In This Issue

Coalition Urges Adoption of MIRA Reforms

In September, key industry associations got the support of nearly 30 patient advocacy organizations in urging that provisions of the Medicare Innovation and Responsiveness Act of 2003 (MIRA) be retained in the Medicare reform bill currently under deliberation in Congress.

Medicare issues: Patient advocacy groups supporting industry call to retain MIRA reforms (click image to enlarge).

The message was delivered in a letter to the bill's conferees in the House and Senate, calling on Congress to pass legislation to expedite Medicare's reimbursement process and make new medical technologies available to patients in a shorter amount of time. "Fair and adequate reimbursement for new technologies saves lives, lowers the cost barriers faced by hospitals, and encourages further investment in the research and development needed to produce advancements in medical technology," the letter noted.

According to industry association AdvaMed (Washington, DC), Medicare patients currently face delays of 15 months to 5 years in gaining full access to new, FDA-approved medical tests and treatments.

Industry associations signing the letter included AdvaMed, the Biotechnology Industry Association, the Pharmaceutical Research and Manufacturers Association, and the Healthcare Leadership Council.

The bipartisan MIRA legislation was initially introduced in the House by Representatives Jim Ramstad (R–MN), Anna Eshoo (D–CA), and Joseph Pitts (R–PA) in February. Similar Senate legislation was introduced in April by Senators Rick Santorum (R–PA) and Blanche Lincoln (D–AR). Many of MIRA's provisions remain under consideration as part of the Medicare Prescription Drug and Modernization Act of 2003 (H.R. 1), which is currently being negotiated in Congress. A decision on the entire bill is expected before the end of this year.

Mannen: Affirmative changes required.

Ted Mannen, managing director of Aventor (Washington, DC), a medical device and pharmaceutical consultancy, says that adoption of the MIRA provisions would help to make the reimbursement system more receptive to new medical technologies. "For innovative new products to be appropriately recognized for reimbursement purposes, there need to be affirmative changes to reimbursement classifications and payment amounts," he says. "They have to be adjusted to account for a continual flow of new information and innovations. The MIRA provisions would help systematize these needed adjustments."

Among other reforms, the act calls on the Centers for Medicare and Medicaid Services (CMS) to set reasonable deadlines for implementation of national coverage, coding, and payment decisions, and to reduce delays in setting adequate payment for new medical technologies used in inpatient settings (currently running between 2 and 4 years).

The act would also require CMS to cover routine-care costs associated with FDA-approved clinical trials; establish a council for technology and innovation to improve the coordination of coverage, coding, and payment decisions; and reduce delays in the Medicare appeals process.

According to Ron Podraza, CEO of Reimbursement Principles Inc. (Littleton, CO), aspects of MIRA are valuable, but the legislation may not be necessary. Medicare has the mechanisms in place to deal with new technologies, he says, but it is stymied by a lack of funding.

"Congress insists that Medicare do more for new technologies, but it also insists that it can't cost the Medicare program overall any more money," Podraza says. "So for every step forward Medicare might take with new technologies, it takes a step backward in existing treatments. This is very difficult for the administrators of the Medicare program."

"CMS is taking its own initiatives to streamline the time it takes to make national coverage decisions," Podraza says. "Those initiatives may have been prompted by MIRA's appearance on the legislative scene, but this provision of the legislation is probably not needed at this point."

Slurzberg: Finding the right deadline.

Jo Ellen Slurzberg, vice president of Boston Healthcare Associates (Boston), agrees that the provisions of MIRA would streamline many reimbursement processes and add transparency to the system—particularly for the device industry—but she adds that the issue of setting timelines for CMS coverage decisions is complex.

"To ensure that patients have timely access to new technologies, CMS needs to adhere to deadlines for its coverage decisions," says Slurzberg. "The question is, 'what is the right deadline?' I don't think industry knows.

"According to the nature of the technology, the appropriate timeline for a coverage decision may vary widely," says Slurzberg. "The more clinically sophisticated or revolutionary the product, the more likely it is that those characteristics will have a dramatic impact on the appropriate length of an approval timeframe. And the time required for CMS to say 'yes' to a reimbursement decision is very different from the time it takes to say 'no.' The agency requires a great deal more due diligence to issue a positive decision.

