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Regulatory, Quality and Good Manufacturing Practices
Monday, Sep 23
9:30 am

Case for Quality
Location: Room 157 B
Joe Sapiente – Hologic Inc.; Sara Sulfridge – Baxter Healthcare; George J. Serafin, MSc – Grant Thornton; Francisco Vicenty – USFDA/CDRH/Office of Compliance; Pamela Goldberg, MBA – MDIC
Monday, Sep 23
11:00 am

Efficiently Collect Real World Data: Industry, Policy, and Regulatory Perspectives
Location: Room 156 C
Seth Goldenberg, PhD – Veeva Systems; Owen Faris, PhD – FDA/CDRH; Manish Bharara, PhD, MBA – Siemens Healthineers; Diane Wurzburger, JD – GE Healthcare; Rachel Rath, MBA, MPH – Medical Device Innovation Consortium (MDIC)
Monday, Sep 23
1:00 pm

Developing a Framework for Patient Input in Medical Device Clinical Trials
Location: Room 157 A
Barry Liden, J.D. – Edwards Lifesciences; Dean Bruhn-Ding, B.S., RAC – CVRx, Inc.; Michelle Tarver, MD, Ph.D – CDRH, FDA; Bray Patrick-Lake – Evidation Health; Jon Hunt – MDIC
Monday, Sep 23
2:00 pm

The New World of 510(k)
Location: Room 156 AB
Jeff Shuren, MD, JD – Food and Drug Administration; Susan Alpert – SFA Consulting; Maureen L. Mulvihill, PhD – Actuated Medical, Inc.; April Veoukas, JD – Abbott; Phil Desjardins – Johnson & Johnson
Tuesday, Sep 24
9:15 am

FDA’s New Approaches to Software Regulation: Pre-Certification and Artificial Intelligence
Location: Room 156 C
Venk Varadan, MBA – Nanowear; Diane Johnson, MS – Johnson & Johnson; Bakul Patel, MSEE, MBA – FDA; Nathan A. Brown, JD – Akin Gump LLP
Tuesday, Sep 24
10:10 am

Realizing Organizational and Global Value with Sustainable Business Actions
Location: Hall B, 300 Aisle
Walt Rosebrough – STERIS Corporation; Caroll H. Neubauer – B. Braun Medical Inc.; Greg Crist – AdvaMed
Tuesday, Sep 24
11:00 am

It Takes a Village: How the Health Care Community is Working Together to Tackle Cybersecurity
Location: Room 156 AB
Zach A. Rothstein, Esq. – AdvaMed; Jithesh Veetil, PhD – Medical Device Innovation Consortium (MDIC); Denise Anderson, MBA – H-ISAC; Greg T. Garcia – Health Sector Coordinating Council; Suzanne Schwartz, MD, MBA – FDA; Chris Tyberg – Abbott
Tuesday, Sep 24
2:15 pm

Going Viral: Best Practices in Social Media
Location: Room 157 A
Sandra Cohen Kalter, JD – Medtronic; Richard Cleland – Federal Trade Commission; Lisa Dwyer – King & Spalding; Eric Boyles – Medtronic; Jeanne Mell – OraSure Technologies, Inc.
Tuesday, Sep 24
3:45 pm

EtO Sterilization of Medical Devices: The Impact of Evolving Regulatory Requirements
Location: Room 157 A
Ellen Kondracki – BD; Phil Cogdill, MBA – Medtronic; Dan Carestio – STERIS Corporation; Suzanne Schwartz, MD, MBA – FDA; Steve Yeadon – Boston Scientific
Tuesday, Sep 24
3:45 pm

MDR/IVDR - What Now?
Location: Room 156 AB
John B. Wilkinson, MBA – Medicines and Healthcare products Regulatory Agency (MHRA), U.K.; Oliver D. Bisazza, Master of Economic Sciences – MedTech Europe; Michel Marboeuf, Master Business Administration – Stryker; Angela Brown – ICON
Wednesday, Sep 25
8:45 am

One Year In: What We’ve Learned from Creating 100's of MEDDEV 2.7/1 Rev. 4 and EU MDR Compliant CERs (It’s Harder Than You Think)
Location: Room 052A
Jon Gimbel, PhD – Regulatory & Quality Solutions (R&Q); Ibim Tariah, PhD – Regulatory & Quality Solutions (R&Q); Dona Occhipinti, MPH, CCRP – Hillrom; Theresa Miles – Regulatory & Quality Solutions (R&Q)
Wednesday, Sep 25
10:00 am

Clarifying Impact: Determining and Driving Quality and Technical Documentation Compliance
Location: Room 052A
Pat Shafer – Grant Thornton; Marty Zuzulo – Grant Thornton
Wednesday, Sep 25
11:15 am

MDR Readiness Seven Months from Date of Application
Location: Room 052A
Erik Vollebregt – Axon Lawyers
Wednesday, Sep 25
9:15 am

Inspections and MDSAP
Location: Room 156 C
Melissa Torres – FDA; Luann Pendy, PhD – Medtronic; Thomas Westrick – GE Healthcare; Laila Gurney – GE Healthcare; Ted Wilson – Hogan Lovells
Wednesday, Sep 25
10:30 am

Essentials of Regulatory Digital Transformations
Location: Hall B, 200 Aisle
Christopher Knerr – Mareana
Wednesday, Sep 25
10:30 am

Strengthening FDA's 510(k) Third Party Review Program: Streamlining the Process, Maximizing Patient Benefit
Location: Hall B, 500 Aisle
Gregory Pishko, PhD – FDA
Wednesday, Sep 25
10:45 am

Global Regulatory Convergence – Emerging Trends and Future Opportunities
Location: Room 156 C
Nicole Taylor Smith – Medtronic; Jeff Shuren, MD, JD – Food and Drug Administration; Melissa Torres – FDA; John B. Wilkinson, MBA – Medicines and Healthcare products Regulatory Agency (MHRA), U.K.; Augusto Geyer, MSc – Brazilian Health Regulatory Agency – ANVISA
Wednesday, Sep 25
11:00 am

Mitigating Human Factors Risk
Location: Hall B, 200 Aisle
Roger Mazzella, MBE – The Qt Company
Wednesday, Sep 25
2:15 pm

CDRH Town Hall
Location: Room 156 AB
Jeff Shuren, MD, JD – Food and Drug Administration; Suzanne B. Schwartz, MD, MBA – FDA; William H. Maisel, MD, MPH – CDRH, FDA; Janet Trunzo – AdvaMed; CAPT Raquel Peat, PhD, MPH – FDA
Payment & Health Care Delivery
Monday, Sep 23
11:00 am

Delivering Great Care and Technology Transformation in the World’s Largest Integrated Health System
Location: Room 157 B
Lord Prior of Brampton – NHS England; Ashley McEvoy – Johnson & Johnson; Tara Donnelly – NHSX; Sam Roberts – NHS England and NHS Improvement; Roland Sinker – Cambridge University Hospitals NHS Foundation Trust
Monday, Sep 23
12:30 pm

Value Based Care: Lessons and Learnings in LATAM Impacting the MedTech Industry
Location: Room 157 B
Marcia Makdisse, MD, PhD, MBA, VBHC Green Belt – CareCycle - Value Based Healthcare; Adolfo Llinas, MD – Fundacion Santa Fe de Bogota; Luly Castellanos de Samper, Science Degree from Boston College and Executive MBA from Andes University – Johnson & Johnson Medical, LATAM; Fabio Katayama – Hospital Samaritano
Monday, Sep 23
2:00 pm

Chasing Value: Understanding How to Work with GPOs to Introduce New Health Care Innovation in the Supply Chain
Location: Room 157 B
Chaun Powell, MBA – Premier Inc.; Becky Foret, RN, BSN, MBA – Vizient; Khatereh Calleja, JD – Healthcare Supply Chain Association; Kyle Chenet, MBA – 410 Medical; Phil Royston – Access Scientific, LLC; Larry Koesterer, RPh, CPSM – Intalere
Tuesday, Sep 24
8:30 am

China Market Access Updates - Regulatory, Clinical, Reimbursement & IP
Location: Room 157 A
Grace Palma, MBA – China Med Device, LLC; Jeff Potkul – Medtronic MITG; LiJuan He – Johnson & Johnson; Xing Zhou – Siemens Healthcare Diagnostic; Daisy Du – Medtronic; Lindsay Tao, MD – Johnson & Johnson; Zhi Tao; Jason Liang – China Med Device; Anita Wei – BD Greater China; Deng Shao Ping – China Med Device; Eric Rugo – Stryker; Li Ding – GuangDong NMPA (CFDA) Bureau; Jiang Feng – China Association of Medical Devices Industry; Elizabeth Woody – BD
Tuesday, Sep 24
2:10 pm

Emerging Issues Regarding the HCPCS Coding Process for Medical Devices
Location: Hall B, 500 Aisle
Stephanie A. Webster, Partner – Akin Gump Strauss Hauer & Feld LLP; DeChane Dorsey, Esq. – AdvaMed; William Scheinler, Esq. – Alcresta Therapeutics, Inc.
Wednesday, Sep 25
8:30 am

Value Based Health Care in Action: Enhancing Patient Outcomes and Managing Costs
Location: Room 157 B
Richard Charter – Value Based Healthcare; Andrew M. Baker – Stryker; Signe Haughton – Stryker Corp; Ansaar Rai, MD – , J.W. Ruby Memorial Hospital, West Virginia University Medicine; Thomas Vande Casteele – Awell
Wednesday, Sep 25
9:45 am

Strategic Use of Post Market Real World Evidence and Data Regarding Quality and Value
Location: Room 157 C
Tom Valuck, MD, JD – Discern Health; David J. Wierz, MA – The OCI Group, LLC; Maggie Alston, CHFP – Milliman, Inc.; Tracey Dodenhoff, MBA, MID – Archimedic
Wednesday, Sep 25
11:15 am

The Changing Payer/Provider Landscape: Opportunities for Medtech
Location: Hall B, 500 Aisle
Carlotta Rinke, MD, FACP, MBA – Accountable Care Solutions; David Gregory, MPA, FACHE – Baker Tilly; Alan Lieber – Atlantic Health System
Wednesday, Sep 25
11:15 am

What Do Hospital Administrators Really Want?
Location: Room 157 B
Maria Shepherd, MBA – Medi-Vantage; Jeanne O'Brien – Value Care Alliance; Shannon Kane, MBA – Value Care Alliance; Susan Martin – Middlesex Health
Sponsored By: Medmarc
Regulatory
Monday, Sep 23
9:30 am

