August 1, 2005

8 Min Read
SUD Reprocessing: Growth Amid Controversy

ssue Update

August 2005

Tucker Tucker: Legislating reprocessed devices.

In spite of its widespread use and growing application in a varietyof 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 healthcareproviders

to notify 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.

CCF logoThe 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 ofGen-Probe Inc.(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 approximately27% of the 143 medical device deals announced during the past fourquarters.[ More ]

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.

The editors welcome your suggestions for future content in MX: Issues Update. Please feel free to contact us with your comments and ideas. —Steve Halasey, Editor in Chief, MX


Sign up for the QMED & MD+DI Daily newsletter.

You May Also Like