2018 Annual Public Forum Agenda

To download a copy of the agenda, please click here .

8:30 am Check-in and Continental Breakfast

9:00 am Welcome

9:10 am Fireside Chat with FDA Commissioner and MDIC Board Chairman

9:50 am MDIC Celebrates 5 Years

10:05 am NESTcc: Developments Over the Last Year 

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Description: The National Evaluation System for health Technology Coordinating Center (NESTcc) launched its Strategic and Operational Plan in January 2017 and has since then focused on achieving strategic goals such as launching its Data Network and implementing its first test-cases across a range of different devices.  Dr. Rachael Fleurence, Executive Director of NESTcc, will lead a panel focusing on advances in developing the Coordinating Center.  Panelists will discuss NESTcc priority initiatives, areas of advancement since the last Annual Public Forum, and the value of NESTcc for stakeholder groups.  Attendees will also learn the vision for the role of NESTcc in opening the front door and understand the role NESTcc plays in addressing FDA priorities, both pre- and post-market.   

ModeratorRachael Fleurence, PhD | Executive Director, NESTcc 

Panel: 

  • Jeffrey Shuren, MD, JD | Director, CDRH, FDA 
  • Michelle McMurry-Heath, MD, PhD | WW Vice President Regulatory and Clinical Affairs, Johnson & Johnson 
  • Kathleen Blake, MD, MPH | VP, Healthcare Quality, American Medical Association  

10:45 am Break

11:05 am Cybersecurity: Coordinated Vulnerability Reporting 

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 The FDA’s Center for Devices and Radiological Health (CDRH) has issued guidance to address cybersecurity as an ongoing effort to ensure safety and effectiveness of the complete medical device lifecycle. In support of this, some medical device manufacturers have implemented coordinated vulnerability portals and processes as part of their overall threat detection and response process. MDIC explored and gathered insights from various perspectives to better understand best practices and opportunities to advance medical device coordinated vulnerability reporting. Key findings from this work will be presented and the audience will have the opportunity to engage with panelists as the group participates in a robust dialogue identifying activities and research opportunities for MDIC to further the agenda of advancing coordinated vulnerability reporting. 

Moderator: Randy Schiestl | VP, R&D and Global Technology, Boston Scientific 

Panel: 

  • Luke Dembosky, JD | Partner, Debevoise & Plimpton 
  • Paul Rubin, JD | Partner, Debevoise & Plimpton 
  • John deCraen Sr. Director, Global Cyber Risk Services, Alvarez & Marsal 
  • Seth Carmody, PhD | Cybersecurity Project Manager, CDRH, FDA 
  • Greg Garcia | Executive Director for Cybersecurity, Health Sector Coordinating Council  
  • Zach Rothstein, JD | Associate VP, Technology & Regulatory Affairs, AdvaMed 
  • Dana-Megan Rossi, JD | Product Security Policy & Strategy, BD 

11:45 am MDIC Founders Recognition

12:00 pm Lunch + Keynote: Innovation and Modern Monopolies

12:50 pm Science of Patient Input:  Influencing Device Development  

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Part I: Research Methodologies to Expand SPI  

Part II: Patient Experiences in Product Development  

The healthcare system is increasingly interested in “patient perspectives” on the development of new medical technologies, but there lacks consensus on when and where is the best opportunity to incorporate this perspective. This panel will explore what medical device companies can learn from patients and patient organizations and how patients can impact the development of medical devices along different stages of the product development lifecycle. 

Moderator: Barry Liden | VP Patient Engagement, Edwards Lifesciences 

Panel: 

  • Brett Hauber | Sr. Economist and VP, Health Preference Assessment, RTI Health Solutions  
  • Mike Otleweski | Clinical Program Scientist, Med Institute  
  • Michelle Tarver | Director of Patient Science & Engagement, US FDA CDRH  
  • Adam Amdur | Chief Patient Officer, American Sleep Apnea Association, Patient 
  • Tonya Roney Moore | Patient
  • Donnette Smith | Patient

1: 50 pm Concurrent Tracks I *Exclusively for in-person attendees only.

