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
  • 9:10 – 9: 40 am

    Fireside Chat with FDA commissioner
  • 9:40 – 10:10 am

    Fireside Chat with CMS Chief Medical Officer
  • 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 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.

  • 11:05 - 11:20 am

    Coffee Break
  • 11:20 – 12:15 pm

    General Session 2 – NESTcc Quality Evidence by Design (NESTcc)

    Leveling up with Real-World Evidence 
    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. 

  • 12:15 – 1:15 pm


    Location: Penn Terrace

  • 1:15 – 2:10 pm

    General Session 3  Real World Evidence Benefiting Patients and Payers (HEPV) 
  • 2:10 – 3:00 pm

    FDA Roundtable
  • 3:15 – 4:00 pm

    Concurrent Session 1
    • Session A      Cloud and Clear: NESTcc Active Surveillance (NESTcc)
    • Session B      Clinical Diagnostics (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.

    • Session C      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.

  • 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 models 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 working 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.

    • 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 all 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.

    • Session C      What Patients Prefer (HEPV)
  • 5:00 – 7:00 pm

    Closing Reception

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