3D printing, also referred to as “additive manufacturing” or “rapid prototyping,” is the process of making three-dimensional objects from digital designs. Two of the most common types of printers are “disposition printers,” which deposit layers of materials until the 3D object is built, and “binding printers,” which build the object by binding, usually with adhesive or laser fusing, the underlying layers, to create a whole object at the end of the process.

Perhaps this seems pretty straightforward, but delving into the 3D printing of medical devices highlights the multiple aspects of this process, and underscores the potential challenges associated with the FDA’s current and future regulatory paradigm.

When it comes to printing medical devices, the first step involves developing a computer-aided design (“CAD”) file, or animation modeling software, which tells the printer what to make and how to make it.  After the finished design file is sent to the 3D printer, the user chooses a specific material.

3D-printed medical devices allow for a high degree of customization. Think of 3D-produced dental implants which fit perfectly the first time because they are manufactured for your mouth. Or a map of a highly delicate cardiovascular procedure sized precisely to your needs or, more importantly, those of your newborn. 
Continue Reading 3D Printing Series: 3D Printing of Medical Devices

Image via Inhabitat.Since we are now fully comfortable with “smart” everything, it should be no surprise that 3D printing has taken center stage in the tech world. It’s easy to imagine 3D-printed machine parts, prototype models, or even toys, but it might be harder to accept 3D-printed foods, implantable medical devices, cosmetics, drugs, and even human tissue.  Too futuristic? Not really. The technology to 3D-print, U.S. Food and Drug Administration (“FDA”)-regulated products is, in large part, already here and rapidly progressing.

Yet, as technology continues to develop, questions arise as to whether, and how, the FDA regulatory framework will keep pace to impose the same safety, quality, and efficacy standards to 3D-printed foods, drugs, cosmetics, and medical devices that currently apply to traditionally manufactured goods. How FDA chooses to deal with 3D-printed products will significantly impact not only barriers to market-entry, but also post-marketing enforcement risks. Similarly, even assuming an FDA-regulated 3D-printed product is successfully brought to market in accordance with FDA standards, manufacturers must still assess options and potential challenges associated with protecting their intellectual property.


Continue Reading 3D Printing Series: Be Right Down — Printing My Makeup

As expected, NASA recently successfully completed the first hot-fire tests on an advanced rocket engine thrust chamber assembly using copper alloy materials.  This was the first time a series of rigorous tests confirmed that 3D manufactured copper parts could withstand the heat and pressure required of combustion engines used in space launches. In all, 19 hot-fire tests on four injector and thrust chamber assembly configurations were conducted. These successful tests represent a milestone in NASA’s use of 3D printing.  However, NASA leaders have set their sights on many other uses of 3D printing, including the on-site preparation of meals.

3D printing, also referred to “additive manufacturing” or “rapid prototyping,” is the process of making three-dimensional objects from digital designs. Two of the most common types of printers are “disposition printers,” which deposit layers of materials until the 3D object is built, and “binding printers,” which build the object by binding, usually with adhesive or laser fusing, the underlying layers, to create a whole object at the end of the process.

Perhaps this seems pretty straightforward, but delving into 3D printing applied to the preparation of food ushers in images of the Jetsons eating on their supersonic armchairs. So it won’t require much of a leap to imagine real astronauts in real space vehicles preparing 3D foods to be consumed in space.


Continue Reading 3D Printing Series: No One Goes into Space for the Food – Yet

We are entering a brave new world of food design and regulation brought to us through the mechanical development and visual artistry of 3D printing. As with any new medium, understanding what we confront and its regulation lag behind the medium’s implementation.

3D printing, also referred to as “additive manufacturing” or “rapid prototyping,” is the process of making three-dimensional objects from digital designs. Two of the most common types of printers are “disposition printers,” which deposit layers of materials until the 3D object is built, and “binding printers” which build the object by binding, usually with adhesive or laser fusing, the underlying layers, to create a whole object at the end of the process.


Continue Reading 3D Printing Series: Can You Put my Boyfriend’s Face Inside That Pizza?

3DPrinterWe agree – the Jetsons era has indeed arrived. Beyond the days of “smart” everything, now 3D printing has taken center stage in the tech world. While it is not so farfetched to imagine 3D-printed machine parts, prototype models, or even toys, it is might be harder to watch it printing foods, implantable medical devices, cosmetics, drugs and even human tissue. All too futuristic? Not really. The technology of 3D-print FDA-regulated products is, in large part, already here and rapidly progressing.

Yet, as technology continues to develop, questions arise as to whether, and how, the U.S. Food and Drug Administration’s (“FDA”) regulatory framework will keep pace to impose the same safety, quality and efficacy standards to 3D-printed foods, drugs, cosmetics, and medical devices that currently apply to traditionally manufactured goods. How FDA chooses to deal with 3D-printed products will significantly impact not only barriers to market entry, but also post-marketing enforcement risks. Similarly, even assuming an FDA-regulated 3D-printed product is successfully brought to market in accordance with FDA standards, manufacturers must still assess options and potential challenges associated with protecting their intellectual property.

Through this multi-part blog series, we will explore these questions, considerations and challenges for 3D printing that are likely to be regulated by FDA, with particular focus on foods (consumed on earth and in space), cosmetics and medical devices. While, at this stage, FDA issues may raise more questions than clear answers, this blog series will explore and discuss the topics that are at the forefront of FDA’s agenda regarding 3D printing and, therefore, require careful consideration by any company that contemplates involvement in the 3D-printed foods, cosmetics or devices industries. 
Continue Reading 3D Printing Series: Before You Click “Print” On Your Pizza, Palette or Prosthetic: FDA and IP Considerations With 3D-Printed Foods, Cosmetics And Medical Devices