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
Our sixth annual medical device industry report surveyed over 500 professionals, revealing the current landscape of challenges, opportunities, and goals facing medical device companies. This session highlights key findings, including:
- Pre-market companies overestimate time-to-market (predicting 3.7 years for Class II and 6.6 years for Class III, while actual timelines are 2.7 and 4.6 years).
- Post-market companies spend over 52 hours monthly on reactive remediation, significantly more than the 17 hours pre-market.
- 50% of post-market companies identify project management and timeline risks as their top new product launch challenge.
- Ensuring data integrity and compliance throughout clinical trials
- Addressing data errors, regulatory risks, and inefficiencies to accelerate innovation with Greenlight Guru
- 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
This session focuses on regulatory strategies that enable the continuous improvement of AI algorithms in clinical applications. We will examine the Predetermined Change Control Plan (PCCP) approach and FDA methodologies to ensure compliance while maintaining innovation.
Key Topics:
- Understanding the PCCP approach – how it facilitates AI updates while ensuring regulatory compliance
- Best practices for AI algorithm updates – methods for maintaining performance, safety, and clinical efficacy
- Case studies – real-world examples of AI regulatory approvals and iterative updates in clinical settings
- Addressing complexities of European market access frameworks
- Leveraging EU MDR compliance to optimize market entry
- Integration of local and global market strategies
- Collaborative approaches to overcome regulatory and funding barriers
Moderator
Dave Ribble, Medical Devices Expert, GlobalData
Panelists
Divya Raman, Senior Director of Policy, Intelligence, and Strategy, Teleflex
Jason Neff, Senior Principal Scientific Affairs Specialist, AtriCure
Lisa Griffin Vincent, Chief Regulatory, Quality, Clinical Officer, GT Metabolic
Transforming care: advancing medical devices for a smarter, connected future
- Exploring how emerging technologies are reshaping the design, functionality, and connectivity of medical devices
- Identifying opportunities for improving patient outcomes by integrating data, diagnostics, and real-time monitoring
- Addressing challenges in scaling innovation while ensuring safety, interoperability, and regulatory compliance
Moderator
Dave Ribble, Senior Consultant, Medical Devices, GlobalData
Panelists
Monika McDole-Russell, Former Senior Director, Global Regulatory Affairs, Medtronic
Kristian Killian, Regional Vice President, VitaTek
Michael Morton, Senior Director of Government Affairs & Policy, Medical Alley
Dr. Nikhil A. Khadabadi, Chief Medical Officer, Eclevar Medtech
Taking F&B tech from theory to practice through key discussions on:
- Creating a harmonious service model that empowers guests to choose their preferred way to order and dine
- How leading hotels are using technology to enhance rather than replace human interactions
- Real success stories of hotels maintaining service excellence while expanding digital capabilities
- Strategies for training staff to confidently switch between digital and traditional service modes
