Speakers
Linda Ricci
MME MPH Director, Division of All Hazard Response, Science and Strategic Partnerships
US Food & Drug Administration (FDA)
Conference Day Two
Thursday 18th May 2023
8:45 am | Presentation: Cybersecurity across the Total Product Lifecycle
Robert Ezzell
Senior Director, Regulatory Affairs
ATAI Life Sciences
Conference Day Two
Thursday 18th May 2023
10:35 am | Presentation: Ensuring Your Current Cybersecurity Architecture is Suitable for 2023
Xenophon (Xenios) Papademetris
Professor
Yale University School of Medicine
Conference Day One
Wednesday 17th May 2023
4:50 pm | Panel Discussion: Navigating the Medical Device Industry: Rethinking Careers Pathways & Attracting Next Gen Scientific Talent to Drive Organizational Growth
Randy Horton
Co-Chair of Cloud Working Group and Technical Information Report
AAMI
Conference Day One
Wednesday 17th May 2023
3:50 pm | Presentation: This Is Not Your Grandmothers’ Medical Device: Cloud 2.0 & Distributed Computing in Medical Devices
John Beebe
Quality Systems Manager
Medtronic
Sara Jafari
Product Reviewer, Design Dossier Evaluator & Medical Device Certification Project Manager
LNE/G-MED North America, Inc.
Oleg Yusim
Senior Director - Product Security & Information Tehcnology
Edwards Lifesciences
Pat Baird
Head of Global Regulatory & Software Standards
Philips
Conference Day One
Wednesday 17th May 2023
8:50 am | A Deep Dive into the AI Regulatory and Standards Landscape Including Cybersecurity
Jennifer Newberger
VP Regulatory and Compliance
Cognito Therapeutics Inc.
Conference Day One
Wednesday 17th May 2023
10:40 am | Round Table Discussion Session: Changing Perspectives: How to Turn FDA Ambiguity & Restrictions into Creativity
4:50 pm | Panel Discussion: Navigating the Medical Device Industry: Rethinking Careers Pathways & Attracting Next Gen Scientific Talent to Drive Organizational Growth
Cabell Maddux
Director - Software Engineering
Day Zero Diagnostics Inc.
Conference Day One
Wednesday 17th May 2023
9:20 am | Presentation: The DevOps Toolchain & Your Medical Device: Considerations for a Modern DevOps Technology Stack in a Cloud-based SaMD Context
Stephen Odaibo
Founder, Chief Executive Officer& Chief Software Architect
RETINA-AI Health, Inc
Conference Day One
Wednesday 17th May 2023
8:15 am | Panel Discussion: Overcoming the Challenge of a Fast-Paced Software World in A Slow-Paced Regulatory World
1:10 pm | Presentation: Clinical Validation of AI Software as a Medical Device for Regulatory Approval / FDA Approval
4:50 pm | Panel Discussion: Navigating the Medical Device Industry: Rethinking Careers Pathways & Attracting Next Gen Scientific Talent to Drive Organizational Growth
8:05 am | Chair’s Opening Remarks
Conference Day Two
Thursday 18th May 2023
5:10 pm | Panel Discussion: Reconsidering How to Incorporate Useability into Software Development & Managing Customer & Stakeholder Expectations
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
Anthony Watson
Vice President Regulatory Affairs & Quality
Windgap Medical
Conference Day One
Wednesday 17th May 2023
1:40 pm | Presentation: Rethinking Regulatory Processes & Reducing Ambiguity Around FDA Guidelines for SaMD Devices
Sucheth Koppa
Head Of Software Verification, Validation, Computational Science & Informatics
Roche
Conference Day One
Wednesday 17th May 2023
3:20 pm | Presentation: SAFe Software Development Methodologies for Complex SaMD
Harshal Dear
Manager, Regulatory Affairs - Devices & Wellness US
Johnson & Johnson Services, Inc
Conference Day One
Wednesday 17th May 2023
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
Conference Day One
Wednesday 17th May 2023
8:15 am | Panel Discussion: Overcoming the Challenge of a Fast-Paced Software World in A Slow-Paced Regulatory World
Chris Puryear
Vice President - Development
Bigfoot Biomedical Inc.
Conference Day Two
Thursday 18th May 2023
4:40 pm | Presentation: Post Market & Patching: Past, Present & A Cyber- Secure Future
Uma Chandrashekhar
Global Information Product Security Officer
Alcon
Conference Day Two
Thursday 18th May 2023
10:05 am | Presentation: Integrating Cybersecurity into the Lifecycle of Medical Device Software
Bemin Ghobreal
Research & Development Engineering Manager, Product Owner
Medtronic
Conference Day Two
Thursday 18th May 2023
1:40 pm | Presentation: Medical Device Software Maintenance and Patching Future
Sameer Jaiswal
Dir
Abbott Laboratories
Conference Day Two
Thursday 18th May 2023
1:10 pm | Presentation: Traditional Risk Management & Software Validation is Not Working So What’s Next?
