Archives: Agenda
Afternoon Refreshments, Networking & Prize Draw
CASE STUDY Bringing a consumer digital health device to market – developing software, building credibility, and navigating regulations
- Solving a personal challenge to create a solution for thousands
- Marketing effectively through advocacy and community engagement
- Building credibility with clinical trials and provider partnerships
- Developing and refining software to enhance user experience and outcomes
- Navigating the regulatory environment for digital health technologies
PANEL DISCUSSION Economic pressures: innovating under budget constrains
- Exploring the impact of reduced medtech investments and cost-cutting strategies
- Trends in outsourcing and supplier consolidation to reduce overheads
- Encouraging innovation despite financial pressure
Moderator
Dave Ribble, Medical Devices Expert, GlobalData
Panelists
Al Crouse, VP of Quality Assurance and Regulatory Affairs, CVRx
Sameer Kumar, Chief Executive Officer, HabitAware Inc
Fostering positive CRO relationships: tips and best practice
- The sponsor’s role in building successful CRO collaborations
- Best practices that form productive sponsor-CRO relationships
- Overcoming sponsor-CRO challenges
- Managing sponsor expectations and optimizing interactions
Navigating USA regulations for device-drug combination products
- Exploring how combination products are regulated
- How to determine the primary mode of action (PMOA)
- Capturing and maintaining critical data points
- Challenges and best practices
Networking Lunch
Afternoon Networking & Refreshments
Morning Refreshments & Networking
Responsibly leveraging AI and real-time data in post-market surveillance
- AI in the post-market surveillance landscape
- How AI might enhance risk management
- Regulatory considerations: presenting AI data in submissions