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Robotic Surgery Litigation Offers IP Lessons, Caveats

Originally Published MDDI February 2003

NEWSTRENDS

Maureen Kingsley

(Above) The da Vinci surgical system from Intuitive Surgical Inc., and (below) Zeus from Computer Motion.

Even as robotically assisted surgery is touted in the media, a legal battle is raging between the market's two major players. Computer Motion Inc. (Goleta, CA), maker of the Zeus and other surgical robots, and Intuitive Surgical Inc. (Sunnyvale, CA), which makes the da Vinci system, have been engaged in a long series of patent-infringement lawsuits whose outcomes remain in question. Experts in intellectual property (IP) law say these cases offer lessons to makers of advanced products.

The legal battle began in 2001, when IBM and Intuitive filed a joint lawsuit against Computer Motion in the U.S. District Court for the District of Delaware. They alleged infringement of one of IBM's patents, to which Intuitive holds an exclusive license. 

A Delaware jury ultimately found Computer Motion liable and awarded Intuitive $4.4 million for damages. The decision and award are now subject to judicial review and Computer Motion says it is exploring its options. These include requesting a new trial or a reduction in the damage award.

Meanwhile, Computer Motion has filed its own suit with the U.S. District Court for the Central District of California, claiming that Intuitive Surgical infringed on nine of its U.S. patents. The trial is expected to begin in April 2003.

Executives are advised to take note of such high-stakes IP lawsuits. Joel Covelman, an IP attorney for Levin & Hawes (Laguna Beach, CA), says,  "Basically, these two companies are the current dominant players in an emerging technology field.” He describes this situation as one in which the company that controls the technology could very well end up controlling the market. This battle for market dominance provides an incentive for companies to wage a long and expensive war over the question of who owns the key technology, he explains.

Barbara Wrigley, an IP attorney with Oppenheimer Wolff & Donnelly (Minneapolis), agrees. She points out that this case demonstrates that “if you're trying to mimic or copy somebody else's product, you really need to do your homework about what patents are protecting that competitive portfolio.”

But that may be easier said than done. Covelman explains that most people don't realize that patent applications are confidential until the patent actually issues. “So [a company] can't go into the patent office and say, ‘Hey, let me see what applications are pending at the moment,'” he says. In some cases, “you don't know until after you've infringed that you've even infringed at all, because you don't know that the patent exists yet.” Preventing litigation in such cases is next to impossible, he says. 

The ante is upped even higher when the two players doing the litigating are essentially each other's only competitors in a particular market. “I think nowadays, especially when the potential market is huge, companies do use patent litigation to harass their competitors,” Wrigley says. A typical example of this is when a competitor files a patent lawsuit against another competitor to keep it out of the market, delay its entry into the market, or send it “back to the R&D drawing board.” Wrigley explains that the corporate strategy in these cases “isn't to litigate, per se, but to defend one's turf.”

Covelman agrees. “Certainly, there are companies out there who have made a strategy of amassing large numbers of patents as a means of trying to protect their market share.” But he points also to companies that realize they are better off not fighting with each other and instead come to a cross-licensing arrangement. “That happened with Apple and Microsoft,” he says. “After years of litigation, they ultimately cross-licensed each other on various copyrights they had.”

A very different type of outcome, Covelman says, is one in which a company wins a lawsuit, and the monetary judgment is so large that “the winner basically takes over the keys to the [losing] company.” Yet another possibility is that one company acquires another as a result of the “crushing expense and damage to the product viability of the [losing] company,” he says.

Unpredictability seems to be the name of the IP game. Says Wrigley, “You can never prevent somebody from suing you, you can make sure you're in the best position to defend against that lawsuit. Research the prior art and understand the patent of your competitor, and how the patent claims would be interpreted by a court. An understanding of everything a competitor is doing will help you develop a viable defense.”

Copyright ©2003 Medical Device & Diagnostic Industry

Health Canada Moves One Step Closer to Harmonization

Originally Published MDDI February 2003

NEWSTRENDS

Stuart Logie

As 2002 drew to a close, Canadian authorities found themselves in a tough spot. On one side, they had a January, 2003, deadline to comply with the new Medical Device Regulation requirement for quality system certificates; on the other, a mid-2003 revision of the international quality standard for medical devices. They have now said they will accept either certificate from U.S. device makers for three years.

