MedCon 2017 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 2, 2017

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 3, 2017

Time Description
8:30 AM - 9:00 AM

Let's Make a Difference!

Welcome to MedCon, 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.

Moderator: Marla Phillips

9:00 AM - 9:45 AM

The Solution Xchange

Start your day with solutions!  This fast paced, engaging session draws out your experience and ideas by having you work collaboratively with your colleagues to address the challenges that will be discussed throughout the conference, while tying your ideas to the hopes of a patient whose life is depending on you.

Moderator: Dennis Hahn


9:45 AM - 10:05 AM


10:05 AM - 10:50 AM

Center Director Corner: Strategic Priorities for 2017 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.

Moderator: James O’Reilly

10:50 AM - 11:35 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.

Moderator: Gina Brackett (invited)

11:35 AM - 12:35 PM

Lunch Networking by Topic

12:35 PM - 1:20 PM

Update from the Office of Device Evaluation.

New Office Director, Dr. John Sheets, will summarize ODE accomplishments and activities, as well as discuss the recent guidance documents that significantly impact the premarket review process.

Moderator: Phil Phillips

1:20 PM - 2:05 PM

510(k) Modifications Guidance Overview.

FDA will provide an overview of the August 2016 draft FDA Guidance, “Deciding When to Submit a 510(k) for a Change to an Existing Device.” Hear FDA discuss the history of the 510(k) guidance and provide  an update on the comments received to date.

Moderator: Steve Binion

2:25 PM - 5:00 PM Track 1

510(k) Modifications : To submit or not?

A panel composed of FDA and industry experts will address your case studies on device modifications: Is a 510(k) needed or not? If not, why not? What is the appropriate documentation? Learn more about your options for not submitting a 510(k), best practices for documentation, and what FDA will look for during an audit.

Moderator: Steve Binion

2:25 PM - 5:00 PM Track 2

Your contract manufacturer received a Warning Letter. What Now?

Original Equipment Manufacturers (OEM) and Contract Manufacturers (CM) will share challenges and successful practices in managing a Warning Letter given to the CM. Participants will work thorough mini-case studies on solutions for real world scenarios related to CM/OEM partnerships.  OEM will also share successful practices in evaluating and selecting CM partners, and proactively avoiding misunderstandings and issues.

Moderator: Gina Brackett (invited)

May 4, 2017

Time Description
8:30 AM - 9:15 AM

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

9:15 AM - 10:00 AM

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


10:00 AM - 10:20 AM


10:20 AM - 11:20 AM

Defending claims for your device.

Enforcement challenges against claims for your device ma 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

11:20 AM - 12:20 PM

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

12:20 PM - 1:25 PM

Lunch Networking by Topic

1:25 PM - 2:10 PM

The Impact of Quality Culture Misalignment…and the Path Forward.

Xavier University, 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 actionable.  Walk away understanding what causes cultural breakdown, and specific actions you can take today.

Moderator: Bill Brodbeck


2:10 PM - 3:40 PM

The Importance of Quality and Regulatory throughout the Merger and Acquisition Lifecycle – Landmines or Opportunities.

Regulatory and quality personnel should be involved early in the lifecycle of a merger or acquisition, but too often these groups are that last to be called into the due diligence process.  This session will give guidance to RA and QA personnel on how to ensure they are involved early in the due diligence process, what to consider during due diligence, the importance of involving corporate compliance, and how best to report findings the C suite.  An industry representative will provide their experience with preacquisition integration and evaluation, harmonization of corporate culture, quality practices, procedures and supply chains.  The session will close with a discussion of the landmines – the potential risks and costs associated with failing to do due diligence correctly.

Moderator: Steve Niedelman

3:40 PM - 4:00 PM


4:00 PM - 5:00 PM

510(k) – Who Needs One & 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

May 5, 2017

Time Description
8:30 AM - 9:30 AM

What to Expect with FDA’s Program Alignment?

In FY 2017, 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.

Moderator: Karen Coleman

9:30 AM - 9:50 AM


9:50 AM - 11:50 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).

Moderator: Monica Wilkins

11:50 AM - 12:20 PM

To Your Success.

Thank you for joining us, but we insist that you leave with action plans that will enable you to make a difference in your organization and for the patients you serve.  Work with your colleagues on turning your learning into a full action plan.

Moderator: Marla Phillips