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ADDITIVE MANUFACTURING


the need for donor organs—collaboration should be worth it. “I fi rmly believe that this is going to take the combined minds of medicine, biology-minded folks, and the engineering folks who are so familiar with scaling up production who have been working with 3D printing for 30 years, but sometimes they don’t even speak the same language,” McDaniel said. “They talk about things differently, so it’s getting those two groups to talk together, to work together”—which is hap- pening in the SME Medical Additive Manufacturing/3D Printing Workgroup.


Ideas for Best Practices Surfacing Professionals who literally don’t speak the same language seem to be in agreement that best practices are just emerg- ing. Examples are CEOs as diverse as BioBots’ Cabrera and Koji Kuchiishi of Cyfuse Biomedical (Tokyo). They are separated not only by a 15- hour jet fl ight but also fun- damental differences in the bioprinters they produce. But they sing the same tune regarding best practices. Kuchiishi declined an interview with ME, saying it is too early to talk about best practices. Cabrera agreed. “The real- ity is that most of this work [on best practices] is being done by scientists who are trying to fi gure it out.” Some people are ready to talk about ideas for best prac- tices and standards for bioprinting.


with the American National Standards Institute to publish, within a year or less, a roadmap outlining work to be done, said Ed Morris, America Makes director. To be sure, both human tissue engineer- ing and 3D printing are decades old and the absence so far of specifi c standards for marrying human tissue engineering and bioprinting doesn’t mean researchers are on their own in terms of de- veloping best practices. The research on


A bioprinter at Penn State University; the insert shows gel dyed red for demonstration purposes.


bioprinting is, of course, taking place in labs, and there are existing “good manufacturing” practices for labs in general, said Arnold Bos, a consultant on bioprinting and other emerging technologies for Lux Research (Amsterdam). However, he added, “the way that these regula- tions are set up and updat- ed isn’t always conducive for the development of [3D] bioprinting since these regulations are established based on known practices and technologies.”


Bos has also heard from scientists who’ve seen repre- sentatives from the FDA attending bioprinting conferences, Bos said.


The public-private partnership for additive manufacturing and 3D printing, America Makes (Youngstown, OH), recently estab- lished an advisory group called Standards, Specs and Schemas to address all materials used in AM, including biologics. The 169-member group, composed of senior executives from government, industry and academia, has an agreement


54 AdvancedManufacturing.org | June 2016


“The FDA doesn’t really have a good place to put 3D printing for tissue engineering, and it’s the same story in Europe,” Bos said. The US Food and Drug Administration, which regulates medical devices and biological products, is “reaching out to research groups” early on to ask what should be regulated and what risks should be considered. Some companies are, of course, not waiting for govern- ment agencies to come up with standards. Gatenholm said his company has set a standard of its own in the absence of formalized best practices. Cellink’s


Photo courtesy Penn State University


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