Conference Day One
Tuesday 28th January, 2025
7:50 am Badge Collection & Registration
8:50 am Chair’s Opening Remarks
Optimising AI/ML tools to Improve Software Design
9:00 am Addressing The Challenges Around Complying with Stringent Regulations with AI/ML Models
Synopsis
- Implement explainability techniques to enhance transparency and interpretability of black box models, aiding compliance with regulatory requirements
- Ensure continuous alignment with evolving regulations by integrating compliance checks and audits throughout the model development lifecycle
- Establish robust data governance frameworks that manage data access, quality, and security to facilitate auditability and compliance reporting
9:30 am From Algorithms to Approvals: Integrating AI across the Total Product Lifecycle
Synopsis
AI is transforming medtech, from advancing diagnostics to automating compliance. Join experts from Aignostics, moderated by Erez Kaminski, Founder & CEO of Ketryx and former Head of AI at Amgen, to explore how AI drives innovation in regulated environments. Panelists will share real-world strategies and the opportunities they’re most excited about for 2025 and beyond. Key topics include:
- Reducing documentation bottlenecks to speed up development cycles
- Implementing systems of systems to enable component reuse and improve scalability
- Aligning with FDA guidance on AI-enabled devices through TPLC strategies
10:00 am Strategies to Seamlessly Integrate Existing Systems with AI Modules to Ensure AI systems to Function Effectively Within Existing Workflows
Synopsis
- Design AI modules as flexible, interoperable components that can be easily integrated into existing systems without disrupting workflows
- Ensure seamless data flow by establishing standardized data formats and interfaces between existing systems and AI modules
- Adopt a phased integration approach, allowing gradual AI adoption and minimizing disruption while fine-tuning system compatibility
10:30 am Speed Networking
Synopsis
This session is a great opportunity to introduce yourself to the attendees that you would like to have more in depth conversations with. This session is the ideal opportunity to get face-to-face time with many of the brightest minds working in the software development for medical device space and establish meaningful business relationships
11:00 am Morning Break & Networking
11:30 am Appreciating the Ethical & Legal Concerns for AI Modules to Ensure Complete Transparency
Synopsis
- Define and assign clear responsibility for AI decisions and outcomes, ensuring traceability and accountability throughout the AI lifecycle
- Establish and enforce ethical guidelines that prioritize fairness, transparency, and non-discrimination in AI module development and deployment
- Ensure AI modules comply with relevant laws and regulations, addressing liability risks and protecting against potential legal challenges
12:00 pm Artificial Intelligence in the context of the IVDR
Synopsis
How to keep the revolution under control:
- Describing the tremendous potential of Artificial Intelligence in the In Vitro Diagnostic Medical Device area
- To list challenges related to the regulatory compliance and the ensuring of the safety and effectiveness of IVD(R) AI devices
- To use approaches for demonstrating compliance and considering risks related to IVD AI devices
12:30 pm Lunch Break & Networking
Shaping Software Engineers to Be Well-Equipped Working When Working in the Medical Device Industry
1:30 pm Panel: Optimizing Training Programmes for Engineers to Ensure They are Well-Equipped to Operate Under the Regulatory Guidelines Required for Software in Medical Devices
Synopsis
- Develop specialized training modules focused on regulatory standards tailored specifically for software/system engineers
- Incorporate practical, scenario-based exercises that simulate real-world challenges in developing compliant medical device software
- Implement ongoing education programs to keep engineers up to date with evolving regulations and best practices in the medical device industry
2:00 pm Navigating Difficulties in Recruiting Teams including Software Engineers Well-Versed in the Medical Device Industry
Synopsis
- Focus recruitment efforts on niche platforms and networks that cater to professionals with experience in medical device software
- Invest in training programs to upskill engineers from related fields, bridging the gap between software development and medical device regulations
- Case-study based insights into overcoming recruitment challenges
2:30 pm Roundtable: Reshuffling Organizational Priorities to Ensure Medical Device Manufacturers Overcome Technical, Organizational, & Financial Gaps
Synopsis
- Prioritize investments in critical areas such as R&D and regulatory compliance to address technical and organizational gaps effectively
- Foster collaboration across departments to streamline processes and resolve organizational inefficiencies impacting medical device production
- Develop robust financial strategies to allocate budgets wisely, addressing both immediate needs and long-term growth objectives
3:00 pm Afternoon Break
3:30 pm Balancing Funding and Sustainability in software for Medical Devices
Synopsis
- Building a business case around introducing and implementing new features
- Challenges with implementing new features from different stakeholders such as cybersecurity experts
- Case-study based insights into how this can be practiced
4:00 pm Interoperability as a Mindset: Strategies for an Integrated Ecosystem of Digital Health Solutions & Connected Devices
Synopsis
- Exploring the importance of adopting an interoperability mindset, achieve a common language and understanding between teams and systems
- Creating synergy between business and engineering through a unified data strategy
- How an interoperability mindset can be an enabler for embracing a shift-left strategy when designing connected solutions