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Changing Healthcare Delivery through New Technologies

MDEA 2006

When a new device comes on the market, it is often a simple upgrade of something already available. It's not only difficult—it can be quite expensive to develop a product that is truly revolutionary. But there are those few devices that come along that may just change the way doctors and hospitals deliver healthcare. And, as expected, these devices are, by nature, award winners. A few of these potentially disruptive technologies are highlighted here.

The OmniPod delivers insulin at preprogrammed rates. The system eliminates wires between the pump and the controller.

OmniPod

The OmniPod insulin management system, manufactured by Insulet Corp. (Bedford, MA), delivers insulin at preprogrammed rates to people with diabetes. The system includes a handheld personal diabetes manager that communicates wirelessly to a three-day wearable insulin-delivery device.

“There is a lot of patient involvement in the management of diabetes,” explains John Garibotto, vice president of engineering for Insulet. “When the patient is in the doctor's office, the doctor determines whether the patient is technically savvy enough to handle the currently available pumps. “There are lots of mistakes that could happen,” he says. “For example, a patient can over infuse and become hypoglycemic.”

With the OmniPod, insulin enters the body through a soft cannula that is inserted into the subcutaneous tissue. The system uses a handheld diabetes manager that communicates wirelessly to the OmniPod. Because it has no tubing, patients sleep more comfortably.

“With tubing sets, it is difficult to inject the needle at the right angle into the subcutaneous layer. Patients often insert too shallow or too deep (intramuscular),” he says. “With the pod, the cannula is placed on the body and, through wireless automation, the needle and tubing are inserted at a 45Þ angle subcutaneous every time. There are no sharps because the needle is retracted into the device.”

The system's automated cannula insertion system is designed to reduce physical discomfort resulting from insertion errors because it eliminates variability in insertion angle and depth, says Garibotto. “The patient never sees the needle, and there are no sharps to dispose of after use,” he says. The handheld portion programs the pod with delivery instructions and monitors the pod's operation. The handheld device contains the glucose meter and automatically stores patient records.

“What was very appealing about this product was the elimination of user action in the cannula insertion step,” says MDEA juror Craig Jackson, president and chief technical officer of Hemosage Diagnostic Corp. (San Diego).

According to Garibotto, conventional insulin pumps have hundreds of components. By separating the user interface and focusing on minimizing part count, Insulet reduced the number of components in the pod to 40 parts.

The OmniPod is designed to bring the therapy to a larger patient population. “From the perspective of intuitiveness and ease of use,” says Garibotto, “we tried to see why insulin pumps were not as prevalent as they should be as a therapy to treat diabetes.” The OmniPod has the same overall cost over a four-year period as conventional insulin pump therapy; however, it doesn't have the typical large up-front costs. Costs are distributed over the life of the product. “Insulin pump therapy remains out of reach for many diabetes patients who would most benefit from pump therapy,” explains Garibotto. In addition to cost, another factor that rules out some patients is their inability to see the small screen of existing pumps. Insulet made the user interface a separate handheld wireless device. “It's much friendlier and explains instructions in full sentences,” says Garibotto.

Jackson points to the elimination of wires between the pump and the controller as an important part of the device's design. “Added control is possible using the integrated glucose monitor, and it provides more-appropriate insulin dosage, that is, better glycemic control,” he says.

“We want to make pumps available to a wider audience,” says Garibotto. “By designing the separate interface, the pump is much easier to use. Doctors can present this pump to patients they may have previously ruled out,” says Garibotto. Feedback from patients who have used the device has been overwhelmingly positive, he says.

From a technical standpoint, Garibotto notes that one of the company's key decisions was the selection of the motor. “We used a nitinol wire as the actuator to drive the insulin. Current pumps use a dc motor. The wire meant a smaller form factor and less weight,” he says. “It also cost only 25 cents compared with a dc motor, which costs around $100.”

