MedCon 2014 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 6, 2014

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 in the 2nd floor Continental Room of this historic hotel, to reconnect with colleagues and make new connections. Light refreshments and beverages will be served.

May 7, 2014

Time Description
8:30 AM - 9:00 AM

MedCon Conference Welcoming

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 - 10:00 AM

EU Regulations: New Regulations, Company Strategy and Open Discussion

The EU device directive is being implemented by national authorities and the Notified Bodies. You want to sell in Europe? You should listen closely as the norms and policies are being transitioned. Visits may be a surprise at your European facilities, but changes in the CE Marking process should not be a surprise to those who participate in this session.

Moderated by: Monica Wilkins, Abbott

10:00 AM - 10:15 AM


10:15 AM - 11:00 AM

CDRH Update, Vision and Strategy

Dr. Jeff Shuren, Director for the Center of Devices and Radiological Health (CDRH), will discuss his strategic priorities for 2014 and beyond.  The mission of promoting and protecting public health requires mastering the balance of safety, efficacy, quality, access and innovation.  Understand the role each of us has to collaboratively identify solutions to the most pressing challenges we face for the patients we serve.

Moderated by: Steve Niedelman, King & Spalding

11:00 AM - 11:45 AM

Office of Compliance Update

There are many influences and interests that compete for the limited staff and resources of FDA’s medical device center, so it is very important to listen when the leaders of FDA’s Office of Compliance speak publicly about the implementation of their strategic priorities. Get the answers to your questions and find out the likely direction that FDA may take in the coming year.

Moderated by: Gina Brackett, FDA

11:45 AM - 1:00 PM


1:00 PM - 2:00 PM

How to Implement the Unique Device Identification Requirements

The 2012 law called FDASIA extended FDA’s authorities in ways that could toughen the bite of inspections, and require greater transparency about the source of devices to improve the quality of post-market data and reduce medical errors. The Universal Device Identifier, like a car’s VIN provides important information about the pedigree of devices. Use of UDI will improve the quality of post-market data, improve recalls and enable firms to better trend information about how their devices are performing in the market. Implementing UDI presents great logistical challenges and depending on the device, may present more than a few alternative ways to accomplish the necessary identification steps. This panel will update current FDA plans for the rollout and implementation of the new UDI rule.

Moderated by: Susan Rolih, Meridian Bioscience

2:00 PM - 3:00 PM

Managing Scientific and Regulatory Disagreement

Understand the means by which disagreements encountered in the regulatory environment can be effectively resolved. Case studies will illustrate what means are most appropriate given particular circumstances.

  • What decisions are eligible for appeal?
  • Is there a time to just accept an improper FDA decision and its consequences?
  • When is it appropriate to request supervisory review and what elements of a request are essential to achieving a fair outcome?

Moderated by: Phil Phillips, Phillips Consulting Group, LLC.

3:00 PM - 3:15 PM


3:15 PM - 5:00 PM Track 1

Operationalizing Post-Market Surveillance

Effective management of the Total Product Lifecycle of your product requires a robust Post-Market Surveillance system that works. Explore with the experts how to build product intelligence with inputs from adverse events, complaints, corrections, removals, recalls, health hazard evaluations, corrective fixes, and servicing.

Moderated by: Steve Niedelman, King & Spalding

3:15 PM - 4:15 PM Track 2

FDA Regulation of Health Information Technology: Medical Apps, Cybersecurity, and “the Cloud”

Health information technology rapidly evolves and challenges all regulatory authorities’ ability to keep pace. Attendees of this session will hear from a panel of experts on the latest developments relating to FDA regulation of this exciting field.

  • What are FDA’s expectations for the future?
  • How has FDA’s new guidance on medical apps affected industry?
  • When is FDA regulation of health information technology in a company’s best interest?

Moderated by: Barbara Fant, Clinical Research Consultants

4:15 PM - 5:00 PM Track 2

Understanding Changes to Patient Labeling Requirements

Patient labeling is critical to the safe use, administration and effectiveness of your medical device. What are the evolving FDA criteria for the studies needed to support what is stated on the label? Explore labeling comprehension studies, when they are needed, and how are they designed. Understand FDA expectations of your products during development, instead of finding out that your application is declined.

