Archives: Agenda

PANEL DISCUSSION The intersection of geopolitics, U.S. health policy, and the medical device industry

  • Assessing the impact of recent U.S. policy changes on the FDA’s effectiveness and medical device regulation
  • Navigating international relations and potential WHO disengagement in shaping global regulatory alignment and CE mark recognition
  • Understanding the broader implications for community-building and industry collaboration amid shifting geopolitical and regulatory landscapes

Moderator
Cathrine Longworth, Editor-in-Chief, Healthcare, GlobalData

Panelists
Divya Raman, Senior Director of Policy, Intelligence, and Strategy, Teleflex
Jennifer Bolton, Senior Fellow, Regulatory Affairs, Boston Scientific

Approved and abandoned: why 90% of devices die without lifecycle strategy

Regulatory approval is no longer the finish line—it’s just the starting point. In today’s MedTech landscape, clinical success alone doesn’t guarantee market survival. This session offers a lifecycle-driven blueprint that integrates clinical, regulatory, reimbursement, and market strategy from the start. Through real-world cases and usable frameworks, you’ll learn how to build devices that get adopted, paid for, and scaled. In this session we will explore:

  • How clinical trial design can sabotage reimbursement success and how to fix it
  • A blueprint for integrating clinical, regulatory, and market access planning
  • Real-world examples where lifecycle thinking saved or doomed devices
  • A checklist for building lifecycle-centric strategies from day one
  • A high value bonus handoutwill be provided to those who attend the talk

Revolutionizing clinical trial operations by expanding globally and streamlining processes

  • Navigating global and domestic trial complexities by adapting to regional regulatory landscapes and healthcare systems
  • Optimizing site selection and patient recruitment by balancing global expansion with local engagement strategies
  • Building strong CRO and vendor partnerships by ensuring alignment on trial objectives and performance expectations
  • Streamlining trial processes by leveraging digital tools, real-time monitoring, and risk-based management approaches

Leveraging technology for seamless collaboration

This session will showcase effective, tech-driven approaches to improving complex clinical workflows.

  • Demonstrating how innovative tools reduce workflow friction
  • Showcasing case study data across dynamic, multi-stakeholder clinical workflows
  • Highlighting methods for optimizing project delivery through centralized platforms
  • Streamlining patient eligibility review processes
  • Enhancing remote monitoring with integrated solutions
  • Leveraging a single collaboration platform for complex data exchanges and coordination

PANEL DISCUSSION Overcoming ethical challenges in AI and big data for clinical trials

  • Ensuring ethical AI use by considering patient rights, informed consent, and the responsible integration of AI in clinical trials
  • Mitigating bias in AI datasets by identifying sources of bias, improving data diversity, and implementing fair AI practices
  • Promoting accountability and transparency by establishing clear oversight, understanding algorithm decision-making, and maintaining regulatory compliance

Moderator
Cathrine Longworth, Editor-in-Chief, Healthcare, GlobalData

Panelists
Mac McKeen, Adjunct Professor, University of Minnesota
Ivan Pandiyan, Executive – R&D, Product, Program, Digital/ AI Transformation, GE Healthcare
Tarek Haddad, Senior Director AI Research, Medtronic