Printing a Medical Revolution
By Russ Banham
Of the many uses for 3D Printing technology, one of the most impactful is how it can be used to improve living standards, and perhaps even prolong life. With the startling advances in 3D Printing, the human body might someday be thought of as a system of interchangeable parts.
This isn't science fiction, and it isn't as far off as you might think.
Dental and Prosthetics
Two uses of the technology are already generating revenue as viable medical businesses: dental fabrication of crowns, bridges, and implants; and prosthetics manufacturing.
With dental fabrication, a digitized, intra-oral scan is made of a patient's teeth, uploaded into a computer, and then
e-mailed to a dental lab that prints out a new porcelain bridge. It's an affordable and precise way to create a restorative prosthesis, and the new process means patients no longer have to endure uncomfortable, foul-tasting, and less accurate oral impressions using trays and molding materials.
3D Printing has also brought about a sea change in how prosthetic limbs are made and customized.
"The way most artificial limbs are made hasn't changed much over the years—you take a piece of foam, shave it into a rough approximate of a person's leg, then make a mold and stamp it out," says Scott Summit, an industrial designer and co-founder of Bespoke Innovations, which uses 3D Printing technology to produce customized prosthetics. "We wanted to design and produce something unique and far more personal—to bring greater humanity to people who've experienced a traumatic or congenital limb loss."
Bespoke Innovations manufactures customized prosthetic limb coverings, or "fairings," that perfectly mirror the sculptural symmetry and function of the wearer's remaining limb. These can be designed to capture the wearer's particular fashion sense, as well.
"We're turning something ordinary and dehumanizing into something cool and amazing," says Summit, who also teaches courses in design at Stanford University.
The applications of the technology go beyond replacing missing limbs. This past February, doctors and engineers in the Netherlands collaborated on the 3D Printing of a prosthetic lower jaw, which was subsequently implanted into an 83-year-old woman who suffered from chronic bone infection. The printer produced the prosthetic jaw from 33 layers of titanium powder that were heated, fused together and then coated with bioceramic artificial bone.
This application of 3D-printing technology isn't just a breakthrough for the patient, but for the doctor as well. 3D Printing can improve medical outcomes by helping surgeons plan their surgical approaches more effectively. Dr. Anthony J. Atala, director of the Wake Forest Institute for Regenerative Medicine, says that the typical treatment in the past for someone whose pelvis was shattered in an automobile accident was to X-ray or CAT-scan the broken bones, plan the surgery, and then conduct it. Since the injury may be life threatening, correcting it in a timely manner is of the essence.
"It may be more effective to scan the victim's pelvis and three-dimensionally reconstruct the broken bones," Atala says. "Surgeons can then take the printed pieces in hand, design needed replacement pieces, and have them ready at the time of surgery."
Perhaps the most disruptive (in a good way) application of 3D Printing in the medical world is "bioprinting"—the production of human organs for transplant.
The technology involves the creation of replacement tissues and organs that are printed layer-by-layer into a three-dimensional structure. The parts are made from the organ recipient's own genetic matter, and precisely match the tissue or organ they replace. Think about it: skin, windpipes, bladders, and more complex structures like hearts, waiting to be printed on demand with the click of a computer mouse.
Since these printed organs or tissue are made from the patient's own cells—rather than those of a donated heart or liver, for example—there's little risk of an immune response, which lessens the need for debilitating immunosuppressive drugs.
The breakthroughs in bioprinting have been increasing in frequency. Like the race to the moon in an earlier era, the goal of bioprinting appeared lofty but attainable, and the first commercial 3D bioprinter was developed in 2009 by a bioprinting company called Organovo.
The San Diego-based company has signed collaborative partnerships with multiple pharmaceutical companies, including Pfizer, and leading research institutions, including Harvard Medical School and the Sanford Consortium for Regenerative Medicine. The primary market for its 3D NovoGen MMX bioprinters, at present, is academic institutions for disease research and pharmaceutical companies for drug testing, although the company is looking at hospitals as possible future customers.
