7:45 am Morning Coffee & Networking

8:10 am Chair’s Opening Remarks

What To Expect: Emerging Global Trends in 2023 & Beyond

8:15 am Panel Discussion: Combining Innovative, Modern Software Engineering & Product Design with the Latest Innovation Trends to Deliver on Commercially Viable Medical Device Products


  • A Q&A session hosted by the Chair addressing where we can expect to see medical device software innovation in 2023 and beyond. Questions will include:
  • What’s coming on the horizon? How will Bluetooth, 5G, newer wireless tech and other technology innovations mean for what developers can do with medical devices in the future?
  • What does the future hold for current innovative technology? What are sensors going to be able to do in 10 years? What does the future hold for AI, ML and prospective learning in medical devices?
  • How do we design medical devices that are more equitable? How can we better integrate diversity into clinical trials? What more can be done to decentralize clinical trials
  • How can we improve data capture and ensure it is secure especially with decentralized clinical trials?
  • What can we do to prepare for the release of the FDA guidance around Real World Evidence?

Embedding Cybersecurity into Software Development

8:45 am Presentation: Cybersecurity across the Total Product Lifecycle

  • Linda Ricci MME MPH Director, Division of All Hazard Response, Science and Strategic Partnerships, US Food & Drug Administration (FDA)


  • What are FDA expectations for Cybersecurity in device development?
  • How to work with the FDA for cybersecurity considerations once a device is on the market
  • How can we employ adversarial thinking to sharpening strategies for device security to avoid incidents?

9:15 am Presentation: How To Protect Your Mobile Apps From Tampering

  • Daniel Shugrue Application Security Evangelist, Digital.ai Software, Inc.


  • The Mobile Threat Landscape in 2023
  • Mapping Your Security Strategy to OWASP Standards
  • Understanding Mobile Security Software

9:55 am Networking Break

10:05 am Presentation: Integrating Cybersecurity into the Lifecycle of Medical Device Software


  • The role of cybersecurity in the software development of a medical device
  • Discussing the security implications of utilizing third party applications / open sources in software development and how this impacts SW BoM generation.
  • How do you produce the right documentation for patching? Can this be automated?

10:35 am Presentation: Ensuring Your Current Cybersecurity Architecture is Suitable for 2023

  • Robert Ezzell Senior Director, Regulatory Affairs, ATAI Life Sciences


  • Ensuring your protected health information processes are adaptive globally and in light of new cybersecurity guidance from FDA
  • Embedded cybersecurity features to adhere global date protection laws
  • Identifying risk and ensuring you have the correct testing and that your mitigations are fit for 2023

11:05 am Presentation: Presentation to be delivered by Zimperium

Addressing Medical Device Software Development Challenges In a “Lifecycle” Manner

11:20 am Interactive Round Table Discussions:


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.

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12:00 pm Lunch Break

12:50 pm Presentation: Traditional Risk Management & Software Validation is Not Working So What’s Next?


  • The current state of software safety for SaMD
  • The new thinking and skill sets required to manage patient safety, quality system, cybersecurity and business risks
  • Applying latest guidance and reviewing how we: manage risk, implement effective software verification and ensure our devices continue to stay safe, secure and compliant in an ever changing environment.

1:20 pm Presentation: Medical Device Software Maintenance and Patching Future

  • Bemin Ghobreal Research & Development Engineering Manager, Product Owner, Medtronic


  • SW Maintainability best practice and good versioning scheme
  • Fast turnaround for addressing Field bugs and issues
  • Rethinking patching to expand the lifespan of SW as medical device so it doesn’t become a legacy device too soon

1:50 pm Presentation: Presentation to be delivered by Skyflow

2:30 pm Networking Break

2:50 pm Presentation: Scaled Agile & Lean Startup Meets SaMD


  • Tailoring Scaled Agile Development framework (SaFe) to meet SaMD (Software as a Medical Device) needs
  • Comparing Lean Startup version of SaMD to SaFe approach (startups vs large corporation)
  • Using Agile Guidance TIR-45 to assist in the tailoring
  • Embedding Cyber security, Patient Safety assessments in Definition of Ready & Done
  • How to make Build-Test-Learn work in regulated devices
  • Best in class tooling & automation to enable the SaMD methodology

3:20 pm Presentation: The Use of Real World Evidence & Open Source in the Development of SaMD for Regulatory Approval


  • Building a medical device with open source software and radical transparency
  • A technical perspective on the development, verification and validation of a SaMD device in 2023
  • An end-to-end case study on the use of RWE in the development of a innovative new medical device from open source
  • Driving product development using RWE collected via continuous postmarket surveillance

3:50 pm Networking Break

Post Market Challenges, Stakeholder Expectations & End-User Collaboration

4:10 pm Panel Discussion: Reconsidering How to Incorporate Useability into Software Development & Managing Customer & Stakeholder Expectations

  • Mark Lifson Director, Artificial Intelligence Systems Engineering, Mayo Clinic
  • Sunny Webb Chief Technical Officer, Verisk Health
  • Khaudeja Bano Vice President - Combination Product Quality, Amgen Inc.


Hear from the perspective of end users, regulatory and technical experts as well as stakeholders as you unlock the key to effective collaboration.

Questions will include:

  • How can we better align customer needs and future innovation trends as developers and engineers do to continue to push the boundaries of innovation i.e. with AI-enabled medical devices?
  • How can we incorporate useability / human factors into software development and recontextualize the device use for engineers?
  • How can we better work with stakeholders and hospitals to understand each party’s expectations and responsibilities?
  • Discussing medical device deployment environments in hospitals and how that can impact technical development.
  • How is telehealth changing the medical device software development world?
  • What can we do to better address cybersecurity trends and concerns with clients and stakeholders?

4:40 pm Presentation: Tackling the Challenges Associated with Evidence Generation for Clinical Evaluation and Post-Market Surveillance Within the Context of Evolving Global Regulations in a Fast- Paced Industry


  • How can we leverage real world data to demonstrate safety and effectiveness of SaMD products during development and post market?
  • What considerations are needed for the use of RWE to in SaMD development and post-market surveillance given FDA guidance and MDR requirements?
  • What multifunctional devices and digital health technologies can pharma organizations and manufactures deliver that can best support patients and healthcare providers
  • Integrating compliance and reducing delays by ensuring an effective line of communication between Clinical, Usability, Regulatory, Quality, and Software departments in the development process

5:10 pm Presentation: Post Market & Patching: Past, Present & A Cyber- Secure Future

  • Chris Puryear Vice President - Development, Bigfoot Biomedical Inc.


  • Solutions to a series of post market challenges including answers to your cybersecurity concerns
  • What is your cybersecurity infrastructure architecture? Do you have a cybersecurity firm, third party that you’re using?
  • Discussing the security implications of utilizing third party applications /open sources in software development and how this impacts SW BoM generation
  • A comparison of static code analysis and pen testing

5:40 pm Chair’s Closing Remarks & End of Conference