Americans may be surprised to learn that many 21st-century medical products are still being manufactured using technologies commonly employed since the middle of the last century. These manufacturing platforms are not dynamic and can increase the risk of shortages, limit flexibility during an emergency, and contribute to the high cost of medical products.

For the past several years, the U.S. Food and Drug Administration (FDA) has sought to encourage and facilitate the adoption of “advanced manufacturing,” which refers to new and emerging approaches for the production of medical technologies. These approaches are applicable to different medical product areas. For example, process intensification methods, such as continuous manufacturing, can simplify and centralize the production of many essential medicines. Likewise, techniques such as 3D printing can help produce patient-specific medical devices. Furthermore, digital and smart technologies for designing and manufacturing processes also promise to increase efficiency and reduce uncertainty.

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