American Medical Device Manufacturer
A medical device manufacturer with ISO 13485:2016 certification, Casco Bay Molding offers comprehensive design, tooling, and production for all of your medical device production needs. Bolstered by our quality management system, Casco is the medical device manufacturer for several FDA-registered products along with other Class I and Class II medical devices and components.
Ongoing medical equipment projects include surgical handles, menstrual products, protective bumpers for surgery theaters, sleep apnea components, custom medical tubes, over-molding Ultem lab slide covers, Newman sanitary gaskets, and complex custom gaskets that function as seals for medical devices.
Quality-Focused American Medical Device Manufacturer
ISO 13485:2016 certification and decades of experience with technically challenging silicone injection molding projects set Casco Bay Molding apart from the rest. Our engineering team has unique insight into material properties and medical device design. By involving our in-house custom tooling team in our product and mold design process from the start, we’re able to cut down on project time, tooling costs, and material costs.
Casco Bay Molding specializes in high-volume (10,000+ units) Class I and Class II medical device manufacturing. We work with medical-grade silicone, also known as LSR, and thermoplastic; Capabilities include injection molding and overmolding.
Interested in working with a leading medical device manufacturer to design or produce a silicone or thermoplastic part? Submit a quote and a member of our team will be in touch shortly.
OEM (Original Equipment Manufacturer) Markets Served
An established medical device manufacturer, Casco Bay Molding has assembled a product development team involved in the design, production, and tooling of the applications detailed below. We’re confident in our ability to streamline the machining/tooling and production processes necessary to produce market-leading products in the following industries.
Surgical Instruments & Technology
Minimally invasive laparoscopic trocar technology
Mechanical/disposable hand-held devices i.e. collagen injection assist device, Biopsy Gun
Drainage catheter technology
Sterilization tray technology
Micro-Filtration
Sterilizing .2 micron pleated cartridge technology
Reverse osmosis ultra-filtration technology
In-line IV set filter/air vent technology
Over-molding gaskets onto multiple substrates for ease of filtration stack assembly
Respiratory Therapy
Adult/pediatric ventilator valve technology
Sleep apnea flapper valve production
Food Processing Equipment
Custom-designed & over-sized suction cups for frozen food handling
Food formation “booties” to shape food
Over-sized ice cube tray
Dental and Medical tools
Multiple styles and shapes of Dental and Surgical Instrument over-molded handles
Family of strain reliefs for fiber optic lights used in a surgical theater
Sterilization trays
Medical Case for electronic muscle stimulation device
Intravenous Therapy
Luer activated valve technology
pressure activated valve technology
Needle-less access valve technology
Injectable drug devices i.e. syringes, safety needles, insulin pumps, IV infusion pumps, etc.
Medical devices and Lab-ware
384 wells over-molded onto plastic for 384 gene sequencing application
1”x3” Glass slide cover, gasket over-molded to Ultem
Newman Sanitary gasket production
Consumer Kitchen and Bath Products
Evolved OEM two-component: over-molded drinking water faucet spray face design into a manufacturable production part
OEM multifunctional hot/cold drink cap
Personal Protective Equipment (PPE)
Face mask*
*Disclaimer: Our face mask and face shield products have not been tested per ASTM standards. They do not protect against COVID-19.
What Is Medical Device Manufacturing?
From a technical standpoint, a medical device can be any sort of equipment intended for the care and treatment of patients. Everything from surgical equipment to menstrual cups may qualify as such, though rules and regulations vary from country to country. A medical device may be:
Something used in medical treatment, prevention, or health maintenance
Something that can affect human anatomy
The U.S. government, specifically the FDA (Food and Drug Administration) requires the facilities that produce medical equipment to meet certain quality, consistency, and safety standards for the sake of the people who use these products. The FDA recognized three types of medical devices: Class I, II, and III.
Class I has the lowest risk of injury and is not designed to sustain human life, such as a bandage. These can be with or without exemptions.
Class II has more oversight. These have to meet certain performance standards, like a wheelchair or CPAP machine, but do not maintain human life either. These can be with or without exemptions.
Class III must be approved before reaching the market and have a higher chance of incurring injury with use. An example would be a pacemaker.
A legal and safe medical device manufacturer is ISO 13485 certified, meaning that they have exceeded certain standards.
what does iso 13485:2016 certification mean for a medical device manufacturer?
ISO, which stands for International Standards Organization, is a non-government organization responsible for certifying manufacturers based on the quality and consistency of their production processes. It is required to legally produce and sell medical equipment worldwide. To receive this high level of certification, a manufacturer must have a quality management system in place, as we do at Casco Bay Molding.