“We will respect the three-year transition period proposed by the ISO TC 210 working group for the adoption of the revised ISO 13485 standard,” Egan Cobbold, a Quality Systems Officer with the Medical Devices Bureau in Health Canada told MD&DI.

“That means from U.S. medical device makers we will accept ISO 13485:1996 and 13488:1996 from approved registrars until mid-2006.”

Indeed, Health Canada is showing considerable flexibility to foreign medical device makers as it moves to harmonize its medical device regulations with international quality rules. Health Canada's quality system rules for medical devices follow international rules, with the exception of specific requirements for recall procedures and reporting. 
Health Canada already has made a number of changes to the Canadian Medical Devices Conformity Assessment System (CMDCAS), the program that will grant quality system certification for makers of Class II, III, and IV medical devices. It dropped the Regulatory Profile as a CMDCAS requirement, and more importantly it jettisoned the Made-in-Canada component of the CMDCAS registrars program. 

That component would have seen all medical device manufacturers—both foreign and domestic—obtaining quality system certification only from Canadian incorporated registrars. Now, Health Canada is prepared to accept foreign incorporated registrars so long as the Standards Council of Canada accredits them. “We smartened up on that issue,” said Cobbold. 
“We realized that most registrars are multinational organizations anyhow.”

But while Canada is a partner of the Global Harmonization Task Force (GHTF), this hasn't prevented Canada's own harmonization process from being mired in confusion and controversy. “Health Canada went at this program backwards and this has created a lot of confusion in the medical devices industry,” explained Kevin Murray, vice president of regulatory affairs for MEDEC, a medical devices trade association based in Toronto. “The industry has been aware of the quality systems requirement since 1998, yet we only knew about the registrars some months ago. The guidance documents are still in draft form, and the government has still to pass the legislation that will amend the Medical Device Regulations requiring quality system certificates.” Murray added that the deadline for compliance is past, and the government is still putting things in place. 

In fact, Health Canada had abandoned its earlier July 2001 deadline for quality system certification because of delays in amending the regulations. It then called on medical device makers instead to follow voluntary compliance before the new January 2003 deadline. The industry response disappointed Canadian officials. “The compliance period wasn't used as widely as we thought it would be, and when it was used the certification was wrong, the standards were wrong, and in general there was a lack of awareness of what was expected,” said Cobbold.

The current deadline for quality system compliance continues to be a nagging source of confusion. Last August, Health Canada included a note in the license renewal packaged sent to all licensed medical device manufacturers selling in the Canadian market. The letter informed them of new regulatory quality system requirements that would come into force on January 1, 2003. However, some auditors have told manufacturers that they could wait until November 1, 2003, before conforming to the new regulations.

“It should be pretty clear,” explained Cobbold. “If you are applying for a new license after January 1, 2003, then you must include a quality system certificate from an approved registrar. If you have an existing license, then you need to show a quality system certificate at the time of license renewal, which occurs on November 1, 2003.”

But Cobbold warns that this “is not another grace period. We expect all medical device makers to be actively complying with quality systems certification as we speak.”

That may be a problem. So far there are only eight Standards Council of Canada–recognized registrars able to perform CMDCAS quality system audits, with another eight in waiting. MEDEC fears the delays and the number of available auditors could create bottlenecks that would further delay the introduction of certain products into the Canadian market.

“The process of quality system certification can take from 12 to 18 months,” said MEDEC's Murray. “And there's no guarantee that the registrars in waiting will still be there when we need them. That means there clearly isn't enough coverage for the market spectrum.” 

Already some medical device manufacturers have informed the government that they intend to exit the Canadian market since their market share cannot justify the added expense and delays due to the quality system certification.

“If that involves a company with a unique technology, that really represents a loss for the Canadian healthcare market,” said Murray.
For more info: http://www.scc.ca/ standards/cmdcas/index_e.html. Send email inquiries: ISO13484CMDCAS _SCECIM@hc-sc.gc.ca.

Copyright ©2003 Medical Device & Diagnostic Industry

Expanded Notification of Device Recalls Urged

Originally Published MDDI February 2003

NEWSTRENDS

Gregg Nighswonger

Broader and more timely distribution of product recall notices could help increase patient safety, say infection control experts from Johns Hopkins Hospital (Baltimore). The group suggested changes to the current voluntary system after studying a series of infections at the Maryland facility.

The Johns Hopkins team traced the source of infections in 32 patients last year to three faulty bronchoscopes. The group now argues that more stringent regulations and a faster recall of the devices could have prevented the outbreak. 

