The COVID-19 pandemic created a ripple effect for U.S. manufacturers that revealed not only a lack of redundancy in the supply chain but also a lack of transparency. As the pandemic took hold, worldwide demand for personal protective equipment (PPE) dramatically increased and many material and product costs skyrocketed. It quickly became apparent that the PPE supply chain in the U.S. would need reinventing.
The predictable and important immediate response to a short supply of PPE such as N95 masks was to find ways to make more. But several manufacturing innovation institutes in the Manufacturing USA network have taken an expanded view of the issues and asked questions that could fundamentally change the PPE supply chain:
- How can we empower U.S. manufacturers to make PPE?
- How do we match emerging PPE producers with purchasers who need it most?
- How do we test and validate the efficacy of new PPE coming on the market?
Manufacturing USA is a network of 16 institutes and their sponsoring federal agencies — the Departments of Commerce, Defense and Energy. Manufacturing USA was created in 2014 to secure U.S. global leadership in advanced manufacturing. Many of these institutes are engaged in reshaping the PPE supply chain and have received CARES Act funding to prepare the nation for future emergency responses.
This is a look at a handful of areas in which the institutes are leading the PPE supply chain effort.
With so much production of PPE focused in Asia, when the pandemic started it created a ripple effect on U.S. manufacturers that revealed issues in the supply chain. U.S. manufacturers that were making higher-value-add products may not have had adequate backup sources and also might have lacked visibility into all layers of the supply chain, which means they were not able to mitigate disruptions.
PPE supply chain management was, and remains, largely a manual process. All of this combined to make workarounds difficult.
With the onset of the pandemic, the Manufacturing x Digital institute (MxD) quickly produced step-by-step instructions for manufacturers to make face shields for their employees and potentially for their communities. The responsiveness demonstrated the flexibility of digital manufacturing — a quicker path to Plan B and how it might be practical to build products in places that traditionally don’t produce them.
MxD’s face shield initiative provided incentives for its 300 members to jump in and contribute to the greater cause. It also reinforced the institute’s and members’ agility and resolve. In many ways, shifting operations to work on producing face shields was a “proof of concept” for the kinds of adjustments that manufacturers will later face.
Manufacturers jumping into the PPE supply chain or expanding their presence need capital investment and are required to meet legal compliance standards, such as with the CDC or FDA. Another institute, Advanced Functional Fabrics of America (AFFOA), went to work with its partners to create a regional network of testing locations to meet this demand.
These locations provide compliance testing for N95 masks and evaluate the quality of foreign-sourced respirators. They also provide preliminary performance results to researchers seeking to develop new filter media for N95 respirators and surgical masks and evaluate the efficacy of various mask sterilization techniques.
AFFOA also has helped develop the first product lifecycle management system specifically for PPE. This helps designers and developers capture specifications to recreate products moving forward.
This pioneering work has led to CARES Act funding for “Creating a Blueprint for Manufacturing During Periods of Surge Demand.” The initiative will provide product management and oversight to produce additional certified medical PPE, facilitate rapid prototyping of PPE by non-traditional performers, and provide testing/certification capabilities to evaluate new designs.
In addition to testing and product management, AFFOA has created a blueprint for government-owned N95 mask production and distribution; an important safety net for the future.