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Articles from 2012 In July

Simulator Could Help Improve Knee Implant Design

Simulator developed by researchers at Clemson University is being used to investigate the effects of different UKA alignment and ligament configurations on the movement and contact pressure distributions on the knee.

In an effort to investigate the effects of different unicompartmental knee arthroplasty (UKA) alignment and ligament configurations on the movement and contact pressure distributions on the knee, researchers at Clemson University (Clemson, SC) have designed and constructed a knee simulator in which cadaveric specimens can be mounted for study. By better understanding the causes of UKA failures, the researchers hope to improve implant designs, surgical techniques, and patient selection criteria. At the same time, they seek to provide patients with better information about possible postoperative or rehabilitation risks.

UKA is a surgical procedure that is used for treating osteoarthritis when the damage is only limited to one compartment of the knee. The main advantages of this procedure over a total knee replacement include preservation of bone stock, more physiological joint movement, improved proprioception (awareness of the position of the body), increased range of motion, and faster recovery times.

Despite its reported success rates (87 to 98% survivorship at ten years), UKA has not gained universal recognition as the appropriate procedure for treating arthritis afflicting a single condyle. Some of the procedure's failure modes include progression of arthritis in the nonoperated compartment, polyethylene wear, aseptic loosening, fracture, and the need for revision surgery because of pain. These failure modes are believed to be associated with poor implant design, patient selection, and alignment during surgery and with a mismatch in compliance between soft tissues and implant material. All of these factors can result in abnormal loading distributions on the knee, which are thought to accelerate degradation and lead to increased rates of clinical failure.

In addition to performing a reasonable simulation of the body's entire lower extremity during such activities as rising from a seated or a crouching position, the machine allows the scientists to measure internal loadings (contact pressures), which cannot not be performed accurately in living patients. The researchers also use a motion-tracking system enabling 3-D position tracking of knee movement during simulation. The contact pressure and area of the articulating surfaces are measured using paper-thin film pressure sensors that can be inserted between the knee joint.

Move by Cardinal Health May Signal Growth of Generic Medical Devices Market

Cardinal Health Inc, one of the three largest medical device wholesalers, raised eyebrows when it announced last week that it would begin offering lower cost orthopedic products for broken bones as part of its partnership with Denver-based Emerge Medical, a manufacturer of surgical screws, drill bits, and guide wires. “Based upon our market and customer research, we believe that U.S. health care providers are ready to support a simpler, more transparent, fair priced orthopedic business model,” Cardinal Health executive Lisa Ashby said in a statement published in The Philadelphia Inquirer.

While FDA does not apply the term generic to medical devices as it does to pharmaceuticals, the move by Cardinal Health marks what could be an increasing trend in medical device companies offering lower-cost alternatives to products. Anyone who has ever had to get a prescription filled has been offered a generic alternative to a given drug – usually based upon what your health insurance provider will or won't pay for. A shift in focus among medical devices companies could result in this same type of factors being taken into consideration when a patient needs an implant or other medical device.
The decision by Cardinal Health comes amidst reports that companies are being pressured to lower costs as the cost of medical devices continues to rise (in an industry that already brings in a reported $40 billion annually). A report released in January by the Government Accountability Office (GAO) titled “Lack of Price Transparency May Hamper Hospitals' Ability to Be Prudent Purchasers of Implantable Medical Devices” found substantial variation in the prices hospitals paid for cardiac devices – variance that is accounted for by the difficulty some hospitals have in bargaining with manufacturers and the lack of transparency in device pricing. These costs that the hospitals incur are, of course, often passed down to patients.
Is the medical device market primed for the introduction of generic products? If it becomes widespread, the practice could create the same sort of glut of product often seen in the pharmaceutical sector. Then again, with a comparatively smaller market in relation to Big Pharma, the introduction of lower-cost alternatives for patients could be both a boom and a means of stabilization.
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-Chris Wiltz is the Assistant Editor at MD+DI

