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LEAD STORIES
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Roche Asserts Patents against Entire Industry to Enjoin Sales of Diabetes Test Strips
Limbach |
At the end of November, Roche Diagnostics Operations Inc. (Indianapolis) took on every major player in the blood glucose test strip industry by filing a lawsuit in U.S. District Court for the District of Delaware. The Roche suit seeks to enjoin meter and test strip sales by the defendants, which include Abbott Diabetes Care (Alameda, CA), Bayer Healthcare (Tarrytown, NY), and LifeScan (Milpitas, CA), a Johnson & Johnson company. The financial stakes of the case are enormous, and the way in which the patent law issues play out will be well worth watching. In this article, Douglas C. Limbach, an attorney with Shay Glenn LLP (San Mateo, CA), explores the main issues being raised by the Roche lawsuit. [More]
Survey: Medtech Firms Challenged by Contract Complexity and Pricing
Rao |
The challenges of driving net revenue and profit targets while complying with evolving government legislation place medical technology manufacturers in a highly complex demand-chain landscape. In this article, Gopkiran Rao, senior director of industry marketing at Model N Inc. (Redwood Shores, CA), describes results from the 2007 Revenue Management Excellence Survey, an industry survey designed to help medtech companies benchmark their performance and identify best practices for pricing and contracting. [More]
Supreme Court Considers Preemption for PMA Devices
Silverman |
On December 4, 2007, the U.S. Supreme Court heard oral arguments in Riegel v. Medtronic Inc. The Court’s much-anticipated decision—expected in July 2008—should provide a definitive resolution to the issue of federal preemption for medical devices approved by FDA under the premarket approval path. In this article, Caryn M. Silverman, a partner in the New York office of the law firm of Sedgwick, Detert, Moran & Arnold LLP, provides an analysis of several key arguments the judges will be weighing in making their final decision. [More]
ECRI–Boston Scientific Settlement Raises Transparency Issues
Lerner |
When the ECRI Institute (Plymouth Meeting, PA) brought suit against then Guidant Corp., now a wholly owned business unit of Boston Scientific Corp. (Natick, MA), many medtech industry observers saw the case as a potential forum on medical device pricing transparency. At issue was ECRI’s right to continue publishing the prices paid by hospitals for a number of medtech products, notably, in the dispute with Guidant, cardiac rhythm management devices such as pacemakers and implantable cardioverter-defibrillators (ICDs).
The case was scheduled to go to trial on December 3, but several weeks earlier, on November 19, the two parties announced that they had reached a settlement. Under terms agreed to by ECRI and Boston Scientific, details of the agreement could not be disclosed. However, Jeffrey C. Lerner, PhD, president and CEO of ECRI, said that the firm would continue to publish the PriceGuide, including information about Boston Scientific’s Guidant brand of CRM devices. [More]
CMS Memos Explore Application of Coverage with Evidence Development
Mannen |
After months of inaction on its much-debated proposal to implement a new approval category for coverage with evidence development, this month the Centers for Medicare and Medicaid Services (CMS) suddenly leapt into action. Within the span of eight days, the agency issued memos explicitly citing the possibility of coverage with evidence development for three distinct technologies. But this latest flurry of CMS activity has sparked questions as to whether coverage with evidence development will be applied as narrowly as CMS has previously suggested.
To date, this relatively new type of national coverage decision has been the subject of more discussion than action. “If this signals greater willingness of CMS to deploy coverage with evidence development in 2008, then the reimbursement ground beneath device manufacturers may be about to shift,” says Ted R. Mannen, a member of Epstein Becker & Green PC and managing director of EBG Advisors Inc. (Washington, DC). [More]
Sleep and Respiratory Device Markets Poised for Growth
Zable |
The fundamentals of the respiratory device market, including the sleep disorders market, remain strong, with both U.S. and international markets poised for growth into the foreseeable future. “Over the years, the increased development of evidence-based care, continued prevalence of respiratory and sleep disorders, internationalization of respiratory care paradigms—as developed in the United States—increasing industry participation, and breakthroughs in information technology have led to the present strong state of the market,” says Joshua Zable, a medical devices analyst at Natixis Bleichroeder (New York City). This article provides a look at the latest products and trends in advanced respiratory technology, as demonstrated at this year’s International Respiratory Congress, organized by the American Association for Respiratory Care (Irving, TX). [More]
FDA Advocacy Organizations Join Forces
Grossman |
In mid December, the Coalition for a Stronger FDA and the FDA Alliance announced plans to merge into a single organization known as the Alliance for a Stronger FDA. Both organizations, which emerged as independent entities in 2006, were founded on the notion that FDA does not have the necessary resources to fulfill its mission of protecting the public health. According to the groups, the merger—which will go into effect at the beginning of January—will create a stronger, more multifaceted organization dedicated to securing a higher level of congressional funding for FDA.