The company did get one surprise. “When we started, we were interested in converting existing pump users. We have found, however, that more than 70% of our users are coming from conventional insulin patients—those who inject insulin. Existing pump patients have been slower to convert. This is one of our most interesting findings.” Garibotto attributes this outcome to the way that insulin pumps are covered by health insurance and the expensive investment diabetics make in their current pumps.

The OmniPod is the culmination of five years of development. Insulet is a start-up company that was founded to develop this insulin management system.

Nucleus Freedom

The Nucleus Freedom system, developed by Cochlear Ltd. (Lane Cove, NSW, Australia) restores hearing to people with profound hearing loss. Sounds picked up by a processor behind the ear are transmitted by radio to the implant. The implanted electrodes stimulate the cochlear nerve, and this stimulation of the nerve is perceived as sound.

The Nucleus Freedom system restores hearing by using implanted electrodes to stimulate the cochlear nerve.

The Nucleus Freedom is the fourth-generation of cochlear implant technology developed by the company. Modern cochlear implants enable recipients to hear well in quiet situations, but it can be difficult for them to hear in environments like restaurants because of the ambient noise. According to the company, the Nucleus Freedom is the first implant system to use beam-forming technology, which is specifically designed to function well in noisy situations. The technology detects and eliminates noise from any direction other than the speaker straight in front of the user.

“More than 7000 people have seen a dramatic change in their lives since we launched the product last year, and 20% of them are under 3 years old,” says Robert Southwood, program manager for product development for Cochlear Ltd. “A child who is born deaf and receives a Nucleus Freedom system can attend mainstream school and can have life opportunities similar to those of a child with normal hearing,” says Southwood. “At the other end of the spectrum are the 20% of Freedom users over the age of 65, many of whom are enjoying sounds that they haven't heard for decades or who are able to communicate with their grandchildren for the first time,” he says.

“Studies have shown that of all medical interventions, the cochlear implant system is second only to neonatal intensive care in terms of the quality of life improvement per dollar spent,” Garibotto says.

According to the company, a design goal for the device was to prevent ingress of liquid and contaminants, and implant reliability was paramount. A speech processor chip consumes 50% less power than the digital signal processor (DSP) application-specific integrated circuit (ASIC) in the previous generation system.

“Cochlear implants can be expensive to run due to the cost of the batteries used by the external speech processor,” explains Southwood. “Power consumption is at the forefront of our designers' minds in order to reduce the cost of batteries for patients and to reduce the inconvenience of having to frequently change batteries,” he says. Because the newer speech detection algorithms can also require more power, he says that saving power in the DSP ASIC gives more patients access to better performance.

“With Nucleus Freedom, most patients can run advanced algorithms for three days before having to change their batteries. With some older products, patients had to change their batteries twice in one day.”

This new system comprises four components: an electronic module that is surgically implanted under the skin behind the ear (including an electrode that is inserted inside the cochlea cavity); a speech processor worn externally behind the ear like a hearing aid that converts environmental sounds, such as speech, into electrical stimulation patterns transmitted to the implant over a radio-frequency link; software used by audiologists to test the performance of the implant and speech processor; and a small piece of hardware connecting the audiologist's computer to the patient's speech processor.

The company conducted extensive market research in many countries before starting to design the Nucleus Freedom. “We wanted to make sure we really heard and understood the voices of all of our customers,” says Southwood. “For example, they told us that conventional cochlear implants work well in quiet surroundings but not so well in background noise, say at school or in a restaurant, so this became a high priority for us in the development of the beam algorithm. They told us that children wanted to be able to wear their processor in the rain, or to run through a sprinkler, or to play sports in humid conditions, so we designed the external parts to be water resistant,” he says.

Southwood says Cochlear implemented dozens of features as a direct result of carefully listening to customers and to clinical professionals. “We also conducted a lot of concept testing sessions, and we did extensive prototyping. We conducted an exhaustive clinical trial to make sure we got the features just right,” says Southwood. “Even now, a year after launch, we are monitoring customer experience and making fine-tune adjustments and adding some major new improvements to the Nucleus Freedom system.”

