Siemens has received a $1.78 million contract with the U.S. Food and Drug Administration to showcase how digital twin representations can improve medical device manufacturing. Results will be closely watched, as much is riding on such manufacturing breakthroughs.

While it was already a matter of national concern, government agencies’ ability to quickly and safely approve vital medications and equipment was put under a bright spotlight with the arrival of COVID-19. The pandemic placed new and continued attention on digital twin technology, as the FDA-Siemens contract indicates.

The pilot FDA program will demonstrate how medical device manufacturers can use digital twins to enhance product quality, speed up product development, and increase manufacturing capacity. Future goals will highlight best practices for quicker vaccine rollouts and safer drug development.

“We hope this will inspire the medical device leadership to think more holistically and strategically about digital transformation and to invest in bringing our industry up to the level of many other industries,” Del Costy, senior vice president and managing director, Americas at Siemens Digital Industries Software, told VentureBeat. “We must continue to push for more digital design and manufacturing to increase accuracy, supply chain resilience, and improve patient outcomes.”

Siemens has long been a leader in medical software and digital twins. This partnership will also give the FDA team hands-on experience with cutting-edge tech that could safely speed regulatory processes.

The project will also showcase best practices for medical companies to adopt into their development workflows. Carryline USA and Premier Automation will also supply cutting-edge 3D conveyors and robotic systems that automate materials handling. These can be dynamically reconfigured for product variations and different products to support hyperautomation of factory lines.

The project could also help FDA teams improve their understanding of new processes and tech to improve industry guidance, develop better regulatory science tools, and prepare for new manufacturing processes.

This builds on prior FDA research on 3D printing, which led to several international standards and widespread adoption of the technology. It has also researched continuous manufacturing techniques for drug substances that led to draft international standards and guidance documents.

Simplifying regulation

One key goal of the program is to demonstrate how digital threads could simplify workflows that cross medical, engineering, quality, and regulatory processes. A digital thread connects multiple data feeds models and representations comprising digital twins of products and factory configurations.

“Creating and leveraging digital threads are an invaluable capability for both medical device manufacturers and the FDA,” Costy said

For example, digital threads can support integrated modeling and simulation processes that span product design, optimized production, and regulatory approval processes. One goal is to help regulators like the FDA find ways to better visualize the product and manufacturing risks, provide more robust traceability and impact analysis, and enable more comprehensive data sets that are easier and faster to review. This will allow regulators to respond much faster, with more precision and better information, to both emergency and non-emergency needs.

The effort was specifically funded by the FDA’s Office of Counterterrorism and Emerging Threats (OCET), which leads FDA efforts to address national and global health security, counterterrorism, and emerging threats.

Transforming med production

The pandemic was a significant factor in pursuing this kind of collaboration between the FDA and industry. “While the medical device industry has been advancing over the past few years, the pandemic exposed the gaps,” Costy said, “especially when compared with the non-medical device manufacturers that jumped in to help manufacture ventilators and other critical supplies.”

Some of the improvements that digital twins can introduce to various types of processes include:

• Simplify design transfer across product development and manufacturing teams;
• Bring agility to scale production and transfer products across manufacturing lines;
• Improve the ability to analyze product and process risks;
• Transition from paper-based quality processes to digital workflows; and
• Facility supplier collaboration and visibility.

“The promise of digital twins, closed loop production systems, distributed manufacturing, and other advanced technologies is that they will enable more efficient use of resources,” FDA spokesperson Stephanie Caccomo told VentureBeat. That means better access to production where it is needed, and better resilience to disruptions by simulating outcomes and product quality with inputs, she continued.

For its part, Siemens plans to configure many different use cases for digital twins workflows such as labeling, supplier collaboration, and designing for service. Down the road, the company hopes to explore new capabilities such as trusted traceability for improving the supply chain. This could help manufacturers rapidly mitigate supply shortages, swap out parts, and reduce counterfeit issues.

The initial use cases will focus on medical devices. Down the road, Siemens would like to demonstrate how digital twins could be used for biologics, pharmaceuticals, food and beverage, and cosmetics manufacturing.