Day Two

• Deploying internal AI agents to support product security and software development activities by streamlining security reviews, improving efficiency and helping teams keep pace with increasingly AI-enabled R&D workflows
• Establishing governance principles that enable AI adoption while maintaining security, compliance and regulatory confidence
• Aligning AI-driven development with evolving FDA expectations and product security requirements to accelerate innovation while maintaining audit readiness, quality standards and stakeholder trust

• Integrating regulatory, cybersecurity and quality requirements into development processes from day one to avoid costly redesigns and late-stage surprises
• Creating alignment between engineering, compliance and business teams to balance innovation objectives with regulatory obligations
• Building scalable development frameworks that support faster software iteration

• The Agile Manifesto is turning 25 this year. Is it still relevant?
• How can the principles of Agile be interpreted for development of complex medical devices and how does it fit with AI?
• Practical learnings from design and sustained maintenance of a surgical robotic system

Whether you’re building your first software-enabled device or scaling AI and cybersecurity programmes across a global portfolio, organisations face very different challenges depending on their size and maturity. Join peers from similarly sized companies for an interactive roundtable discussion designed to share experiences, benchmark approaches and uncover practical solutions to common software development, AI and compliance challenges.

Start-Up Sprint for Small & Emerging Innovators

• How to build quality and regulatory foundations with limited resources while accelerating growth
• Discussing challenges and questions around balancing agility versus compliance
• Lessons learned from training teams about adequate compliance and optimising processes to empower efficiency

Scaling for Success for Mid-Sized Medical Device Manufacturers

• Strategies for scaling software teams, AI initiatives and compliance processes without sacrificing agility

Enterprise Exchange for Large Medical Device Manufacturers

• Managing global software portfolios, AI governance, cybersecurity programmes and complex regulatory requirements across multiple product lines
• The Small-Team Paradox: Development, QA, Regulatory, Systems, UX, Cybersecurity, Program Management, etc. all need to have a voice in product development. How small can teams realistically be?

• Implementing compliant DevOps operating models that support secure, scalable deployment and monitoring of medical software while addressing the unique challenges of operating within hospital environments rather than cloud-native infrastructures
• Leveraging AI to strengthen traceability, documentation review and standards compliance while reducing manual effort across quality and regulatory workflows
• Balancing innovation ambitions with regulatory and business priorities while making strategic decisions about product classification, compliance scope and long-term regulatory impact

• Modernising regulated medical software platforms through incremental architecture evolution, platform engineering, and technical debt reduction while maintaining delivery momentum and compliance
• Applying AI-assisted development to accelerate code analysis, refactoring, documentation, testing, and knowledge transfer without compromising software quality or patient safety
• Building resilient, future-ready platforms using cybersecurity-by-design, engineering governance, interoperability standards, and modern software engineering practices

• Building teams with the technical skills, soft skills, and clear responsibilities needed to bridge regulated and non-regulated ways of working
• Listening to teams’ hard-won knowledge and good practices, and just as openly to their fears and criticisms of regulation, before attempting to change anything
• Reconnecting documentation and process back to the objectives, regulations are actually seeking, so good engineering practice and compliance stop feeling like separate exercises

• Aligning software, quality, clinical and regulatory stakeholders around common objectives to support the development, validation and commercialisation of connected digital health solutions while maintaining focus on patient outcomes and safety
• Managing risk, cybersecurity and regulatory expectations throughout the product lifecycle by strengthening risk assessment processes, adopting new validation approaches and navigating increasingly complex FDA-led submission requirements
• Scaling people, processes and operational capabilities to support global growth by balancing outsourced development models, complaint management, customer support functions and future expansion across the US, Europe and additional international markets