MedCon 2016 Program & Agenda


Inspiring Collaboration…
•Feel the Purpose-Driven nature of this conference as soon as you enter the room.
•Expect orchestrated engagement with your peers across the industry on topics you are passionate about.
•Find attendees openly sharing their expertise to help advance the industry in collaboration with global regulators.
•Work side-by-side with regulators to deepen the understanding on both sides of challenges and opportunities.

Leading Innovation…
•Identify solutions that will protect your patients around the world, your company brand, and your business.
•Talk about the “elephant in the room” to get to the real pain that plagues our industry.
•Learn what you didn’t know you didn’t know! Other industries successfully demonstrate what the device industry lacks. Walk away with real solutions.
•Hear directly from speakers who passionately challenge the status quo.

Making a Difference…
•Work through real working models that can improve the reliability of your product…today.
•Learn how you can be part of the solution.
•Understand who your stakeholders are so you can implement meaningful and sustainable change.
•Leave the conference armed with action plans that are orchestrated throughout the conference and solidified before you leave.

May 3, 2016

Time Description
5:00 PM - 7:00 PM

Welcome Reception

Please join the MedCon Strategic Committee at the Hilton Netherlands hotel for an evening Welcome Reception, to reconnect with colleagues and make new connections. Light hors d’oeuvres and beverages will be served.

May 4, 2016

Time Description
8:30 AM - 9:00 AM

MedCon Conference Welcome

Welcome to the Conference…Welcome to Xavier University…and Welcome to the Cincinnati District of the FDA. This purpose-driven conference will lead you to actionable learning and implementation plans.

9:00 AM - 9:45 AM

Center Director Corner: Strategic Priorities for 2016 and Beyond

Dr. Jeff Shuren, Director of the Center for Devices and Radiological Health (CDRH) will share strategic priorities related to protecting public health, including collaborative activities shared with industry on the balance of safety, efficacy, quality, access and innovation.

Moderated by: Steve Niedelman, King & Spalding


9:45 AM - 10:05 AM


10:05 AM - 10:50 AM

Office of Compliance Strategic Priorities

Director, Robin Newman will outline the top priorities for CDRH Office of Compliance, the Case for Quality progress, and other emerging issues. Learn how these priorities can impact you.

Moderated by: Gina Brackett, FDA


10:50 AM - 11:50 AM

Navigating Japan’s Regulatory Environment

This session will discuss the regulatory impact to manufacturers of the recent transition of the JPAL to PMDL.  The speaker will discuss the unique medical device labeling requirements in Japan, and expectations and responsibilities of the Market Authorization Holder (MAH) in managing relationships between the MAH, PMDA, and the manufacturer.

Moderated by: Susan Rolih, Meridian Bioscience


11:50 AM - 1:05 PM


  1. Networking by Topic
  2. Kim Trautman Lunch Presentation:  “WHO Medical Device Regulatory Model”
  3. Bakul Patel (CDRH) Lunch Presentation:  “FDA and International Update on Cybersecurity Progress”
1:05 PM - 3:40 PM Track 1

Regulatory Strategy for Innovation

Recognizing opportunities for accelerating FDA’s evaluation of innovative medical technology, as well as developing strategies that exploit available opportunities to advance a company’s interests, are challenges facing all regulatory professionals today.  The rapidly changing regulatory landscape makes regulatory strategy development a more critical part of the development process than it has been at any time in the past.  This session will discuss the means by which FDA regulatory processes can actually fuel innovation and provide insight into actions that can maximize the commercial potential of innovative medical technology.

Moderated by: Dennis Hahn, Ethicon

1:05 PM - 3:40 PM Track 2

Working through Challenges with Supplier Quality and Design-What to do and When

Participate in an afternoon of working through case studies relating to supplier quality and design issues and subsequent actions that need to be considered and/or taken. Learn best practices from industry experts and understand common 483 findings from FDA.