The IDI-MRSA assay can provide definitive and fast results, allowing earlier treatment.

IDI-MRSA Assay

The IDI-MRSA assay, developed by GeneOhm Sciences Inc. (San Diego), is a qualitative in vitro diagnostic test for the direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA) to help prevent and control MRSA infections in healthcare settings. In March, Becton Dickinson acquired GeneOhm, which will now be known as BD Diagnostics– GeneOhm business unit.

Infection control programs that use active surveillance to identify patients and strict application of barrier precautions for patients colonized or infected with MRSA have shown success in controlling MRSA. The company's IDI-MRSA assay provides results in just two hours of lab time compared with the 16–72 hours required for a conventional culture.

According to the company, such definitive, rapid results combined with earlier treatment intervention can significantly improve patient outcomes, prevent outbreaks, and control hospital costs. Without active surveillance testing for MRSA, most colonized patients go undetected.

“MRSA is increasing at an alarming rate in hospitals, carrying a heavy burden of mortality and morbidity. In the United States alone, CDC estimates MRSA accounts for 2 million infections, 8 million excess hospital days, and more than 90,000 deaths per year,” explains Peter Klemm, president of BD Diagnostics–GeneOhm. “In fact, it is ranked as the fifth-leading cause of death in hospitals.”

“The key is time—sooner is better,” says MDEA juror Jackson. “The sooner identification is made, the sooner appropriate action can be taken. The action is treatment of the infected patient who is at the greatest risk simply because he or she is sick. Many may be immunocompromised,” he says. “Even more effective is the identification of hospital employees who are carriers and then eliminating the opportunity for them to inadvertently infect others, particularly patients,” says Jackson.

Klemm says that hospitals can now actively prevent infections, rather than merely reacting to control them. “Identifying the reservoir of MRSA carriers enables better infection control processes, leading to reductions in the transmission and infection rates of MRSA,” notes Klemm. “Early screening of patients for MRSA nasal carriage to identify those patients that require isolation can be a pivotal part of an effective infection control program.”

According to the company, current techniques require one or more culture steps. They require the isolation of pure colonies followed by either oxacillin susceptibility testing, detection of the medA gene, or detection of the penicillin binding protein (PBP 2a) encoded by the mecA gene or an 18–24-hour incubation on a specialized agar plate. The time to definitive resolution of MRSA carrier status takes a minimum of 16 hours.

“Providing the absolute minimal turnaround time was a critical design goal, combined with achieving performance equal to or exceeding the gold standard of culture,” says Klemm. “Another significant aspect of the turnaround time is tied to the negative predictive value of 98%.” He says that knowing within hours that a patient is not colonized with MRSA enables hospitals to avoid the costs and complications of isolating patients under contact precautions while they wait for up to two additional days for a definitive test result.

“By enabling hospitals to identify patients colonized with MRSA within hours of admission, or even prior to admission, use of this rapid MRSA test means that hospitals no longer have to accept these infections as a cost of doing business,” says Klemm. “Armed with the early, actionable information provided by this rapid test, hospitals can employ targeted interventions to prevent medical complications, reduce the spread of infection, shorten hospital stays, reduce medical costs, and improve patient outcomes.”

Many healthcare institutions have implemented active surveillance screening and search-and-destroy policies that use a zero tolerance approach to multi-drug-resistant organisms like MRSA, says Klemm. “As the prevalence of MRSA, as well as other multi-drug-resistant organisms and healthcare-associated infections, such as Vancomycin-resistant Enterococcus (VRE) and Clostridium difficile, continue to increase, it is expected that hospitals will be driven to adopt best practice protocols that are demonstrated to reduce infection rates.”

CereTom Mobile CT Scanner

The CereTom Mobile CT (computed tomography) Scanner, developed by Neurologia (Danvers, MA), is a compact, lightweight, mobile, high-speed, battery and line-powered multislice CT scanner. It is optimized for scanning anatomy that can be imaged in the 25-cm field of view, primarily head and neck. The system generates up to eight slices per revolution, using the system's Modular Multirow Detector (MMD).