Case for Quality
Location: Room 157 B
Joe Sapiente – Hologic Inc.; Sara Sulfridge – Baxter Healthcare; George J. Serafin, MSc – Grant Thornton; Francisco Vicenty – USFDA/CDRH/Office of Compliance; Pamela Goldberg, MBA – MDIC
Monday, Sep 23
11:00 am

Efficiently Collect Real World Data: Industry, Policy, and Regulatory Perspectives
Location: Room 156 C
Seth Goldenberg, PhD – Veeva Systems; Owen Faris, PhD – FDA/CDRH; Manish Bharara, PhD, MBA – Siemens Healthineers; Diane Wurzburger, JD – GE Healthcare; Rachel Rath, MBA, MPH – Medical Device Innovation Consortium (MDIC)
Monday, Sep 23
1:00 pm

Developing a Framework for Patient Input in Medical Device Clinical Trials
Location: Room 157 A
Barry Liden, J.D. – Edwards Lifesciences; Dean Bruhn-Ding, B.S., RAC – CVRx, Inc.; Michelle Tarver, MD, Ph.D – CDRH, FDA; Bray Patrick-Lake – Evidation Health; Jon Hunt – MDIC
Monday, Sep 23
2:00 pm

The New World of 510(k)
Location: Room 156 AB
Jeff Shuren, MD, JD – Food and Drug Administration; Susan Alpert – SFA Consulting; Maureen L. Mulvihill, PhD – Actuated Medical, Inc.; April Veoukas, JD – Abbott; Phil Desjardins – Johnson & Johnson
Tuesday, Sep 24
9:15 am

FDA’s New Approaches to Software Regulation: Pre-Certification and Artificial Intelligence
Location: Room 156 C
Venk Varadan, MBA – Nanowear; Diane Johnson, MS – Johnson & Johnson; Bakul Patel, MSEE, MBA – FDA; Nathan A. Brown, JD – Akin Gump LLP
Tuesday, Sep 24
8:30 am

China Market Access Updates - Regulatory, Clinical, Reimbursement & IP
Location: Room 157 A
Grace Palma, MBA – China Med Device, LLC; Jeff Potkul – Medtronic MITG; LiJuan He – Johnson & Johnson; Xing Zhou – Siemens Healthcare Diagnostic; Daisy Du – Medtronic; Lindsay Tao, MD – Johnson & Johnson; Zhi Tao; Jason Liang – China Med Device; Anita Wei – BD Greater China; Deng Shao Ping – China Med Device; Eric Rugo – Stryker; Li Ding – GuangDong NMPA (CFDA) Bureau; Jiang Feng – China Association of Medical Devices Industry; Elizabeth Woody – BD
Tuesday, Sep 24
10:10 am

Realizing Organizational and Global Value with Sustainable Business Actions
Location: Hall B, 300 Aisle
Walt Rosebrough – STERIS Corporation; Caroll H. Neubauer – B. Braun Medical Inc.; Greg Crist – AdvaMed
Tuesday, Sep 24
11:00 am

It Takes a Village: How the Health Care Community is Working Together to Tackle Cybersecurity
Location: Room 156 AB
Zach A. Rothstein, Esq. – AdvaMed; Jithesh Veetil, PhD – Medical Device Innovation Consortium (MDIC); Denise Anderson, MBA – H-ISAC; Greg T. Garcia – Health Sector Coordinating Council; Suzanne Schwartz, MD, MBA – FDA; Chris Tyberg – Abbott
Tuesday, Sep 24
2:15 pm

Going Viral: Best Practices in Social Media
Location: Room 157 A
Sandra Cohen Kalter, JD – Medtronic; Richard Cleland – Federal Trade Commission; Lisa Dwyer – King & Spalding; Eric Boyles – Medtronic; Jeanne Mell – OraSure Technologies, Inc.
Tuesday, Sep 24
3:45 pm

EtO Sterilization of Medical Devices: The Impact of Evolving Regulatory Requirements
Location: Room 157 A
Ellen Kondracki – BD; Phil Cogdill, MBA – Medtronic; Dan Carestio – STERIS Corporation; Suzanne Schwartz, MD, MBA – FDA; Steve Yeadon – Boston Scientific
Tuesday, Sep 24
3:45 pm

MDR/IVDR - What Now?
Location: Room 156 AB
John B. Wilkinson, MBA – Medicines and Healthcare products Regulatory Agency (MHRA), U.K.; Oliver D. Bisazza, Master of Economic Sciences – MedTech Europe; Michel Marboeuf, Master Business Administration – Stryker; Angela Brown – ICON
Wednesday, Sep 25
8:45 am

One Year In: What We’ve Learned from Creating 100's of MEDDEV 2.7/1 Rev. 4 and EU MDR Compliant CERs (It’s Harder Than You Think)
Location: Room 052A
Jon Gimbel, PhD – Regulatory & Quality Solutions (R&Q); Ibim Tariah, PhD – Regulatory & Quality Solutions (R&Q); Dona Occhipinti, MPH, CCRP – Hillrom; Theresa Miles – Regulatory & Quality Solutions (R&Q)
Wednesday, Sep 25
10:00 am

Clarifying Impact: Determining and Driving Quality and Technical Documentation Compliance
Location: Room 052A
Pat Shafer – Grant Thornton; Marty Zuzulo – Grant Thornton
Wednesday, Sep 25
11:15 am

MDR Readiness Seven Months from Date of Application
Location: Room 052A
Erik Vollebregt – Axon Lawyers
Wednesday, Sep 25
9:15 am

Inspections and MDSAP
Location: Room 156 C
Melissa Torres – FDA; Luann Pendy, PhD – Medtronic; Thomas Westrick – GE Healthcare; Laila Gurney – GE Healthcare; Ted Wilson – Hogan Lovells
Wednesday, Sep 25
10:30 am

Essentials of Regulatory Digital Transformations
Location: Hall B, 200 Aisle
Christopher Knerr – Mareana
Wednesday, Sep 25
10:30 am

Strengthening FDA's 510(k) Third Party Review Program: Streamlining the Process, Maximizing Patient Benefit
Location: Hall B, 500 Aisle
Gregory Pishko, PhD – FDA
Wednesday, Sep 25
10:45 am

Global Regulatory Convergence – Emerging Trends and Future Opportunities
Location: Room 156 C
Nicole Taylor Smith – Medtronic; Jeff Shuren, MD, JD – Food and Drug Administration; Melissa Torres – FDA; John B. Wilkinson, MBA – Medicines and Healthcare products Regulatory Agency (MHRA), U.K.; Augusto Geyer, MSc – Brazilian Health Regulatory Agency – ANVISA
Wednesday, Sep 25
11:00 am

Mitigating Human Factors Risk
Location: Hall B, 200 Aisle
Roger Mazzella, MBE – The Qt Company
Wednesday, Sep 25
2:15 pm

CDRH Town Hall
Location: Room 156 AB
Jeff Shuren, MD, JD – Food and Drug Administration; Suzanne B. Schwartz, MD, MBA – FDA; William H. Maisel, MD, MPH – CDRH, FDA; Janet Trunzo – AdvaMed; CAPT Raquel Peat, PhD, MPH – FDA
Patient Perspectives
Monday, Sep 23
1:00 pm

Developing a Framework for Patient Input in Medical Device Clinical Trials
Location: Room 157 A
Barry Liden, J.D. – Edwards Lifesciences; Dean Bruhn-Ding, B.S., RAC – CVRx, Inc.; Michelle Tarver, MD, Ph.D – CDRH, FDA; Bray Patrick-Lake – Evidation Health; Jon Hunt – MDIC
Monday, Sep 23
2:15 pm

More Value for Patients & Society Through Data-Driven Health Care: US and International Perspectives
Location: Room 157 A
Mitja Kurki, PhD – Broad Institute of MIT and Harvard, Finnish Institute of Molecular Medicine, Helsinki, Finland; Jaqueline Corrigan-Curay, MD, JD – FDA; Marja Liisa Niinikosk, DBA – Helsinki Business Hub; Pekka Kahri, MSc (Tech) – HUS Helsinki University Hospital; Stasha Ler, MBA – Medtronic; Tero Silvola – BC Platforms
Legal & Health Care Compliance
Monday, Sep 23
9:30 am

A Values-Based Approach to MedTech Business Integrity
Location: Room 157 C
Ilyssa Levins – Center for Communication Compliance; Ann Ford, BSN, JD – Hall Prangle & Schoonveld; Michael Varadian, JD, MBA – HealthSpan Advisors; Denis Jacob – Orthofix
Monday, Sep 23
2:00 pm

AdvaMed’s New Code of Ethics: Is Your Company Prepared to Comply?
Location: Room 157 C
Matt Wetzel, JD – Akin Gump Strauss Hauer & Feld LLP; Jonathan Turner – Smith & Nephew; Kristi Schrode Travers, JD, PhD – Johnson & Johnson; Avi Spira, MA, JD – FUJIFILM Holdings America Corporation; Nancy S. Travis, MA – AdvaMed
Tuesday, Sep 24
11:55 am

Everyone Knows Health Care Is DOJ’s Favorite Target; What Does That Mean for MedTech Executives?
Location: Hall B, 500 Aisle
Chris White – AdvaMed; Ralph J. Caccia, JD – Wiley Rein; Daniel Gerhan – Boston Scientific; Blaine Dart – Zimmer Biomet; Drew Bradylyons
Wednesday, Sep 25
8:15 am

Innovation, Regulation, and Adaptation: Emerging Legal Issues in Digital Health
Location: Hall B, 500 Aisle
Daniel I.A Smulian, JD – Greenberg Traurig, LLP; Kate Black, JD – Greenberg Traurig, LLP; Jackie Haydock, JD – Microsoft
Wednesday, Sep 25
8:30 am

Health Care Fraud: The Government View and the Compliance Perspective
Location: Room 157 C
Miranda Hooker, JD – Pepper Hamilton LLP; Amanda Strachan – United States Attorney's Office for the District of Massachusetts; Lisa A. Schlatz, JD – Partners HealthCare; Maureen Ruane
International
Sunday, Sep 22
12:30 pm

US Market Access Seminar
Location: Room 156 C
Christine Sarkisian, MA – Boston Business Acceleration; Angus McQuilken – McDermott Will & Emery LLP; Steve Miller – U.S. Department of Commerce; Mark Sullivan – Massachusetts Office of International Trade and Investment (MOITI); Mike Graney – Charleston Regional Development Alliance; Kwame Ulmer – Ulmer Ventures; Vernessa T. Pollard – McDermott Will & Emery; Michael Ryan, JD – McDermott Will & Emery LLP; Jennifer Bock – McDermott Will & Emery LLP; Albert Sokol – McDermott Will & Emery LLP
Sponsored By: McDermott Will & Emery
Monday, Sep 23
9:00 am

