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Complex Devices Complicate Interconnectivity

When designing a device, one of the most important things to remember is to “treat the patient, not the medical device,” according to Rick Hampton, wireless communications manager at Partners HealthCare Information Systems (Charlestown, MA). Hampton spoke about the standard and its potential effect on manufacturers at an AAMI conference in March. The clinician shouldn’t be distracted from this mission with a complicated device. Although devices are created with new features and capabilities to accomplish more tasks, the goal of designers should be to make devices that solve problems, not create them.

IEC 80001 recognizes that hospitals, medical device vendors, and network infrastructure vendors play a role in how networked medical devices operate. However, the largest burden is placed on the hospital in terms of responsibility and ensuring that risks are managed. The standard also places responsibility on the manufacturer by requiring documentation of a device’s intended use with an IT network as well as how the network must be configured to work with a device.

Better communication with clinicians during the design phase of an IT project should help create point-of-care devices that interact more efficiently and effectively. This will help designers understand work flow efficiencies and how wireless technology can be used to support both new and existing processes at the point of care, said Hampton. Device manufacturers should form partnerships with IT vendors and create a cross-functional risk management team during the design phase.

As security becomes a critical issue, companies should also conduct security risk assessments. This includes implementing realistic and scalable encryption and authentication mechanisms, advised Hampton. For more information about securing wireless connections, visit the U.S. Computer Emergency Readiness Team’s Web site at www.us-cert.gov/control_systems/csstandards.html#secure

Update on China’s Healthcare Reform

In April 2009, the Chinese government announced the guidelines for healthcare reform, with the core principle of providing universal healthcare services to the country’s 1.3 billion population. From 2009 to 2011, China will invest 850 billion RMB ($124 billion USD) in healthcare. These developments are discussed in a report, “Analysis of the Chinese Healthcare Industry: A Guide for Medical Device Manufacturers,” created by InMedica (Wellingborough, Northamptonshire, UK).

Healthcare expenditures in China have steadily increased. Source: Analysis of the Chinese Healthcare Industry, InMedica

According to the report, grassroots-level hospitals and clinics are being given priority for development. The construction of centers as well as developing regulations are an opportunity for medical device OEMs, says Owen Tang, market analyst for InMedica.

Suppliers of basic equipment, such as general-purpose ultrasound machines, analog x-ray equipment, and patient monitors, all of which are funded by the reform, stand to gain significantly. “The reform offers opportunities for medical device companies with county-level hospitals, but those hospitals need a different type of equipment than the big cities do.

Companies that will see success are those that recognize needs, especially the price requirements,” Simon Harris, InMedica’s senior research director, medical group explains. “Companies that get it right stand to do pretty well.”

Multinational companies should prepare to work harder than Chinese companies to build their reputations. “China has additional regulations or requirements that apply to multinational companies, but do not apply to local suppliers,” Tang says.

For multinational firms, being part of the system is challenging, but not impossible. Companies should have some local presence, says Tang. “GE and Siemens, for example, have joint ventures or fully owned companies in China.”

Tang advises firms to be active in promoting their corporate citizenship in the county. “For example, they could train doctors in rural areas in using medical devices or provide donations (e.g., free breast cancer screening),” he says. “In this way, a company can get a reputation for social responsibility.”

For example, Tang says the Chinese government is looking into supplying rural facilities with CT devices and is running feasibility trials. “GE Healthcare has presented two new CT types that are designed for China users, with limited functions and a lower price. These devices are being provided specifically to serve rural hospitals.”

Tang also recommends building strong sales channels, especially in the county areas. “Setting up a good customer relationship with each hospital is vital, but it’s very difficult in rural areas. A distributor must be able to have a strong relationship with the decision makers in hospitals.”

China’s central government will fund the construction of 2000 county-level hospitals and 29,000 township hospitals, as well as the upgrading of 5000 township hospitals. Furthermore, about 3700 community health centers and 11,000 community health stations will be established or upgraded by 2011.

