ARTHUR WONG
SUPPLIER DIVERSITY
“ In recent months,” Michelle continues“ the FDA has had to rely mostly on hearing about medical device shortages from healthcare providers and clinical professional societies. Given this often occurs at the point-of-care, it is typically far too late to put measures into place that would otherwise avert these shortages.”
For example, in 2022 the US experienced a shortage of paediatric tracheostomy tubes. Triggered by production problems and sterilisation delays, the lack of early alerts for the shortage meant hospitals had to improvise by reusing devices beyond recommended limits or substituting adult versions – increasing the risk of complications.
Engaging stakeholders through formal supply chain partnerships, community forums or real-time inventory data sharing helps build trust in these scenarios and allows innovation from the ground up. Clinicians can point out usability issues with devices whilst NGOs can highlight ethical concerns in sourcing and governments can respond with policy support.
ARTHUR WONG
TITLE: MANAGING DIRECTOR FOR HEALTHCARE
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.
The pitfalls of reactive regulation One of the core reasons the FDA struggles to act early is because it lacks the authority to require advance notification of medical device shortages, except during an official public health emergency. In contrast, the European Union introduced a rule in January 2025 requiring manufacturers to notify regulators of anticipated shortages, a proactive model which gives governments more time to intervene.