The United States lacks a resilient domestic manufacturing base that can rapidly manufacture respiratory personal protective equipment (PPE) during biological emergencies. The coronavirus disease 2019 (COVID-19) pandemic exposed dangerous shortages of PPE; supply disruptions, foreign export restrictions, and spikes in global demand left health care workers and the public without adequate protection when it was needed most.
Among the U.S. manufacturers that were able to step up or turn to production of PPE during the pandemic were small and medium-sized enterprises (SMEs). SMEs represent an important but underleveraged part of a more resilient domestic industrial base: Their flexibility, regional distribution, and potential for surge production make them well positioned to support emergency response, but current market and policy conditions leave these SMEs at a persistent disadvantage.
The barriers U.S. SMEs face are interconnected across production, regulation, procurement, workforce, and demand. These challenges include access to raw materials, the capital for specialized equipment, regulatory approval, and procurement systems that favor large incumbent firms and group purchasing organizations (GPOs). The central challenge is not whether domestic SMEs can produce respiratory PPE but whether U.S. policy creates the conditions for them to remain viable, competitive, and surge ready.
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