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LEAD STORIES
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Massachusetts Healthcare Industry Transparency Bill Becomes Law
Patrick |
Despite vigorous objections from the medtech, pharmaceutical, and life sciences industries, on August 10 Massachusetts Governor Deval Patrick (D–MA) signed into law the Act to Promote Cost Containment, Transparency, and Efficiency in the Delivery of Quality Health Care.
A major provision of the law requires the Massachusetts Department of Public Health (DPH) to establish a pharmaceutical and medical device marketing code of conduct, and develop and impose compliance and reporting requirements on pharmaceutical and medical device companies that have employees involved in marketing or selling prescription drugs or medical devices in the state.
While companies are concerned about the costs and administrative burdens involved in compliance, they take particular issue with the public disclosure aspects of the law. Industry representatives believe this requirement threatens the integrity and security of proprietary information belonging to companies pursuing research and product development initiatives with partner firms, doctors, hospitals, or other organizations. In contrast to FDA disclosure laws and the Physician Payments Sunshine Act pending in Congress, the Massachusetts law requires public disclosure of any collaborative relationship or industry partnering soon after such actions are first initiated—risking exposure of product development plans to competitive firms. [More]
Spine Sector Shows Continued Growth
Denhoy |
In recent years, analysts have frequently referred to the market for spine treatment products as one of the hottest fields in the medtech industry. Considering that worldwide spinal market revenues were less than $100 million in 1990, grew to $3.5 billion by 2004, and reached more than $6 billion last year, growth of the segment has indeed been impressive. The pace of that growth may have cooled since the torrid 15–20% annual increases of a few years ago, but the spine segment continues to post year-over-year revenue gains as a steady stream of new companies enter the market.
Industry analysts generally see continued growth in the spine sector for the foreseeable future. Medtech analyst Raj Denhoy, research director for medical devices in the New York office of Thomas Weisel Partners LLC (San Francisco), says, “As new implants, surgical instruments and procedural technologies for improving and enhancing spinal motion preservation continue to demonstrate efficacy, safety, and cost-effectiveness, they will steadily be embraced by an increasing number of spine surgeons, who as a professional group, have demonstrated their openness and receptivity to new technology.” [More]
Update on Pending Congressional Medtech Legislation
Pallone |
When Congress returns to session this September, it is expected to begin addressing a number of bills that directly affect the medtech industry. Legislation already introduced includes bills relating to medical device safety, transparency with regard to both physician relationships with medtech manufacturers and the pricing of devices, and consumer advertising.
Generally considered to be the pending legislation of greatest concern to medtech manufacturers is the Medical Device Safety Act of 2008, which, if it became law, would set aside the recent Supreme Court decision upholding the federal preemption clause contained in the Medical Device Amendments of 1976. The House bill was introduced on June 26 by representatives Frank Pallone (D–NJ), chairman of the House Energy and Commerce Subcommittee on Health, and Henry Waxman (D–CA), chairman of the House Oversight and Government Reform Committee. Opponents of the court’s interpretation of the federal preemption clause assert that it limits the right of injured patients to sue medical device manufacturers and that corrective legislation is needed. The proposed Medical Device Safety Act explicitly preserves the right of medical product liability lawsuits to be adjudicated in state courts.
Zieve |
The proposed legislation has the support of several public interest and consumer groups, including the Alliance for Justice (Washington, DC) and Public Citizen (Washington, DC). “The possibility of being held liable for injuries their products cause creates an invaluable incentive for manufacturers to make their products as safe as they can, to revise labels as soon as they become aware that they are inadequate, and to remove unsafe products from the market,” said Public Citizen lawyer Allison Zieve. [More]
Medtech Industry Asserts Value and Effectiveness of FDA 510(k) Classification as GAO Readies Assessment Report
Trunzo |
Under the provisions of the FDA Amendments Act of 2007 (FDAAA), the Government Accountability Office (GAO; Washington, DC) is scheduled to issue a report to Congress on the “appropriate use” of FDA's 510(k) premarket notification process for the evaluation and approval of medical devices. The provision calling for such a report grew out of Congressional hearings during the Summer of 2007, before the bill was approved and signed into law by President Bush last September.
