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Choosing the right material for disposable medical devices

Alphagary, an Orbia business

Disposable medical devices and medication delivery systems play a crucial role in the medical, pharmaceutical, and healthcare industries. For any medical device manufacturer, research and development (R&D) is far from just a preliminary step—it’s the defining phase that determines whether a product will succeed or fail. Failing to identify all necessary requirements during R&D can lead to escalating costs and delays, giving competitors the opportunity to beat you to market.


One of the most critical aspects of designing a medical device is material selection. The FDA mandates a premarket submission 510(k), making it essential to choose the right materials for your medical device. Similarly, foreign regulatory bodies have their own specific requirements for disposable medical products. With numerous factors to consider—ranging from environmental exposure to functional, safety, and mechanical performance—it’s vital to follow the proper processes and collaborate with the right partners to ensure compliance and product success.


Medical device engineers designing a new disposable medical device
Material engineers working on a new medical device

When it comes to choosing the most suitable compound for your disposable medical device, there is a wide range of important questions to ask and answer during the R&D process:


  • What is the application or end-use?


  • What is the manufacturing process (extrusion, injection molding or thermoforming)?


  • Does the medical device material need to be compatible with blood, solution drugs or anticoagulants?


  • What are the most important properties (i.e. durometer, clarity, physical, “bovine-free”, chemical resistance, UV stability, high or low temperature resistance, etc.)?


  • Are there any plasticizer restrictions or regulatory requirements (i.e. USP Class VI, FDA, EU MDR, REACH, RoHS, Prop 65, etc.)?


  • What sterilization method (gamma, autoclave, etc.) will be used?


  • Are any other factors relevant? (i.e. kink-resistance, bonding/assembly techniques, cosmetic appearance, price restrictions, etc.)



Medical device aesthetics and user-friendliness are key considerations, ensuring it meets both functional and ergonomic needs.
Grip and texture of the medical device are essential for usability


Additional factors to consider during the material selection process include specific requirements tailored to the intended application.


  • In some cases, certain compounds may need specific additives to ensure their properties align with the device’s requirements—this could include resistance to a specific amount of gamma or e-beam radiation or suitability for chemical sterilization, shielding from radio frequency or electromagnetic interference, and more.


  • If the device requires printing or labeling, it's crucial to choose the right materials early in development to avoid complications later in the process.


  • Biocompatibility is a non-negotiable requirement for disposable medical devices. Many devices must undergo biocompatibility testing according to standards like USP, ISO 10993-1, or other relevant regulatory guidelines.


  • The device's aesthetics and user-friendliness are also key considerations, ensuring it meets both functional and ergonomic needs.


  • The grip and texture of the materials are essential for usability, particularly for healthcare professionals who will handle the device regularly.


By addressing these factors early in the development process, manufacturers can ensure their products meet the necessary standards while reducing the risk of costly setbacks.

With so many considerations in the materials selection process, it is imperative to choose a compound manufacturer that understands not only the specific characteristics of every material, but also has a working knowledge of the materials selection process from the perspective of the medical device manufacturer.



Alphagary has been formulating and manufacturing compounds for disposable medical devices since the 1960s.  In addition to providing PVC, TPE, TPU and other next-generation solutions, we offer hands-on regulatory support that is so critical for our customers from the beginning of a project (choosing the right material) through to providing transparent regulatory information for FDA submission.  Contact Us for more information.

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