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September 2007
LEAD STORIES

IVD Companies Face Service-Offering Conundrum  

Rosen
Rosen

Expertise and skill in managing the various aspects of the service mix can help medical device and diagnostics companies offer service programs that are just enough to differentiate them from the competition. But the balance that must be achieved is a delicate one. Service programs that offer too much may result in revenue loss for the manufacturer. Meanwhile, programs that are perceived to be inadequate place the company at a competitive disadvantage.

In this issue’s top story, author Shara Rosen, senior analyst with Kalorama Information (New York City), discusses the results of a recent survey on maintenance and service contracts in the hospital laboratory marketplace. The May 2007 survey involved clinical lab managers and directors, chosen at random, at 13 hospitals of varying size (360 to 902 beds) from across the United States. The goal was to establish a benchmark for the current status of instrumentation service contracts now held by clinical core laboratories. [More


Senate Bill Would Monitor Medtech Payments to Doctors

Grassley
Grassley
Earlier this month, U.S. Senators Charles Grassley (R–IA) and Herb Kohl (D–WI) introduced new legislation that would impose greater scrutiny over payments to doctors by medtech and pharmaceutical firms. Known as the Physician Payments Sunshine Act (S. 2029), the proposed bill would require drug and device manufacturers to file quarterly reports listing all payments and gifts to doctors with a value of $25 or more.
 
“This legislation will bring much-needed transparency to the financial relationships that exist between the drug and device industries and doctors,” said Grassley, who is the ranking Republican on the Senate Finance Committee. “Drug and device companies spend billions and billions of dollars every year marketing their products. A good amount of this money goes directly to doctors in the form of these payments.”

“Companies wouldn’t be paying this money unless it had a direct effect on the prescriptions doctors write, and the medical devices they use,” Grassley continued. “Patients, of course, are in the dark about whether their doctor is receiving this money.” [More


Changing of the Guard at Medtronic Draws Industry Attention

Hawkins
Hawkins
During the annual shareholders meeting of Medtronic Inc. (Minneapolis), on August 23, the company’s board of directors elected William A. Hawkins III to the position of president and chief executive officer, carrying out a succession plan that had been announced in February of this year. Hawkins assumes command of a leading medtech company that can lay claim to a string of technological advances and product innovations, including the development of the first cardiac pacemaker. As the largest pure-play company in the industry, Medtronic has a strong record of achievement forged over its nearly six-decade history.

While most analysts still praise Medtronic for the quality and innovation of its products, some have begun to criticize the company’s overly optimistic projections and forecasts, which have often come up short. The most frequent refrain from Wall Street is the call for company management to take actions that will boost shareholder value. [More]


 Boston Scientific Benefits as Guidant Liability Awards Diminish

If recent settlements are any indication, Boston Scientific Corp. (Natick, MA) may end up paying out significantly less in damage claims stemming from the failure of Guidant’s cardiac pacemakers and implantable cardioverter defibrillators (ICDs) than it originally thought.  

Shortly after Boston Scientific closed its $27 billion deal to acquire Guidant, in April 2006, the company reportedly set aside $331 million to settle such claims. By the end of that year, it revised the figure upward to $485 million. And according to its filing with the Securities and Exchange Commission, in May 2007 the company raised the fund further, to $732 million. So far, however, the case settlements related to Guidant liability claims have fallen far short of even the lowest amount set aside. [More]


President Bush Signs FDA Amendments Act

On September 27, President Bush signed into law the FDA Amendments Act of 2007, including provisions to reauthorize the user-fee program for medical device manufacturers. Although the legislation also includes other device-related provisions, it has gained attention mostly for its wide-ranging changes related to drug safety.

UblCommenting on passage of the act, AdvaMed president and CEO Stephen J. Ubl said, “This law is good news for every patient who depends on medical innovation. The enactment of this bipartisan legislation before the current user fee program expires on September 30 means there will be no disruption in FDA’s work to ensure that medical devices continue to meet FDA’s high standards of safety and effectiveness.”

 

IN THIS ISSUE

IVD Companies Face Service-Offering Conundrum

Senate Bill Would Monitor Medtech Payments to Doctors

Changing of the Guard at Medtronic Draws Industry Attention

Boston Scientific Benefits as Guidant Liability Awards Diminish

President Bush Signs FDA Amendments Act

INDUSTRY IN BRIEF
CALENDAR
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INDUSTRY IN BRIEF

On September 21, Alphatec Holdings Inc. (Carlsbad, CA), a medical device company focused on the surgical treatment of spine disorders, announced the pricing of its public offering of 8,800,000 shares of its common stock at a price of $3.45 per share. Canaccord Adams Inc. (Vancouver), the sole underwriter of the public offering, later exercised in full its option to purchase an additional 1,200,000 shares of common stock.

On September 20, Celera (Rockville, MD), the molecular diagnostics business unit of Applera Corp. (Norwalk, CT), and Atria Genetics Inc. (South San Francisco) announced that the companies have signed a definitive agreement under which Celera will acquire substantially all of the assets of Atria for about $33 million in cash. Atria has a line of human leukocyte antigen testing products that are used for identifying potential donors in the matching process for bone marrow transplantation. Earlier in September, Celera announced its plan to purchase cardiovascular healthcare company Berkeley HeartLab Inc. (Burlingame, CA) for about $195 million in cash.
 
FDA’s Center for Devices and Radiological Health has released its annual report for fiscal year 2006. To access the report, go to www.fda.gov/cdrh/annual/fy2006.

 

CALENDAR

October 3-4: BIOMEDevice Forum, San Jose.

October 5: Current Issues in Medical Device Litigation Workshop, New Orleans.

October 11: Patent Rules, Laws, and Decisions, Cambridge, MA.

October 16: Update on China’s Medical Device Market, Web seminar.

October 16–18: Medical Design & Manufacturing Minneapolis, Minneapolis.

 

ABOUT MX

MX: Issues Update is a monthly e-supplement prepared by the editors of MX: Business Strategies for Medical Technology Executives and sent to you as a benefit of your online registration with Canon Communications. To become a regular subscriber to this monthly medtech business update, click here.

The editors welcome your suggestions for future content in MX: Issues Update. Please feel free to contact us with your comments and ideas.Steve Halasey, Editor in Chief, MX

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