Clinical significance of three-dimensional printed biomaterials and biomedical devices
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Introduction The US Food and Drug Administration (FDA) was established in 1906 to protect and promote advancements in drugs, biological products, medical devices, food, and cosmetics. It was not until 1976 that the FDA established a risk-based classification system1 to provide assurance of safety and effectiveness for all medical devices. Class I encompasses devices that are minimal in potential harm, such as bandages and examination gloves. Class II devices present moderate risk of harm, including powered wheelchairs and air purifiers. Class III devices sustain or support life, are typically implanted and have a high risk of potential injury such as pacemakers and defibrillators. Most Class II devices are required to be FDA approved and all Class III devices must be FDA approved. These devices have traditionally been made through processing methods such as casting and machining, favorable for high volume production, low cost, reproducible, and reliable. However, conventional manufacturing comes with
limitations especially in the medical field, as no two patients are identical and treatment needs will vary. Threedimensional printing (3DP) has become the pinnacle for patient-specific medical devices ranging from metal implants such as those used in arthroplasties, ceramic implants used for bone defects, and even bioprinting to produce artificial organs potentially eliminating the need for donors and organ transplants.2–5 Such a versatile manufacturing approach also allows for the redesigning of implants to aid in clinical success (see Figure 1). Not only can 3DP be used to build physical biomaterials and biomedical devices, the methodology includes 3D modeling, which can also be used for surgical planning. Parts derived from 3DP can be tailored to incorporate other medically relevant necessities such as drug delivery. This article reviews the clinical significance of various 3DP techniques and their use within a multitude of biomedical devices. An outline of the most relevant 3DP processes for biomedical applications is shown in Table I.
Susmita Bose, W.M. Keck Biomedical Materials Research Laboratory, School of Mechanical and Materials Engineering, Washington State University, USA; [email protected] Kellen D. Traxel, W.M. Keck Biomedical Materials Research Laboratory, School of Mechanical and Materials Engineering, Washington State University, USA; [email protected] Ashley A. Vu, W.M. Keck Biomedical Materials Research Laboratory, School of Mechanical and Materials Engineering, Washington State University, USA; [email protected] Amit Bandyopadhyay, W.M. Keck Biomedical Materials Research Laboratory, School of Mechanical and Materials Engineering, Washington State University, USA; [email protected] doi:10.1557/mrs.2019.121
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