|
LEAD STORIES
|
|
Federal Court Places Hold on New Patent Rules
Rawlins |
On October 31, the U.S. District Court for Eastern Virginia issued a preliminary injunction preventing the U.S. Patent and Trademark Office (PTO) from implementing its new rules on the patent-application process, which were scheduled to go in effect November 1. The motion for injunction was filed by GlaxoSmithKline (Greenford, Middlesex, UK), which is suing PTO over the issue.
The proposed rule changes, which would have increased the burden on patent applicants, have been the subject of much controversy among medtech manufacturers and patent lawyers. In this article, Andrew E. Rawlins, a partner with Foley & Lardner LLP (Washington, DC), discusses the recent injunction and its implications for medtech manufacturers. [More]
J&J Restructures to Explore Convergence Opportunities
On November 15, Johnson & Johnson Inc. (J&J; New Brunswick, NJ) announced plans for a significant company restructuring designed to accelerate growth by capitalizing on its broad base of businesses and decentralized structure. The restructuring includes the formation of a new strategy and growth organization and two new business operating groups.
Driscoll |
Although few would dispute that J&J is unique in its broad-based market position, some industry observers are skeptical that the proposed restructuring will enable the company to truly unify the efforts of its decentralized divisions. “J&J is uniquely that—decentralized—so any effort to centralize it, such as creating a centralized entity for growth, at least has great potential to run counter to the organization’s essence,” says Patrick Driscoll, founder and president of MedMarket Diligence LLC (Foothill Ranch, CA). “Corporate culture is a beast with huge inertia, and it’s hard to imagine a beast with more inertia than J&J.” [More]
Proposed Legislation Would Reward Life Sciences Investments
Hui |
This past summer, the American Life Sciences Competitiveness Act of 2007 (HR 3264) was introduced in Congress. Designed to stimulate investment in life sciences companies, the bill would modernize numerous elements of the federal tax code to help life sciences companies continue to raise the funds needed to bring new therapies to market. In particular, the legislation promotes long-term investment in small life sciences companies, reforms net operating-loss rules, revises the research tax credit and the orphan drug credit, and encourages the development of new biodefense and pandemic flu countermeasures.
Although the proposed legislation still has a long way to go in Congress, it has already garnered support from industry associations AdvaMed (Washington, DC) and the Biotechnology Industry Organization (Washington, DC). In this article, Gary Hui, a tax senior manager at Burr, Pilger & Mayer LLP (San Francisco), examines the various provisions of the pending legislation and what it could mean for start-up medical technology firms and their investors. [More]
Coalition Survey to Guide FDA on Combination Products
Thompson |
Medtech companies involved in developing combination products have a golden opportunity to offer input about future policy development priorities for FDA’s Office of Combination Products (OCP), thanks to an online survey launched earlier this month. Sponsored by the Combination Products Coalition (CPC; Washington, DC), the “FDA Guidance Survey” is intended to assess the needs of medtech companies for regulatory guidance on combination product issues.
According to CPC general counsel Bradley Merrill Thompson, a member in the healthcare and life sciences practice of Epstein Becker & Green PC (Washington, DC), the survey results will be useful to FDA and members of industry in reviewing OCP’s guidance and rule-making activities. “The goal of the survey is to take the pulse of companies in the combination product area, and to discover what their most-pressing FDA-related issues are,” says Thompson. [More]
New Findings Buoy Rebounding Drug-Eluting Stent Market
Stone |
For more than a year, drug-eluting stents have been battered by a storm of negative publicity that questioned the efficacy and safety of the devices. Having captured almost 90% of the coronary stent market shortly after receiving FDA approval, drug-eluting stents experienced a precipitous decline in usage as a result of widely reported safety concerns. While signs of a slight rebound in sales were already being seen, stent manufacturers and interventional cardiologists were buoyed by a number of positive clinical studies recently released at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, DC, and the American Heart Association’s Scientific Sessions in Orlando, FL.