“We have each been successful in educating about the need for more appropriated funds for FDA, and now we’ll be able to do an even more effective job,” said Steven Grossman, executive director of the FDA Alliance, who will serve as deputy executive director for government relations and communications in the merged organization. [More]
2008 MDEA Jurors Announced
Organizers of the Medical Design Excellence Awards program have announced the members of the jury panel who will be charged with evaluating entries in the 2008 competition. The MDEA competition is the premier awards program for the medical technology community. Now entering its 11th year, the program has previously presented awards to more than 250 groundbreaking healthcare products. The jury panel typically encompasses experts from a wide range of healthcare- and design-related fields, including clinical practice, biomedical engineering, human factors, industrial design, manufacturing, and other areas. The final deadline for entries in the 2008 MDEA competition is January 18, 2008. [More]
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| IN THIS ISSUE |
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Roche Asserts Patents against Entire Industry to Enjoin Sales of Diabetes Test Strips
Survey: Medtech Firms Challenged by Contract Complexity and Pricing
Supreme Court Considers Preemption for PMA Devices
ECRI–Boston Scientific Settlement Raises Transparency Issues
CMS Memos Explore Application of Coverage with Evidence Development
Sleep and Respiratory Device Markets Poised for Growth
FDA Advocacy Organizations Join Forces
2008 MDEA Jurors Announced
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INDUSTRY IN BRIEF
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Abbott (Abbott Park, IL) announced that the circulatory system devices advisory panel to FDA has recommended approval for the company’s Xience V everolimus-eluting coronary stent system. The committee voted to recommend the Xience V stent system for approval with conditions related to postmarketing study requirements and language related to dual antiplatelet therapy. FDA is not required to, but frequently follows the recommendations of its advisory committees.
Frazier Healthcare Ventures (Seattle), a healthcare-focused venture capital firm, announced the closing of a $600 million institutional fund, bringing total capital under its management to $1.8 billion. Frazier reports that it will use the funds for continued investment in three core sectors of the healthcare industry: biopharma, medical devices, and healthcare services. It intends to invest at all stages of company development.
In the wake of numerous product recalls and fears over contaminated imports, U.S. and Chinese officials have signed safety pacts that will give American inspectors access to Chinese factories while granting Chinese manufacturers continued access to the U.S. market. The agreement related to medical devices and drugs can be viewed here.
Industry association AdvaMed (Washington, DC) has joined a coalition of stakeholders calling on Congress to make permanent the research and development (R&D) tax credit that was first ratified in 1981. The coalition is also asking legislators to provide parity in the formulas used to determine the percentage of credit that companies receive. The tax credit, which is set to expire at the end of December 2007, provides assistance to companies engaged in R&D activities. The current tax credit involves three formulas whereby some companies receive a higher tax credit and others receive much less.
Boston Scientific Corp. (Natick, MA) and private equity firm Avista Capital Partners (New York City) have signed a definitive agreement under which Avista will acquire Boston Scientific’s fluid management and venous access businesses for $425 million in cash. The transaction is expected to close in the first quarter of 2008, at which time combined divisions will operate as an independent company under a new name. Avista also recently signed an agreement to acquire Bristol-Myers Squibb Medical Imaging, a business unit of Bristol-Myers Squibb (New York City), for approximately $525 million.
Royal Philips Electronics (Amsterdam, The Netherlands) announced its plans to acquire clinical IT and service provider Visicu Inc. (Baltimore) for approximately $300 million. Philips plans to integrate Visicu’s remote patient monitoring and clinical decision support technology with its patient monitors. The transaction is expected to close in the first quarter of 2008.
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CALENDAR
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January 7–10: JP Morgan Annual Healthcare Conference, San Francisco.
January 14–15: Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices, Malvern, PA.
January 22: Thailand’s Growing Medical Device Market, Web seminar.
January 22–23: Complaints, MDRs, Reports of Removals and Corrections, and Recalls, Orlando.
January 28–31: Medical Design & Manufacturing (MD&M) West Conference and Exposition, Anaheim, CA.
January 29–30: Private Equity Analyst Outlook, New York City.
February 19–22: Medical Technology Reimbursement Specialist Workshop, Las Vegas.
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