8:50 am Chair’s Opening Remarks

Creating a Competitive Advantage Through Software

9:00 am Machine Learning Considerations for Device Developers


  • Discovering how machine learning for clinical outcomes supports medical devices & mimics how human clinicians learn
  • Outlining the strengths and weaknesses with how clinicians and ML medical devices learn
  • Understanding what engineers should be thinking about this as they design ML approaches, and how best to proceed in both the short term and long term

9:30 am Securing Your Device Connected Apps in the Current mHealth Threat Landscape


  • Outlining the current mHealth threat landscape and how it impacts medical device connected apps
  • How to design security into software early in order to avoid risk and vulnerabilities for patients and organizations
  • Why ensuring the app is secured doesn’t have to end once it’s released

9:45 am Practical Application of AI/ML to Improve Outcomes & Streamline the Diagnostic/Care Journey of Paediatric Behavioural Health Conditions


  • Understand how AI/ML has the potential to reduce bias
  • Discover Cognoa’s regulatory milestones and lessons learned you can apply
  • Discuss practical applications of AI/Ml in diagnostics

10:15 am AI SaMD Start Up Case Study: Setting Up a Quality Management System


  • Outlining platforms and tools used – enabling engineering team to follow
  • Walking through key aspects of SOPs (standard operating procedures) like making software changes, and git branching with patient safety baked in
  • Processes, controlling workflows, approvals, e-Signatures

10:45 am Morning Coffee & Networking Break

11:15 am Examining Benefits & Challenges with Developing a Software Platform


  • Defining a platform
  • Discussing challenges faced today as a result of digital health, legacy products, changing technologies, regulatory compliance considerations
  • Understanding the benefits of creating a platform

Prioritizing Risk Management

11:45 am Security Concerns for Health Delivery Organizations

  • Jim Jacobson Principal Cybersecurity Officer, Siemens Healthineers


  • Understanding FDA guidance with cyber security and patient
  • Reducing cloud misconfigurations, web application attacks, and phishing
  • Overcoming the surge of Cyberattacks targeting the healthcare sector

12:15 pm Implementing Risk Analysis into the Software Development Lifecycle

  • Ephrat Most Senior Software Design Quality Engineering Manager , Medtronic


  • Identifying the risk response strategy
  • Planning Software risk monitoring
  • Core problems with software risk management

12:45 pm Lunch & Networking

1:45 pm Three Lessons from the Verification of Complex Software Systems

  • John Beebe Software Quality Manager - Surgical Robotics, Medtronic


  • Strategies to overcome common issues in the testing and delivery of large integrated medical software
  • Optimize team collaboration and outputs
  • Integrated verification across these approaches

2:15 pm Interactive Roundtable Discussion Groups

  • Ephrat Most Senior Software Design Quality Engineering Manager , Medtronic
  • Randy Horton Co-Chair, Software Mgmt Working Group 10 and TIR 115, AAMI


This interactive session will give you the opportunity to dive into the conversation with your fellow colleagues to discuss, debate and get inspiration on how to approach specific challenges. Choose the table most relevant to you, and get ready to be part of this conversation!

3:15 pm Chair’s Closing Remarks & End of Conference