The CereTom Mobile CT Scanner generates up to eight slices per revolution and transmits the images wirelessly.

“The eight-slice capability means that you do not sacrifice quality to get an extremely valuable asset that can be transported to a critical patient,” says juror Jeff Butler, principal engineer for Sysmed Enterprises (Richardson, TX). “ICU patients are switched from bedside monitoring to a portable monitoring system and wheeled down hallways to the CT scanner accompanied by nurses or other medical professionals who generally have other responsibilities.”

The CereTom's wireless image transfer system enables clinicians to process examinations wherever a patient is located. The scanner is designed to provide high-quality imaging anywhere it is needed. Any clinician can use the scanner to obtain noncontrast CT, CT angiography, and CT perfusion studies of the head and neck in as little as two minutes. The Silhouette scan board, an accessory to the scanner, converts gurneys, ICU beds, operating room tables, or hospital beds into the scanning platform.

The bed remains stationary in a patient's room or in ICU. The patient never moves; only the scanner moves. Trauma to patients is greatly reduced or eliminated by minimizing the need to transport for CT scanning. According to the company, the CereTom has very low scatter radiation, which makes it safe to operate anywhere in the hospital, without the need for a shielded room.

The scanner provides three major benefits to patients; lower dose during scanning, elimination of the need for transport, and faster scan times. The CereTom scanner delivers less than one-third the radiation than that of a standard CT scanner while delivering the same image quality. The patient is exposed to a lower dose, making it a safer diagnostic imaging alternative. By converting the patient bed into the scanning platform, the scanner eliminates the need to transport critically ill patients for head and neck imaging. Eliminating transport greatly reduces the risk to patients and thus improves patient outcomes.

“The scanner is a compact, lightweight, high-speed mobile battery-powered multislice CT on wheels,” says juror Matthew Weinger. Weinger is professor of anesthesiology, biomedical informatics, and medical education at Vanderbilt University School of Medicine (Nashville, TN). “Preprogrammed protocols are automated into one touch. It can be operated with minimal training,” he says.

The major benefit of the CereTom is that clinicians can move the point of care to the patient. According to the company, the CereTom is the first major upgrade to the delivery of CT scans since these scanners were first put into mobile trailers in the early 1990s. As a result, more patients will have the opportunity to be scanned in a safer and more efficient manner. “This is a very interesting product,” says Butler.

The Image Guided Implantology system guides dental implantation surgical instruments with a CT-based surgical plan.

Image Guided Implantology System

The Image Guided Implantology system, manufactured by DenX Advanced Dental Systems Ltd. (Jerusalem, Israel), is a computerized navigational system that assists in the preoperative and intraoperative phases of dental implantation surgery, accurately guiding surgical instruments according to a CT-based presurgical plan.

The system provides assistance in both the planning (preoperative) and the surgical (intraoperative) phases of dental implantation surgery. In the preoperative phase, the system enables the surgeon to accurately evaluate the alveolar bone and the critical anatomical structures, as displayed on a patient's dental CT scan. Consequently, the system enables the surgeon to create an accurate digital preoperative plan of implants' positions, based on the CT imaging. The planned positions are correlated to the anatomical structures and to the patient's individual occlusion.

In the intraoperative phase, the system guides the surgeon to place the implants exactly as planned and warns the surgeon of significant deviations from the plan. According to the company, this reduces risk of failure and damage to adjacent structures. The combination of the pre- and intraoperative steps ensures a quality final restoration. The optics-based navigational system uses an infrared camera sensor and light-emitting diodes to monitor objects in a confined space. The system includes a tracker attached to a standard dental handpiece and a patient tracker attached to the patient's jaw through a pole screwed to a horseshoe.

