By: Sugato De, Principal Consultant, PAREXEL Consulting
Additive manufacturing (3-D printing) has long been identified as disruptive technology with significant potential to alter business, manufacturing, and consumer access in fields ranging from aerospace to automobiles and construction. Given the exponential advances in 3-D printing equipment and capabilities over the past decade, the healthcare industry in particular is on the precipice of a new wave of innovation in the field encompassing medical devices, medications, and human tissues. To date, the Food and Drug Administration (FDA) has reviewed over 100 3-D printed medical products, including custom spinal and craniofacial implants, printed pills, and even a material intended to replace portions of a human trachea. Coinciding with correlating industry trends of patient centricity, customization, and ease-of-access, the potential applications for 3-D printing are truly vast.
In recognition of these developments, the FDA published a new guidance document on December 5, 2017 that outlines technical considerations for additive manufactured medical devices. In doing so, the FDA has outlined a comprehensive regulatory framework that is intended to keep pace with innovation and facilitate efficient access to these products. Specifically, the guidance document provides detailed recommendations on design and manufacturing considerations and broadly outlines the types of performance characterization that are required for additive manufactured products. Cumulatively, this guidance document adds a welcome level of transparency on the FDA’s current regulatory and technical positions relating to 3-D printed devices and provides a useful roadmap to developers.
PAREXEL Consulting features dedicated subject-matter expertise that is uniquely suited to advise manufacturers on the development, evaluation, and regulation of additive manufactured medical products. PAREXEL is currently supporting clients in developing regulatory strategies, clinical development plans, and premarket submissions for a variety of 3-D printed custom implants and drug-delivery systems. PAREXEL is also involved the development of printed implants that feature novel drug or biological components.