SUD Reprocessing: Growth Amid Controversy

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 providers

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 ]

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

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 ]

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 ]

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 ]

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 Gen-Probe Inc. (San Diego), said the report provided

"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 ]

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 quarters. [ More ]