"If deadlines are so inflexible that the agency is required to reach a decision regardless of whether its review is really complete, we will see many more noncoverage decisions," cautions Slurzberg. "The equally relevant issue is 'when is there enough evidence for CMS to reach a decision?' Lack of evidence is often cited as the reason for CMS delays, but there must be a happy medium when a decision can be reached, realizing that research is an ongoing process."

In addition, Slurzberg says, CMS and industry need to maintain the local coverage decision process, "so that decisions that really belong to the local carrier aren't automatically raised to the national level, creating a situation in which CMS is backlogged at the top. MIRA also includes a provision for contractor reform, which is extremely important."

Unfortunately, congressional mandates to make the Medicare program better rarely come with all the necessary resources, says Slurzberg. "Many manufacturers forget that CMS's authority is administrative—its job is to interpret and act on the legislation. That action is not always in line with industry expectations. And there are some things that the agency can't do administratively without additional resources."

However difficult to implement, proponents of the MIRA provisions nevertheless argue that mandated reductions in processing time could make a difference.

Executives at Thoratec Corp. (Pleasanton, CA), say that MIRA's provisions to reduce delays in the adoption of breakthrough technologies in inpatient settings could have made its heart-assist device available to critically ill patients sooner.

Grossman: A need for parallel progress.

Thoratec manufactures the HeartMate XVE left ventricular assist system, which is the only such device currently approved by FDA for use in patients too ill to undergo heart transplant surgery. The cardiovascular company waited about 14 months for CMS to issue a coverage and payment decision.

"We would have liked to see the process go faster," says D. Keith Grossman, president and CEO of Thoratec.

Based on its product's strong clinical trials, in July 2002 Thoratec filed a formal request with CMS to expand Medicare coverage for ventricular assist devices that are used for destination therapy, or permanent support. The following November, Thoratec received FDA approval to market the HeartMate system.

After several delays, CMS issued a decision earlier this month to expand coverage of heart-assist devices for destination therapy. CMS also raised the reimbursement amount by 25%, to a base level of approximately $70,000. According to Thoratec, payments to hospitals could be double that amount as a result of their geographical location and other factors.

Although CMS was cooperative with Thoratec, says Grossman, the decision-making process could be improved. "CMS covered a lot of ground with us, but the process is not quite there," he says.

Codifying review timelines for coverage and payment would be beneficial, Grossman says. "Instead of doing things in series, there's no reason why these two decisions cannot be considered in parallel."

According to the Medical Device Manufacturers Association (MDMA; Washington, DC), the clinical trial and new technology provisions are not the only proposals important to the device industry.

"Although MIRA would have been helpful legislation, MDMA is focused on the Medicare reform bill currently in conference," says Benjamin Wallfisch, MDMA policy director. "We are concerned that the legislation should support a strong and independent local coverage process that promotes medical device innovation. MDMA is also working to ensure that any competitive bidding program for durable medical equipment does not harm patient care or curb innovation."

In September, MDMA delivered a separate position paper to the House and Senate conferees, expressing the organization's views on the provisions of the Medicare reform legislation under consideration.

For Aventor's Mannen, the need for MIRA grows out of a fundamental mismatch between innovation and reimbursement systems. "The device industry is continually producing innovations that change healthcare," he says. "But reimbursement systems are resistant to change—they are static blueprints that can only reflect the knowledge that exists at a given point in time.

"No single piece of legislation is likely to be able to address all of the issues associated with the innovation and reimbursement mismatch," Mannen says, "because reimbursement is so complex and vast. But it's important to note that MIRA is both thoughtful and appropriately far-reaching—it addresses the issues that are high on industry's priority list."

Federal Circuit Revisits Festo

With market share and millions of dollars potentially hanging in the balance, medtech executives are keeping a wary eye on strategies for defending their companies' IP portfolios. According to experts in the field, some companies may have received a helping hand from a decision issued recently by the U.S. Court of Appeals for the Federal Circuit.

The September ruling modifies slightly the Federal Circuit's infamous Festo decision, which restricts the use of an intellectual property protection in patent disputes. It's not yet clear how significant the modifications will prove, but IP experts say they may have implications for IP and patent strategies at medical device firms.

Until 2000, patent holders could defend their IP through the use of the doctrine of equivalents, which offered protection beyond the literal language in the patent. The doctrine permitted a patent holder to successfully claim infringement if the technology in question was insubstantially different from that in the patent, even if it wasn't an exact copy.

