Supply chains have never had a higher profile than they do right now. Once the arcane purview of specialists and scholars, the field of supply chain management has been front page news throughout the COVID-19 pandemic. Unfortunately, the reason for this newfound notoriety is that everything, from cars to coffee, seems to be in irritatingly short supply. These shortages have awakened us all to the reality that the products we take for granted are delivered through complex, global supply chains, which can break down.

Not being able to buy toilet paper or a television set is certainly an inconvenience. But not being able to get a chemotherapy drug or mechanical ventilator is life threatening. Of the many supply chains whose fragility was exposed by the pandemic, none are more vital to public health and safety than those for medical products. Recognizing this, Congress, as part of the 2020 CARES Act, called for establishment of an ad hoc committee to examine the security and resilience of U.S. medical product supply chains. This report is the result of a year-long study by that committee.

To focus its work, the committee interpreted “resilience” to refer to the ability of medical product supply chains to match supply with demand under both normal and emergency conditions, so that patients and providers can count on access to medical products when they need them. But matching supply with demand is precisely the role of supply chain management. Why then have we experienced so many shortfalls in normal times, such as chronic shortages of generic injectable drugs for over a decade, and during emergencies, such as inadequate supplies of N95 masks to meet surging demand during the recent pandemic?

The kneejerk response in the media and elsewhere has been to blame globalization. And to be sure, long supply chains with many production stages spread over many locations with many transportation links between them have more failure modes than short domestic supply chains. However, there are also reasons supply chains have become increasingly globalized. Locating production of the various steps in places with cost or capability advantages can facilitate lower prices, higher quality, wider variety, and more innovation. On-shoring a global supply chain by moving all production stages to domestic sites would therefore have consequences. Most prominently, on-shoring could increase costs and reduce affordability of medical products. Indeed, affordability concerns are the reason domestic companies that stepped up to produce N95 masks at the beginning of the pandemic found themselves struggling to survive once international supplies resumed and health systems shifted back to them to reduce costs.

Beyond cost concerns, the resilience benefits of on-shoring depend on what stages are domesticated and how. Moving only the final assembly stage to the United States, as is often proposed in glib on-shoring proposals, will have a limited impact on resilience because it leaves the supply chain vulnerable to disruptions of component and raw material supplies. Even if all stages of a medical product supply chain could be on-shored, if this served to concentrate production of a key stage in a single location, it could leave the very supply chains we are trying to protect more vulnerable to disruption by local disasters like earthquakes or hurricanes.

Finally, even if we could overcome the economic obstacles and risks of supply concentration, it would be irresponsible to on-shore medical products if there were more cost-effective ways to achieve medical product supply chain resiliency. For example, if holding a vast stockpile of a critical medical product would provide more protection for less cost than onshoring the product, why wouldn’t we do it? As a country, we have many social priorities. Unnecessary spending on one means less funds will be available for another.

All this quickly led the committee to the realization that our focus could not be limited to assessing risks of globalization and finding ways to on-shore critical medical products. Nor could it be to simply enumerate ways to make medical product supply chains more resilient. To serve the overarching goal of making the American public safer and more secure, we had to create a framework for systematically enumerating, evaluating, and combining measures into a cost-effective medical product supply chain resiliency strategy.

Fortunately, the committee was comprised of experts in supply chain management, economics, and medicine. While this sometimes led to discussions that sounded like those of the five blind men describing an elephant, it allowed us to leverage our different disciplinary lenses to create a medical product supply chain resilience framework. We made use of this framework, which contains four tiers that address awareness, mitigation, preparedness, and response, to craft and motivate our recommendations. Under the awareness category, we propose measures to collect, compile, and disseminate information about medical product supply chain risks and vulnerabilities. Under the mitigation category, we advocate steps to reduce the likelihood and magnitude of supply disruptions. Under the preparedness category, we describe a range of options for preventing a supply shortage from impacting patients and medical personnel. Under the response category, we suggest policies for building organizational capabilities that protect health during emergency disruptions.

In the end, as our report makes abundantly clear, there is no single “silver bullet” for the medical product supply chain problem. Instead, we believe it is a case of the quote, “God is in the details.” Slogans won’t make us safer in the next crisis than we were in this one, but a host of coordinated activities by medical product supply chain managers, government agents, and medical providers will.

Lastly, I want to express my deepest gratitude to the committee members and the National Academies staff members who worked on this study. The volunteers on the committee devoted major amounts of time and energy on top of their regular professional responsibilities that were heightened by the added burden of dealing with a pandemic. In the case of the clinical members of the committee, this often meant rotating in and out of meetings to treat patients. It was truly an example of America at its best, with people helping people in every way they could. But the discussions, emails, snippets of text, and comments on drafts from these dedicated committee members could not have become a report without the writing and editing skills of the staff. In particular, Lisa Brown and Carolyn Shore organized both the activities of the committee and the writing of the report with exceptional vision and leadership, while Kelsey Babik, Leah Cairns, Andrew March, Margaret McCarthy, and Shalini Singaravelu skillfully bore the brunt of the writing responsibility. It was an honor and a delight to work with all of these wonderful people.

Wallace (Wally) Hopp, Chair

Committee on Security of America’s Medical Product Supply Chain