03.31.09
Industry News
AdvaMed unveils new advertising guidelines for medical devices.
The days of unrestricted medical device advertising are coming to an end. The Advanced Medical Technology Association (AdvaMed) has released guidelines to make advertisements for medical devices easier to understand. The guidelines, according to the trade group, are designed to present “clear and balanced” information to consumers and “encourage dialogue between patients and their physicians.”
“Our industry is all about patients. And I think everyone knows that today’s patients are voracious about information,” Stephen J. Ubl, AdvaMed president and CEO, said recently in a conference call with reporters from his Washington, D.C. office. “AdvaMed developed these principles because we believe direct-to-con-sumer (DTC) advertising can help improve patient outcomes by encouraging the exchange of information and empowering patients to take charge of their own health by initiating important discussions with their physicians.”
Ads for medical devices typically are not subject to as much scrutiny as pharmaceuticals. The Federal Trade Commission reviews ads for over-the-counter products such as bandages, while the U.S. Food and Drug Administration (FDA) regulates advertising materials for more serious medical devices (such as implants and stents) to ensure they are not misleading and contain information about risks. But device firms are not required to submit advertisements to the FDA before releasing them, and there are virtually no guidelines governing ads that may appear online.
AdvaMed’s guidelines, however, urge device manufacturers to voluntarily submit television commercials to the FDA for review. And while the guidelines apply to all types of media (print, broadcast, websites, and online videos), the provision that all advertising video be submitted to the FDA before release does not apply to online videos posted to company-owned sites or third-party Web sites such as YouTube.
In addition to expanding the FDA’s role in device advertisements, the guidelines promote the use of user-friendly language that is “appropriate for the intended audience,” and present information in a manner that is “free from distraction.” The guidelines also allow companies to use celebrities to endorse products, as long as the ads are truthful and clearly communicate when actors are being used.
The release of AdvaMed’s “Guiding Principles for Direct-to-Consumer Device Advertising” comes just six months after several members of Congress suggested that large-scale advertising of medical devices poses a greater risk to patients than pharmaceutical advertising. Sen. Herb Kohl (D-Wis.), held hearings on device marketing last fall, saying, “We need to be sure that people who are considering getting medical devices get as much information as they need from the right sources, so that they can make the proper decision.”
Though Kohl and Sen. Ken Salazar (D-Colo.) discussed possible restrictions on device ads at that hearing, no legislation has been proposed. In a statement he released after AdvaMed unveiled its guiding principles, Kohl said he will now closely monitor the ways companies implement AdvaMed’s strengthened policies.
MedPlast Adds to its Facilities in Arizona and New Jersey
MedPlast Inc. has expanded its operations in two states.
The Tempe, Ariz.-based contract manufacturer has expanded its mold manufacturing facility in West Berlin, N.J., to accommodate new equipment. The facility, which specializes in complex molds for the medical and industrial markets, has a new suite for two-shot molding that features high-speed CNC machining centers and electric discharge machines with robotic tool-changing capabilities. MedPlast invested $1.5 million to upgrade and redesign the New Jersey tool shop, according to company executives. The upgrade, executives noted, will allow the facility to shorten lead times on tooling, increase throughput and hold tighter tolerances.
MedPlast also rebuilt its headquarters in Tempe to add a 20,000-square-foot clean room and a 20,000-square-foot white room. Executives said the facelift was completed to help the company expand its array of services to the medical device industry. MedPlast conducts about 70 percent of its business with medical device customers, focusing largely on companies that manufacture surgical instruments and diagnostic devices.
Formed last year from the acquisitions of Applied Tech Products of Wayne, Pa., and K&W Medical Specialties of Westfield, Pa., MedPlast manufactures precision molded plastic and rubber components to the healthcare and commercial markets. It operates five plants that contain more than 200 rubber and plastics molding machines. Its plants in Arizona and New Jersey produce trocars, staplers, autosutures and other handheld single-use devices, as well as medicinal applicators and handheld diagnostic equipment for the women’s health market.
ATEK Medical Officially Opens Costa Rica Facility
After several years of laying the groundwork for international expansion, ATEK Medical has opened the doors of its first overseas manufacturing facility.
