Chairman's Message

The season of giving thanks, celebrating holidays with family and friends, and looking forward to a new year is upon us.  At the FMMC we are giving thanks to all of our members and sponsors who continue to support the activities of the association.  We are concluding a year that has proven challenging to most companies, although fortunately our industry has continued to grow despite the overall economic downturn felt throughout the economy.

While we at FMMC wish everyone a very happy and healthy holiday season, we are also reminding everyone to be vigilant and involved in the activities of the government.  As is described in other sections of this newsletter, the government is very active in trying to remake the American health care system, the ramifications of which cannot be underestimated for our industry.  At the FMMC we continue to monitor the situation and to offer our suggestions to legislators to avoid the very negative impacts on the medical device industry that many have predicted.  The poor economic conditions are also having an impact on our industry in the way of higher taxes to offset declining government revenues at a time of increased government support to those adversely affected by the recession.

Please continue to offer your support and suggestions to your organization and take time to enjoy the holidays!

Geary A. Havran
FMMC Chairman

January 19th Executive Briefing

FMMC Presents Social Media Marketing
  
Social media marketing is a term that describes the use of social networks, online communities, blogs or any other online collaborative media for marketing, sales, public relations and customer service.  It includes creating buzz or newsworthy events, videos, tweets, or blog entries that attract attention. Buzz is what makes social media marketing work. It replicates a message through user to user contact, rather than the traditional method of purchasing of an ad or promoting a press release. The message does not necessarily have to be about the product. Many successful campaigns have gathered steam through an amusing or compelling message, with the company logo or tagline included incidentally.  Join us in January to learn more about what social media marketing can do for your business.

Tuesday, January 19, 2010
Feather Sound Country Club - Clearwater, Florida
 
7:30 am - 8:00 am - Onsite Registration and Networking
8:00 am - 9:00 am - Breakfast and Presentation

Click here for online registration form. 

Thank you to our November speaker, William Judge, Jr. of Bavol Judge, P.A. 
Bill's extensive business, entrepreneur and medical device background provide him with the unique ability to bring a client's business perspective to the table while simultaneously representing its interests as a litigator.  Bill's presentation provided attendees insight into the litigation process and lessons learned.  

Regulatory Issues 

Florida Unemployment Taxes set to skyrocket in 2010
Effective January 1, 2010 the unemployment tax rate for Florida employers will increase dramatically and apply to the first $8,500 in wages as opposed to the first $7,000 in wages.  Please see the fact sheet from the Florida Chamber of Commerce for additional details.

Member News 

WELCOME TO OUR NEW MEMBERS!

Endo-Therapeutics, Inc.

Endo-Therapeutics, Inc., a leading manufacturer of instruments for endoscopy, was established in 1992.  Its manufacturing and commercial offices are located in Clearwater, Florida.  ETI has private label and distribution arrangements for its products in markets around the world - US / Canada / Europe / Latin America / Asia / Australia.  Prospective international distributors can contact us at 1-727-538-9570 or at info@bioceps.com. 

Endo-Therapeutics also works with companies and inventors that require product development and manufacturing to bring new products to market.  In addition to BioCeps in the US, ETI's network of international distributors and private label partners can provide distribution alternatives for international sales of new products.  For additional information, contact ETI at docrq@bioceps.com.  

Endo-Therapeutics is ISO 13485 certified and FDA registered (Reg. No. 1056129).  Products are approved in Canada and Endo-Therapeutics has approvals to CE Mark products sold into International markets .  Endo-Therapeutics follows the strictest of industry standards to assure customers that the instruments manufactured meet the highest quality industry standards.

Toxikon Corporation 
Toxikon Corporation is an ISO 17025-accredited preclinical Contract Research Organization (CRO) that conducts safety studies for the medical device and biopharmaceutical industries.

With more than 30 years of experience, Toxikon provides testing services to meet FDA/ISO/ICH, OECD, USP and Japan's MHLW standards. Services include a complete range of PK, TK, ADME and toxicology studies, bioavailability, chemical characterization, impurities analysis and synthesis, bioanalytical and microbiology assays.

Toxikon operates a 125,000 square foot facility at their headquarters in Bedford, Massachusetts and has additional offices in the U.S., Europe and Asia. Toxikon maintains a subsidiary laboratory in Belgium to facilitate growing demands from international clients.

 
THANK YOU TO OUR RENEWING MEMBERS!
CTC Tampa Bay, Inc.
FTSI
Gray Robinson
Southern Star Engineering
USF College of Engineering 

JABIL RECEIVES FROST & SULLIVAN MARKET LEADERSHIP OF THE YEAR AWARD IN THE GLOBAL EMS MEDICAL MARKET
 
Jabil today announced that it was recently honored with the 2009 Market Leadership of the Year Award in the global electronics manufacturing services medical industry by Frost & Sullivan. The independent industry firm cited Jabil's 56 percent growth rate from 2003 to 2008 and highlighted the factors that enabled this performance when presenting the award to Jabil executives on Sep.15. The award lauded Jabil's depth of knowledge and industry experience, financial strength, lean supply chain, and nine FDA-compliant facilities manufacturing Class II and Class III devices. (More....)