Moderated by: Lenore Faulhaber, Procter & Gamble

5:00 PM - 6:45 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.

May 8, 2014

Time Description
8:30 AM - 10:00 AM

Changing Perceptions–Moving from a Necessary Evil to a Strategic Partner

Getting recognized as a strategic partner rather than a necessary evil is an ongoing challenge for regulatory and quality professionals. An analysis of a pre-meeting survey will reveal how business partners view RA and QA functions. Gain insight to tools that other RA and QA professionals have used to gain recognition as strategic contributors. Survey results, panel discussions, and case studies will provide examples of tactics that worked in transforming the perception of the value of RA and QA.

Moderated by: Nancy Singer, Compliance Alliance

10:00 AM - 10:15 AM


10:15 AM - 11:15 AM

What to expect in 2014 with Combination Products

2013-14 has seen significant growth in personalized medicine, with continued development of increasingly sophisticated drug delivery systems and companion diagnostics. In parallel, FDA has published several guidances on product development, and the cGMPs for combination products became final in July of 2013. As industry focus on this increasingly challenging area increases, it is critical for device and drug manufacturers to understand what FDA’s Office of Combination Products is doing, and how to work with OCP. 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 2014 and beyond.

Moderated by: Steve Binion, Becton Dickinson

11:15 AM - 12:00 PM

Updates from ODE Leadership

FDA Leadership form the Office of Device Evaluation will share their top priorities and strategic direction, as well as anticipated challenges.

Moderated by: Heather Rosecrans, Greenleaf Health, LLC.

12:00 PM - 1:00 PM


1:00 PM - 2:00 PM Track 1

Implementing Effective Risk Management Programs

You have heard of risk management-now how can you apply it? What does “as low as reasonably possible” mean in actual practice? You will share in the discussion to formulate examples of risk information, and how multiple types of risk can be addressed throughout a company’s internal processes almost on a daily basis. What level of potential harm could cause us to recall? What level of uncertainty holds us back from making the decision to report a possible risk? Learn about the importance of implementing an effective risk management program and applying it wisely.

Moderated by: Steve Neidelman, King & Spalding

2:00 PM - 3:00 PM Track 1

Inspection Readiness-Industry’s Got Talent

Join us for a reenactment of America’s Got Talent featuring Quality, Regulatory, Internal Audit professionals and FDA as they showcase a standout approach to FDA inspection readiness. Come cast your vote via electronic ballot as the talented professionals ready their way to inspection success. Complete your game show experience with parting gifts for the audience.

Moderated by: Kathie Bardwell, Steris

1:00 PM - 2:00 PM Track 2

Increasing the Integrity and Efficiency of the 510(K) Process

The FDA Safety and Innovation Act has resulted in many changes that affect the premarket notification 510(k) process. In addition, FDA has implemented several changes to the program designed to increase the integrity and efficiency of the review 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 the modifications guidance, Refuse to Accept (RTA) procedures, interactive review, effective use of “pre-subs”, and update on exemptions and current thinking on the limitations of the exemptions. Learn where the FDA is headed so your organization can be prepared.

Moderated by: Ralph Hall, Faegre Baker Daniels

2:00 PM - 3:00 PM Track 2

Combination Products Working Session

Participants in this breakout session will have the opportunity to work through case studies that will highlight some of the ongoing challenges associated with combination products involving various device technologies.  The case studies will combine aspects of product development, manufacturing, and postmarket compliance in a highly interactive session that will give participants real time feedback from OCP staff and industry experts. The emphasis will be on ‘what works and what doesn’t’ for manufacturers who want to work successfully with FDA to bring combination products to market, and to meet cGMP requirements under the Final rule that became effective in July 2013.

