Medical Device Link.

When the 1980s ushered in the information technology (IT) revolution—which roared across many industries with unprecedented efficiency and productivity gains—healthcare, for the most part, was a nonparticipant. However, over the past decade, there has been a growing recognition of the need to integrate IT into the broad spectrum of clinical care. As the movement has gained momentum, it has been accompanied by a proliferation of standards organizations, government initiatives, professional societies, and other advocacy groups—all committed to the development of modern interoperable healthcare networks that promise to improve the quality of care while reducing errors and lowering costs. In this issue, MX: Issues Update examines the progress of current healthcare IT initiatives and provides a glimpse of those on the horizon. [More]

Moving away from proprietary standards, which have long stymied connectivity initiatives in medical technology, Continua intends to advance open architecture and the use of common interfaces and communication protocols. Products developed in compliance with Continua guidelines will be certified and promoted with an identifying logo. The first such products are expected to appear in 2008. [More]

"This law recognizes the value and contribution of the medical device industry to the state's high-technology sector and its overall economy," said Thomas J. Sommer, president of the Massachusetts Medical Device Industry Council (Boston), a statewide trade association that originally developed and proposed the legislation. "We believe it will provide additional incentives for companies to grow and expand their operations here." [More]

"Moving to ICD-10 is not an if, but rather a when," says Jo Ellen Slurzberg, vice president of reimbursement and health policy for Almyra Inc. (Boxborough, MA). "The current system is antiquated and the United States really pales in comparison to the rest of the Group of Eight world powers. All of the other G8 countries—Canada, France, Germany, Italy, Japan, Russia, and the United Kingdom—have already moved on to ICD-10 for diagnosis codes. U.S. adoption is just critical from a safety and world health perspective." [More]

"In the short term, we expect to gain equipment market share and to grow the installed base by expanding our product offerings with an accelerated innovation rate and a lower-cost supply chain," said Jouko Karvinen, member of the Philips board of management and CEO of Philips Medical Systems. "Intermagnetics' leading positions in the high-growth and high-value markets of radiofrequency coils and MRI patient monitoring will enable us to build unique solutions for our customers. In the longer term, we believe that MRI technology will become important in molecular imaging, therefore positioning us well for the future." [More]

Noting that the exact scope of the latest investigation is unclear, Jan Wald, medical technology analyst with A.G. Edwards Inc. (St. Louis), says the DoJ's new inquiry may go beyond the scope of the previously initiated investigation. "The March 2005 probe was primarily focused on the relationships—some would say cozy relationships—between implant manufacturers and orthopedic surgeons," he says. "This latest round may well focus on company-funded research studies that are actually marketing programs. But the larger issue that may emerge is the presence of an oligarchy, in which a few powerful companies control the prices of hundreds of implants for thousands of patients." [More]

Last year, Boston Scientific (Natick, MA) paid $750 million to settle patent litigation with its former business partner, Medinol (Tel Aviv, Israel), over the design of cardiac stents. Earlier this month, Medinol got another windfall when Abbott Laboratories agreed to settle a similar lawsuit over cardiac stent design. Financial terms of the settlement were not disclosed, but the deal opens the door for Abbott to move forward with the European launch of its Xience drug-eluting stent. Abbott and Medinol weren't the only medtech companies talking settlement this month. [More]

Issues surrounding group purchasing organizations, gainsharing, changes to current patent rules, and other governmental moves took center stage at last month's annual meeting of the Medical Device Manufacturers Association (Washington, DC). Over the course of two days, attending medical technology executives heard from more than two dozen policymakers, policy experts, and other specialists regarding the current state of federal regulations and initiatives affecting the medical device industry, as well as changes that may lie on the horizon. [More]