R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

The Med Device Industry (and the FDA) Embrace 3D Printing Innovation

Just this week the world's first 3D-printed office opened in Dubai. It took all of 17 days to print a 2,700-square-foot building at half the price of conventional methods. In short, this 3D printing thing has some legs... and we mean that literally, too.

3D printing is definitely a hot topic across the medical device industry. This ground-breaking technology that began in the 80s has advanced into a valuable tool for manufacturers, and even earned itself draft guidance from the FDA earlier this month.

Medical “Wow”: 3D Printed Skull

Last week I saw several articles published about a new device that is going to shake up the Craniomaxillofacial device market, and the Orthopedic market is next on the list. 3D Printing – chances are you’ve just started hearing about it, mostly concerning gun controls laws for assault rifle cartridges. The other week in Milan the first 3D Printed dress was worn by a model on the fashion runway. 3D printing has the capabilities to change hundreds of industries in my opinion – it’s cheap, relatively easy, and I believe it will be the next revolution in manufacturing.
So let’s talk about how the big “wow” in medical devices that occurred last week. Last month the FDA cleared the 510(k) for a 3D printer that prints a human skull. That’s right – and on March 4th, the first one was implanted in a patient who was missing 75% of his skull! The company that developed this technology, Oxford Performance Materials – developed the Class 2 OsteoFab Patient Specific Cranial Device with a digital Computer Assisted Design (CAD) file, by matching the symmetry of the patient’s existing skull, so that the implant is a near-perfect anatomic fit for that particular patient. The skull itself is made of a material called polyetherketoneketone (PeKK) which is radiolucent and demonstrates a modulus of Elasticity similar to bone. The plastic also has key holes through it, which encourage natural bone growth to fill the voids.
The company is already working on Orthopedic implants using 3D printing technology for other applications.
As I said at the beginning – the implications of 3D printing for medical devices is massive! I can’t wait to see how this will impact the medical device industry. Also, the relatively low cost will allow for more start-up sized companies to utilize the technology, so the door is wide open for innovation that will improve the lives of countless patients. -SJG 3/27/13

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