To find out how you can benefit from a membership in the FMMC or to join FMMC online click
www.FlaMedMfg.org/membership.cfm.

Capitol Notes 
by John Ray 
John Ray Consulting, LLC 

This month's edition of Capitol Notes takes us to our nation's capital where the mother of all health care debates rages on.  The House of Representatives passed their health care overhaul legislation of November 7th, and the U.S. Senate began floor debate on its 2,074-page health care reform bill this month.  Like its House counterpart, the Senate bill contains major changes to the Medicaid Rebate Program, Medicaid drug reimbursement, Medicare Part D, the 340B Drug Discount Program, and the Federal Food, Drug, and Cosmetic Act, as well as new physician payment reporting requirements for drug and device companies. 

But, perhaps most worrisome to the medical device industry, both bills contain a new medical device tax to help finance health care reform.  The Senate legislation imposes an annual flat fee of $2 billion on the medical device manufacturing sector beginning in 2010. This non-deductible fee would be allocated across the industry according to market share and would not apply to companies with sales of medical devices in the U.S. of $5 million or less. The fee does not apply to any sale of a Class I product or any sale of a Class II product that is primarily sold to consumers at retail for not more than $100 per unit (under the FDA product classification system).  The House version of the device tax would impose a new excise tax on medical device manufacturers for medical devices sold for use in the United States equal to 2.5 percent of the wholesale price.  The tax would be collected at the "point of sale" by healthcare product distributors and would apply to sales beginning on January 1, 2013.  Excluded from the tax are retail sales available to the general public and exported devices.  A full summary of the Senate health care bill can be found here; the House version here.

The FMMC, in coordination with Medical Device Manufacturers Association and other industry advocates, supports efforts to eliminate this new tax or at least mitigate its impacts as the health care legislation is debated and amended.
On the state front, there is some good news and bad news to report.  Workers' compensation insurance will go down 6.8 percent in Florida next year, making Florida one of the 10 lowest-rate states in the country.  The rate decrease requested in August by the National Council on Compensation Insurance will produce savings of more than $166 million for Florida employers.  It will be the seventh consecutive decline in workers' compensation rates since the Florida Legislature passed sweeping reforms in 2003, representing a cumulative rate drop averaging 63.2 percent statewide.  

On the negative side, unemployment compensation taxes paid by all Florida businesses will increase dramatically next year due to the state's high jobless rate.  The minimum tax will jump from $8.40 per employee to $100.30 -- an almost 12-fold increase -- in 2010, according to the Department of Revenue.  The maximum will go up from $378 per employee to $459.  Taxable wages will also be increased from $7,000 to $8,500 per employee.  These automatic increases have been triggered to replenish the state's Unemployment Compensation Trust Fund which, as of August, had been drained and Florida then began borrowing $300 million a month from the federal government to pay unemployment benefits.  The Florida Legislature is currently holding hearings on this issue and exploring policy options to potentially mitigate the impacts of these increases on small business. 

FDA Law Blog

Tenth Circuit Affirms Civil Money Penalties Against Device Manufacturer and President for Failure to Submit Medical Device Reports

By JP Ellison -
Last year we posed the question "Are the Stars Lining Up for FDA Civil Penalties?"   The intervening year has not answered that question, but a recent decision from the Tenth Circuit affirming civil penalties against TMJ Implants, Inc. ("TMJI") and its founder and president Robert Christensen serves as a reminder of this FDA enforcement tool.  In last year's blog post we referred to an earlier Food and Drug Law Institute article discussing civil money penalties (CMPs) generally, and the TMJI case specifically.

At that time, the penalties had not yet been assessed in the case.  Subsequently, the administrative law judge ("ALJ") assessed CMPs totaling $170,000, which represented a $10,000 penalty for failure to submit 17 medical device reports ("MDRs").  The maximum penalty allowed by regulation for each violation was $165,000.  Yesterday, the Tenth Circuit affirmed a decision of the HHS Departmental Appeals Board ("DAB"), which had, in turn, affirmed the ALJ's decision. (more...)

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

2010 FMMC Calendar of Events

Executive Briefing Dates

Tuesday, January 19, 2010
Tuesday, March 16, 2010
 
Feather Sound Country Club - Clearwater, Florida
7:30 am - 8:00 am - Registration and Networking
8:00 am - 9:00 am - Breakfast and Presentation

4th Annual Medical Device Symposium & Trade Show

April 12 - 13, 2010
Sheraton Inn & Suites Westshore Tampa Airport
 
Log-on to www.FlaMedMfg.org or email meetings@FlaMedMfg.org for more information.