7:15 am Registration & Networking

8:00 am Program Director’s Opening Remarks

  • Eleanor Roshier Senior Conference Producer & Program Director, Hanson Wade

8:05 am Chair’s Opening Remarks

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

Tackling the Innovation vs Compliance Conflict

8:15 am Panel Discussion: Overcoming the Challenge of a Fast-Paced Software World in A Slow-Paced Regulatory World

  • Katherine Pacheco Director Regulatory Affairs, Insulet Corporation
  • Harshal Dear Manager, Regulatory Affairs - Devices & Wellness US, Johnson & Johnson Services, Inc
  • Komaladevy Dhanapal Director, Engineering Research & Development, Edwards Lifesciences
  • Stephen Odaibo Founder, Chief Executive Officer& Chief Software Architect, RETINA-AI Health, Inc


A Q&A session hosted by the Chair addressing how to integrate regulatory awareness into technical software design

  • How do you adapt the best of modern software engineering, modern product design, and modern product management to the device world? 
  • What are the unique challenges for your device in terms of evolving global regulations?
  • As device manufacturers continue to navigate the evolving global regulatory framework (especially for SaMD) what is the biggest stride you have taken to drive innovation in this ‘regulatory whitespace’?
  • What is the impact of new cybersecurity regulations on the development of innovative, compliant medical device software? What are some early steps you have taken to remain compliant? Can you share best practices?
  • What is your general approach to innovation and bringing new software products to market?

8:50 am A Deep Dive into the AI Regulatory and Standards Landscape Including Cybersecurity

  • Pat Baird Head of Global Regulatory & Software Standards, Philips


  • What’s different about ML vs. traditional MD software?
  • Mapping out the regulatory and standards landscape for AI
  • Emerging topic: Rethinking the standards on cybersecurity for ML systems

9:20 am Presentation: The DevOps Toolchain & Your Medical Device: Considerations for a Modern DevOps Technology Stack in a Cloud-based SaMD Context

  • Cabell Maddux Director - Software Engineering, Day Zero Diagnostics Inc.


  • Which tools, from infrastructure provisioning and CI/CD to container orchestration and observability, might be included in a modern cloud DevOps technology stack?
  • How might regulatory requirements impact how these tools can or should be used during cloud-based SaMD development and deployment?
  • What trade-offs are made in balancing modern DevOps practices with SaMD development regulatory requirements and how might emerging DevOps trends impact that balance?

9:50 am Speed Networking Break


As the medical device software development community is reunited, this valuable session will ensure you can reconnect with your peers in the room to make new and lasting connections. All attendees will have the opportunity to meet and network with their industry colleagues

Navigating Global Regulatory Guidelines in 2023

10:40 am Round Table Discussion Session: Changing Perspectives: How to Turn FDA Ambiguity & Restrictions into Creativity


A combined presentation and round table discussion session addressing how to shift your mindset and innovative in a highly regulated space

How do you collaborate with regulators to find new ways to do things while working within this ‘regulatory whitespace’? Join this interactive session as thought leaders address the ambiguity around FDA guidance and how to shift your mindset and view this as a positive as opposed to a negative

11:10 am Presentation: Navigating the Regulatory Landscape


  • Overview of FDA submission requirements
  • FDA Submission Process and various regulatory pathways
  • Preparation steps including device classification, intended use and highlevel guidance’s and regulations

11:40 am Presentation: Addressing the Changing FDA Expectations Regarding the Development of SaMD, SiMD, AI & ML Devices to Enable the Production of Compliant & Innovative Software in the US

  • Arti Tandon Digital Health Specialist, Digital Health Center of Excellence, US Food & Drug Administration (FDA)


  • Discussing when the FDA Draft Guidance will be formalized and how it will align with the ISO standards
  • Revealing how software developers can better understand what does and does not clarify as a medical device, how can developers identify if a 510k is required for the medical device and what exactly is required in this documentation
  • Shedding light on the FDA’s view on how to validate products, how to manage products that involve artificial intelligence and machine learning both during development and prospectively 

