As we move into 2015, stories about the use of 3-D printing (also called additive manufacturing) in the health care industry continue to hit headlines. Some 3-D printed products are already available to U.S. patients, including knee and cranial implants, while others, including a graft device to treat aneurysms, are coming down the pipeline.

In touch with this trend, FDA has formed an Additive Manufacturing Working Group, and in October 2014, the Agency engaged industry stakeholders to discuss technical considerations surrounding 3-D printed products. However, according to workshop remarks from Dr. Matthew Di Prima, head of the FDA Additive Manufacturing Working Group, the workshop was strictly focused on technical issues related to 3-D printing and "regulatory policy" was "going to be a whole separate discussion."

Indeed 3-D printing presents many regulatory questions that currently translate to regulatory uncertainty.   However, leading innovators seem to be moving full steam ahead in the development of various 3-D printed technologies because of the value they offer patients.  With the right kind of regulation, the "personalized medicine" these 3-D printers can provide, and the speed with which custom devices can be produced relative to conventionally manufactured products, could greatly advance the public health.  Accordingly, many are hoping that FDA will soon move past technical discussions and work with stakeholders to develop the best possible regulatory framework to expand access to safe and effective 3-D printed devices.

Below is a roundup of some of the latest news stories in the 3-D printing field. The buzz that these stories are creating further demonstrates the need for FDA to take a more definitive stance on how it plans to regulate an increasingly complex array of 3-D printed products.

New 3-D Printed Devices in the Works

The Washington-based Aortica Corporation announced in November of 2014 that it had raised $7 million to complete a pivotal FDA study on its groundbreaking 3-D device intended to treat abdominal aortic aneurysms (AAA).  An AAA is an enlarged bulge in the aorta that gradually gets bigger over time and can eventually burst, causing severe internal bleeding and death without immediate specialized treatment. Over 150,000 U.S. patients are diagnosed with AAA each year.

Open heart surgery can be used to treat AAA, but the gold standard (and less invasive) treatment option is endovascular therapy, which involves the insertion of a graft through the femoral artery.  Despite the advantages of endovascular therapy, Aortica co-founder, Dr. Starnes, explains, "Approximately 30-40% of patients diagnosed annually in the U.S. with moderate to severe AAA disease are ineligible for less invasive endovascular therapy due to anatomical limitations." To address this, Aortica is working to develop a patient-specific 3-D printed endograft to make more candidates eligible for this gold standard treatment option.

Researchers in Washington, D.C. are also making waves in the development of 3-D printed products. For example, George Washington University assistant professor, Lijie Grace Zhang, recently received a $2.2 million NIH grant to study the use of 3-D printing to build human tissue.  While Zhang admits that the tissue engineering field has a long way to go, she ultimately hopes to build 3-D printed organs in her lifetime. One obstacle she and her team will have to overcome, however, is the task of printing vascular tissue, such as veins and arteries, which was cited by Zhang as the biggest challenge in tissue organ regeneration (the specific difficulty is replicating the density of vascular tissue such that blood is able to circulate through the entire structure).

What about Cost?

Because 3-D printed products are so cutting edge, patients might assume that the ones currently available are incredibly expensive. But, according to Maryland surgeon, Chris Cannova, this is not necessarily the case. Cannova, who performs knee replacements with 3-D printed knee implants, explained that insurance companies see a knee replacement as a knee replacement regardless of whether a traditional or 3-D printed implant is used. He noted that both insured and Medicaid patients receiving 3-D printed implants only face a minor cost increase compared to traditional implants as most insurance companies will cover the CT scan needed to size the patient's knee to create the 3-D printed implant (and such scans only cost a few hundred dollars).

Texas surgeon, Bruce Bollinger, confirmed Cannova's insight on cost. He stated that his office usually charges between $4,000 and $7,000 for a knee implant, and that the cost of a 3-D printed implant (of the same brand used by Cannova) is $5,000.

Cost considerations surrounding 3-D printed products are also a topic of discussion among device manufacturers. One commentator has noted the benefits of 3-D printing for device manufacturers, particularly in the prototype phase, explaining that "3-D printing gives you the freedom to redesign while in production." Whereas a design change for a traditional mold would typically set a manufacturer back at least a few thousand dollars and create a timing delay, a 3-D printing company could immediately implement the change and start printing the revised products.

3-D printed products will undoubtedly continue to be a hot topic in 2015. And, hopefully, FDA will respond by offering some definitive insight into its regulatory intentions with respect to these products. While it's hard to predict what this guidance might look like, back in 2013, Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, provided some thoughts on this topic. Shuren explained that the manufacturing component (i.e., how 3-D printing actually occurs and the materials used) would likely be the focus of the guidance. This seems to align with the "technical" focus of the recent public workshop.  Shuren also shared that FDA is not aiming to get in the way of 3-D printing innovators in carrying out its regulatory efforts, and that the Agency views 3-D printing as an important piece of the personalized medicine movement.

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