The Food and Drug Administration’s (FDA) Office of Counterterrorism and Emerging Threats (OCET) has awarded a contract worth over $1.78M to Siemens Government Technologies (SGT) with technology from Siemens Digital Industries. Siemens will provide its expertise to implement advanced industrial software for digital design and an automated manufacturing production demonstration line for regulatory science use in the FDA OCET advanced manufacturing program. This program is collaborating with the Center for Devices and Radiological Health (CDRH) to provide FDA with access to extensive software from 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.
The digital showcase will help facilitate evaluation, education and industry adoption of smart design and manufacturing processes, which can improve performance, speed regulatory review, reduce supply shortages and increase supply chain resilience in the Lifesciences industry.
“The FDA is focused on developing standards, metrics and data needs for the use of advanced digital design and manufacturing technologies,” said FDA Chief Scientist Rear Adm. Denise Hinton. “Furthering the adoption of these new technologies can help increase U.S. manufacturing capacity, increase supply chain resilience, decrease time to market for medical diagnostics, therapies and vaccines that are needed for public health emergency response.”
“We are excited to support the FDA as it evaluates applicable digital technologies for supply chain resilience in the face of great national challenges,” said Tina Dolph, president and CEO of Siemens Government Technologies. “Our supply chains are the true lifeblood of our ability to respond and adapt when facing a crisis, which is why the FDA’s work is so consequential.”
In addition to providing demonstrations of “the art of the possible” with advanced digitalization and factory automation, the showcase will help the FDA to gain an understanding of the different processes and technologies to help inform industry guidance, develop regulatory science tools and standards to evaluate incoming submissions, and prepare for potentially disruptive changes to design and production norms. This preparation and understanding aids in rapid responses 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 the exploration of and experimentation with advanced digital capabilities that can be used to develop and manufacture life-saving products,” said Del Costy, Senior Vice President & Managing Director, Americas at Siemens Digital Industries.
“In addition to helping the FDA gain new perspectives in developing industry guidance, evaluation of 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 leading the way, this partnership will help accelerate the digital transformation occurring across the healthcare industry,” 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 live, the FDA may also host 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.