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Is Additive Manufacturing Right For Your Business?

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Is Additive Manufacturing Right For Your Business?

The FDA regulates medical products, and this transparency in the regulatory pathway for additively manufactured devices is essential for public health. In 2010, the Center for Drug Evaluation and Research approved the first 3D-printed drug, which met existing manufacturing and chemistry standards. In 2011, the Center for Devices and Radiological Health cleared the first additively manufactured device. This clears the way for future innovations that will improve the quality of healthcare and patient care. In 2016, the FDA formally acknowledged the safety of additively manufactured devices.

The FDA classifies additively manufactured devices as Class II medical devices, based on risks to health and the level of control needed to achieve reasonable assurance of safety. In addition to reducing the number of potential hazards, this process also makes it possible to customize products and create better outcomes for patients. However, it does introduce additional challenges in terms of design, performance, and sterilization, but there is no need to fear that the device will not meet the highest standards of safety.

Despite the challenges, additively manufactured medical devices are still affordable. Cost-effective industrial-grade printers and common materials make AM accessible to a wide range of industries. As a result, many patients are now using these products. These innovations can make medical devices more affordable and increase patient safety. And if you’re wondering if additive manufacturing is right for your business, you’re not alone. This process is becoming increasingly popular, and it’s not just limited to the medical field.

Additive manufacturing is a viable technology for high-quality additively manufactured components. As a result, these devices can be used for a variety of different industries. Key applications for additive manufacturing include turbine blades, down-hole tool parts, fluid/water flow analysis, pressure gauge pieces, and pump manifolds. These technologies can also be applied to corrosion-resistant materials. These technologies are already paving the way for new types of applications.

Additive Manufacturing Advantages | 3D Printing Benefits | ATS

More applications

Other applications for additively manufactured products include customized medical parts, including dental implants. In addition to a wide range of applications, additive manufacturing is especially advantageous for the aerospace industry. Its capabilities allow it to produce complex geometries, which would otherwise be impossible in conventional manufacturing. The machine’s software can divide the 3D model into layers and transmit this data set as production instructions. In most cases, this process is a viable alternative to conventional manufacturing and is an excellent choice for small businesses.

Moreover, additively manufactured medical devices have undergone rigorous testing to ensure their safety. As of now, the FDA has classified additively manufactured devices as Class II medical devices. The regulations for additively manufactured devices are based on the level of risk to human health and the level of control necessary to ensure a reasonable level of safety. Further, the experts in the workshop agreed that adding features to a device would require several attempts before a successful product is achieved.

Despite the technical challenges of additive manufacturing, additively manufactured medical devices have met the criteria for a Class II medical device. Unlike traditional medical devices, additively manufactured medical devices can be made from a variety of materials. Including stainless steel, titanium, and plastics. Additionally, the FDA has approved an application for additively manufactured medical devices that can be used for implantables. Another potential application is the medical equipment industry. It is not uncommon for the technology to be incorporated into surgical procedures, but this is a relatively new technique.

Classification

To date, the FDA has classified additively manufactured devices as Class II medical devices. The classification process for these medical devices is based on the level of risk to humans and the amount of control necessary to provide a reasonable level of safety. In this case, a medical device that is made with an additively manufactured component. May have different physical properties than a conventional one. Besides, the FDA has not considered the benefits of using the additively manufactured product to make a difference to the health of humans.

In addition to the clinical benefits, additively manufactured medical devices are also highly effective in delivering precision and efficiency. Researchers in this field are increasingly evaluating the effects of 3D medical devices on patient health. To this end, they can help predict the consequences of an additively manufactured medical device. And because these technologies are highly advanced, the benefits are immense. And as a result, the FDA has stepped up its efforts to ensure that the technology is ready for widespread use.

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