7:45AM - 8:30AM

Join us for Breakfast

Join your colleagues from around the country as we kick-off the second day of MedCon 2017 with a nice complimentary warm breakfast.


8:30AM - 8:35AM

Conference Day 2 Milestone: Your Learning Put into Action

Speakers: Jim Wulfeck, Complete Mastery


8:35AM - 9:20AM

EU Regulations - Exploring the Unknown

The European Regulations for Medical Devices and In Vitro Diagnostic Devices are now published, but there are many details yet to be worked out. This session will review the significant changes associated with these regulations, the implementation timelines, and will discuss the remaining delegated Acts (sub-regulations). This session will also review what is known about the impact of Brexit on medical technologies.

Moderator: Patricia Murphy, BSI Group America

Speakers: Gert Bos, Ph.D., Qserve Group


9:20AM - 10:05AM

Impact of the New EU Regulations on Your Global Regulatory Strategy

Your Global Regulatory Strategy is the foundation of your product development lifecycle, which ensures a well-planned clinical trial design, right first time production, successful approval of your product globally, and an on-market product that meets the needs and expectations of your patients. Understand how to proactively realign your strategy to meet the requirements of the new EU regulations.

Moderator: Susan Rolih, Meridian Bioscience

Speakers: Philippe Auclair, Abbott


10:05AM - 10:20AM

Break


10:20AM - 11:20AM

Defending Claims for Your Device

Enforcement challenges against claims for your device may come in court, or in Federal Trade Commission proceedings. This session addresses both the FTC process for defending a device claim, and the recent court cases dealing with FDA authority over device benefit claims under the First Amendment.

Moderator: James O’Reilly, University of Cincinnati

Speakers: James O’Reilly; Jon Steiger, FTC


11:20AM-12:20PM

Track 1
Digital Health - Key Focus Areas for FDA and Industry

FDA will provide insight on the key areas they are addressing related to the evolution of digital health. How can FDA and industry work together to protect and assure the integrity of digital health information, and come to a deeper realization of how devices are being used by consumers to take health care into their own hands.

Moderator: Barbara Fant, Clinical Research Associates

Speakers: Bakul Patel, FDA

Track 2
The Convergence of International Regulatory Changes Through 2020

As most medical device companies supply their products beyond the borders of the United States, it is critical to understand the compounded effect of converging changes across multiple regulatory authorities around the globe. Have you mapped these changes together to understand the implications to your product, your company and the patients you serve? Walk away with a deeper understanding of the gravity of changes ahead of us:  MDSAP, ISO 13485, EU MDR, New ASEAN Regulations and EU IVDR.

Moderator: Monica Wilkins, Abbott

Speakers: Kim Trautman, NSF International


12:20 PM - 1:20 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 on the following topics:

  • Digital Health and Cybersecurity
  • The Impact of EU Regulation Changes
  • Quality and Cultural Metrics
  • FDA Inspection Readiness

1:20PM - 1:25PM

Conference Day 2 Milestone: Your Learning Put into Action

Speakers: Jim Wulfeck, Complete Mastery


1:25PM - 2:10PM

How to Measure Cultural Misalignment and its Impact on Product Reliability

FDA and Industry have begun to explore how to measure the cultural maturity of an organization. It is recognized that the strength of an organization’s culture impacts its ability to reliably produce product that meets the needs of its patients and customers (fit for purpose). Xavier University, PricewaterhouseCoopers (PwC) and SchellingPoint led a team of industry thought-leaders to address the question of “What do I need to see in action to know my company has a strong culture of quality?” The results are staggering and provide new information and insight that can inform decisions and trigger action. Walk away understanding what causes cultural breakdown, how culture impacts product reliability, and specific actions you can take today.

Moderator: Bill Brodbeck, STERIS

Speakers: Marla Phillips, Xavier Health


2:10PM - 3:40PM

Beyond Metrics – Using Artificial Intelligence to advance the Predictive Capabilities of your Organization

Through the power of artificial intelligence, cognitive computing is able to learn beyond human capabilities by scanning complex information (data and text) to identify trends and patterns that have not previously been identified. This engaging and interactive session will explore the use of cognitive computing across post-market signals in a way that will advance your organization from reacting to metric output, to predicting product-impacting outcomes. Through presentation, interview and table discussions this session will explore how artificial intelligence can be implemented in your organization.

Moderator: Marla Phillips, Xavier Health

Speakers: Bakul Patel, FDA; John Daley, IBM Watson Health


3:40PM - 4:00PM

Break


4:00PM - 5:00PM

510(k) – Who Needs One and What You Actually Own When You Have One

Quality and regulatory personnel should view their cleared 510(k) as a company asset. They need to have a working knowledge of the rights and obligations as this knowledge can limit the filings of unnecessary 510(k)s or help with a company’s due diligence process. During this interactive session, the attendees will be divided into teams and asked to answer specific questions related to hypothetical case studies about 510(k)s. Afterwards, an expert panel will comment on the team responses.

Moderator: Nancy Singer, Compliance Alliance

Speakers: Daniela Drago, George Washington University; Barbara Fant, Clinical Research Associates; Phil Phillips, Phillips Consulting Group; Susan Rolih, Meridian Bioscience; Nancy Singer, Compliance-Alliance


5:00PM - 7:00PM

Networking Reception

After the conference sessions on Thursday, benefit from open dialog while enjoying drinks and hors d’oeuvres. You and your colleagues can continue to share ideas with Strategic Committee Members and speakers in a pleasant, informal setting.