Chairman's Message

The New Year is beginning with a seemingly never ending barrage of news reports telling of the economic gloom and doom enveloping the domestic and international economies.  Fortunately for most of the medical device industry the business forecasts and performance are much better.

On the other hand challenging budget circumstances at both the state and federal levels of government, as well as the change in administrations at the national level, raise issues of concern to the medical device industry.  Recent actions at the state level such as the Massachusetts legislation limiting gifts to healthcare providers and requiring disclosure of payment to physicians, as well as proposed legislation at the federal level regarding disclosures of payments to physicians will burden the industry with additional regulations and potential conflicts between state and federal rules as well as a potential myriad of inconsistent state regulations.  The challenge of bringing healthcare expenditures under control is sure to affect the industry as well.

The FMMC through its relationships with other organizations will continue to monitor these activities.  At the Florida level, the FMMC will work to provide our positions to the legislature and monitor its activities relevant to our industry.  During the legislative session, the FMMC will issue "Members Only" special reports to provide current information of value to our members.

Here's looking forward to a healthy, safe, and prosperous 2009!

Geary A. Havran

FMMC Chairman

 January Executive Briefing

Tuesday, January 20, 2009

FMMC Executive Briefing/Breakfast

The Potential Power of Florida's First Polytechnic 

Special Guest Speaker: Dr. Marshall Goodman, Campus Executive Officer, University of

South Florida - Lakeland 

Dr. Marshall Goodman will provide an overview of the polytechnic model, its implementation by the University of South Florida, and its relevance to Florida's economic development prospects. In the process of providing this overview, the CEO of Florida's first public polytechnic explains what a polytechnic is and why it matters to students, parents and Florida businesses. The world is changing, and this presentation provides insight into how those changes impact higher education in the United States.

Feather Sound Country Club
2201 Feather Sound Drive 
Clearwater, FL 33762

Ballroom A

7:30 am - 8:00 am - Registration and Networking
8:00 am - 9:00 am - Breakfast and Presentation

For more information please click www.FlaMedMfg.org.

For directions to Feather Sound Country Club click www.feathersoundcc.com.

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Sponsorships Available
 
FMMC Executive Briefing/Breakfast Sponsorships and 2009 Florida Medical Device Symposium Sponsorships are available to member companies. Both of these sponsorships afford FMMC member organizations an opportunity to support FMMC, facilitate networking, and educate the Florida Device Industry about your company's products and services.

For more information on sponsorships or for information about joining and becoming a member of the Florida Medical Manufacturers' Consortium please contact Lisa Kamper at 866-437-6534 or info@FlaMedMfg.org.

Florida Medical Device Symposium

An Annual Event Presented by Florida Medical Manufacturers' Consortium, Inc.
 
April 7-8, 2009

Florida's premier event for medical device companies includes presentations by nationally recognized speakers, industry panel discussions on regulatory issues and outsourcing, legislative updates and networking opportunities.

Be sure to mark your calendar and reserve your room as this is an event you will not want to miss! FMMC is excited to bring you exemplary educational sessions, dedicated networking time, and vendor displays!

Hotel Reservations

To make a reservation, call Marriott Tampa Waterside Hotel & Marina at 800-228-9290 and request a room for the Florida Medical Device Symposium to receive the special room rate of $199.00.  To receive this special rate, reservations must be made by Friday, March 13, 2009. 

For more information on the Symposium click www.FlaMedMfg.org/upcomingevents.cfm.

Click here to visit Marriott Tampa Waterside Hotel & Marina.

Membership News 

NDH Medical, Inc. has recently expanded its manufacturing operations to accommodate existing and planned sales growth.  With over double the space, and the addition of new extrusion capacity, the firm is now able to supply tubing in sizes up to 1 inch in diameter in a wide array of medical grade polymers.  Additional value added manufacturing steps, such as tip forming, printing, assembly, insert molding, and packaging are available to meet turnkey outsourcing requirements.

