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Shuren is “Acting” No More, Named CDRH Chief

After months of the word “acting” in front of his title, the U.S. Food and Drug Administration (FDA) has named Jeffrey Shuren, M.D., J.D., as permanent director of its Center for Devices and Radiological Health (CDRH). FDA Commissioner Margaret Hamburg, M.D., appointed Shuren to the job on a permanent basis on Jan. 20.

In recent years, the device division of the agency has been widely criticized by lawmakers, industry watchdog groups and consumers for controversial approvals and review practices, as well as for being too cozy with device makers.

Shuren had served as acting head of the unit since CDRH’s former director, Daniel Schultz, was pressured to resign in August 2009 after more than 15 years with the agency. (See Schultz’s latest job move in People News on page 90.) Shuren has held various positions with the FDA since 1998, including associate commissioner for policy and planning. In a previous job, he oversaw development of Medicare’s national coverage decisions for medicine and non-implantable devices.

Notably, the Institute of Medicine currently is evaluating—in a $1.3 million project due to be completed in 2011—CDRH’s 510(k) approval process. The agency also has undertaken an internal review. Hamburg has made no secret of her intent to shake things up within the agency and clean house at CDRH. The device unit’s priorities for 2010 will include strengthening product reviews and increasing transparency about decision-making, according to documents posted on the FDA’s Web site.

In a statement released by the Advanced Medical Technology Association (AdvaMed), Steve Ubl, president and CEO, said the trade group looks forward to working with Shuren and said he has shown “effective leadership skills” and has clearly established his goals for regulatory approvals, adapting to changing technology and resolving internal disputes.  “As one of the key negotiators during the reauthorization of the Medical Device User Fee Act, Dr. Shuren demonstrated he understands the unique needs of the medical technology industry,” Ubl said. “His more than 10 years experience at FDA, in various high-level policy and planning positions within the commissioner’s office, will serve him well as he takes control of an organization that oversees such a wide range of lifesaving and life-enhancing products.”

Welch Allyn Opens New Facility in Asia

Medical diagnostic equipment manufacturer Welch Allyn will design next-generation digital connected products specifically for Asian and emerging markets at a new international research and development facility in Singapore.

The company’s recent move to a larger facility comes just six years after it opened its first Asia-based research and development center in Singapore, which was the Skaneateles Falls, N.Y.-based company’s first such venture in the Asia-Pacific region.

“We chose to establish our first Asia-based research and development facility in Singapore because of the exciting opportunities it offers our business,” said Julie Shimer, president and CEO of Welch Allyn. “We have been pleased with the progress made thus far and are eager to build on our successes at our new facility.”

Shimer said the move is a key component of the company’s strategic objective to expand its global reach. Singapore’s “skilled talent and vibrant infrastructure” make it an attractive location, company officials said, adding that the company chose Singapore over other locations in Asia because of its position as a “leading site” for biomedical research, its highly educated workforce, its close proximity to major markets in Asia, and strong government support.

“Relocating to a larger facility in Singapore reaffirms our commitment to the region,” Shimer added.

Welch Allyn currently has four other research and development facilities located in North America and Europe. (Learn more about Singapore’s expanding medtech market and OEM-supplier partnerships on page 82.)

BSX Settles DOJ Probe, Pays Fine

In late December, Natick, Mass.-based Boston Scientific settled a U.S. Department of Justice (DOJ) investigation by paying a fee and signing an integrity agreement. The company agreed to pay $22 million in a civil settlement and sign a corporate integrity agreement related to its pacemaker business. According to the DOJ, the company will disclose on a Web site any payments to physicians.

The DOJ has been investigating Guidant Corp. for trying to boost sales by paying physicians between $1,000 and $1,500 to participate in one of four studies the company claimed were designed to assess the performance of pacemakers and defibrillators. In reality, the company was paying doctors to select Guidant devices over competing products, the government said.

Boston Scientific, the world’s biggest maker of heart stents, purchased Guidant in 2006 for more than $27 billion. At the time, Fortune magazine characterized the deal as the “second worst deal ever,” saying that Boston Scientific paid too much for the company. The investigation began in 2005 and included no admission of wrongdoing, Boston Scientific said in a press release.

“Although medical device and pharmaceutical companies can use postmarket studies legitimately to obtain information about how their products work in the field, they cannot use those studies, and the honoraria associated with them, to induce physicians to use their products,” said U.S. Attorney Carmen Ortiz.

