One of the most interesting new tools in the medical device manufacturer's toolkit is three dimensional printing. With implications for R&D prototyping and testing, customized implants, and manufacturing processes, improvements on this technology are leading to exciting solutions to persistent problems. There are a few hurdles to overcome, but the technology has the potential to revolutionize several aspects of medical care while shortening the device development pathway.
Let's start with patient care and treatment. Whether developing a patient customized exoskeleton, such as a cast or brace, or an implant such as a plate, stent or prosthesis, 3-D blueprinting from medical imaging and then printing the device embodies individualized medicine. Currently the technology can be accomplished with various polymers and metals (using hybrid 3-D printing and post machining techniques) as well as some biosorbable polymers. Once the vascularization technology barrier is overcome, tissue generation using the patient's own cells may be accomplished using 3-D printed molds and layering skin, cartilage, and endothelial cells. Organ generation is a long way off, but molded tissue generation represents a substantial and achievable advance.
The variety of materials available also helps ensure that the structure of the device is as rigid or as flexible as the treatment needs to be. Some 3-D printing materials can be absorbed by the body as the body's own systems heal and replace a temporary biosorbable implant. Another advance that 3-D printing can accommodate is growth. Specific materials and structures can be printed to build an implant that stretches to accommodate a growing system, such as the three-year airway splint used in an infant's procedure for tracheobronchomalacia in 2012 at University of Michigan's C.S. Mott Children's Hospital. (New Yorker, November 24, 2014)
Another way that 3-D printing has revolutionized patient care concerns the ability to build anatomical models of an individual patient for surgical planning. Using 3-D blueprinting developed from medical imaging, a model of the area in question can be built so that a surgeon can determine, given the patient's anatomy and pathology, which approaches and which tools are most likely to be successful. Since every patient has a completely individual internal landscape, this is particularly helpful in situations with high vascularity, high risk neurosurgery, or where pathology such as a malignancy has warped the anatomy. Practice makes perfect and leads to better outcomes for patient and physician alike.
For manufacturers, the technology has some additional applications. The ability to generate polymer prototypes of tools rapidly has the potential to make the R&D pathway, human factors validation process, and the concept evaluation process much faster. In addition, manufacturers can now generate new prototypes affordably and quickly, ensuring that their final design is informed by solid user feedback instead of conjecture.
The technology has huge implications for the manufacturing process itself. The current applications span everything from Hybrid 3-D printing (metal printing and machining in the same machine for steel, copper and nickel), to generating production molds. The savings in the cost of raw materials and the reduction in industrial waste when you build up versus carve represent a sea change for the industry.
For now, the regulatory hurdles associated with manufacturing devices via 3-D printing are not substantially higher than those manufactured using traditional industrial molding and machining processes. The FDA has chosen to view the method of manufacture with the same diligence applied to CNC manufacturing, according to an article in the February 11, 2015 issue of MD&DI. The typical issues of cleaning, removing processing agents, biocompatibility, infection and contamination still apply.
As of February, 2015, 85 3-D printed medical devices have been approved by the FDA. Although these were primarily 510k and emergency submissions, there's a strong possibility that an industry which has always looked for efficient ways to manufacture devices that need to conform to the demands of individual anatomy will include 3-D printing into its standard product development and customization processes.
So let's hear from our industrial designers, R&D teams and physician inventors- how have you used 3-D printing in medical applications?