ARTHUR WONG
MEDICAL SERVICES & DEVICES to find alternative solutions, which sometimes exposed patients to greater risks.
How the FDA is addressing the crisis The FDA has taken steps to improve supply chain resilience, but gaps remain. One of the biggest differences between the US and other regions, such as the European Union( EU), is in the approach to shortage reporting.
Since January 2025, the EU has required mandatory reporting of potential medical device shortages, providing governments with early warnings to manage risks. In contrast, the US only mandates such reporting during public health emergencies, leaving hospitals and healthcare providers poorly prepared to anticipate or address shortages.
The FDA’ s reliance on voluntary notifications related to disruptions hasn’ t been plain sailing, resulting in shortages only discovered after healthcare providers report them, often at the point of care – too late to take preventive action.
Michelle Tarver, Director of the FDA’ s Center for Devices and Radiological Health( CDRH), sums it up:“ While the vulnerabilities in the medical device supply chain are not new, we’ re growing increasingly concerned that the rise in shortages is having a significant adverse impact on neonatal and paediatric patients.”
To address these challenges, the FDA has established the Office of Supply Chain Resilience( OSCR) within its CDRH.
ARTHUR WONG
TITLE: HEALTHCARE MANAGING DIRECTOR
COMPANY: S & P GLOBAL RATINGS INDUSTRY: FINANCIAL SERVICES
Arthur has been at S & P for 27 years, having previously been a Senior Auditor at Ernst & Young. He is a dedicated analyst whose key areas of expertise include corporate finance, financial modelling and financial analysis.