Archives: Agenda

• Examine critical regulatory pathways, with strategic insights for achieving market clearance/approval in the US and EU
• Present streamlined approaches for planning and designing effective clinical studies, highlighting the benefits of budgeting early
• Discuss efficient processes for regulatory submissions and applications, from clinical study conduct to market clearance/approval

• The impact of AI and cyber threats on medical devices
• The cyber challenges 2025 may bring
• How regulators and tech companies are meeting the AI challenge

• Analysis of current trends in investment within the medical device sector and exploring what factors contribute to the investment gap
• Discussing financial, operational and regulatory challenges that startups and small to medium-sized companies face in the industry and how to overcome them
• Identifying potential solutions for improving the investment landscape

• Challenges and opportunities from a technology, economic perspective
• Geopolitical, legal and regulatory changes and their impact from an ecosystem perspective

• Discussing challenges in communication, project management, and regulatory compliance
• Role of CROs in fostering innovation in medical device development
• Case studies highlighting successful collaborations and lessons learned
• Emerging trends and technologies shaping future collaborations

• Planning of a robust study design
• Common hurdles during the start-up phase
• Adhering to timelines for event reporting to regulatory authorities
• Considering financial aspects during the course of a study

• Findings from Greenlight Guru’s 2025 State of Medical Device Industry Report, providing valuable insights into the latest trends, challenges, and innovations in the medical device landscape
• Key industry shifts, including evolving regulatory demands, advancements in clinical technology, and strategies that successful companies are using to navigate complex quality and clinical requirements
• A session for MedTech professionals looking to stay ahead of industry changes and drive forward-thinking quality and clinical practices
• Be among the first ones to access the report before its public release

• Understanding the increasing trend of combining medical devices and drugs
• Gaining insights from the European Medicines Agency (EMA) on the future of medical device and drug combinations
• Explaining the distinction between Medical Devices Regulation (MDR) and Medical Devices Directive (MR) for combination products
• Identifying compliance requirements and implications based on the device’s primary mode of action
• Presenting various regulatory pathways available for combination products
• Understanding how partnerships can drive innovation and development in this domain

This session will explore the pivotal role of clinical technology and AI in driving the success of Medtech trials, focusing on how a unified, AI-enabled platform can serve as the foundation for an expanded data health ecosystem. Attendees will learn the benefits of interconnected data flows, starting with purpose-built, simple electronic data capture (EDC) systems for Medtech trials, scaling by integrating Imaging capabilities, leveraging AI for enhanced data analysis, and enabling seamless one-click imports of Electronic Health Records (EHRs). This approach eliminates redundancies, enhances data integrity, reduces site burden, and can bridge clinical trial data with real-world evidence to improve device observation and long-term insights. By adopting an integrated, AI-driven platform, sponsors can meet current trial demands while building a robust data ecosystem to advance future patient care.

• Recognize the importance of choosing a scalable platform to future-proof clinical trials and enable seamless connections between trial data and real-world evidence for long-term impact
• Understand the role of a unified cloud-based platform in creating a connected data health ecosystem tailored to Medtech trials
• Explore how integrating Imaging and EHR data can enhance operational efficiency, data accuracy, and site engagement