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2014 Agenda - PP Presentations
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Symposium Agenda (with Linked Presentations)


10:00 – 1:00 Registration/Exhibitor Set-up
1:00 – 1:15 Welcome & Introductory Remarks
Geary Havran, Chairman, Florida Medical Manufacturers Consortium
Jim Jones, Chair, FMMC Symposium Committee
1:15 – 1:30 The State of the FMMC
1:30 – 2:45 New Trends in Medical Device Development
This panel session will explore the new business models and technologies for developing and manufacturing medical devices,
such as the use of 3D printing/additive manufacturing and novel outsourcing arrangements.
Dr. Stuart Hart, Medical Director, Tampa Bay Research and Innovation Center (TBRIC), CAMLS, University of South Florida
Peter Arneson, Senior Product Manager, Cooper Surgical
Christopher H. Delporte, Editorial Director, Medical Devices, Rodman Media and MPO Magazine (moderator)
2:45 – 3:15 Refreshment Break with Exhibitors
3:15 – 4:15 Washington Review: Comprehensive Update on Issues
Facing the Medical Device Industry
Get a fresh update on Congressional and agency action impacting the industry, including efforts and strategies to repeal
the Medical Device Excise Tax, updates on recent CDRH guidance and rulemaking, and pending legislation to again change the U.S. patent system.
4:15 – 5:15 Keynote Speaker:  A Florida Success Story
Florida-based New Wave Surgical — newIy acquired by Covidien —  
manufactures a device that keeps laparoscopic and robotic lenses heated, 
defogged and clean during surgical procedures. New Wave’s founder and 
(former) president, Alex Gomez, will share his rigorous and inspirational 
journey of developing and commercialization his device, and building a 
Florida company that was twice listed among Inc.'s 500 fastest growing companies,
and ultimately acquired by a global healthcare company.  
5:15 – 8:30 Opening Night Reception & Exhibit Hall Grand Opening
Cocktails, Hors d'oeuvres, Networking, Exhibits and Live Music
8:00 – 9:00 Full Breakfast Buffet in Exhibit Hall
9:00 – 10:00 Sterilization of Medical Devices (Panel)
Representatives from Sterigenics, International Sterilization Laboratory (ISL), and Synergy Health to discuss the various technologies
and issues surrounding the sterilization of medical devices.
Jim Carnall, Vice President & COO, Command Medical Products, Inc. (moderator)
10:00 –10:45   Keynote Speaker
Develop and Implement a Strategic Plan that Drives Action and Accountability
Learn how a one-page strategic plan can lead an organization to work together to become a high-performing, goal-oriented team.
10:45 – 11:15 Refreshment Break
11:15 – 12:15 International Regulatory Updates: Asia & Japan
This session will cover basic strategic consideration for all Asian markets, including market characteristics, overview of the regulatory process, device
classification scheme, quality systems requirements, in-country representative requirements, length and cost of regulatory process, and FDA regulation
of the importation of medical devices from Asia.  The session will also provide more in-depth analyses of the Japan, China and South Korean markets.
12:15 – 1:30    Keynote Luncheon
1:30 – 2:30     Human Factors Engineering for Medical Devices
This session will review the history of HFE-related regulations and standards worldwide, and will share a practical
view of how various types of companies have responded to the imperative to perform HFE when developing
a medical device. Mr. Wiklund will also share lessons learned on how to approach HFE work in a manner that
accelerates rather than slows the process of bringing products to market
2:30 – 3:30     Fueling the Fire of Kaizen throughout the Lean Enterprise
Kaizen can be like a spreading virus from the inside out when people are engaged and see the results.
A culture of continuous improvement is contagious and sustainable if deployed correctly and this presentation will define ways of eliminating waste through
Kaizen Events that are fun, structured and repeatable. The focus of manufacturing today is the continuous improvement of Safety, Quality, Productivity, Delivery,
Morale, Cost and Inventory. The presentation will show exactly how you can address these focal points by using lean tools, creative employee thinking and
a defined Kaizen structure. 
3:30 – 3:40 Closing Remarks & Adjournment
Geary Havran, Chairman, Florida Medical Manufacturers Consortium
3:40 - 5:00     Exhibit Hall Breakdown
9:00am - 5:00pm     Human Factors Enginering (HFE) for Medical Devices - Workshop
This is a full-day workshop led by Michael Wiklund, General Manager of UL's Human Factors Engineering (HFE) practice.
(Workshop will be held in the Van Gogh Room. Continental breakfast and lunch included.)


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