Conference Day Two
8:20 am Coffee & Networking
8:55 am Chair’s Opening Remarks
Navigating Barriers Around Interoperability to Consolidate Cybersecurity Across Medical Device Environments
9:00 am Securing SaMD: Navigating Complexity & Implementing Controls
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
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
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