Siemens has been awarded a contract by the FDA to implement advanced industrial software and an automated manufacturing production line as part of the FDA’s Office of Counterterrorism and Emerging Threats (OCET) advanced manufacturing programme.

The FDA will gain access to software from Siemens Digital Industries Software’s Xcelerator portfolio including 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; and IIoT.

The new automated production line will help support evaluation and industry adoption of smart design and manufacturing processes in the life sciences, with the aim of improving the performance, speed regulatory review, supply and supply chain resilience in the United States.

In addition to providing demonstrations of “the art of the possible” with digitalisation 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.

The programme is designed to support more 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.

“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 US 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.”

“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.