The considerations for medical device material selection run the gamut. Consider these two very different cases: a single-use disposable and an implantable medical device. In the first case, an important material property is cost-effectiveness. For the second case, biocompatibility and immune response characteristics are on the top of the material properties list. In this article we elaborate on five of the most important considerations for selecting medical device materials.
A material’s ability to comply with a product’s functional requirements is a primary consideration in any application. Functionality compliance includes basic material properties such as mechanical strength, stiffness, and wear and tear endurance.
Primary environmental condition considerations include humidity, temperature, and exposure to UV. But there are also secondary conditions that need to be taken into consideration. For example, medical devices that need to comply with certain cleanliness and sterility specifications, require materials that can offer very low surface roughness so as to avoid microbial retention.
A critical factor for successful material selection, is being cost efficient for the application. Naturally, the most cost effective choice is best, even though there are cases where this is not such a straightforward decision. For example, consider a part that can be manufactured through both injection molding and cnc machining. The latter is a slower and more expensive process per part. The former is a much more cost efficient choice, however it also requires more capital invested upfront. This makes it a better choice when the number of pieces produced are high enough to amortize the investment cost, and vice versa.
Compatible materials are ones that work well with each other. For example, when materials touch it’s important to ensure one material will not corrode or in any way alter the other’s integrity. This ranges from metal – alloy anti-corrosion interfaces, to simple applications where two moving parts that touch shouldn’t introduce unnecessary wear and tear.
Biocompatibility means the materials in contact with body tissue can hold up to the task, without triggering an immune response that will cause harm to the patient. This includes applications from disposable medical devices used in routine procedures, to making sure the body doesn’t reject surgically implantable medical devices.
Taking into account the shelf life of the medical device product is a critical factor in selecting the right material candidates for the job. For example, consider a small surgical aid component that is disposable and one that is reusable. The first one will only be used once over a period of a few minutes, while the second needs to be durable and withstand repeated cleaning and sterilization cycles. So it doesn’t take much to realize that for these two medical devices, although used for the same application, completely different material choices would be required due to a difference in their shelf life.
Depending on your medical device, the task of selecting the right materials can be as simple as it can be daunting. Moreover, your material selection directly ties in to major design choices that you will take, based on those material’s attributes.
Contact Quasar today to discover the best material options for your specific medical device.
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