Conference Day One
Tuesday 28th January, 2025
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 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
10:00 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
10:30 am Morning Break & Networking
11:00 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
11:30 am Artificial Intelligence in the context of the IVDR – How to keep the revolution under control
Synopsis
The integration of Artificial Intelligence (AI) into In Vitro Diagnostic Medical Devices (IVD) promises transformative advances in patient care and diagnostics and is believed to bear the potential to revolutionize healthcare diagnostics by enhancing accuracy, efficiency, and personalized patient outcomes. However, these innovations must navigate a complex web of regulatory challenges to ensure safety, efficacy, and compliance. Successful implementation of AI will require a collaborative effort by all stakeholders involved in development and conformity assessment.
- Describe the tremendous potential of Artificial Intelligence in the In Vitro Diagnostic Medical Device area
- List challenges related to the regulatory compliance and the ensuring of the safety and effectiveness of IVD(R) AI devices
- Use approaches for demonstrating compliance and considering risks related to IVD AI devices
12:00 pm Lunch Break & Networking
12:00 pm Establishing Processes for Successful Data Management for AI Models to Improve AI-based Software Designs
Synopsis
Session Details TBC
1:00 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
1:00 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
1:30 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
Shaping Software Engineers to Be Well-Equipped Working When Working in the Medical Device Industry
2:00 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
2:30 pm Afternoon Break & Networking
3:00 pm Striking a Balance Between Funding & Sustainability of Medical Software Implementation 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
3:30 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