"A Major Milestone in Digital Medicine:" FDA Clears Ingestible Smart Pill

bubble patchProteus Digital Health Inc. (Redwood City, CA) has announced that FDA has cleared its swallow-able sensor, which can be integrated into a pill to monitor medication adherence. The medical device, which the company refers to as an ingestible event marker (IEM), can monitor the timing of drug ingestion in the stomach and relay that information to a patch worn on the body. The patch also can track heart rate, activity levels, and sleep patterns, and relay such information, as well as information regarding drug compliance to caregivers via text message or e-mail. In addition, the device can be used to send text reminders to patients who forgot to take a pill on time. 

The company began working with FDA in 2008 to determine the product's regulatory pathway. The device was ultimately cleared as a de novo medical device via the 510(k) premarket approval process, designed for low-risk products without a predicate. 

The sensor is made of materials present in food such as copper, magnesium, and silicon (which is a trace mineral found in plants such as oats, barley, and rice). The device has no antenna or battery

In a statement, Eric Topol, professor of genomics at The Scripps Research Institute and author of "The Creative Destruction of Medicine," hailed the FDA decision as "a major milestone in digital medicine," adding that the device when used in conjunction with wirelss technology could "set a new standard for influencing medication adherence and significantly aid chronic disease management."  

The company's co-founder and chief medical officer, George Savage, MD, said in an interview with MD+DI that the technology has an array of potential applications. One of its advantages, he says, is that it can help bridge the gap in patient monitoring in inpatient and outpatient care settings. In a hospital settings, doctors generally know which medications their patients are taking. By contrast, in ambulatory settings, how well patients comply with pharmacotherapy regiments can be something of an unknown variable.

Proteus received a CE mark for the technology in August 2010, which cleared the technology's path to market in Europe. 

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz

Related Content

More Medtech Outsourcers Buy Offshore Operations

More Medtech Outsourcers Buy Offshore Operations

Consolidation among contract manufacturers serving the medical device industry is nothing new, but recently medtech outsourcers have been buying up firms overseas in attempts to help their OEM customers cut costs and expand into new markets. 

Medical device contract manufacturer Tegra Medical purchased this facility in San Jose, Costa Rica, in 2010.

The trend has been gaining momentum over the past three or four years, says Mark Surowiak, a director in the Philadelphia office of Capstone Partners, an investment banking advisory firm. He cites 16 overseas acquisitions by medical device contract manufacturers in the past 12 months as evidence that the practice is continuing in 2012.

“Domestic players are continuing to acquire overseas, and firms in overseas countries still are trying to gain a foothold in the U.S. market,” Surowiak says. Companies based in the Netherlands, Italy, and Ireland have been especially active in acquiring medtech outsourcing firms in the United States, while companies in China, Brazil, India, and Latin America have been popular targets for U.S. contract manufacturers, he says.

Two years ago, medical device contract manufacturer Tegra Medical (Franklin, MA) bought a 20,000-sq-ft manufacturing plant in San Jose, Costa Rica, in an effort to cut costs for its OEM customers.

“When products mature, price pressures increase, and you need to take cost out of products every year,” says Tom Burns, vice president of development for the company. “At some point, you run out of options domestically.”

The facility, which Tegra Medical purchased from Penn United Technologies, was a good fit for the company for a number of reasons, Burns says. Its general manager was bilingual, originally from the United States, and had relevant experience; the plant already had a good technical staff and about 10 toolmakers; and it came with basic manufacturing capabilities and equipment.

Tegra Medical chose the facility in Costa Rica over others in Central America largely because it is located in a tax-free trade zone that is also home to several other medical manufacturing companies. That has allowed the company to react quicker and reduce shipping costs, and enables its customers to carry less inventory.

