2020 Annual Public Forum (Virtual)
Visit apf.mdic.org to see the full agenda and register for future sessions. Catch up on past sessions below.
Fireside Chat
Thursday, June 18, 2020
FDA Commissioner, Dr. Stephen Hahn sits down with MDIC’s President and CEO, Pamela Goldberg to discuss his role as Commissioner, key priorities for the Agency, and how COVID-19 has impacted the device industry.
Speakers:
- Stephen Hahn, MD | Commissioner, FDA
- Pamela Goldberg, MBA | President and CEO, Medical Device Innovation Consortium (MDIC)
CDRH Town Hall
Thursday, June 25, 2020
Hear from FDA’s CDRH leaders as they discuss the important work and partnership between the Agency and MDIC, and how it relates to FDA’s strategic priorities.
Speakers:
- Nadim Yared | President and CEO, CVRx and MDIC Board Chairman (Moderator)
- Jeff Shuren, MD, JD | FDA Center for Devices and Radiological Health (CDRH), Center Director
- Michelle Tarver, MD, PhD | FDA CDRH, Office of Strategic Partnerships & Technology Innovation (OST), Director for Patient Science Engagement
- Andrew Farb, MD | FDA CDRH, Office of Product Evaluation and Quality, Office of Health Technology 2, Chief Medical Officer
- Daniel Caños, PhD, MPH | FDA CDRH, Office of Clinical Evidence and Analysis, Director
- Jessica Wilkerson | FDA CDRH, Office of Strategic Partnerships & Technology Innovation (OST), All Hazards Readiness Response & Cybersecurity, Cyber Policy Advisor
- Francisco “Cisco” Vicenty | FDA CDRH, Office of Product Evaluation and Quality, Compliance and Quality Staff, Program Manager – Case for Quality
- Sara Brenner, MD, MPH | FDA CDRH, Office of Product Evaluation and Quality, Office of Health Technology 7, Associate Director for Medical Affairs
- Anindita “Annie” Saha | FDA CDRH, Office of Strategic Partnerships & Technology Innovation (OST), Director for Partnerships to Advance Innovation Regulatory Science
Includes exclusive extended Q&A not shown in the live session!
How can RWE advance diagnostics in the COVID-19 era?
Thursday, July 9, 2020
The COVID-19 pandemic has illustrated the value of in vitro diagnostics like never before. At the same time, it has challenged the healthcare ecosystem to determine how these important, innovative IVDs perform in the real world, and how we might use the data generated in regulatory decision-making. Join this expert panel in exploring the barriers and opportunities to timely access to RWE, and the new Medical Device Innovation Consortium Framework for addressing quality issues and potential clinical study designs to support submission for clearance or approval of IVDs currently under EUA.
Speakers:
- Danelle Miller, JD | Roche Diagnostics, VP, Global Regulatory Policy and Intelligence (moderator)
- Wendy Rubinstein, MD, PhD | Director, Personalized Medicine, FDA:CDRH:OHT7-OIR
- Tyler O’Neill, DVM, PhD| Roche Diagnostics, Clinical Science Leader, Acute Care, Infectious Diseases, Clinical Science, Medical & Scientific Affairs
- Ed Heierman, PhD | Abbott, Sr Product Cybersecurity Architect | IVD Industry Connectivity Consortium (IICC), Chief Technology Officer
- William G. Morice II, MD, PhD| Mayo Clinic Laboratories, Professor and Chair, Department of Laboratory Medicine & Pathology, President
Patient preference and RWE strategies to develop a patient-centered regulatory strategy
Thursday, July 16, 2020
FDA’s CDRH has issued several guidance documents in consideration of using patient preference data in regulatory benefit-risk assessments and real-world evidence to support regulatory decision-making for medical devices. But rather than considering these as two separate topics, device manufacturers should consider these guidance documents together in the development of a cohesive regulatory strategy that maximizes patient input and the potential for regulatory success. Patient preference information can help manufacturers, providers, and regulators understand the level and type of risks patients with a given condition would be willing to endure and the level and type of benefit that would be most meaningful. Real-world evidence has the potential to give a more comprehensive view of how a technology performs and enables manufacturers and regulators to understand the long-term outcomes of medical technology without delaying initial approval. Patient experience and preference information can help inform effective real-world evidence strategies by capturing insight into how patients interact with health technology, their preferences for how their data is used, and their perspectives on risks. A real-world evidence strategy ultimately means working with patients’ real-time and long-term health data and provides an opportunity to capture longitudinal experience and preference information. As such, researchers should seek patient consent to use the data and patient input on how their data are used. Combining the objectives of using patient preference and real-world evidence data in a comprehensive regulatory strategy will ensure sponsors are maximizing the potential for patient input in their regulatory submissions. FDA guidance can be leveraged to ensure this strategy will meet FDA expectations. This panel will discuss the value of patient preference and real-world data and how FDA guidance can be used to ensure a device sponsor’s regulatory strategy meets the needs of both the patient and the regulators.