Between June 2001 and January 2002, the rate of Pseudomonas aeruginosa at Johns Hopkins was three times higher than the usual rate in patients undergoing bronchoalveolar lavage. The group's review showed that a potentially contaminated bronchoscope may have had a role in the increased infection rate and in three deaths. 

In November 2001, certain Olympus bronchoscopes, including those used at Johns Hopkins, were recalled nationwide because a loose port could allow contamination of the devices. The firm first sent letters to facilities using the scopes. But the letters were not addressed to individual physicians who use the devices, according to the group. The result was that individual physicians were not aware of the recall.

According to Arjun Srinivasan, MD, assistant professor of medicine at Johns Hopkins, a more effective recall of the devices could have shortened the duration of the outbreak and decreased the number of patients at risk. His group believes that the federal government should implement and enforce standards more like those used for drug recalls.

Asked whether such a recall strategy would be applied generally or required only for critical devices, Srinivasan told MD&DI, “Understandably, this type of regulation would be a lot of work, and thus the efforts need to be targeted where they are likely to have the highest yield. Clearly, the major concern is for the more serious recalls that may adversely impact patients. However, it would be helpful for information on all recalls to be readily available.”

Srinivasan explained that the problems encountered with the recall also prompted the facility to assess its own procedures. “The notice was sent to the same address that the equipment had been shipped to,” he says. “We have extensively studied and have worked to improve the way we handle recall notices in our hospital.” The group reported on their findings and recommendations in the January 16, 2003, issue of the New England Journal of Medicine.

Copyright ©2003 Medical Device & Diagnostic Industry

ISO 13485 Splits from ISO 9000

Originally Published MDDI February 2003

NEWSTRENDS

Robert Drummond

Ed Kimmelman is the convener of TC 210.

In the area of quality, manufacturers have come to know well ISO 9000/ 9001 and ISO 13485. But now ISO 13485 is becoming a separate, standalone standard in an attempt to better serve the medical device industry.

The new ISO 13485 standard, “Quality management systems—Medical devices—System requirements for regulatory purposes,” diverges from ISO 9001 in three key areas: customer satisfaction, continual improvement, and procedural documentation. 

In revising 13485, ISO Technical Committee (TC) 210 had a specific goal in mind. “We wanted to make it clear that [the new] ISO 13485 is intended to reflect the current level of quality system regulation around the world,” says Ed Kimmelman, a regulatory affairs and quality systems consultant who also convenes TC 210. “It will serve as a model for any country that intends to begin regulation of their medical device quality management systems.” 

TC 176, which has the overall responsibility for quality systems standards, based the new ISO 9001 on the process approach. That system is based on four interrelated processes: management, resource-handling, product realization, and measurement and analysis. But according to Kimmelman, this system was not compatible with the medical device industry. TC 176 also reduced the procedural documentation requirements in an attempt to make 9001 more applicable to smaller organizations. Kimmelman says this too was inconsistent with 13485's regulatory objective, since documentation is one form of objective evidence showing that the quality management system is in place.

Rather than targeting customer satisfaction—as the new ISO 9001 does—ISO 13485 targets customer requirements. 

“This objective is both more measurable and more consistent with regulatory goals,” Kimmelman says.

TC 210 also believed that ISO 9001 went a bit too far in its explicit requirement for improvement, Kimmelman says. The regulatory requirement is to have a quality system that continually assesses its effectiveness in meeting customer requirements and providing safe and effective medical devices—not necessarily one that continually improves. “You've got to keep assessing it, and keep searching for any deficiencies,” he says. Continually monitoring the quality management system, Kimmelman says, is more consistent with existing regulatory requirements. 

So what should a medical device manufacturer do with this knowledge? It depends on where that manufacturer is in quality management compliance. If your customers are not currently requiring you to comply with ISO 9001, or if you are certified only to ISO 9001:1994, Kimmelman's advice is to “make your system comply with ISO 13485:1996 right away.” ISO 9001:1994 expires in December of 2003. So firms that want to maintain their ISO 9001 certification must change their quality systems over to the 2000 version before the end of 2003. Manufacturers that are certified to ISO 13485:1996 will likely have until the first quarter of 2006 to change their systems, because there will be a three-year transition period to the new ISO 13485. 

