Meet Our Speakers
Industry leaders sharing insights on regulatory affairs, payment policy, and global market expansion
Keynote
Mark Leahey ⭐
CEO
Medical Device Manufacturers Association
June 12 • 12:15 PM
The view from DC: How tariffs, and changes to FDA and CMS will impact Medtech
Keynote Address
Jeanne Ireland
Principal
Ireland Strategies
June 12 • 10:00 AM
Mastering FDA Interactions
Panel Discussion
Jeff Valk
CEO
Admetsys
June 12 • 10:00 AM
Mastering FDA Interactions
Panel Discussion
Kate Stohlman
Vice President Quality and Regulatory Affairs
Corvia Medical
June 12 • 10:00 AM
Mastering FDA Interactions
Panel Discussion
Mira Leiwant
Senior Vice President, Regulatory, Quality, Clinical Affairs
Anika Therapeutics, Inc.
June 12 • 11:00 AM
The State of MDR
Hot Topic
Sean Timmons
Reimbursement Manager
Siemens Healthineers
June 12 • 1:15 PM
Coordinating Payment and Regulatory Strategy
Panel Discussion
Stephanie Nelson Wimmer, MBA, MPH
Global Vice President, Health Economics, Market Access and Reimbursement (HEMAR)
Philips
June 12 • 1:15 PM
Coordinating Payment and Regulatory Strategy
Panel Discussion
Dave Carey
Chief Commercial Officer
Pristine Surgical
June 12 • 2:00 PM
Driving Product Adoption in the Post-KOL Era
Panel Discussion
Meg Eckenroad
Senior Advisor, Health Policy, Innovation, and Technology
Origyn Solutions
June 12 • 2:00 PM
Driving Product Adoption in the Post-KOL Era
Panel Discussion
Cindy Friedman
State Senator
Massachusetts State Senate
June 12 • 2:45 PM
In our Backyard: The State of Hospital in MA
Panel Discussion
David Seltz
Executive Director
Massachusetts Health Policy Commission
June 12 • 2:45 PM
In our Backyard: The State of Hospital in MA
Panel Discussion
Kate Walsh
Sec. Health, Human Services
Commonwealth of Massachusetts
June 12 • 2:45 PM
In our Backyard: The State of Hospital in MA
Panel Discussion
Brian Scogland
Senior Director of Strategy – MedTech
Veeva
June 12 • 1:15 PM
Coordinating Payment and Regulatory Strategy
Panel Discussion
Noor Malki
SVP, Global Regulatory & Quality Operations
Varian, a Siemens Healthineers Company
June 12 • 1:15 PM
Coordinating Payment and Regulatory Strategy
Panel Discussion
Charlie Micelli
Strategic Advisor Network Finance
University of Vermont Health Network
June 12 • 2:00 PM
Driving Product Adoption in the Post-KOL Era
Panel Discussion
Rachel Robinson
Chief Operating Officer
MassMEDIC
June 12 • 2:00 PM
Driving Product Adoption in the Post-KOL Era
Panel Moderator
June 13 • 10:45 AM
Alignment Between FDA Clinical Trial Requirements and CMS Requirements for IDE Coverage
Panel Moderator
Brian Johnson
President
MassMEDIC
June 12 • 2:45 PM
In our Backyard: The State of Hospital in MA
Panel Moderator
Caitlin Haven, MPH
Decision Scientist
SHEOR, LLC
June 12 • 11:30 AM
The When and Why of Real World Data: Being Compelling to Payers in 2025
Hot Topic
Ellyn Russo, MS
Decision Scientist
SHEOR, LLC
June 12 • 11:30 AM
The When and Why of Real World Data: Being Compelling to Payers in 2025
Hot Topic
Jeff Abraham
Partner
Health Advances
June 13 • 10:15 AM
State of Telehealth Payments
Hot Topic
Michael Ferguson
Vice President, Global Healthcare Economics and Reimbursement
AtriCure
June 13 • 10:45 AM
Alignment Between FDA Clinical Trial Requirements and CMS Requirements for IDE Coverage
Panel Discussion
Yajuan Lu
Director, HEMA Interventional Cardiology
Boston Scientific
June 13 • 10:45 AM
Alignment Between FDA Clinical Trial Requirements and CMS Requirements for IDE Coverage
Panel Discussion
Tara Turney
Senior Director, Regulatory Affairs, Advanced Repair & Reconstruction Surgery
BD Surgery
June 13 • 11:30 AM
Vigilance: How/When to Prioritize Inspection Preparation
Panel Discussion
Marie O’Malley
Chief Commercial Officer
Pisa Manufacturing
June 13 • 11:30 AM
Vigilance: How/When to Prioritize Inspection Preparation
Panel Discussion
Sean McCarthy
Senior Regulatory Manager
ECI
June 13 • 11:30 AM
Vigilance: How/When to Prioritize Inspection Preparation
Panel Discussion
Paul Seltman
Senior Vice President of Global Public Policy and Government Affairs
Smith+Nephew
June 13 • 1:30 PM
Government Affairs in Action: What MedTech is Facing
Panel Discussion
Al Lytton
Head of Government Affairs
Insulet
June 13 • 1:30 PM
Government Affairs in Action: What MedTech is Facing
Panel Discussion
Ira Goldman
Senior Advisor, Government and Industry Affairs
Lantheus
June 13 • 1:30 PM
Government Affairs in Action: What MedTech is Facing
Panel Discussion
Pam Mejia
Senior Manager of Government Relations
ML Strategies
June 13 • 1:30 PM
Government Affairs in Action: What MedTech is Facing
Panel Discussion
Kevin Stevens
Head, Global Regulatory Affairs Device, PDT
Takeda
June 13 • 2:15 PM
Impact of AI on the Regulatory Function
Panel Discussion
Bobby Bouthillette
Director, Quality & Regulatory Sales
Dassault Systemes
June 13 • 2:15 PM
Impact of AI on the Regulatory Function
Panel Discussion
Matt King
Vice President, Regulatory Affairs
Precision Neuroscience
June 13 • 2:15 PM
Impact of AI on the Regulatory Function
Panel Discussion
Patrick Moore
Life Sciences North America Portfolio Leader
Cognizant Life Sciences
June 13 • 2:15 PM
Impact of AI on the Regulatory Function
Panel Discussion