Annual Public Forum Agenda

September 13, 2022

The MDIC Annual Public Forum 2022 will bring together at the JW Marriott Washington, DC, MDIC members and the medical device and diagnostics community to discuss current trends in regulatory science and highlight the development of innovative regulatory science tools.

Be a part of the event that gathers industry experts, innovators, and regulators and addresses the latest issues facing the medical device community. Hear from industry experts, patients, and other community innovators on a range of regulatory topics from cybersecurity and real world evidence to patient input, quality, and innovative medical device developments.

  • 8:00 - 9:00 am

    Breakfast and Registration
  • 9:00 – 9:10 am

    Welcome & Opening Remarks

    Speaker: Andrew Fish, President & CEO, Medical Device Innovation Consortium

  • 9:10 – 9: 40 am

    Fireside Chat with FDA commissioner

    Speakers:

    • Robert Califf, MD, Commissioner, FDA
    • Jijo James, MD, MPH, Chief Medical Officer, MedTech & External Innovation, Johnson & Johnson
  • 9:40 – 10:10 am

    Fireside Chat with CMS Chief Medical Officer

    Speakers:

    • Lee Fleisher, MD, Chief Medical Officer and Director of the Centers for Medicare & Medicaid Services Center for Clinical Standards and Quality
    • Nadim Yared, President & CEO, CVRx
  • 10:10 – 11:05 am

    General Session 1 – Digital Health Technologies for Healthcare: Advancing Innovation and Regulatory Science Through Global Collaboration

    Experts will examine how the digital health revolution is challenging the existing regulatory frameworks, including current regulatory barriers to adopting digital medical technologies, potential regulatory improvements, key considerations for patients and healthcare providers, and implications for the future of digital health innovation. Panelists will also discuss MDIC’s ongoing efforts in advancing digital health regulatory science.

    Moderator: Yarmela Pavlovic, VP of Regulatory Strategy, Medtronic

    Speakers:

    • Brendan O’Leary, Acting Director, Division of Digital Health, FDA
    • Anindita Saha, Assistant Director, Supervisor for Digital Health Center of Excellence, Division of Digital Health, FDA
    • Amy McDonough, Managing Director & General Manager, Fitbit Health Solutions at Google
    • Cassie Scherer, Senior Director of Digital Health Policy and Regulatory Strategy, Medtronic
    • Heather Benz, Associate Director of Clinical Research for Robotics & Digital Solutions, Johnson & Johnson MedTech
  • 11:05 - 11:20 am

    Coffee Break
  • 11:20 – 12:15 pm

    General Session 2 – NESTcc Quality Evidence by Design: Leveling up with Real-World Evidence (NESTcc)

    As NESTcc completes its last year of MDUFA IV funding and enters MDUFA V funding, we are building the national evaluation system based on our learnings from pilots and independent assessment. Learn how NESTcc is advancing the system architecture for scalability and interoperability to generate quality evidence by design.

    Speakers:

    • Sandi Siami, MPH, Senior Vice President, NESTcc (Pre-recorded)
    • Moderator: Richard Smith, MBA, Director of Business Development and Partnership, NESTcc
    • Diane Wurzburger, JD, Executive Regulatory Affairs and Quality, GE Healthcare (Virtual)
    • Doug Fridsma, MD, PhD, Head of Government Partnerships, Datavant
    • Christian Howell, Senior Vice President & General, Manager, Medical Device and Diagnostic Group, Aetion
    • Felipe Aguel, PhD, Deputy Director, Office of Clinical Evidence & Analysis, FDA
  • 12:15 – 1:15 pm

    Lunch

    Location: Penn Terrace

  • 1:15 – 2:10 pm

    General Session 3  Real World Evidence Benefiting Patients and Payers (HEPV) 

    Real-world evidence is becoming increasingly important for reimbursement decision making. Historically used for post-market safety monitoring, Real-world evidence is now integrated throughout the product development lifecycle and has led to the real-time analysis of data to better understand and gain insights on disease, approaches to treatment, and how to achieve coverage decisions. Gain insights on how payer stakeholders are impacted by real-world data and real-world evidence; learn how to apply successful use cases, real-world examples, and practical outcomes into your own company; recognize how real-world data can be used to assist in study design and as a data source to facilitate device development, clinical trials, and evidence generation; and anticipate and plan for future requirements by CMS in the appropriate use of RWE in Coverage with Evidence Development

    Moderator: Kimberly Sterling,​ PharmD, Vice President, Health Economics and Outcomes Research ResMed

    Speakers:

    • Lindsay Bockstedt, PhD, Vice President, Global Health Economics and Outcomes Research, Medtronic
    • Daniel Caños, PhD, MPH, Director, Office of Clinical Evidence and Analysis, FDA
    • Shelby Harrington, Principal, Quality and Clinical Strategy, Avalere Health
  • 2:10 – 3:00 pm

    FDA Roundtable

    Speakers:

    • Suzanne Schwartz, MD, Director, Office of Strategic Partnerships & Technology Innovation (OST), FDA
    • Michelle Tarver, MD, PhD, Deputy Director, Office of Strategic Partnerships & Technology Innovation (OST), FDA
    • Brendan O’Leary, Acting Director, Division of Digital Health, FDA
    • Daniel Caños, PhD, MPH, Director, Office of Clinical Evidence and Analysis, FDA
    • Edward Margerrison, PhD, Director, Office of Science & Engineering Laboratories, FDA
  • 3:15 – 4:00 pm

    Concurrent Session 1
    Session A    Clinical Diagnostics, “A Critical Path for Innovation and Precision Medicine” (CS&T)

    Accurate and accessible diagnostics are the prerequisite for effective precision medicine. Representatives from FDA, NIST, MDIC, and industry will discuss approaches to an improved regulatory path for innovative diagnostics incorporating evolving technologies or targeting new diseases while ensuring accuracy in performance.