NESTcc:  Launching the Data Network 

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Description: NESTcc is working to accelerate the development and translation of new and safe health technologies, leveraging Real-World Evidence (RWE) and innovative research, and launched its test-case initiative in late 2017 to answer industry questions and test the capabilities of its Data Network.  During this panel, attendees will hear insights from Network Collaborators participating in the test-case projects, including lessons learned, the benefits of working with NESTcc, and innovative solutions.  Panelists will also share how the NESTcc Data Quality Subcommittee will shape the NESTcc Data Network and they’ll provide an industry perspective on the value of the NESTcc test-case initiative.   

ModeratorOwen Faris, PhD | Clinical Trials Director, ODE, CDRH, FDA  

Panel: 

  • Lesley Curtis, PhD, MS | Chair and Professor, Department of Population Health Sciences, Duke University School of Medicine  
  • Joe Drozda, MD, FACC | Director, Outcomes Research, Mercy Health 
  • Paul Coplan, ScD, MBA, FISPE | VP and Global Head of Medical Device Epidemiology, Johnson & Johnson 

Early Feasibility Study: Facilitating Patient Access  

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Recognizing opportunities to improve medical device innovation and increase patient access to potentially beneficial technologies, the FDA/CDRH released the Early Feasibility Study (EFS) Guidance document in 2013. In partnership with clinical sites and industry sponsors, MDIC has launched an EFS pilot initiative to (i) develop EFS tools and best practices, (ii) evaluate the use of these tools and best practices with clinical sites, and (C) prospectively collect EFS performance metrics, all with the aim to reduce administrative barriers when conducting EFS trials. The panel will discuss opportunities to advance U.S. leadership in EFS, establish a national EFS site consortium, and facilitate patient access to early innovative medical devices.           

Moderator: Chip Hance, CEO | Regatta Medical, and MDIC Board of Directors 

 Panel: 

  • David R. Holmes, Jr, MD, MACC | Scripps Professor in Cardiovascular Medicine at the Mayo Clinic 
  • Maureen L. Dreher, PhD | Policy Analyst, Clinical Trials Program, FDA 
  • Rick Geoffrion | President & CEO, Mitralign 
  • Jamie Walkowiak, JD | COO, Baylor Scott & White Research Institute 

Case for Quality: Leveraging Lessons from Pilot for the Future  

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In December 2017 CDRH launched the Voluntary Medical Device Manufacturing and Product Quality Program Pilot, utilizing a maturity model refined in collaboration with CMMI, MDIC and our regulatory and industry partners. Nine months into the pilot, this panel will review results of the pilot and a vision for how the program will be expanded in 2019, as well as explore the impact of the pilot on advancing continuous quality improvement in medical device manufacturers.  

Moderator: Joe Sapiente | VP, Quality Assurance and Regulatory Affairs, Hologic
Panel: 

  • George Zack | Principal and Co-Founder, Two Harbors Consulting 
  • Cisco Vicenty | Program Manager, Case for Quality, FDA CDRH 
  • George Serafin | Health Care and Life Sciences Leader, Grant Thornton 
  • Beth Staub | Group Compliance Officer, Global Quality and Operations, Stryker 
  • Al Crouse | Quality Director, CVRx 

2:40 pm Break

2:55 pm Safety Signal Transparency: Using the Power of Data 

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Transparency is a key attribute to empowering a learning healthcare system that maximizes the benefits and minimizes the risks in medical device use. It is important to establish a “safe space” to enable transparency and evaluate signals early when potential issues arise. Join this panel for a discussion on the role of transparency in medical device lifecycle management, ranging from clinical trial data access, to the use of real-world data in active safety surveillance, and device quality management. 

