mold design and fabrication, accelerating development cycles.

Material Options: Molding offers broader choices in durometer, transparency, color, and biocompatibility.

Biocompatibility: Certain molding-grade silicones hold established ISO certifications for medical use.

Durability & UV Resistance: Molding-grade silicones maintain mechanical properties better under long-term UV exposure.

Odor Sensitivity: Molded parts often have a more neutral scent immediately after production.

At Neosilicone, our technical team is happy to review your designs and recommend the best manufacturing route based on your application, quantity, and regulatory requirements.

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The Power of 3D Printed Tooling in Healthcare Manufacturing

Traditional metal molds, while durable, carry long lead times and high costs — limiting their feasibility for prototyping or short production runs. By contrast, SLA 3D printed molds offer a fast, cost-effective solution for medical product development.

Printed using Milosilicone BioMed Clear Resin, these molds deliver smooth surfaces and capture intricate details, minimizing defects on final silicone parts. Transparent molds also allow technicians to observe silicone flow, improving fill patterns and venting strategies.

Compared to FDM-printed molds, which leave visible layer lines, SLA tooling produces flawless parts suitable for demanding healthcare applications. Rapid iterations are easily achieved in-house, without relying on external suppliers or costly CNC machining.

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Let’s Bring Your Medical Silicone Project to Life

At Neosilicone, we specialize in providing high-precision silicone manufacturing services for the healthcare industry. Whether you need functional prototypes, short-run production parts, or custom tooling for new product development, our team is ready to support your project.

With advanced silicone molding capabilities, SLA 3D printed tooling, and a selection of biocompatible materials, we help clients reduce time-to-market and maintain uncompromising product quality.

Reach out to us today for a consultation or quote. Let’s turn your concept into a fully realized, medical-grade silicone solution.Contact Neosilicone now — your next healthcare innovation starts here.

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