3D printing medical technologies were introduced in 1984 but the application for innovative healthcare solutions has progressed significantly over the past 3 to 5 years. Today, advancements are underway to develop sophisticated, individualized healthcare treatments to improve patient outcomes in a broad range of specialty practice areas. Allied Market Research reported that “3D printing technologies for medical devices will be a $2.3 billion industry by 2020.”
3D printing, often referred to as additive manufacturing, produces a customized physical model or object from digital information. Technology configures a 3-dimensional object from a digital model utilizing additive processes whereby layers of materials are assembled on top of one another to build the desired object. Medical imaging techniques, such as X-rays, CT scans, MRIs and ultrasound reports generate the digital file that is fed into the 3D printer. The four primary uses of 3D technologies are creation of surgical tools and instruments, tissues and organs, patient-specific surgical models and exterior custom-made prosthetics. 3D manufacturing is considerably less costly than traditional production methods, thus rapidly displacing older medical production techniques.
Customized models specific to the individual’s medical condition and anatomy for diagnostic and surgical planning are leading to improved patient outcomes. Surgeons, for example, can design specific /tools to guide an operation, such as the positioning of implants with greater efficiency. Cardiologists at the Arkansas Children’s Hospital in Little Rock are creating 3D printed models of a child’s heart so the surgeon can hold, feel and view from various angles prior to operating. Spiritam is the first 3D printed medication to receive FDA approval. The prescription oral tablets to treat epilepsy seizures are more porous so can melt in the patient’s mouth almost instantly and the layered construction allows for precise active-ingredient dosages. 3D printed casts to treat broken bones are reported to promote healing 40-80% faster than traditional methods.
Exposure to risk associated with new medical technologies typically involves claims linked to allegations of patient bodily injury or manufactured product defect. Legal claims discovery process of damages undoubtedly leads to regulatory scrutiny of the 3D manufactured device. Based on the application, FDA approval is required one of the three appropriate regulatory divisions: Medical Devices, Biologics, and Drugs. Product manufacturers also can pursue premarket approval through the 510(k) process that is less strict and does not require testing of the patented technology. FDA has issued “guidance” on 3D printing technologies for additive manufacturing of what to include in premarket submissions. The guidance states that “premarket submissions made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is substantially equivalent, to a legally marketed device that is not subject to premarket approval.”
3D medical technology is and will be fully embraced by the medical community to undercover evolving healthcare solutions that can be individualized for each patient. Personalized medicine is the long term goal for greater treatment efficiencies and improved patient outcomes. “3D printing is certain to alter the daily practice of medicine where patients will be treated with medical products manufactured specifically for them,” stated FDA Commissioner Scott Gottlieb.
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