Tapani Otala
Vice President of Engineering
Tidepool
Conference Day Two
Thursday 18th May 2023
3:40 pm | Presentation: The Use of Real World Evidence & Open Source in the Development of SaMD for Regulatory Approval
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
Gregory Stern
Director of Product (SaMD)
Insulet Corporation
Conference Day One
Wednesday 17th May 2023
4:50 pm | Panel Discussion: Navigating the Medical Device Industry: Rethinking Careers Pathways & Attracting Next Gen Scientific Talent to Drive Organizational Growth
Conference Day Two
Thursday 18th May 2023
2:40 pm | Presentation: Scaled Agile & Lean Startup Meets SaMD
Khaudeja Bano
Vice President - Combination Product Quality
Amgen Inc.
Conference Day Two
Thursday 18th May 2023
5:10 pm | Panel Discussion: Reconsidering How to Incorporate Useability into Software Development & Managing Customer & Stakeholder Expectations
Mark Lifson
Director, Artificial Intelligence Systems Engineering
Mayo Clinic
Conference Day Two
Thursday 18th May 2023
5:10 pm | Panel Discussion: Reconsidering How to Incorporate Useability into Software Development & Managing Customer & Stakeholder Expectations
Lesley Butler
Head of RWE Digital Innovation
UCB S.A.
Conference Day Two
Thursday 18th May 2023
4:10 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
Ken Tubman
Director
Takeda
Conference Day Two
Thursday 18th May 2023
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
Caroline Kirwan
Director Regulatory Affairs and Quality
Cumulus Neuroscience
Conference Day Two
Thursday 18th May 2023
11:30 am | Interactive Round Table Discussions:
Gregg Harris
VP
VisCardia Inc.
Conference Day Two
Thursday 18th May 2023
11:30 am | Interactive Round Table Discussions:
Lynda Jeffcoat
Director, Software LCM
Alcon
Conference Day Two
Thursday 18th May 2023
10:05 am | Presentation: Integrating Cybersecurity into the Lifecycle of Medical Device Software
11:30 am | Interactive Round Table Discussions:
Shawnnah Monterrey
Founder & Chief Executive Officer
BeanStock Ventures
Conference Day One
Wednesday 17th May 2023
11:10 am | Presentation: Navigating the Regulatory Landscape
Daniel Shugrue
Application Security Evangelist
Digital.ai Software, Inc.
Conference Day Two
Thursday 18th May 2023
9:15 am | Presentation: How To Protect Your Mobile Apps From Tampering
Venk Varadan
CEO & Co-founder
Nanowear, Inc.
Conference Day Two
Thursday 18th May 2023
11:30 am | Interactive Round Table Discussions:
Andrey Madan
Director of Solution Engineering
Parasoft
Conference Day One
Wednesday 17th May 2023
4:20 pm | Exploring Software Unit Verification: Strategies, Approaches, & Considerations
Robin Andruss
Chief Privacy Officer
Skyflow
Conference Day Two
Thursday 18th May 2023
2:10 pm | Presentation: Stop Slouching! Improve Your Medical Data Privacy Posture
Robert Pearsall
Senior Principal Reliability Engineer
Medtronic
Arti Tandon
Digital Health Specialist, Digital Health Center of Excellence
US Food & Drug Administration (FDA)
Conference Day One
Wednesday 17th May 2023
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
Loren Shade
Vice President of Marketing
Allegro Software Development Corp.
Conference Day One
Wednesday 17th May 2023
2:10 pm | Advancing Healthcare Digital Transformation with a Digital Immune System for Medical IoT
Samuel Bandara
Senior Principal Software Engineer
Roche
Conference Day One
Wednesday 17th May 2023
3:20 pm | Presentation: SAFe Software Development Methodologies for Complex SaMD
Tim Carlson
Chief Architect, Mobile Technology
Medtronic
Conference Day Two
Thursday 18th May 2023
9:15 am | Presentation: How To Protect Your Mobile Apps From Tampering
Eleanor Roshier
Senior Conference Producer & Program Director
Hanson Wade
Conference Day One
Wednesday 17th May 2023
8:00 am | Program Director's Opening Remarks
4:50 pm | Panel Discussion: Navigating the Medical Device Industry: Rethinking Careers Pathways & Attracting Next Gen Scientific Talent to Drive Organizational Growth
Komaladevy Dhanapal
Director, Engineering Research & Development
Edwards Lifesciences
Conference Day One
Wednesday 17th May 2023
8:15 am | Panel Discussion: Overcoming the Challenge of a Fast-Paced Software World in A Slow-Paced Regulatory World
Eric Kalis
MAPS Solution Sales
Zimperium
Conference Day Two
Thursday 18th May 2023