A Guide To Prototyping Materials For Medical Devices

The medical device is a general term that includes an array of devices and devices, including Band-Aids, dental floss blood pressure cuffs, defibrillators MRI scanners, as well as many more.

It's no surprise that the design of medical devices is an important part of mechanical engineering, particularly for the U.S., which is an international leading field of medical devices R&D and consumer.

The process of development for medical devices is not like any other device. Design prototype, test, and then repeat. You can find more information about medical devices prototype online.

medical devices prototype

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However, the requirements for materials are more stringent. A lot of medical device prototypes require biocompatible and/or sterilizable material, because of the requirements for clinical trials and testing.

Biocompatible Materials

Plastics are regulated by the strictest classification can be USP Class VI. USP Class VI testing involves three in-vivo biological reaction testing on animals which include:

The Acute Toxicity of the System (Systemic Injection) Test: This test evaluates the effects of irritation when the substance is administered orally, injected into the skin, then inhaled.

Intracutaneous test: It evaluates the effect of irritation when the specimen comes into contact with subdermal tissue that is life.

Test for Implantation: This test evaluates the irritant effects of the intramuscular injection of the specimen into an animal test over five days.

3D printing produces practically unlimited geometries, which makes it ideal for the rapid creation of intricate designs. The 3D printing materials that Fictiv provides, VeroClear and Nylon are USP Class VI-certified. Particularly, VeroClear is used for rapid-turn orthopedic and dental surgical guides.