Possis is best known for its mechanical thrombectomy devices that are used to treat narrowed or blocked arteries and veins. Medrad believes the firms have "highly compatible sales organizations" and "shared target customer groups." Medrad is also known for winning the Malcolm Baldridge National Quality Award in 2003.

The CryoValve SynerGraft Pulmonary Valve and Valved-Conduit Allograft has been cleared for use in patients who need their pulmonary valve replaced as a result of disease, malformation, or the malfunction of their pulmonary valve. The graft could potentially be helpful for children, because allograft heart valves avoid the need for taking blood-thinning drugs for long periods of time.

The device is also smaller and thinner than previous models, and on medium setting can go two weeks without having to be recharged. Medtronic intends to begin selling the device by the end of the month.

The state is looking in to whether the companies and the doctors involved in the products clinical trials divulged the doctors' financial stake in the product to FDA. About half of the 17 trial sites had doctors who stood to benefit financially if the product succeeded. Viscogliosi Brothers says it made all the necessary disclosures. As I have stated before, it is inevitable that there will be doctors who have financial stakes in the devices they help develop. That in and of itself is no big deal and shouldn't be treated as such. But proper disclosures are crucial, as failure to make them undermines public trust in medical technology.

President Bush has proposed a $2.4 billion budget for FDA in fiscal year 2009, a 5.7% increase over the current year. That figure includes funds from user fees; without it, the budget comes to $1.77 billion. It includes additional funds targeted at improving the safety of medical devices and other FDA-regulated products, and implements programs to be funded by user fees as per the FDA Amendments Act of 2007. But is it enough? Some think not. The Alliance for a Stronger FDA recommends that Congress appropriate $2.1 billion instead of $1.77 billion. An alliance spokesman said that the appropriation is "barely half" of what the agency needs just to keep up with inflation. (The alliance was formed from a merger of two groups, the FDA Alliance and the Coalition for a Stronger FDA.) FDA's responsibilities have increased dramatically over the past 20 years, but its funding has not kept up at the same pace. The government is faced with a choice: Either give the agency the money it needs to perform its mission, or scale back its mission. Perhaps some combination of both is warranted.

CDRH Director Daniel Schultz said approval was granted after the center reviewed "a substantial amount of clinical evidence." Nothing less would have flown in today's climate. Indeed, Medtronic showed the agency data from a whopping seven trials. Their findings included positive data on the device's performance in regards to heart attack, cardiac death, and repeat procedures to re-open the coronary artery. Also importantly, blood-clot risk was similar to that for bare-metal stents. However, the agency advises patients to take blood-thinning medication for at least six months after the procedure. Also good news for Medtronic is that the DES market appears to have bottomed out. The Wall Street Journal reports that the market share for drug-eluting stents is no longer falling. It held steady for all four quarters of 2007.

The doctor can then use those patterns to assist him or her in coming up with an optimal therapy. The recorder may be particularly useful for patients who have inconsistently high and low glucose levels.

NEED TO KNOW

Davis-Standard LLC (Pawcatuck, CT; www.davis-standard.com) will host a workshop entitled, "The Basics of Plastics Extrusion" on April 1 and 2 at the company's headquarters in Pawcatuck. The two-day class covers the fundamentals of plastics extrusion, as well as the composition and properties of various polymers and the mechanics of downstream processes. Topics include extrusion system components, temperature control, maintenance, and screw design.

"On day one, we'll concentrate on how to use the single-screw extruder, which is perhaps the most common type of extrusion equipment," says Simon Dominey, a business manager at the company. "On day two, we'll touch on various extrusion processes."

In addition to instruction, course participants will benefit from touring the company's laboratory and manufacturing facilities and meeting polymer process engineers and technical specialists. Course books are included with the enrollment fee, which is discounted for groups of three or more. Class size is limited to promote discussion among students and teachers.

Davis-Standard designs and manufactures complete extrusion systems for flexible medical tubing. The systems incorporate advanced bump-tubing technology for both single- and multilumen tubing, together with microbore, encapsulated, braided, jacketed, and coextruded tubing. The company's patented feed-screw designs yield products using all types of polymers and blends.

For more information, contact Dominey by e-mail at sdominey@davis-standard.com. To enroll, visit www.davis-standard.com.

NEED TO KNOW

In an effort to further position itself in the North American market, Invetech (Melbourne, Victoria, Australia ; www.invetech.com.au) has opened a 15,000-sq-ft facility in San Diego . Specializing in instrumentation, disposables, and custom automation and engineering, the company has experience in medical device manufacturing, including work on such applications as a supercapacitor and a mobile x-ray imaging system.

The Australian company has had an active business development team in place in North America since 2002. However, it hopes to build on its established U.S. client base by offering design, engineering, and contract manufacturing services from the convenient California facility. "Our new office extends our skills, expertise, and proven experience, allowing us to better bridge the gap between research, product development, and manufacturing," says Jari Palander, company vice president. "From this base, a more responsive and flexible approach enables us to deliver the best outcome for our client -commercial success."

Invetech anticipates that the Southern California location will further bolster its offerings to North American OEMs owing to the strong high-tech and medical device manufacturing presence in the region. "The facility will have the infrastructure necessary to provide an expanded local service to our clients, including a range of specialized development labs, workshop, and contract manufacturing production area," says Richard Grant, who will serve as vice president of operations at the San Diego plant.