For those companies beginning their transition to the 2003 version of ISO 13485, the final draft international standard is the place to look. There are few substantive requirement changes between 1996 and 2003, Kimmelman says, but the organization of the requirements might take some getting used to. “In order to have the top-level documentation of your quality management system aligned with that standard, you're going to have to change the documentation,” Kimmelman says. “I'm talking about your quality manual, your high-level, quality system procedures.”

For more information, visit ISO Online, at www.iso.org.

Copyright ©2003 Medical Device & Diagnostic Industry

Mohan Assumes Key Role in IVD Firm 

Originally Published MDDI February 2003

NEWSTRENDS

Kshitij Mohan, PhD, an experienced device industry senior executive, joined International Remote Imaging Systems Inc. (Chatsworth, CA) in January as the firm's president and CEO. Mohan is a former chief of medical device evaluations at FDA, and was a science examiner in the White House Office of Management and Budget. He also held key executive positions with Boston Scientific Corp. and Baxter International. Most recently, Mohan was the chief regulatory and technology strategist for King & Spalding LLP, a Washington-based law firm. Mohan has also been a longtime member of MD&DI's Editorial Advisory Board. International Remote Imaging Systems Inc. manufactures automated urinalysis technology and image flow cytometry systems.

Copyright ©2003 Medical Device & Diagnostic Industry

Monitor Noninvasively Measures Premature Infants’ Vital

Originally Published MDDI February 2003

R&D DIGEST

Monitor Noninvasively Measures Premature Infants' Vital

Current systems for measuring neonatal vital signs are invasive and can be used for a relatively short period of time following birth. The new noninvasive device overcomes these limitations. 

The Purdue Research Foundation (West Lafayette, IN) and Theron Technologies LLC (Indianapolis) have joined forces to develop a noninvasive device to take the vital signs of premature infants. The device, invented at Purdue University (West Lafayette, IN), uses optical techniques to measure systolic, mean, and diastolic blood pressure; heart and respiratory rates; and oxygen saturation in premature and other low-birthweight babies.

Low-birthweight babies, who weigh less than 5 lb, 8 oz, make up 7% of births in the United States each year. Very-low-birthweight babies, weighing less than 3.3 lb, account for about 1% of births. These conditions result in about two-thirds of newborn deaths each year. The blood pressure of these small babies must be monitored to check for indications of hypovolemia—an abnormal decrease in blood volume. Monitoring requires that a catheter be passed through the baby's umbilical cord to directly measure aortic pressure. 

The new device provides a noninvasive yet more comprehensive method to measure blood pressure and other critical blood parameters. The Purdue research team is led by Leslie Geddes, PhD, Showalter Distinguished Professor Emeritus of Bioengineering. Says Geddes, “The neonatologist, the premature infant physician, and the small-infant pediatrician do not currently have one single instrument to measure vital signs in their patients. 

And they don't have a noninvasive blood pressure monitor that's accurate enough.” Discussing direct umbilical artery catherization, he adds, “Although this method is beyond criticism, it is available for only a short time after birth, before the umbilical artery starts to close. The device we are developing will allow the neonatologist to monitor blood in a noninvasive manner beyond the period of umbilical artery recording. Physicians can also use the device to obtain oxygen saturation and heart and respiration rates with no added effort.” 

Theron Technologies is a joint venture of Barnard Life Sciences (Indianapolis) and Theron Inc. (Carmel, IN) that was formed to commercialize this Purdue-licensed technology. To date, Theron Technologies has developed a working prototype of the system and plans to demonstrate its performance in clinical trials. The firm intends to use the technology as the basis for a number of products for several distinct markets. 

Copyright ©2003 Medical Device & Diagnostic Industry

Using Sound to Sterilize Medical Instruments

Originally Published MDDI February 2003

R&D DIGEST

Cunefare's test chamber has demonstrated that enhanced transient cavitation can kill bacterial spores. 

Cavitation, an acoustic phenomenon often studied for its effects on submarines, could be the basis for an improved disinfection method. Researchers at Georgia Institute of Technology (GIT, Atlanta) and Georgia State University (Atlanta) believe the patented technique may be able to quickly kill microorganisms on medical instruments without using heat or harsh chemicals. Conventional heat treatments can damage costly devices, such as endoscopes.

Cavitation occurs when acoustic energy applied to a liquid induces the creation of voids, or bubbles, that release energy when they collapse. The phenomenon has been studied for years because it can damage submarines' propellers when they are operating at certain depths. 