Revolutionizing the Silver Economy
Location: Room 156 AB
Harriet Harriet Finne-Soveri, MD, PhD – National Institute for Health and Welfare, Finland; Sayaka Tomihara – Ministry of Economy, Trade, and Industry, Japan; Lord Prior of Brampton – NHS England; Daniel Grant, PhD, MBA – MTPConnect; Joseph Coughlin – MIT AgeLab
Monday, Sep 23
11:00 am

Delivering Great Care and Technology Transformation in the World’s Largest Integrated Health System
Location: Room 157 B
Lord Prior of Brampton – NHS England; Ashley McEvoy – Johnson & Johnson; Tara Donnelly – NHSX; Sam Roberts – NHS England and NHS Improvement; Roland Sinker – Cambridge University Hospitals NHS Foundation Trust
Monday, Sep 23
12:30 pm

Value Based Care: Lessons and Learnings in LATAM Impacting the MedTech Industry
Location: Room 157 B
Marcia Makdisse, MD, PhD, MBA, VBHC Green Belt – CareCycle - Value Based Healthcare; Adolfo Llinas, MD – Fundacion Santa Fe de Bogota; Luly Castellanos de Samper, Science Degree from Boston College and Executive MBA from Andes University – Johnson & Johnson Medical, LATAM; Fabio Katayama – Hospital Samaritano
Monday, Sep 23
12:30 pm

US - China Relationship: From Cooperation to Confrontation
Location: Room 157 C
James McGregor – APCO Worldwide
Tuesday, Sep 24
8:30 am

China Market Access Updates - Regulatory, Clinical, Reimbursement & IP
Location: Room 157 A
Grace Palma, MBA – China Med Device, LLC; Jeff Potkul – Medtronic MITG; LiJuan He – Johnson & Johnson; Xing Zhou – Siemens Healthcare Diagnostic; Daisy Du – Medtronic; Lindsay Tao, MD – Johnson & Johnson; Zhi Tao; Jason Liang – China Med Device; Anita Wei – BD Greater China; Deng Shao Ping – China Med Device; Eric Rugo – Stryker; Li Ding – GuangDong NMPA (CFDA) Bureau; Jiang Feng – China Association of Medical Devices Industry; Elizabeth Woody – BD
Tuesday, Sep 24
2:30 pm

International Digital Health: Perspectives on Data, Partnerships and Scaling Internationally
Location: Room 157 B
Toby Sainsbury, PhD – IDA Ireland; Ivan Houlihan – IDA Ireland; Shaun Braun – Stryker; John O’Brien – S3 Connected Health; Mick Farrell, SM, MBA – ResMed
Tuesday, Sep 24
3:45 pm

MDR/IVDR - What Now?
Location: Room 156 AB
John B. Wilkinson, MBA – Medicines and Healthcare products Regulatory Agency (MHRA), U.K.; Oliver D. Bisazza, Master of Economic Sciences – MedTech Europe; Michel Marboeuf, Master Business Administration – Stryker; Angela Brown – ICON
Wednesday, Sep 25
8:30 am

Value Based Health Care in Action: Enhancing Patient Outcomes and Managing Costs
Location: Room 157 B
Richard Charter – Value Based Healthcare; Andrew M. Baker – Stryker; Signe Haughton – Stryker Corp; Ansaar Rai, MD – , J.W. Ruby Memorial Hospital, West Virginia University Medicine; Thomas Vande Casteele – Awell
Wednesday, Sep 25
8:45 am

One Year In: What We’ve Learned from Creating 100's of MEDDEV 2.7/1 Rev. 4 and EU MDR Compliant CERs (It’s Harder Than You Think)
Location: Room 052A
Jon Gimbel, PhD – Regulatory & Quality Solutions (R&Q); Ibim Tariah, PhD – Regulatory & Quality Solutions (R&Q); Dona Occhipinti, MPH, CCRP – Hillrom; Theresa Miles – Regulatory & Quality Solutions (R&Q)
Wednesday, Sep 25
10:00 am

Clarifying Impact: Determining and Driving Quality and Technical Documentation Compliance
Location: Room 052A
Pat Shafer – Grant Thornton; Marty Zuzulo – Grant Thornton
Wednesday, Sep 25
11:15 am

MDR Readiness Seven Months from Date of Application
Location: Room 052A
Erik Vollebregt – Axon Lawyers
Emerging Trends
Monday, Sep 23
9:30 am

The Business Value of Design: How Do the Best MedTech Design Performers Increase Their Revenues and Shareholder Returns at Nearly Twice the Rate of Their Industry Counterparts?
Location: Room 157 A
Stephanie Henze – McKinsey and Company; Paul Hermes – Medtronic; Craig R. Loomis, MS, MBA – General Electric; Claudio D'Ambrosio – Varian Medical Systems
Monday, Sep 23
2:15 pm

More Value for Patients & Society Through Data-Driven Health Care: US and International Perspectives
Location: Room 157 A
Mitja Kurki, PhD – Broad Institute of MIT and Harvard, Finnish Institute of Molecular Medicine, Helsinki, Finland; Jaqueline Corrigan-Curay, MD, JD – FDA; Marja Liisa Niinikosk, DBA – Helsinki Business Hub; Pekka Kahri, MSc (Tech) – HUS Helsinki University Hospital; Stasha Ler, MBA – Medtronic; Tero Silvola – BC Platforms
Tuesday, Sep 24
10:00 am

Preparing for Medical Device Cybersecurity in 2020
Location: Hall B, 200 Aisle
Vidya Murthy
Tuesday, Sep 24
10:30 am

From Data to Data Science
Location: Hall B, 200 Aisle
Manu Swami – Virtusa; Santanu Sen – Virtusa; Kartik Iyengar
Tuesday, Sep 24
11:30 am

Device Connectivity Platform as a Service: Build vs Buy, Accelerate Time to Market
Location: Hall B, 200 Aisle
Krishna Padmanaban – L&T Technology Services Limited
Tuesday, Sep 24
2:30 pm

International Digital Health: Perspectives on Data, Partnerships and Scaling Internationally
Location: Room 157 B
Toby Sainsbury, PhD – IDA Ireland; Ivan Houlihan – IDA Ireland; Shaun Braun – Stryker; John O’Brien – S3 Connected Health; Mick Farrell, SM, MBA – ResMed
Tuesday, Sep 24
4:00 pm

How Major New Players Are Challenging the Current Health Care Ecosystem
Location: Room 157 C
Gabriele Brambilla – Alira Health; Cindy Kent, MBA – Best Buy; Luba Greenwood – Verily, a Google company; David Inns, MBA – GreatCall Inc.; Oxana Pickeral – Amazon Web Services
Wednesday, Sep 25
10:00 am

Evolving Commercial Models In The New Health Care Ecosystem
Location: Hall B, 200 Aisle
Craig Ackerman, MBA – The Alexander Group
Wednesday, Sep 25
10:30 am

Essentials of Regulatory Digital Transformations
Location: Hall B, 200 Aisle
Christopher Knerr – Mareana
Wednesday, Sep 25
11:30 am

Phase Zero: How to be Resource-Efficient with New Product Opportunities
Location: Hall B, 200 Aisle
Scott C. Thielman, PhD – Product Creation Studio
Global Health
Monday, Sep 23
11:00 am

Delivering Great Care and Technology Transformation in the World’s Largest Integrated Health System
Location: Room 157 B
Lord Prior of Brampton – NHS England; Ashley McEvoy – Johnson & Johnson; Tara Donnelly – NHSX; Sam Roberts – NHS England and NHS Improvement; Roland Sinker – Cambridge University Hospitals NHS Foundation Trust
Monday, Sep 23
11:00 am

SME MedTech Innovations That Are Transforming Health Care in the US and Abroad
Location: Room 157 A
Xavier Urtubey – AccuHealth; Chris Macek – SystemOne; Kaakpema "KP" Yelpaala – access.mobile; Lisa Bourget, MBA – Duke Global Health Innovation Center, Innovations in Healthcare
Digital Medtech
Tuesday, Sep 24
10:30 am

Connected Ecosystems for Smarter Decisions
Location: Hall B, 500 Aisle
Vidya Viswanathan, MBA – Cognizant; Arnaub Chatterjee – Medidata Solutions
Tuesday, Sep 24
11:00 am

It Takes a Village: How the Health Care Community is Working Together to Tackle Cybersecurity
Location: Room 156 AB
Zach A. Rothstein, Esq. – AdvaMed; Jithesh Veetil, PhD – Medical Device Innovation Consortium (MDIC); Denise Anderson, MBA – H-ISAC; Greg T. Garcia – Health Sector Coordinating Council; Suzanne Schwartz, MD, MBA – FDA; Chris Tyberg – Abbott
Tuesday, Sep 24
11:15 am

Diverse Perspectives on Developing and Deploying Digital Technologies
Location: Room 157 B
Russell L. Jones, CISSP, CSSLP – Deloitte Consulting; Vernessa T. Pollard – McDermott Will & Emery; Afia Asamoah, J.D. – Google Health; Uday Kumar, MD – Element Science; Leslie Wise, J.D. – Evidence Matters
Wednesday, Sep 25
8:15 am

Innovation, Regulation, and Adaptation: Emerging Legal Issues in Digital Health
Location: Hall B, 500 Aisle
Daniel I.A Smulian, JD – Greenberg Traurig, LLP; Kate Black, JD – Greenberg Traurig, LLP; Jackie Haydock, JD – Microsoft
Wednesday, Sep 25
9:00 am

Beyond Silos: Fusing Digital Across the Enterprise
Location: Hall B, 500 Aisle
Brian Williams – Cognizant
Diagnostics
Monday, Sep 23
9:30 am

Articulating the Value of Diagnostics: Moving Toward Value Based Approaches
Location: Room 156 C
Lena Chaihorsky – Alva10; Rochelle C. Fink, MD, JD, MBA – U.S. Food and Drug Administration; Heather Brown – HeartFlow; Matt Tucker, MBA – Highmark Health
Monday, Sep 23
1:00 pm

Using Data and Analytics to Demonstrate the Value of Diagnostics
Location: Room 156 C
Barry Rosenberg, MD MBA – Boston Consulting Group; Joseph Bernardo – Linden Capital Partners; Alan Wright, MD – Roche Diagnostics; Thierry Bernard
Tuesday, Sep 24
2:15 pm

