In today’s fast-paced world, demonstrations of “the art of the possible,” combined with advanced digitalization and factory automation, are one way Siemens showcases how different processes and technologies can help prepare for potentially disruptive changes to design and production norms. This preparation and understanding can lead to more rapid responses to pandemics, such as the COVID-19 virus, as well as enhance our ability to respond to future emerging threats.
To support the FDA’s Office of Counterterrorism and Emerging Threats (OCET) advanced manufacturing program, Siemens will install and configure an advanced digital design and manufacturing showcase to demonstrate “the art of the possible” in creating digital twins and digital threads for some medical devices. This will include an actual manufacturing line with Siemens Digital Industries Software’s Xcelerator portfolio, including advanced integrated software capabilities for design control and risk management; product lifecycle management; product, plant, and process design modeling and simulation; manufacturing execution; closed-loop quality management; Industrial Internet of Things (IIoT) and much more. This advanced digital technology is already used in many industries, including aerospace, defense, automotive, and consumer products.
Creating and leveraging digital threads are an invaluable capability for both medical device manufacturers and the FDA. Digital twins and threads, with the use of integrated advanced modeling and simulation, can enable significantly better product design and performance with more optimized production. Digital artifacts can be reused across the lifecycle, creating efficiency, fewer mistakes, and increased quality. This capability can also help regulators better visualize product and manufacturing risks, provide more robust traceability and impact analysis, and enable more comprehensive data sets that are easier and faster to review. In summary, regulators will be able to respond much faster with more precision and with better information to both emergency and non-emergency needs.
Siemens’ long-term goal for this project is to use technology to help educate and drive digital thread adoption for both the manufacturers and regulators. That can lead to better patient outcomes and a more efficient and competitive industry.