3-D printing grows to scale within industry

Over the past two decades, 3-D printing has grown from a niche technology to a multibillion-dollar industry. The manufacturing process was developed in the 1980s as a way to produce small volumes of scale models but has since expanded to include the manufacturing of medical devices and implants for surgical and clinical use. The process, also known as additive manufacturing, uses computer models to build three-dimensional objects by printing materials like plastic, polymers, metals and powders in layers.

Companies like Kalamazoo, MI-based Stryker ($SYK) and Minneapolis-based Medtronic ($MDT) are cashing in on the technology to create innovative orthopedic and cardiovascular products, while other operations like San Diego-based Organovo ($ONVO) are churning out 3-D printed organs and tissue that could be used in implants and clinical testing.

But implants and organs are only part of the 3-D printing equation, as "bioprinting" also holds sizable potential in the field of medical diagnostics and drug testing. Earlier this year, U.S. and Chinese researchers created a realistic 3-D model of a cancerous tumor for testing purposes, and Harvard's Wyss Institute unveiled their "bone-marrow-on-a-chip" technology for drug testing. The device mimics live bone marrow and could provide a more accurate alternative to animal testing.

Companies could face significant cost and regulatory hurdles moving forward, but many devicemakers and research outfits have already charted significant progress in 3-D printing. Here is an overview of recent corporate and clinical efforts in the field. As always, please feel free to contact us with any questions or comments.

-- Emily Wasserman (email | Twitter)

Next: 3-D Printed Implants >>

3-D printed skull--Courtesy of UMC Utrecht

3-D Printed Implants

As devicemakers compete for the most innovative products in a saturated orthopedics market, 3-D printed implants could become more common in operating rooms and surgical procedures.

A breakthrough in the field came earlier this year, when a consultant orthopedic surgeon at Newcastle Upon Tyne Hospitals NHS Trust used the hospital's 3-D printer to create a replacement hip out of titanium powder for an elderly cancer patient. Dr. Craig Gerrand fused together the implant with a laser and coated the outside of the device with mineral onto which the new bone can grow. Gerrand then implanted the pelvis using a standard hip replacement, allowing the patient to walk with the help of a cane.

3-D printed tracheal splint--Courtesy of University of Michigan

But 3-D printed implants are hardly a new phenomenon in the operating room. In 2012, Belgian orthopedic surgeons collaborated with a 3-D printing company to create the "world's first patient-specific implant of the entire lower jaw," according to a BBC report. In May 2013, doctors at the University of Michigan implanted a 3-D printed tracheal splint in an infant with tracheobronchomalacia, a life-threatening breathing disorder. Physicians took a CT scan of the baby's respiratory tract to create a model of the device and then printed the implant with bioabsorbable plastic. During the same month, Princeton University engineers used a 3-D printer to create a bionic human ear with an antenna woven into the cartilage.

Another breakthrough came in March, when doctors at University Medical Center Utrecht announced that they had successfully replaced the top part of a patient's skull with a 3-D printed implant. Anatomics, an Australian 3-D printing outfit, helped manufacture the device, and the implant restored the patient's vision and motor coordination.  

Outside of the surgical arena, researchers are creating custom-designed bone implants that could treat unusual sports injuries. Washington State University researchers Susmita Bose and Amit Bandyopadhyay use laser engineered net shaping (LENS) technology to create implants that integrate into the body and encourage bone growth. Scientists used CT scans or MRI to make a 3-D model of the injury, and a manufacturer could then create the implant within 5 to 6 hours. 

3-D printed implants have also found applications in the hearing aid and dental industry. Dentists use biocompatible 3-D printed materials to create dental temporaries, or implants placed in the patient's gum between surgery and the placing of a permanent implant. The hearing aid industry is no slouch in the 3-D printed implant department, with customized devices that are printed to match a patient's ear shape and skin coloration.

For more:
3-D printer Materialise slated to price $104M IPO
Surgeons have implanted a 3-D-printed pelvis into a U.K. cancer patient

Next: 3-D Printed Organs >>

3-D printed blood vessels--Courtesy of Khademhosseini Lab

3-D Printed Organs

While 3-D printed implants are already making their way into patients, 3-D printed organs are on their way to becoming an industry trend. San Diego, CA-based Organovo Holdings ($ONVO) is implementing 3-D printing technology to develop living tissue for organ transplants and testing purposes. In February, the company announced that it would use 3-D printers to produce tissue that helps researchers quickly test many samples from different cell types, and to create organs, blood vessels and skin. Organovo is also exploring "strips" or tubes of cells that could be used to "patch" faulty organs, but the strips are still 5 to 6 years away from clinical trials, CEO Keith Murphy told Bloomberg earlier this year.

3-D printed liver tissue--Courtesy of Organovo

Much remains in the way of research and development for Organovo's printed tissue, but the company has already made significant headway into the medical 3-D printing field. In April 2013, Organovo unveiled an artificial liver product made from 3-D bioprinting technology. The liver replicates features of natural tissues and was designed to help drug companies more accurately predict liver toxicities.

Organovo is not alone in its quest to develop 3-D printed organs. In May, researchers at Boston's Brigham and Women's Hospital created functional, synthetic blood vessels using 3-D printing technology. Scientists printed a mold of the blood vessels from agarose fiber and covered the structures with hydrogel, a jelly-like substance. The team then removed the templates from the casts to make functioning vessels. Layers formed within the fabricated vessels could hold positive implications for developing transplanted tissues and testing drugs outside the body.

