Siemens Government Technologies recognized by Fast Company for developing new digital model for FDA regulatory review

Fast Companys 2022 World Changing Ideas Awards

Changing the world requires innovative thinking. And innovation begins with an idea—an idea that inspires and transforms.

As part of the Fast Company’s 2022 World Changing Ideas Awards, Siemens was named the “World Changing Company of the Year,” a tremendous honor recognizing companies relentlessly pursuing innovation for the good of people and planet.

Yet as Barbara Humpton, CEO of Siemens USA, states, “This recognition didn't happen overnight. Instead, it’s the outcome of consistently creating technology with purpose, meeting challenges with innovative solutions and making a difference in people’s lives.”

Leading the path to innovative digital evaluation

Over the past decade, Fast Company has honored many Siemens projects, including the deployment of microgrids to keep power on in emergency situations, development of smart buildings and more sustainable transportation, and industry-leading technologies that are charting a new era of manufacturing. But this year, Siemens’ projects clearly stood out among the nearly 3,000 submissions Fast Company received, showcasing Siemens as a leading global technology company supporting the industries and infrastructure forming the backbone of economies.

One of the projects recognized this year by Fast Company was a collaboration between Siemens Government Technologies (SGT)—the federally focused U.S. arm of Siemens—and Siemens Digital Industries. Receiving honorable mention, the project features the use of digital twins and Siemens’ advanced industrial software to provide the Food and Drug Administration’s Office of Counterterrorism and Emerging Threats a virtual digital production capability for study and evaluation. The goal is to 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.

Fast Company has honored many Siemens projects

Helping the FDA expedite regulatory review

FDA approval processes comprise numerous steps to ensure the safety and efficacy of new drugs, devices, and therapies. Navigating the process can be complex and time-consuming, and as a result, the FDA is proactively looking for methods to accelerate the pace of review.

Initiated in 2021 by the FDA’s OCET office through a contract to SGT, the program is a collaboration with the Center for Devices and Radiological Health (CDRH) to provide the FDA with access to Siemens Xcelerator, 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 opportunity at hand is to truly explore the “art of the possible” and evaluate smart design and manufacturing processes of medical devices, such as ventilators and personal protection equipment, to improve performance, speed regulatory review, reduce supply shortages and increase supply chain resilience.

“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.”

The contract between Siemens and the FDA will last for several years as new use cases are developed and implemented. In addition to showcasing the potential of advanced digitalization and factory automation within life sciences, the contract will help the FDA better understand the processes and technologies that inform industry guidance, develop new regulatory frameworks, and prepare for potentially disruptive changes to design and production norms, such as those experienced with the SARS-CoV-2 virus.

Innovation that achieves your mission

Innovation that achieves your mission

SGT is honored to be recognized by Fast Company for our work with the FDA. Our mission is to harness the innovation and excellence of Siemens to secure and modernize the largest infrastructure in the world – the U.S. Federal Government – so it can keep its citizens safe and economy thriving. Each day, we aim to drive real impact and make a difference within the communities we serve. For us, change begins with a simple idea that opens the world to new possibilities.

Learn more about our mission here