Medical Device Link.

If a bill under consideration in Massachusetts becomes law, Bay State patients will have another consent form to consider when they are admitted to the hospital or undergo medical procedures in doctors’ offices. A bill currently before the state’s senate would require that patients be informed of—and consent to—the use of any reprocessed medical device previously designated by its manufacturer as a single-use device (SUD).

MassMedic's Sommer:
Safety over savings.

The Massachusetts bill is the first legislation of its kind in the United States regarding reprocessed SUDs and is being closely watched by medtech manufacturers and hospitals across the nation. Manufacturers, who cite safety and efficacy concerns with reprocessed SUDs, generally support the legislation. Hospitals are typically opposed since they see the use of reprocessed SUDs as an essential cost-control measure that also reduces medical waste.

"Hospital use of reprocessed devices to cut costs may come at the price of jeopardizing patient safety," says Thomas J. Sommer, president of the Massachusetts Medical Device Industry Council (Boston). The Association of Medical Device Reprocessors (Washington, DC), however, dismisses the proposed Massachusetts

Aware of the brewing controversy over gainsharing, the U.S. Department of Health and Human Services Office of Inspector General (OIG) continues to emphasize the need for limited implementation of the practice. Testifying at an October hearing on gainsharing, OIG’s chief counsel, Lewis Morris, said that the office has been “historically wary” of gainsharing arrangements due to their potential to violate federal antikickback statutes.

Kathleen McDermott, a partner with Blank Rome LLP (Washington, DC) and a specialist in healthcare law, describes OIG’s advisory guidance on gainsharing arrangements as “very limited” in scope. “They’ve given hospitals a yellow light—urging caution—while emphasizing the need for patient access to quality care,” she says. McDermott sees properly structured gainsharing arrangements with short-term limits and other safeguards as having a place on hospitals’ cost-containment menus, but she acknowledges that the potential for fraud and abuse is “always there.” [ More ]

After being put on indefinite hold and, at times, rumored to be off the table entirely, the planned merger of Johnson & Johnson Inc. (J&J; New Brunswick, NJ) and Guidant Corp. (Indianapolis) is going forward after all. Under the revised terms of the transaction, J&J has agreed to pay Guidant $21.5 billion in cash and stock—about 15% less than the original $25.4 billion deal struck last December. Adjusting for Guidant’s cash on hand at the close, both companies estimate the net cost of the acquisition to be about $19 billion.

Commenting on the closing the deal, William C. Weldon, chair and CEO of J&J, said, “We are delighted that our companies have reached an accord. Our agreement demonstrates that we remain committed to the goal of together building an extraordinary cardiovascular business that can deliver better medical options sooner to millions of patients.”

In consummating the deal, J&J, the world’s largest medtech manufacturer, adds Guidant’s heart rhythm management products to its cardiovascular lineup. The acquisition makes J&J the world’s largest supplier of devices to treat

It isn’t often that a small manufacturer can go up against a powerful federal regulatory agency and prevail, but that’s exactly what Utah Medical Products Inc. (Midvale, UT) did in October. The company vigorously defended itself against FDA’s charges that the company had failed to comply with the good manufacturing practices requirements of the agency’s quality system regulation (QSR). In the end, Utah Medical won a stunning victory when the U.S. District Court in Salt Lake City dismissed the case with a ruling that chided the actions of FDA.

Judge Bruce S. Jenkins described FDA’s oversight actions as "extended" and "at times, nitpicking." In affirming Utah Medical’s full compliance with the QSR, Jenkins said he was impressed with the company’s documented procedures and added, "It makes no sense for the court to order Utah Medical to do something they are already doing."

Hailing the decision as a precedent-setting ruling, Utah Medical attorney Larry R. Pilot, a partner with McKenna Long & Aldridge LLP (Washington, DC), lauded the company’s "courage in defending itself against meritless claims by FDA." [ More ]

OraQuick: Offering
at-home detection?