Overall, Burns says the facility in Costa Rica has helped Tegra Medical reduce labor and overhead costs, but Surowiak says cost cutting isn’t the only factor driving contract manufacturers to make overseas acquisitions. The trend can be attributed in part to a broader shift toward consolidation in contract manufacturing. As medtech OEMs outsource more of their operations, they’re looking for contractors that offer a wide range of capabilities, Surowiak says. Outsourcers have responded by making acquisitions to boost their portfolio of services and increase their global footprint.

All of this has resulted in an evolving relationship between OEMs and their contract manufacturing partners. “OEMs now look to contract manufacturers as partners, and they want to explore new market opportunities with their existing vendors,” Surowiak says.

Many of those opportunities are in emerging economies, where reimbursement rates for medical devices are typically lower than in the United States and Europe. To compensate, OEMs are working with contract manufacturers to build scaled-down versions of their products closer to where they will be distributed, Surowiak says. Regulations can make it difficult for outsourcers to build operations from scratch in developing countries, so outsourcers are acquiring firms in their target markets instead.

“You are seeing more of it as there’s more recognition of emerging markets being a significant growth opportunity,” Surowiak says.

But while working with a contract manufacturer with a presence around the world can hold benefits for OEMs, there are downsides, including delays.

“It’s not as easy to get equipment serviced in Costa Rica or other countries outside the U.S.,” Burns says. “It can add days or a week or more if you have a problem with equipment or need spare parts.”

Foreign facilities also often need to be brought into compliance with relevant standards, and that can take time. In some cases, language barriers must be overcome, and in countries such as China, intellectual property protection can be a concern. If secondary operations, such as sterilization, aren’t available in the new country, the product will have to be shipped elsewhere to have them performed, which increases costs. There’s also availability of labor and political stability to consider.

Burns says some of Tegra Medical’s customers took a wait-and-see approach before using the new Costa Rica facility, in some cases holding off until the plant was up and running for six months before performing an audit of their own. Others were eager to move operations there.

The bottom line: Using an offshore outsourcing operation is not right for every company or every product.

“OEMs have to do their homework and really look at the true delivered cost and what they’ll have to invest in resources on their end,” before working with an outsourcer to move production across borders, Burns says.

Jamie Hartford is the associate editor of MD+DI. Follow her on Twitter @readMED.

Medical Device Tax Will Curb Cook Medical's Growth

The folks over at Cook Medical are no fans of the device tax, as they have made abundantly clear. They're probably really cursing the tax today, as it's forcing them to scrap their plans for expansion.

The Indianapolis Business Journal (IBJ) reports that the company expects to pay as much as $30 million when the tax goes into effect in January. That's about how much the company recently spent to open a plant in Canton, IL, that will eventually employee at least 300 people. According to the IBJ, Cook had hoped to open a facility a year for the next five years, but those plans won't be possible if the tax stays in place.

“We have fewer resources to be able to spend on those kinds of projects,” Pete Yonkman, executive vice president of strategic business units, told the publication.

—Jamie Hartford

Kollmorgen Releases New Stepper Solutions Catalog

A global provider of motion systems and components for medical machine builders has released a new stepper solutions catalog. The catalog details the features, benefits, and specifications of the company's complete range of stepper motors and stepper drives, AC synchronous motors, XTRUE planetary gearheads, and optimized solutions. The company's stepper motors provide high torque in a small package and come in a range of standard sizes constructions, windings, and options to suit a wide variety of application needs. These high-performance brushless, maintenance-free stepper motors provide very precise, extremely cost-effective motion control. They are two phase motors that inherently move in small, very precise, 1.8° increments (200 steps/ revolution) - stepping action that is simple to control and does not require complicated, expensive feedback devices. The company's stepper drives and controls are available in full, half, and micro-stepping models in both modular and packaged designs.

Radford, VA

Dymax Releases New Adhesive Selector Guides

A developer of innovative oligomer, adhesive, coating, dispensing, and light-curing systems for applications in medical devices has released two new adhesive selector guides for catheter assembly and needle bonding applications. These comprehensive guides provide detailed information on the company’s products and unique value proposition – The Dymax Edge. They’re intended to help device manufacturers choose the appropriate adhesive and compatible dispensing and curing equipment for their specific application. The guides are available for download at the company Web site.

