Bringing a new medical device to market is challenging – especially for early-stage startups balancing innovation with regulatory compliance. One concept that often trips up founders is the “Legal Manufacturer” in medical device regulations. What is it, and should you… Read More »Outsourcing the Legal Manufacturer Role in MedTech: What Founders Need to Know
On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a strategic roadmap to phase out the requirement for animal testing in the development of monoclonal antibodies and other therapeutic drugs. This represents a pivotal transformation in regulatory… Read More »FDA’s Landmark Shift Away from Animal Testing
Introduction Over the past decade, South Korea’s adult thyroid cancer screening program has been known for its aggressive approach, offering widespread ultrasound screening to asymptomatic adults. This strategy led to a sharp rise in thyroid cancer diagnoses, predominantly small papillary… Read More »South Korea’s Thyroid Cancer Screening: Too much good?
Trauma Care in the U.S. vs. South Korea: A Comparative Analysis Trauma care systems are fundamental to reducing mortality and morbidity following severe injuries. The United States and South Korea both acknowledge the necessity of specialized trauma care, yet their… Read More »Trauma Care in the U.S. vs. South Korea: A Comparative Analysis
As we step into 2025, the FDA has introduced a draft guidance that is set to reshape the regulatory landscape for AI-enabled medical devices. For those unfamiliar, an FDA draft guidance outlines the agency’s current thinking on a topic and… Read More »Happy New Year 2025: A New Era for AI in MedTech
When analyzing healthcare systems worldwide, the relationship between doctor visit frequency and healthcare expenditure offers valuable insights. Using data from OECD countries, we identified four distinct clusters that reflect unique healthcare dynamics. These clusters not only shed light on system… Read More »Understanding Global Healthcare Groups for Market Entry Insights
In today’s healthcare system, only the sickest patients in intensive care units (ICUs) receive continuous, close monitoring. These setups often involve bulky, uncomfortable wires attached to patients, gathering data on their vitals. However, the future of patient monitoring is rapidly… Read More »The Future of Patient Monitoring: Continuous, Predictive, and Preventative
In a groundbreaking announcement, the Centers for Medicare & Medicaid Services (CMS) has unveiled its new Transitional Coverage for Emerging Technologies (TCET) pathway. This initiative promises to transform the landscape for medtech startups by providing a clearer, faster path to… Read More »CMS Announces New Pathway for Breakthrough Device Reimbursement
When I moved to the US from Taiwan, I quickly discovered a fundamental difference in healthcare systems. In Taiwan, my first instinct was to visit a hospital for medical care, where hospitals serve as central hubs with doctors readily available… Read More »Comparing Asian and Western Healthcare Systems
One of the critical aspects of launching a successful medtech product is understanding who will be footing the bill. Whether it’s patients, payers, or providers, each customer type has unique needs and priorities that must be addressed through tailored marketing… Read More »Who’s Paying for Your MedTech Innovation?