Conference Day Two

8:20 am Coffee & Networking

8:55 am Chair’s Opening Remarks

  • Stephen Odaibo Founder & Chief Executive Officer & Software Architect, RETINA-AI Health, Inc

Navigating Barriers Around Interoperability to Consolidate Cybersecurity Across Medical Device Environments

9:00 am Securing SaMD: Navigating Complexity & Implementing Controls

  • Leo Park Senior Director - Cyber, Click Therapeutics

Synopsis

  • Strategies to develop and safeguard software as a medical device while maintaining cybersecurity standards
  • Best practices for deploying comprehensive security controls to safeguard data integrity and protect against cyber threats
  • Guidance on implementing effective risk management frameworks to mitigate security risks associated with integrated medical devices

9:30 am Generating Feedback Loop Systems in Cybersecurity Frameworks from Early Architecture Designs to Post-Market Monitoring to Accurately Assess Entire Life Cycle

Synopsis

  • Embedding cybersecurity considerations into the initial architecture designs of systems and devices to establish a strong foundation for security.
  • Establishing feedback loops between cybersecurity frameworks and operational practices to enhance security measures.
  • Case-study based insights showcasing the processes behind this style of monitoring

10:00 am Organizing Internal Frameworks within Companies to Manage Regulatory Guidelines Brought by External Bodies

  • Damien Sharp Director of Medical Device Software Quality, AstraZeneca

Synopsis

  • Strategies to implement cybersecurity guidelines into risk management lifecycles
  • Best practices for internal quality process/system o effectively implement cybersecurity across medical devices
  • Case study based insights into robust cross-functional collaboration to ensure cybersecurity is compliant

10:30am Morning Break & Networking

11:00 am Improving Collaboration Between Software Developers & Cybersecurity Experts to Ensure Device Security From the Very Beginning

Synopsis

  • Ensuring robust cybersecurity from the planning stages of the software verification and design development plans
  • Embedding systems engineering perspectives in cybersecurity frameworks
  • Implementing robust security measures throughout the device development lifecycle

11:30 am Roundtable: Assessing Medical Device Cybersecurity Maturity: where do you stand?

Synopsis

  • Hands-on activity using a questionnaire from Medical Device Innovation Consortium (MDIC) to understand where your organization stands as compared to industry
  • Comparing your results to industry standards to identify gaps in your cybersecurity program
  • Taking actions back to your organization to develop a more mature cybersecurity framework

12:30 pm Lunch Break & Networking

Optimizing Security Interventions to Bullet-proof Cybersecurity and Minimize Device Infiltration

1:00 pm Establishing a Robust CIA (Confidentiality, Integrity, Availability) Triad to Serve as The Principal Foundation of Risk Analysis

Synopsis

  • Strategies to balance the trade-off between product safety, security, and desirability
  • Implementing robust encryption and access control measures to protect sensitive information from unauthorized access
  • Securing update protocols to maintain the accuracy and consistency of data and establishing disaster recovery plans to ensure that medical devices remain operational in the face of cyber threats

1:30 pm Panel: Embedding the Cybersecurity Value System Upstream to Ensure Security Processes Are Implemented in the Early Architecture to Minimize Downstream Security Compliance Issues.

Synopsis

  • Increasing the understanding behind cybersecurity literacy which does not require cybersecurity expertise
  • Through this managerial committee ensuring smoother collaboration across wider members of the team
  • Solutions to overcome challenges in implementing this internal shift in medical device companies

3:45 pm Roundtable: Strategizing a Plan of Action After Your Cybersecurity System Has Been Infiltrated

  • Stephen Odaibo Founder & Chief Executive Officer & Software Architect, RETINA-AI Health, Inc

Synopsis

  • Designing a robust plan of action to undertake as soon as an infiltration has taken place
  • How will the users of the devices be kept informed, despite you as the manufacturer having limited insight into what has occurred
  • Case-study based insights into potential action plans

4:30 pm Chair’s Closing Remarks

  • Stephen Odaibo Founder & Chief Executive Officer & Software Architect, RETINA-AI Health, Inc