But 2011 is not the endgame. “Healthcare will continue to grow well beyond 2011,” Tang says. The reform represents a shift in Chinese culture that will continue to provide opportunities for medical device OEMs.

Attitudes are changing in China, explains Harris. “People are much more aware of health issues and are requesting better levels of care. They expect hospitals to have equipment and services. The demand for devices should be strong for quite a while.”

Healthcare Reform: How the Device Tax Will Work

Legislators had abandoned an earlier fee scheme that was based on market share in favor of a much more predictable excise tax based on sales. As an excise tax, it is deductible. But the industry still largely considers any tax “highly regrettable,” says Wanda Moebius, vice president, policy communications, for the Advanced Medical Technology Association (AdvaMed).

The tax covers most Class I, II, and III medical devices. Products that are sold at retail for use by an individual as well as hearing aids and contact lenses are explicitly exempt from the tax. The exclusions prevent the tax from being labeled as a consumer tax.

“The tax will present significant challenges for companies large and small,” says Moebius. “It could require a cut in research and development or jobs or some combination thereof, or it could be passed on to customers.”
Companies with high-margin products might be better prepared to handle the tax than those with products with small margins. “If you’ve got a company with a 1% margin, there’s no way it can absorb a 2.3% tax,” says Moebius.

She adds that AdvaMed will continue to pursue any regulatory and legislative opportunities to mitigate the tax. “We fought for healthcare reform, and we agree that patients need more access to our technologies and devices, but we didn’t think a tax was the way to pay for it.”

According to market research firm IBISWorld (Santa Monica, CA), “consolidation will be spurred by the reform’s implementation of effectiveness research; that is, studies on which medical devices work best. Smaller manufacturers may not have the resources to rebut studies that question a product’s value.” As a result, the firm says that the industry could consolidate to 9200 operators during the next five years. 

“Profits will decline as a result of the new taxes, and sales growth will slow to 2.9% on average per year through 2015,” says Sophia Snyder, industry analyst with IBISWorld.

Moebius notes that many members of Congress from both parties “fought for this industry in an effort to get that tax eliminated or reduced and [fought to] make it tax deductible.” It would not surprise those who work in this industry that there are a lot of good paying jobs in a lot of states all across the country, she says. But she thinks members of Congress may have been surprised to see the breadth of constituents in this industry.

Champions of industry will continue to push for a repeal of the tax. It has touched a nerve that some say will force companies to lay off employees, make cuts in R&D, or raise ­prices—or some combination of all three.

Industry may benefit from some outcomes of the healthcare legislation, but most of these benefits are intangible, difficult to measure, and likely to be seen only over the long term. First and foremost, expanded insurance coverage is good for America and good for patients. The device industry should see some benefit from improvements to the reimbursement system, which are designed to reward value rather than volume of services. Much depends on the way future regulations are written. If laws are written in a way that encourages the adoption of new technologies, they could reduce healthcare costs in the long term.

Noninvasive Blood Glucose Monitor Goes Portable

To measure glucose levels, users press a finger against the sensor. The sensor uses electromagnetic waves to measure blood glucose levels in the body. As the energy goes from the sensor through the skin and back to the sensor, the glucose level is measured through the transference of energy.

Jean took daily samples of 31 people over the course of a few months and compared those samples with levels measured by an over-the-counter commercial sensor. He found that the noninvasive sensor is capable of achieving the same or better accuracy than current commercial sensors.

Jean has applied for a provisional patent for his noninvasive glucose monitoring technology. The next step is to conduct further tests on a wider diabetic population.

Flex Electronics Get Closer to the Tissue

A team of cardiologists, materials scientists, and bioengineers have created and tested a new type of implantable device that, among other options, can measure the heart’s electrical output in a way that improves on current devices. The new device uses flexible silicon technology to apply electronic circuits directly to tissue.

