Conference Day Two
Wednesday 29th January, 2025

8:50 am Chair’s Opening Remarks

Cybersecurity & Compliance Considerations to Ensure Secure Software Development

9:00 am Demonstrating Methodologies to Effectively Translate Different Regulations into Technical & Non-Technical Security Requirements to Ensure Robust Software Security

Synopsis

  • Create a detailed mapping of regulatory requirements to identify specific technical and non-technical security needs for compliance
  • Implement security frameworks that align with regulatory standards, translating them into actionable security protocols and controls
  • Provide targeted training for both technical and non-technical teams to ensure a comprehensive understanding and implementation of security requirements

9:30 am Initiate Early Feedback Loops with Security Experts to Ensure Compliant & Secure Software for Medical Devices

  • Harsh Jain Senior Manager - Quality Engineering, Align Technology

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 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

  • Rajasekar Solai Senior Engineer, Quality Design Assurance, BD Technologies

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 How Can we Remain Agile During Development to Meet User Expectations While Ensuring Regulatory Documentation is Up to Date?

Synopsis

  • Navigating the integration of more advanced software to match the demands of the industry while reducing waiting times for every update
  • User-driven changes and the need to address evolving software dependencies and security concerns necessitate greater agility. However, regulatory documentation must also keep pace
  • Outlining how we developed a process that meets regulatory requirements while allowing for rapid market adaptation

2:00 pm From Silos to Synergy: Developing a Flexible Agile Framework to Deliver Integrated Digital Health Solutions for Pharma

2:30 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

3:00 pm Afternoon Break & Networking

3:30 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

4:00 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

4:30 pm Agile Software Development: A Solution in the Software Development Lifecycle of Medical Devices for Early Market Entry

Synopsis

  • Describe Integration of Agile in SDLC: Upon completion, participants will be able to describe how Agile software development methodologies can be integrated into the Software Development Lifecycle (SDLC) of medical devices to accelerate early market entry while maintaining compliance with regulatory standards
  • Identify Key Agile Practices and Techniques: Upon completion, participants will be able to identify key Agile practices and techniques that can streamline the development process, enhance cross-functional collaboration, and improve the quality of software products in the context of medical device development
  • Application of Agile Principles to Manage Change: Upon completion, participants will be able to demonstrate the application of Agile principles to manage changes in requirements and design, ensuring timely delivery of medical device software while adhering to regulatory constraints

5:00 pm Chair’s Closing Remarks