Gregg Stone, MD, chairman and chief medical officer of the Cardiovascular Research Foundation (New York City), organizer of TCT, said, “The conference released the findings of seven longer-term clinical studies representing more than 61,000 patients—all with serious degrees of coronary artery disease. In each of the studies, drug-eluting stents performed significantly better in preventing restenosis and the need for revascularization, as well as reducing mortality rates, compared to bare-metal stents.” [More]
Orthopedic Surgeons May Dictate True Impact of DOJ Settlement
McDermott |
Earlier this fall, when the U.S. Department of Justice (DOJ; Washington, DC) announced the terms of its settlement with leading orthopedic manufacturers, few analysts perceived the agreement as a significant or long-term setback for the sector. However, industry observers are now taking note of the response of orthopedic surgeons to the terms of the settlement. Doctors who serve as industry consultants are now finding their names on manufacturers’ Web sites, and they are required to disclose the terms of these agreements to their patients—including how much they have been paid.
“The settlement is having a chilling effect on orthopedic surgeons, who are obviously concerned about avoiding conflicts of interest and maintaining their professional integrity and reputations,” says Kathleen McDermott, an attorney with Sonnenschein, Nath & Rosenthal LLP (Washington, DC). McDermott says she expects the settlement “will result in significant modification of the behavior of orthopedic surgeons toward manufacturers, who, in turn, will have to make their own adjustments . . . even beyond the formal terms of the DOJ settlement.” [More]
Panelists: Opportunities amid Cardiology Market Turmoil
Rajan |
MX magazine recently called on a panel of industry experts to get their views about how current and future trends are likely to affect the medical technology marketplace in 2008. The conversation—the expanded online version of which is available here—covered hot topics in a variety of sectors, including the ongoing controversy over physician payment practices in the orthopedics sector and the heavy mergers and acquisitions activity in the in vitro diagnostics sector. Panelists also discussed recent recalls and product efficacy concerns in cardiology markets, which have seen decreases in the markets for both cardiac rhythm management and interventional cardiology products—especially implantable cardioverter-defibrillators and drug-eluting stents.
Venkat Rajan, an industry analyst in the healthcare group of Frost & Sullivan (San Antonio, TX), says the real impact of recent turmoil in the cardiology sector is going to be on new technologies. “In the future, new products are likely to meet with a much more skeptical reception,” Rajan says. “Physicians are going to question what the appropriate niche for a new product is. And we’ll see more of that sort of evaluation, instead of physicians just jumping in with both feet.” [More]
Specialty Societies Expanding Influence over Reimbursement Decisions, Say MDMA Panelists
Slurzberg |
Medical specialty societies often play a large role in determining which treatments in their area of expertise deserve reimbursement, especially when the decisions are being made for a private healthcare plan. According to a panel of experts at the Medical Device Manufacturers Association Coverage, Reimbursement, and Healthcare Policy Conference, held November 13 in Washington, DC, the influence of such professional associations makes it imperative that device companies cultivate relationships with their leaders and members—but not too cozily.
During the panel discussion, reimbursement consultant Judy Rosenbloom, founder and president of JR Associates (Reseda, CA), explained that healthcare plans are flexing their muscle and taking greater control over the practice of medicine. In turn, the healthcare plans contract with benefits-management companies, assigning them the task of determining issues of medical necessity. Those firms often look to medical specialty societies to help develop appropriateness criteria using evidence-based guidelines.
“Private payers have asked specialty societies to provide services that impact coverage, coding, and payment,” said Jo Ellen Slurzberg, vice president for reimbursement and healthcare policy at Almyra Inc. (Boxborough, MA). “Many are writing guidelines that serve as a basis for technology assessments and policy guidelines.” [More]
|
|
 |
|
| IN THIS ISSUE |
|
Federal Court Places Hold on New Patent Rules
J&J Restructures to Explore Convergence Opportunities
Proposed Legislation Would Reward Life Sciences Investments
Coalition Survey to Guide FDA on Combination Products
New Findings Buoy Rebounding Drug-Eluting Stent Market
Orthopedic Surgeons May Dictate True Impact of DOJ Settlement
Panelists: Opportunities amid Cardiology Market Turmoil
Specialty Societies Expanding Influence over Reimbursement Decisions, Say MDMA Panelists
INDUSTRY IN BRIEF
CALENDAR
ABOUT MX
|
 |
| PREVIOUS ISSUES |
2007
October
September
August
July
June
May
April
March
February
January
|
|
 |
|
INDUSTRY IN BRIEF
|
|
Enterprise Florida has added a new life sciences council to its board of directors. The council, which includes Florida executives representing state and national organizations in the life sciences field, is designed to increase the organization’s understanding of the state’s business climate for life sciences companies. To read more about Florida’s medical device and other life sciences industries, check out the article “Medtech in the Southeast” in the November/December issue of MX magazine. An expanded version of the article is available here.
