Conference Day One
8:00 am Check In & 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- Strategies for assessing design and regulatory gaps in outdated software systems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 Session Reserved for Ketryx
11:00 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
Track One: Advancing Medical Software Development
Track Two: Ensuring Compliance in Medical Devices
Accelerating Compliance & Innovation with Agile Software Development
12:00 pm Efficient Iterations: Reducing Time-to-Market for Medical Devices
Synopsis
- Implementing agile methodologies to shorten development cycles and speed up time-to market
- Integrating agile processes with regulatory requirements to avoid bottlenecks in approval timelines
- Highlighting how iterative testing and validation have expedited product launches without compromising safety or compliance
- Real-world examples: Fibresolve (de novo) and ScreenDx (510k)
12:30 pm Roundtable: Adapting Agile Methodologies for Modern Medical Device Development: Navigating Regulatory Frameworks
Synopsis
- Exploring the evolving landscape of medical device software development beyond traditional waterfall methods
- Mapping agile workflows to the latest regulatory standards
- Best practices for integrating agile development cycles within a compliance-driven environment, ensuring iterative sprints meet both innovation and regulatory needs
Ensuring Transparency & Trust in AI-Powered Medical Devices
12:00 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, and enhance regulatory readiness in real-world applications
12:30 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
1:00 pm Lunch & Networking
2:00 pm Leveraging Open-Source Tools for Medical Device Software Development
Synopsis
- Improving speed and flexibility by utilizing open-source tools to streamline development and enable faster iterations
- Ensuring regulatory compliance by integrating open-source solutions that meet industry standards
- Building collaborative ecosystems by tapping into opensource communities for innovation and shared expertise while managing risks
Advancing AI Model Development from Data to Deployment
2:30 pm Building Efficient Data Pipelines: Accelerating AI Model Training & Validation in Regulated Environments
Synopsis
- Discussing strategies for designing robust data pipelines to streamline collection, processing, and storage
- Leveraging automation for data cleaning, feature engineering, and validation to optimize AI readiness
- Ensuring adherence to industry standards while maintaining data integrity and traceability
2:00 pm Roundtable: Addressing Ethical & Bias Challenges in AI-Driven Medical Devices
Synopsis
- Identifying and mitigating bias in AI systems to prevent patient care disparities based on demographics, race, or gender
- Designing ethical AI models for medical devices to ensure patient safety and equitable outcomes across diverse populations
- Testing and validating AI algorithms to ensure fairness and equity in decision-making for all patients, regardless of background or health condition
Transforming Change Control for a New Era of Medical Device Innovation
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
4:00 pm Roundtable: Governance Strategies for AI in Regulated Environments
Synopsis
- Building a robust AI governance framework to monitor AI models throughout their lifecycle, ensuring that safety, performance, and compliance are continuously met
- Implementing transparent and explainable AI models to improve regulatory confidence by making AI decisions interpretable and traceable
- Integrating change control and validation processes to incorporate AI governance seamlessly into regulated workflows
4:30 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
4:00 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
4:30 pm Harmonizing Quality Management with Regulatory Expectations: Bridging the Gap
Synopsis
- Aligning quality systems with regulatory standards by ensuring quality management systems (QMS) are designed to meet both regulatory and internal quality expectations
- Managing software and hardware integration by integrating regulatory compliance into hybrid systems where software and hardware components interact seamlessly in medical devices
- Optimizing Post-Market Surveillance and Compliance through strategies that harmonize regulatory expectations with postmarket activities, ensuring ongoing compliance and quality management