MedCon 2017 Program & Agenda

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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

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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

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Time Description
7:45 AM - 8:30 AM

Join us for Breakfast

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

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

Speakers:

9:45 AM - 10:05 AM

Break

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.  Dr. Shuren will be presenting remotely via video, and questions can be asked by participants via video for a face-to-face interaction with Dr. Shuren.

Moderator: James O’Reilly

Speakers:

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

Speakers:

11:35 AM - 12:30 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:

  • Premarket Review Process
  • 510(k) Modifications – When to Submit
  • Purchasing Controls
  • Case for Quality Metrics
12:30 PM - 12:35 PM

Conference Day 1 Milestone: Your Learning put into Action

Speakers:

12:35 PM - 1:20 PM

Update from the Office of Device Evaluation.

Angela Krueger, Acting Deputy Director for Engineering and Science Review in the Office of Device Evaluation, will summarize ODE accomplishments and activities, as well as discuss the recent guidance documents that significantly impact the premarket review process.

Moderator: Phil Phillips

Speakers:

1:20 PM - 2:05 PM

FDA Insight on the 510(k) Modifications Guidance.

FDA will provide an overview and insight on 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

Speakers:

2:05 PM - 2:25 PM

Break

2:25 PM - 5:00 PM Track 1

510(k) Modifications : To submit or not to submit?

A panel composed of FDA and industry experts will address 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

5:45 PM - 8:30 PM

Keynote Dinner

Recognizing that so many of us are impacted and challenged by a world of constant change, Keynote Speaker Joe Sapiente (Vice President of Hologic; former Vice President of Medtronic) will paint a different picture for our dinner guests – a picture of opportunity and growth.  Joe will share insights he has gained throughout his career journey that will help you focus on, and appreciate, the value of every experience you have.  This keynote address is a refreshing reminder of what is important in life.

Don’t miss this opportunity to join your colleagues for a relaxing evening and enlightening keynote dinner at Anderson Pavilion (Smale Park) along the Ohio River.

We will have directions to the pavilion available for you at the conference, as well as a complimentary parking pass for all those who are driving.

Speakers:

May 4, 2017

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Time Description
7:45 AM - 8:30 AM

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.

8:30 AM - 8:35 AM

Conference Day 2 Milestone: Your Learning put into Action

Speakers:

8:35 AM - 9:20 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

Speakers:

9:20 AM - 10:05 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

10:05 AM - 10:20 AM

Break

10:20 AM - 11:20 AM

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

11:20 AM - 12:20 PM 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

Speakers:

11:20 AM - 12:20 PM 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

Speakers:

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
1:20 PM - 1:25 PM

Conference Day 2 Milestone: Your Learning put into Action

Speakers:

1:25 PM - 2:10 PM

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

Speakers:

2:10 PM - 3:40 PM

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

3:40 PM - 4:00 PM

Break

4:00 PM - 5:00 PM

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

5:00 PM - 7:00 PM

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.

May 5, 2017

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Time Description
7:45 AM - 8:30 AM

Join us for Breakfast

Join your colleagues from around the country as we begin the last day of MedCon 2017 with a nice complimentary warm breakfast.

8:30 AM - 8:35 AM

Conference Day 3 Milestone: Your Learning put into Action

Speakers:

8:35 AM - 9:05 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

Speakers:

9:05 AM - 9:35 AM

Meet ORA's Inaugural Ombudsmen

Jessica Zeller, JD is the newest FDA ombudsmen in a position that was created for the first time in the Office of Regulatory Affairs.  In this position, Jessica serves as an impartial voice to bring FDA and external parties toward a common understanding (often referring to herself as a translator).  This newest position is instrumental in bridging gaps that might have existed for decades, as the Office of Regulatory Affairs houses all of the investigators across the country. Jessica will share insight with participants on her new role.

Speakers:

9:35 AM - 9:55 AM

Break

9:55 AM - 11:55 AM

Investigator Insights and 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.

Moderator: Monica Wilkins

11:55 AM - 12:25 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

Speakers: