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ADDITIVE MANUFACTURING


The device makers that came up with this said they had


to develop non-digital ways to track patient names “be- cause it does not accommodate the patient’s information,” McDaniel said, conjuring up visions of notes attached to bioprinted tissues with paper clips.


Approvals for use in humans sought Those visions of notes and paper clips lead to thoughts of paperwork and administrative functions. Erik Gatenholm, CEO of the bioink firm Cellink, thinks the


No. 1 challenge for bioprinting is regulatory in nature. “How do we approve this technology for clinical use?” he said. Gatenholm is well aware of the arduous process to get biologics and medical devices approved by the FDA for use in the United States and by other agencies for use in Europe. McDaniel’s SME workgroup will take up the issue of getting approval for using bioink in humans. The group is working to build evidence for 3D printing applications in medicine—where every device will be a one-off if bioprint-


on them through the first week of August. The FDA makes it clear that the guidelines are not intended for bioprinting, and it indicates that patient-specific devices made at the point of care may raise additional technical considerations. “The FDA has indicated that bioprinting is being dis-


cussed by the Center for Biologics Evaluation and Research (CBER), a division of the FDA. A different division, called the Center for Devices and Radiological Health (CDRH), released the draft guidelines,” McDaniel said. “So the regu- lations for bioprinting are more likely to look like those for blood products and similar biologics than a traditionallly manufactured device.”


Medicine = Mars, Engineering = Venus With all of the uncertainties swirling around bioprint- ing, one thing is sure. No individual researcher is going to figure out how to get blood vessels to form, and no single regulator will decide on how the authorities view manufactured tissue. But with so much at stake—forsak- ing animal testing for skin creams and pharmaceuti- cals and reducing or eliminating the need for donor organs—collaboration should be worth it. “This is going to take the combined minds of


medicine, biology-minded folks, and the engineer- ing folks ..., 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 ... work together”—which is happening in the SME Medical Ad- ditive Manufacturing/3D Printing Workgroup.


This sample in a petri dish shows a bioprinted scaffold with bone cells growing into it.


ing organs becomes reality–by connecting key stakehold- ers. They can then share best practices and pinpoint the most effective methodologies and most reliable proto- cols to increase the impact of their research—not only on bioprinted tissues and organs but also for patient-specific models and surgical guides that are already in use. The FDA in May released draft guidelines for additive manufacturing of medical devices and solicited comments


62


Ideas for best practices surfacing Professionals who literally don’t speak the same language seem to be in agreement that best prac- tices are just emerging. Examples are CEOs as diverse as BioBots’ Cabrera (Philadelphia) and Koji Kuchiishi of Cyfuse Biomedical (Tokyo). Even though there are fundamental differ- ences in the bioprinters they produce, 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 reality is that most of this work


[on best practices] is being done by scientists who are try- ing to figure it out.” Some people, however, are ready to talk about ideas for


best practices and standards for bioprinting. The public-private partnership for AM and 3D printing, America Makes, recently established an advisory group


Summer 2016 Photo courtesy Penn State University


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