Unleashing the Potential of 3D-Printed Battery Technology With Arwed Niestroj of Sakuu – Battery + Storage Podcast
Key Considerations for Reshoring U.S. Drug Manufacturing
The medical device industry and the Food and Drug Administration (FDA) have been experimenting with three-dimensional (3D) printing for years. Shortages of medical devices such as personal protective equipment (PPE) and...more
Recently, my colleagues Colin Kelly, Caroline Gieser, Michael Polatsek, and I thought about the role that additive manufacturing (3D-printing) is playing in today’s brave new world....more
As the spread of COVID-19 accelerates across the globe, everyone wants to find a way to tackle the pandemic, from Governments asking manufacturers to urgently make vital equipment to inventors creating innovative solutions. ...more
In December, the U.S. Food and Drug Administration (FDA) issued guidance on Technical Considerations for Additive Manufactured Medical Devices. The guidance represents FDA’s efforts to provide regulatory direction about...more
On December 5, 2017, the U.S. Food and Drug Administration (FDA or the Agency) finalized its “leapfrog guidance” entitled, “Technical Considerations for Additive Manufactured Devices”. ...more
The U.S. Food and Drug Administration released finalized guidance regarding 3D printing in medical devices. The guidance document, which issued on December 5, 2017, is based on the FDA’s review of more than 100 devices...more
3D printing offers great promise for innovation and manufacturing, but this tool has expanded the scope of patented products that can be easily and cheaply copied, and may make it harder to identify and prosecute infringers....more
A few years ago, a custom-fabricated bioresorbable tracheal splint saved the life of an infant suffering from a collapsed bronchus due to severe tracheobronchomalacia. The splint was implanted around the baby’s airway,...more
3D printer shipments in U.S. jump 20% in 2015: IDC - International Data Corp (IDC) research found 3D printer shipments in the U.S. grew by almost 20% in 2015 compared to 2014. Looking ahead, 3D printer shipments in the...more
On May 10, 2016, the FDA issued a document entitled Technical Considerations for Additive Manufacturing Devices. The document consists of 25 pages of “draft” guidelines that provide the FDA’s “initial thinking on...more
3D printing raises significant technical considerations for device manufacturers. In response to the increasing use of 3D printing in the medical device arena, on May 10, the US Food and Drug Administration (FDA or...more
On May 10, 2016, FDA released a much-anticipated draft guidance (the “Guidance”) concerning medical devices that incorporate additive manufacturing (AM) technologies, a category which includes 3D printed devices. AM...more
Several hundred business leaders, engineers, attorneys and academics gathered last week for an annual symposium on 3D Printing hosted by Benesch, Friedlander, Coplan & Aronoff. The ability to form physical objects from...more
Intellectual property (IP) law is undergoing a major transformation just as additive manufacturing? or 3D printing? has begun to revolutionize the manufacturing industry. The interplay between these two forces could end up...more