Tucker: Legislating reprocessed devices.
In spite of its widespread use and growing application in a variety
of markets, the reprocessing of medical products designated as
single-use devices (SUDs) continues to be a controversial subject.
The objectivity of reports regarding the safety, efficacy, and
cost savings of the practice is frequently compromised by the
agenda of the organization behind the particular study. In general,
medical device manufacturers have tended to resist third-party SUD
reprocessing since it is seen as having an adverse impact on their
sales. Hospitals tend to be supporters, since purchasing such
devices lowers their operational costs.
And now a new wrinkle may be emerging. Massachusetts State Senator
Susan Tucker (D-Andover) has introduced a bill that would require doctors, hospitals, and other healthcare
patients if any reprocessed devices will be used in the course of
their treatment. Countering, hospitals and reprocessors say that
such a requirement would drive up medical costs.
[ More ]
Frist Calls for Restrictions on Pharma DTC Advertising
In early July, U.S. Senate majority leader Bill Frist, (R-TN)
called for a two-year moratorium on direct-to-consumer (DTC)
advertising of new pharmaceuticals. In making his case, Frist
contended that such advertising "can lead to inappropriate prescribing and fuel prescription drug spending" and that the ads "oversell benefits and undersell risks."
The pharmaceutical industry has been quick to respond to Frist's statements, and, although Frist currently has not extended his calls for a moratorium to the device market, the medtech industry
is keeping abreast of the situation's developments. Although medtech's
Frist: Targeting DTC drug advertising.
expenditures for DTC advertising are currently
infinitesimal compared with those in the pharmaceutical industry,
industry consultants say that the current debate could set a new
standard for all to follow. [ More ]
Cleveland Clinic Turns Spotlight on Orthopedics
The 2005 Cleveland Clinic Medical Innovation Summit: Bench to
Bedside and Back, being held October 24-26, will immerse industry
professionals in three days of discussion and analysis of the latest
trends and developments in the orthopedic sector.
The summit comes eight months after the Cleveland Clinic's
announcement that it had formed a 10-year alliance with Stryker
Corp. (Kalamazoo, MI) under which the medical device company will
support the clinic in the advancement and testing of image-guided
surgery systems and other sophisticated orthopedic surgical
technologies, with the ultimate goal of developing "the orthopedic
operating rooms of the future." [ More ]
Guidant's Good News Month
Guidant's McCoy: Upward momentum.
After months when it seemed as though every announcement went from
bad to worse, August turned out to be a good news month for
executives at Guidant Corp. (Indianapolis). During August, the
company received a handful of critical approvals: approval to move
its implantable cardiac defibrillators (ICDs) back on the market,
approval to expand its U.S. drug-eluting coronary stent trials,
approval of a next-generation heart synchronization device with
wireless programming, and European approval of its acquisition by
Johnson & Johnson Inc. (New Brunswick, NJ).
By all accounts, the market return of Guidant's recalled ICDs came
much sooner than expected, and such a quick turnaround is
considered likely to minimize any
loss of market share. "Our progress toward full inventory availability is ahead of schedule," said Fred McCoy, president of Guidant's cardiac rhythm management division. "Already we have achieved an inventory position to meet all current implant demand and to replenish customer inventory." [ More ]
AdvaMed Report Promotes Value of Diagnostics
A recently released report, The Value of Diagnostics: Innovation,
Adoption, and Diffusion into Healthcare, from industry association
AdvaMed (Washington, DC) seeks to raise the visibility of diagnostics
and document their importance and contribution to patient care.
The report also points out that diagnostics are significantly
underutilized—as much as 51% of the time—and that their adoption,
full utilization, and ongoing development and innovation are all
adversely affected by inadequate coding, coverage, and reimbursement.
Henry L. Nordhoff, chairman, president, and CEO of
(San Diego), said the report provided
Nordhoff: Hopeful of change for diagnostics.
"compelling information and will likely emerge as a standard reference tool for the subject of diagnostics." Nordhoff, who is also chair of AdvaMed's diagnostics sector, reinforced the findings of the report, stating, "Coding and reimbursement have not kept pace with the realities of the science of diagnostics" or the healthcare marketplace. With the steady advance of diagnostics developments and the rapidly emerging era of molecular diagnosis and the promise of personalized medicine, we're a totally different industry than we were when these coding and coverage policies were established. I'm hopeful that Congress and CMS will recognize these realities and implement the recommendations of the report. [ More ]
Healthpoint Capital Report Highlights Opportunities
in Sports Medicine
A new report produced by Healthpoint Capital (New York City) details
the "orthopedic opportunity" that the growing sports medicine market
holds for manufacturers. The report, 2005 Orthopedic Market Report:
Sports Medicine, projects a $1.36 billion market value in 2005 for
the products used in orthopedic arthroscopy, including surgical
instruments and equipment ($850 million) and implants ($510 million)—a 39% increase over 2001 market value of $0.98 billion. In addition,
it estimates the 2005 nonsurgical product market at $622 million,
a 26% increase since 2001.
[ More ]
Devices Lead Medtech Deals in Second Quarter
The device sector accounted for the greatest number of medical
technology deals in the second quarter of 2005, according to The
Medical Technology Acquisition Record, published by Irving Levin
Associates Inc. (Norwalk, CT). The 38 transactions represented a
gain of 9% over the 35 deals reported in the year-ago quarter, but
were down 12% from the 43 deals in the first quarter of 2005. The
number of second-quarter 2005 transactions represents approximately
27% of the 143 medical device deals announced during the past four
[ More ]
Issues Update is a monthly e-supplement prepared by the editors
of MX: Business Strategies for Medical Technology Executives
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feel free to contact us with your comments and ideas.
Halasey, Editor in Chief, 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.
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