But on November 29, 2000, in deciding the case of Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co. Ltd., the Federal Circuit decreed that the doctrine of equivalents is severely limited by the principle of prosecution history estoppel. In essence, that principle holds that if a firm amends a claim during the prosecution of its patent application, it cannot later use during a patent infringement case what it gave up as part of any such amendment.

After the Festo decision, the device industry and others that rely heavily on IP for corporate value worried that valuations would plummet if the doctrine of equivalents could no longer be used in many cases.

Wheeler: Judges know better.

Some relief came from the U.S. Supreme Court in 2002, when it outlined three exceptions that allow for use of the doctrine of equivalents. The first is if demonstrating equivalence was unforeseeable at the time of the patent-claim amendment. The second is if the rationale underlying the argument bears no more than a tangential relation to the equivalent. The third is any other reason the patentee "could not reasonably be expected to describe the insubstantial equivalent in question."

The latest Federal Circuit decision fleshes out those exceptions. Most prominently, it mandates that judges—not juries—must decide whether the doctrine of equivalents can be used. Patent holders, some experts say, can more easily sway juries, than judges.

"Juries will get in the mind-set that a government act took place, an examiner passed on this . . . and the inventor came out with a patent with a ribbon and seal. They see that the federal government decided the inventor was entitled to a patent, and it is presumed valid," says George Wheeler, a patent and IP attorney at McAndrews, Held & Malloy (Chicago). "In front of a jury, patent holders will play on that. By contrast, judges know that examiners can make mistakes and be bamboozled."

The most-recent decision offers some leeway for patent holders pursuing the first exception, allowing them to use expert witnesses and other extrinsic evidence to address the question of whether it was foreseeable to demonstrate equivalence at the time of prosecution.

But the decision allows only the prosecution history to be used in determining eligibility for the second exception, whether the subject matter is tangential. And it narrows the vaguely worded third exception to cases where "there was some reason, such as the shortcomings of language, why the patentee was prevented from describing the alleged equivalent when it narrowed the claim."

Hoffman: The burden is on the inventor.

Wheeler notes that successful use of the doctrine of equivalents has risen slightly each year after there were none in 2000, the year of the original Festo decision. However, experts say the doctrine still doesn't hold the power it once did, even with the exceptions in place.

After the recent court decision, "the doctrine of equivalents has a little more life in it than it did, but it is still pretty weak," says Perry Hoffman, a patent attorney with Michael Best & Friedrich (Chicago). "It's rather difficult to identify technology that was not foreseeable at the time of amendment. But at least now there's a basis for arguing; previously it was foreclosed altogether. It is possible to prove equivalence, but the burden is on the inventor to show it factually."

The decision's impact may vary depending on the age of the technology, says Barbara Wrigley, an attorney with Oppenheimer Wolff & Donnelly LLP (Minneapolis). "Medical device companies having patents on truly cutting-edge medical technologies (i.e., those that have no precedent in the prior art) will have an easier time proving that the accused equivalent was 'unforeseeable at the time the application was filed'," she says. "These companies will, more likely than not, be able to continue to successfully assert infringement of amended claims under the doctrine of equivalents.

Wrigley: A more difficult time.

"Conversely, a patentee having a patent with amended claims covering older, well-established medical technologies will have a more difficult time alleging infringement under the doctrine of equivalents," says Wrigley. "They probably will not be able to demonstrate that the accused equivalent was unforeseeable at the time of the application."

What device companies must understand about the new Festo landscape, says Mark Barrish, practice group leader for medical devices at Townsend and Townsend and Crew (San Francisco), is that "ignorance is not bliss. Some used to say they didn't want to know what was out there. But now it is helpful to know the field."

Another lesson, Hoffman says, is to "be realistic about what you try to claim. There is so much more value to getting a claim that does not have to be amended. If you get through unscathed, you are not subject to as much scrutiny. The upside to Festo is that it makes people think realistically about what they're really trying to patent, rather than going for broad claims that are not likely to get by."

Barrish: Ignorance is not bliss.

Other experts take a different tack on the issue. "The advice that if you never amend a claim, you won't have a problem with Festo, is only true to a point," says Wheeler. "I would suggest that patent owners and applicants work harder to get liberal claims. One way to do that is to get one claim issued, then keep the prosecution going and try to get broader claims."

One surefire way to get around the issue, Barrish says, is "if you have an application for an improvement to a device, describe it in your competitor's system. You've showed your improvement could have been foreseen to be used somewhere else. That can be devastating to your competitor."