One of the key benefits of the system is that it allows less-experienced practitioners to place implants with confidence, the company says. An important consideration at all stages of design was the need to simplify the work flow and overhead associated with the system. The system promotes a more controlled protocol for implant placement, which increases safety and contributes greatly to achieving optimal restoration and implant placement results. This is particularly evident in the edentulous (toothless) patients. The company has developed a unique hardware kit to address the needs of these patients.

“Many techniques and procedures in medicine are more art than science, or at least require significant art or learned techniques,” says juror Butler. “Products like this one shorten the learning curve for the art of implanting and introduce more precision. To see—really see—what the physician is doing can be quite revolutionary,” he says.

Copyright ©2006 Medical Device & Diagnostic Industry

Abbott Consolidates Top Leadership

Gonzalez

Abbott's Gonzalez: A broader charge.

Richard A. Gonzalez, president and chief operating officer for the medical products group of Abbott (Abbott Park, IL), has been promoted to the role of president and COO for all of the company's medical and pharmaceutical products.

His promotion comes following the departure of Jeffrey M. Leiden, MD, PhD, president and COO of the pharmaceutical products group. According to the company, Leiden resigned “to pursue other career interests.”

White

Abbott's White: Confident in change.

“Rick is a 29-year Abbott veteran and an exceptional leader with a proven record of achievement,” said Miles D. White, chairman and chief executive officer of Abbott. “He has created a portfolio of global medical products businesses that is delivering double-digit growth, built a strong medical products pipeline, and attracted and developed an impressive leadership team. I have great confidence that Rick will lead the organization to take advantage of the many opportunities in both areas of our business.”

Gonzalez joined Abbott in 1977 and held several positions in the company's diagnostics division. In 2001, he was elected president and chief operating officer of the medical products division. At that time, he was also elected to Abbott's board of directors. Prior to joining Abbott, Gonzalez was a research biochemist at the University of Miami School of Medicine.

Under the new corporate structure, leadership of Abbott's pharmaceutical operating divisions and research and development organizations will report to Gonzalez, as will the company's medical products division. The change of power became effective March 27.

Less than two weeks after the switchover, Abbott reported that the European Commission had cleared its proposed acquisition of the vascular business of Guidant Corp. (Indianapolis). The proposed transaction, in which Gonzalez played a key role, is currently under review by the U.S. Federal Trade Commission.

Guidant was required to the make the divestiture as a condition of approval of its merger with Boston Scientific (Natick, MA). As part of the $6.4 billion deal, Abbott will pay $4.1 billion in cash, provide a $900 million loan to Boston Scientific, and acquire $1.4 billion in the company's stock.

In the wake of the corporate restructuring, several analysts speculated that the promotion of Gonzalez underscored a larger shift within the company toward medical devices. A company spokesperson, however, was cited as saying the company is still committed to a diversified presence with a significant focus on pharmaceuticals.

In 2005, Abbott's estimated medical product sales were approximately $5.9 billion, a 14% increase over 2004's estimated sales of $5.2 billion. 1 Abbott does not provide detailed data for its medical products group sales. Abbott's overall sales for 2005 totaled $22.3 billion, a 13% increase over 2004 sales of $19.7 billion.

Reference

1. “Majority of Top 20 Medtech Companies Post Double-Digit Sales Growth in 2005,” MX: Issues Update [online] (March 2006); available from Internet: www.devicelink.com/mx/issuesupdate/06/03/Top20.html.

© 2006 Canon Communications LLC

Return to MX: Issues Update.

Award-Winning Devices Get Better All the Time

MDEA 2006

It is difficult to talk about innovation without using comparative terms (as in faster, safer, better). After all, rewarding a product that improves delivery time, or that includes a locking system so patients can take it home, is what the Medical Design Excellence Awards (MDEA) are all about.

So when you see a device designed to reduce use error, suture with less damage to tissue, or stay cool more efficiently, you'll understand the effort that goes into improving such a product.