 The Medical Design Excellence Awards (MDEA) program has begun accepting entries for its 2008 competition. The premier awards program for the medical technology community, the MDEA competition is open worldwide to companies and individuals involved in the design, engineering, manufacture, or distribution of finished medical devices or medical packaging. To be eligible for the 2008 competition, products must be commercially available—able to be ordered or purchased—by December 31, 2007. The standard deadline for entries is December 17, 2007. The final deadline for entries (with payment of a late fee) is January 18, 2008. More.
In mid October, the Centers for Medicare and Medicaid Services (CMS) announced that the first of two planned demonstration sites for its clinical laboratory competitive bidding demonstration program would be the San Diego–Carlsbad–San Marcos region in Southern California. Previously postponed due to wildfires in the area, the bidders conference for regional laboratories has been rescheduled for December 5. Industry association AdvaMed (Washington, DC), the American Association for Clinical Chemistry (Washington, DC), and other laboratory groups have raised concerns that many laboratories could be forced out of business in regions where the demonstrations are conducted.
Early this fall, the Continua Health Alliance (Beaverton, OR)—a group of technology, medical device, and health and fitness industry leaders—unveiled the key components of its first set of technical guidelines to help establish a market of connected personal health and fitness products and services. The alliance says the first set of guidelines, due out in early 2008, are based on proven connectivity standards and will help to increase assurance of interoperability among devices.
The Access to Medical Imaging Coalition reports that nearly a third of the members of the U.S. Senate have joined together to oppose additional cuts to medical imaging, including those proposed by the Children’s Health and Medicare Protection Act (HR 3162). The coalition continues to push for passage of the Access to Medicare Imaging Act of 2007 (HR 1293), which calls for a two-year moratorium on the cuts imposed by the Deficit Reduction Act of 2005, which was implemented in January 2007. The group says the moratorium would permit the Government Accountability Office to complete a study on specific outcomes of the Medicare cuts to medical imaging.
Early this month, Medtronic Inc. (Minneapolis) completed its acquisition of Kyphon Inc. (Sunnyvale, CA). Under the terms of the agreement, Kyphon shareholders will receive $71 per share in cash for each share of Kyphon common stock they own. The total value of the transaction, including payment of Kyphon debt, was approximately $4.2 billion.
Boston Scientific Corp. (Natick, MA) has signed a definitive agreement for the sale of its cardiac surgery and vascular surgery businesses to the Getinge Group (Getinge, Sweden), a global provider of healthcare equipment and systems. The units, the combined revenues of which were approximately $275 million in 2006, will be sold for about $750 million in cash.
Becton Dickinson (Franklin Lakes, NJ) has signed an agreement with the U.S. President’s Emergency Plan for AIDS Relief to establish a public-private partnership to improve overall laboratory systems and services in African countries severely affected by HIV-AIDS and tuberculosis. The five-year partnership, valued at up to $18 million, will focus on improving laboratory capacity for HIV-AIDS testing and monitoring. The organizations will also work to advance tuberculosis diagnostic capabilities in sub-Saharan Africa. Specifically, the partnership will focus on improving training materials and practices on the diagnosis and management of people living with HIV-AIDS who are coinfected with tuberculosis.
Midwest healthcare start-ups reported a record-breaking $1 billion in total investments for 104 companies through the third quarter of 2007. Medical device companies accounted for $251 million of the total investment, reports BioEnterprise (Cleveland).
|
|
|
CALENDAR
|
|
December 3–4: Regulatory Strategy Forum: Tools for Designing a Global Regulatory Strategy, Atlanta.
December 3–5: Vendor and Contract Supplier Qualification, New Brunswick, NJ.
December 4: Update on India’s Medical Device Markets, Web seminar.
December 5: Regulatory Update: New FDA Guidance Documents for Combination Products, Webcast.
December 9–11: World Healthcare Innovation and Technology Congress, Washington, DC.
December 12–14: Bohemian Medical Device Summit, Prague, Czech Republic.
December 13: Regulatory Boot Camp: Bringing a Product to Market and Avoiding Regulatory Pitfalls, Waltham, MA.
January 7–10: JP Morgan Annual Healthcare Conference, San Francisco.
January 17-18: Manufacturers Seminar, Miami.
January 22: Thailand's Growing Medical Device Market, Web seminar.
|
|
|
