Although the economic benefits of 3D printing to consumers and businesses are obvious and profound, they also have a negative side.

As a company that invents and manufactures 3D printers and materials, EnvisionTEC has a history of 15 years and has a leading position in the 3D printing industry. In the face of the future development prospects of the 3D printing industry, the company is very optimistic, especially in medical applications. Today, EnvisionTEC president AI Siblani shared his views on the role of 3D printing in healthcare.

Although the economic benefits of 3D printing to consumers and businesses are obvious and profound, they also have a negative side.

Unfortunately, manufacturers themselves are experiencing a great deal of this interference. Increasingly, they have found that 3D printers can be closer to the end user, and in many cases, users can completely manufacture certain items from the actual manufacturing facilities.

For example, the dental industry. Dentists and orthodontists are purchasing 3D printers to create items that are manufactured almost entirely by dental laboratories and manufacturers. Today, these doctors can print a custom device in 3D. For example, there is no occlusion splint or recovery device that any laboratory or manufacturer participates in making.

Although some of these companies are finding ways to bring about these changes, many companies will still experience a painful period through their new approach to 3D printing services. They must face lower service needs or re-create business models.

At the same time, this shift to more local manufacturing has also caused serious safety problems. For example, if a formal 3D printer office is now facing the same regulatory review as a lab or manufacturer, to protect patient and component print quality. Does all 3D printers really provide the same level of quality as the manufacturer?

"These are serious problems, and their answers may directly affect the safety of patients. For example, at EnvisionTEC, we usually inform 3D printers to clinicians that these printers are unable to provide the accuracy they promised. This applies to certain applications. Say it is necessary. Sometimes, they actively promote the printing parts of materials that have not been approved for long-term use in the mouth," said AI Siblani.

In May 2016, the FDA issued the “3D Printing Technology Notes” to solicit opinions on these types of issues. In August, AdvaMed of the Medical Device Manufacturers Association wrote: “The nursing organizations that install 3D printers and use these 3D printers to regularly produce equipment must meet relevant FDA requirements, including premarketing review, and postmarketing supervision, such as establishing and maintaining Quality system and adverse events report."

Johnson & Johnson stressed that "Installing 3D printers and using 3D printing technology to manufacture parts in hospitals, doctors' offices, laboratories and similar places exceeds the exemption limits of licensed practitioners, including doctors, dentists, and optometrists."

Although we recognize that medical device manufacturers want to protect patients and also provide manufacturing directly from clinical services, EnvisionTEC does not want to see progress stagnant. We believe that AdvaMed's recommendations put too much burden on clinicians and impair the time and cost of 3D printers for clinicians and patients.

In other words, we do realize that the 3D printer market for clinicians has become a bit like "Wild West." Therefore, EnvisionTEC welcomes the direct supervision of 3D printers and materials to protect consumers and clinicians, and to provide clinically demanding products.

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