Medical Silicone Injection Molding for Healthcare & Medical Devices

Extreme Molding is an ISO 13485:2016 certified medical injection molding manufacturer specializing in precision silicone components for healthcare and medical device applications. With more than 20 years of experience, our team is known for solving complex medical molding challenges. From prototype through full production, we deliver FDA compliant, USP Class VI silicone components with full material traceability, all manufactured in our New York facility.

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Why Choose Extreme Molding for Medical Injection Molding

Medical device manufacturers and healthcare product companies work with us for our combination of technical expertise, quality systems, and Made-in-USA manufacturing advantages:

ISO 13485:2016 Quality Management System – Our certified QMS ensures controlled, compliant processes for the manufacture of medical device components in accordance with international quality requirements. US
USP Class VI & FDA-Compliant Materials
100% US-Based Manufacturing – Protect your intellectual property, simplify audits, and reduce supply chain risk
Full Traceability & Lot Documentation
20+ Years Industry Experience – Our founders bring decades of medical device manufacturing expertise across cardiology, radiology, urology, and general surgery applications

About the Company

Our founders, Lynn Momrow-Zielinski and Joanne Moon Duncan, built Extreme Molding with their combined experience in medical injection molding, Class VI-compliant, high-performance materials, and international trade. They understood that many manufacturers wanted to keep their production of baby and healthcare products within the United States, instead of taking it overseas.

FDA regulations, material contamination, the threat to intellectual property, or the simple desire to offer a made-in-the-USA product led to their decision to offer a domestic alternative. Joanne spent over 20 years in the medical device field, leading manufacturing healthcare products producing devices for cardiology, radiology, urology and general surgery applications.

Medical Silicone Molding Applications We Manufacture

We manufacture silicone components for a wide range of healthcare and medical device applications. Our capabilities include liquid silicone rubber (LSR) injection molding, silicone overmolding, and compression molding for medical-grade parts.

Infant & Female Healthcare Products

We support infant and female healthcare products such as silicone nursing pads, breast pump accessories, neonatal pacifiers, artificial nipples for mastectomy patients, baby bottle feeding accessories, and infant oral care items where softness and material safety are essential.

Surgical & Clinical Products

Our silicone molding capabilities support components used in surgical and clinical environments, such as device grips, handles, seals, gaskets, and catheter-related parts requiring consistent performance.

Wound Care & Therapeutic Products

Silicone components for wound care and therapeutic use rely on flexibility and biocompatibility. We manufacture scar management products, wound dressings, and skin-contact therapeutic components.

Orthopedic & Podiatric Products

We mold silicone cushioning and protective components for orthopedic and podiatric applications, including foot cushions, digit covers, gel pads, and protective inserts.

Our Medical Injection Molding Capabilities

Liquid Silicone Rubber (LSR) Injection Molding

Our precision LSR injection molding process is ideal for medical components requiring biocompatibility, extreme temperature resistance, and complex geometries. LSR offers excellent durability, flexibility, and is naturally hypoallergenic, making it perfect for patient-contact applications.

Silicone Overmolding

We specialize in overmolding silicone onto thermoplastics, metals, and other substrates using self-bonding LSRs. This two-shot molding process creates integrated components with improved grip, shock absorption, and sealing properties. This process is ideal for surgical instruments, medical device handles, and ergonomic healthcare products.

Compression & Transfer Molding

For certain medical applications, compression and transfer molding provide cost-effective alternatives to injection molding. These processes are well-suited for larger parts, lower volumes, or specialized silicone formulations.

Post-Molding Services

Our end-to-end manufacturing capabilities include:

Medical adhesive and coating application
Assembly in white-wall environment
100% visual inspection when required
Custom packaging and labeling
Fulfillment and drop-shipping

Quality & Traceability

Quality Assurance & Full Traceability for Medical Devices

At Extreme Molding, we can provide full traceability and lot tracking since we do all of our medical injection molding in our own facility. We also source all of our molds and raw materials in the United States. Our quality control systems are second to none, and we have a thorough understanding of FDA regulations.

Our ISO 13485:2016 certified quality management system ensures:

Complete lot traceability from raw material to finished product
Material certifications and Certificates of Conformance (CoC)
First Article Inspection (FAI) reports
Statistical Process Control (SPC) monitoring
CAPA (Corrective and Preventive Action) procedures

How We Operate

Quality, safety, and customer satisfaction are the core values our injection molding services are founded on.