It is difficult to take a device that could use improvement and meet design challenges to make necessary changes. Sometimes it takes more imagination to rethink a device to make it better than it does to come up with a completely new product.

That's why the following devices come out on top. They have each greatly improved the way things are done. And it's a sure bet the manufacturers are already looking at these award-winning devices to see where they can make advances—and the products are getting better all the time.

Patton Surgical's PassPort Shielded Trocar addresses safety concerns and does not interfere with surgical methods.

Getting Safer: Injury Reduction

PassPort Shielded Trocar. Injury reduction is one of the most important aspects of surgery. Sharps that can hurt patients and pose risks to doctors and nurses are continually being examined for ways to reduce the chance of injury.

The trocar has significantly changed medicine. Used in laparoscopic operations, a trocar makes the first puncture to allow surgeons to perform image-guided surgery. The minimally invasive procedure means a quick, painless operation, shorter recovery time, and less scarring. It is a decidedly useful device.

The problem is that trocars are by necessity very sharp devices that are driven into the body by a surgeon who can't yet see below. The method creates a risk because the surgeon could hit an artery or an organ, causing serious and sometimes fatal injuries in patients. Michael Patton of Patton Surgical (Austin, TX) says that trocars are not yet at the same level as other laparoscopic devices. “Trocar technology has not advanced at the same pace and with the same sophistication as other laparoscopic instrumentation. Trocars are the common denominator in laparoscopy, so change was imperative.”

Attempts to create safe trocars have yielded mixed results. Some trocars rely on a spring-loaded sheath to deploy over the sharp edge once the device has been pushed through skin, fat, and connective tissue. But the shield may not always deploy fast enough, or it may get caught on tissue and not deploy at all. Surgeons may also break the shield by pushing too hard.

The PassPort Shielded Trocar by Patton Surgical has incorporated several design features that attempt to make the trocar safer. Based on a method created by Harrith Hasson, PhD, the PassPort uses a sharp blade to cut through connective tissue, fat, and skin, but then uses a shield over the blade to create a blunt piercing object for the last few millimeters. Patton says that the company strove to meet certain design challenges so that surgeons would feel comfortable with the device for differing use methods. “Some surgeons prefer a trocar with a sharp blade for a more-controlled feel,” he says. “Others choose bladeless trocars because they are concerned about the sharp blade. The main challenge was creating one trocar that satisfies the needs of all surgeons.”

The device has a shark-tooth-shaped blade that enables the tip shield to ride down the center of the obdurator. This means the tip and blade are fitted into obdurator shells and are welded together. Fewer parts and dual protection mean the shield can deploy more quickly in a limited space (down to 5 mm). The shield deploys before it breaks through the cavity, enabling blunt penetration.

As Patton explains, shield indicators on the proximal end of the device tell the surgeon where the shields are in relation to the blade. “The PassPort provides the surgeon with both audible and visual signals to indicate where the shields are at any given time during insertion,” he says.

First, the surgeon hears a click when the tip and blade shields are retracted, exposing the cutting blade. Additional clicks sound when the tip and blade shields advance to cover the cutting tip and blade edges, respectively. Shield indicators on the side of the obdurator display whether the trocar is in cutting mode, and display the position of the tip and blade shields relative to the blade.

MDEA jurors were impressed with the trocar's design. Yadin David, director of biomedical engineering and television services at the Texas Children's Hospital (Houston), was particularly interested in the design and safety mechanisms. “Trocars are being scrutinized for the injuries they cause, and I paid particular attention to this when reviewing the device,” he says. “I liked the innovation that was built right into the device, with the double defense mechanism. The instrument provides a new approach.”

360° Fascia Closure Device. In addition to devices that protect patients, sometimes products need to protect those performing surgeries. According to the American College of Surgeons, 59% of all needlesticks occur during fascia closure. Nurses and doctors are at a high risk for needlestick injuries, and great strides have been made to reduce that risk. The best devices combine a reduced risk for needlestick while also improving the method for use.