On March 3, the company inaugurated its new 33,000-square-foot facility located in a Free Trade Zone nine miles north of San José, Costa Rica. The new plant specializes in Class II, single-use disposable medical device manufacturing, primarily for use in cardiovascular applications. The facility, which includes a Class 10,000 clean room, already is ISO 13485-certified and FDA-registered for medical device production.
Company leadership gathered with officials from Costa Rica’s government for a ribbon-cutting ceremony. Óscar Arias Sánchez, president of Costa Rica, was on hand for the event. He told his audience—after quoting lyrics from the Bob Dylan song “My Back Pages”—that “the status quo is not enough” and people must continually question norms and encourage change if they are to grow. “We could continue to be a small, little republic in the middle of the Americas, but that’s not who we are,” Sánchez said. He said that kind of mentality is necessary if a company or country is to be successful. Sánchez described a vision for Costa Rica—one of prosperity through measured but aggressive growth strategies that include a positive environment for business and foreign direct investment.
Marco V. Ruiz, the minister of foreign trade for Costa Rica said companies such as ATEK have helped his country “write a success story,” and outlined the role foreign investment has played. According to Ruiz, in 2008, the medical device sector exported $916 million and experienced growth of 26.4 percent compared with 2007. In addition, he said medical technology represented the fourth-largest export product category for Costa Rica. Though he acknowledged that times had become “more challenging,” long-term forecasts remain solid.
Chris Oleksy, president of ATEK Medical in Grand Rapids, Mich., echoed the optimism of his Costa Rican hosts.
“This is very exciting time for us,” Oleksy said, addressing a crowd of clients, press, company and local officials, and the new facility’s employees. “We’re very positive about what we’ve found in Costa Rica. We looked all over the world for our new facility—Mexico, the Dominican Republic, Ireland—and this was the best fit.”
He said the caliber of the local workforce helped to guide ATEK’s decision. The company currently has approximately 70 people at the new facility, but he said that number soon would become insufficient and more would be needed in the near future. The company’s long-term goal includes employing 150 or more workers at the existing location. In addition, plans already call for expansion this year by adding 5,000 square feet of modular class space. Oleksy said the move to Costa Rica strategically has positioned the company to better serve its clients’ domestic and international growth goals.
According to Kay Phillips, president of Minneapolis, Minn.-based ATEK Companies, the parent company of ATEK Medical, adding capabilities in Costa Rica was a forgone conclusion.
“Five years ago when I visited Costa Rica for the first time as a possibility for site expansion, we already had been considering a lot of different places,” she explained. “But when I came back, I had already decided that we’d have a plant here. I knew we still had to do the due diligence for other countries, but this beautiful country made sense to me. And just as I knew we’d be here, I know we’re going to be successful. As ATEK Costa Rica goes, so does the rest of our business. We’ll win as a team.”
Founded in 1979, ATEK Medical offers full-service manufacturing services for the medical, disposable, electro-mechanical and implantable device markets.
Report Predicts Neurosurgical Technology Growth
According to a new report from Life Science Intelligence based in Huntington Beach, Calif., the market for minimally invasive neurosurgical technologies for intracranial applications is expected to reach $3.7 billion by 2015.
Growth will be strongest in stereotactic radiosurgery and neurovascular embolization, according to the study. Stereotactic radiosurgery growth will be driven by new product introductions that yield better precision and accuracy while improving patient throughput. The report predicts that improved accuracy and precision will expand the treatable population, and greater patient throughput will provide an economic incentive for acquiring stereotactic radiosurgical systems. Upgrades and modules that allow the treatment of extracranial lesions also will boost product sales.
Neurovascular embolization technology, which include aneurysm coils, arteriovenous malformation embolics and accessories, also will see broader adoption in the next six years. Growth will be driven by the clinical benefits of minimal access, the introduction of advanced technologies that provide better occlusion while resisting coil migration, and increasing use in countries outside of the United States and Europe. The ability to deliver treatment using endovascular access will continue to shift procedure volumes away from surgical clipping for aneurysm patients, according to the study.
Advanced technologies, such as balloon catheters, stents, and new coil products, are expected to contribute to better clinical outcomes than older systems. Also, increasing use beyond domestic healthcare facilities and Europe, where these technologies already are well-established and have received broad adoption, will help to drive revenues through 2015.