“We believe that this technology may herald a new generation of active, flexible, implantable devices for applications in many areas of the body,” says cosenior author Brian Litt, MD, an associate professor of neurology at the University of Pennsylvania School of Medicine and also an associate professor of bioengineering in the school of engineering and applied science. “Initially, we plan to apply our findings to the design of devices for localizing and treating abnormal heart rhythms.” Litt believes these devices allow doctors to quickly, safely, and accurately target and destroy abnormal areas of the heart.

“The new devices bring electronic circuits right to the tissue, rather than having them located remotely, inside a sealed can that is placed elsewhere in the body, such as under the collarbone or in the abdomen,” explains Litt. “This enables the devices to process signals right at the tissues, which allows them to have a much higher number of electrodes for sensing or stimulation than is currently possible in medical devices.”

Current technologies for mapping and eliminating life-threatening heart rhythms allow for up to 10 wires in a catheter that is moved in and around the heart and is connected to rigid silicon circuits distant from the target tissue. Such design limits the complexity and resolution of devices because the electronics cannot get wet or touch the target tissue.

In contrast, the circuit device is made of nanoscale, flexible ribbons of silicon embedded with 288 electrodes, forming a latticelike array of hundreds of connections and 2000 transistors. The shape hugs the tissue, enabling measurements of electrical activity with greater resolution in time and space. The device can operate even when exposed to the body’s fluids. It collects large amounts of data at a high speed.

Researchers tested the device on porcine hearts. The proof-of-principle findings were published in a recent issue of Science Translational Medicine. “Our hope is to use this technology for many other kinds of medical applications, for example to treat brain diseases like epilepsy and movement disorders,” says Litt.

The team plans to design advanced pacemakers that can improve the pumping function of hearts weakened by heart attacks and other diseases. For each of these applications, researchers are conducting experiments to test flexible devices in animals before starting human trials.

Another focus of the work is to develop similar types of devices that are not only flexible, like a sheet of plastic, but fully stretchable. A device that can fully conform and wrap around large areas of curved tissues could be the next big step. Moving to the next generation will require attaching a power source.

This research is a result of a collaboration between the Rogers laboratory, where the flexible electronics technology in the devices was developed and fabricated, and Litt’s bioengineering laboratory at the University of Pennsylvania. The research was funded by the National Institute of Neurological Disorders and Stroke, the Klingenstein Foundation, the Epilepsy Therapy Project, and the University of Pennsylvania Schools of Engineering and Medicine.
 

Anchor Driver Could Improve Doctor’s Feel for Skull

When attaching a drill guide to a patient’s skull, surgeons must rely on feel to determine whether the bone-implanted anchor is correctly seated. But, according to Vanderbilt University researchers, “anchor placement is complicated by the variation in bone density and by obscuring tissue and bleeding that make visual confirmation of seating very difficult if not impossible.” In an effort to prevent misplacement, which increases the potential for guide failure, the team has developed a device called the PosiSeat.
 

The PosiSeat is a depth-release rotary driver that stops rotating when a prescribed seating depth is reached. The scientists say that the device consists of a sleeve that features an end with an internal hexagonal pattern (see Figure 1 to view the different parts of the device). This end engages with the anchor and allows for relative axial motion, but prohibits rotation between the sleeve and the anchor. The other end of the sleeve has an external hexagonal pattern that allows for relative axial motion between the sleeve and stem base, but prohibits relative rotation.
 

Researchers say, “the height of the hexagonal portion on the sleeve is equivalent to the depth to which the fastener is to be driven.” Additionally, there is a spring between the sleeve and stem, which places downward pressure on the sleeve to keep it firmly seated against the bone. The upper end of the stem engages with a rotationally powered tool. External threads on the stem attach to threads on the stem base and permanently join the two parts. There is also an extrusion on the stem, which transmits axial force to the anchor, according to the Vanderbilt scientists.
 