The SuturTek 360° Fascia Closure Device introduces needlestick prevention methods and is designed to reduce hand fatigue for surgeons.

Such is the case for the SuturTek 360° Fascia Closure Device from SuturTek Inc. (North Chelmsford, MA). The SuturTek device is an engineered sharps-injury-prevention device that complies with OSHA regulations and federal and state needlestick prevention and safety laws. Gerald Brecher, president of SuturTek, explains that the company is the only one to receive 510(k) approval for the claim that the device is for the prevention of needlestick injuries, but he thinks that other companies may soon follow suit.

The device comprises a reusable needle driver and a disposable suture cartridge that protects the user from the needle. The needle driver is an ergonomically designed handle that uses a gear-drive mechanism that transfers two hand squeezes of a trigger-like actuator into a 360° rotation of the suture needle through the tissue. The suture cartridge has a preloaded suture needle bent into 3¼4 of a circle and has suture material swaged into its tail. These needles, Brecher explains, can be attached with any type of standard suture material: braided, monofilament, absorbable (dissolving), or nonabsorbable. According to Brecher, the design mimics surgical needles already in use. “Our technology is designed to replicate the way surgeons suture. And surgeons suture with curved needles.”

Another benefit of the device is that the design enables the needle to follow its own arc, meaning the needle does not change course, which reduces the chance of further damaging tissue as it is being sutured.

Employing the device inhibits hand fatigue during an operation, because the procedure only requires two hand squeezes, rather than the manual grasping, repositioning, and release of hand suturing. MDEA juror David says that he was intrigued by the ease of use presented by the device. “It is straightforward. You don't need to learn a new technique or skill, but a surgeon will probably have more-consistent closures using the device.”

The company worked closely with surgeons and nurses to develop the device, and Brecher is adamant that such a relationship is critical for creating quality surgical devices. “We have an active surgeon advisory board and we tested our prototypes with groups of OR nurses as well. The devices need to be easy to use and easy to learn to use. Only customers can tell you if you're on the right track,” he says.

Brecher explains that SuturTek will continue to redesign surgical needles to increase safety, building on the technology platform of the fascia closure device. “Our first product is the 360° Fascia Closure Device, designed for closing large open surgical wounds. Our next product will be for closing the sternum (bone) following open-heart and other thoracic surgery procedures.”

In addition, Brecher says the company will look at other applications. “We have built and are testing smaller versions of the device for other types of closure, as well as minimally invasive and intraoperative surgical applications.”

The eFlow Electronic Nebulizer by Pari GmbH delivers required medications quickly and is child friendly.

Getting There: It's All in the Delivery

eFlow Electronic Nebulizer. Aerosol medication delivery is a popular method for diseases that require pointed drug delivery, especially to the lungs. As a rule, however, the design of these life-saving devices still need much improvement. Nebulizers are bulky and inefficient. With a commonly used nebulizer, administration of drugs that treat asthma, chronic obstructive pulmonary disease, cystic fibrosis, pneumonia, and other diseases can take anywhere from 8–30 minutes. And, as the drugs often require several administrations per day, patients often complain about inconvenience.

With a new delivery technique in hand, Pari GmbH (Munich, Germany) decided to tackle the various problems presented by nebulizers. And the company's efforts are impressive. “This nebulizer is a very friendly product, especially for children,” says MDEA juror Mary Beth Privitera, assistant professor, biomedical engineering, in the medical device innovation and entrepreneurship program at the University of Cincinnati. Privitera says the eFlow allows patients more portability. It is also less intimidating than other nebulizers on the market, she says.

The eFlow Electronic Nebulizer features a vibrating membrane that concentrates the drug and reduces waste as the drug is aerosolized. Concentrated delivery means a 2–3× reduction in administration time. But the change is so dramatic that it is difficult to compare. That is, a drug that usually takes 8–30 minutes to administer may only take 15–20 breaths with the eFlow.

