The term “3-D printing” is seemingly ubiquitous, but is it just a novel technology or one that will advance medical device design, development, and manufacturing?

Three-dimensional printing, also known as additive manufacturing, is the process of making a 3-D solid object from a digital model. The technology creates products by building them up, layer by layer, from a particular material, as opposed to more traditional subtractive prototyping approaches of cutting, drilling, or machining products. The process can cut down prototyping time immensely; processes that once took days and weeks may now take minutes and hours.

Chuck Hull, founder and chief technology officer of Rock Hill, S.C.-based 3D Systems, invented the first 3-D printing technology and printed the first 3-D part in 1983. According to Wohlers Associates, an independent consulting firm specializing in 3-D printing, the global market for 3-D printers and services was worth $2.2 billion in 2012, up 29 percent from 2011. It is expected to reach $3.1 billion worldwide by 2016 and $5.2 billion by 2020.

While the expectation is that 3-D printers will be utilized in the future to create a whole host of medical devices, tissues, and organs, the technology is already being used in healthcare, from saving money and time in creating low-volume, personalized products to enabling a paraplegic to walk again, to saving a baby’s life. According to 3D Systems, professionals in healthcare were among the first to embrace the company’s 3-D printing technology, though the uses have greatly expanded.

Medical Devices

Ekso Suit

Ekso Bionics created a suit that allows people who cannot walk without assistance to do so again. The Ekso suit became commercially available in 2012. 3D Systems collaborated with Ekso Bionics on the first 3-D printed hybrid Exoskeleton robotic suit, test piloted by Amanda Boxtel, who was paralyzed from the waist down following a skiing accident more than 20 years ago.

The process began with a full 3-D scan of Boxtel’s body and then moved to a 3-D underlay that served as the basis for the printed parts. Designers digitized Boxtel’s body and created CAD models of new components to correspond with specific points on the suit, including her shins, thighs, and spine. These components were designed to integrate seamlessly with the suit’s complex parts while providing a comfortable and stable interface with her body. In addition to designing for function, the team created a visual connection between Boxtel’s body and the suit by incorporating complex patterns like muscle strands.

After creating the 3-D models, they printed the 3-D prototypes overnight and tested for fit and function. This testing process continued until they arrived at precisely how the final parts should be printed. Boxtel debuted the hybrid suit this past November. (See the video here.)

Robohand

South African carpenter Richard Van As endured a woodworking accident that severed four fingers on his right hand in May 2011. He wasted no time after being released from the hospital in researching and developing replacement fingers after realizing that standard prosthetics cost thousands of dollars. “After my accident, I was in pain, but wouldn’t take painkillers…the more pain I had the more ideas I got,” Van As told the Associated Press. “Sometimes you have to chop fingers off to start thinking.”

Van As created a few prototypes before inviting U.S.-based Ivan Owen to collaborate on the design of a replacement finger. Owen wasn’t in prosthetics, but Van As discovered his online video showcasing a large mechanical hand he had built as a prop. They created the first working prototype in September 2012 and not long after fitted a young boy with the first aluminum hand.

The duo investigated 3-D printing as a rapid way to create prototypes, but decided to recreate the hand in 3-D print after realizing its vast potential. The Robohand, as it is called, is made from cables, screws, thermoplastic, and 3-D printing. A glove-like covering is fitted in thermoplastic. Fingers are then created on the printer by melting plastic and stacking it to make “Lego-like” digits. Finally, the digits are connected to the glove with small cables and screws. A rotating joint allows the fingers to grasp. (For more details, check out the video here.)

Using a 3-D printer provided more flexibility than they had with their original milling machine; Robohand may now be re-sized on the computer for each user and then manufactured through the printer. Production time went from a couple of weeks to about 20 hours, which is important given that Robohands are not mass produced.

Robohands’ functionality, simplicity, and cost differentiate it from other prostheses. Van As and Owen made the Robohand an open-source design available online in order to increase their reach as much as possible. Van As collects donations to make hands for people around the world. Owen has since stopped working with Robohands; he is now in education, with a focus on introducing students to 3-D printing.       

First Saved Life

Baby Kaiba first stopped breathing when he was six weeks old. His father successfully resuscitated him, but it wasn’t the last time Kaiba would stop breathing and need resuscitation. Doctors diagnosed him with tracheobronchomalacia, a rare and pathologic condition in which softening of tracheal and bronchial cartilage causes one’s airways to continually collapse.

Kaiba’s doctors contacted the University of Michigan, where a bioresorbable device was being developed. Glenn Green, M.D., associate professor of pediatric otolaryngology, and Scott Hollister, Ph.D., professor of biomedical engineering and mechanical engineering and associate professor of surgery, designed a customized splint and received emergency FDA approval to allow the device to be implanted into Kaiba, which they did in February 2012. They sewed the splint around Kaiba’s airway to expand the bronchus. Within minutes, Kaiba began breathing; within three weeks, he was off the ventilator. The splint will be reabsorbed by the body within approximately three years.

Drs. Green and Hollister started with a CT scan of Kaiba's trachea/bronchus and integrated an image-based computer model with laser-based 3D printing to produce his customized tracheal splint. This same printing process can be adapted to build and reconstruct different tissue structures, with which Green and Hollister have both been involved.

Last week, Medical Design reported on a second baby whose life was saved through a similar process, after his parents read about Baby Kaiba.

General Consumer Products and Medical Devices

Louis Foreman, CEO of Charlotte, N.C.-based family of companies Edison Nation Medical, Edison Nation, Enventys, and the inventor reality television show “Everyday Edisons” recognized the current and increasing importance of 3-D printing in medical and consumer product development. Foreman selected 3D Systems’ portfolio of 3-D printers to use for parts and prototype development.

Edison Nation Medical is a medical device incubator that helps hopeful inventors bring their products to life and get them commercialized. When Enventys engineers need to create parts for a medical device prototype for Edison Nation Medical, they can do so in-house—within hours if necessary—using a variety of printers housed on-site.

“The number-one advantage to having onsite 3-D printers is the time we save for each product development program. In fact, we save on average five weeks per project, which is equivalent to thousands of dollars,” said Tom Philpott, vice president of Enventys.

Edison Nation Medical works to break down traditional barriers and provide an easy way for anyone to bring new medical invention ideas to life. People interested in trying to get their medical product commercialized can submit it to Edison Nation Medical’s confidential online portal, after which staff and medical expert panels review them for clinical efficacy, intellectual property, and commercialization potential. The best ideas are designed and developed by Edison Nation Medical, which then works to match the product with a licensing partner. The company splits licensing royalties 50/50 with successful inventors.

In speaking about the value of 3-D printing in medicine, Carolinas HealthCare System’s Dr. Jean Wright, vice president of innovation, said, “The future for 3-D printing in health care is the next frontier. The surface for applications in health care is largely untouched; it is a future for us to define.”

While these 3-D printed medical devices illustrate the amazing lengths people have already taken the technology in the quest to increase a patient’s quality of life and save a person’s life, we’ve only seen the very tip of the iceberg.