3D-Printed Body Parts Grow Regulatory Legs
The use of 3D printers in the medical field appears limitless. In 2013, scientists in China used a 3D printer to successfully produce a functioning kidney. Then, in February 2014, a surgeon in England created and implanted a pelvis from a 3D printer to help a cancer patient walk again.
But where does 3D printing of body parts stop? And should it stop? The answers may be found in new regulations focused on how 3D printers should be used by physicians.
The new developments in 3D printing for medical uses have triggered an avalanche of regulatory issues that need to be addressed, says John Farrell, CSC global head, Life Sciences Business Process Services. “The biggest challenge is that we’re opening an area of medicine where the regulation isn’t currently fully scoped to manage,” he says. “We are looking at a scenario where technological capacity and capability has been brought to — and slightly beyond — the limits envisaged when developing current regulation.”
Going beyond limits
As regulators begin to ponder how to deal with the coming explosion in 3D printing for medical uses, patient safety is a top consideration. Joel Finkle, senior strategist, regulatory informatics, CSC, says 3D printer manufacturers, software developers and physicians all need to make sure that what they are producing makes sense before putting it into production, and eventually, into a human body. “Regulation is a way of making sure your stuff is real, rather than playing with a 3D model on a screen,” he says.
Farrell points out that in the 1980s and 1990s, regulation was slow to catch up with technology advances. Likewise, “We will probably be generating 3D replacements for every bone in the body before we see even the draft regulation needed to appropriately regulate it,” he says.
In the healthcare industry, medical solutions are highly specialized, and much of the risk is placed on the physician. Farrell cites several issues highlighted by the case of the English surgeon who printed a pelvis. Namely, even though the printer in question was not specifically approved as a medical device, there is an exemption for anything produced by an approved physician for specific use by a patient.
Farrell explains: “The key thing is that it is the algorithm driving the printer and not the physical device itself that will need to be regulated, and that regulation needs to go beyond what we currently have.”
A complex process
The process for obtaining approval for drugs and medical devices from regulatory bodies such as the U.S. Food and Drug Administration is laborious and complicated. 3D printing in the medical field increases the need for expert guidance in jumping through the regulatory hoops, and CSC is a global leader in this field.
Going forward, Farrell and Finkle see that a key to improving safety will be to determine the best ways to regulate the algorithms used to design 3D printing applications as well as the materials used in their outputs. “You need to make sure of the long-term biomechanical performance of devices and that you are not introducing any contaminants into the body,” Finkle says.
Other issues to be considered include how to deter people from using 3D printers for nefarious purposes, such as producing counterfeit medical devices. Whatever the case, CSC experts agree that technology advances are outpacing regulatory changes, and regulators need to either move quickly or, as Farrell says, “very rapidly change the way they go about regulating.”