    Moderator: Maryellen de Mars, PhD, Program Director, Clinical Diagnostics, MDIC

    Speakers:

    • Brad Spring, Global Head of Regulatory Policy and Intelligence, Roche
    • Wendy Rubinstein, MD, PhD, Deputy Office Director for Personalized Medicine, Office of Health Technology 7 (In Vitro Diagnostics), FDA
    • Justin Zook, PhD, Co-Leader Biomarker and Genomic Sciences Group at National Institute of Standards and Technology (NIST)
    • Victor Sementchenko, PhD, Director of IVD Development, Illumina
    Session B    Transforming Patient Engagement in MedTech (SPI)

    Learn how MDIC is expanding patient science in Total Product Life Cycle. Join our steering committee chair, Dan Stephens and MDIC’s Science of Patient Input team to learn more about our ongoing and new initiatives to accelerate patient engagement in Total Product Life Cycle. Interact with industry experts to explore innovative pathways for improving patient engagement and outcomes across the healthcare continuum. Share your input and insights in this small group concurrent session.

    Speaker: Dan Stephens, Co-Chair SPI Steering Committee, Medical Device Innovation Consortium (MDIC)

    • Heidi Dohse, President, Founder, Tour de Heart; Patient Advocate
    • Maddie Gittens, Patient
    • Maria Gmitro, President & Founder, Breast Implant Safety Alliance
    • Greg Guinther, Patient
    • Erich Lin, Patient
  • 4:05 – 4:50 pm

    Concurrent Session 2
    Session A      Computational Modeling and Simulation: Bringing Transformative Advancements to Healthcare

    Experts across industries recognize that physics-driven and data-driven models complement each other and together can yield maximum insight into observed behavior while motivating future innovations. However, computer-based testing and generation of regulatory evidence for medical devices lag far behind similar efforts in other industries, such as aerospace, automotive, and nuclear energy. MDIC is collaborating with key stakeholders, including FDA, industry, academia, and international non-profit organizations to close this gap by creating the necessary frameworks, models, and simulation practices to support efficient use and regulatory evaluations. This session will focus on global developments, key considerations, and innovative ideas from government, regulatory and industry experts in addressing the medical device industry’s needs.

    Moderator: Randall Schiestl, Vice President, Research & Development, Global Technology, Boston Scientific

    Speakers:

    • Grace Peng, PhD, Program Director, Division of Discovery Science & Technology, Mathematical Modeling, Simulation and Analysis, National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health (NIH)
    • Edward Margerrison, PhD, Director, Office of Science & Engineering Laboratories, FDA
    • Cheryl Liu, PhD, Senior Principal Engineer, Stryker
    • Steven Levine, PhD, Senior Director, Virtual Human Modeling, Dassault Systèmes
    Session B      Case for Quality: Envisioning a Formative MDIC Program

    MDIC’s Case for Quality Program looks to define how RWE/RWD, quality, and risks collide to shift the culture of quality across industry. The Case for Quality team will outline its visionary efforts and detail how innovation will bring value to the healthcare landscape. This impactful session will allow you to engage with thought leaders from industry, FDA, and MDIC in envisioning the Case for Quality at the next level.

    Moderator: Todd West, Vice President of Membership & Development, Medical Device Innovation Consortium

    Speakers:

    • Steven Silverman, President, The Silverman Group
    • Francisco Vicenty, Program Manager, Case for Quality, OPEQ, FDA
    • Bleta Vuniqi, Policy Analyst, Case for Quality, OPEQ, FDA
    • Sara A. Sulfridge, Senior Director Quality Strategy, Baxter
    • Ravi Nabar, PhD, MBA, Senior Director Quality, Thermo Fisher
    • Joseph Sapiente, Vice President of Clinical Science and Technology, Medical Device Innovation Consortium
    Session C      What Outcomes Matter Most to Patients (HEPV)

    While researchers, clinicians, medical device companies, regulators, payers, and HTAs play critical roles in evaluating the benefits and risks of medical products, only patients live with their medical conditions and make choices regarding their own care. Learn from the unique perspectives of patients about the value of the potential benefits and the impact of potential harms and burdens of their medical treatments.

    Moderator: Barry Liden, JD, Director of Public Policy, USC Schaeffer Center

    Speakers:

    • Keely Scamperle, MJ, FACHE, CPC, CCS-P, CHC,Vice President of Reimbursement and Market Access, Apollo Endosurgery
    • Joe Nadglowski President & CEO, Obesity Action Coalition
    • Juan Marcos Sepúlveda, PhD, Duke University
  • 5:00 – 7:00 pm

    Closing Reception

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