Speakers:
- Stephanie Christopher, MA, CCRC | Senior Program Manager, Health Insights, Providence St. Joseph Health
- Carrie M. Kuehn, MA, MPH, LPD, RAC | Evidation Health
Perspectives on RWE: Assessing Its Use, Impact, and Role in the U.S. and EU
Thursday, July 23, 2020
The adoption of real-world evidence (RWE) can help ensure the availability of safe, effective and innovative technologies for patients. Demand for RWE continues to grow, with global regulatory bodies looking to Real-World Data (RWD) for pre- and post-market decisions and payers requiring more evidence to make their coverage decisions.
In this virtual session, attendees will learn about the types of RWE, explore the role of technology in advancing device evaluation, understand barriers and facilitators for RWE, and hear how RWE can be used to support patients, as well as regulatory and coverage decisions.
Speakers:
- Robbert Zusterzeel, MD, PhD, MPH | NESTcc Research Network Director, MDIC (Moderator)
- Daniel Caños, PhD, MPH | FDA CDRH, Office of Clinical Evidence and Analysis, Director
- Martin Gibson | CEO, NorthWest EHealth Limited
- Bray Patrick-Lake, MFS | Director of Strategic Partnerships, Evidation Health
- Justin W. Timbie, PhD | Senior Health Policy Researcher, RAND
New Frontiers in Access with RWE Development
Thursday, July 30, 2020
Market access is a critical step in achieving widespread adoption of cutting-edge medical technologies. Insurers consider a variety of factors when formulating medical coverage policies for medical devices, including the overall strength of evidence and availability of clinical guidelines and health technology assessments by independent organizations.
Join access and reimbursement experts throughout the device industry as we explore and evaluate new frontiers in market access with RWE development.
Speakers:
- Jeff Farkas | Vice President, Global Health Economics, Reimbursement, and Government Affairs, Medtronic | Chair, MDIC Health Economics and Patient Access Steering Committee (Moderator)
- Tamara Syrek Jensen, JD | Director, Coverage and Analysis Group, Centers for Clinical Standards and Quality, CMS
- Gregory Daniel, PhD, MPH | Head, U.S. Healthcare Policy, Edwards Lifesciences
- Naomi Aronson, PhD | Executive Director Clinical Evaluation, Innovation and Policy, Office of Clinical Affairs, Blue Cross Blue Shield Association
- Eleanor M. Perfetto, PhD, MS, Executive Vice President, Strategic Initiatives, National Health Council
NESTcc 2020: Progress, Priorities, and the Path Ahead
Thursday, August 6, 2020
The National Evaluation System for health Technology Coordinating Center (NESTcc) seeks to support the sustainable generation and use of timely, reliable, and cost-effective Real-World Evidence (RWE) throughout the medical device lifecycle. By joining this session, attendees will hear an overview of NESTcc initiatives to drive RWE forward, including the status ofNESTcc’sTest-Cases, the publication of the Data Quality and Methods Frameworks, the creation of a roadmap and infrastructure for active surveillance, Data Network expansion, Collaborative Community efforts, and commercialization activities.
Speakers:
- Sandra Siami, MPH | NESTcc Senior Vice President, MDIC (Moderator)
- Adrian Hernandez, MD, MHS | Professor of Medicine at Duke School of Medicine; Vice Dean and Executive Director, Duke Clinical Research Institute
- Diane Wurzburger, JD | Executive of Regulatory Affairs, Developed Markets & Global Strategic Policy, GE Healthcare
- Kathleen Blake, MD, MPH | Vice President of Healthcare Quality, American Medical Association
Cybersecurity: Strides Toward Maturity Benchmarking for the MedTech Sector
Thursday, August 13, 2020
Cybersecurity risks can lead to patient safety risks. There has been a rapid increase in the complexity and frequency of cyber threats in the healthcare space. MDIC is working with stakeholders from FDA, manufacturers of medical products, and security solution providers to improve and ensure that overall cyber resilience match or exceed the prevailing threat. The APF cybersecurity session will overview the collaborative efforts MDIC is leading toward the development of a framework for benchmarking cybersecurity maturity of the global medical technology industry. This will enable individual medical technology companies, HDOs and stakeholders to establish long-term strategic plans to increase their cybersecurity maturity and track our progress along the way. Attendees will also learn about the progress MDIC has made in the threat modeling bootcamp and playbook project as well as recent cybersecurity updates from FDA.
Speakers:
- Rob Suarez | VP, Chief Information Security Officer, BD
- Jessica Wilkerson | FDA CDRH, Cyber Policy Advisor
- Jithesh Veetil, PhD | MDIC Program Director, Data Science & Technology
- Adam Shostack | Shostack & Associates
Case for Quality: Make CAPA Cool & C-Suite Leadership
Thursday, August 20, 2020
This session provides updates on MDIC’s Case for Quality (CfQ) Make CAPA Cool pilot study and the CfQ C-Suite Leadership workstream.
