MxD Addressing Pharmaceutical Supply Chain Resiliency, Medical Device Deployment, and Pharmaceutical Industry Production

MxD is embarking on a three-prong program to address critical public health and infrastructure needs and to support manufacturing as it mobilizes in response to COVID-19.  This effort is being supported by $15 million in funding from the U.S. Department of Defense via the Coronavirus Aid, Relief, and Economic Security (CARES) Act.

MxD, the nation’s digital manufacturing institute, is where innovative manufacturers go to forge their futures.  In partnership with the Department of Defense, MxD equips U.S. factories with the digital tools, cybersecurity, and workforce expertise they need to begin building every part better than the last.

MxD’s three CARES Act-funded programs will focus on supply chain resiliency and transparency, rapid and secure medical device deployment, and pharmaceutical industry production optimization.

Supply Chain Resiliency and Transparency

To modernize manufacturing for critical items, such as medical device parts, a secure, robust, and connected supply chain is essential.  A key challenge across supply chains is the secure sharing of data, including performance specifications, factory operations data, or business contracts.  MxD will deliver a supply chain risk alert framework tool to help the Department of Defense and the U.S. manufacturing industry map existing supply chains to identify vulnerabilities, foreign dependencies, and single source suppliers; and identify alternate or indirect suppliers.  It also will have the capability to analyze public data and determine future potential disruptions in supply chains.  This tool will enable manufacturers to make data-informed decisions in times of crisis or urgency and minimize impact on production capabilities.

Rapid and Secure Medical Device Deployment

Additive manufacturing, or 3D printing, has introduced novel ways to manufacture medical device components needed for the COVID-19 response, but the innovation outpaces capacity for review.  Many solutions cannot be implemented because of long lead times for approval and validation.  MxD is developing a digital process to proactively connect the U.S. Food and Drug Administration (FDA) to the medical industry to expedite validation for products during fabrication.  This would create a standard digital pathway for material testing, approval, and validation of the process or part being produced and would enable digital plans for additive manufacturing to be shared across the industrial base.

Pharmaceutical Industry Production Optimization

MxD will provide lessons learned, best practices, and digital tools for manufacturers to accelerate use of digital technologies to scale or flex production, increase resiliency, and strengthen their supply chains – all while maintaining the highest and necessary levels of cybersecurity.  This builds upon work with the FDA Office of Counterterrorism and Emerging Threat.  The assessment will identify the perceived and real barriers to implementing digital technologies that could increase U.S. manufacturing capacity and decrease time to market for medical diagnostics, therapies, and vaccines needed for public health emergency response.