Torringtong, CT

Artificial Neural Network for Breast Cancer Diagnosis Takes Top Prize at Google Science Fair

Brittany Wenger, a 17-year-old from Lakewood Ranch, FL, took home the grand prize in this year’s Google Science Fair for her “Global Neural Network Cloud Service for Breast Cancer.”

Her project has shown a 99.1% success rate in identifying malignant tumors and could eventually achieve perfection, according to Wenger’s research. It uses a custom artificial neural network that weights malignancy heavily negative to analyze the results of minimally invasive fine needle aspirates.

Because the program she created learns by example, it will only get as more samples are analyzed. It’s also cloud-based, so physicians around the world could use it.  

Jamie Hartford is the associate editor of MD+DI. Follow her on Twitter @readMED.

Honeywell Introduces New Basic Board Mount Pressure Sensors for Medical Manufacturers

A company manufactures new basic board mount pressure sensors for medical equipment manufacturers. These are a cost-effective, basic performance, mV output, unamplified, uncompensated, high quality and high resolution solution for customers seeking high-volume, economical board mount pressure sensors. The NBP Series can be used in a wide range of applications. Potential medical applications include pressure monitoring for wound therapy machines, hospital beds, oxygen concentrators, and blood pressure monitors.

Minneapolis, MN

Device Tax Blowback: Fewer Expansions, More Layoffs

The last weeks and months have been filled with big news for the medical device manufacturing sector, from FDA's proposed unique device identification system and moves to develop an artificial pancreas to a spate of medical device recalls and an apparently endless flurry of mergers and acquisitions. But nothing has roiled the industry as much as the Supreme Court's decision upholding the constitutionality of the Affordable Health Care for America Act--particularly its much-reviled provision imposing a 2.3% excise tax on the first sale of medical devices.

Among the first companies to respond in kind to the device tax is Cook Medical Inc. (Bloomington, IN), which has just reported that it is scrapping plans to open several new manufacturing plants in the Midwest over the next five years. Specializing in the manufacture of devices used in endoscopy, cardiovascular medicine, urology, women's health, and other applications, the nation's largest privately held medical device OEM had been planning to open five new manufacturing plants In Indiana and elsewhere. But projecting that it will have to pay $20 to $30 million once the tax takes effect in January, the company feels challenged, according to Pete Yonkman, executive vice president of strategic business units. "We have fewer resources to be able to spend on those kinds of projects," Yonkman told the Indianapolis Business Journal, referring to a plant that the company recently opened in Canton, IL.

Meanwhile, Stryker (Kalamazoo, MI), maker of hip and knee implants, surgical instruments, and other medical devices, has already taken the bull by the horns as it begins the process of slashing 107 jobs at two facilities in New York in preparation for shuttering the plants altogether. The company's objective, according to the Buffalo News, is to reduce its operating costs by $100 million. Joining Stryker is orthopedic titan Zimmer (Warsaw, IN), which plans to cut 450 jobs.

In the midst of these layoffs, one can't help but note that Stryker's second-quarter financial results--notwithstanding problems resulting from the falling Euro exchange rate--were positive. Driven by higher unit volume, new product mixes, acquisitions, and other factors, the company reported $2.1 billion in net sales, up 2.9% over the same period last year. Net earnings also grew, reaching $325 million during the quarter, up 4.8% over the 2011 second-quarter net earnings of $310 million.

That's Stryker's situation, but what about the rest of the U.S. medical device industry? According to the Wall Street Journal, the nation's medical device industry may see stabilized volumes and growth based on solid results achieved in the previous period, in which there were some signs of stability and even a slight gain.

In light of the foregoing, isn't it possible that medical device opponents of the tax are blowing things out of proportion, as the Center for Budget Policies and Priorities has noted? --Bob Michaels