
Agenda
June 14, 2022
MDI Expo 2022 is packed with professional content; great keynote speakers, and 3 professional tracks:
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Quality & Regulation
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Digital Healthcare
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Design Practices
Note: The Majority of presentations will be given in Hebrew
Professional tracks presentations will start after a general assembly session.
Event agenda - General
08:00 - 09:00
Breakfast, Exhibit Viewing
09:00 - 10:40
General Assembly - Keynote Speakers
10:40 - 11:20
Break, Exhibition Visit
11:20 - 13:00
Professional Tracks - Part 1 (Quality & Regulation, Digital Healthcare, Design Practices)
13:00 - 14:00
Lunch, Exhibit Viewing
14:00 - 15:20
Professional Tracks - Part 2 (Quality & Regulation, Digital Healthcare, Design Practices)
15:20 - 16:30
Happy Hour, Summary, Lucky Draws
Keynote Speakers (General Assembly)
(click here for detailed track agenda)
09:00 - 09:20
Welcome Notes
Shuka Zernovizky
Founder, MDI
09:20 - 9:40
Opening Keynote
Prof. Ronni Gamzu
CEO, Tel Aviv Sourasky Medical Center
09:40 - 10:00
Health Care 2030: The Coming Transformation
Prof. Eyal Zimlichman
Chief Innovation & Transformation Officer, Sheba Medical Center
10:00 - 10:20
Challenges and Opportunities That Will Come Up In the Next Decade in the Life Science Industry
Eyal Lifschitz
Co-founder & Managing General Partner, Peregrine VC
10:20 - 10:40
Human Capital - The Missing Link in the Creation of a Growing Medical Locomotive - on the Challenges and Solutions
Ziv Mandl
CEO, Matrix R&D Services and Offshore, Co - CEO, John Bryce
Quality & Regulation Track
(click here for detailed track agenda)
Sponsored by:
Moderator:
Marina Lebel, VP Medical Device, Gsap
11:20 - 11:40
IVDR EU – In Vitro Diagnostic Regulation in the EU
Dr. Tami Siniaver
Quality and Regulatory Project Manager, Gsap
11:40 - 12:00
Current FDA Premarket Trends and Timeline
Michael Kasser
Director of Regulatory Sciences, Hogan Lovells
12:00 - 12:20
Regulatory Technology - Introduction to Regulatory Management System and Software
Business Development Manager, Arazy Group
12:20 - 12:40
Supplier Management in the New World
Yaron Ziv
Presale Manager, DOT Compliance
12:40 - 13:00
How to Start a Project With a Lab on the Right Foot
Nikitin Anthony
Medical Device Compliance Team Leader, Carmel Laboratories
13:00 - 14:00
Lunch, Exhibit Viewing
14:00 - 14:20
Regulatory Spotlight on Cybersecurity- Are You Ready?
Shlomit Cymbalista
Head of Regulations, Sternum
14:20 - 14:40
MeMed’s Journey: Impacting Patients’ Lives by Transforming an Idea Into a Cleared FDA Product
Efrat Hartog-David, Ph.D
VP of Regulatory Affairs and Quality Assurance, MeMed Diagnostics
14:40 - 15:00
Blueprint For IEC 60601-1 Edition 4 Standard
Steli Loznen, M.Sc., IEEE-SM
Vice President For Technical Activities, IEEE-PSES
15:00 - 15:20
FDA’s Breakthrough Device Designation Program
Shay Levav
VP Quality Assurance, Regulatory Affairs and Clinical, IceCure Medical
Digital Healthcare Track
(click here for detailed track agenda)
Sponsored by:
Moderator:
Dr. Dan J. Gelvan, CEO, t-syte Venture Lab
11:20 - 11:40
Digital Medical & Healthcare Software Development - The Future Should be the Present
Moshe Klaiman
CEO, Matrix Medika
11:40 - 12:00
11 Points to Think About Before Starting a Startup
Ohad Yaniv
Head of BizTEC Entrepreneurship Program, Technion
12:00 - 12:20
Navigating the CE Marking Requirements For Digital Health Products Under the MDR and IVDR
Fabien Roy
Partner, Hogan Lovells
12:20 - 12:40
Medical Device Software and SaMD: Best Practices for Meeting Regulatory Requirements
Yael Himmel-Shlomo
Director or Regulatory Affairs, RS-NESS LTD – Solution For Life Science Companies
12:40 - 13:00
How to Successfully Launch a Digital Medical Product Globally?
Batia Epstein-Buchnick
CEO, Q-Lingua Translation & Content Services
13:00 - 13:15
The Computer Will See You Now – AI and Legal Challenges
Adv Tamar Tavory
Special Counsel, Digital Health, Yigal Arnon & Co.
13:15 - 14:00
Lunch, Exhibit Viewing
14:00 - 14:20
Trends in Early-stage Digital Health Development
Eitan Kyiet
CEO, Road2
14:20 - 14:40
VR Medical Education: Advantages and Opportunities
Dmitrii Grand
International Sales Manager, MEDVR
14:40 - 15:00
Changing Trends in Digital Health - Transitioning to Virtual First
CEO, t-syte Venture Lab
15:00 - 15:20
Delivering Data-driven Personalized Healthcare: Lessons Learned From the Past and Implications For the Future
Yves Nordmann, M.D.
Co-Founder & Chief Medical Officer, docdok.health
Design Practices Track
(click here for detailed track agenda)
Moderator: Avner Gal, Co-founder & CEO, Iridium Consultancy & Technologies
11:20 - 11:40
Solvay High Performance Polymer Solutions For Biopharma and Surgical Robots
Customer Technical Development Engineer, Solvay
11:40 - 12:00
Computerized Software Validation in MD Industry
Haim Eliyahu
Validation & Engineering Team Leader, Gsap
12:00 - 12:20
Factors to Consider when Developing a Medical Device
Aviad Yedgar
Director of R&D, Integer Israel site
12:20 - 12:40
Integrating Industrial Design into Product Development
Gaby Lindenberg
CEO, Lindenberg Industrial Design
12:40 - 13:00
Advanced Storage Solutions For Medical Devices
Daniel Gurevich
Senior Application Engineer, Advantech IL
13:00 - 14:00
Lunch, Exhibit Viewing
14:00 - 14:20
How NEXA3D’s Ultrafast Resin 3D Printers are Accelerating the Design and Manufacturing of Devices
Chief Technology Officer, Nexa3D
14:20 - 14:40
Additive Manufacturing For Human Tissue Engineering
Henrik Bjoerk
Director / Co-owner, IPC – Innovative Polymer Compounds
14:40 - 15:00
15:00 - 15:20
SCUDO - Increases Confidence in Our Ability to Function Continuously During Virus Outbreaks
Yair Paska, Ph.D.
CEO, SCUDO