Moderated by: Gina Brackett, FDA

3:40 PM - 4:00 PM


4:00 PM - 5:00 PM Track 1

Critical Thinking-The Secret to Responding to FDA

Not understanding the Big Picture when responding to FDA action (FDA 483s, warning letters, and deficiency letters) can result in failure to address the citation, or include the necessary information in the response.  Join your colleagues and an expert panel to unlock the secrets of FDA expectations by analyzing different real-life scenarios.

Moderated by: Nancy Singer, Compliance Alliance

4:00 PM - 5:00 PM Track 2

Paradigm Shift – Meaningful Solutions for your Supply Chain

Through the work of FDA, pharmaceutical and medical device manufacturers and suppliers, this Xavier initiative has uncovered major paradigm shifts that are enabling the industry to approach risk to supply and product through a dramatically different approach that has immediate impact.  Join us for this interactive session to start implementing changes in your operations today.

Moderated by: Monica Wilkins, Abbott

5:00 PM - 7:00 PM

Networking Reception

Benefit from the open dialog while enjoying drinks and hors d’oeuvres. You and your colleagues can continue to share ideas and explore issues with Strategic Committee Members and Speakers in a pleasant, informal setting.

For those signed up for the conference shuttle, the driver will take you to the Hilton Cincinnati Netherland Plaza immediately following this event.

May 5, 2016

Time Description
8:30 AM - 9:30 AM

European Medical Device Regulation Progress

The European Commission published proposals to replace the European medical device directives and CE marking with new regulations. Learn how the proposals reviewed by the European Parliament and amended by the European Council are progress rapidly towards confirmation as European Regulations and what to expect in 2016,  what’s changed and what remains the same, expert interpretation/insight on the changes, how to start preparing for and implementing the new requirements, the timetable/process for transition from the current directives to achieve full compliance with the new European Medical Device Regulation and continue placing devices in Europe.

Moderated by: Karen Coleman, IHL Consulting


9:30 AM - 10:30 AM

Canada’s changing Quality System Requirements: 13485/MDSAP/CMDCAS

Health Canada mandated ISO 13485 as the basis for quality systems requirements requiring certification under their CMDCAS accreditation program, Health Canada has announced intention to mandate MDSAP possibly to replace CMDCAS. In 2016 a new version of ISO 13485 is expected and the MDSAP pilot will be completed. Hear the key changes of the new version ISO 13485, the impact of ISO 13485:201X on Healthcare Canada’s CMDCAS program and the impact of declared intention to mandate MDSAP, including possible timetables for transition, implementation issues and how Health Canada’s mandate impacts manufacturers placing devices into the other countries adopting MDSAP (voluntary outside Canada).

Moderated by: Paul Brooks, BSI

10:30 AM - 10:50 AM


10:50 AM - 11:35 AM

Appropriate Use of the Internet and Social Media – FDA and FTC Perspectives

The highly competitive medical device industry increasingly relies on the internet and social media as an efficient and effective means to reach consumers. In this heavily regulated environment, it is critically important that companies understand their regulatory responsibilities under the FDCA and FTC Act. While many medical device companies have an understanding of FDA’s prohibitions against off-label promotion of devices, confusion exists when it comes to applying them to internet and social media communications. Likewise, confusion exists regarding the roles of the FDA and the FTC and the FTC’s dual mission to protect consumers and promote competition. This session will provide attendees valuable insight into the responsibilities of these two Federal regulatory agencies and the means to navigate very uncertain waters and steer clear of being accused of off-label promotion or deceptive business practices.

Moderated by: Phil Phillips, Phillips Consulting Group

11:35 AM - 12:20 PM

MDIC/Xavier University Medical Device Metrics Initiative

Xavier University is leading a metrics initiative with FDA under the Medical Device Innovation Consortium to identify, pilot, plan and publicize predictive product quality system metrics.  Understand how the output of this initiative can inform decisions and trigger action in your organization in a way that shifts the Right-First-Time mentality as close to the initial days of product development as possible.

Moderated by: Steve Niedelman, King & Spalding

12:20 PM - 1:50 PM

Lunch Networking by Topic

1:50 PM - 2:35 PM

Update from the Office of Device Evaluation

Office of Device Evaluation (ODE) leadership will summarize ODE activities and significant accomplishments over the past year,  and share insights into FDA’s initiatives to bring new devices to the U.S. market.