Stephen Carter, DDS, an Atlanta-area dentist, proposed using an enhanced form of cavitation to disinfect instruments and obtained a patent for the idea in 1994. He is now working with Kenneth Cunefare, PhD, associate professor at the GIT School of Mechanical Engineering, to develop the technique. 

Carter first proposed that rapid decompression might be able to kill microbes by breaking their cell walls. Even explosive decompression, however, failed to kill all of the bacterial spores. He then suggested enhancing the technique by combining pressure with powerful cycles of ultrasonic energy. The researchers pressurize the test chamber while inducing cavitation, creating a form of transient cavitation that causes violent collapse of the bubbles. The method takes advantage of the “anomalous depth effect,” in which the impact of bubble collapse increases dramatically when subjected to roughly twice normal atmospheric pressure.

When applied to a solution of 66% isopropyl alcohol containing two strains of bacterial spores as markers, the enhanced cavitation reduced the bacterial count by more than 90%, says Cunefare. Both the alcohol and the increase in pressure were found to be necessary to kill the spores with cavitation.

Subsequent studies suggest that acoustic disinfection can be carried out more quickly than existing heat and chemical techniques. The researchers believe this could offer a number of advantages. “We believe that our methods will sterilize in shorter periods of time, which would be a substantial advantage for expensive medical equipment,” says Carter. In addition to reducing the amount of time that expensive equipment is out of service, the method could also minimize the risk of cross-transmission of infection caused by contaminated instruments, he adds. 

The actual mechanism by which the method works will be the focus of further study. Says Donald Ahearn, PhD, professor emeritus of biology at Georgia State University, “We don't know exactly how the cells die, but we know the end phenomenon.” He adds, “Increased pressure and disinfectant molecules are somehow enhanced by the cavitation process, but the physiology of the death has yet to be determined.” Ahearn performed the biological assays during the study. 

Cunfare explains that similar ultrasound methods have been used to make the skin sufficiently permeable to admit drug cmpounds. The reseacher speculates that the cavitation technique may induce a similar effect that makes bacterial cell walls permeable enough to admit the alcohol molecules. In addition, Ahearn believes the method will work against viral organisms.
 
The researchers are seeking support from the National Institutes of Health to optimize the technique and assess the effectiveness of other additives. They also hope to scale up the method to a practical size, ensure that it will adequately kill microorganisms, and assess potential for damaging medical instruments. 

The researchers also plan to improve the techniques being used to couple power into the fluid in order to treat larger liquid volumes. They beleive that because the amount of energy that can be induced into a liquid depends on the surface area, there may be limits to the volume that can be treated by inducing energy from the boundaries.

Copyright ©2003 Medical Device & Diagnostic Industry

Rapid Method Maps Blood Vessels in Live Tumors

Originally Published MDDI February 2003

R&D DIGEST

Among cancer treatments under current study is the use of angiogenesis inhibitors to limit or prevent tumor growth. Angiogenesis is the method by which tumors connect to blood vessels in the body to tap sources of nutrients and oxygen. The result is that the tumor metastasizes to other organs. If angiogenesis can be prevented, the cancerous tissue cannot spread and may die. 

To quantify the effects of various agents, such as new drugs, on capillary growth, blood vessel properties must be precisely mapped and measured. This task has usually required scientists to manually trace the vessels over several days to quantify the intricate images. 

Because results were often less than perfect, researchers at Rensselaer Polytechnic Institute (RPI, Troy, NY) developed an automated system that can map capillaries in a live tumor with great precision. The diagnostic tool, called RPI-Trace3D, is in use at Harvard Medical School (Boston) and at Northeastern University (Boston). The patent-pending device was developed by a team led by Badri Roysam, director of the Center for Subsurface Sensing and Imaging Systems at RPI.
The RPI-Trace3D system incorporates electronic microscopes connected to computers to generate complex 3-D images, enabling scientists to peer deep inside living tumors. The system makes it possible to identify and trace all the capillaries of a living tumor in less than two minutes.

Researchers using the device expect the system to significantly improve the identification of cancer-fighting drugs. Edward B. Brown, PhD, a researcher at the Harvard Medical School Department of Radiation Oncology, says the RPI team has generated algorithms that trace all the vessels in a 3-D network, as well as identify a number of properties of the vessels. “This allows us to quantify these vessels accurately for the first time,” he explains.


Copyright ©2003 Medical Device & Diagnostic Industry