The OraQuick test kit was approved by FDA in November 2002 and is available at doctors’ offices, hospitals, and clinics worldwide. It uses a swab of saliva and can detect the presence of HIV antibodies within 20 minutes. Although FDA’s advisory panel is not expected to make specific recommendations regarding OraQuick, members are reportedly receptive to the concept of at-home testing. OraSure reports that it plans to continue discussions with FDA. These talks may lead to clinical trials of a home-use version of the test and, eventually, to an application for approval.
[ More ]

This year’s Transcatheter Cardiovascular Therapeutics (TCT) conference drew nearly 12,000 participants from around the world to Washington, DC. Now in its 17th year, TCT is the world’s largest educational event for specialists in interventional vascular medicine. Sponsored by the Cardiovascular Research Foundation (New York), the meeting places an emphasis on evidence-based medicine and has become a major forum for important clinical trial presentations in interventional medicine. This year’s presentations included head-to-head comparisons of drug-eluting coronary stents, the safety and efficacy of distal protection devices, comparative studies of stenting versus endarterectomy for carotid stenosis, and procedures for treating abdominal aortic aneurysms.

Medtech companies are beginning to address the technological challenges involved in developing devices that make intense use of information technologies (IT), but a great deal more effort will be required to prepare healthcare settings for the adoption of such products.

In a special roundtable conducted to conclude the MX series on IT in Healthcare, a panel of experts reviews the current shape of the field, challenges related to the adoption of healthcare IT systems, and how medical device manufacturers should be planning to do business in the emerging IT-rich healthcare environment. The wide-ranging discussion, which appears in the November/December 2005 issue of MX magazine, highlights financial and policy obstacles that are slowing the adoption of healthcare IT systems and reviews the role that various stakeholders—including medtech companies—can play in overcoming those obstacles.

Panelists agree that shaping the future of healthcare IT will involve a lot more than mere technology. “A paradox that the field hasn’t dealt with sufficiently yet is the fact that healthcare IT initiatives are not primarily about technology at all,” says David Lansky, PhD, health program senior director and executive director of the personal health technology initiative at the Markle Foundation (New York City). “Success is not going to be achieved by merely buying high-end hardware and software and plugging it all in. It’s essential that we look at the issues of work flow, system redesign, and interoperability—but as part of a larger strategy of changing the healthcare system and not only as a basis for adopting raw technology.” [ More ]

The Medical Design Excellence Awards (MDEA) program is now accepting entries for its 2006 competition. Now entering its ninth year, the MDEA competition is the premier awards program for the medical technology community. The program offers 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.

To be eligible for the 2006 competition, products must be commercially available by December 31, 2005. The standard deadline for entries is December 19, 2005. The final deadline for entries (with payment of a late fee) is January 17, 2006. For additional details, including a downloadable entry form, entrants should visit the MDEA Web site at www.MDEAwards.com. [ More ]

Recognizing the lack of attention that has traditionally been paid to regulating direct-to-consumer (DTC) marketing of medical devices, FDA in early November held a public hearing to seek input on whether the agency needs to revise its approach to the promotion of medical products, including restricted devices.

ArthroCare Corp. (Austin, TX) this month reported that its third-quarter revenues climbed to a record $53.6 million, up 40% from the year-ago period. The company, which manufactures surgical tools based on its patented Coblation technology, attributed more than half of this growth to its string of acquisitions, including the most recent purchase of Applied Therapeutics Inc. (Tampa, FL).

More information on ArthroCare’s technology and strategy for future growth can be found in the November/December 2005 issue of MX. This issue’s cover story features an interview with Michael A.

The U.S. healthcare equipment leasing market is expected to grow to more than $8 billion by 2007 in terms of annual new business, according to a study released by the Equipment Leasing Association (ELA; Arlington, VA). Growth in the leasing market will be led by information technology systems and outpatient care equipment, according to the study, which was one of two reports on healthcare leasing released concurrently.

"These two studies provide thorough insights into the drivers of healthcare equipment leasing," says Ralph Petta, vice president of industry services for ELA. These drivers include continued growth in the

Investment in Midwestern healthcare start-ups grew 21% in the third quarter of 2005, compared with a national rise of 4% during the period, according to recent data from BioEnterprise (Cleveland). According to the group’s venture investment report, companies in Midwestern states received investments totaling $144 million during the third quarter of the year, up from $119 million in the second quarter.

"The numbers continue to demonstrate strong deal flow in the Midwest region," says Baiju Shah, president of BioEnterprise, an organization that supports the growth of the region’s bioscience companies. "Of particular interest this quarter was the number of biotechnology

The Massachusetts Medical Device Industry Council (MassMedic; Boston) this month honored six local medical technology companies as part of its first-ever Medical Device Innovation Awards program. The program is designed to recognize Massachusetts-based businesses whose novel medical technologies contribute to improved patient outcomes, enhanced medical procedures, and reduced healthcare costs.