Moderator: JiJo James, MD | Chief Medical Officer, Medical Devices, Johnson & Johnson 

Panel: 

  • Jeff Shuren, MD, JD | Director, CDRH FDA 
  • Heather Hawley | Executive Director, Health Innovation, Modernization, and Safety, MITRE 
  • Harlan Krumholz MD, SM | Professor of Medicine and Epidemiology & Public Health at Yale University, and Director of the Yale New Haven Hospital Center for Outcomes Research and Evaluation (CORE) 

3:35 pm Concurrent Tracks II *Exclusively for in-person attendees only.

Diagnostics: Using IVD RealWorld Evidence 

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To accelerate innovation for in vitro diagnostics (IVDs) and to enable patients and healthcare professionals to have access to safe and effective IVD technologies, we must explore innovative methodologies and approaches in clinical evidence generation and utilization in addition to traditional clinical studies/trials. One such clinical evidence source is the real-world evidence (RWE) gathered during routine patient care and reflecting the real-world use of IVDs. The IVD RWE working group, within the MDIC Clinical Dx program, is working on a framework for applying RWE as a source of evidence that can be used to support regulatory decision-making for IVDs. The panel will discuss the challenges and opportunities for using IVD real-world evidence.

ModeratorLesley Maloney, PharmD; Head US Regulatory Policy | Roche Diagnostics
Panel: 

  • Michael Waters | SHIELD Team Lead | FDA|CDRH RWE Tactical Team OIR Representative
  • Brad Spring | VP Regulatory Affairs, BD Life Sciences 
  • Tyler O’Neill, BSc, DVM, MSc, PhD | Scientist (Epidemiologist), Population Health Sciences, Diagnostics Science & Services, Diagnostics Information Solutions 
  • Diane Macculloch Johnson, MS | Sr. Director, North American Regulatory Affairs Policy and Intelligence, Digital Health Policy Lead, Johnson & Johnson Medical Devices

External Evidence Methods: Matching Data and Innovation 

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A paradigm shift is beginning where, rather than looking at a singular body of data from a single clinical trial, we are shifting to a future where historical, prospective, and concurrent data external to the prospective clinical trial can be incorporated and utilized for efficiencies and to better understand safety, efficacy, and performance of devices. MDIC has previously published an approach for incorporating data from engineering models (“virtual patient data”) in a Bayesian clinical trial design. This panel will discuss broader opportunities and barriers to incorporating external evidence, including, real-world evidence (RWE), engineering models, or prior clinical trial data, in the regulatory decision-making process. 

Moderator Kyle Myers, PhD | Director, Division of Imaging Diagnostics and Software Reliability, FDA, CDRH, OSEL 

Panel: 

  • Ram Tiwari, PhD, Director, Division of Biostatistics, FDA, CDRH, OSB 
  • Ted Lystig, PhD, Director, Corporate Biostatistics, Medtronic (invited) 
  • Tobi Karchmer, MD, VP, Global Medical Safety, Becton Dickinson 

Health Economics and Patient Access: Accelerating Innovation 

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MDIC’s newest initiative focuses on clinical evidence, economic value, and patient science and seeks to emulate successes in advancing regulatory science. Our objective is to facilitate collaboration between medical device companies, CMS, FDA, private payers and patients on methods to use scientific and clinical evidence to support more efficient and effective coverage processes.  

As the healthcare delivery model evolves to provide value-based care, how can CMS, industry and patient groups continue to partner to advance high-quality, innovative care for beneficiaries? What types of evidence and outcomes data are required of industry to demonstrate value of new technologies and obtain coverage? The panel will also consider what support clinicians and beneficiaries seek to promote evidence evaluation and shared decision-making. Each panelist will provide an overview and will participate with the audience in a dialogue about stakeholder interests. 

Moderator: Tanisha Carino, PhD, Executive Director, FasterCures
Panel: 

  • Tamara Syrek-Jensen, JD, Director, Coverage & Analysis Group, CMS
  • Robin Bostic | DVP, Global Health Economics & Reimbursement, Abbott 
  • Jennifer Kerr | President, Cook Medical

4:25 pm Keynote: CDRH Updates

4:50 pm Closing Remarks

5:00 pm 5 Year Anniversary Networking Reception