How One Rule Rewrote Global Trade in Medical Devices

Episode 47 of Global Trade with Fexingo dives into the World Trade Organization's 1995 Technical Barriers to Trade Agreement and how one provision—international standards for medical devices—reshaped a $600 billion industry. Lucas and Luna explore the case of pulse oximeters: why devices calibrated for lighter skin failed during the COVID-19 pandemic, and how the TBT agreement's 'necessity test' forced regulators to update standards. They discuss the role of the International Organization for Standardization (ISO), the FDA's 2024 guidance on racial bias in pulse oximeters, and the broader implications for trade in medical goods. The episode reveals how a trade rule written 30 years ago quietly governs the safety of surgical masks, ventilators, and even the accuracy of the device on your fingertip. If you've ever wondered why your doctor trusts that reading, this episode explains the trade law behind it. #MedicalDevices #WTO #TBTAgreement #PulseOximeters #GlobalTrade #ISO #FDA #RacialBias #HealthTech #TradeRules #COVID19 #Standards #InternationalTrade #SupplyChain #MedicalSupplies #Economics #FexingoBusiness #BusinessPodcast Keep every episode free: buymeacoffee.com/fexingo