WHITE OAK, Maryland – (BUSINESS WIRE) – October 1, 2021–
Food and Drug Administration (FDA) Office of Counterterrorism and Emerging Threats (OCET) awarded Siemens Government Technologies (SGT) a contract worth more than $ 1.78 million with technology from Siemens Digital Industries. Siemens will contribute expertise to implement advanced industrial software for digital design and an automated manufacturing production demonstration line for regulatory scientific use in the FDA’s OCET advanced manufacturing program. This program works with the Center for Devices and Radiological Health (CDRH) to provide FDA access to comprehensive software from Siemens Digital Industries Software’s Xcelerator portfolio, including advanced integrated software capabilities for design control and management. risks ; product lifecycle management; modeling and simulation of product, plant and process design; execution of manufacture; closed loop quality management; Industrial Internet of Things (IIoT) and much more.
The digital storefront will help facilitate industry assessment, education and adoption of intelligent design and manufacturing processes, which can improve performance, accelerate regulatory review, reduce supply shortages and increase supply chain resilience in the life sciences industry.
“The FDA is focused on developing standards, metrics, and data requirements for the use of advanced digital design and manufacturing technologies,” FDA Chief Scientist Rear Admiral Denise Hinton said. “The continued adoption of these new technologies can help increase the manufacturing capacity of the United States, increase supply chain resilience, reduce the time to market for medical diagnostics, therapies. and vaccines needed for emergency public health responses. “
“We are delighted to support the FDA in the assessment of applicable digital technologies for supply chain resilience in the face of major national challenges” said Tina Dolph, President and CEO of Siemens Government Technologies. “Our supply chains are the real cornerstone of our ability to respond and adapt in the face of a crisis, which is why the work of the FDA is so important.”
In addition to providing demonstrations of the ‘art of the possible’ with advanced digitization and factory automation, the showcase will help the FDA understand different processes and technologies to help inform industry directions, develop Regulatory science tools and standards to evaluate incoming bids and prepare for potentially disruptive changes in design and production standards. This preparedness and understanding helps to respond quickly to pandemics, such as the SARS-CoV-2 virus, and future emerging threats. This collaboration with Siemens, Carryline USA and Premier Automation will also include the commissioning of a conveyor system.
“Siemens is proud to support the FDA in exploring and testing advanced digital capabilities that can be used to develop and manufacture products that save lives,” said Del Costy, senior vice president and general manager, Americas at Siemens Digital Industries.
“In addition to helping the FDA gain new insights in developing industry guidance, evaluating submissions and preparing for the next disruption; this technology showcase will also help demonstrate to manufacturers the possibilities that exist today to accelerate product development, improve performance, increase production capacity and enable more flexible and agile manufacturing networks. With the FDA in the lead, this partnership will help accelerate the digital transformation underway in the healthcare sector ”, said Barbara Humpton, President and CEO of Siemens Corporation.
The contract between Siemens and the FDA will last for several years as new use cases are developed and implemented. Once the first set of use cases are online, the FDA may also hold public events such as workshops. This project is funded by the FDA under contract but does not necessarily express the views or policies of the FDA.
For more information on using digital twins for advanced manufacturing, please visit https://www.sw.siemens.com/en-US/.
Siemens Government Technologies is the wholly owned and licensed US subsidiary of Siemens Corporation whose mission is to secure and modernize the world’s largest infrastructure, the US Federal Government. To do this, he is the leading integrator of innovative products, technologies, software and services from Siemens in the areas of digital engineering and modeling, efficient and resilient energy solutions and smart infrastructure modernization.
Siemens software for digital industries is driving the transformation to enable a digital business where engineering, manufacturing and electronics design meet tomorrow. The Xcelerator wallet helps businesses of all sizes create and operate digital twins that provide organizations with new perspectives, opportunities and levels of automation to drive innovation. For more information on Siemens Digital Industries Software products and services, visit www.sw.siemens.com or follow us on LinkedIn, Twitter, Facebook and Instagram. Siemens Digital Industries Software – Where today meets tomorrow.
Siemens Company is a US subsidiary of Siemens AG, a global technological powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for over 170 years. Active globally, the company focuses on smart infrastructure for buildings and distributed energy systems, as well as automation and digitization in the process and manufacturing industries. Siemens brings the digital and physical worlds together for the benefit of customers and society. Through Mobility, a leading provider of intelligent mobility solutions for rail and road transport, Siemens is helping to shape the global market for passenger and freight services. Through its majority stake in listed company Siemens Healthineers, Siemens is also one of the world’s leading providers of medical technology and digital health services. In addition, Siemens has a minority stake in Siemens Energy, a world leader in the transmission and generation of electricity listed on the stock exchange since September 28, 2020. In fiscal year 2020, Siemens Group USA generated revenue of ‘billion dollar business and employs approximately 40,000 people serving customers in all 50 states and Puerto Rico.
Note: A list of relevant Siemens brands is available here. Other trademarks are the property of their respective owners.
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PUB: 01/10/2021 09: 00 / DISC: 01/10/2021 09:02