In November, Boston Scientific agreed to pay $296 million to settle a separate DOJ investigation into product recalls issued by Guidant. In a separate regulatory filing, it said it received a subpoena from the U.S. Department of Health and Human Services, Office of Inspector General, to produce information about donations made by the pacemaker division of the company to charities with ties to physicians and their families.

FDA Opens Mexico Office

As part of its continuing effort to bolster its food and medical product safety and work with regulatory counterparts overseas, the U.S. Food and Drug Administration (FDA) recently opened an office in Mexico City. It is the agency’s third post in Latin America and its tenth international post in the past 13 months.

“The opening of this office represents an important step as we redesign our product safety strategy,” said FDA Commissioner Margaret Hamburg, M.D. “We, like our partners in the Mexican government, realize that prevention is the key. For example, more than a third of the fresh fruits and vegetables we eat come from Mexico, as do a large amount of our medical devices. Having FDA experts located permanently there will be mutually beneficial to both our countries and respective citizens.”

Staff assigned to the Mexico City post will work with their counterparts in the Mexican government to harmonize regulations and guidance standards and to work on other collaborative initiatives, according to the FDA. Collaboration will include sharing information on regulatory systems, as well as joint workshops on the safety of food and medical products.

FDA staff also will offer collaboration on the use of the latest laboratory techniques, foster other collaborative initiatives to ensure the safety of food and medical products marketed in the two countries, and be a “portal” to the FDA for counterpart Mexican agencies and the U.S.-export industry in Mexico.

According to Murray Lumpkin, M.D., the FDA’s deputy commissioner for International Programs, FDA staff also will work with industry in Mexico.

“Experts in Mexico City will work closely with local industries that ship food and medical products to the United States to improve their understanding of U.S. safety and product quality expectations,” he said. “Their activities will include providing technical advice and working with government agencies and the private sector to develop certification programs.”

To date, the FDA has opened 10 international posts, including posts in China, India, Europe, and Latin America, along with its U.S.-based staff. The other posts in the Latin America are located in Santiago, Chile, and at the FDA’s Latin America Office headquarters in San José, Costa Rica.

New Indication Approved for Thoratec’s HeartMate II

Thoratec recently received thumbs up from the U.S. Food and Drug Administration (FDA) for an additional indication for its HeartMate II. The agency approved the heart pump for patients with severe heart failure who cannot receive a transplant.

HeartMate II is a battery-powered device implanted in the chest, helping the heart’s lower left chamber pump blood throughout the body. According to the FDA, the approval was based on a company study showing 46 percent of patients implanted with the device were still alive two years later, compared with just 11 percent of patients not receiving the device. HeartMate II is a smaller version of the company’s original HeartMate model.

“This is truly a momentous day for the hundreds of thousands of underserved advanced-stage heart failure patients,” said Gary Burbach, president and CEO of Thoratec. “Those who now have access to the device owe a great deal to the patients and clinicians who participated in this landmark trial.”

Government regulators previously approved HeartMate II in April 2008 as a temporary treatment for patients awaiting transplant. “Its smaller size and mobility should allow more patients, including women and men of smaller stature, access to treatment,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.

Industry analysts, however, have said there is a larger opportunity for the device with patients who are not eligible for transplant because they have a limited life expectancy.

For example, Rick Wise, an analyst with Boston, Mass.-based firm Leerink Swann, predicted the market for the new indication at $2.5 billion, compared with just $250 million for patients using the device as a bridge to transplant. Wise predicted a 15 percent compound annual growth in sales for the company through 2012 as a result. Thoratec reported overall revenues of $87.9 million in the third quarter of 2009 (the most recent available as of press time) compared to $80.8 million in the third quarter of 2008, an increase of 9 percent. Cardiovascular Division revenues were $65.1 million compared to $57.1 million in 2008, an increase of 14 percent. For the first nine months of 2009, Cardiovascular Division revenues were $198.9 million versus $154.8 million in the first nine months of 2008.

The device was approved, however, with a condition. The FDA asked Pleasanton, Calif.-based Thoratec to conduct a post-approval study. Company officials said they would start a rollout of the device immediately. Thoratec has agreed to a study of 247 patients who will be followed until they reach an outcome or two years, whichever occurs first. In addition, the company plans to conduct a second small study to collect data regarding the relationship between bleeding and blood clotting in left ventricular assist device patients.