But the most crucial thing to remember for the purposes of patent and IP strategy, Wheeler says, is not to rely on the doctrine of equivalents unless absolutely necessary. "It is meant to be a special thing that you might pull out if you can't prove literal equivalence," he says. "It's a life raft—not the boat."

2004 MDEA Competition Calls for Entries

Makers of innovative medical device and packaging products are invited to compete in the 2004 Medical Design Excellence Awards (MDEA) competition, which is now accepting entries.

The worldwide competition is open to companies and individuals involved in the design, engineering, manufacture, or distribution of finished medical devices or medical packaging products. To be eligible for the 2004 MDEA competition, products must be commercially available by December 31, 2003.

Now entering its seventh year, the MDEA competition has previously honored nearly 200 products. Gold winners in the 2003 competition included the Angel single-patient-use telemetry system (Medical Data Electronics; Arleta, CA); the Ascension metacarpalphalangeal joint implant (Ascension Orthopedics; Austin, TX); the OraQuick rapid HIV-1 antibody test (OraSure Technologies; Bethlehem, PA); the MammoSite radiation therapy system (Proxima Therapeutics; Alpharetta, GA); and the CORx integrated oxygenation system (CardioVention; Santa Clara, CA).

Entries are evaluated by a multidisciplinary panel of jurors with expertise in engineering, medicine, human factors, industrial design, manufacturing, and other design- and healthcare-related fields.

The competition accepts entries in 10 medical product categories, including critical-care and emergency medicine products; dental instruments, equipment, and supplies; finished packaging; general hospital devices and therapeutic products; implant and tissue-replacement products; in vitro diagnostics; over-the-counter and self-care products; radiological and electromechanical devices; rehabilitation and assistive-technology products; and surgical equipment, instruments, and supplies.

The standard deadline for entries in the 2004 MDEA competition is December 19, 2003. Parties who submit complete entries by November 8 may take advantage of reduced entry fees. Applications will be accepted through January 15, 2004, with the payment of a late fee. Complete rules and other information about how to enter the competition, including a downloadable entry form, are available via the MDEA Web site at www.MDEAwards.com.

Winning products will be announced in the winter of 2004, and honored with gold and silver awards at a ceremony held during the Medical Design & Manufacturing (MD&M) East Conference and Exposition, June 15–17, 2004, in New York City's Jacob K. Javits Convention Center.

The MDEA program is presented by Canon Communications, the publisher of MX and Medical Device & Diagnostic Industry, the program's sponsoring publication. Corporate sponsors of the 2004 competition include Avail Medical Products, DuPont Medical Packaging, the Medtech Group, and Nusil.

For more information about the 2004 Medical Design Excellence Awards competition, call 310/445-4200 or e-mail mdea@cancom.com.

Roche Molecular Growing in NJ Site

For Roche Diagnostics (Basel, Switzerland), deciding where to locate the manufacturing facilities for its molecular systems business unit was a tough call.

About seven years ago, Roche planned to move its entire U.S. molecular diagnostics business to Northern California. But in a reversal of course, the company has recently announced plans to invest $155 million in expanding its existing manufacturing operations in New Jersey. The company believes that the expansion will create the world's largest manufacturing facility for the molecular diagnostics industry.

The challenges faced by Roche are typical of those faced by medtech executives when deciding where to locate company facilities. Considering where to set up or expand manufacturing operations usually involves sifting through incentives offered by economic development agencies and evaluating critical criteria against the company's business strategy. Common concerns include a location's economic incentives, proximity to research facilities, and quality of life.

Towey: Maintaining acquired knowledge.

Robert Towey, senior vice president and general manager of East Coast operations for Roche Molecular Systems, says the company decided to keep its manufacturing facility on the East Coast in part because of the skilled workforce available in New Jersey. "It was important for us to maintain the acquired knowledge of the highly technical manufacturing processes required for Roche's products," says Towey.

"But if the company had moved to California, it would have lost approximately 85–90% of its workforce," he adds. "Attempting to rebuild that knowledge base in another state at a time when the company was experiencing its strongest growth would have been detrimental to our total business strategy."

Instead, Roche Molecular Systems moved its corporate headquarters, marketing, product development, and finance groups to Pleasanton, CA—but decided to keep its manufacturing operations on the East Coast.

The November/December issue of MX examines some of the key issues related to site selection for medtech manufacturers, and provides a review of current and emerging medtech hubs in the United States.

