Conference Day One
8:00 am Registration & Morning Coffee
8:55 am Chair’s Opening Remarks
Enhancing Device Software Security for Long-Term Success
9:00 am Securing Cloud-Connect Medical Devices: Interoperability & Data Privacy
Synopsis
- Addressing cybersecurity challenges in cloud-connected medical devices and ensuring secure data exchange across diverse ecosystems
- Adhering to regulatory standards like HIPAA and GDPR while ensuring data privacy and security in cloud integrations
- Navigating the complexities of interoperability between devices, cloud systems, and healthcare technologies, while safeguarding against cybersecurity risks
9:30 am Overcoming Challenges in Modernizing Legacy Devices: Bridging Cybersecurity & Regulatory Compliance
Synopsis
- Addressing cybersecurity vulnerabilities in legacy medical devices
- Ensuring compliance with evolving global regulations (FDA, EU MDR, etc.) for legacy software
- Strategies for assessing design and regulatory gaps in outdated software systems
- Determining regulatory strategy for release of updated version of legacy medical device software
10:00 am Threats, Attacks, & Vulnerabilities
Synopsis
- Understanding different threat actors, their motivations, and common attack surfaces
- Exploring various vulnerability types and their impact on medical device software
- Analyzing malicious activity indicators and implementing effective defense mechanisms to protect enterprise systems
10:30 am Morning Break & Speed Networking
Synopsis
Join our speed networking session tailored for medical device software experts, like yourselves, to connect with industry peers & facilitating rapid yet meaningful exchanges of insights and expertise. Elevate your networking experience during this session designed for impactful connections within the space of medical device software
11:30 am Session Reserved for Ketryx
Building Trustworthy & Scalable AI: From Development to Global Regulatory Approval
12:00 pm Building AI Capabilities within a Medical Device
Synopsis
- Finding the right AI use case by balancing technical feasibility, commercial potential, clinical impact, and regulatory challenges
- Ensuring high-quality, curated, and regulation-compliant data including synthetic data to drive AI success
- Navigating regulatory challenges such as bias, transparency, accountability, and safety to secure approval and maintain compliance
- Adapting post-market with continuous learning and leveraging Gen AI for enhanced performance and innovation
12:30 pm Fireside Chat: Adapting to FDA & CDRH Changes: What’s Ahead for Software-Driven Devices
Synopsis
- How internal restructuring and funding pressures at the FDA/CDRH may affect review timelines, submission predictability, and early engagement (e.g. pre-subs)
- Preparing for increased reviewer turnover – and what it means for continuity, communication, and expectations across the submission lifecycle
- Best practices for clearly documenting architecture, validation, and risk for AI/ML and connected devices – to minimize friction and rework during review
- Strategies to ensure alignment between software, regulatory, and quality teams in an environment of tighter resources and shifting FDA prioritiesÂ
1:00 pm Lunch & Networking
2:00 pm Demystifying AI Transparency: Building Systems That Regulators Trust
Synopsis
- Addressing the challenges of designing and developing AI/ML enabled medical devices that ensure transparency and meet FDA global regulatory expectations
- Navigating multi-region submission complexities, including FDA, EU MDR, and Japan, with a focus on AI-specific guidelines and clinical data requirements
- Integrating post-market surveillance insights to refine AI models, mitigate risks, an enhance regulatory readiness in real-world applications
Navigating Software Change Control: Ensuring Compliance from Development to Post-Market
2:30 pm Navigating Product Change Control: Balancing Innovation & Regulatory Compliance
Synopsis
- Insights into the new FDA guidance, its objectives, and its implications for medical device submissions which include software
- Navigating the shift from traditional change processes to a forward-looking compliance strategy including regulatory strategies and optimizing documentation
- Practical strategies for managing change justification and maintaining compliance in a rapidly evolving regulatory landscape
3:00 pm
Poster Session & Refreshments Break
Synopsis
This poster session is your go-to session to obtain competitive insights and present your
most innovative work to medical device thought leaders and decision makers. For more
information or to submit your abstract, please email info@hansonwade.com
3:45 pm Accelerating Approvals: Leveraging the FDA’s Product Change Control Plans (PCCPs)
Synopsis
- Streamlining product changes by using PCCPs to accelerate approvals for AI-powered medical devices while maintaining compliance with the FDA
- Optimizing change documentation by understanding best practices for creating comprehensive change control plans that align with FDA expectations for medical devices with AI components
- Avoiding approval delays through real-world case studies that demonstrate how leveraging the PCCP process can reduce time-to-market for AI-driven medical devices
4:15 pm Optimizing SBOMs & Change Control Management for Regulatory Compliance in Medical Device Software
Synopsis
- Best practices for integrating SBOMs into the software development lifecycle to meet FDA, EU MDR, and other regulatory requirements, ensuring end-to-end traceability
- Establishing robust procedures to handle software changes post-market, ensuring compliance with change control regulations while maintaining device safety and performance
- Understanding regional differences in SBOM requirements and change management practices, and how to manage these complexities in the context of global submissions