During operation, a tool such as an electric driver is attached to the stem to provide torque while it is pushed toward the anchor. The anchor threads go deeper into the bone and the anchor moves down axially relative to the sleeve. The stem and stem base also move down, and less of the hexagonal interface between the sleeve and stem base is engaged.
 

The PosiSeat is designed to attach to power drivers. Here it is attached to Stryker Corp.’s QuickDrive mini.

“Once the seating depth has been reached (goes to zero),” researchers say, “the hexagonal surfaces are no longer in contact and the sleeve is no longer rotationally constrained to the stem base. As such, the sleeve will now be stationary along with the anchor while the stem and stem base are still rotating.” At this point, it is clear to the operator that that anchor is properly seated.
 

Figure 1. Unexploded and exploded views of the PosiSeat.

J. Michael Fitzpatrick, a professor in the Department of Electrical Engineering and Computer Science at Vanderbilt, says that the device can be customized to accommodate different shapes and sizes of anchors and screws. “The customization is required so that (a) the head of the anchor or screw can be driven by the device and (b) torque will be released when, and only when, the head is seated.”
 

Currently, surgeons are testing the PosiSeat at beta sites outside Vanderbilt. Fitzpatrick says their comments could result in minor ergonomic changes.
 

In addition to attaching drill guides, the research team says the device could have application to the insertion of plating screws, which are used in maxillofacial, orthopedic, and spinal surgery to attach metal plates. “As with an anchor, ideal attachment requires that the screw be driven completely into the bone so that its head contacts the plate,” Fitzpatrick says.
The team plans to test the plating application at Vanderbilt later this year. It says it may need to make changes to the design during this alpha testing stage.
 

Other Vanderbilt contributors include Robert F. Labadie, associate professor in the department of otolaryngology; Jason E. Mitchell, an engineer in the department of mechanical engineering; and John E. Fitzpatrick, a mechanical engineering student.

LSA Laser Opens New Cleanroom

LSA's new cleanroom is equipped to perform medical-device manufacturing operations.

Continuing the expansion of its medical device manufacturing facilities, LSA Laser (Plymouth, MN) has announced the installation of a Class 100,000 cleanroom that will include a CO2 laser system. Up to five more systems are planned for precision processing of silicone, TPE, Teflon, and other polymers, in addition to a range of medical-grade metal materials.

"Growing demand for precision laser-processed medical components and assemblies is the reason for this continuing expansion," comments Tom Noll, LSA's president. "Our unique facilities and processes, together with our partner relationships with customers, drive this growth. By teaming with customer development engineers during the product development process, we work through design iterations utilizing our laser machines and engineers to refine a design and an appropriate manufacturing process. Our new cleanroom facility enables us to expand these customer partnerships."

A contract manufacturer of medical device components and assemblies, the ISO 13485:2003-certified company recently moved into new 26,000-sq-ft manufacturing and office facilities. It utilizes 26 laser welding and cutting systems with up to six-axis motion control and specializes in computer-aided manufacturing techniques.

LSA employs laser cutting, laser welding, laser ablation, and laser marking to manufacture a range of medical devices, including defibrillation leads, stents, catheters, surgical instruments, orthopedic components, hearing devices, and other products. The company can process a variety of materials, such as platinum, titanium, nitinol, and nichrome in sizes as small as 0.001 in.

Patent Eligibility for Personalized Medicine

Advances in molecular diagnostics and genetic mapping are ushering in the era of personalized medicine. Although medicine has always considered each patient individually, personalized medicine enables even more-precise and individually tailored treatment or preventive care decisions based on the patient’s genetic or molecular makeup. The ability to correlate patients’ disease or treatment with their unique genomic or molecular biomarkers allows physicians to go beyond the one-size-fits-all paradigm that may be ineffective or have undesirable side effects. Many experts consider personalized medicine as part of an overall transformation to a more cost-effective healthcare system, and several federal agencies, including FDA, have already embarked on their own personalized medicine agendas.1

Of course, more innovations will be needed before personalized medicine can achieve widespread adoption in the healthcare system. But stakeholders in these innovations may ask what kind of intellectual property protections are available for personalized medicine. This article addresses the question of whether innovations in personalized medicine meet the basic threshold requirement for patent eligibility—that is, whether such innovations can even be considered for patent protection.