Leadership Views on Diagnostics
Location: Hall B, 300 Aisle
Joseph Bernardo – Linden Capital Partners; Ramon Benet, MBA – Instrumentation Laboratory (IL); Dave Hickey – Becton Dickinson; Susan Van Meter – AdvaMedDx; Thierry Bernard
Tuesday, Sep 24
4:00 pm

The Role of Diagnostics in Promoting the Health and Health Care of Women
Location: Room 157 B
Nicole Sweeney – BD; Margaret Eckenroad – Hologic; Shamiram R. Feinglass, MD, MPH – Danaher; Marsha Henderson, MCRP – Healthy Women
Wednesday, Sep 25
9:15 am

The Democratization of Personalized Medicine – Bringing it Closer to the Community
Location: Room 157 A
David Parker, PhD – Precision For Medicine; Sheryl Elkin, PhD – N-of-One, Inc.; Paul Gerrard, MD – Palmetto GBA; Stephen Schleicher, MD, MBA – Tennessee Oncology/OneOncology
Wednesday, Sep 25
10:45 am

New Diagnostic Technologies are Transforming Testing
Location: Room 157 A
Gregory Stutman, MBA – IQVIA; Rahul Dhanda – Sherlock Biosciences; Ariel Beery, MPA/MA – MobileODT; Jonathan Romanowsky – Inflammatix; Ketan Paranjape – Roche
Business Strategies
Monday, Sep 23
8:00 am

AdvaMed Accel Leadership Seminar
Location: Room 052
Ben Glenn, JD – Shay Glenn LLP; Paul Snyder – Write2Market; Tiffany Wilson – Global Center for Medical Innovation (GCMI); Maria Stewart – Boston Scientific; Arthi Chandran, DrPH – BD; Martin Gold, MBA – Integra LifeSciences; Matt Benessere, MBA – Insulet; Deepak Sahu, MBA – Alira Health; Shar Matin – ViewRay, Inc.; David Cassak – The MedTech Strategist; Michael R. Minogue – ABIOMED, Inc.; Dev Kurdikar – Cardiac Science Corporation, now part of ZOLL Medical
Sponsored By: Alira Health
Monday, Sep 23
9:00 am

Revolutionizing the Silver Economy
Location: Room 156 AB
Harriet Harriet Finne-Soveri, MD, PhD – National Institute for Health and Welfare, Finland; Sayaka Tomihara – Ministry of Economy, Trade, and Industry, Japan; Lord Prior of Brampton – NHS England; Daniel Grant, PhD, MBA – MTPConnect; Joseph Coughlin – MIT AgeLab
Monday, Sep 23
9:30 am

The Business Value of Design: How Do the Best MedTech Design Performers Increase Their Revenues and Shareholder Returns at Nearly Twice the Rate of Their Industry Counterparts?
Location: Room 157 A
Stephanie Henze – McKinsey and Company; Paul Hermes – Medtronic; Craig R. Loomis, MS, MBA – General Electric; Claudio D'Ambrosio – Varian Medical Systems
Monday, Sep 23
9:30 am

A Values-Based Approach to MedTech Business Integrity
Location: Room 157 C
Ilyssa Levins – Center for Communication Compliance; Ann Ford, BSN, JD – Hall Prangle & Schoonveld; Michael Varadian, JD, MBA – HealthSpan Advisors; Denis Jacob – Orthofix
Monday, Sep 23
12:15 pm

Health 2040: Medtech’s Role in a Transformed Future
Location: Room 156 AB
Sheri L. Dodd – Medtronic Care Management Service & Non-Intensive Diabetes Therapies; Michael Minette – Zimmer Biomet; Michael Apkon, MD, PhD – Tufts Medical Center; Pedro M. Arboleda, MBA – Deloitte; Luba Greenwood – Verily, a Google company
Monday, Sep 23
2:15 pm

Establishing the Value of Your MedTech Innovation - It's Never Too Early
Location: Room 156 C
Martha Shadan, MBA – Miach Orthopaedics; Scott Schorer – GI Dynamics; Aaron Sandoski, MBA – Norwich Ventures; Amy Siegel – S2N Health, LLC
Sponsored By: Medmarc
Tuesday, Sep 24
9:25 am

Bridging Commercial and Military Market Needs to Advance Medical Device Development
Location: Hall B, 500 Aisle
Joe Berger, MBA – Battelle; Joseph Turk – Fresenius Medical Care North America; Jason Opdyke, PhD – Department of Defense; Joint Program Executive Office for Chemical Biological and Nuclear Defense
Tuesday, Sep 24
9:15 am

MedTech Innovator Showcase - Cardiovascular
Location: Hall B, 500 Aisle
Arvind Thiagarajan – HD Medical; Harsh Vathsangam, PhD – Moving Analytics; Eric A. Kriegstein, MBA – Respirix; Ken Nelson – Bardy Diagnostics; Oren Goldshtein, MSc – Vectorious Medical Technologies
Tuesday, Sep 24
9:45 am

The New World of Medtech M&A Valuation: Strategies to Adapt and Thrive
Location: Room 157 B
John Babitt – EY; Charlie Attlan – Boston Scientific; Chris Cleary – Medtronic; Susan E. Morano – Johnson & Johnson; J.P. Peltier – Piper Jaffray
Tuesday, Sep 24
2:15 pm

Medtech, Look to Marketing for the Solution
Location: Room 156 C
Matt Singer – ZS Associates; Randy Randal Pritchard, MBA – Roche Diagnostics Corporation; Robert Clark – Medtronic; George Parr – BD; Rajit Kamal – Johnson & Johnson
Tuesday, Sep 24
9:50 am

MedTech Innovator Showcase - Vascular Solutions
Location: Hall B, 500 Aisle
Andy Doraiswamy, PhD – Koya; Conrad Rasmus – Protembis; Vanessa Gore – Soletics; Stephen Cox, MBA – Venari Medical; Rob Abrams – Epic Neuro
Tuesday, Sep 24
10:30 am

MedTech Innovator Showcase - Oncology
Location: Hall B, 500 Aisle
Michael Allen – Embolx; Cécile Dupont – HEPTA Medical; Katharine Giles, MBBS(Hons), MBA, GAICD – OncoRes Medical; Enhao Gong – Subtle Medical; Jay Lichter, PhD – Avelas Biosciences
Tuesday, Sep 24
11:05 am

MedTech Innovator Showcase - Molecular Diagnostics
Location: Hall B, 500 Aisle
Tara Dalton, BEng (Aeronautical Eng) PhD – Altratech; David Ludvigson, MAS – Nanomix; Dede Willis, MBA – Orbit Genomics, Inc.; Jeff June – Ischemia Care; Federico Buersgens, PhD – GNA Biosolutions
Tuesday, Sep 24
11:15 am

Small Companies Selling Big Ideas to Huge Corporations
Location: Room 157 C
Paul L’Archevêque – Québec; Steven Arless – SoundBite Medical Solutions Inc.; Kathryn Zavala, PhD – MedTech Innovator; Adam L. Wollowick, MD, MBA – Stryker; Nick Dougherty – PULSE@MassChallenge
Sponsored By: Medmarc
Tuesday, Sep 24
11:45 am

MedTech Innovator Showcase - Neurotechnology
Location: Hall B, 500 Aisle
Matt Kesinger, MS – Forest Devices; Ronald Jay Solar, PhD – ThermopeutiX, Inc.; Daniel S. Chao, MD, MS – Halo Neuroscience; Dan Kogan – Savonix
Tuesday, Sep 24
2:15 pm

MedTech Innovator Showcase - Chronic Disease Management
Location: Hall B, 500 Aisle
Jeffrey Brewer – Bigfoot Biomedical; Xina Quan, PhD – PYRAMES; Matthew Banet – toSense; Rui Jing Jiang – Avisi Technologies; Pat Antaki – Evergaze LLC
Tuesday, Sep 24
2:15 pm

Pulse of the Industry 2019
Location: Room 156 AB
John Liddicoat, MD – Medtronic Americas Region; Ashley McEvoy – Johnson & Johnson; James Welch – EY
Tuesday, Sep 24
2:50 pm

MedTech Innovator Showcase - Personalized and Precision Medicine
Location: Hall B, 500 Aisle
Eric D. Benson, MBA – American BioOptics; Lawrence Cohen – Glycotest; Joshua Tauber, MBA – HealthReveal; James A. Reinstein – Previvo; Sean Curry – Onkos Surgical
Tuesday, Sep 24
3:05 pm

Advancing Inclusion and Diversity
Location: Hall B, 300 Aisle
Cathi Rittelmann – Korn/Ferry; Mary Anne Heino – Lantheus Medical Imaging, Inc.; Martha Shadan, MBA – Miach Orthopaedics; Steffen Hovard, MSc Economics – Coloplast; Namal Nawana – Smith & Nephew
Tuesday, Sep 24
4:00 pm

How Major New Players Are Challenging the Current Health Care Ecosystem
Location: Room 157 C
Gabriele Brambilla – Alira Health; Cindy Kent, MBA – Best Buy; Luba Greenwood – Verily, a Google company; David Inns, MBA – GreatCall Inc.; Oxana Pickeral – Amazon Web Services
Wednesday, Sep 25
9:15 am

MedTech Innovator Showcase - Critical Care
Location: Hall B, 500 Aisle
Aly El Badry, MBA – CloudCath; Howard Carolan – CoapTech; Robert Quinn – Patch'd; Jeffrey Alvarez, MBA – Potrero Medical
Wednesday, Sep 25
9:45 am

Digital Transformation of the Medical Technology Market - the Disruptor or Enabler?
Location: Hall B, 500 Aisle
Sowmya Rajagopalan, Masters in Science ( Integrated) – Frost & Sullivan; Ravi Kuppuraj – Philips; Mukund Paravasthu – Johnson & Johnson
Wednesday, Sep 25
9:50 am

MedTech Innovator Showcase - Surgical Advancements
Location: Hall B, 500 Aisle
Marc Bessler, MD – EndObetes; Antti Roine – Olfactomics; Cyrus Doctor, MBBS, MRCS, MSc, Assoc ISCM – Starling Surgical; Doug Bartlett – Medasense Biometrics Ltd.; John Uecker – ClearCam
Wednesday, Sep 25
10:30 am

MedTech Innovator Showcase - Orthopedics
Location: Hall B, 500 Aisle
Jan Hunik, PhD – ATRO Medical; Dan Burnett – Bone Health Technologies; Bryan Lord, MBA, JD – Pristine Surgical; John Barrett – ZKR Orthopedics; Cédric Goarant – Surgivisio
Wednesday, Sep 25
11:15 am