Site selection criteria that medtech companies often consider include proximity to research institutions and the availability of facilities. According to Towey, Roche originally planned to move its manufacturing to the West Coast in order to be closer to the company's research scientists, who are based in Alameda, CA. In addition, Roche had ready access to facilities in Pleasanton, which came with its acquisition of Boehringer Mannheim in 1998.

Still, the company chose to leave its manufacturing facilities on the East Coast. The company currently plans to expand its Branchburg, NJ, polymerase chain reaction manufacturing center to a total of 285,000 sq ft. The new facility will have a phased occupancy beginning in late 2004, and will employ up to 800 people. Construction on the site began in April.

In the end, says Towey, the temptation to move was outweighed by the benefits of New England's medical technology research cluster and New Jersey's economic development incentives, which include energy-conservation incentives and various employee-related tax breaks.

"The fact that Roche can draw scientists from Washington, DC, and Maryland up through the Boston area is a big plus," says Towey. "New Jersey itself has a lot of pharmaceutical companies that also have diagnostic businesses. So the scientific community here offers a lot to draw from."

An expanded version of the MX article on site selection for medtech manufacturers, "Home Base, U.S.A.," is available free to on-line users via the MX Web site at www.devicelink.com/mx.

GE Spending Spree Continues

Last December, when GE Medical Systems (GEMS; Waukesha, WI) announced its intent to buy Instrumentarium (Helsinki, Finland) for $2.33 billion, the deal was described as the company's largest acquisition ever—far eclipsing the $810 million purchase of Marquette Medical Systems in 1998. This October, on the day after that transaction closed, GEMS announced its intent to purchase Amersham plc (London) for an amount more than four times greater than the Instrumentarium deal—$9.5 billion.

GEMS CEO Hogan: Customer support.

Instrumentarium: Significant to Growth. Commenting on the acquisition of Instrumentarium, a leading supplier of anesthesia and critical care systems, Joseph M. Hogan, president and CEO of GEMS, said, "Instrumentarium is a leading innovator in the area of healthcare technology, with a strong focus in the perioperative area. The combination of Instrumentarium and GE positions us to support our healthcare customers with a complementary range of anesthesia monitoring and delivery, critical care, infant care, and diagnostic imaging solutions to help ensure the highest quality of patient care."

Wilson: Improving clinical workflow.

Dow Wilson, president and CEO of the GEMS information technologies business described the acquisition as "significant" to the company's growth. "This is an extremely important business for GE, and we plan to grow Instrumentarium even further by investing in new technologies to improve clinical workflow, physician confidence, and patient outcomes. We now have a terrific opportunity to create a new and better kind of healthcare for clinicians and their patients."

As part of the reorganization following the acquisition, Olli Riikkala, president and CEO of Instrumentarium, has been named CEO of GEMS's European operations as well as executive vice president with the company's healthcare information technologies unit. Riikkala sees the move as "greatly benefiting our customers and employees—particularly in regard to GE's strengths in research and development." GEMS's European operations will now be headquartered in Helsinki.

Riikkala: Helsinki headquarters.

The deal was delayed by regulatory hurdles in both Europe and the United States. To address potential anticompetitive concerns, the EU and the U.S. Department of Justice (DOJ) required Instrumentarium to divest Spacelabs (Redmond, WA), a manufacturer of patient monitoring systems. As a condition of approval, the DOJ also required GE to divest itself of Instrumenatium's Ziehm surgical imaging business unit.

Instrumentarium has product development and manufacturing sites in Finland, Sweden, Germany, and the United States. Datex-Ohmeda, Instrumentarium's largest division, which manufactures anesthesia operating room systems and critical care equipment at its Madison, WI, facility, is expected to remain intact and be integrated into GEMS.

Instrumentarium's products and services are sold in more than 100 countries worldwide. With 5400 employees, the company had sales of $1.1 billion for 2002.

Amersham: The Fast Lane to the EU. On the surface, GEMS's acquisition of Amersham seems like an obvious move with a strong and immediate upside. After all, GE makes imaging systems and Amersham makes contrast agents that are used to enhance images for better diagnostic interpretation. The move marks GE's initial entry into the so-called passive pharmaceutical business and is certain to generate a steady flow of income by providing hospitals with a one-stop resource for both imaging systems and related media and radiopharmaceuticals.

GE's Immelt: Tailored therapies, sooner.