To date, NovoGen prints simpler tissues like skin, heart muscle patches, and blood vessels, although the company anticipates printing out solid organs like hearts and livers within a generation.
Another type of 3D bioprinter is getting a workout at Wake Forest. In 2003,
Dr. Atala and his colleagues published work in Nature Biotechnology showing that miniature kidneys could be engineered, and these experimental kidneys were shown to be functional; able to filter blood and produce and dilute urine. Wake Forest in now using a 3D bioprinter to engineer more sophisticated prototypes of these miniature kidneys. The goal is to make larger functioning kidneys and other solid organs like hearts and livers, in addition to solid organs like the uterus.
"Other applications that have also shown promise include ear, muscle, and the cartilage-bone interface," Dr. Atala says.
The Business of Bioprinting
Researchers from publicly traded Organovo as well as those at universities like Wake Forest, Stanford, and Harvard are collecting data right now proving the viability of 3D bioprinting. Once enough data is collected, the clinical trials process will begin, and at some point in the future, the U.S. Food and Drug Administration will rule on whether or not this "therapeutic technology" gets the green light.
If and when this occurs, the key objective is to mass-produce from a person's cells all sorts of flat, tubular, hollow, and solid organ structures. Unlike a prosthetic leg, a kidney doesn't need to be an exact replica of the original organ. Instead, it needs to be the correct size for the patient's body and be engineered with the patient's own cells. But the customizability lies more in the cellular composition itself than in recreating the exact shape and form of the original organ. So rather than a "one-of-a-kind" proposition, it's more of a "several-sizes-fit-all" proposition, albeit the materials in each case—a person's cells—are different.
"By pre-programming what you're trying to create in a computer, you can do it exactly the same way every time, which brings down cost," Dr. Atala explains.
Bringing down manufacturing costs may be just as important as passing rigorous clinical trials. NovoGen, for instance, costs a "few hundred thousand dollars," according to Keith Murphy, Organovo's chairman and CEO. He compares the financial goals of regenerative medicine to the private and public investments that went into the Human Genome Project.
Dr. Atala agrees. "Research and development is very expensive, in part because of the time it takes to get a new technology to market," he says. "Basically, given the high expense, what we can achieve scientifically is dependent on resources. But there is no question that someday, perhaps in the span of a generation, you can have a heart made out of your own cell tissue. Isn't that amazing?"
It's too soon for researchers and scientists to speculate how much bioprinted tissues and organs will cost to produce or store, or how quickly those customized products can be produced once the need has been identified. However, the estimated average costs of today's organ transplant procedures in the U.S.—which start in the low six figures and escalate to over $1 million—are staggering by any measure.
According to United Network for Organ Sharing (UNOS), more than 113,000 patients in the U.S. are currently waiting for an organ transplant, but viable donor organs are extremely hard to come by for a rather stark reason.
"Only 1 to 2 percent of the population dies in a way that makes them potential organ donors," says Anne Paschke, a UNOS spokesperson. "So we are left with a situation where people are waiting, hoping and, sadly, dying. Any technology, including 3D bioprinting, that ends up reducing the need for donated organs will simply save a lot more lives."
Russ Banham is a veteran financial journalist and frequent contributor to The Wall Street Journal, Chief Executive, CFO, and many other business publications. He is the author of several books, including the international best-selling history of Ford Motor Co., The Ford Century, which has been translated into 13 languages.
3D Systems composed 0.36% of the T. Rowe Price T. Rowe Price Small-Cap Stock Fund's portfolio and 0.86% of the T. Rowe Price Small-Cap Value Fund's portfolio as of December 31, 2011. The funds' portfolio holdings are historical and subject to change. This material should not be deemed a recommendation to buy or sell any of the securities mentioned.
T. Rowe Price and Dan Carney are not affiliated.
Wake Forest Baptist Medical Center