What Do Hospital Administrators Really Want?
Location: Room 157 B
Maria Shepherd, MBA – Medi-Vantage; Jeanne O'Brien – Value Care Alliance; Shannon Kane, MBA – Value Care Alliance; Susan Martin – Middlesex Health
Sponsored By: Medmarc
Wednesday, Sep 25
11:35 am

Lessons from a Legend
Location: Hall B, 300 Aisle
Larry Ferrere – IQVIA MedTech; Vince Forlenza – BD; Cathy Burzik; Todd Fruchterman, MD, PhD – 3M Health Care Business Group, Medical Solutions Division; Chris Simon – Haemonetics
Sunday, Sep 22
8:00 am

Pediatric Device Symposium
Location: Room 052
Sunday, Sep 22
12:00 pm

Registration Open and Badge Pick-Up
Location: NE Lobby A (Level 1)
Sunday, Sep 22
12:30 pm

US Market Access Seminar
Location: Room 156 C
Christine Sarkisian, MA – Boston Business Acceleration; Angus McQuilken – McDermott Will & Emery LLP; Steve Miller – U.S. Department of Commerce; Mark Sullivan – Massachusetts Office of International Trade and Investment (MOITI); Mike Graney – Charleston Regional Development Alliance; Kwame Ulmer – Ulmer Ventures; Vernessa T. Pollard – McDermott Will & Emery; Michael Ryan, JD – McDermott Will & Emery LLP; Jennifer Bock – McDermott Will & Emery LLP; Albert Sokol – McDermott Will & Emery LLP
Sponsored By: McDermott Will & Emery
Sunday, Sep 22
5:30 pm

International Reception
Location: Legal Harborside
Sponsored By: Quebec Government
Monday, Sep 23
7:00 am

Registration Open and Badge Pick-Up
Location: NE Lobby A (Level 1)
Monday, Sep 23
8:00 am

Coffee Reception for Key Japanese Medical Device Official
Location: Room 153 C
Sayaka Tomihara – Ministry of Economy, Trade, and Industry, Japan
Monday, Sep 23
8:00 am

AdvaMed Accel Leadership Seminar
Location: Room 052
Ben Glenn, JD – Shay Glenn LLP; Paul Snyder – Write2Market; Tiffany Wilson – Global Center for Medical Innovation (GCMI); Maria Stewart – Boston Scientific; Arthi Chandran, DrPH – BD; Martin Gold, MBA – Integra LifeSciences; Matt Benessere, MBA – Insulet; Deepak Sahu, MBA – Alira Health; Shar Matin – ViewRay, Inc.; David Cassak – The MedTech Strategist; Michael R. Minogue – ABIOMED, Inc.; Dev Kurdikar – Cardiac Science Corporation, now part of ZOLL Medical
Sponsored By: Alira Health
Monday, Sep 23
8:30 am

Medtech as IT
Location: Room 156 AB
Sean Lennon – Medtronic
Monday, Sep 23
8:30 am

MedTech Connect Partnering Open
Location: Hall B
Sponsored By: Veeva Systems
Monday, Sep 23
9:00 am

Revolutionizing the Silver Economy
Location: Room 156 AB
Harriet Harriet Finne-Soveri, MD, PhD – National Institute for Health and Welfare, Finland; Sayaka Tomihara – Ministry of Economy, Trade, and Industry, Japan; Lord Prior of Brampton – NHS England; Daniel Grant, PhD, MBA – MTPConnect; Joseph Coughlin – MIT AgeLab
Monday, Sep 23
9:30 am

The Business Value of Design: How Do the Best MedTech Design Performers Increase Their Revenues and Shareholder Returns at Nearly Twice the Rate of Their Industry Counterparts?
Location: Room 157 A
Stephanie Henze – McKinsey and Company; Paul Hermes – Medtronic; Craig R. Loomis, MS, MBA – General Electric; Claudio D'Ambrosio – Varian Medical Systems
Monday, Sep 23
9:30 am

A Values-Based Approach to MedTech Business Integrity
Location: Room 157 C
Ilyssa Levins – Center for Communication Compliance; Ann Ford, BSN, JD – Hall Prangle & Schoonveld; Michael Varadian, JD, MBA – HealthSpan Advisors; Denis Jacob – Orthofix
Monday, Sep 23
9:30 am

Articulating the Value of Diagnostics: Moving Toward Value Based Approaches
Location: Room 156 C
Lena Chaihorsky – Alva10; Rochelle C. Fink, MD, JD, MBA – U.S. Food and Drug Administration; Heather Brown – HeartFlow; Matt Tucker, MBA – Highmark Health
Monday, Sep 23
9:30 am

Case for Quality
Location: Room 157 B
Joe Sapiente – Hologic Inc.; Sara Sulfridge – Baxter Healthcare; George J. Serafin, MSc – Grant Thornton; Francisco Vicenty – USFDA/CDRH/Office of Compliance; Pamela Goldberg, MBA – MDIC
Monday, Sep 23
9:30 am

Pediatric Innovation Framework – Working Meeting with FDA
Location: Room 153 B
Monday, Sep 23
11:00 am

Delivering Great Care and Technology Transformation in the World’s Largest Integrated Health System
Location: Room 157 B
Lord Prior of Brampton – NHS England; Ashley McEvoy – Johnson & Johnson; Tara Donnelly – NHSX; Sam Roberts – NHS England and NHS Improvement; Roland Sinker – Cambridge University Hospitals NHS Foundation Trust
Monday, Sep 23
11:00 am

Efficiently Collect Real World Data: Industry, Policy, and Regulatory Perspectives
Location: Room 156 C
Seth Goldenberg, PhD – Veeva Systems; Owen Faris, PhD – FDA/CDRH; Manish Bharara, PhD, MBA – Siemens Healthineers; Diane Wurzburger, JD – GE Healthcare; Rachel Rath, MBA, MPH – Medical Device Innovation Consortium (MDIC)
Monday, Sep 23
11:00 am

SME MedTech Innovations That Are Transforming Health Care in the US and Abroad
Location: Room 157 A
Xavier Urtubey – AccuHealth; Chris Macek – SystemOne; Kaakpema "KP" Yelpaala – access.mobile; Lisa Bourget, MBA – Duke Global Health Innovation Center, Innovations in Healthcare
Monday, Sep 23
11:00 am

Value Based Arrangements: New Proposed Rules – Implications for Future Arrangements and Activities
Location: Room 157 C
Saliha Greff, JD, MPH – Medtronic; Thomas C. Conniff – Johnson & Johnson; Andrew Furlow – Hogan Lovells US LLP
Monday, Sep 23
1:00 pm

Using Data and Analytics to Demonstrate the Value of Diagnostics
Location: Room 156 C
Barry Rosenberg, MD MBA – Boston Consulting Group; Joseph Bernardo – Linden Capital Partners; Alan Wright, MD – Roche Diagnostics; Thierry Bernard
Monday, Sep 23
12:00 pm

Welcome Lunch
Location: East Registration
Monday, Sep 23
12:15 pm

Health 2040: Medtech’s Role in a Transformed Future
Location: Room 156 AB
Sheri L. Dodd – Medtronic Care Management Service & Non-Intensive Diabetes Therapies; Michael Minette – Zimmer Biomet; Michael Apkon, MD, PhD – Tufts Medical Center; Pedro M. Arboleda, MBA – Deloitte; Luba Greenwood – Verily, a Google company
Monday, Sep 23
12:30 pm

Value Based Care: Lessons and Learnings in LATAM Impacting the MedTech Industry
Location: Room 157 B
Marcia Makdisse, MD, PhD, MBA, VBHC Green Belt – CareCycle - Value Based Healthcare; Adolfo Llinas, MD – Fundacion Santa Fe de Bogota; Luly Castellanos de Samper, Science Degree from Boston College and Executive MBA from Andes University – Johnson & Johnson Medical, LATAM; Fabio Katayama – Hospital Samaritano
Monday, Sep 23
12:30 pm

US - China Relationship: From Cooperation to Confrontation
Location: Room 157 C
James McGregor – APCO Worldwide
Monday, Sep 23
1:00 pm

Developing a Framework for Patient Input in Medical Device Clinical Trials
Location: Room 157 A
Barry Liden, J.D. – Edwards Lifesciences; Dean Bruhn-Ding, B.S., RAC – CVRx, Inc.; Michelle Tarver, MD, Ph.D – CDRH, FDA; Bray Patrick-Lake – Evidation Health; Jon Hunt – MDIC
Monday, Sep 23
1:15 pm

Emerging Leaders Meetup
Location: Meetup Zone - East Registration
Monday, Sep 23
1:45 pm

Ribbon Cutting Ceremony
Location: Hall B
Monday, Sep 23
2:00 pm

AdvaMed’s New Code of Ethics: Is Your Company Prepared to Comply?
Location: Room 157 C
Matt Wetzel, JD – Akin Gump Strauss Hauer & Feld LLP; Jonathan Turner – Smith & Nephew; Kristi Schrode Travers, JD, PhD – Johnson & Johnson; Avi Spira, MA, JD – FUJIFILM Holdings America Corporation; Nancy S. Travis, MA – AdvaMed
Monday, Sep 23
2:00 pm

Chasing Value: Understanding How to Work with GPOs to Introduce New Health Care Innovation in the Supply Chain
Location: Room 157 B
Chaun Powell, MBA – Premier Inc.; Becky Foret, RN, BSN, MBA – Vizient; Khatereh Calleja, JD – Healthcare Supply Chain Association; Kyle Chenet, MBA – 410 Medical; Phil Royston – Access Scientific, LLC; Larry Koesterer, RPh, CPSM – Intalere
Monday, Sep 23
2:00 pm

The New World of 510(k)
Location: Room 156 AB
Jeff Shuren, MD, JD – Food and Drug Administration; Susan Alpert – SFA Consulting; Maureen L. Mulvihill, PhD – Actuated Medical, Inc.; April Veoukas, JD – Abbott; Phil Desjardins – Johnson & Johnson
Monday, Sep 23
2:00 pm

AdvaMed Accel and MedTech Innovator Partnering Forum (invite-only)
Monday, Sep 23
2:00 pm

Exhibit Hall Open
Location: Hall B
Monday, Sep 23
2:15 pm

Improving Lives by Adding to the Quality of Life
Location: Hall B, 300 Aisle
Richard Paxman, BSc – PAXMAN US INC; Bruce Japsen – Forbes; Bruce Roberts – RM Global Partners, LLC; Maria Palasis, PhD – Lyra Therapeutics
Monday, Sep 23
2:15 pm