Steven Yu

The problem can be illustrated using an example in which an oncologist is treating a breast cancer patient. The ERBB2 gene (also known as the HER2 gene) is known to be a marker for the aggressiveness of a breast tumor. Now let’s consider a hypothetical discovery that a treatment X is more effective if the patient’s ERBB2 gene contains a single nucleotide polymorphism (SNP) at sequence position 101. If the inventors sought a patent for their discovery, a patent claim might look like the claim presented in the sidebar “Hypothetical Patent Claim 3."2

The method of claim 3 is essentially the making of a treatment decision based on the genetic makeup of the patient. The method determines whether treatment X would be effective in treating the patient based on whether the patient has a SNP at position 101 of her ERBB2 gene. Patent claim 3 could be implemented by a physician viewing a laboratory report and then making a treatment decision, based on the presence of the SNP in the ERBB2 gene, about whether or not to use treatment X to treat the breast cancer patient. In other words, the diagnostic algorithm can be implemented purely through mental steps performed by the physician.

The question remains: is this algorithm-based approach to making a treatment decision eligible for patent protection? First, it may be useful to clarify that not all types of inventions are eligible for patent protection. The U.S. patent statute defines four categories of inventions that are eligible for patent protection, as follows:3

? Processes.
? Machines.
? Manufactures.
? Compositions of matter.

Although the statute appears to define a broad scope of patent-eligible subject matter for just about “anything under the sun that is made by man,” the federal courts have determined that there are certain limits.4 In particular, the patent laws prohibit the patenting of abstract ideas, mathematical formulas, principles of nature, natural phenomena, and mental processes (i.e., these are not patent-eligible subject matter).

From the beginning, the patent laws have never been entirely friendly to method inventions that solely involve an algorithm because they were considered abstract ideas, which are not eligible for patenting. But for a period of 10–15 years beginning in the early 1990s, the federal courts began to view such types of inventions more favorably. During this period, the general test for patent eligibility was whether the process “produced a useful, concrete, and tangible result.”5

This relatively loose standard for patent eligibility ushered in a proliferation of business method patents, so-called because they typically involve methods of conducting business transactions (e.g., algorithms for financial or insurance analysis, or performing Internet commerce). Under this standard, the U.S. Patent and Trademark Office (USPTO) would have considered the method in hypothetical patent claim 3 to be patent eligible because it results in a medical treatment decision, which would be considered a “useful, concrete, and tangible result.” In fact, the USPTO has granted many such types of diagnostic method patents.6

Bilski And Its Aftermath

With this proliferation of business method patents, however, came a backlash. Many critics argued that the patent system was impeding instead of encouraging innovation. These critics insisted that the threshold for patent eligibility should be raised, and the federal courts responded.

In 2008, the warm environment for algorithm-based inventions suddenly grew cold with the In re Bilski decision by the Federal Circuit court, which effectively negated 10 years of legal standards in the body of law governing patent eligibility.6 (Note: The Federal Circuit court is often referred to as the patent court for its special role in making judicial decisions related to patent law.) The Bilski case involved a method of hedging against particular investment risks in commodities trading (in what patent practitioners would consider a typical business method patent). The method was not restricted to implementation on a computer or any other sort of machine, meaning that it could be performed entirely by a person’s mental reasoning. In Bilski, the court set forth a two-part machine-or-transformation test for determining whether a process or method invention is patent eligible. The test requires that the method either be tied to a particular machine or apparatus or transform a particular article into a different state or thing. The hedging method in Bilski satisfied neither prong of this test, and thus did not qualify as patent-eligible subject matter.