For many products, ISO 13485:2016 certification is a prerequisite or strong preference among customers.
7 Advantages of ISO:13485 Medical device manufacturing
The benefits of working with an ISO 13485:2016 certified manufacturer are manifold, whether or not your product qualifies as medical equipment. It ensures that our factory has been audited based on:
Quality management
Risk management in design and production
Working environment control and consistency
Material traceability
Product inspection
Proper documentation
A protocol for preventative and corrective actions
In other words, we are obsessed with safety and quality at every stage of the injection molding process — and no matter the product.
Our One Roof Approach
In addition to ISO13485:2016 certification, Casco Bay Molding also offers a unique "one roof" approach to manufacturing to healthcare and biomedical equipment production. In other words, we offer:
Medical product development
Precision machining
Turn-key system manufacturing
Product inspection
Fulfillment
Medical Device Manufacturer Traceability
In keeping with ISO 13485:2016 certification procedures, we produce material traceability certifications with every shipment as required. Normally, we supply a certificate of conformance and biocompatibility certificates received from one of our class VI – healthcare grade liquid silicone rubber suppliers. We are also happy to assist in implementing UDI (Unique Device Identification) numbers. According to federal regulations, UDIs — Unique Device Identification system — are required for Class I, II, and III medical devices.
The Casco Bay approach cuts down on lost time, expenses, and margin for error by putting all elements of the medical device manufacturing under one roof.
Quality Control Is Crucial for Medical Device manufacturers
Our array of healthcare and biomedical projects are injection molded in our clean molding area to customer specifications. Working with our customers to define the critical dimensions, our quality assurance technician visually inspects parts and uses custom jigs/fixtures, as well as our optical comparator, to generate inspection data. This data is entered into our quality software to document the part quality and molding process repeatability.
We are happy to work with our clients to develop quality control processes that meet their explicit specifications.
8 Ways that we add value as a medical device manufacturer
We work hard to be the most efficient medical supply manufacturer. The backbone of an injection molding manufacturing cell system is a quality injection process capable of running a stable molding process. Our tool-making partners, coupled with our injection molding know-how, guarantee a strong in-line manufacturing foundation from the start.
Beyond providing cost-effective solutions and our signature attention to quality, this means adding as much value as possible. Cell manufacturing, also known as in-line or turn-key system manufacturing, is the best way to reduce a product's cost for our customers.
Here are a few examples of how we can add value to the injection molding process:
Vapor deposition or sputtering (per compact disc manufacturing)
Ultrasonic welding of two plastic components together
Foil or filter insertion and assembly
Printing-decorating, including silicone ink onto silicone parts
Assembly, snap-fit, stiffening element addition or part connections
Loading an ingredient into an injection molded component
Die punching
Retail packaging assembly
We also work closely with our automation vendors, normally EAM or Province Automation on the downstream system. We would be pleased to develop a turn-key system for your specific product and look forward to learning about your requirements.
What Is a Medical Device?
What is a medical device? In short, it’s an implement that is used for medical purposes — and can range from hospital equipment to mechanisms aimed at helping sick patients to consumer products. In all cases, anything that is classified as a medical device is subject to country-specific regulations regarding production and quality control. In the United States, the FDA (Food and Drug Administration) is responsible for such regulations. More specifically, the FDA has three medical device classifications:
Class 1
Class 2
Class 3
Each class has its own regulations around production — with class III being the strictest. Casco Bay Molding may produce certain class I and class II medical devices because we are ISO 13485:2016 certified. This means that our production, documentation, and quality control procedures meet certain regulations put forth by the International Standards Organization (ISO).
Wondering, what is a medical device and how are they subdivided per U.S. regulations? Here’s what you need to know.
F.D.A. Medical Device Definition
A medical device can be anything from a bedpan to a pacemaker. Put simply, it’s anything used in the treatment of a patient, a healthcare setting, or touching/within the human body.
More technically, FDA (Food and Drug Administration) answers, what is a medical device, in Section 201(h) of the Food, Drug, and Cosmetic Act:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
a) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
b) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
c) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and
which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 520(o).
As you can imagine, this encompasses a lot of things we use every day. Did you know that wheelchairs and bandaids are technically class 1 medical devices? For a medical device manufacturer, this means that producing bandaids requires more oversight than manufacturing a toy, for example.
Setting the Standard for American Medical Device Manufacturing
Casco Bay Molding is a product design, tooling, production, and fulfillment team dedicated to bringing challenging medical equipment projects to life. Benefit from 20+ years of expertise in quality control, problem-solving, and injection molding when you work with us. We offer ISO 13485:2016 certification and full material traceability.
Disclaimer: This article was written for informational purposes only. It is not medical nor legal advice.