Symmetry Shutters Plant, Restructures

Symmetry Medical Inc. will close its plant in Auburn, Maine, and consolidate its operations into other facilities as part of a broader restructuring program. The consolidation is slated to be complete by the middle of 2010, and the company did not release any information on how many employees would be affected. The consolidation will include the transfer of current production capacity, including equipment and machinery.

Company execs said the move would better position the company for the anticipated recovery of the orthopedic sector.

With this move, the Warsaw, Ind.-based manufacturer of orthopedic implants, instruments and cases hopes to streamline its business and reduce costs. The restructuring, once complete, is expected to generate annual cost savings of approximately $3.4 million. The total one-time cost of the plan will be $2.4 million to $2.8 million, according to Symmetry.

“These decisions are difficult under any circumstances, and we recognize the personal impact they have on those dedicated employees who have made contributions to the success of our business,” said Brian Moore, president and CEO of Symmetry. “We are committed to treating them fairly and with respect throughout this process.”

Symmetry has facilities throughout the United States and Europe, in addition to a plant in Malaysia.

Medical Device Industry Responds to Haiti

Responding to the devastating earthquake that hit the Caribbean nation of Haiti on Jan. 12—the most severe to strike the country in 200 years—the medical device industry has proven that its charitable side is stronger than a magnitude of 7.0. Medtech firms have been quick to support relief efforts, donating millions worth of dollars in aid and much-needed medical supplies.

“There are still thousands of patients with major fractures, major wounds, that have not been treated yet,” said Eduardo de Marchena, M.D., a University of Miami cardiologist who oversaw a tent hospital near the airport where hundreds of severely injured people were being tended, told The New York Times. “There are people, many people, who are going to die unless they’re treated.”

Partners in Health, an organization that has been providing health care in Haiti for two decades, estimated that 20,000 Haitians were dying daily from lack of surgery. But that figure was not backed up by other aid organizations in Haiti and appeared to be much higher than other estimates of the continuing death toll from injuries.

Some of the medical device firms donating money and supplies, include:

• Abbott Laboratories, of Chicago, Ill., will donate a total of $2.5 million in cash, pharmaceuticals and nutritional products.

• Becton, Dickinson & Co. is donating $550,000 in cash and matching employee contributions and plans to ship another $500,000 in medical equipment, including needles, syringes, IV catheters and blood collection tubes. The Franklin Lakes, N.J.-based firm will split $250,000 between the American Red Cross and the U.S. Fund for UNICEF. Another $250,000 will go to Partners in Health, AmeriCares, the Catholic Medical Mission Board, Direct Relief International, Heart to Heart International, Project HOPE and Save the Children.

• CareFusion, based in San Diego, Calif., will donate 100 CareFusion ventilators and 200 infusion pumps. Additionally, the company has purchased and will donate 100,000 bottles of silver dihydrogen citrate, a water purification product that can purify and make drinkable up to 20 million gallons of water. CareFusion’s donation is valued at approximately $3.1 million.

• Hanger Orthopedic Group, in Bethesda, Md., and its philanthropic organization The Hanger Ivan R. Sabel Foundation will provide $250,000 in funding and orthopedic devices. A direct cash donation of $25,000 and a contribution of $225,000 in orthopedic devices, including neck and back braces, limb immobilizers, fracture boots, wrist splints, and cervical collars, will be donated to two charitable organizations currently providing care in Haiti—Physicians for Peace and Project HOPE.

• Kinetic Concepts Inc., of San Antonio, Texas, will contribute more than $2 million worth of advanced wound care products, collaborating with the Surgical Implant Generation Network and Project Medishare to distribute the products. KCI also is developing a program to match donations made by its employees.

• Minneapolis, Minn.-based Medtronic Inc. pledged $1 million through the Medtronic Foundation. Contributions could exceed $1.25 million with product and employee donations. The foundation will match employee donations up to $250,000, with matching funds directed to Partners in Health. An additional $750,000 in grants will be directed to the rebuilding of healthcare infrastructure. The foundation currently is assessing potential nonprofit partners to lead those efforts. Employees worldwide also are offered five days of paid leave to assist in recovery efforts.

• Smith & Nephew, with U.S. headquarters in Memphis, Tenn., is donating more than $2 million in implants and surgical instruments to treat bone fractures. Supplies are being distributed by Hope Force International.