6 Things You Didn’t Know About How Medical Devices Were Made

June 21, 2019

Medical devices are subject to regulations by the Food and Drug Administration (FDA) and include products that serve therapeutic purposes for patients as well as devices that assist doctors in diagnosing and treating various illnesses. The design and manufacturing processes for medical devices are quite complicated. Check out these interesting facts you might not have known about how medical devices are made.

1. Did you know that the U.S. represents the largest market share for medical device manufacturing and sales in the world? It makes up about 40 percent of global sales of medical devices on average.

2. Some medical products are a combination of medical devices and drugs to treat or diagnose a particular illness. They have their own special category of regulation by the FDA and are increasing in popularity for their versatility.

3. While some companies specialize in the design, conceptualization and making of prototypes for a new medical device, they may contract with other companies that specifically fabricate and make the devices. The medical device manufacturing companies also handle the packaging and labeling of these medical devices to prepare for their ultimate dissemination to the public or health care providers.

4. 3D printing is revolutionizing the process of medical device manufacturing because it allows engineers to make necessary improvements to the design without slowing down the manufacturing process. It provides for quicker access to prototypes of new medical devices and cuts down on costs in the manufacturing and packaging processes for medical devices.

5. Responsible companies involved in the manufacturing of medical devices strive to reduce the amount of waste involved in the fabrication and manufacturing processes. This includes using sources of green energy and reducing the unnecessary steps in the manufacturing process that do not add value to the quality of the final result. While efficiency and urgency are important considerations, responsible medical device manufacturers prioritize maintaining high quality standards and abiding by environmental good practices as well.

6. It can take years before a newly designed medical device makes it to the manufacturing process. In addition to all of the internal testing that it is subjected to, FDA review and approval can be extremely time-consuming. This ensures that the medical device is safe for public use and free of serious risks.

In conclusion, medical devices play a critical role in the health care field and are the subject of constant innovation and improvement. You may find that you rely on a medical device to help treat a condition that you are suffering from or as a diagnostic test to determine your course of medical care. The process of making and marketing medical devices is very involved and requires many engineers and doctors to work together.

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