Speakers:
- Alan Baumel | MDIC Program Director, Case for Quality
- Kathryn Merrill | Sr. Lead Sigma Manager, Medtronic
- Pat Shafer | Managing Director, Health Care and Life Sciences, Grant Thornton
- Bleta Vuniqi | FDA CDRH
- Dan Beuhner | Edwards Lifesciences
- Marc-Henri Winter | FDA CDRH
- Jackie Torfin | Quality Leadership Consulting
- Ramakrishna Pidaparti | L&T Technology Services
Case for Quality Collaborative Community, VIP & MDIAS
Thursday, August 27, 2020
This session provides updates on Case for Quality (CfQ) as a Collaborative Community, the Voluntary Improvement Program (VIP), and initiation of the Medical Device Information Analysis and Sharing (MDIAS) program.
Speakers:
- Alan Baumel | MDIC Program Director, Case for Quality
- Kim Kaplan | CMMI Institute
- Al Crouse | CVRx
- Michael Ruhlen | Atrium Health
- Joseph Sapiente | Hologic
- Francisco “Cisco” Vicenty | FDA CDRH, Office of Product Evaluation and Quality, Compliance and Quality Staff, Program Manager – Case for Quality
- Rob Becker | Edwards Lifesciences
- Mike McCarthy | Baxter
External Evidence Methods for Regulatory Decision-Making: Opportunities and Innovations
Thursday, September 3, 2020
MDIC, through its Clinical Science & Technology as well as NEST initiatives, is working closely with healthcare stakeholders to generate evidence across the total product lifecycle of devices and diagnostics by strategically and systematically leveraging external evidence such as real-world evidence (RWE), historical data, and modeling & simulation data. A widespread adoption of external data warrants advanced analytics tailored to the unique data needs and innovation cycles along with aligned regulatory framework. In this session attendees will learn about the External Evidence Methods (EEM) framework document that is being developed through MDIC for leveraging external data sources in pre-market medical device regulatory submissions. The framework document aims to categorize different sources of external data, catalog existing statistical methods used for leveraging external data sources, include examples to illustrate use of statistical methodology and identify “gaps” where innovative methods need to be developed. Experts from the working group will discuss the progress made so far and share the results from the MDIC EEM survey that was administered to capture use of external data in pre-market clinical studies by medical device and diagnostic manufacturers. The session will also highlight the strides made by the medtech community in utilizing external evidences for COVID-19 pandemic management.
Speakers:
- Daniel Caños, PhD, MPH | FDA CDRH, Office of Clinical Evidence and Analysis, Director
- Ted Lystig, PhD, FASA | Senior Director, Corporate Biostatistics, Medtronic
- Ram Tiwari, PhD | FDA CDRH, Division of Biostatistics, Director
- Vandana Bhatia | FDA CDRH, Division of Biostatistics, Assistant Director
Applying the IVD RWE Framework
Thursday, September 10, 2020
MDIC will provide an overview of its IVD RWE Framework and an update on the COVID RWE project. View the framework here. Read the full press release here.
Speakers:
- Danelle Miller, JD | Roche Diagnostics, Head Global Regulatory Policy and Intelligence (moderator)
- Wendy Rubinstein, MD, PhD | Director, Personalized Medicine, FDA:CDRH:OHT7-OIR
- Ed Heierman, PhD | Abbott, Sr Product Cybersecurity Architect | IVD Industry Connectivity Consortium (IICC), Chief Technology Officer
- Nilay D. Shah, PhD | Chair, Division of Health Care Policy and Research, Mayo Clinic
- Sue Dahlquist | Senior Director Global Strategic Regulatory & Clinical Affairs, Thermo Fisher Scientific
Patient Preferences for Heart Failure Devices: A Collaborative Study
Thursday, September 17, 2020
MDIC’s Science of Patient Input: Heart Failure Study was officially launched in October of 2018 as an industry-wide collaborative effort including medical device industry sponsors, regulatory agencies, and preference assessment experts from Duke Clinical Research Institute (DCRI) to advance the science of regulatory patient preference assessment. Based on research objectives, study attributes, patient population, and a stated preference survey instrument, the study will help us gain a better understanding of patient preferences based on efficacy and safety outcomes of possible medical devices for heart failure. The results of this study will strengthen MDIC’s broader effort to promote regulatory science and develop a framework for Patient Input in the Design of Medical Device Clinical Trials.
Speakers:
- Liliana Rincon-Gonzalez, PhD | MDIC
- Dean Bruhn-Ding | CVRx
- Shelby Reed, PhD, RPh | Duke University, Duke Clinical Research Institute
Computational Modeling & Simulation: Towards Good Simulation Practices
Thursday, September 24, 2020
MDIC is working with various stakeholders including FDA, industry, academia international non-profit organizations like Avicenna Alliance to transform computational modeling and simulation (CM&S) from ‘a valuable scientific tool’ to a ‘valuable regulatory tool’ as well as to develop mechanisms to rely more on digital evidence. To achieve this objective, the community need frameworks and good simulation practices to support the evaluation and utility of CM&S in health technologies. In this APF session, specifically focused on CM&S, attendees will learn about the recent global developments in this front. The session also will overview the learnings from MDIC CM&S landscape survey conducted in summer 2020.
Speakers:
- Tina Morrison, PhD | FDA
- Randy Shiestl, PMP | Boston Scientific
- Steven Levine, PhD | Dassault Systèmes
- Markus Reiterer, PhD | Medtronic
- Pras Pathmanathan, PhD | FDA