Moderated by: Steve Binion, Becton Dickinson

3:00 PM - 3:15 PM


3:15 PM - 4:15 PM Track 1

Impact of the Changes to the FDA Biocompatibility Guidance

As the rules for biocompatibility studies are changing, learn how to set-up your organization for successful product approvals. In this session, industry and FDA speakers will explore the impact of the changes linked to the FDA Biocompatibility Guidance, and will discuss product development and design change impact.

Moderated by: Lenore Faulhaber, Procter & Gamble

4:15 PM - 5:00 PM Track 1

Successfully Navigating the Pre-Sub Process

The submission of a device application is often a time of uncertainty and anxiety. The PreSub Program offers Industry a mechanism to gain FDA feedback prior to making an IDE or marketing application. Learn from industry experts how to navigate this process proactively with confidence. When is it appropriate to use this process, what data is needed, when do you need to meet with FDA, who makes decisions? Set your organization up for success with the process.

Moderated by: Karen Coleman, IHL Consulting Group

3:15 PM - 5:00 PM Track 2

Purchasing Controls – “How to”

This dynamic session will begin with FDA inspection trends related to purchasing controls.  Industry leaders will then work with the audience to demonstrate unexpected sources of dysfunction that will enable companies to focus their efforts in the right places.  “How to” presentations will explore how to implement an effective corporate audit strategy, and will end with industry-wide efforts to establish industry managed critical manufacturing process capability assessments.

Moderated by: Gina Brackett, FDA

5:00 PM - 5:45 PM

Travel to Great American Ball Park • 100 Joe Nuxhall Way, Cincinnati, OH 45202

  • For those signed up for the Shuttle, the driver will take you directly from the Cintas Center to the event.
  • For those driving, directions to a reserved parking lot will be posted in the near future.

** Dinner seating is limited.  Sign up today for this exclusive event **

5:45 PM - 8:15 PM

Reception, Dinner & Keynote Address

Join us as Dr. Thomas Fogarty, internationally recognized cardiovascular surgeon, inventor and entrepreneur provides insight on how to balance speed of innovation with patients in mind and how to balance speed of innovation with patients in mind and how driving meaningful innovation results in business success.

The evening event will be held at Great American Ball Park, the home of the Cincinnati Reds, baseball’s first professional franchise.  Our reception will be held in the Champions Club, which offers spectacular views.

If you want to explore the stadium, we will be offering a walking tour so you can get a behind-the-scenes look at the ball park, including areas such as the dugout and press box.

May 9, 2014

Time Description
8:30 AM - 9:30 AM

Strategic Thinking on Access in China

What are the distinct requirements your company needs to know for access in China? This program focuses on the entry of US device firms into the medical market within China; and once there, how to operate. The unique governmental layers and divergent expectations among national and provincial regulators are worthy of attention. The best model for entry and how the CFDA is really different from SFDA will be shared.

Moderated by: Dennis Hahn, Ethicon Endo-Surgery

9:30 AM - 10:30 AM

Understanding and Addressing the Challenges of Import

Industry and FDA leaders will explore areas of Import operations that are challenging for companies to strategically navigate. Who are the players? How do I manage Import Detention, and how do I handle when pro codes and the device listing don’t match? What is an Affirmation Code, and when do I use the Import for Export Provisions? Navigate the challenges, and position your organization for success.

Moderated by: Gina Brackett, FDA

10:30 AM - 10:45 AM


10:45 AM - 12:15 PM

FDA Investigator Insights

A panel of FDA officials from the Cincinnati District will share their insight on FDA inspections.  This session will begin with a presentation of the CDRH 2013 Medical Device Quality System Data, including top Warning Letter and FDA-483 Quality System Regulation (21 CFR Part 820) observation cites.  The panel members will then answer pre-submitted questions and new questions as they work to address the challenges and concerns of the attendees.

Moderated by: Monica Wilkins, Abbott

12:15 PM - 12:30 PM

Action Plan Writing

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

Moderated by: Marla Phillips, Xavier Health

12:30 PM - 12:45 PM

Conference Close-out

12:45 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.

1:00 PM

Shuttle Departure

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