Establishing the Value of Your MedTech Innovation - It's Never Too Early
Location: Room 156 C
Martha Shadan, MBA – Miach Orthopaedics; Scott Schorer – GI Dynamics; Aaron Sandoski, MBA – Norwich Ventures; Amy Siegel – S2N Health, LLC
Sponsored By: Medmarc
Monday, Sep 23
2:15 pm

More Value for Patients & Society Through Data-Driven Health Care: US and International Perspectives
Location: Room 157 A
Mitja Kurki, PhD – Broad Institute of MIT and Harvard, Finnish Institute of Molecular Medicine, Helsinki, Finland; Jaqueline Corrigan-Curay, MD, JD – FDA; Marja Liisa Niinikosk, DBA – Helsinki Business Hub; Pekka Kahri, MSc (Tech) – HUS Helsinki University Hospital; Stasha Ler, MBA – Medtronic; Tero Silvola – BC Platforms
Monday, Sep 23
2:30 pm

Patient Story - Abiomed
Location: Hall B, #128
Michael R. Minogue – ABIOMED, Inc.
Monday, Sep 23
2:45 pm

Global Health Meetup
Location: Meetup Zone - East Registration
Monday, Sep 23
2:55 pm

Culture, Leadership and Perseverance
Location: Hall B, 300 Aisle
Maria Fagan – Regulatory & Quality Solutions (R&Q); Peter Shen, PhD – Johnson & Johnson; John Somers
Monday, Sep 23
3:00 pm

Patient Story - Edwards Lifesciences
Location: Hall B, #128
Barry Liden, J.D. – Edwards Lifesciences
Monday, Sep 23
3:30 pm

Opening Plenary
Location: Hall B, Plenary Theatre
Scott Whitaker – AdvaMed; C. Michael Gibson, MS, MD – Baim Clinical Research Institute; John Carlson – Flex Health Solutions; J. Craig Venter, PhD; Jeff Karp, Eng. PhD – Brigham and Women's Hospital
Monday, Sep 23
5:00 pm

Welcome Reception
Location: Hall B
Sponsored By: Nypro
Monday, Sep 23
5:45 pm

Patient Story - Haemonetics
Location: Hall B, #128
Chris Simon – Haemonetics; John Boyle – Immune Deficiency Foundation (IDF)
Monday, Sep 23
6:00 pm

Patient Story - BD
Location: Hall B, #128
Monday, Sep 23
6:00 pm

LGBTQIA+ Reception
Location: Committee, 50 Northern Ave, Boston, MA 02210
Monday, Sep 23
6:00 pm

MedTech Insight Awards*
Location: State Room, 60 State St, Boston MA
Tuesday, Sep 24
7:00 am

Registration Open and Badge Pick-Up
Location: NE Lobby A (Level 1)
Tuesday, Sep 24
7:30 am

Networking Breakfast Hosted by MedTech Color*
Location: Room 052
Tuesday, Sep 24
9:15 am

FDA’s New Approaches to Software Regulation: Pre-Certification and Artificial Intelligence
Location: Room 156 C
Venk Varadan, MBA – Nanowear; Diane Johnson, MS – Johnson & Johnson; Bakul Patel, MSEE, MBA – FDA; Nathan A. Brown, JD – Akin Gump LLP
Tuesday, Sep 24
9:25 am

Bridging Commercial and Military Market Needs to Advance Medical Device Development
Location: Hall B, 500 Aisle
Joe Berger, MBA – Battelle; Joseph Turk – Fresenius Medical Care North America; Jason Opdyke, PhD – Department of Defense; Joint Program Executive Office for Chemical Biological and Nuclear Defense
Tuesday, Sep 24
8:30 am

China Market Access Updates - Regulatory, Clinical, Reimbursement & IP
Location: Room 157 A
Grace Palma, MBA – China Med Device, LLC; Jeff Potkul – Medtronic MITG; LiJuan He – Johnson & Johnson; Xing Zhou – Siemens Healthcare Diagnostic; Daisy Du – Medtronic; Lindsay Tao, MD – Johnson & Johnson; Zhi Tao; Jason Liang – China Med Device; Anita Wei – BD Greater China; Deng Shao Ping – China Med Device; Eric Rugo – Stryker; Li Ding – GuangDong NMPA (CFDA) Bureau; Jiang Feng – China Association of Medical Devices Industry; Elizabeth Woody – BD
Tuesday, Sep 24
9:00 am

MedTech Connect Partnering
Location: Hall B
Sponsored By: Veeva Systems
Tuesday, Sep 24
9:00 am

Exhibit Hall Open
Location: Hall B
Tuesday, Sep 24
9:15 am

MedTech Innovator Showcase - Cardiovascular
Location: Hall B, 500 Aisle
Arvind Thiagarajan – HD Medical; Harsh Vathsangam, PhD – Moving Analytics; Eric A. Kriegstein, MBA – Respirix; Ken Nelson – Bardy Diagnostics; Oren Goldshtein, MSc – Vectorious Medical Technologies
Tuesday, Sep 24
9:15 am

Transformational Innovation: Delivering Outcomes, Fueling the Future
Location: Hall B, 300 Aisle
Glenn Snyder – Deloitte Consulting LLP; Antoinette Gawin – Terumo BCT; Lisa Earnhardt – Abbott; David C. Pacitti – Siemens Healthineers; Dow R. Wilson – Varian Medical Systems
Tuesday, Sep 24
9:30 am

Patient Story - Insulet
Location: Hall B, #128
Shacey Petrovic – Insulet Corporation
Tuesday, Sep 24
9:45 am

Investor Trends in Medtech
Location: Hall B, Innovation Pavilion (#441)
David Cassak – The MedTech Strategist; Kadir Kadhiresan
Tuesday, Sep 24
9:45 am

Seeing is Not Always Believing – Tackling Legal Advertising Disguised as Medical Alerts
Location: Room 157 C
Raymond De Rise – Sekisui Diagnostics, LLC; John F. Brenner, J.D. – BD; Aviva Wein – Johnson & Johnson; Becky Wood, JD – Sidley Austin LLP; Rusty Silverstein, JD – X Ante
Tuesday, Sep 24
9:45 am

The New World of Medtech M&A Valuation: Strategies to Adapt and Thrive
Location: Room 157 B
John Babitt – EY; Charlie Attlan – Boston Scientific; Chris Cleary – Medtronic; Susan E. Morano – Johnson & Johnson; J.P. Peltier – Piper Jaffray
Tuesday, Sep 24
2:15 pm

Medtech, Look to Marketing for the Solution
Location: Room 156 C
Matt Singer – ZS Associates; Randy Randal Pritchard, MBA – Roche Diagnostics Corporation; Robert Clark – Medtronic; George Parr – BD; Rajit Kamal – Johnson & Johnson
Tuesday, Sep 24
9:50 am

MedTech Innovator Showcase - Vascular Solutions
Location: Hall B, 500 Aisle
Andy Doraiswamy, PhD – Koya; Conrad Rasmus – Protembis; Vanessa Gore – Soletics; Stephen Cox, MBA – Venari Medical; Rob Abrams – Epic Neuro
Tuesday, Sep 24
10:00 am

Preparing for Medical Device Cybersecurity in 2020
Location: Hall B, 200 Aisle
Vidya Murthy
Tuesday, Sep 24
10:10 am

Realizing Organizational and Global Value with Sustainable Business Actions
Location: Hall B, 300 Aisle
Walt Rosebrough – STERIS Corporation; Caroll H. Neubauer – B. Braun Medical Inc.; Greg Crist – AdvaMed
Tuesday, Sep 24
10:30 am

Patient Story - Olympus
Location: Hall B, #128
Lucie
Tuesday, Sep 24
10:30 am

From Data to Data Science
Location: Hall B, 200 Aisle
Manu Swami – Virtusa; Santanu Sen – Virtusa; Kartik Iyengar
Tuesday, Sep 24
10:30 am

Connected Ecosystems for Smarter Decisions
Location: Hall B, 500 Aisle
Vidya Viswanathan, MBA – Cognizant; Arnaub Chatterjee – Medidata Solutions
Tuesday, Sep 24
10:30 am

MedTech Innovator Showcase - Oncology
Location: Hall B, 500 Aisle
Michael Allen – Embolx; Cécile Dupont – HEPTA Medical; Katharine Giles, MBBS(Hons), MBA, GAICD – OncoRes Medical; Enhao Gong – Subtle Medical; Jay Lichter, PhD – Avelas Biosciences
Tuesday, Sep 24
10:30 am

NIH SBIR/STTR Program Company Presentations - Epitel, Fibralign and Hemotek Medical Inc.
Location: Hall B, Innovation Pavilion (#441)
Tuesday, Sep 24
10:30 am

GPOs Meetup: Meet with Supply Chain Leaders
Location: Meetup Zone - East Registration
Tuesday, Sep 24
10:45 am

The Effect of Medicare for All on the Medical Device Industry
Location: Room 156 C
Marc M. Boutin, JD – National Health Council; Parashar Patel – ViewRay; Tom Hubbard – NEHI; John McDonough, DrPH, MPA – Harvard T. H. Chan School of Public Health; Jay Jackson – Avalere Health
Tuesday, Sep 24
11:00 am

How Leading Emerging Medtech Companies are Leveraging Technology to get Products to Market Faster
Location: Hall B, 200 Aisle (Solutions Showcase stage)
Tuesday, Sep 24
11:00 am

How Data Will Transform Patient Outcomes, Medtech and the Practice of Health, and Why It Hasn’t Happened Yet
Location: Hall B, 300 Aisle
Brian Chapman – ZS Associates; Cindy Perettie – Foundation Medicine; Richard Loomis – Elsevier; Yvonne Bokelman, MBA, FACHE – Zimmer Biomet
Tuesday, Sep 24
11:00 am

It Takes a Village: How the Health Care Community is Working Together to Tackle Cybersecurity
Location: Room 156 AB
Zach A. Rothstein, Esq. – AdvaMed; Jithesh Veetil, PhD – Medical Device Innovation Consortium (MDIC); Denise Anderson, MBA – H-ISAC; Greg T. Garcia – Health Sector Coordinating Council; Suzanne Schwartz, MD, MBA – FDA; Chris Tyberg – Abbott
Tuesday, Sep 24
11:05 am

