Critical Shortcomings in the US' Public Health Crisis Plans

In this Pharmaceutical Executive video interview, Marcel Botha, CEO of 10XBeta, discusses shortcomings in the US' emergency plans for rapid innovation and manufacturing during public health crises, highlighting the need for innovation pipelines, supply chain resilience, and regulatory clarity. He also emphasizes the importance of localized manufacturing, public-private partnerships, and advanced manufacturing techniques like AI and additive manufacturing. Botha notes the success of the Spiro Wave project in reducing ventilator size and the need for better coordination and funding structures. He also advocates for a more agile and collaborative approach to ensure rapid response in future emergencies.

Pharmaceutical Executive: It's been five years since the COVID-19 pandemic. Given your experience with the Spiro Wave project, what do you believe are the most critical shortcomings in the US' emergency plans for rapid deployment of innovation and manufacturing during a public health crisis?

Marcel Botha: It was an honor to be part of the ventilator crisis response for New York and to work with MIT on open-source technology that was shared globally. However, it was also alarming to realize how unprepared we were—not just at that moment, but in general—for responding to critical challenges quickly. Despite living in a world where disaster scenarios dominate our media and climate-driven and man-made emergencies frequently remind us of our vulnerabilities, we remain in a state of unpreparedness.

Our responses during the pandemic were ad hoc and disorganized, unavoidable due to the lack of established innovation pipelines and a clear framework for emergency responses. We figured things out quickly, with the Emergency Use Authorization process being a prime example. The FDA did a commendable job keeping pace with the speed at which innovators and community members mobilized. Still, the agency was never designed to engage with so many stakeholders simultaneously. This lack of a structured process slowed critical decision-making and introduced uncertainty around whether efforts to help would result in real impact.

Supply chain vulnerabilities were another major issue. During the pandemic, we solved this by vertically integrating everything into one facility. But this level of agility was only possible because we cashed in every favor and pulled together resources creatively. Future responses cannot rely on such improvisation. We need a more resilient and decentralized supply chain that can withstand geopolitical threats and component shortages without collapsing.

Fragmentation between the public and private sectors also hindered an effective, unified response. The pandemic response became politicized, and competition for limited resources created a hierarchy where some groups believed they should be prioritized over others. Private sector involvement filled the gaps, but that shouldn’t be the default response. We need better public-private collaboration to ensure a more cohesive approach in future crises.

High-speed innovation is expensive, and the lack of clear funding and accountability structures made rapid action even riskier. During the pandemic, it became evident that investing in solutions without a clear customer or funding model could be a costly gamble. Future disaster responses need transparent communication around funding, contracting, and vetting to prevent fraud and ensure that resources are used efficiently.

Finally, while vertical integration allowed us to meet the ventilator demand during COVID-19, future responses should not rely solely on centralized systems. We need flexible, scalable manufacturing and supply chain systems that can adapt quickly to evolving needs. Without these improvements, we risk repeating the same mistakes when the next crisis arises. The pandemic made it clear that we can no longer assume the government will step in to save us. Those capable of acting must do so, but we need a more structured framework to ensure those efforts are coordinated, effective, and sustainable.