Chairman's Message 

The medical device industry is facing a number of challenges led by the economic turmoil and a slew of new regulatory and legislative proposals.  Gov. Bob Martinez addressed a group of FMMC members and guests on November 18th to offer suggestions and insights into the likely changes that will face our industry.

On the federal level, the GAO is releasing a report on the 510(k) process which is expected to provide the rationale for an increase in the requirements needed to bring products to market.  The new administration has promised significant changes to the healthcare system which will create challenges and opportunities for medical device companies.

Recent events in Florida will likely result in increased costs to many of the firms producing medical devices in the state.  A few of those items are reviewed in the Capitol Notes section of this newsletter.

The FMMC will continue to monitor the events that affect medical device companies and to advocate on behalf of our members.  Your input and participation is vital to the success of our efforts.

And finally, on behalf of the Board of Directors and the staff of FMMC we wish everyone a safe and enjoyable Thanksgiving holiday.

Geary A. Havran

FMMC Chairman

 January Executive Briefing

Tuesday, January 20, 2009

FMMC Executive Briefing/Breakfast

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.

 Ballroom A

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 Heather Erato 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 

ISL Joins FMMC
 
International Sterilization Laboratory (ISL) of Groveland, Florida, has joined the FMMC as a new member. ISL specializes in EtO sterilization, and is the only contract EtO sterilizer in the State of Florida. ISL uses its unique chemical technology to sterilize medical products and medical devices. The company has multiple sterilization chambers and provides expertise in validation runs and pilot runs. ISL is FDA registered and ISO 13485 certified.

With a central location and outstanding quality and customer service, ISL is committed to continue to be the leading choice of device manufacturers requiring EtO sterilization in Florida. For more information, visit ISL at their website, www.ISL-Fl.com or contact John Pellegrino at 941-379-0300 ext. 1124.

Underwriters Laboratories Inc. ® (UL) has joined the FMMC as a new member.  UL is an independent product safety certification organization that has been writing Standards for Safety, testing products and involved in conformity assessment for well over a century. UL evaluates more than 19,000 types of products, components, materials and systems annually with 21 billion UL Marks appearing on 71,000 manufacturers' products in the global marketplace each year. UL has also issued nearly 9,000 registrations to management system standards and has performed over 12,000 assessments in 62 countries. UL's worldwide family of companies and network of service providers includes 66 laboratory, testing and certification facilities serving customers with business operations on six continents.

Underwriters Laboratories Health Sciences is a leading provider of end-to-end regulatory, certification, and registration services for the medical industry. Through our portfolio of global accreditations, our customers have access to all the major medical device markets. Our services include: FDA 510(k) third-party reviews for the U.S., MDD / IVDD Notified Body certification for Europe, CB scheme certification, INMETRO certification for Brazil, PAL third party for Japan, risk management registration to ISO 14971, and UL is a CMDCAS recognized registrar for Canada . As a recognized third party for the major medical market public health organizations, UL Health Sciences can facilitate the timing and predictability of your product launch so you have market access to multiple countries with one set of tests, one quality system audit, and one company evaluating conformance of your technical file. For more information, visit www.ul.com/medical. 

Capitol Notes 

Workers' Comp Rate Hikes On The Horizon 

As reported and predicted in last month's edition, the Florida Supreme Court's recent reinstatement of hourly attorney fees (Murray v. Mariners Health/ACE USA) within Florida's workers' compensation system has quickly led to a reversal of six straight years of significant reductions in workers' comp premiums.   Since the enactment of major legislative reforms in 2003, Florida employers have witnessed a 60 percent reduction in average workers' compensation rates.  But this week, the rate-setting National Council on Compensation Insurance (NCCI), which originally proposed a rate reduction (18.6%) which will become effective January 1st, recommended an 18.6% increase in premiums (beginning March 2009) in response to the Florida Supreme Court's reversal of the cost containment feature capping attorney's fees. The new rates are subject to approval by Insurance Commissioner Kevin McCarty, who has set a public hearing for Dec. 16th.  The Florida Legislature will certainly seek a remedy to this situation during the next legislative session, and the FMMC intends to offer its support to a coalition of united business organizations seeking a legislative solution to this critical business climate issue.
 
 
"Tax Glich" Fix Proposed 

FDA Law Blog

By Jeffrey N. Wasserstein & William T. Koustas -

On November 12, 2008, Senate Finance Committee Chairman Max Baucus released a white paper detailing what he sees as the substantial problems in our health care system.  The paper, titled "Call to Action: Health Reform 2009" ("the Baucus Plan") details the Chairman's concerns about the state of our nation's current health care system as well as possible solutions.

Chairman Baucus divides his plan into three sections:

(1) Increasing access to affordable health care by placing some responsibility on individuals, increasing existing government health care programs such as CHIP, strengthening the employer-based system, creating a Health Insurance Exchange for families and small businesses, increasing access to preventative care and address health care disparities in minority or immigrant communities

(2) Improving the value of health care by reforming how that care is delivered to patients by using Federal reimbursement systems to improve the value placed on the role of the primary care provider, focusing payment incentives on the quality of care and not the quantity, modifying payment systems to encourage collaboration and accountability and improving the health care "infrastructure" by using health information technology and new research to determine which treatments work best

(3) Making the health care system use the money it receives more efficiently by eliminating waste, fraud and abuse, providing greater transparency in the health care system, reforming medical malpractice to reduce costs and spending, eliminating overpayments to private insurance providers in Medicare Advantage program, reforming long-term care and implementing tax incentives to promote the use of health care services directly by the consumer. more...
 
Reprinted with the permission of Hyman, Phelps & McNamara, P.C.

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