What is OEM? A Guide for Portable Medical Device Manufacturers

OEM stands for Original Equipment Manufacturer. OEMs are companies that produce components or products that are used in another company’s end products. Within the portable medical device manufacturer community, it’s common to need the expertise of an OEM who focuses on building best-in-class regulatory-compliant medical device carrying cases.

If you’re a product engineer or perhaps a member of the sourcing team in the portable medical device and medical equipment manufacturing community, you understand that carrying cases are an essential component of your original product. However, choosing the right OEM partner for medical devices and medical equipment carrying cases can be a daunting task. There are many factors to consider, ranging from material selection to compliance with regulatory guidelines. In this post, we’ll answer some of the most frequently asked questions about OEM for medical device carrying cases and provide you with the information you need to make an informed decision.

1. What materials do OEMs typically use for medical device carrying cases?

Portable medical device carrying cases can be made from a variety of materials including plastic, metal, and fabric. The material you choose will depend on the specific needs of your product. For example, if you need a case that can withstand repeated heavy cleaning, you may want to consider a case made of coated or wipeable materials. Or, you could consider a fabric case if you need something more lightweight and easy to carry. Working with an OEM gives you the flexibility to choose from a range of materials. (Learn more about Shell-Case’s material options here).

2. What regulatory guidelines do OEMs for medical device carrying cases have to comply with?

Your Portable medical device carrying case may need to comply with a variety of regulatory guidelines, including ISO 13485, ISO 9001, and biocompatibility driven from ISO 10993-5 and ISO10933-10 (click here to view Shell-Case’s standards and certifications). Also, Original Equipment Manufacturers must ensure that their cases are designed and manufactured to meet the industry standards relevant to their device. As such, OEMs must have a thorough understanding of the device being carried and the conditions under which it will be transported. Further, your device might need to comply with local regulations, for example, REACH, RoHS, and CAL PROP 65.

3. What customization options are available for OEM for portable medical device carrying cases?

You can do some high-level customization with your portable medical device carrying case. You can add design customizations, such as size, shape, and interior organizing, and branding options, such as logos and colors. All these customizations can help to improve your company’s visibility and business branding. Finally, you can add customization options to the inner organization, and additions to improve ease of use. You might consider, for example, ergonomic handles, access and visual openings, locking mechanisms, and the addition of casters.

In case design customization, consider the capabilities of your OEM carrying case manufacturer, your options are limited by what they offer. At Shell-Case we offer advanced textile and sewing technology, thermoforming of multi-layered materials, over-molding, high-frequency welding, and plastic injection. These customization capacities allow you to think creatively about the way your carrying case can reinforce the functionality of your custom medical device, for example, a custom carrying case can be built to include an indication window that allows monitoring while the device case is closed. Dream big, and always consider your vision for your carrying case when you’re imagining your finished medical device product.

4. What can I expect from the OEM process for my medical device’s carrying case?

After meeting to discuss your vision, our team creates a concept design presentation to suit your specifications. Once you approve the design we will build you a prototype and define an end-to-end breakdown of every single specification, material, and all product-related documentation. Simultaneously, our engineers will prepare the components and equipment for the original design manufacturing process — and then move forward with production. At Shell-Case, we do most of our manufacturing using multiple technologies, often in combination, in the technical textile, plastic, and metal parts fields.

5. What is the overall production time for OEM for medical device carrying cases?

Lead times for OEM for medical device carrying cases can vary depending on the complexity of the product and the production capacity of the OEM. Most OEMs will provide you with a lead time estimate when you request a quote. It’s important to plan ahead and to provide ample time for the OEM to design, manufacture, and ship your finished product.

6. How can I ensure that the OEM for medical device carrying cases I choose is reliable?

Choosing a reliable OEM for medical device carrying cases is essential to ensuring the safe transport of your medical device. When choosing an OEM, be sure to do your research. Look for companies that have experience in the medical device industry, experience creating best-in-class custom solutions, and have a proven track record of producing high-quality products. Additionally, be sure to ask for references and check online reviews.

Choosing the right OEM for medical device carrying case production is essential to ensuring your custom equipment’s safety and longevity. It’s also essential in keeping your project within the expected timeframe and budget. You’ll be better equipped to make an informed decision if you understand the answers to these frequently asked questions. Remember to consider the material selection, regulatory guidelines, customization options, lead times, and the reliability of the OEM.

With the right OEM, your vision will come to life and your product will go the distance. As a custom case company, we understand your vision, your industry, and your concerns — reach out to Shell-Case to work with us, and to learn how to receive your own custom 3D product demo today.