Speakers

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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

11:05 am | Security Gap Coverage for Mobile-Based Threats