Although the Bilski decision focused on business method patents, because it defines the concept of transformation in a physical sense, it affects other types of processes that primarily involve the gathering of data and interpretation of those data by human intervention. In particular, it affects patent practice in the bioinformatics fields, including personalized medicine. If a physician makes a diagnostic decision based on analyses of laboratory data, the question is whether any physical transformation has occurred.

Following the Bilski decision, the biotechnology, chemical, and pharmaceuticals technology groups at the USPTO held a customer partnership meeting on December 3, 2008. At this meeting, the USPTO offered its views on the patent eligibility of personalized medicine in a presentation titled, “A Look at Personalized Medicine.” Hypothetical patent claim 3 was shown in this presentation, and the USPTO announced that it would not qualify as patent-eligible subject matter under the Bilski decision because it is neither tied to a machine nor performs a transformation. Note that all the steps of the claim can be performed mentally by a physician.

For inventions that can be performed mentally or with pencil and paper, how can a patent claim be written to conform to the requirements for patent eligibility? In regard to this question, the USPTO announced that something like patent claim 4 would meet the patent eligibility requirements under the Bilski test (see the sidebar, “Hypothetical Patent Claim 4”).
Note that claim 4 is for a “method of treatment” instead of a “method of determination,” as in claim 3. Note also that this method is performed by a series of physical steps, instead of mental activities—namely, obtaining a nucleic acid sample, then subjecting the sample to PCR (polymerase chain reaction) analysis, and then treating the patient.

But although patent claim 4 may be patent eligible, it suffers from another potential problem. It may require multiple actors to perform the process, which can raise difficulties when the patent is enforced against an alleged infringer. Claim 4 can be implemented by one person obtaining the sample (e.g., a medical technician at a local collection facility), by another person performing the PCR analysis (e.g., a testing laboratory), and by another person performing medical treatment (e.g., a physician). In general, patent infringement requires that a single person or single entity perform all the steps of the method. In this example, if the medical technician, the lab technician, and the physician are not part of a single entity, there may be difficulty in enforcing this patent. (This issue, as well as the implications of the medical practitioner exemption from infringement liability under 35 USC 287(c), are outside the scope of this article and are not fully explored here.)

The Prometheus Case

Following the USPTO policy announcement, the Federal Circuit court offered its own post-Bilski view on personalized medicine. In the Prometheus Laboratories v. Mayo Collaborative Services case decided in summer 2009, the Federal Circuit court applied the Bilski test to a patent relating to a method for optimizing the treatment of inflammatory bowel disease by administering 6-mercaptopurine to a patient, and then determining the level of various drug metabolites as a guide to further treatment.7 Specifically, claim 1 of the Prometheus patent can be seen in the sidebar “Prometheus Claim 1."

Notably, the Prometheus case attracted numerous amicus brief filings (i.e., filings by noninvolved parties who volunteer their views on the case because the outcome could affect their own interests), including ones submitted by Novartis, Myriad Genetics, and the Biotechnology Industry Organization. Submission of the amicus briefs highlighted the importance of this case to the molecular diagnostics industry. The amicus brief filed by Myriad Genetics argued that patents on these types of diagnostic method inventions are critical for ensuring innovation in diagnostics and personalized medicine. Other amicus briefs argued that while Bilski’s machine-or-transformation test may be suitable for business method inventions, it is not well suited for biotechnology inventions.

These arguments appear to have been heard because the court upheld the validity of the Prometheus patent. The Federal Circuit court held that when a drug is administered to a patient, “the human body necessarily undergoes a transformation.” Thus, according to the holding in Prometheus, a claim containing a method step that involves treatment of human body tissue meets the patent-eligibility requirement set forth in Bilski.

Although the Prometheus decision is good news for medical diagnostics, the law on patent-eligible subject matter is still in a state of flux. Adding to this uncertainty, the Bilski decision is now being reviewed by the U.S. Supreme Court. The Court’s final ruling on this debate is expected in spring 2010. Amidst such uncertainty, it is clear that federal courts and the USPTO will be holding a more restrictive view of patent-eligible subject matter.

