MedTech Global Insights

Navigating the FDA's 510(k) premarket notification process is a critical hurdle for most Class II medical device manufacturers seeking entry into the lucrative U.S. market. This pathway is designed to demonstrate that a new device is "substantially equivalent" to an existing one, but the journey from submission to clearance is often complex and fraught with challenges that can lead to significant delays and unexpected costs. This episode of MedTech Global Insights unpacks the three most common and

This episode of MedTech Global Insights delves into the critical process of FDA medical device registration, the essential first step for entering the lucrative U.S. market. We break down the three core regulatory pathways—510(k), Premarket Approval (PMA), and De Novo—and explore the strategic decisions that determine success or failure. Navigating this landscape is fraught with potential missteps. Choosing an incorrect pathway or failing to provide sufficient evidence can result in years of delays

In this episode of MedTech Global Insights, we explore the rapidly growing orthopedic implant market and the immense regulatory challenges that manufacturers face. With an aging global population driving demand for devices like knee, hip, and spinal implants, the path to international market access has never been more complex. We break down the specific hurdles in key regions, from the stringent clinical evidence requirements of the EU's MDR to the nuanced 510(k) pathway of the US FDA. We also

In this episode of MedTech Global Insights, we explore the high-stakes world of cardiovascular device registration. This sector sees a massive volume of regulatory submissions, from life-saving innovations to incremental improvements. We break down the two core U.S. FDA pathways, the 510(k) and Premarket Approval (PMA), revealing the critical challenges and strategic decisions that can make or break a product launch. We go beyond the basics to discuss the nuanced complexities of global market

As artificial intelligence and machine learning transform healthcare, Software as a Medical Device (SaMD) presents a massive opportunity. From diagnostic algorithms to digital therapeutics, these innovations promise a new era of patient care. However, the regulatory pathways for SaMD are complex, fragmented globally, and fundamentally different from those for traditional hardware devices. This episode of MedTech Global Insights explores the unique challenges SaMD developers face when seeking

The COVID-19 pandemic thrust the In-Vitro Diagnostic (IVD) industry into the global spotlight. This rapid ascent brought unprecedented opportunities but also triggered a wave of intense regulatory scrutiny worldwide. The old ways of bringing a diagnostic test to market are no longer viable in this new, more stringent environment.This episode of MedTech Global Insights explores the post-pandemic regulatory landscape for IVD manufacturers. We break down the key challenges companies face when seeking

In this episode of MedTech Global Insights, we explore the explosive trend of wearable medical devices. From smartwatches with ECG features to continuous glucose monitors, the line between consumer tech and regulated medical products is blurring. We break down the critical regulatory pathways these innovative devices must navigate to reach the market.We cover the essential first step of device classification, dive into the crucial concept of Software as a Medical Device (SaMD), and explain the most