Earlier this month, the Bush administration announced a proposed FDA budget of $2.4 billion for the 2009 fiscal year. The administrations proposal represents an increase of $129.7 million, or 5.7%, above current funding. The request includes a $50.9 million increase in budget authority and $79 million increase in industry user fees. Under the president's proposal, FDA's Center for Devices and Radiological Health (CDRH) would receive $290.9 million—an increase of $7.14 million, or 2.5% more than in FY08.

	Grossman: A strong case for greater funding.

Almost as soon as the Bush proposal was announced, it was met with a barrage of criticism from members of congress, professional societies, trade associations, mainstream media outlets, and a wide range of other stakeholders and advocacy groups. A leading critic and organizing force in seeking greater funding for the agency is the Alliance for a Stronger FDA (Silver Spring, MD), whose 177 members represent industry groups; nonprofit organizations; medical device, pharmaceutical, and related life science companies; three former secretaries at the Department of Health and Human Services; and six former FDA commissioners.

Describing the administration's budget proposal as “not only inadequate, but barely half of what FDA needs just to keep pace with inflation,” the alliance called for “budget levels that strengthen the agency and reflect the realities documented by a number of recent assessments.”

One of the assessments cited by the alliance and others seeking increased FDA funding is a November 2007 report prepared by a specially commissioned subcommittee of the agency's Science Board. The detailed, 300-page report, FDA Science and Mission at Risk, was adopted by the full board in December and received widespread attention in both industry and the general-interest press.

Requested by F DA Commissioner Andrew Von Eschenbach in 2006, the report's central finding is that FDA is in a “precarious position” and suffering from serious scientific deficiencies that threaten the agency's ability to meet “current or emerging regulatory responsibilities.” The report's central thesis is that FDA's resources have not kept pace with its increasing responsibilities.

	AdvaMed's Ubl: A good start.

Citing the Science Board report and its positive reception among policy makers on both sides of the aisle, Steven Grossman, deputy executive director of the Alliance for a Stronger FDA, says that the agency's FY09 funding will likely be increased as the budget works its way through Congress. “We believe we have a strong case for increased funding. We have the support of industry groups; medical device, drug, and other firms; nonprofits; and a host of other advocates and supporters. Basically, everybody is on board.”

Commenting on the administration's proposed funding for FDA's medical device related activities, Grossman says, “CDRH doesn't do so well in this budget. Nobody does, but CDRH does particularly poorly.”

	AdvaMed's Trunzo: Varying needs.

Although many advocacy groups joined the alliance in taking a hard-line position on the Bush budget proposal, the two leading medtech industry associations—which are both alliance members—offered more measured responses. Stephen J. Ubl, president and CEO of AdvaMed (Washington, DC), said he “appreciated the President's proposal to increase funding for the FDA . . . which would enable the agency to expand its resources to fulfill its mission to promote and protect the public health and to oversee the increasingly sophisticated medical technologies that play such a vital role in improving patient care.” Pleased with the balance between appropriations and user fees, Ubl continued, “While this additional funding is a good start, the FDA could benefit from additional increases in appropriations to better prepare for the future and to perform its core functions.”

Elaborating on AdvaMed's position, Janet Trunzo, executive vice president of technology and regulatory affairs, added, “There is no question that FDA could use additional appropriations to upgrade its infrastructure and to enhance its expertise to deal with the rapidly evolving pace of medical technology and pharmaceutical innovation. However, centers within the agency have varying needs for resources. For the device center, additional resources could be used for IT infrastructure, critical path projects, and enhancing scientific expertise.”

	MDMA's Leahey: Balancing needs.

Mark Leahey, executive director of the Medical Device Manufacturers Association (Washington, DC), said, “We're relatively pleased with the funding proposal for CDRH, particularly with respect to keeping the user fees in balance. While we believe that CDRH could definitely use more evaluators to review submissions, we do not especially see FDA's device-sector needs as perhaps as pressing as what appear to be legitimate concerns regarding FDA's oversight activities involving food, drugs, and other areas.”

Echoing the conclusions of the Science Board report, many agency observers agree that FDA's mission and scope have significantly expanded over the past 25 years. To carry out such increased responsibilities, some argue that the regulatory agency should receive increased funding from Congress rather than increased user fees. Or, failing such additional appropriations, that the agency's mission should be modified or scaled back.

	Freiberg: Setting agency priorities.

Glen Paul Freiberg, president of RCQ Consulting (Rancho Santa Fe, CA) recognizes that FDA has legitimate concerns, particularly with regard to the need for more staff for product reviews and inspections. “The agency needs more primary reviewers for device submissions, and resources in the field for both domestic and foreign manufacturing facility inspections.”

But Freiberg contends that the agency also needs to set limits on its demands for new resources. “FDA needs to adopt more business-oriented analysis methods, particularly with regard to the application of resources to perform its primary mission—that is, determining, prioritizing, and differentiating what it needs to do rather than what would be nice to do,” he says. “As in business, this could and should result in the reallocation of some resources and the elimination of others, to open slots for the primary mission tasks.”

Information about the proposed FY09 budget is available from the FDA Web site at www.fda.gov/oc/oms/ofm/budget/documentation.htm.

© 2008 Canon Communications LLC

Return to MX: Issues Update.