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By i3dadmin

News: GE Opens $40 million Center For Additive Technology Advancement

GE Opens $40 million Center For Additive Technology Advancement

With all of the big names getting the attention in 3D printing, many are surprised to learn that GE (General Electric) is also a big player.  GE is pretty cautious when it comes to large investments in technology as they have seen trends come and go, however, their $40 million investment this past week in a facility for Additive Technology (3D printing) confirms that they see the writing on the wall: Additive Manufacturing is not a fad or trend, it’s here to stay.

One really exciting thing that will come to fruition is the fact that GE never opens a facility just for the sake of using a technology; they will advance it further and that’s really why this announcement is such a big deal.  GE opened the new center in Pittsburgh which was exciting to the city because it puts them on the map as a leader in 3D printing and the advancements that come from it.

“We’ve tapped into America’s best-kept secret,” says Jennifer Cipolla, who runs CATA, in regards to Pittsburgh, where Tesla and Google have also opened offices.

“We think Pittsburgh has the chance to be one of the four or five destinations for advanced manufacturing,” adds GE Chief Executive Officer Jeff Immelt.

The new facility is funded by each of the GE businesses, with the goal of integrating 3D printing for all. GE has historically been very involved with 3D printing to create fuel nozzles for jet engines.

 “Our mission is to ensure additive technology becomes a standard part of the tool kit for each business,” Cipolla says. “By having a shared facility, they can share the cost burden and we can advance the technology across the entire company much more rapidly than if they were to invest individually.”

The goal is to push the limits of additive manufacturing and stay at the forefront of innovation within the industry. The CATA industrialization lab is meant to promote this mission, allowing GE businesses to bring in their 3D printing concepts and optimize them, as well as working to bring them to fruition.

If there was any doubt about the future of additive manufacturing and DMLS, then this move by GE should cement the fact that it’s not only here to stay but it’s going to become the standard in metal printing.

By i3dadmin

FDA Releases New Guidance For 3D Printed Medical Devices

FDA Releases New Guidance For 3D Printed Medical Devices

Due to concerns over the various qualifications processes and impact of different materials, the FDA has been slow to approve the use of 3D printing when it comes to medical devices and drugs.  In order for the process to move quicker and more smoothly, the FDA has [finally] released a draft guidance for 3D printed medical devices.

Since technology typically moves a lot faster than most agencies can keep up with, this guidance comes at a time when then FDA has been been confronted with both the 3D printing of drugs and medical devices.

To date, there have only been 85 3D printed medical devices that have been approved by the FDA.   Back in March, a 3D printed tritanium PL posterior lumbar cage was approved. But so far few of them include high-risk devices that require premarket approval. The FDA feels that this group is more likely to benefit patients in the short term, so their new draft guidance is fully focused on these medical devices. Its goal? To provide developers with more insights into FDA thinking about the technical considerations and validation processes that 3D printed devices require.

The new FDA guidance is focused on two of the most important areas of development: design and manufacturing, and device testing.  The benefit here is that this new draft guidance provides insights into the most complicated parts of the approval process.

For 3D printers, this means they will need to “clearly identify each step in the printing process… from the initial device design to the post-processing of the final device.”  The developers and clients who might hire outsourced 3D printers also need to understand all upstream effects of the different manufacturing steps.

“For example, the ratio of recycled to virgin powder can affect melting properties, which affects the energy needed to create consistent bonding between layers, which in turn affects [a device’s] final mechanical properties,” they write in the draft.

This new FDA draft reiterates the fact that 3D metal printing holds numerous advantages for the development of medical devices.  The FDA writes this in their draft,

“[3D printing] has the advantage of facilitating the creation of anatomically-matched devices and surgical instrumentation by using a patient’s own medical imaging. Another advantage is the ease in fabricating complex geometric structures, allowing the creation of engineered porous structures, tortuous internal channels, and internal support structures that would not be easily possible using traditional (non-additive) manufacturing approaches…”

The full draft can be found here in our library.