Imagine creating an arm for an amputee at a third-world medical facility, printing wet models for surgical training or even growing organs made of real living tissue. These healthcare innovations are, or soon will be, possible using 3D printing. This innovative field has the potential to completely change how physicians around the world approach treatment of their patients.

With 3D printing, if you need an organ or other body part, it’s just a matter of pushing a few buttons and the 3D printing machine creates what you need — on the spot. This makes for exciting times, but one potential pitfall lies in the legal ramifications of 3D printing and how it will change the landscape of intellectual property rights.

Dr. Joseph Beaman of the University of Texas at the Austin Department of Mechanical Engineering, and a pioneer in the field of medical 3D printing technology, and Elliot Kotek, editor-in-chief at Not Impossible Now, and whose Not Impossible Labs works to bring new innovative technologies to developing nations, recently talked about the innovations and pitfalls of medical 3D printing.

Innovative developments in 3D printing in the medical field

One recent example of 3D printing in the medical field included printing a prosthetic arm for a boy from Sudan, named Daniel, who lost both his arms in an attack on his village. He had lost all hope in life due to the burden he was to his family. Kotek’s Not Impossible Labs, which helped bring the prosthetic limb to Daniel, works with innovative technology ideas, such as 3D printing, to help those in need around the world.

And it’s not just your everyday scientist or entrepreneur who is helping develop this new and exciting field. Everyday laymen are learning about 3D printing and helping to push the field forward. With 3D printing moving to the consumer level, a whole new market of innovators has opened up. Most of the knowledge learned on the consumer level, though, is through trial and error.

According to Dr. Beaman, some of the innovations associated with 3D printing include using lasers to solidify the powder used in the process. This helped solve a major problem that developers were having, building a support structure for the rest of the item being created. This, in turn, gives something for the rest of the material to adhere to, making it more durable.

Regulatory and safety concerns

With all the benefits of using 3D printing in healthcare, concerns have also arisen as a result of recreating parts in 3D form. How do those using 3D printing operate in a landscape of intellectual property rights? And with potential looming legal ramifications, do companies now need to “go through 10 years of trials to do something useful,” Dr. Beaman asked?

Kotek went on to add, “That’s why a lot of tech we implement has to be done overseas first, so we don’t infringe on intellectual property rights.”

Part of the problem is that innovation is outpacing regulations in the European Union (EU) and elsewhere. Luckily, legislators are working to update current medical device directives to support new technologies and innovations while also protecting patient safety.

Part of those safety concerns lie in the materials needed to create items using a 3D printer. The biggest question for regulators is how those materials will hold up and perform over time. Many feel that further testing is needed before use of items created through 3D printing can enter into everyday use by consumers.

And while the above concerns are just a couple of the many out there when it comes to 3D printing technology in general, the exciting possibilities fuel the drive to find ways to use this technology to improve the lives of people around the world, including within the healthcare industry. The U.S. Food and Drug Administration (FDA) is aware of these issues and is working with developers of the technology to bring it into mainstream use, especially in the area of medical devices.

The 3D printing field continues to grow with new innovations on a constant basis. And while intellectual property rights could prohibit the scanning and production of items using 3D printing, regulators and legislators are working to make it easier to produce such products for use by everyday consumers while also ensuring their safety.

Written by Cheryl Knight and Kristen Nicole. photo credit: Press conference presso CNA via savona presentazione Wunderkammer 14-4-15-26 via photopin (license)