MedCon 2015 Program & Agenda


Key Outcomes for the Conference

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 5, 2015

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 6, 2015

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

Update from FDA’s Office of Combination Products

The universe of combination products continues to expand, with development of increasingly sophisticated drug delivery systems and companion diagnostics. Join us in this timely session as we hear directly from OCP leadership on key FDA initiatives, the current regulatory environment for combination products, and what to expect from OCP in 2015 and beyond.  In addition to this presentation, when registering, MedCon attendees can sign up for individualized discussions with Thinh Nguyen and John (Barr) Weiner to address specific questions related to OCP and combination products.

Moderated by: Steve Binion, BD

9:45 AM - 10:05 AM


10:05 AM - 10:50 AM

Center Director Corner: Strategic Priorities for 2015 and Beyond

Dr. Jeff Shuren, Director of the Center for Devices and Radiological Health (CDRH) will share his views on the importance of  protecting the public health and the collaborative activities shared with industry on the balance of safety, efficacy, quality, access and innovation (Dr. Shuren is presenting remotely).

Moderated by: Steve Niedelman, King & Spalding

10:50 AM - 11:35 AM

Office of Compliance Strategic Priorities

Acting Office Director, Jan Welch will outline the top priorities for CDRH Office of Compliance,  the newest Case for Quality Initiatives, and other emerging issues. Learn how these priorities can impact you.

Moderated by: Gina Brackett, FDA

11:35 AM - 1:05 PM

Lunch Networking by Topic

Engage with your colleagues from across the Industry on topics that are important to you.

1:05 PM - 3:40 PM Track 1

Advancements in Medical Device Software Technology

Attendees of this session will hear from a panel of experts on this hot and evolving topic, including discussion of the following:

  • Mobile Medical Apps (MMA)
  • Software as a Medical Device (SaMD)

Moderated by: Barbara Fant, Clinical Research Consultants

1:05 PM - 2:35 PM Track 2

Understanding & Preparing for the Revision of ISO13485

How well do you understand the future direction and structure of ISO13485?  In this session a diverse panel will provide a global perspective and help you understand how the standard has evolved to address QMS and Regulatory Requirements.  This includes increased emphasis on:  Product Lifecycle, Post-Market Activities,  Impact on Suppliers and Risk Management.  The future relationship with ISO9001 will be discussed.

Moderated by: Paul Brooks, BSI

2:35 PM - 3:40 PM Track 2

UDI – Implementation “Ain’t” Easy

Now that the first compliance wave is complete, what have we learned about the difficulties related to UDI Implementation? Has use of DUNS Number helped or hindered? How has the database software modified the regulation? What do you do when your UPC code doesn’t fit the new form?  How about those conforming amendments, are we ready for MDR reports, recall reports, Annual Reports?  Hear from experts before Wave 2 and 3 hit.

Moderated by: Dennis Hahn, Ethicon

3:40 PM - 4:00 PM


4:00 PM - 5:00 PM

Addressing 483 Observations: What to Do and How to Do It

Join your colleagues and reflect upon the challenges in understanding, addressing, and responding appropriately to FDA 483 observations.  Hear results from a preconference survey, participate in a small group discussion and learn form an expert panel.

Moderated by: Nancy Singer, Compliance Alliance

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 7, 2015

Time Description
8:30 AM - 9:30 AM

EU Medical Device/IVD Regulation Review

Update on progress and timetable regarding the revised European regulations for medical devices and in vitro diagnostics, insights regarding practical implementation issues, impact on conformity assessment, revision of technical documentation, reclassification of devices and continuity of EU market access. Also learn the latest experiences gained with unannounced visits under EU requirements.

Moderated by: Francis Blacha, Eli Lilly

9:30 AM - 10:15 AM

Understanding the Current Activities of the International Medical Device Regulators Forum (IMDRF)

Kim Trautman, FDA’s Associate Director of International Affairs, will provide a general overview of IMDRF and its accomplishments. She will describe the IMDRF Medical Device Single Audit Program (MDSAP) and how the pilot, which started January of 2014, applies to you.

Moderated by: Karen Coleman, IHL Consulting Group

10:15 AM - 10:35 AM


10:35 AM - 11:20 PM

Update from the Office of Device Evaluation

Recent changes in the law, combined with the release of numerous guidance documents significantly impact premarket review.  Office of Device Evaluation (ODE) leadership will provide recent ODE performance data and share insights into the regulatory challenges in reaching the US market.  Attendees will hear about recent ODE activities and significant accomplishments that impact all premarket review programs.

Moderated by: Phil Phillips, Phillips Consulting Group

11:20 AM - 12:35 PM

Living Life at Performance Level

This patient-centric, leadership focused session will inspire participants to live their lives at a higher level of performance.  This nationally-recognized keynote transforms organizations by inspiring individuals to live their lives at a higher level of performance. Inspired by Curtis’ 25 years in the entertainment industry, Living Life at Performance Level is a dynamic, experiential program that hands participants the tools to ignite their ultimate potential. Curtis guides participants to lead with transparency and authenticity, to fail successfully, to take risks, to make character-driven decisions, and to create a life of accountability.

