MedCon Agenda: Day 2
Thursday, May 3, 2018
7:45 AM - 8:30 AM
Join your colleagues from around the country as we kick off the second day of MedCon with a complimentary warm breakfast.
8:30 AM - 8:40 AM
Day 2 Opening
Participants will feel the Xavier Difference at MedCon—a purpose-driven, action-oriented conference. We will start the day recapping the take away points from Day 1 through the Act-Change-Transfer process with a focus on “action.”
- Dennis Hahn, Johnson & Johnson
- Dennis Hahn
8:40 AM - 9:40 AM
EU Regulations: Beyond the Unknown
The European Regulations for Medical Devices and In Vitro Diagnostic Devices have been published for more than a year. Now that there are fewer unknowns, we can dive deep into understanding the “how to” and the impact of these regulations. During this session participants will understand the implementation progress related to NB designation, Governance of the MDR/IVDR (MDCG), defining the “Implementing and Delegated” acts and the EUDAMED database. Participants will also walk away with insight on what is known about the impact of Brexit on medical technologies. Don’t miss this opportunity to ensure your organization is aligned with your colleagues across the industry.
- Patricia Murphy, BSI Group America
- John Wilkinson, MHRA (invited)
9:40 AM - 10:00 AM
10:00 AM - 10:45 AM
Align Your Organization with the FDA PreMarket Priorities
Product approval is vital to your organization and to the patients and customers you serve. Learn directly from FDA on how they are working to increase speed to market for some products that are proven to be safe, and how you can work to have your products on that fast-track list. Don’t miss this opportunity to stay abreast of the priorities FDA has for premarket submissions.
- Steve Binion, BD
- Bill Maisel, FDA-CDRH (invited)
10:45 AM - 11:30 AM
FDA PostMarket Update and Strategic Priorities
CDRH is working internally and with industry to collectively advance how “quality” can be leveraged for the benefit of your patients. CDRH is taking a Total Product Lifecycle approach to decisions they make about your product, folding in real-world evidence to PreMarket and PostMarket approvals, and working to assess the maturity of your company. Learn firsthand what is on the horizon and how to position your company for patient success.
- Sean Boyd, FDA-CDRH (invited)
- FDA-CDRH (invited)
11:30 AM - 11:35 AM
Focus on Learning
Participants will assess their key learnings through the Act-Change-Transfer process with a focus on “change.”
- Dennis Hahn, Johnson & Johnson
- Dennis Hahn
11:35 PM - 12:35 PM
Lunch Networking by Topic
Sit with FDA officials, speakers, industry experts and your colleagues at tables dedicated to topics that are important to you. Enjoy the discussion with others who share your passion.
12:35 PM - 2:40 PM
POSTMARKET, Digital Health & PreMarket TRACKS
1. PostMarket Track (12:35pm - 2:40pm)
Understanding and Applying Critical to Quality Principles in Device Design: Through interactive case studies, gain a better understanding of critical to quality attributes that focus around principles of product risk, and their resulting impact on the design of your finished device. Learn about the importance of establishing the criticality of the cTQs and linking it to the acceptance activities and/or design verification/validation activities for your device.
- Gina Brackett, FDA-ORA (invited)
- Phil Pontikos, FDA-ORA (invited)
- Steve Niedelman, King & Spaulding
- Ben Dastoli, FDA-ORA (invited)
2. Digital Health Track (12:35pm - 2:40pm)
Digital Health Innovation...The Future is Now: Digital health is transforming our daily lives. Hear FDA’s latest initiatives in digital health innovation, cybersecurity, and Software as Medical Device pre-certification. Learn from industry how to navigate the challenge of regulatory compliance for third party hosting services, and qualification of a software based medical device development tool. Our panel of experts will discuss the latest hot topics in digital health and how FDA and industry rises to meet the challenges.
- Barbara Fant, CRC
- Bakul Patel, FDA-CDRH (invited)
- Clinic speaker TBD
- Industry speaker TBD
3a. PreMarket Track (12:35pm - 1:35pm)
How to Effectively Implement the New 510(k) Guidance Expectations: Join Marjorie Shulman, CDRH (invited), as she explains what CDRH expects from industry based on the Final Guidance on 510(k) Modifications. She will share what the CDRH 510(k) staff is seeing from industry, especially what is working well and what isn’t. Since the medical device innovation cycle results in continuous changes to medical devices as technology evolves and new uses for existing devices are evaluated, don't miss this opportunity to better understand when a new 510(k) submission is required for modifications made to an existing device or software.
- Barbara Fant, CRC
- Marjorie Shulman, FDA-CDRH (invited)
- April Veoukas, Abbott
3b. PreMarket Track (1:35pm - 2:40pm)
The CDRH 510(k) Review Template: A Demo of the 510(k) Smart Template Used by CDRH Reviewers to Review 510(k)s: This demo will begin with a brief description on how the Smart Templates were developed and are presently maintained, followed by a demo of the main characteristics and parts of the 510(k) Smart Template. The demo will include a brief look inside the automated guides used by reviewers to review cross-cutting disciplines (e.g., Biocompatibility, Sterilization, Cybersecurity). By the end of the demo you will understand how the template is used, how a single template can be used to review multiple device types, and what the components of the template are.
- Heather Rosecrans, Greenleaf Health
- Patrick Axtell, FDA-CDRH (invited)
2:40 pm - 3:00 pm
3:00 pm - 4:00 pm
The Balance of Benefit and Risk – FDA Insight
Benefit-risk evaluations are at the center of everything we do as medical device professionals, striving to provide safe and effective devices for patients and providers. When problems are encountered, decisions concerning device availability, regulatory actions, and enforcement options need to consider the balance between benefit and risk. FDA has prioritized developing uniform, transparent, and harmonized methods and tools for use throughout the postmarket space. In this session, you will learn about these new tools, how and when they are employed, how they drive decision making, and how you might integrate them into your processes.
- Adam Saltman, FDA-CDRH (invited)