Disposable medical device and medication delivery system products are critical sectors in the medical, pharmaceutical and health-care industries. Any medical device manufacturer knows that research and development (R&D) is not merely a preamble. It is actually the stage which accounts for whether a large number of products succeed or fail; neglecting to determine all the necessary requirements can lead to spiralling costs and unwanted setbacks that can make your competitors beat you to market.
In no area is this as pertinent as material selection. The Food and Drug Administration (FDA) requires a premarket submission 510(k) which makes it vitally important that you choose the right materials for your medical product. Foreign regulatory agencies have their own requirements for disposable medical devices. The number of considerations you have to make when selecting materials as a medical device manufacturer – from environmental exposure to functional, safety and mechanical aspects – means that it is important to go through the right processes, and employ the right partners.
When it comes to 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 have 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 is the sterilization method if applicable?
- Are there price restrictions and/or any other relevant characteristics (i.e. kink-resistance, bonding/assembly techniques, cosmetic appearance, etc.) required?
Other factors considered at the material selection stage may include other specific requirements, such as:
- In some applications, these compounds will need specific additives in order to ensure that their properties meet the requirements of the device (i.e. Gamma Radiation, E-beam or chemical sterilization resistance, shielding radio frequency or electromagnetic interference, etc.).
- If the product needs to be printed or have a label, select the appropriate materials early in the developmental process in order to avoid major difficulties further down the line.
- When selecting materials for disposable medical devices, biocompatibility is a non-negotiable requirement. In many cases, these devices will be tested for their biocompatibility in accordance with the USP, ISO 10993-1 standard or other foreign regulatory requirements.
- The aesthetics/appearance and user-friendliness of the medical device itself are also important considerations
- Grip and texture of the materials can be critical to their suitability.
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.
Mexichem Specialty Compounds (MSC) has a long, proven history as a dependable supplier of quality compounds designed for a variety of markets, including compounds designed for disposable medical devices. In addition to providing next-generation solutions based on market trends, as well as regulatory and environmental requirements, MSC modifies products to suit its customers’ needs precisely. When it comes to material selection for disposable medical device manufacturing, trust the team at MSC to guide you through the materials selection process.