Capitol Notes 

by John Ray 

Beginning in March, with the opening of the 2009 Session of the Florida Legislature, FMMC members will receive a succint weekly report with developments and analysis on legislative issues and outcomes that are important to Florida's medical manufacturers.
 

Cabinet Passes Temporary Fix to Tax Glitch
On December 9th, the Florida Cabinet approved an emergency rule to insulate businesses from inadvertent changes in the state tax code made earlier this year in response to federal stimulus legislation. As reported last month, without this emergency rule and the enactment of a permanent statutory solution next year, businesses that take advantage of an accelerated federal depreciation schedule could permanently lose 50 percent of their allowable state depreciation deductions. The emergency rule was necessary at this juncture because Florida businesses must make depreciation decisions by the end of the calendar year.  Legislative leaders have pledged to craft a permanent fix no later than the 2009 Regular Session which ends in May 2009.
 
Special Session Called to Address Budget Deficit
Leaders of the Florida Legislature convened in Special Session this week to address the estimated $2.3 billion state budget shortfall.  Initial drafts of the budget bills reveal significant cuts in all State programs.  A full report on the outcomes of the 2009A Special Session of the florida Legislature will be available to FMMC members next week.  The special session is scheduled to conclude by January 16th, if not earlier.  The Regular Session of the 2009 Legislature begins on March 3, 2009.
 
Governor Crist Unveils Economic Stimulus Plan
This week Governor Crist and the Florida Legislature unveiled legislation to create a $10 million small business loan program to encourage job creation.The program would provide low-interest loans (2%) for up to 4 years, with a maximum loan of $250,000 per applicant.  An eligible applicant must be a business that: 

• is for-profit, privately held, investment grade;
• employs between 10 and 99 employees;
• has been in existence in the state for at least   two years;
• generates between $1 million and $50 million in annual revenue;
• is within one of the state's targeted industries (this includes all manufacturing); and
• has exhibited a ten percent or greater rate of employment growth in the past two years.

FDA Law Blog

AdvaMed Releases Revised "Code on Ethics on Interactions with Health Care Professionals" that is More Restrictive than Prior Version and Mirrors Revised PhRMA Code in Many Respects; HPM Issues Summary Memorandum

By Jeffrey N. Wasserstein, Michelle L. Butler, and Jamie K. Wolszon -

On December 18, 2008, the Advanced Medical Technology Association ("AdvaMed") announced the release of a newly revised version of the "Code on Ethics on Interactions with Healthcare Professionals," which is a voluntary code focusing on the industry's interactions with healthcare professionals as they relate to the marketing of products.  The revised Code will take effect on July 1, 2009.  The "updated and more rigorous Code of Ethics reflects the medical technology industry's ongoing commitment to openness, transparency and high ethical standards," AdvaMed chairman Michael Mussallem, chairman and CEO of Edwards LifeSciences, stated in a press release.
The revised Code is more restrictive than the 2005 version of the Code.  The revised Code also includes some of the new restrictions incorporated in the recently revised Pharmaceutical Research and Manufacturers of America ("PhRMA") "Code on Interactions with Healthcare Professionals" (see our previous post) including a prohibition on the distribution of promotional non-educational items (e.g., pens adorned with a company or product logo), and a complete prohibition on entertainment and recreational activities. 

more...

 
Reprinted with the permission of Hyman, Phelps & McNamara, P.C.

Other Events & News

2009 FMMC Calendar of Events
 
Mark your calendar!
 
Executive Briefing Dates
 
Tuesday, January 20, 2009
Tuesday, March 17, 2009
Tuesday, May 19, 2009
Tuesday, September 15, 2009
Tuesday, November 17, 2009
 
Feather Sound Country Club - Clearwater, Florida
7:30 am - 8:00 am - Registration and Networking

8:00 am - 9:00 am - Breakfast and Presentation
 
 
 
Log-on to www.FlaMedMfg.org or email meetings@FlaMedMfg.org for more information.