
American Medical Device Summit
Lunch & Learn
Roundtables
Day 1
12:50 pm – 1:50 pm CST
12:50 pm – 1:50 pm CST
TABLE 1

Mark Su
Digital Health Strategy Lead
Keysight Technologies
AI-Driven Test Automation in PLM: Ensuring Reliability, Delivering Business Performance
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TABLE 2

René Zöelfl
Global MedTech Industry Advisor
PTC, Inc.
ENABLING INTELLIGENT PRODUCT LIFECYCLE FOR SMARTER, SAFER MEDICAL DEVICE INNOVATION
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TABLE 3

Mark Flanick
Compliance Navigator Sales, North America
BSI Compliance Navigator
AI Workflow Tools for Managing Compliance Risk
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TABLE 4

Mitch Hayes
SVP, Life Science & Healthcare
Clarivate Analytics
Real-world strategies for deploying GenAI platforms at scale
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TABLE 5

Christian Ballard
Director, Business Development and Client Services
Mission Plastics, Inc.
Leveraging precision molding for complex medical components
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TABLE 6

Kim Kaplan
Senior Product Manager
The Voluntary Improvement Program
Operational Excellence in Action with Lessons from the Frontlines of MedTech
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TABLE 7

Vishaka Rajaram
Senior Director, Quality Strategy
Veeva MedTech

Amra Racic
VP, Government Strategy
Veeva MedTech
Enabling an Agile and Efficient Culture of Quality
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TABLE 8

Manish Nayyar
SVP
Agiliad
Experiences in Improving Productivity through Gen AI
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TABLE 9

Sean McCarthy
Senior Regulatory Manager
ECI
QMSR Readiness: Common Challenges and Practical Strategies
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TABLE 10

Gilberto Jimenez
Senior Director, Engineering
SQA Services
Ensuring Global Medical Device Quality Through Expert Supplier Management
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TABLE 11

Brett Freeman
President
Providence Enterprise
Medical Device Contract Manufacturing in the East & West + Managing Tariffs
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TABLE 12

Rick Smith
Director, IoT Sales, North America
QNX
Designing medical systems with safety included from the start with commercial open source, real-time software
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TABLE 13

Ram Gudur
SVP, Healthcare & Lifesciences Sector
Qualitest

Norbert Leinfellner
EVP, Global Engineering
CAIRE, Inc.
De-Risk by Design: Proactive Strategies to Strengthen Medical Device Development
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TABLE 14

Vikram Gopal
SVP and Chief Technology Officer
Ascend Performance Materials
Designing the Future: Engineered Polyamides for Medical Innovation
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TABLE 15

Chris Povich
VP, Sales, Automation
Ascential
Designing for Manufacturability: Building Automation Readiness Into Product Design
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TABLE 16

Bob Rajewski
Founder and President
CriTech
FDA Compliance: Avoid common pitfalls in software development to ensure compliance and steer clear of FDA Requests for Additional Information
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TABLE 17

Caryn Mills
Medical Device Sales Director
HID
Driving Innovation in Medical Devices with RFID: Authentication, Safety, Compliance
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Day 2
12:25 pm – 1:25 pm CST
12:25 pm – 1:25 pm CST
TABLE 1

David Navazio
President, CEO
Gentell Inc
THE FUTURE OF WOUND CARE SUPPLY CHAIN: INNOVATION AND PATIENT-CENTERED SOLUTIONS FOR HOSPITALS AND LONG-TERM CARE
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TABLE 2

Jaya Tiwari
SVP, Medical Affairs
XVIVO
Advancing Organ Transplantation: Navigating Regulatory and Clinical Pathways For Innovation
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TABLE 3

Luis Lasalvia
VP, Global Medical Officer
Siemens Healthineers
LEVERAGING AI STRATEGIES FOR BETTER OUTCOMES IN MEDICAL DEVICES
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TABLE 4

JD Meler
VP, Enterprise Clinical Excellence
BD
STRATEGIES FOR LEVERAGING CLINICIANS WITHIN MEDICAL DEVICE COMPANIES
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TABLE 5

Kamala Kodihally Nanjundeshaiah
Senior Manager, Quality Assurance, Software Medical Devices
Pfizer
Enhancing the Medical Device Lifecycle and Process with AI Solutions
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TABLE 6

Matthew Weber
VP, R&D and Operations
FlexDex Surgical

Emily Skanron
Director, Regulatory and Quality
FlexDex Surgical
From Concept to Commercialization: Overcoming Startup Hurdles in Surgical Instrument Development
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TABLE 7

Dane Popovski
Senior Director, Regulatory Affairs
BD
AGILE GLOBAL REGULATORY STRATEGY: ACCELERATING INNOVATION WITHOUT COMPROMISING COMPLIANCE
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TABLE 8

Jacqueline Huber
Chief Compliance Officer
Medacta USA
INNOVATIVE, INTEGRATED HCP ENGAGEMENT: EMBEDDING COMPLIANCE INTO BUSINESS FOR SUSTAINABLE SUCCESS
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TABLE 9

Hari Krishna Kapparapu
Associate Director
Alcon Research
NAVIGATING AI, SAMD, AND REGULATORY SHIFTS IN MEDICAL DEVICE INNOVATION
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TABLE 11

Elena Mack
Chief Quality Officer
SaniSure
Supplier Quality: Should your Critical Suppliers be ISO 13485 Certified
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TABLE 12

Stephanie Muir
Senior Director, Product Delivery Excellence & Commitment to Quality, HST
Baxter
Advancing Connected Care Through Integrated R&D and Strategic Global Collaboration
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TABLE 13

Kimberly Adcock
Executive Director, Search and Strategy, Global
Medtronic
Navigating Talent Scarcity in Specialized Fields Within R&D or CMRA
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