EnvisionTEC: 3D printers manufacturing medical components should be regulated

As a company that invents and manufactures 3D printers and materials, EnvisionTEC has a 15 year history and is a leader in the 3D printing industry. In the face of future developments in 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 medical care.

EnvisionTEC:制造医疗部件的3D打印商应受到监管

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

Unfortunately, the manufacturer itself is experiencing a lot of this interference. They are increasingly finding that 3D printers can be closer to the end user, and in many cases, users can completely manufacture certain items from actual manufacturing facilities.

For example, the dental industry. Dentists and orthodontists are buying 3D printers to make items made almost entirely by dental laboratories and manufacturers. Today, these doctors can print a custom device in 3D. For example, there is no lab or manufacturer involved in making a bite splint or recovery device.

While some of these companies are looking for ways to bring 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 security problems. For example, if a formal 3D printer office now faces the same regulatory review as a lab or manufacturer to protect patient and component print quality. Can 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 notify 3D printers to clinicians that these printers are unable to provide the accuracy they promise, which is for some applications. It is necessary. Sometimes, they actively promote print parts of materials that have not been approved for long-term use in the mouth," AI Siblani said.

In May 2016, the FDA issued “Notes on 3D Printing Technology” to solicit opinions on these types of issues. In August, AdvaMed of the Medical Device Manufacturers Association wrote: “The care facilities that install 3D printers and use these 3D printers to produce equipment on a regular basis must comply with relevant FDA requirements, including pre-market review, and post-market surveillance, such as establishment and maintenance. Quality system and adverse event reporting."

Johnson & Johnson emphasizes that “the installation of 3D printers and the use of 3D printing technology to manufacture parts in hospitals, doctors' offices, laboratories, and the like exceeds the exemption limits of licensed practitioners, including doctors, dentists, and optometrists.”

While 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 place too much burden on clinicians and compromise the time and cost that 3D printers provide to clinicians and patients.

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

(Editor)

PU Chaise Lounges

  • This PU chaise lounge features comfortable and extraordinary sturdy with 19.5" high backrest and 46" large cushioned recliner bed which can bear up to 500 lbs, provides comfy sit on for extended periods
  • Side curved rolled tufted armrest meets contemporary clean lines, streamlined design, and modern comfort, perfect for placing your book/magazine / Laptop when you lie - down
  • The cover material is PU which is soft and with good toughness, and PU is easy to clean and anti water, PU is also eco-environmental.

PU Chaise Lounges,PU Royal Chaise Lounge,PU Chaise Lounge Chairs,PU Chaise Lounge Sofa

Kaifeng Lanwei Smart Home Co., Ltd , https://www.sofawickles.com

Posted on