Patent Strategies

What are some strategies for patent protection of personalized medicine in this uncertain environment? One solution, as suggested by both the USPTO and the Federal Circuit, is to cast the invention as a method of treatment, rather than a method of diagnosis. This may be accomplished by including the step of administering a treatment to a patient. Another idea is to replace the data collection step with a step involving the collection of a blood or tissue sample from the patient. But although claiming treatment or sample collection steps may solve the problem of patent eligibility, it could introduce problems with enforcement if multiple actors are involved, especially if an outside laboratory performs the testing.

Activities relating to the analysis of the sample may also be added to satisfy the requirement of a physical transformation step. For example, the claim can include a biochemical reaction of the sample or the analysis of the sample can be tied to a specific diagnostic machine. Also, the diagnostic method can be tied to the use of a computer that performs the diagnostic algorithm.

Conclusion

Companies involved in molecular diagnostics should closely monitor judicial activity on the issue of patent eligibility and determine whether it affects their existing patent portfolio. It should be noted that the Bilski decision applies only to inventions that are claimed as processes or methods. Inventions that are claimed as diagnostic kits, diagnostic devices, diagnostic reagents, or biomolecular or chemical techniques are generally not directly affected by the Bilski decision.

References

1. M Rugnetta and W Kramer, “Paving the Way for Personalized Medicine,” Science Progress (September 2009).
2. K Bragdon, “A Look at Personalized Medicine,” presented at the USPTO customer partnership meeting on December 3, 2008.
3. 35 USC 101.
4. Diamond v. Chakrabarty, 447 U.S. 303 (1980).
5. In re Bilski, 545 F.3d 943 (Fed. Cir. 2008).
6. For example, U.S. Patent No. 4,968,603 and No. 5,674,680.
7. Prometheus Laboratories v. Mayo Collaborative Services, No. 2008-1403 (Fed. Cir., Sept. 16, 2009).

FDA Demands Pump Recall from Baxter

"The situation has languished far beyond what it should have," said Baxter's CEO and chairman Bob Parkinson yesterday at the company's annual meeting in Deerfield, IL.

Over the past five years, FDA has received more than 56,000 adverse-event reports involving infusion pumps, including serious injuries and more than 500 deaths. The agency launched an initiative less than two weeks ago to address pump safety and issued a draft guidance soon after.

This Week In Brief: May 4, 2010

Silver-based antimicrobial solutions provider Agion Technologies (Wakefield, MA) has announced the launch of its Medical Device Market Acceleration Program (MedMAP). The program offers medical device manufacturers a service designed to accelerate the development and regulatory clearance of 510( k) and CE-marked devices featuring the company's antimicrobial protection engineered to minimize bacterial colonization.

Carl Zeiss Industrial Metrology has opened a West Coast Tech Center in Irvine, CA. Featuring such metrology technology as optical, touch scanning, CT, x-ray, and measuring software, the 3800-sq-ft facility was established to support customers in the region as well as local growing markets, according to the company.

This year marks the 50th anniversary of Kurt Manufacturing Co. (Minneapolis). The company provides a range of workholding options for manufacturing, including CNC vises, rotary table workholding, static milling chucks, zero-point clamping systems, and accessories.

Algoryx Inc. (Los Angeles), a systems engineering company that provides mold characterization studies (MCS), has received its sixth and seventh U.S. patents for its technology for injection molding cycle-time reduction, process monitoring, and control. Its MCS technology can reduce production costs by reducing cycle time to eliminate 1 to 2 shifts per week for 24/7 operations; reducing press energy consumption by 4 to 5%; eliminating 99% of in-process dimensional inspections and analyses; reducing automated assembly line shut-downs due to out-of-spec parts; and removing risk during mold development and part production.