Bio-printing human parts will spark ethical, regulatory debate

3D printing also threatens intellectual property rights

The day when 3D-bioprinted human organs will be readily available is drawing closer, and will result in a complex debate involving a great many political, moral and financial interests.

The rapid development of 3D bio-printers will spark calls to ban the technology for human and non-human tissue within two years, according to research firm Gartner Inc.

In a report released today, Gartner predicted that the time is drawing near when 3D-bioprinted human organs will be readily available, an advance almost certain to spark a complex debate involving a variety of political, moral and financial interests.

An example of 3D printed liver tissue by a San Diego-based company named Organovo.

"At one university, they're actually using cells from human and non-human organs," said Pete Basiliere, a Gartner Research Director. "In this example, there was human amniotic fluid, canine smooth muscle cells, and bovine cells all being used. Some may feel those constructs are of concern."

Gartner also noted that 3D printing will change retail models and threaten intellectual property (IP), resulting in massive losses for companies that hold those licenses. In fact, Gartner predicts that by 2018, 3D printing will result in the loss of at least $100 billion a year in IP.

"The very factors that foster innovation -- crowdsourcing, R&D pooling and funding of start-ups -- coupled with shorter product life cycles, provide a fertile ground for intellectual property theft using 3D printers," Basiliere said.. "Already, it's possible to 3D print many items, including toys, machine and automotive parts, and even weapons."

John Hornick, an IP attorney with Finnegan, Henderson, Farbow, Garrett & Dunner LLP in New York, said as much at the Inside 3D Printing Conference last fall. "IP will be ignored and it will be impossible or impractical to enforce," Hornick said. "Everything will change when you can make anything."

3D bio-printing ethics

The technology of 3D "bio-printing", which uses extruder needles or inkjet-like printer heads to lay down successive rows of living cells, is advancing at breakneck speed, Gartner said.

Major challenges still face the industry, such as creating the connective tissue or scaffolding-like structures that support the functional tissue in a human organ. And, laying out living cells is one thing, but creating the vascular structure to support tissue with oxygen and nutrients is yet another challenge. Traditionally, tissue created in a lab dies before leaving the petri dish, experts said.

San Diego-based bio-printing company Organovo has overcome the vascular issue -- to a degree. "We have achieved thicknesses of greater than 500 microns, and have maintained liver tissue in a fully functional state with native phenotypic behavior for at least 40 days," said Mike Renard, Organovo's executive vice president of commercial operations.

Organovo hopes to be able to print a functioning liver this year. The organ would not be used for implant purposes, but for pharmaceutical testing and development.

Organovo's bio-printing technology creates functional human tissue. The company's bio-printer places a specially formulated "bio-ink" made of human cells into a 96 well plate. The process results in tissue with natural architecture that can be tested for drug development. It can also produce tissue for human transplant.

Clinical trials and testing of organs for transplants in the U.S. could take up to a decade because of stringent reviews by the U.S. Food and Drug Administration (FDA). But 3D bio-printing is advancing unabated in other countries with less-restrictive government oversight.

"What's going to happen, in some respects, is the research going on worldwide is outpacing regulatory agencies ability to keep up," Basiliere said. "3D bio-printing facilities with the ability to print human organs and tissue will advance far faster than general understanding and acceptance of the ramifications of this technology."

For example, in August 2013, the Hangzhou Dianzi University in China announced it had invented the biomaterial 3D printer Regenovo, which printed a small working kidney that lasted four months. Earlier in 2013, a two-year-old child in the US received a windpipe built with her own stem cells, Basiliere said.

Munich-based EnvisionTEC is selling a 3D printer called a Bioplotter that sells for $188,000 and can print 3D pieces of human tissue. EnvisionTEC's Bioplotter uses a computer-driven syringe system to lay out cellular structures, Basiliere said.

"These initiatives are well-intentioned, but raise a number of questions that remain unanswered. What happens when complex enhanced organs involving nonhuman cells are made? Who will control the ability to produce them? Who will ensure the quality of the resulting organs?" Basiliere said.

EnvisionTEC's Bioplotter uses a computer driven syringe system to lay out cellular structures.

The Gartner report also notes that as 3D printing technology continues to mature, its ability to build customized human anatomical parts has pervasive appeal in medical device markets especially in economically weak and war-torn regions where it addresses high demand for prosthetic and other medical devices.

In addition, better familiarity within the material sciences and computer-augmented design services sectors, along with integration with healthcare and hospitals, will further increase demand after next year.

At the same time, 3D printing of non-living medical devices such as prosthetic limbs, combined with a burgeoning population and insufficient levels of healthcare in emerging markets, is likely to cause an explosion in demand for the technology by 2015.

"The overall success rates of 3D printing use cases in emerging regions will escalate for three main reasons: the increasing ease of access and commoditization of the technology; ROI; and because it simplifies supply chain issues with getting medical devices to these regions," Basiliere said. "Other primary drivers are a large population base with inadequate access to healthcare in regions often marred by internal conflicts, wars or terrorism."

Lucas Mearian covers consumer data storage, consumerization of IT, mobile device management, renewable energy, telematics/car tech and entertainment tech for Computerworld. Follow Lucas on Twitter at @lucasmearian or subscribe to Lucas's RSS feed. His e-mail address is lmearian@computerworld.com.

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This story, "Bio-printing human parts will spark ethical, regulatory debate" was originally published by Computerworld .

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