|Scientists think it will be possible to
print a 3-D heart in 3 to 5 years' time.
Imagine a time when a clinician can modify and manufacture an implant sized for a particular patient on-demand in a health care facility—or print a human organ as easily as a paper document. As futuristic as it sounds, that time is not far off, according to scientists who continue to find new and truly mind-blowing ways to apply three-dimensional (3-D) printing techniques to the medical field.
As its name suggests, 3-D printing, also known as additive manufacturing, is a process in which objects are made by fusing or depositing materials, such as plastic, ceramics or even living cells, in layers to produce a 3-D object. The concept is not new; 3-D printing technology has existed in some form since the 1980s. However, what was once considered a niche manufacturing process has blossomed into a multi-billion-dollar industry, responsible for fabricating everything from wristwatches to airplane parts.
Until recently, though, 3-D printing had been used sparingly in the device industry, primarily to create surgical guides and prototypes or products that required only simple materials such as polymers, acrylics or ceramics. A lack of qualified materials prevented applications from being used in and around the body. The technology was also considered too slow and expensive for widespread prototyping and design work. However, with the new generation of faster, more accurate 3-D printers, these limitations have all but disappeared. Today, device makers are using 3-D printers to build clinical trial-ready devices in-house to check everything from form, fit and function to manufacturability. In fact, some of the most exciting applications of this disruptive technology are occurring in the medical device space.
The greatest advantage 3-D printing offers device manufacturers is the ability to fabricate customized medical products and equipment. Custom-made implants, prosthetics, fixtures and surgical tools can significantly reduce the time required for surgery, as well as patient recovery time and follow-up care. This in turn reduces health care costs.The technology is transforming the way medical care is practiced and delivered, shifting from a reactive population-based model to a customized one, typically referred to as personalized medicine.
Personalized medicine targets individualized treatment and care based on personal and genetic variation, taking into consideration the patient’s genetic make-up, key biomarkers, treatment history, environmental factors and behavior preferences. The treatment model has already had a positive impact on clinical research and patient care, particularly in the treatment of breast cancer, melanoma and cardiovascular disease. According to PricewaterhouseCoopers, the core diagnostic and therapeutic segment of the personalized medicine market, which is comprised primarily of pharmaceutical, medical device and diagnostic companies, is expected to reach $42 billion this year.1 However, the full realization of personalized medicine relies on the continued improvement and acceptance of disruptive technologies like 3-D printing among health care professionals, regulators, policy makers and insurers.
Customization of Medical Devices
Additional Benefits of 3-D Printing
Three-dimensional printing enables mass customization, in that multiple individualized items can be produced simultaneously while improving manufacturing productivity. Early adopters of 3-D printing for the mass production of customized medical devices include dental laboratories and hearing aid manufacturers. In fact, the hearing aid industry boasts the highest installed base of customized final consumer devices that have been produced using 3-D printers.
As the technology becomes more cost-effective for small production runs, the use of 3-D printing in mass device production is rapidly expanding. This is especially true for small-sized standard implants and prosthetics used to treat spinal and craniofacial disorders.2 Three-dimensional printing technology is much faster than traditional (i.e., subtractive) methods of making prosthetics and implants. It cost less, too, with the first item being as inexpensive to print as the last. This is especially advantageous for device companies that have low production volumes or produce parts or products that are highly intricate or require frequent modifications.
The nature of 3-D printing data files also offers an unprecedented opportunity for global collaboration among researchers who can now access downloadable .stl files available in open-source databases. In 2014, the National Institutes of Health (NIH) established the NIH 3D Print Exchange (3dprint.nih.gov) to promote open-source sharing of 3-D printable files for medical and anatomical models. The Exchange allows users to generate high-quality and scientifically-accurate 3-D printable models in minutes, simply by uploading a file or typing in a database accession code.3 Design sharing is expected to accelerate innovation and deliver life-saving products to market sooner.