Moderated by: Marla Phillips, Xavier Health

12:35 PM - 1:50 PM


1:50 PM - 5:00 PM Track 1

Complaints, CAPAs, Recalls – What to Do and When

Participate in an afternoon of working through case studies relating to complaints/MDRs/Corrective and preventive actions and corrections and removals/recalls. Learn best practices from Industry experts and understand common 483 findings from FDA. (This session includes a 20 minute break).

Moderated by: Steve Niedelman, King & Spalding

1:50 PM - 2:50 PM Track 2

Regulatory Submissions – What’s New, What to Do, What Not to Do

The FDA Safety and Innovation Act has resulted in many changes that continue to affect the premarket notification 510(k) process. In addition to changes that FDA has implemented which are designed to improve the integrity and efficiency of the review process, FDA has released a number of guidances that impact the submissions process.  FDA and industry experts will provide an update on the work FDA is doing to implement the new legislative requirements and improve the overall program, including recent developments in the area of device modifications guidance, Refuse to Accept (RTA) procedures, interactive review, the presubmission process, and proposed changes to device reclassification.

Moderated by: Phil Phillips, Phillips Consulting Group

2:50 PM - 3:10 PM


3:10 PM - 4:10 PM Track 2

Increase Speed to Market with an Effective Regulatory Strategy

The rapidly changing FDA regulatory landscape has created opportunities for medical device manufacturers to increase predictability associated with reaching the US market.  To take full advantage of these opportunities, developing a comprehensive regulatory strategy is essential to achieving corporate objectives.  This session will identify opportunities that can reduce regulatory uncertainty and steps that can be taken to reach the market with greater speed and efficiency.

Moderated by: Heather Rosecrans, Greenleaf Health

4:10 PM - 5:00 PM Track 2

Improving your Chance of 510(k) Success

Refusal to Accept (RTA) notifications continue to impact over 50% of the 510(k) submissions made to FDA. This workshop will bring you up to date on current 510(k) guidances and procedures, and provide hands-on experience with this important submissions topic through interactive case studies in a session led by industry experts and FDA (Ms. Shulman is presenting remotely).

Moderated by: Heather Rosecrans, Greenleaf Health

5:00 PM - 5:45 PM

Travel to Newport Aquarium

1 Aquarium Way, Newport, KY 41071; (859) 261-7444

  • For those signed up for the Shuttle, the driver will take you directly from the Cintas Center to the Aquarium.
  • For those driving, directions to a reserved parking lot will be available at the Cintas Center.
5:45 PM - 8:15 PM

MedCon 2015 Reception, Dinner, & Keynote Address

Mr. William Kent will open the eyes of the MedCon dinner attendees as he paints a picture of the future of hospital systems and health care in America.  Through a combination of evolving government policy, rapid technological advancements, and an increase in accountability for patient outcomes, the health care experience will be different from what we know today.  In his current role as the Senior Vice President for Infrastructure and Operations at the Cincinnati Children’s Hospital Medical Center, Mr. Kent is working to help shape the future of our health care experience.  Join us for this engaging evening to become aware of the changes that will certainly impact all of us in our lives going forward.

The evening event will be held at the state-of-the-art Newport Aquarium. The Newport Aquarium was named the No. 1 aquarium in the 2012 Readers’ Choice Travel Awards from

May 8, 2015

Time Description
8:30 AM - 9:30 AM

Understanding the Regulatory Challenges in Asia

Evangeline Loh will use her on the ground experience to compare and contrast the registration requirements of countries such as China, Japan, Korea, Malaysia, and Singapore. Differences in the requirements are noteworthy and may impact how you select a distributor, assign an in-country representative or designated market authorization holder, or prepare the common technical file. The best models for market entry will be discussed.

Moderated by: Dennis Hahn, Ethicon

9:30 AM - 10:30 AM

FDA Investigator Insights–Part #1

Every year at MedCon, FDA investigators and compliance officers explain the Agency’s inspection insights. The FDA sends veteran device investigators to “tell it like it is” from their perspective. Use this friendly forum to prepare today for tomorrow.

Moderated by: Monica Wilkins, Abbott

10:30 AM - 10:50 AM


10:50 AM - 12:00 PM

FDA Investigator Insights–Part #2

Every year at MedCon, FDA investigators and compliance officers explain the Agency’s inspection insights. The FDA sends veteran device investigators to “tell it like it is” from their perspective. Use this friendly forum to prepare today for tomorrow.

Moderated by: Monica Wilkins, Abbott

12:00 PM - 12:30 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.

12:30 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.

12:45 PM

Shuttle Departure

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