Restructuring Medical Device Supply Chains to Withstand Global Emergencies

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: Medical device supply chains remain vulnerable to geopolitical disruptions and material shortages. In your opinion, beyond the resilience built since 2020, what specific, actionable steps can be taken to further restructure these networks to better withstand future global emergencies?

Marcel Botha: Many practical solutions align with bipartisan incentives and long-term job creation goals, which can help strengthen the US as a manufacturing economy and make us more resilient for future rapid-response initiatives. Over the past 30 to 40 years, we've prioritized offshore manufacturing for cost efficiency instead of investing in a high degree of automation like Japan did. As a result, we adopted a commoditized approach, and much of our manufacturing shifted to China or Southeast Asia.

We need a dual approach to build a more resilient future: maintaining a distributed, diverse supply chain while fostering localized, agile manufacturing hubs across the US. While international suppliers provide cost benefits, critical infrastructure—such as healthcare and adjacent sectors—should rely on domestic stockpiling, final assembly, quality control, and intellectual capital. A resilient system doesn’t come from massive, single-source facilities making one thing well. It comes from a fleet of small to mid-sized manufacturing hubs that can rapidly pivot to meet crisis demands. Our work during COVID-19 proved that this model works, and with an investment of $100 to $200 million, similar advanced hubs could be replicated nationwide. These hubs would serve as rapid-response centers capable of stepping in immediately when national emergencies arise.

We also need to overhaul our National Defense Stockpile system. Right now, it’s little more than a collection of outdated equipment gathering dust. We need real-time inventory tracking linked to preventative maintenance schedules to know precisely what we have and whether it’s ready to deploy. For example, traditional ventilators require regular servicing—O-rings dry out, and the devices become inoperable over time, even when unused. Without routine oversight, we risk having unusable equipment during an emergency. We could simulate potential disaster scenarios with AI and predictive modeling and forecast resource needs to improve preparedness.

Another critical gap is the lack of modularity and cross-compatibility in medical device design. Competing manufacturers like Philips, GE, Medtronic, and Boston Scientific create device ecosystems that don’t easily interoperate with minimal cross-licensing or modular design. Medical devices should be more like consumer electronics—modular, hot-swappable, and easier to upgrade or repair. The FDA’s regulatory environment discourages this, but we must rethink device design for future emergencies where agility and adaptability are essential.

Another key area is transparency in supply chain reporting. While the FDA is considering implementing supply chain metrics similar to European standards, we need broad, consistent reporting across all medical devices. This transparency would strengthen the system by ensuring a minimum six-month supply of raw materials and subcomponents without compromising competitive advantage. Greater supply chain visibility would also accelerate response times in emergencies.

Finally, we need international agreements focused on innovation and healthcare resilience, similar to NATO’s framework for military collaboration. Nationalist, isolationist thinking hampered our ability to respond effectively during the pandemic. For example, even when we had surplus equipment for donation to other countries, bureaucratic red tape and unclear funding, regulatory, and shipping processes slowed down or prevented aid. Establishing clear bilateral and multilateral agreements would allow for smoother international cooperation in future crises.

To truly improve our emergency response capabilities, we need a combination of localized manufacturing agility, more intelligent supply chain systems, modular device design, and international collaboration. Without these changes, we risk repeating the same mistakes when the next crisis hits.