MedTech Innovator Showcase - Molecular Diagnostics
Location: Hall B, 500 Aisle
Tara Dalton, BEng (Aeronautical Eng) PhD – Altratech; David Ludvigson, MAS – Nanomix; Dede Willis, MBA – Orbit Genomics, Inc.; Jeff June – Ischemia Care; Federico Buersgens, PhD – GNA Biosolutions
Tuesday, Sep 24
11:15 am

Successful Elevator Pitches and Investor Interactions
Location: Hall B, Innovation Pavilion (#441)
Ajay Khatri; Darshana Zaveri; Julie Hamill
Tuesday, Sep 24
11:15 am

When Data-Driven Training, Marketing and Sales Came Together to Turn a Product Around; A Powerful Case Study
Location: Hall B, 500 Aisle
Kapil Kalra – ACTO; Jacqueline Cronin – Teleflex
Tuesday, Sep 24
11:15 am

Diverse Perspectives on Developing and Deploying Digital Technologies
Location: Room 157 B
Russell L. Jones, CISSP, CSSLP – Deloitte Consulting; Vernessa T. Pollard – McDermott Will & Emery; Afia Asamoah, J.D. – Google Health; Uday Kumar, MD – Element Science; Leslie Wise, J.D. – Evidence Matters
Tuesday, Sep 24
11:15 am

Small Companies Selling Big Ideas to Huge Corporations
Location: Room 157 C
Paul L’Archevêque – Québec; Steven Arless – SoundBite Medical Solutions Inc.; Kathryn Zavala, PhD – MedTech Innovator; Adam L. Wollowick, MD, MBA – Stryker; Nick Dougherty – PULSE@MassChallenge
Sponsored By: Medmarc
Tuesday, Sep 24
11:30 am

Patient Story - Johnson & Johnson
Location: Hall B, #128
Rajit Kamal – Johnson & Johnson
Tuesday, Sep 24
11:30 am

Device Connectivity Platform as a Service: Build vs Buy, Accelerate Time to Market
Location: Hall B, 200 Aisle
Krishna Padmanaban – L&T Technology Services Limited
Tuesday, Sep 24
11:45 am

MedTech Innovator Showcase - Neurotechnology
Location: Hall B, 500 Aisle
Matt Kesinger, MS – Forest Devices; Ronald Jay Solar, PhD – ThermopeutiX, Inc.; Daniel S. Chao, MD, MS – Halo Neuroscience; Dan Kogan – Savonix
Tuesday, Sep 24
11:55 am

Everyone Knows Health Care Is DOJ’s Favorite Target; What Does That Mean for MedTech Executives?
Location: Hall B, 500 Aisle
Chris White – AdvaMed; Ralph J. Caccia, JD – Wiley Rein; Daniel Gerhan – Boston Scientific; Blaine Dart – Zimmer Biomet; Drew Bradylyons
Tuesday, Sep 24
11:55 am

Future of Surgery
Location: Hall B, 300 Aisle
Joe M. DeVivo – InTouch Health; Monish Rajpal – LEK Consulting; Vasant Padmanabhan, PhD – Smith & Nephew; Nancy Briefs
Tuesday, Sep 24
12:00 pm

Patient Story - RTI Surgical
Location: Hall B, #128
Tuesday, Sep 24
12:30 pm

Plenary Lunch
Location: Hall B, Plenary Theatre
Omar Ishrak – Medtronic; Kevin Lobo – Stryker; Scott Whitaker – AdvaMed; Michael R. Minogue – ABIOMED, Inc.; Dorothy Puhy – Dana-Farber Cancer Institute
Tuesday, Sep 24
2:10 pm

Emerging Issues Regarding the HCPCS Coding Process for Medical Devices
Location: Hall B, 500 Aisle
Stephanie A. Webster, Partner – Akin Gump Strauss Hauer & Feld LLP; DeChane Dorsey, Esq. – AdvaMed; William Scheinler, Esq. – Alcresta Therapeutics, Inc.
Tuesday, Sep 24
2:15 pm

MedTech Innovator Showcase - Chronic Disease Management
Location: Hall B, 500 Aisle
Jeffrey Brewer – Bigfoot Biomedical; Xina Quan, PhD – PYRAMES; Matthew Banet – toSense; Rui Jing Jiang – Avisi Technologies; Pat Antaki – Evergaze LLC
Tuesday, Sep 24
2:15 pm

Perfecting Partnership
Location: Hall B, Innovation Pavilion (#441)
Ibraheem Badejo – Johnson & Johnson; Kadir Kadhiresan; Jennifer Kozak; Nick Pachuda – Johnson & Johnson
Tuesday, Sep 24
2:15 pm

Leadership Views on Diagnostics
Location: Hall B, 300 Aisle
Joseph Bernardo – Linden Capital Partners; Ramon Benet, MBA – Instrumentation Laboratory (IL); Dave Hickey – Becton Dickinson; Susan Van Meter – AdvaMedDx; Thierry Bernard
Tuesday, Sep 24
2:15 pm

Going Viral: Best Practices in Social Media
Location: Room 157 A
Sandra Cohen Kalter, JD – Medtronic; Richard Cleland – Federal Trade Commission; Lisa Dwyer – King & Spalding; Eric Boyles – Medtronic; Jeanne Mell – OraSure Technologies, Inc.
Tuesday, Sep 24
2:15 pm

Pulse of the Industry 2019
Location: Room 156 AB
John Liddicoat, MD – Medtronic Americas Region; Ashley McEvoy – Johnson & Johnson; James Welch – EY
Tuesday, Sep 24
2:15 pm

Global Markets: Where to Invest?
Location: Hall B, 200 Aisle (Solutions Showcase stage)
Guillaume Corpart – Global Health Intelligence; Val Kratzman – Business Finland; Guljit Singh, MS – Nexdigm Incorporated (SKP Business Consulting); Jorge Sequeira – Costa Rican Investment Promotion Agency; Abraham Nick Morse, MD MBA – Guangzhou Women and Childrens Medical Center
Tuesday, Sep 24
2:30 pm

Patient Story - B Braun Medical, Inc.
Caroll H. Neubauer – B. Braun Medical Inc.; Rolf Benirschke – Legacy Health Strategies
Tuesday, Sep 24
2:30 pm

International Digital Health: Perspectives on Data, Partnerships and Scaling Internationally
Location: Room 157 B
Toby Sainsbury, PhD – IDA Ireland; Ivan Houlihan – IDA Ireland; Shaun Braun – Stryker; John O’Brien – S3 Connected Health; Mick Farrell, SM, MBA – ResMed
Tuesday, Sep 24
2:45 pm

Price Monitoring of Medical Devices in Brazil
Location: Room 157 C
Renato Porto, Director – National Sanitary Surveillance Agency – ANVISA; Gabrielle Troncosco – Anvisa
Tuesday, Sep 24
2:50 pm

MedTech Innovator Showcase - Personalized and Precision Medicine
Location: Hall B, 500 Aisle
Eric D. Benson, MBA – American BioOptics; Lawrence Cohen – Glycotest; Joshua Tauber, MBA – HealthReveal; James A. Reinstein – Previvo; Sean Curry – Onkos Surgical
Tuesday, Sep 24
3:00 pm

Patient Story - Stryker
Location: Hall B, #128
Kevin Lobo – Stryker
Tuesday, Sep 24
3:00 pm

NIH SBIR/STTR Program Company Presentations - Actuated Medical, NeuroSigma and Vivaquant
Location: Hall B, Innovation Pavilion (#441)
Tuesday, Sep 24
3:05 pm

Advancing Inclusion and Diversity
Location: Hall B, 300 Aisle
Cathi Rittelmann – Korn/Ferry; Mary Anne Heino – Lantheus Medical Imaging, Inc.; Martha Shadan, MBA – Miach Orthopaedics; Steffen Hovard, MSc Economics – Coloplast; Namal Nawana – Smith & Nephew
Tuesday, Sep 24
3:15 pm

ANVISA – The State of Regulatory Efficacy at 20 Years
Location: Room 157 C
Renato Porto, Director – National Sanitary Surveillance Agency – ANVISA; Diane Wurzburger, JD – GE Healthcare
Tuesday, Sep 24
3:30 pm

Patient Story - Paxman Scalp Cooling
Location: Hall B, #128
Richard Paxman, BSc – PAXMAN US INC; Wendy Siminski
Tuesday, Sep 24
3:45 pm

EtO Sterilization of Medical Devices: The Impact of Evolving Regulatory Requirements
Location: Room 157 A
Ellen Kondracki – BD; Phil Cogdill, MBA – Medtronic; Dan Carestio – STERIS Corporation; Suzanne Schwartz, MD, MBA – FDA; Steve Yeadon – Boston Scientific
Tuesday, Sep 24
3:45 pm

MDR/IVDR - What Now?
Location: Room 156 AB
John B. Wilkinson, MBA – Medicines and Healthcare products Regulatory Agency (MHRA), U.K.; Oliver D. Bisazza, Master of Economic Sciences – MedTech Europe; Michel Marboeuf, Master Business Administration – Stryker; Angela Brown – ICON
Tuesday, Sep 24
3:45 pm

MedTech Innovator Finals
Location: Hall B, Plenary Theatre
Tuesday, Sep 24
4:00 pm

How Major New Players Are Challenging the Current Health Care Ecosystem
Location: Room 157 C
Gabriele Brambilla – Alira Health; Cindy Kent, MBA – Best Buy; Luba Greenwood – Verily, a Google company; David Inns, MBA – GreatCall Inc.; Oxana Pickeral – Amazon Web Services
Tuesday, Sep 24
4:00 pm

The Role of Diagnostics in Promoting the Health and Health Care of Women
Location: Room 157 B
Nicole Sweeney – BD; Margaret Eckenroad – Hologic; Shamiram R. Feinglass, MD, MPH – Danaher; Marsha Henderson, MCRP – Healthy Women
Tuesday, Sep 24
5:00 pm

AdvaMed Advance Meetup by Women's Executive Network
Location: Hall B, AdvaMed Booth (#229)
Tuesday, Sep 24
5:00 pm

Chairmen's Networking Reception
Location: Hall B
Sponsored By: IDA Ireland
Tuesday, Sep 24
8:30 pm

MTC LIVE! (Formerly MedTech After Party)
Location: Lawn on D
Sponsored By: Alira Health, Novasyte
Wednesday, Sep 25
7:30 am

MedExec Women Breakfast (by invitation)
Location: Room 153 C
Wednesday, Sep 25
8:00 am

Networking Breakfast with Exhibitors
Location: Hall B
Sponsored By: Leavitt Risk Partners
Wednesday, Sep 25
8:00 am

