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Siemens has received a $ 1.78 million contract with the U.S. Food and Drug Administration to show how digital twin presentations can improve medical device manufacturing. The results will be closely monitored as much is running on such manufacturing breakthroughs.
Although already a matter of national concern, the ability of government agencies to quickly and safely approve vital drugs and equipment was put under a bright spot with the arrival of COVID-19. The pandemic drew new and continued attention to digital twin technology, as the FDA-Siemens contract indicates.
The FDA pilot program will demonstrate how medical device manufacturers can use digital twins to improve product quality, accelerate product development, and increase production capacity. Future goals will highlight best practices for faster vaccine rollout and safer drug development.
“We hope this will inspire medical device management to think more holistically and strategically about digital transformation and invest in bringing our industry up to par with many other industries,” said Del Costy, senior vice president and CEO , 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 provide the FDA team with hands-on experience in cutting-edge technology that can safely accelerate regulatory processes.
The project also demonstrates best practices for medical companies to incorporate into their development workflows. Carryline USA and Premier Automation will also provide cutting-edge 3D conveyor belts and robotic systems that automate material handling. These can be dynamically reconfigured for product variations and different products to support hyperautomation of factory lines.
The project can also help FDA teams improve their understanding of new processes and technologies to improve industry guidance, develop better regulatory scientific tools, and prepare for new manufacturing processes.
This builds on previous FDA research on 3D printing, which led to more international standards and widespread use of the technology. It has also examined continuous manufacturing techniques for drug substances that led to draft international standards and guidance documents.
Simplification of regulation
A key goal of the program is to demonstrate how digital threads could simplify workflows that cross medical, technical, quality, and regulatory processes. A digital thread connects multiple data feed models and representations that include digital twins of products and factory configurations.
“The creation and exploitation of digital threads is an invaluable capacity 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 product and production risks, provide more robust traceability and impact assessment, and enable more comprehensive data sets that are easier and faster to review. This will enable regulators to respond much faster, with more precision and better information, to both urgent and non-urgent needs.
The effort was specifically funded by the FDA’s Office of Counterterrorism and Emerging Threats (OCET), which directs the FDA’s efforts to address national and global health security, counter – terrorism, and emerging threats.
Transformation of production
The pandemic was a major factor in the pursuit of this kind of collaboration between the FDA and the industry. “While the medical technology industry has been booming over the past few years, the pandemic revealed the gaps,” Costy said, “especially compared to non-medical device manufacturers who jumped in to help manufacture fans and other critical supplies.”
Some of the improvements that digital twins can introduce to different types of processes include:
- Simplify design transfer across product development and production teams;
- Gain flexibility to scale production and transfer products across production 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 production systems, distributed manufacturing and other advanced technologies is that they will enable more efficient use of resources,” FDA spokeswoman Stephanie Caccomo told VentureBeat. That means better access to production where needed, and better resistance to disruption by simulating results and product quality with input, she continued.
For its part, Siemens plans to configure many different application cases for digital twin workflows, such as labeling, vendor collaboration, and service design. Along the way, the company hopes to explore new opportunities, such as reliable traceability to improve the supply chain. This can help manufacturers quickly alleviate supply shortages, replace parts, and reduce counterfeit problems.
The first cases will focus on medical devices. Along the way, Siemens would like to demonstrate how digital twins can be used for biology, medicine, food and beverage and cosmetics manufacturing.
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