Conference Day Two
Wednesday 29th January, 2025
8:20 am Check in & Registration
8:50 am Chair’s Opening Remarks
Cybersecurity & Compliance Considerations to Ensure Secure Software Development
9:00 am A cybersecurity journey: from pre-clinical research to market launch.
Synopsis
- Understand and balance technical and regulatory requirements at the different phases of a new medical device development
- Implement and improve cybersecurity processes and good practices compliant with different regulations
- Tips, tricks and lessons learned from a recent regulatory submission for a connected device
9:30 am Initiate Early Feedback Loops with Security Experts to Ensure Compliant & Secure Software for Medical Devices
Synopsis
- Involve security experts from the project’s inception to identify potential vulnerabilities and compliance issues early
- Establish regular feedback sessions throughout development to address security concerns and refine compliance strategies
- Integrate continuous risk assessments and expert feedback into the development cycle to ensure ongoing security and regulatory alignment
10:00 am Don’t Talk, Just Patch
Synopsis
- Learn about requirements for security patching
- Learn about patching failure scenarios to avoid
- Challenges of building and running a patching program covering legal, technical, logistical, and contractual aspects
10:30 am Morning Break & Networking
11:00 am Strategies to Effectively Complete Vulnerability Exploitability eXchange (VEX) Files to Bulletproof Medical Device Software
Synopsis
- Conduct thorough vulnerability assessments to identify and document all potential exploit vectors in VEX files
- Include specific, actionable mitigation strategies for each identified vulnerability to enhance software security
- Ensure VEX files are continuously updated with the latest threat intelligence and vulnerability information to maintain robust protection
Operating Effectively Under Agile Methodologies
11:30 am Strategies to Seamlessly Shorten Release Cycles & Ensure Rapid Feedback Loops & Increased Patient Retention for Medical Device Users
Synopsis
- Adopt agile methodologies to rapidly incorporate user feedback into iterative design cycles while maintaining regulatory compliance
- Develop efficient documentation practices to quickly address regulatory requirements without slowing down the iteration process
- Engage users early and frequently in testing phases to refine the product swiftly and ensure alignment with both business models and regulations
12:00 pm Roundtable Discussion: Bridging the Gap Between Agile Methodology’s Iterative Nature with the Strict Documentation & Validation Required by Regulatory Bodies to Ensure Ongoing Compliance
Synopsis
- Integrate rigorous documentation processes within agile sprints to maintain regulatory compliance while preserving flexibility
- Schedule regular compliance checkpoints to ensure that iterative changes align with regulatory requirements and validate each increment
- Utilize automated tools to track changes and maintain comprehensive records, ensuring traceability and adherence to regulatory standards throughout development
12:30 pm Lunch Break & Networking
1:30 pm From Silos to Synergy: Developing a Flexible Agile Framework to Deliver Integrated Digital Health Solutions for Pharma
2:00 pm Optimizing Risk Management Processes for Effective Regulatory Submissions to Ensure Robust Patient Safety
Synopsis
- Strategies to ensure streamlined risk management processes
- Challenges with addressing risk management issues when making regulatory submissions
- Case study based insights into how this can be overcome
2:30 pm Afternoon Break & Networking
3:00 pm Establishing Strategies to Overcome Fragmented Outputs When Operating Under Agile Methodologies
Synopsis
- Use centralized project management tools to aggregate and coordinate fragmented outputs, facilitating better integration and visibility
- Establish clear and efficient communication channels to align team efforts and consolidate fragmented outputs into a unified workflow
- Implement consistent documentation practices across all teams to ensure cohesive and comprehensive output tracking
3:30 pm Applying the Concept of an Internal Development Platform to Improve Software Development Effectiveness
Synopsis
- Automation for ‘always releasable’ software as part of a surgical robotic system
- Integrated regulatory compliance into software development
- Case-study based insights into how these challenges can be effectively implemented in practice