Medical Device Product Development

Looking for medical device product development and manufacturing in America? Casco Cup is owned and operated by Casco Bay Molding, a factory in Maine that offers medical device product development and ISO:13485 certified production services. We can assist you in developing your own cup design or private labeling one of our existing designs (as seen on this website).

Interested in medical device product development? We’d love to hear from you. Please bear in mind that we do not have the capacity to accept short volume orders (under 20,000 units) for product development. If you are looking to private label one of our designs, smaller volume is fine.

Why American Medical Device Product Development?

We feel strongly about designing and manufacturing products in America. That’s why Casco Bay Molding conducts all designing, tooling and manufacturing in Sanford, Maine. Here are a few reasons why international and domestic customers seek our medical device product development services:

  1. International Reputation: Though we are a small company in Maine, we export products to five continents. Our medical device product development services are sought from Aukland to Taipei to Lima, and we have the experience to prove it.
  2. Production Certifications: FDA medical device registration is necessary to sell menstrual cups in the United States. To do so, a manufacturing company must follow specific product design, documentation, and quality control protocols. In addition to abiding by FDA (Food and Drug Administration) regulations, we are also ISO:13485 certified, which is an international quality standard for medical device manufacturing especially.
  3. Experienced Female Product Designer: Our lead designer brings tremendous experience to the table, no matter the project. Our precision tooling and quality control teams are also highly experienced in medical device product development.
  4. I.P Protection: Protecting your intellectual property is much easier in the United States. As medical device product developers ourselves, we understand how valuable your I.P is and are happy to sign an NDA (you can find this on Casco Bay Molding’s website). Though you can request the same from overseas manufacturers, it is much harder to enforce internationally.
medical device product development

We Also Offer Medical Device Manufacturing

One of the main benefits of working with Casco Bay Molding is that all product development, tooling, and production is done under one roof in Sanford, Maine. Not only do our processes help protect your IP, but they reduce costs and lag time. From Day 1 of medical device product development, production and tooling teams are involved in the design process so that we avoid expensive hiccups later on.

Our 10 Step Medical Device Product Development Process

This process can seem confusing for newcomers. But don’t worry: We’ll be here to guide you through the various steps of design, tooling, production, and fulfillment.

Fill Out Our Form

In this form, please tell us if you are looking to develop your own cup or private label an existing design. Please note that developing your own cup means purchasing a steel tool, which can cost in the tens of thousands.

In the form, also include:

  • Expected annual volume
  • Dimensioned PDF (a drawing of your design with measurements) if you are looking to design your own product
  • Your contact information
  • Anything else you can tell us about your business.

Please be patient with us. We are experiencing a high volume of inquiries. We do our very best to respond to everyone in a timely manner, but we are a small team.

Our Team Reviews Your Information

UPDATE: If you are looking for medical device product development for a menstrual cup or other product, we are only considering high volume orders (orders over 20,000 units a year with growth potential).

A little about our business: Casco Bay Molding, at beast, breaks even on product development. We feel that small businesses and entrepreneurs are the backbone of the world economy, however, we simply cannot afford new projects with lower annual volume.

For menstrual cup companies, our solution to this is to offer private labeling services. For a much lower cost than full product design services, we can private label one of our existing designs for you. Our cup designs are lauded for their comfort and made from 100% medical grade silicone. We have five menstrual cup sizes that we can private label.

Once we have reviewed your information, a member of our sales staff will get in touch either with follow up questions or will connect you with a product designer.

medical device product development steel tool

Medical Device Product Development Brainstorming Begins

If you are designing a menstrual cup, this process is much simpler because we have so much experience in the feminine care industry. If you are designing a different device, we will have a discussion during which we talk about the product’s potential:

  • Uses
  • Environment/location
  • Size*
  • Application
  • Material
  • Regulations

We will recommend a material and process. Please keep in mind that we are an injection molding and over-molding company; we do not do compression molding.

*Making massive silicone products is often not in your best interest as medical-grade silicone is expensive.

We Review Target Pricing and Volume

Before we head to the drawing board, we will discuss your annual expected part volume and your target price per part. Keep in mind that the target price per part affects how we proceed: the two main costs associated with medical device manufacturing are material cost and machine time.

For example, a mold with 6 cavities will produce more parts per second than a mold with 4 cavities, however, it is more expensive. In general, the larger the part, the more expensive it is because it requires more material. Additionally, the complexity of a design can affect the price.

Medical Device Product Development Begins

In most cases, the customer comes to us with sketches — though the more information the better. We request that customers send us a dimensioned PDF when they submit a quote (an image with approximate measurements) so we can get a sense of size/main complications etc.

No matter what you start with, during this phase, we discuss your medical device’s critical areas, materials, function, and potential issues that we’ll encounter during production.

Examples of the sorts of questions we’ll cover include:

  1. Where will the injection point/gate be? This is where the material goes into the mold.
  2. How will the part be extracted from the machine?
  3. Where will the parting line occur?

By answering these questions at the start, we save you time and expense.

Based on these initial medical device product development conversations, we are able to create concept designs to help you visualize what your final product. At this point, we’ll ask for feedback — especially on the look/feel, dimensions and overall size.

medical device manufacturing

You Receive the First Medical Device Product Development and Production Quote

in this initial quote, you’ll receive an estimate of how much mold cavitation and production will cost. These depend on machine cycle time, part weight, and complexity, along with other factors that we can go over.

Once you approve the quote, we can proceed with a technical part drawing.

Creation of Medical Device Control Drawing 

Now, we create another drawing called a “control drawing.” Essentially, it’s a 3D or 2D drawing of your part to scale. Why do we create a control drawing? Our precision molders require one in order to design your steel tool, otherwise called a mold.

Before we create a CAD or SolidWords file, we’ll again ask for feedback. This is a 3D drawing that allows us to print your part using a 3D printer. This step also allows us to give you an official part and mold quote.

Using 3D Prototypes in Medical Device Product Development 

In many cases, our customers decide to create a 3D part. Note that this part will not be made out of silicone, like the final product. We do use material that mimics it, though it will not have the same quality or functionality.

In many cases, our customers want to hold a 3D version of the part before continuing. If you decide to proceed, you will issue a purchase order and submit a mold down payment.

Mold Review: The Next Step in Medical Device Product Development

Once we’ve received approval and a P.O., we have an internal meeting which we call the “mold design review.” During this meeting, our designers, toolmakers and production teams review how best to make your steel tool. This includes designing gating, cavitization, and venting, as well as making a final material selection and conducting mold flow and shrinkage calculations.

After this meeting, we will submit a mold design to you and agree on delivery times. We also proactively address issues that we could encounter later on through our tool design.

How long does it take to design a mold? This depends on a variety of factors, including mold complexity and how busy our tool shop is. We also quote times based on completion of a part drawing, a down payment on the mold, a successful review of mold and part designs, purchase order, and your approval. We cannot proceed with medical device product development without these critical steps.

Final Mold Testing and Medical Product Design Approval

There are two things that happen next:

  1. We conduct internal mold testing, which we call a core and cavity test. We will ship you parts at this stage — just in case it requires adjustments, which is common. We can repeat this process, too.
  2. We receive final approval from our customer and begin production.

Interested in Medical Device Product Development?

Whether or not you choose Casco Bay Molding as your manufacturer, we wish you the best of luck with your project. We have deep respect for entrepreneurs and innovators across all industries.