Casco Bay Molding

Certified Design, Tooling, & Production — All Under One Roof

 

Award-Winning Product Design & Manufacturing

Casco Bay Molding is an ISO 13485:2016 Certified product development and injection molding facility located in Sanford, Maine. Complete with an in-house tool shop, we offer decades of silicone and thermoplastic part design and production experience, focusing on Class I and II medical device components.

 

Medical Product Design

Our engineering team specializes in challenging medical device component design. Let’s work together to optimize your medical device for function and manufacturability.

In-House Precision Tooling

Thanks to our in-house machine shop, we’re able to diminish mold production time and costs by involving our toolmaker throughout the product development process.

Injection Molding

Casco Bay Molding is an injection molding factory with over two decades of production experience. We specialize in high-volume silicone and thermoplastic production.

 

Experts in medical device manufacturing

As an ISO 13485:2016 Certified facility with FDA registration experience, we’re pleased to offer comprehensive medical device product design, mold making, production, and fulfillment — all from our factory in Maine. Current and past projects include surgical handles, sleep apnea machine components, medical valves and tubes, custom gaskets, wholesale menstrual cups, and much more.

 
 

Leaders in Menstrual Cup Production

Casco Bay Molding has manufactured over a million menstrual cups for B2B customers across the world. Interested in designing a menstrual cup or menstrual disc or private labeling an existing design? Contact us and a member of our team will be in touch.

menstrual cup
 

Our factory in sanford, Maine

Casco Bay Molding History


Casco Bay Molding Founded

February 2000

Andrew Powell founds Casco Bay Molding in Sanford, Maine with a vision for making silicone and thermoplastic products in America. Some of our earliest products include our scuba line, including mouthpieces, regulator straps, and octopus necklaces.


ISO:9001 Certification

January 2003

Casco Bay Molding exceeds the necessary quality control requirements to receive ISO:9001 Certification. We have been ISO:9001 certified since 2003.


Legu Tool & Mold Partnership

June 2016

Casco partners with Legu Tool & Mold, a precision mold making shop, to offer in-house tooling expertise. This helps shorten product development and tooling times and costs for our customers.


Maine MEP Manufacturer of the Year

March 2019

We are honored to be named the Maine Manufacturing Extension Partnership 2018 Maine MEP Manufacturer of the Year. Casco is grateful for all the support we receive from the Maine community and our customers around the world.


FDA Inspection

September 2019

The Casco team passes an FDA (Food and Drug Administration) inspection. We are pleased to announce that our menstrual cup quality control processes exceed those put forth by the FDA.


ISO 13485:2016 Certification

January 2020

Casco Bay Molding is ISO 13485:2016 Certified following a successful 3-day audit. We are pleased to exceed the safety and quality standards needed for medical device component development.


COVID-19 Response

May 2020

In response to the COVID-19 pandemic and demand for PPE suppliers, we partnered with Thermoformers of New England to release our face shield. The Casco Shieldfeatures a bendable polypropylene headband component, adjustable silicone strap, and replaceable clear visors. It fits users 4’7” and taller and is available for wholesale and individual orders.