The emergence of 3D printing as a viable technology which can be used in the medical industry is nothing new, but it has moved forward in leaps and bounds over the past 12 months.
Last year in India, a 32-year-old woman with tuberculosis of the spine who had suffered severe damage to her first, second and third cervical vertebrae and who was facing potential paralysis had her damaged vertebrae replaced with a 3D-printed implant by a team of specialist surgeons. Surgery of this type had never been performed in India before but the growing confidence of medical professionals in 3D printing technology and their keenness to use it as well as the obvious surgical skill allowed that woman to walk again.
This is one of a number of examples of how 3D printing is fast becoming a viable option in wider medical practice – and with the United States’ Food and Drug Administration (FDA) choosing to release the first “comprehensive technical framework” to advise manufacturers creating medical products on 3D printers, it seems that the technology is now here to stay.
In producing the guidelines, the FDA reviewed more than 100 devices currently on the market which were manufactured on 3D printers, including a number of patient-matched devices, tailored to fit a patient’s anatomy, such as knee replacements and implants designed to fit like a missing puzzle piece into a patient’s skull for facial reconstruction.
“In order to help ensure the safety and effectiveness of these products, we’re working to establish a regulatory framework for how we plan to apply existing laws and regulations that govern device manufacturing to non-traditional manufacturers like medical facilities and academic institutions that create 3D-printed personalised devices for specific patients they are treating,” said FDA Commissioner Scott Gottleib, upon the release of the guidelines.
“Overall, it will help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submissions and making sure our regulatory approach is properly tailored to the unique opportunities and challenges posed by this promising new technology.”
“Promising new technology” may even be an understatement. It’s estimated that 100,000 knee replacement surgeries are now completed each year using 3D-printed, patient-matched surgical guides – just one specific application within the entirety of the industry.
Lauralyn McDaniel is Industry Manager of Medical Device Manufacturing for not-for-profit SME and she is as enthusiastic as anyone about the role 3D printing has to play in medicine moving forward.
“I would not be surprised if more than a quarter of hospital patients globally will be directly impacted by the technology in 10 years,” she says.
“Medical applications have always been a leader in using the technology for end-use. With the ability to build from medical imaging data to create truly personalised tools and devices, AM3DP (Advanced Materials & 3D Printing) is an enabler for precision medicine.
“From anatomic models to support patient education to developing patient-matched devices to treat rare diseases like Tuberculous Meningitis, I think the entire healthcare industry is beginning to understand the impact it can have.”
No doubt, the ability to match the construction of devices to an individual patient is one of the leading benefits. For some devices, additive manufacturing and 3D printing offers a method to more effectively create complex structures, more closely matching a person’s anatomy – “such as the porous structures need for osseointegration of orthopedic implants,” suggests McDaniel.
The ability to cost-effectively manufacture on a smaller, more precise scale has potential for development of devices for rare conditions. One of the greatest benefits of the technology for any industry is the complexity it enables, which is such that traditional design and engineering approaches often have to be put to the side. With 3D printing in particular, surfaces and structures can be optimised for strength, weight and material use.
With this in mind, the FDA has characterised the guidelines not just as a “comprehensive framework” but also as what they are calling “leap-frog guidance” offering the Agency’s “initial thoughts” on medical devices created by additive manufacturing.
For McDaniel, this is an important distinction.
“Essentially, this a manufacturing method,” she says. “It’s not often that a regulatory body would provide guidance on a manufacturing method.
“That the FDA has done this indicates an understanding of the possibilities and a willingness to help the industry understand that it can use AM3DP for medical devices with some considerations. They have also dedicated resources to help better understand the technology, conducting research on material properties and other key factors in additive manufacturing.
“The key takeaways from the report are that the FDA is anticipating that even more applications will be developed due to the unique capabilities of AM3DP, and that they want to support the efforts through a regulatory process that supports the next generation of devices.
“With the publication of the final guidance, the FDA has indicated the technologies can be used safely and they’ve provided the framework to do that as AM3DP processes get faster and even more precise including to the micro and nano-scale. This can only help.”
One of the key goals here for the FDA is to establish a standard process for production of these devices which ensures they are safe.
“More capital needs to be invested developing integrated systems within the 3D printer that monitor the source code that designs the device, and the reliability of the output of the printer,” Dr. Robroy MacIver, a congenital heart surgeon who has pioneered the use of 3D printed models for surgery preparation, told Medical Design and Outsourcing. “Safety, therefore, will depend on adherence to a rigid process, rather than simply the end result.”
The requirement to establish a cover-all-bases approach which is safe does not, however, mean that all research into how the technology can be used, adapted and developed will now grind to a halt.
In fact, according to a recent report published by Market Research Future, the general global 3D bioprinting market is booming, and is expected to gain prominence by demonstrating spectacular growth over the next decade.
Many industry experts actually expect to see major innovation in the space over the coming years.
"The access to patient-matched devices will be enhanced greatly by the FDA's acceptance of this new technology,” Dean Carson, vice president of U.S. operations for medical-device manufacturer Anatomics, told Modern Healthcare.
“They're trying to create a pathway that people can walk along in order to create high quality implants that meet all the standards.
"You've got two ends of the spectrum: the companies trying to create the products that are going to advance healthcare and then FDA trying to ensure those products are as safe as possible. A guidance document like this is bridging the gap."