Several consumer groups, including Public Citizen (Washington, DC) and the National Research Center for Women and Families (NRC; Washington, DC) questioned the wisdom and validity of the ‘substantially equivalent’ predicate device concept, which is a core tenet of the 510(k) process.
Concerned that FDA’s 510(k) protocol is misunderstood, AdvaMed earlier this month issued a report titled The 510(k) Process: The Key to Effective Device Regulation. “The 510(k) process has a proven track record in ensuring the safety and effectiveness of medical technology while encouraging device development and meeting the needs of American patients, said Janet Trunzo, AdvaMed executive vice president of technology and regulatory affairs. “Unfortunately, this key regulatory process and the important role it plays in ensuring the integrity of medical devices in the U.S. market is not well understood.” [More]
IP Watch: Medtronic Cites NuVasive for Patent Infringement
Lukianov |
Earlier this month, Medtronic Inc. (Minneapolis) brought suit against NuVasive Inc. (San Diego), alleging that the company has infringed on 12 Medtronic patents in four product categories. Medtronic and NuVasive vie in the highly competitive $6.2 billion global market for spine surgery instruments, implants, and related devices. Medtronic, the world’s largest pure-play medical device manufacturer, dominates the spine space with a 35–40% market share.
NuVasive chairman and CEO Alex Lukianov expressed confidence in his company’s response to the suit. “It is not surprising that Medtronic would attempt to intimidate NuVasive with this suit, since NuVasive represents a growing threat to Medtronic’s spine business,” he said.
This issue's IP Watch offers more about the current dust-up between Medtronic and NuVasive, as well as other recent litigation moves involving medtech intellectual properties. [More]
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| AUGUST 2008 CONTENTS |
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Massachusetts Healthcare Industry Transparency Bill Becomes Law
Spine Sector Shows Continued Growth
Update on Pending Medtech Legislation
Medtech Industry Asserts Value and Effectiveness of FDA 510(k) Classification as GAO Readies Assessment Report
IP Watch: Medtronic Cites NuVasive for Patent Infringement
INDUSTRY IN BRIEF
CALENDAR
ABOUT MX
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2008
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INDUSTRY IN BRIEF
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Diagnostics manufacturer Qiagen (Venlo, The Netherlands) has acquired Corbett Life Science Pty. Ltd. (Sydney, Australia), a privately-held developer, manufacturer, and distributor of life sciences instrumentation. The transaction was valued at approximately $66 million in cash and $4 million in restricted Qiagen common stock, plus performance and development milestone payments of up to approximately $65 million over the next four years.
Medtronic Inc. (Minneapolis) announced in July that it had completed its acquisition of Restore Medical Inc. (St. Paul, MN). The total value of the transaction, including payment of Restore debt, was approximately $29 million. Restore Medical’s Pillar palatal implant system for the treatment of sleep breathing disorders will be integrated into the surgical technologies business unit at Medtronic.
Aculight Corp. (Bothell, WA), a developer of innovative laser technologies, has been awarded a new contract under the federal Small Business Innovation Research (SBIR) program. The $125,000 Phase I award from the National Institutes of Health will fund development of a handheld laser-based nerve stimulator for use by ear, nose, and throat specialists to identify cranial nerves during surgery.
Ethicon Endo-Surgery (Cincinnati, OH), a Johnson & Johnson company, has entered into a definitive agreement to acquire SurgRx (Redwood City, CA), a privately held developer of the advanced bipolar tissue sealing system used in the EnSeal family of devices. Terms of the agreement were not disclosed.
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CALENDAR
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September 7–10: North Carolina Healthcare Information and Communications Alliance Annual Conference and Exhibition, Greensboro, NC.
September 10-11: BIOMEDevice Forum, San Jose, CA.
September 14–17: Regulatory Affairs Professionals Society 2008 Annual Conference & Exhibition, Boston.
September 15–16: PharmaMed Marketing and Media, New Brunswick, NJ.
September 21–24: AdvaMed 2008, Washington, DC.
September 23: MedTech 08 Biosciences Summit, Skaneateles Falls, NY.
September 23–25: Medical Design & Manufacturing Midwest, Rosemont, IL.
October 1: Update on Hong Kong's New Medical Device Regulations, Webcast.
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