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LEAD STORIES
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Watching for Wyeth: High Court Decision Could Have Strong Implications for Medical Device Manufacturers
Gibbs |
At the beginning of this month, the U.S. Supreme Court heard oral arguments in Wyeth v. Levine, potentially a landmark case regarding federal preemption of state tort lawsuits filed against manufacturers of drugs and biologics. Although the immediate implications of a decision in this case will be greatest for drug companies, there also are potential ramifications for medical device manufacturers.
In this issue, attorneys Karen A. Gibbs, Heather L. Hodges, and Cathy L. Burgess review recent litigation leading into the Wyeth case, and describe the differing views being considered by the Court. According to the authors, the coming political changes in the White House and Congress may increase the likelihood of new antipreemption legislation. A defense victory in Wyeth v. Levine could serve to spur on additional antipreemption legislation activities. [More]
Developing Capabilities to Thrive in the Economic Downturn
Masloski |
The medical technology industry has successfully weathered tough economic times before, and has always emerged with the reputation as a safe haven during such turmoil. But according to all indications, this time is different.
Some medical device sectors are already beginning to feel the impact of recessionary pressures. Among the medtech companies feeling the pinch are those whose business is tied to consumer discretionary spending, such as those in the aesthetics market. Businesses dependent on capital equipment budgets are also under stress, including, in particular, companies in the diagnostic imaging market.
In spite of such a seemingly grim outlook, however, medtech companies remain in a good position to grow the capabilities necessary to survive—and even to thrive—in tough economic times. In this issue, Pete Masloski of ZS Associates (Evanston, IL) discusses five capabilities that can help medtech companies to improve their marketing and sales capabilities, with the goal of improving financial performance and reinforcing the overall health of the company. [More]
Stanford Study Examines Value of Imaging Technologies
Baker |
The availability and use of magnetic resonance imaging (MRI) has soared since its introduction in the 1980s and, along with other forms of imaging technology such as computed tomography units (CT), has led to major increases in costs for Medicare and other payers. Whether society ultimately gets its money’s worth for expanded imaging availability is a multifaceted question, one that researchers at Stanford University sought to answer in a study published in the November issue of Health Affairs.
The research team, led by Laurence C. Baker, PhD, professor of health research and policy at Stanford, says that the high costs associated with imaging technologies raise concern about whether widespread availability is justified. But the value of the technologies, he says, depends on whether the imaging procedures lead to improved health outcomes for patients, or reduce the need for more expensive or invasive diagnostic tests. “Imaging is an area where capabilities are changing rapidly and where treatments can be quite costly, which is not unlike some other areas in medicine,” says Baker. “In all areas of medicine, we need to get the evidence and develop paradigms that will help us take advantage of the tremendous potential of new approaches to diagnosis and treatment, while still being sensitive to the costs that indiscriminant use can generate.” [More]
Sector Spotlight: Wound Care
Ikeda |
Wound care is one of medtech’s broadest and most diverse markets, encompassing traditional dry bandages, tapes, dressings, and wound-closure products as well as newer therapies based on tissue engineering, stem cells, growth factors, and sophisticated electromechanical and computer-driven devices. While traditional products are slow-growth performers, the increasing acceptance and integration of new and emerging technologies into hospital wound-care protocols is triggering a new round of interest and investment in the wound-care sector.
The field of wound care offers a wealth of opportunities that have so far remained untapped by medical device manufacturers. “Although there has been a lot of progress in the wound-healing field—new antibiotics, high-tech bandages, and even skin substitutes for very problematic wounds—there is only one product on the market, a growth factor, that targets the biology of wound healing,” says Richard Ikeda, PhD, program director of the wound-healing research portfolio at the National Institute of General Medical Sciences (Bethesda, MD). NIGMS’s research is directed toward an improved understanding of the process of wound healing, fundamental aspects of wound healing, and the process of biological repair and regeneration. [More]
MDEA Issues Call for Entries
Organizers of the Medical Design Excellence Awards (MDEA) program have issued a call for entries in the 2009 competition. The MDEA competition is the premier awards program for the medical technology community, offering recognition to manufacturers, suppliers, and the many people behind the scenes—engineers, scientists, designers, and clinicians—who are responsible for the groundbreaking innovations that are changing the face of healthcare.
Although entries are most often submitted by manufacturers, firms that provide materials, components, or other services may submit an entry on behalf of a product manufacturer with that manufacturer’s written consent.
Now entering its 12th year, the program has previously presented awards to more than 280 groundbreaking healthcare products. To be eligible for the 2009 competition, products must be commercially available—able to be ordered or purchased—by December 31, 2008. The final deadline for entries (with payment of a late fee) is January 20, 2009. [More]
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| NOVEMBER 2008 CONTENTS |
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Watching for Wyeth: High Court Decision Could Have Strong Implicationsfor Medical Device Manufacturers
Developing Capabilities to Thrive in the Economic Downturn
Stanford Study Examines Value of Imaging Technologies
Sector Spotlight: Wound Care
MDEA Issues Call for Entries
INDUSTRY IN BRIEF
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Former Senate majority leader Tom Daschle (D–SD) will be nominated as secretary of the Department of Health and Human Services for the incoming Obama administration. Not previously known for his involvement in health affairs, Daschle recently authored Critical: What We Can Do about the Healthcare Crisis, in which he proposes creation of a Federal Health Board modeled after the banking industry’s Federal Reserve Board.
Philips Healthcare (Amsterdam) is acquiring Meditronics (Mumbai, India), a leading manufacturer of general x-ray systems targeting the economy segment in India. Meditronics will become part of the imaging systems business within Philips Healthcare. The deal is expected to close in the fourth quarter of 2008. Financial details were not disclosed. Philips has recently acquired several companies in high-growth healthcare markets, including Alpha X-Ray Technologies (India), Shenzhen Goldway Industrial (China), and Dixtal Biomédica e Tecnologia and VMI Sistemas Medicos (both in Brazil).
IVD developer MicroPhage (Longmont, CO) recently concluded a round of financing, bringing capital raised by the company to $11 million. The company will apply proceeds of the financing to validation and launch preparation for its initial diagnostic products for hospital-acquired infections such as methicillin-resistant Staphylococcus aureus. Investors in the round were a combination of existing and new investors. All funds to date have come from private investors.
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CALENDAR
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December 8–9: IT for the Non-IT Executive, Cambridge, MA.
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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.
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