12:10 pm Lunch Break

Effectively Combining Compliance & Innovation in Medical Device Software Including SiMD, SaMD, A.I. & ML

1:10 pm Presentation: Clinical Validation of AI Software as a Medical Device for Regulatory Approval / FDA Approval

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


  • Discussing what a good clinical trial design must look like for an AI enabled Medical Device
  • Aligning QMS against A.I. regulations, determining where the gaps are and then augmenting the QMS in to encompass those gaps
  • Discussing what risk management needs to look like and wherein lies the responsibility of patient safety for true A.I medical devices
  • An end-to-end case study on implementing cybersecurity into the development of a compliant and innovative A.I enabled device

1:40 pm Presentation: Rethinking Regulatory Processes & Reducing Ambiguity Around FDA Guidelines for SaMD Devices

  • Anthony Watson Vice President Regulatory Affairs & Quality, Windgap Medical


  • Closing the gaps on how to build, safe and effective SaMD with regulatory awareness
  • Reducing ambiguity around the FDA guidelines while finding new ways to do things while working within this ‘regulatory whitespace’
  • A case study example around applying FDA guidance to optimize regulatory compliance and regulatory flexibility

2:10 pm Advancing Healthcare Digital Transformation with a Digital Immune System for Medical IoT

  • Loren Shade Vice President of Marketing, Allegro Software Development Corp.


  • Six elements of a strong Digital Immune System (DIS)
  • Applying DIS to IoT Lifecycle
  • Understanding Risk, DIS and the Medical IoT lifecycle
  • How to mitigate risk with FIPS validated cryptography

2:40 pm Networking Break

3:20 pm Presentation: SAFe Software Development Methodologies for Complex SaMD

  • Sucheth Koppa Head Of Software Verification, Validation, Computational Science & Informatics, Roche
  • Samuel Bandara Senior Principal Software Engineer, Roche


  • A case study of a SAFe based development of genomic informatics solution for oncology
  • One team approach for bioinformatics & software development, verification and release
  • Discuss best practices, tools and lessons learnt

3:50 pm Presentation: This Is Not Your Grandmothers’ Medical Device: Cloud 2.0 & Distributed Computing in Medical Devices

  • Randy Horton Co-Chair of Cloud Working Group and Technical Information Report, AAMI


  • What happens when medical device software, data and connectivity spur new MedTech business and regulatory strategies?
  • Recommendations for Responsibly Embracing the Cloud for Medical Devices
  • A new framework for thinking about the emergence of “blurry lines” around medical device software.

4:20 pm Exploring Software Unit Verification: Strategies, Approaches, & Considerations


  • Unit verification is critical to meet IEC 62304 regulatory requirements for Class II and III medical device software
  • Methodologies to identify and define a unit under test and practical strategies to determine what constitutes a unit in the context of software verification
  • Comparative analysis of unit testing environments, including the advantages and disadvantages of conducting unit tests on different platforms like host machines, simulators, and target boards
  • Join this session to explore different aspects of software unit verification including code coverage in the context of unit verification

People Progression in the Medical Device Industry

4:50 pm Panel Discussion: Navigating the Medical Device Industry: Rethinking Careers Pathways & Attracting Next Gen Scientific Talent to Drive Organizational Growth


A combined discussion-led and Q&A session hosted by the Chair to help you map out your career and better understand talent

acquisition processes with the medical device industry.

Discussion topics will include:

  • Tell us about your journey through the medical device industry in 60 seconds.
  • As the medical device industry continues to rapidly grow and become increasingly competitive, how can we ensure we are hiring the right technical and regulatory talent to drive organizational growth and ensure future scientific innovation?
  • If attracting the talent is the easy part, how do you train up engineers at speed in order to get them effective in the shortest amount of time possible?
  • What is your approach and how do you educate your software engineers? How do we effectively communicate to them the importance of items less valued in non-regulated backgrounds, such as documentation? How do we educate on these basics?
  • What is the role of Universities in producing graduates that are ready to enter this industry?

5:20 pm Chair’s Closing Remarks & End of Day 1

5:30 pm Post-Event Drinks Reception Hosted by Hanson Wade