But industry analysts also see the potential value of the deal in terms of what it means for next-generation imaging technologies and the promise of patient-personalized diagnosis. Lauding the "resources, talents, and technologies" of the two companies, GE CEO Jeffrey Immelt emphasized that the "combination of this technological and market knowledge will allow GE to accelerate the development of molecular imaging and personalized medicine where it will be possible to predict and treat disease with therapies tailored to the individual."

Describing the opportunity as "a new chapter in medicine," Amersham CEO Sir William Castell said, "Combined with the complementary capabilities of General Electric, this transaction enables us to accelerate the realization of our vision of personalized medicine. We will have the competencies, the marketing reach, and the financial resources to bring disease prediction, diagnosis, and personalized treatment into the mainstream of medical practice."

Although targeted radiopharmaceuticals and smart imaging agents are still in the early stages of development, several industry analysts characterized these technologies as having the ability to transform the imaging business. It was also noted that Amersham has already achieved success with genetically based diagnostic agents, a fact that was believed to be a major factor in GE's interest in the company.

In a prepared press release, the acquisition was seen as creating a healthcare company with "broad expertise in imaging, diagnostic pharmaceuticals, and drug discovery"; advancing "the development of molecular imaging and personalized medicine . . . by bringing to market new targeted imaging agents and diagnostics"; and generating combined revenues in excess of $13 billion.

As the former head of GEMS, Immelt has an inside understanding of the potential represented by the Amersham deal. But according to Greg Freiherr, editor of Diagnostic Imaging SCAN, a biweekly business newsletter for the radiology community, the Amersham acquisition would probably have been pursued by anyone at the helm of GE. "It's a complementary move, and it makes perfect sense in relation to GE's overall growth strategy of building strong divisions in business categories where the company competes.

"In initiating moves to grow the company, the medical industry appears to offer both near- and long-term growth opportunities that are not available in other GE sectors such as plastics and jet engines," says Freiherr. "GEMS is moving aggressively on two healthcare fronts: imaging and information systems, while also building the groundwork for so-called digital hospitals—sites in which medical enterprise systems hold the key to improved diagnostic and treatment efficacy, patient safety, medical professional productivity, and overall operational efficiency—the factors that ultimately sell the equipment."

GE's establishment of a European headquarters in Helsinki and a new healthcare technologies office in London is a "smart move" according to Freiherr, and should greatly facilitate GE's efforts at selling into EU hospitals. "While the company is certainly recognized the world over, having a strong local presence can go a long way toward building all-important customer relationships."

Freiherr also sees far-reaching technological implications in the Amersham deal. "GE is getting an enormous jump start, not only in the emerging field of molecular imaging, but also in the even more nascent field of molecular diagnostics, which holds great promise for early detection and elimination of disease processes," he says. "All and all, the Amersham deal appears to be a strategically smart move. And considering the enormous resources of the company, it poses little, if any, downside risk."

Sir William Castell: Leading from London.

The acquisition is not expected to face any undue regulatory hurdles and should be finalized in the first half of 2004. Upon completion, Castell will become CEO of GE Healthcare Technologies, a new London-based business unit formed by the acquisition. He was also named a vice chairman and member of GE's board of directors. Joseph Hogan, senior vice president of General Electric, will continue to head the GE medical business.

The Amersham Group, formed in 1997 through the mergers of Amersham International (UK), Pharmacia Biotech (Sweden), and Nycomed (Norway), employs over 10,000 people worldwide and had 2002 sales of $2.43 billion.

Six Targets for GE Growth. While the acquisitions of Instrumentarium and Amersham captured the headlines, GEMS brought six additional companies into the fold during the last twelve months:

Prior to its recent deal, GEMS employed 30,000 and had operations in more than 100 countries. 2002 revenues were $9 billion.

But the company is clearly pursuing the strategic objectives of its corporate parent, General Electric Corp. (Fairfield, CT), which has targeted the medical sector as a prime opportunity for growth. And now, with its acquisition of Amersham, GEMS has stepped over Tyco Healthcare to become the world's second-largest medical technology company—still following Johnson & Johnson, but perhaps not for long.

MX: Issues Update is a monthly e-supplement prepared by the editors of MX: Business Strategies for Medical Technology Executives and sent to you as a benefit of your on-line registration with the magazine. We welcome your suggestions for future content in MX: Issues Update; please feel free to contact us with your comments and ideas.
—Steve Halasey, Editor in Chief, MX

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