Challenges 3-D Printing Poses to Manufacturers and Regulators
Clearly 3-D printing has the potential to revolutionize the device industry, but the technology is not without drawbacks. Three-dimensional printers can copy almost anything, making products highly vulnerable to counterfeiting. The use of 3-D printing on a large scale has the potential to allow counterfeiters to manufacture devices in their home market thereby avoiding customs seizures, which could have deadly consequences for consumers.Some experts predict that one day all products will be produced locally, if not in households, making manufacturing as we know it obsolete. Others argue that the technology will have to improve significantly before a 3-D printer is capable of producing realistic fakes made from a single material, let alone composite products made of several different materials, as is the case with most medical devices.
There are a myriad of regulation challenges to confront, as well, acknowledged Steven Pollack, the director of FDA’s Office of Science and Engineering Laboratories. For example, in a traditional manufacturing setting, design controls are in place that may be lacking in a 3-D setting. Devices manufactured using 3-D printers may also require additional or different testing than what is performed on products produced using traditional manufacturing techniques. Although 3-D printing techniques have different technical considerations than standard manufacturing, devices constructed using additive manufacturing techniques are subject to the same regulatory review standards as traditionally manufactured devices.4
Validation and Design Control are the Biggest Areas of Concern
In October 2013, the FDA released a 63-page report, titled “Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development,” which is available at www.fda.gov. The report discussed 3-D printing and other technological advancements that have the potential to disrupt the regulatory status quo. The FDA has also created an additive manufacturing working group to explore some of the design and testing challenges posed by the revolutionary technology. On October 8-9, 2014, the agency held a 3-D printing workshop for industry stakeholders, including OEMs, device manufacturers, testing labs, hospitals, and government agencies. The majority of participants agreed that paying close attention to quality control and process validation was essential to their future success.5
Submission Advice for Designers and Developers
To achieve timely clearance with 3-D printing or other novel technologies, the FDA recommends scheduling a pre-submission meeting, or Q-sub, to interact directly and early with the review team who will ultimately be reviewing the device submission.6 A keen understanding of the capabilities and limitations of the 3-D printing process can also facilitate interactions with regulators regarding device design and testing. These meetings are free. More information about the FDA's Pre-Sub Program can be found here.
As the aging developed world population continues to grow so does the consumer demand for medical devices, particularly diagnostic equipment and other devices that focus on disease prevention. Three-dimensional printing may make the development of such devices feasible that previously was not. The fact that the FDA is addressing 3-D printing at this early stage of its adoption in medical devices should convince manufacturers to pay close attention to it in 2015.
(1) “$232 Billion Personalized Medicine Market to Grow 11 Percent Annually, Says PricewaterhouseCoopers,” PR Newswire. (http://www.prnewswire.com/news-releases/232-billion-personalized-medicine-market-to-grow-11-percent-annually-says-pricewaterhousecoopers-78751072.html) Accessed March 31, 2015.
(2) Ventola, C. Lee, “Medical Applications for 3D Printing: Current and Projected Uses,” Pharmacy and Therapeutics, October 2014. (http://www.ptcommunity.com/system/files/pdf/ptj3910704.pdf)
(3) National Institutes of Health. http://3dprint.nih.gov
(4) Sparrow, Norbert, “An FDA Perspective on the Use of 3D Printing in Medical Applications,” Plastics Today, January 5, 2015. (http://www.plasticstoday.com/articles/FDA-perspective-on-use-3D-printing-medical-applications-150105)
(5) Leonard, Shana, “FDA Grapples with Future Regulation of 3-D Printed Medical Devices,” MD+DI, June 13, 2014. (http://www.mddionline.com/article/fda-grapples-future-regulation-3-d-printed-medical-devices-140613)
(6) Sparrow, Norbert, “An FDA Perspective on the Use of 3D Printing in Medical Applications,” Plastics Today, January 5, 2015. (http://www.plasticstoday.com/articles/FDA-perspective-on-use-3D-printing-medical-applications-150105)
Lisa Weeks, a marketing communications specialist at MasterControl, writes extensively about technology, the life sciences, and other regulated environments. Her two decades of marketing and advertising experience include work with McNeil Pharmaceuticals, SAP AG, SCA Mölnlycke Health Care, Crozer-Keystone Health Systems, and NovaCare Rehabilitation/Select Med.