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Digital Stockpile and National Response Network

A collaborative MOU between the FDA and the Veterans Health Administration.

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Digital network
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Digital Network

Performer: FDA/VHA
Project leaders: James Coburn, Kirstie Snodderly, Joseph Iaquinto, Beth Ann Ripley, Jamie Elliott
Key U.S. Government Collaborators: 

  • Food and Drug Administration (FDA) 
  • Veterans Health Administration (VHA) 
  • White House Office of Science and Technology Policy (OSTP) 
  • National Institutes of Health (NIH) 
  • National Institute of Standards and Technology (NIST) 
  • Department of Defense (DoD) 

Manufacturing USA Partners and Stakeholders: 

  • America Makes (AM) 
  • Advanced Functional Fabrics of America (AFFOA) 
  • Advanced Robotics Manufacturing (ARM) 
  • Leading Innovations for Tomorrow (LIFT) 

Project dates: July 2023 - Present 

History and Purpose

The COVID-19 pandemic revealed significant weaknesses in the medical supply chain, highlighting the need for a more resilient system. The U.S. medical supply chains have been heavily reliant on foreign sources for materials and manufacturing, which poses a risk during global disruptions. To address this risk, there is a critical need to develop domestic capabilities that can ensure the continuous supply of essential resources to patients, even in times of crisis. 

Many governmental, industrial, academic, and non-profit programs are addressing the many facets of this problem. The concept of a Digital Stockpile & National Response Network has been introduced to complement traditional physical stockpiles. It would aim to bolster the production of medical supplies during pandemics or supply chain disruptions. The Digital Stockpile stores comprehensive electronic plans, instructions, and methods for the production and testing of medical products, ensuring that critical resources can be produced on demand. A National Response Network of manufacturers with capabilities to make those products can then be activated in times of need. Many of the manufacturers may use advanced manufacturing techniques in their normal operations, which enable them to quickly change products when needed. These technologies reduce the cost and time to change production, making it possible distribute manufacturing across many small sites that may reach smaller and more remote areas during a crisis.  

Bilateral Memorandum of Understanding (MOU) - MOU 225-23-008

On July 7, 2023, the U.S. Food and Drug Administration (FDA) and the Veterans Health Administration (VHA) initiated a collaboration to enhance emergency preparedness and response capabilities. This partnership is focused on distributed manufacturing and the creation of a roadmap for the development of a digital stockpile. The collaboration is set to last for five years and aims to protect public health and strengthen the resilience of the medical supply chain during emergencies.  

White House Office of Science and Technology Policy Roundtable  

In September 2023, the White House Office of Science and Technology Policy (OSTP) hosted a Roundtable at the Eisenhower Executive Office Building (EEOB) to discuss the concept of a Digital Stockpile and National Response Network. Organizers included the FDA, the VHA, and the Radiological Society of North America 3D Printing Special Interest Group. Participant groups included medical manufacturers, digital infrastructure companies, other U.S. government agencies such as the Department of Defense and Administration for Preparedness and Response (ASPR), healthcare institutions, and supply chain companies. Discussions identified the potential shape and structure of a framework to enhance medical supply chain resilience. They also underscored the importance of choosing products and clinical needs that would be most impactful while also being feasible for external producers to adapt - setting a clear direction for future initiatives. The Roundtable also produced an executive summary highlighting initial ways a digital stockpile could help address the need for risk mitigation in medical supplies, increase the geographic distribution of medical resources, and build a collaborative community to support emergency preparedness and supply chain resilience. 

Current Actions 

Based on the recommendations of the OSTP Digital Stockpile Roundtable, an interagency, public private initiative was launched. The activities of the initiative divided into two working groups to bring focused expertise to different aspects of the problem. Over 25 organizations are represented from healthcare institutions, manufacturing industry, software developers, and government on two collaborative working groups.   

  • Working Group 1 is focused on creating a robust clinical needs and acceptability review framework to assess and manage tiered risks, ensuring clinical acceptability, and setting up comprehensive accreditation processes.   
  • Working Group 2 is focused on building a robust, secure, and interoperable digital infrastructure that supports operation of a Digital Stockpile including needs for data standards, packaging protocols, and ensuring the protection of intellectual property (IP). 

As the initiative moves forward, it will continue to gather insights from end-users, finalize standards and certification requirements, develop risk mitigation strategies, enhance emergency preparedness plans, and develop a framework for a secure digital infrastructure. 

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