For more:
Researchers use 3-D printing to create synthetic blood vessels
Organovo is extending its 3-D printing technology beyond livers

Next: 3-D Printing and "Bioprinting" for Testing >>

3-D tumor model--Courtesy of the Institute of Physics

3-D Printing and "Bioprinting" for Testing

For drug testing and diagnostics, 3-D printing could offer promising potential. In April, a team of U.S. and Chinese researchers used 3-D printing technology to create a model of a cancerous tumor. The model measures 10 mm in width and length, and could help drug developers test new compounds during preclinical research. Before, scientists developed 2-D models made up of a single layer of cells to mimic tumors so drugs could be tested in a realistic environment. A 3-D printed model provides a more accurate representation of a tumor environment and is more scalable than a 2-D printed version, researchers said.

Microscopic view of engineered bone in Bone Marrow on a Chip--Courtesy of James Weaver, Harvard's Wyss Institute

In May, scientists at Harvard's Wyss Institute for Biologically Inspired Engineering revealed a new tool for drug testing, "bone marrow-on-a-chip." The device mimics the structure, function and cellular makeup of bone marrow, and could be used in the future to develop treatments to reverse cell death. The engineered bone marrow could also provide a more accurate alternative to animal testing, as most bone marrow is currently studied intact in living animals.

This is not the Wyss Institute's first foray into organ-on-a-chip technology. Wyss scientists have already constructed lung, heart, kidney and gut chips that mimic important aspects of organ function. To make the engineered marrow, scientists used a complex bioprinting process. Investigators packed bone powder into a ring-shaped mold and implanted the disk under the skin on a mouse's back. After 8 weeks, scientists removed the mold and ran it through a CT scanner. The scan unveiled a structure that looked identical to real bone marrow.

Researchers kept the bone marrow alive by removing it from animals and placing it on specially designed microfluidic chips. The engineered marrow remained healthy for up to one week, allowing scientists to test the effectiveness of a new drug.

Seattle-based Nortis is also forging ahead with its 3-D chip technology. Earlier this month, the company roped in $2 million in angel funding to develop its next-generation microfluidic chips for in vitro studies. The company is currently working on developing a number of "organoids" on microfluidic chips for testing purposes, including the kidney, intestines and liver.

For more:
Harvard's bone marrow-on-a-chip could replace animal drug testing
3-D printed tumor mimics cancer better than 2-D model

Next: Other 3-D Printed Innovations >>

LUXeXcel 3-D printed glasses--Courtesy of LUXeXcel

Other 3-D Printed Innovations

Devicemakers are exploring other applications for 3-D printing beyond implants and organs. Dutch-based LUXeXcel is using the technology to create 3-D-printed reading glasses with individually polished lenses. The company based its "Printoptical" 3-D printing technology on a large-format commercial inkjet printer with adapted print heads that deposit droplets of fluid to form the shape of the lens. Unlike traditional 3-D printers, droplets form pools rather than layers. The pools are then measured by lasers and solidified with ultraviolet light, producing smooth surfaces that do not require any polishing.

For more:
Dutch company develops 3-D printing process for lenses and glasses

Next: Future of 3-D Printing >>

Stryker's triathlon tritanium knee system--Courtesy of Stryker

Future of 3-D Printing

Big and small companies are looking to 3-D printing to facilitate manufacturing and advance product portfolios. Kalamazoo, MI-based Stryker ($SYK) uses 3-D printing to create its cementless, triathlon tritanium knee system, and Medtronic ($MDT) also hopes to capitalize on the technology. In September 2013, the device giant opened a $10.2 million state-of-the-art R&D center in Galway, Ireland, with a virtual operating room and 3-D printing technology. The company hopes to combine the expertise of its engineers with that of Irish academics to develop new cardiovascular devices and therapies.

In June, Belgian device outfit Materialise joined the 3-D printing sector with a $96 million IPO. The company printed more than 146,000 customized, patient-specific medical devices in 2013 and count joint-replacement products and craniofacial implants among their product offerings. Devices are distributed through partners Biomet, DJO Surgical, Synthes and orthopedics giant Zimmer ($ZHM).

Although many 3-D-printed devices have won 510(k) clearance over the past few years, new regulatory considerations could make it more difficult for companies to bring the products to market. The FDA is exploring issues related to 3-D printing, including whether a machine becomes an extension of a clinician, or whether custom-made devices could be printed in a healthcare facility.

The agency recently created an additive manufacturing working group to discuss the talking points and is asking experts to weigh in on potential challenges and solutions for producing devices through 3-D printing. It also runs two laboratories to delve into how 3-D printing could affect the way devices are manufactured in the future. The Functional Performance and Device Use Laboratory uses computer-modeling methods to help the regulators evaluate device safety and performance, and the Laboratory for Solid Mechanics helps the agency develop standards in regards to manufacturing.

In October, the FDA will hold an additive manufacturing workshop that could weigh heavily in future technical guidance.

Cost also remains a significant obstacle in 3-D printing, as the technology is not yet covered by insurance, and most of the current technology relies on collaborative efforts. High-resolution printers run from $40,000 to more than $1 million, and federal funding is difficult to obtain.

Still, as medical breakthroughs continue to surface and the technology finds more applications in clinical settings, 3-D printing could chart impressive growth in the years to come.

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Medtronic cuts ribbon on $10M Irish R&D shop