Why AM Certifications are so difficult (Authentise Weekly News-In-Review – Week 97)

For AM to take a greater hold on the industries it’s poised to impact, there are certain angles to smooth out and one of those is certifications. Early adopters of additive production such as aerospace and medical are rightly picky about its certifications and the AM community is making sure to have its own record straight. Safety certifications are the highest priority in this regard and Lockheed Martin’s facility in Sunnyvale, California now holds the first UL certified in the world. Govt. bodies are also moving to help a wider audience to stay within standards, like Health Canada’s newest draft guidance on AM medical devices. However, the main reason why certifications are difficult is that AM is still not an exact science. With fast and multi-spectrum monitoring technologies, we are starting to see what happens during the process. However, certain aspects of the physics behind it are full of variables we don’t understand.

Lockheed Martin extends additive manufacturing to key spacecraft components

Lockheed Martin’s Additive Design and Manufacturing Center in Sunnyvale, California, where the company produces military, commercial and civil space technology, attained a comprehensive safety certification.

“We are the first UL certified additive manufacturing facility in the world,” Servando Cuellar, Lockheed Martin Space Systems engineering senior manager, told SpaceNews.

Read more here.

Health Canada Drafts Policies on 3D-Printed Implantable Devices

Health Canada Drafts Policies on 3D-Printed Implantable Devices

 

 

 

 

Health Canada released draft guidance Thursday to aid manufacturers in preparing license applications for implantable medical devices produced by additive manufacturing or 3D-printing. The guidance “represents the first phase of 3D-printing policy in Canada” because Health Canada intends to continuously adapt its policies to emerging issues on the topic “due to the fast-changing technological environment,” the regulator said.

Read the full article here.

High-Speed Cameras Used to Monitor 3D Printing Process

3D printing, particularly laser-powder bed fusion or L-PBF, requires a great deal of monitoring to avoid defects and flaws in the final parts. In a thesis entitled “Process Monitoring for Temporal-Spatial Modeling of Laser Powder Bed Fusion,” a student named Animek Shaurya studies the use of high-speed video cameras for in-situ monitoring of the 3D printing process of nickel alloy 625 to detect meltpool, splatter, and over melting regions to improve the quality of the print.

Read more here.

We’ll be at Formnext in Frankfurt from the 13th to 16th November. Come see us at booth #B30J.

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Integrating the Future & the Present (Authentise Weekly 3D News Review – Week 51)

Hi all, welcome to another (festive!) edition of the weekly review by Authentise!

We hope you had a merry Christmas time! As we go back to our usual day-to-day, we gathered last week’s juiciest 3D news. Many companies are tackling the issues of integrating their work on new tech into present standards and workflows. Sounds like Organovo’s work on pre-clinical bioprinting is finally getting there, Oas are standards for AM enabled medical. Other times industrialization doesnt need to be so complicated: IIoT allows smaller, incremental steps to be taken to integrate new tech and practices to benefit businesses.

Let’s dig in.

Organovo 3D bioprinted liver tissue could make it to the FDA by 2019

Organovo demonstrate toxicity testing with ExVive liver product. Image via Organovo

Speculation on 3D printed tissue coming to humans sooner than we think is backed by new pre-clinical findings from 3D bioprinting company Organovo. Though it will still be 3–5 years before the U.S. based Organovo apply for clearance of their liver tissue, that is still sooner than perhaps even the FDA had in mind. Pre-clinical trial data shows that 3D bioprinted liver tissue has been successfully planted into lab-bred mice. The human liver-cell tissue shows regular functionality and, at this stage, is being explored as a suitable patch for the organ.

Read more at 3D Printing Industry.

3D Printing Production Medical Devices — Pitfalls And Best Practices

In May 2016, the FDA released a draft guidance titled Technical Considerations for Additive Manufactured Devices. Any manufacturer or organization considering 3D-printed components during the development of a medical device should refer to this document. The guidance goes into detail regarding risk and other considerations related to 3D printing, as well as how to employ 3D printing within device development.

Read the article here and the FDA guidance here.

Use Existing Data to Optimize IIoT Sensor Deployment

It is hard to know where to start [in IIoT], and whether the solution being designed will be palatable to the end customer in terms of function and price. Rather than ordering highly marketed solutions from outside the enterprise and “tipping” consultants with exorbitant fees, they can find ingredients that are already on hand, apply basic analytics, and come up with some surprisingly tasty ways to translate raw data into process information to improve maintenance or business decisions.

Read about the useful, and easy, ways IIoT can easily be integrated in your business here.

 

We hope to see you next week for another edition brought to you by Authentise!