When appropriate, we do 100% inspection. In other cases, we work with you, our customer, to develop AQL standards. Our return rate of less than 0.01 percent speaks to our attention to detail. We source all of our molds in the United States for superior quality and protection of intellectual property. This also shortens lead time, so we can get your custom injection molding product started and brought to market that much sooner. We handle both large and small runs with the same professionalism and efficiency, and we will always work within your tight schedule.

We will consult with you on materials, color integrity, durability, and texture to find the right match for your product, and will source it from a network of reputable material suppliers based primarily in the United States.

We also work closely with mold fabricators, most of whom are headquartered near us in upstate New York, to ensure top quality, a shortened lead time and a quick resolution to any issues.

Extreme Molding is a trusted leader in silicone injection molding for high-end consumer and life science applications. We specialize in products for women and babies, including nursing pads, and food-safe silicone pacifiers, teethers and dinnerware. We offer one-of-a-kind silicone expertise and have a strong network within the materials supplier community.

Medical-Grade Silicone Materials

We work with premium medical-grade silicones from trusted suppliers.

USP Class VI Certified
ISO 10993 Compliant
FDA 21 CFR 177.260
BPA-Free Formulations
Following CGMP and TQMS

Our silicones offer key properties for medical applications:

Biocompatibility and hypoallergenic properties
Temperature resistance (-85°F to 392°F)
Sterilization compatibility (autoclave, EtO, gamma radiation)
Chemical and UV resistance
Variable durometer options (10 Shore A to 80 Shore A)

The Made in USA Advantage for Medical Components

For medical device manufacturers, domestic production offers significant advantages over offshore alternatives:

IP Protection – US-based manufacturing with enforceable NDAs protects your proprietary designs and trade secrets
Simplified Audits – Easier supplier qualification visits and ongoing quality audits without international travel
Supply Chain Security – Reduce risk of disruptions, tariffs, and extended lead times
Faster Response Time – Same time zone communication and rapid engineering changes when needed
Regulatory Confidence – Manufactured under FDA jurisdiction with full regulatory transparency
'Made in USA' Labeling – Valuable marketing differentiator for your healthcare products

Post Production

Our relationships with the healthcare industry and baby product manufacturers do not end with the medical injection molding process. We will assemble your product in our white-wall environment and add any necessary medical adhesives or coatings in post-production. Then, the product components are thoroughly inspected, packaged, and shipped.

Medical Injection Molding FAQs

We know the world of injection molding can be complex. Here are some frequently asked questions along with the answers to help you get started. If you still have questions, please contact us.

What certifications does Extreme Molding hold for medical manufacturing?

We are ISO 13485:2016 certified, the international standard for medical device quality management systems. Our facility is FDA registered, and we use USP Class VI certified materials.

What is USP Class VI certification and why does it matter?

USP Class VI is the United States Pharmacopeia's classification for biocompatibility of plastics. Materials must pass acute systemic toxicity, intracutaneous toxicity, and implantation tests. This certification is essential for medical devices that contact patients.

What is the difference between white-wall and cleanroom manufacturing?

White-wall environments provide controlled manufacturing conditions with strict protocols for cleanliness, material handling, and personnel gowning, suitable for many Class I and Class II medical devices. Certified cleanrooms (ISO Class 7 or 8) offer particle count certification and are required for certain implantable or sterile devices.

What medical device classes can you manufacture?

We specialize in components for Class I and Class II medical devices and non-regulated healthcare products. Our capabilities and quality systems support the requirements for these device classifications.

What is your minimum order quantity for medical silicone parts?

We work with companies at various production volumes, from prototype quantities to high-volume production runs. Contact us to discuss your specific requirements.

How do you protect intellectual property?

As a US-based manufacturer, we provide enforceable NDA agreements and secure handling of your proprietary designs. All molds are sourced domestically, and our facility maintains strict access controls and confidentiality protocols.

Launch a Product

If you have a great idea, we can help bring it to life. We’ve done this before and enjoy becoming partners throughout product creation. From advising you through the mold sourcing process, to delivering your new product to customers, we want to work with you every step of the way.