Personal protective equipment (PPE) was essential during the coronavirus disease 2019 (COVID-19) pandemic, but supply disruptions, foreign export restrictions, and spikes in global demand meant PPE was in short supply. U.S. small and medium-sized enterprises stepped up production in response. The central challenge is not whether they can do so again but whether the conditions exist for them to remain viable, competitive, and surge ready.

Respirator Surge Manufacturing

Options to Ensure U.S. Small and Medium-Sized Enterprises Can Surge the Manufacturing of Respiratory Personal Protective Equipment

Saskia Popescu, Rushil Bakhshi, Derek Roberts, John P. Tarangelo, Henry H. Willis, Rebecca Moritz, Nikhil Kalathil, David Glickstein, Amy Nabel

ResearchPublished Aug 12, 2026

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.

Key Takeaways

High up-front costs remain a major barrier to SME participation in respiratory PPE manufacturing

  • The costs of the specialized machinery and automation necessary to achieve the scale and per-unit efficiency to compete with low-cost foreign producers are high.

Workforce instability is both a symptom and a driver of PPE SME fragility

  • Inconsistent demand, lower compensation, and a shrinking manufacturing talent pipeline make long-term workforce planning difficult.

Constrained market access limits SME participation even when firms can produce quality PPE

  • GPOs, distributors, and incumbent supplier relationships dominate health care procurement and often exclude smaller domestic manufacturers from meaningful opportunities.

Unstable demand is the single most important factor undermining SME survival and long-term readiness

  • Many SMEs that produced compliant respiratory PPE during COVID-19 could not sustain operations once crisis demand receded.

Current stockpiling strategies are not sufficient to sustain domestic manufacturing capacity

  • Stockpiling is essential but cannot, on its own, substitute for a stable, exercised, and commercially viable domestic PPE manufacturing ecosystem.

Certification and compliance requirements are disproportionately burdensome for smaller manufacturers

  • SMEs often lack the in-house regulatory expertise, standardized procedures, and compliance resources available to larger firms.

Loopholes, inconsistent definitions, and limited accountability have weakened domestic sourcing laws

  • Agencies can rely on waivers, narrow price comparisons, weak nonavailability determinations, and ambiguous definitions of the term domestically manufactured to continue purchasing offshore products.

Recommendations

  • Consider a coordinated strategy to strengthen domestic respiratory PPE manufacturing through U.S. SMEs.
  • Integrate the goal of supporting PPE SMEs and the goal of supporting domestic manufacturing to reduce dependence on foreign suppliers, diversify the industrial base, and improve the nation’s ability to respond rapidly during future biological crises.
  • Consider addressing supply, production, and capacity constraints by expanding affordable equipment financing; supporting warm-basing arrangements and precrisis production readiness; funding technical assistance for automation and scale-up; and creating incentives to help SMEs recruit and retain skilled manufacturing, quality assurance, and regulatory personnel.
  • Address demand and market access barriers by creating more-stable and more-predictable demand for domestic PPE, such as through long-term contracts, reforming stockpiling strategies, and requiring hospitals receiving federal reimbursement to source a portion of PPE from U.S. SMEs.
  • Consider targeted tax incentives for health care purchasers that buy from U.S. SME manufacturers, and, when appropriate, use trade tools to reduce the pricing advantages of foreign-made PPE.
  • Consider addressing anticompetitive procurement practices that disadvantage SMEs, particularly within GPOs and distributor contracting.
  • Consider reducing regulatory and procurement loopholes by tightening waiver criteria for domestic sourcing, requiring total cost of ownership analysis instead of simple unit-price comparisons, establishing a clear and uniform definition of what constitutes domestically manufactured PPE, and publicly reporting waiver use and nondomestic procurement decisions.

Topics

Document Details

Citation

Chicago Manual of Style

Popescu, Saskia, Rushil Bakhshi, Derek Roberts, John P. Tarangelo, Henry H. Willis, Rebecca Moritz, Nikhil Kalathil, David Glickstein, and Amy Nabel, Respirator Surge Manufacturing: Options to Ensure U.S. Small and Medium-Sized Enterprises Can Surge the Manufacturing of Respiratory Personal Protective Equipment. Santa Monica, CA: RAND Corporation, 2026. https://www.rand.org/pubs/research_reports/RRA5031-1.html.
BibTeX RIS

Research conducted by

This research was independently initiated and conducted by the Center on AI, Security, and Technology within RAND Global and Emerging Risks using income from operations and gifts and grants from philanthropic supporters.

This publication is part of the RAND research report series. Research reports present research findings and objective analysis that address the challenges facing the public and private sectors. All RAND research reports undergo rigorous peer review to ensure high standards for research quality and objectivity.

This document and trademark(s) contained herein are protected by law. This representation of RAND intellectual property is provided for noncommercial use only. Unauthorized posting of this publication online is prohibited; linking directly to this product page is encouraged. Permission is required from RAND to reproduce, or reuse in another form, any of its research documents for commercial purposes. For information on reprint and reuse permissions, please visit www.rand.org/pubs/permissions.

RAND is a nonprofit institution that helps improve policy and decisionmaking through research and analysis. RAND's publications do not necessarily reflect the opinions of its research clients and sponsors.