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3D Printed Medical Devices

By i3d

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  In order for the process to move quicker and more smoothly, the FDA has [finally] released a draft guidance for 3D printed medical devices.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 The FDA feels that this group is more likely to benefit patients in the short term, so their new draft guidance is fully focused on these medical devices.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  The benefit here is that this new draft guidance provides insights into the most complicated parts of the approval process.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.

By Erin Stone

3D Printing Takes the Cost of Complexity to Zero

3D Printing Takes the Cost of Complexity to Zero

Whats is the definition of “game changer” for metals manufacturing? Direct Metal Laser Sintering (DMLS), a 3D printing process that eliminates binding agents and uses 400-1000 W lasers to melt micro powders together, layer by layer until a 3D CAD model of a part is built, is one of the 3D manufacturing processes that are the the epitome of “game changer” according to Hod Lipson or Cornell University.   Read more

By Erin Stone

Just How Small Can DMLS Print?

Just How Small Can DMLS Print?

3D metal printing is in its element when it comes to production parts at micro scales. While machine development is focusing on creating DMLS paltforms that can print parts over 14″, Direct Metal Laser Sintering (DMLS), current DMLS capabilities are perfect for small, complex parts. 3D printing enables i3D MFG™ to deliver integral tiny, complex parts in Aluminum, Titanium, Maraging Steel, Stainless Steel and Inconel to Aerospace, Prosthetics, Medical Devise, UAV/UAS, Rocket/Spacecraft, Oil & Gas, Firearms, and Recreational Gear industries. For the part shown, a .015″ (15 thousandths of an inch) high latticed geometry was grown in Maraging (tool) steel. Machining the tiny part out of such a tough metal was expensive and problematic. Since DMLS build parts from mirco powder layers, laser melted together one micro layer at a time, 3D printing precise micro geometries is not much more difficult than printing large bulky parts – in fact, the larger the mass on a DMLS machine, the greater the risk of delamination and failed builds.

DMLS Micro Parts in Production Quantities

Currently, DMLS can accurately and repeatably manufacture parts as small as .030″ in Aluminum and Inconel and .015″ in Stainless Steel, Maraging Steel and Titanium. Additionally, complex assemblies of small to medium-sized  parts can be printed as a single part, eliminating weld lines, gaskets and fasteners. With micro parts, this can be a huge savings in precision assembly labor. Combine that  with a cost effective means of manufacturing small, complex parts in ferrous and non-ferrous metals ranging from Aluminum that does not register on the HRC scale to Maraging Steel that can be heat treated to 54 HRC, and the design innovations are astounding. Exotic metals also become affordable because DMLS does not produce the 30-70% scrap that traditional machining operations might. Contact i3D™ to learn more about our DMLS, Wire EDM, 3D Scanning and Design-for-3D serv

By Erin Stone

Direct Metal Laser Sintering offers Optimal Medical Implant Synergy

Direct Metal Laser Sintering offers Optimal Medical Implant Synergy

Spinal implants manufactured using 3D metal printing, or Direct Metal Laser Sintering (DMLS), have been the standard OEM sample to highlight complex latticed geometries. The question being, have any of those cool looking implants been used in the real world? Great new for all DMLS users and manufacturers – 4WEB Medical announced this week that 3,000 of their DMLS spinal implants have been successfully used by surgeons. Even better, the relatively rough surface finish associated with 3D printed metal parts creates an even better patient outcome. According to 4WEB, ” The truss implant designs have a distinctive open architecture, which allows for up to 75% of the implant to be filled with graft material to maximize bone incorporation.The 4WEB Medical ALIF device has a bi-convex surface that brings the implant and graft material closer to adjacent bone across the entire end plate rather than just around the outside edge. This in addition to a unique implant surface texture dramatically improves initial fixation and reduces the chance of migration.”

As a DMLS manufacturer, i3D MFG™ works closely with its clients on surface finish requirements, a commonly misunderstood piece of 3D metal printing. 3D metal parts are nearly 100% dense, allowing for any post process associated with machined or cast parts; however, clients often expect parts to come straight off the DMLS machine with near mirror polish. The reality is that the initial surface finish for a DMLS part before post process ranges form 125-300 Ra depending on the metal. 4WEB’s spinal implant leaves the rough surface which enhances the effectiveness of the implant. This is a huge shift in how we think about design, incorporating roughness as an innovative tool. Not all applications will achieve this type of synergy between the raw DMLS part and function, but as we shift towards design-for-3D, it’s worth taking note of the match between DMLS and medical implant advancements.

Image from: 4webmedical.com

i3DMFG Metals For Additive Manufacturing

By i3d

Oregon Welcomes i3D MFG™ 3D Metal Printing

Oregon Welcomes i3D MFG™ 3D Metal Printing

Why would a new small business opening in The Dalles, Oregon be newsworthy to Aerospace Manufacturing and Design Magazine? Aerospace is big in the Pacific Northwest and the UAV/UAS giant Insitu is located 20 minutes from i3D™ Manufacturing’s Direct Metal Laser Sintering (DMLS) factory. 3D metal printing has emerged as a critical component in aerospace, rocket, and UAV design and manufacturing, but until 2014, there were no Northwest DMLS service providers. Insitu, Boeing, and the like were forced to use services thousands of miles  away, reducing some of the lead time and cost advantages 3D printing is known for. Oregon is defined by innovation and i3D™’s 3D printing technology is at the forefront of advanced and additive manufacturing. DMLS moves 3D printing from the prototyping realm into true production parts manufacturing. DMLS parts are used in final assemblies by Boeing, Lockheed Martin, GE, etc. In addition to aerospace, i3D™ also provides parts for medical and dental device applications, firearms accessory manufacturers, the energy and recreational gear industries, and automotive parts users.

The Future of Manufacturing

In 2013, manufacturing accounted for 28% of Oregon’s economy, over $65 billion in output. So, its not surprising that the Portland Tribune and Portland Business Journal also featured i3D™ in their Summer 2014 publications. As opposed to traditional, or subtractive manufacturing where parts are carved out of billet, the additive manufacturing process starts with 20-40 micron layers of powdered metal and uses a laser to melt thousands of micro layers together, one layer at a time based on a 3D CAD model – adding material only where the model dictates.  The no-waste process enables parts to be built that cannot be traditionally manufactured, including complex geometries, lattice and honeycomb structures, conformal channels, and single part builds of multi-part assemblies. i3D™ prints stock metals including Titanium, Aluminum, Inconel, 15-5 and 17-4 Stainless Steel, and Maraging Tool Steel as well as custom powders created for specific customer applications. The Dalles has a long history of metal manufacturing and gave i3D™ a warm welcome to its community and the Columbia River Gorge region. Both The Dalles Chronicle and Gorge Technology Alliance celebrated i3D™’s headquarters locating in Oregon. 

DMLS Stands Out as 2015 Focal 3D Printing Technology
3D Printing Takes the Cost of Complexity to Zero
Just How Small Can DMLS Print?
Direct Metal Laser Sintering offers Optimal Medical Implant Synergy
i3DMFG Metals For Additive Manufacturing
Oregon Welcomes i3D MFG™ 3D Metal Printing