Moderated by: Barbara Fant, Clinical Research Consultants


2:35 PM - 2:55 PM


2:55 PM - 5:00 PM Track 1

When to File a 510(k) for Modifications to your Cleared Device – What you don’t know can hurt you

FDA intends to revise the current guidance document on changes and modifications to legally marketed class I and II devices.  Issuance of a draft guidance document represents an opportunity to provide the agency with input on what changes require premarket authorization and what impact changing expectations have on industry. Furthermore, initiating the process of revising FDA expectations presents immediate challenges for companies modifying devices in advance of the revised guidance document. This session discusses how decisions regarding what changes in design, manufacture and labeling require 510(k) clearance, how decisions not to file should be documented, and how companies can participate in the guidance document development process.

Moderated by: Steve Binion, BD

2:55 PM - 5:00 PM Track 2

You Really want to store Clinical Data in The Cloud?

In this session, we will explore the risk management lessons learned from case studies that balance the management of patient safety risks as well as the asset (data) risks. From an ISO 14971 device risk management perspective, this session will address cybersecurity best practices globally. We will explore best practices in preparing for FDA submission by collaborating with cloud service providers, securing PHI, cybersecurity, post-market surveillance, safety assurance case methodology, reporting data breaches and adverse events and many other complex issues where clinical data is at risk. We will discuss assurance case methodologies specifically “security” assurance case for asset risk management and “safety” assurance case for patient safety and implications between security risks and safety risks.

Moderated by: Francis Blacha, Eli Lilly

5:00 PM - 5:45 PM

Travel to Paul Brown Stadium

1 Paul Brown Stadium, Cincinnati, OH 45202; 513-455-4800

  • For those signed up for the Shuttle, the driver will take you directly from the Cintas Center to Paul Brown Stadium.
  • For those driving, directions to a reserved parking lot will be available at the Cintas Center.

1 Paul Brown Stadium, Cincinnati, OH 45202

(513) 455-4800
5:45 PM - 8:15 PM

MedCon 2016 Reception, Dinner, & Keynote Address

The evening event will be held at Paul Brown Stadium, Home of the Cincinnati Bengals.

Congressman Erik Paulsen is a member of the U.S. House of Representatives Ways & Means Committee, which has jurisdiction over health care, economic and trade policy and is the chief tax writing committee in the House. Congressman Paulsen serves as co-chair of the House Medical Technology Caucus and is a leader in advocating for the medical technology industry, the life-saving technologies it provides to patients, and the hundreds of thousands of jobs it supports.


May 6, 2016

Time Description
8:30 AM - 9:15 AM

What to Expect with FDA’s Program Alignment?

In 2016-2017, the FDA plans to implement its Program Alignment initiative.  Due to the increased complexity and globalization of medical products, innovation, and legislative changes, the Agency is transforming its operations to best achieve its mission-critical objectives.  Understand what to expect as the FDA centers and districts align on the roll-out and implementation of this new program.

Moderated by: Steve Niedelman, King & Spalding LLP


9:15 AM - 11:35 AM

Investigator Insights (Breaking News)

Every year at MedCon, FDA announces the enforcement data from the previous year and shares insights on inspection trends observed.  The FDA sends veteran device investigators to “tell it like it is” from their perspective. Use this friendly forum to prepare today for tomorrow (This session includes a 20 minute break).

Moderated by: Monica Wilkins, Abbott

11:35 AM - 12:05 PM

Action Plan and Conference Close-out

Participants will turn the top priorities they have captured on their “Act – Change – Transfer” forms into Action Plans.

12:05 PM

Pick-up Pre-ordered Box Lunch

Pick-up your pre-ordered boxed lunch and take the opportunity stay in the conference center and continue networking with your colleagues.

For those of you who have to catch a flight or drive home, this is a great way to make sure you get a good meal to start your journey.

12:20 PM

Shuttle Departure

Shuttle departs Xavier for Cincinnati Airport (CVG) and Hilton Cincinnati Netherland Plaza Hotel.