The report seems to underscore a broad, developing trend toward minimal access in neurosurgery. It also analyzes neurosurgical endoscopy, intracranial shunts, and surgical clips for aneurysm and arteriovenous malformations. Companies covered include Accuray, B. Braun/Aesculap, Boston Scientific, BrainLAB, Elekta, ev3, Integra LifeSciences, Johnson & Johnson, Karl Storz Endoscopy, Medtronic, Micrus Endovascular, Terumo, and Varian Medical Systems.
SIDEBAR: BIOTECH IN BRIEF
Editor’s note: Advances in technology are increasingly blurring the lines between the medical device and lifesciences industries. In an effort to keep our readers up to date with the latest news in both sectors, Medical Product Outsourcing is introducing a new feature in this column called Biotech in Brief. This roundup of biotechnology/lifesciences news is intended to provide aglimpse at some of the most recent headlines in this burgeoning new industry.
Austin, Texas-based AeonClad Coatings LLC has launched a new subsidiary that will focus on biomedical applications. AeonClad Biomedical LLC will utilize the company’s AeonCoat dry coating technology to develop new products and coatings for the medical device market...Sequenom Inc., a genomic analysis company based in San Diego, Calif., has acquired SensiGen LLC in Ann Arbor, Mich., for $8.7 million in stock and cash. SensiGen developed advanced gene-based tests that can identify early biomarkers in people that signal the onset of major diseases…Bioscience jobs in Arizona grew by 23 percent between 2002 and 2007, according to data from Battelle, an Ohio-based contract research firm. Job growth occurred across all five subsectors that comprise the biosciences: medical devices and equipment; hospitals; research, testing, and labs; drugs and pharmaceuticals; and agriculture feedstock and chemicals…Not to be outdone, BioOhio released its own report showing the importance of bioscience and healthcare to the state’s economy. In 2007, according to the report, bioscience had a $148.2 billion impact on the economy, and generated (both directly and indirectly) 1.4 million jobs for the state…California’s bioscience industry is not to be discounted. A study by BayBio, a trade association based in the northern part of the Golden State, concluded that medical treatments developed by California-based life-sciences firms increased 31.5 percent between 2007 and 2008...The Wisconsin Biotechnology & Medical Device Association has changed its name to BioForward. The organization also has implemented a new logo and tagline: “Where innovation and opportunity connect for Wisconsin.” BioForward soon will launch a new Web site….the North Carolina Biotechnology Council will dole out $2.5 million over the next four years to establish a new program to grow the state’s medical devices sector. The grant will be used to establish a Center of Innovation for advanced medical technologies.
SIDEBAR: ISO CERTIFICATIONS
• Kimball Electronics Group Inc., a contract manufacturer of durable electronics for the medical, automotive, industrial and public safety markets, has received ISO 13485:2003 certification. The official recognition was awarded to the company’s facility in Jasper, Ind. Created in 1961, Kimball Electronics Group manufactures a variety of products for the medical device market, including diagnostic imaging equipment, defibrillators, ultrasound and laboratory equipment, and tools that measure glucose, respiration and vital statistics. The firm is a subsidiary of Kimball International Inc., a manufacturer of home, healthcare and hospitality furniture.
• Lionbridge Technologies Inc., a medical device company that provides translation, development and testing services, has received ISO 13485:2003 certification. The 13-year-old company is based in Waltham, Mass.
• ISO 13485:2003 certification has been awarded to maxon Motor, a Fall River, Mass.-based supplier of high-precision drive systems.
• MedPro Safety Products Inc., a Lexington, Ken.-based company that develops and markets medical safety devices, has been granted ISO 13485:2003 certification. MedPro CEO and Chairman Craig Turner said the firm achieved the certification in seven months.
• Contract manufacturer PMC Medical has received ISO 13485:2003 certification. The 80-year-old company is headquartered in Cincinnati, Ohio, and has manufacturing facilities in Shelbyville, Ind.; Guanajuato, Mexico; and Wiesau, Germany. It also has a sales and marketing department in Detroit, Mich.
• Sunburst Electronics, a contract manufacturer of electronic controls based in Erie, Pa., has been awarded ISO 13485:2003 certification. The company also upgraded its ISO 9001: 2000 certification to the 2008 standard.