Navigating the FDA’s processes requires more than just compliance–it demands a strategic approach. This session will highlight the importance of understanding the people behind FDA reviews. Each individual involved has their own set of priorities and incentives that shape their decisions. By recognizing patterns in these dynamics, you can tailor your approach to optimize the results of your current interaction, minimize unnecessary friction, and foster collaboration that will smooth future interactions.

An overview of key updates to EU MDR and the impact for medical device companies.

In this session, we will clarify why real-world evidence is a critical component for building a value proposition that resonates with payers in the US market(s). We will demystify what payers are looking for beyond traditional clinical efficacy data and provide practical suggestions for integrating economic evidence generation from the earliest stages of product development.

In the constantly evolving landscape that is medtech, payment and regulatory policy interact in ways that are often complex and sometimes non-obvious.

This session will explore the manners in which these two critical functions intersect and influence each other. By examining the overlap and divergence of priorities in these disciplines, we’ll highlight the practicalities for organizations in smoothing the path from promising technology to successful product.

Traditional key opinion leaders (KOLs) no longer hold the sway in purchasing decisions that they once did. As the marketing influence of KOLs diminishes, companies must adapt their strategies for driving product adoption.

In this session, we’ll discuss the changing landscape of individual influence, explore evolving strategies for increasing product adoption, and examine whether these approaches are universal or vary across different global markets.

Join us for a deep dive into the future of product promotion in a world where traditional KOL power is no longer the dominant force.

This panel will explore the current state of Massachusetts-owned hospitals, focusing on their operations and the impact of recent policy changes, including the Steward Health Bill and its effects on medical devices.

We’ll discuss the rising costs pressuring hospitals, leading to layoffs, and how this is affecting the hospital workforce—ultimately influencing the buyer landscape.

Additionally, we’ll dive into the impact of rising drug prices, particularly GLP-1 medications, on Medicare and Medicaid budgets, and how these changes are influencing the medical device market.