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
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
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
- 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
- Insights on the differences between represented and underrepresents populations on their barriers to care
- Challenges and nuances of rare disease patients’ journey to receive a diagnosis
- Mental health and well-being: the emotional toll rare diseases take on patients and caregivers
- Exploring overall experiences individuals have had within the healthcare system: strengths and areas for improvement
Harsha K. Rajasimha, MS, Ph.D, Founder and Executive Chairman, Indo US Organization for Rare Diseases