Registration Open and Badge Pick-Up
Location: NE Lobby A (Level 1)
Wednesday, Sep 25
8:00 am

Exhibit Hall Open
Location: Hall B
Wednesday, Sep 25
8:15 am

Innovation, Regulation, and Adaptation: Emerging Legal Issues in Digital Health
Location: Hall B, 500 Aisle
Daniel I.A Smulian, JD – Greenberg Traurig, LLP; Kate Black, JD – Greenberg Traurig, LLP; Jackie Haydock, JD – Microsoft
Wednesday, Sep 25
8:30 am

Health Care Fraud: The Government View and the Compliance Perspective
Location: Room 157 C
Miranda Hooker, JD – Pepper Hamilton LLP; Amanda Strachan – United States Attorney's Office for the District of Massachusetts; Lisa A. Schlatz, JD – Partners HealthCare; Maureen Ruane
Wednesday, Sep 25
8:30 am

Value Based Health Care in Action: Enhancing Patient Outcomes and Managing Costs
Location: Room 157 B
Richard Charter – Value Based Healthcare; Andrew M. Baker – Stryker; Signe Haughton – Stryker Corp; Ansaar Rai, MD – , J.W. Ruby Memorial Hospital, West Virginia University Medicine; Thomas Vande Casteele – Awell
Wednesday, Sep 25
8:30 am

MedTech Connect Partnering
Location: Hall B
Sponsored By: Veeva Systems
Wednesday, Sep 25
8:45 am

One Year In: What We’ve Learned from Creating 100's of MEDDEV 2.7/1 Rev. 4 and EU MDR Compliant CERs (It’s Harder Than You Think)
Location: Room 052A
Jon Gimbel, PhD – Regulatory & Quality Solutions (R&Q); Ibim Tariah, PhD – Regulatory & Quality Solutions (R&Q); Dona Occhipinti, MPH, CCRP – Hillrom; Theresa Miles – Regulatory & Quality Solutions (R&Q)
Wednesday, Sep 25
8:45 am

EU MDR Workshop
Location: Room 052A
Wednesday, Sep 25
10:00 am

Clarifying Impact: Determining and Driving Quality and Technical Documentation Compliance
Location: Room 052A
Pat Shafer – Grant Thornton; Marty Zuzulo – Grant Thornton
Wednesday, Sep 25
11:15 am

MDR Readiness Seven Months from Date of Application
Location: Room 052A
Erik Vollebregt – Axon Lawyers
Wednesday, Sep 25
9:00 am

Beyond Silos: Fusing Digital Across the Enterprise
Location: Hall B, 500 Aisle
Brian Williams – Cognizant
Wednesday, Sep 25
9:15 am

MedTech Innovator Showcase - Critical Care
Location: Hall B, 500 Aisle
Aly El Badry, MBA – CloudCath; Howard Carolan – CoapTech; Robert Quinn – Patch'd; Jeffrey Alvarez, MBA – Potrero Medical
Wednesday, Sep 25
9:15 am

Buyers, Sellers and Facilitators: An M&A Discussion
Location: Hall B, 300 Aisle
Keith Pagnani – Sullivan & Cromwell; Carin Fradin – JMP Securities; Dev Kurdikar – Cardiac Science Corporation, now part of ZOLL Medical
Wednesday, Sep 25
9:15 am

Inspections and MDSAP
Location: Room 156 C
Melissa Torres – FDA; Luann Pendy, PhD – Medtronic; Thomas Westrick – GE Healthcare; Laila Gurney – GE Healthcare; Ted Wilson – Hogan Lovells
Wednesday, Sep 25
9:15 am

The Democratization of Personalized Medicine – Bringing it Closer to the Community
Location: Room 157 A
David Parker, PhD – Precision For Medicine; Sheryl Elkin, PhD – N-of-One, Inc.; Paul Gerrard, MD – Palmetto GBA; Stephen Schleicher, MD, MBA – Tennessee Oncology/OneOncology
Wednesday, Sep 25
9:45 am

Digital Transformation of the Medical Technology Market - the Disruptor or Enabler?
Location: Hall B, 500 Aisle
Sowmya Rajagopalan, Masters in Science ( Integrated) – Frost & Sullivan; Ravi Kuppuraj – Philips; Mukund Paravasthu – Johnson & Johnson
Wednesday, Sep 25
9:45 am

Solving the Addiction Crisis with Devices, and Mobile Health and Digital Therapeutics
Location: Room 157 B
Christian Haller – LifeLine Medical; David Curd, MS – Avanos; John Marler – U.S. Food and Drug Administration; Jamie Wolszon – AdvaMed; Stephanie Fertig – National Institute of Neurological Disorders and Stroke, NIH
Wednesday, Sep 25
9:45 am

Strategic Use of Post Market Real World Evidence and Data Regarding Quality and Value
Location: Room 157 C
Tom Valuck, MD, JD – Discern Health; David J. Wierz, MA – The OCI Group, LLC; Maggie Alston, CHFP – Milliman, Inc.; Tracey Dodenhoff, MBA, MID – Archimedic
Wednesday, Sep 25
9:50 am

MedTech Innovator Showcase - Surgical Advancements
Location: Hall B, 500 Aisle
Marc Bessler, MD – EndObetes; Antti Roine – Olfactomics; Cyrus Doctor, MBBS, MRCS, MSc, Assoc ISCM – Starling Surgical; Doug Bartlett – Medasense Biometrics Ltd.; John Uecker – ClearCam
Wednesday, Sep 25
10:00 am

Evolving Commercial Models In The New Health Care Ecosystem
Location: Hall B, 200 Aisle
Craig Ackerman, MBA – The Alexander Group
Wednesday, Sep 25
10:00 am

Best Practices for Optimizing Relationships Between Medical Technology Companies and Academic Institutions / Academic Meetup
Location: Room 153 C
Eric D. Agdeppa, PhD, MTM – Hill-Rom; Healther Walsh; Vinit Nijhawan; Jerry Kokoshka – Columbia Technology Ventures; Daniel Castro – Partners HealthCare Innovation
Wednesday, Sep 25
10:10 am

Massachusetts - The Who, What and Why of This Medtech Miracle Metropolis
Location: Hall B, 300 Aisle
Randy Barko – Ximedica; Marie K. O'Malley – Medtronic; Brian Johnson – MassMEDIC; Travis McCready – Massachusetts Life Sciences Center
Wednesday, Sep 25
10:30 am

Patient Story - Zimmer Biomet
Location: Hall B, #128
Yvonne Bokelman, MBA, FACHE – Zimmer Biomet
Wednesday, Sep 25
10:30 am

Essentials of Regulatory Digital Transformations
Location: Hall B, 200 Aisle
Christopher Knerr – Mareana
Wednesday, Sep 25
10:30 am

MedTech Innovator Showcase - Orthopedics
Location: Hall B, 500 Aisle
Jan Hunik, PhD – ATRO Medical; Dan Burnett – Bone Health Technologies; Bryan Lord, MBA, JD – Pristine Surgical; John Barrett – ZKR Orthopedics; Cédric Goarant – Surgivisio
Wednesday, Sep 25
10:30 am

Strengthening FDA's 510(k) Third Party Review Program: Streamlining the Process, Maximizing Patient Benefit
Location: Hall B, 500 Aisle
Gregory Pishko, PhD – FDA
Wednesday, Sep 25
10:45 am

Global Regulatory Convergence – Emerging Trends and Future Opportunities
Location: Room 156 C
Nicole Taylor Smith – Medtronic; Jeff Shuren, MD, JD – Food and Drug Administration; Melissa Torres – FDA; John B. Wilkinson, MBA – Medicines and Healthcare products Regulatory Agency (MHRA), U.K.; Augusto Geyer, MSc – Brazilian Health Regulatory Agency – ANVISA
Wednesday, Sep 25
10:45 am

New Diagnostic Technologies are Transforming Testing
Location: Room 157 A
Gregory Stutman, MBA – IQVIA; Rahul Dhanda – Sherlock Biosciences; Ariel Beery, MPA/MA – MobileODT; Jonathan Romanowsky – Inflammatix; Ketan Paranjape – Roche
Wednesday, Sep 25
11:00 am

Mitigating Human Factors Risk
Location: Hall B, 200 Aisle
Roger Mazzella, MBE – The Qt Company
Wednesday, Sep 25
11:00 am

Insights from Executives Navigating High Growth Companies
Location: Hall B, 300 Aisle
Pat Shafer – Grant Thornton; Tracy MacNeal – Materna Medical; Todd H. Usen – Activ Surgical
Wednesday, Sep 25
11:15 am

The Changing Payer/Provider Landscape: Opportunities for Medtech
Location: Hall B, 500 Aisle
Carlotta Rinke, MD, FACP, MBA – Accountable Care Solutions; David Gregory, MPA, FACHE – Baker Tilly; Alan Lieber – Atlantic Health System
Wednesday, Sep 25
11:15 am

What Do Hospital Administrators Really Want?
Location: Room 157 B
Maria Shepherd, MBA – Medi-Vantage; Jeanne O'Brien – Value Care Alliance; Shannon Kane, MBA – Value Care Alliance; Susan Martin – Middlesex Health
Sponsored By: Medmarc
Wednesday, Sep 25
11:30 am

Patient Story - Varian Medical Systems
Dow R. Wilson – Varian Medical Systems; Keelin McGee
Wednesday, Sep 25
11:30 am

Phase Zero: How to be Resource-Efficient with New Product Opportunities
Location: Hall B, 200 Aisle
Scott C. Thielman, PhD – Product Creation Studio
Wednesday, Sep 25
11:30 am

Digital and Connected Health Meetup
Location: Meetup Zone - East Registration
Wednesday, Sep 25
11:35 am

Lessons from a Legend
Location: Hall B, 300 Aisle
Larry Ferrere – IQVIA MedTech; Vince Forlenza – BD; Cathy Burzik; Todd Fruchterman, MD, PhD – 3M Health Care Business Group, Medical Solutions Division; Chris Simon – Haemonetics
Wednesday, Sep 25
12:30 pm

Plenary Lunch
Location: Hall B, Plenary Theatre
Cathy Burzik; Seema Verma – Centers for Medicare & Medicaid Services; Scott Whitaker – AdvaMed
Wednesday, Sep 25
2:15 pm

CDRH Town Hall
Location: Room 156 AB
Jeff Shuren, MD, JD – Food and Drug Administration; Suzanne B. Schwartz, MD, MBA – FDA; William H. Maisel, MD, MPH – CDRH, FDA; Janet Trunzo – AdvaMed; CAPT Raquel Peat, PhD, MPH – FDA