Designers also spent time with the shape and feel of the product. “It is easily packed, stored, and assembled with good design resolution in regard to the ergonomics of medication delivery and aesthetics,” says Privitera. The eFlow is a portable device that can run on batteries or a car charger. The designers gave the device a modular structure that is lightweight and promotes intuitive use. According to its submission, the team spent considerable effort designing audible sounds and lights to guide patients through use. They also created a special mouthpiece to position the device properly.

According to the company, the focus on human factors design combined with increased delivery efficiency will give patients greater incentive for compliance. Juror William Hyman, a professor in the department of biomedical engineering at Texas A&M University in College Station, TX, says “This improves delivery and compliance and reduces lifestyle interruptions. It combines an advance in underlying technology with an attractive and user-friendly unit.”

The design is far from finished, however. “One challenge with the product is that you must pour the medication into a rather small target,” says Privitera. “This was noted in their submission very honestly, as were other potential improvements.” The company has performed several user surveys and will no doubt continue to improve the device based on those results.

Delphi Medical Systems Corp. designed the IVantage Ambulatory Infusion Pump to be useful for patients at home.

IVantage Ambulatory Infusion Pump. Items that are critical in hospitals can often make a transition to other sectors of healthcare, such as in ambulances or even homes. But often, significant changes must be made first to create devices suitable for those environments. An ambulance has limited space, for example. So a device meant for paramedical use must be smaller than one used in a hospital. Furthermore, in the home, devices must have error-proof mechanisms so that untrained patients can use them easily and safely.

Delphi Medical Systems Corp. (Troy, MI) made the IVantage ambulatory infusion pump with various improvements for both ambulances and homes. The infusion system is small. Using an EC 32 flat motor, the whole unit weighs only 13 oz.

One of the first items developed by the company, the IVantage incorporates various safety features. These include a locking system for home use, an anti-free-flow slide lock, and a proprietary pump that only goes one way. The anti-free-flow feature employs a mechanism that ensures that the caregiver engages the clamp to place the cassette on the pump. The same mechanism is also employed to take the cassette off of the pump. According to John Harris, business development manager at Delphi Medical Systems, free flow can be most problematic during removal and replacement of the cassette.

“This is a nice design,” says juror Tor Alden, principal of HS Design Inc. (Gladstone, NJ). “The disposable cartridge is smart, with a nice dosage range. It is a good product.”

Harris also explains that the disposable cartridge plays a significant role, both for safety and for ease of use. “The pump cartridge, or cassette, was designed with the intent to place most of the moving parts of the system into the disposable. Thus, the pump itself requires less maintenance, as it is mostly comprised of electronics,” he says.

The company's goals included safety, explains Harris, in that it brought about the greater goal of creating a usable and valuable product. “Our first and foremost concerns have been on reducing time and trouble, or benefiting the bottom line. Naturally, safety plays a large role in reducing time and trouble, but it can also have a huge effect on the bottom line.”

The NanoCool Shipping System employs a self-cooling mechanism to regulate the contents to specific temperatures during transit.

NanoCool Shipping System. Sensitive medical products often need to remain at specific temperatures during storage. Juror Hyman says, “The NanoCool is, dare I say it, cool. It addresses the need to ship materials under refrigerated conditions in an innovative, easy-to-use, self-cooling system.”

According to John W. Hoffman Jr., marketing director for NanoCool LLC (Albuquerque), not meeting the temperature needs for drug-delivery devices has a significant effect on patients and manufacturers. “Often sensitive products that require refrigeration during shipment are delivered at unacceptable temperatures. This creates several human factors problems in that patients cannot get the product on time, or worse yet, may use a product that has spoiled during shipment. Also, the cost of the spoiled drug can be very expensive for both the company and the patient.”

This poses a challenge for shipping, for which most manufacturers use ice packs and other cooling devices during transport. Because the ice packs add weight and therefore cost, freight can be a significant expense. Hyman is enthusiastic about the potential of the product. “Living in Texas, I wonder about the thermal conditions pharmaceuticals have been subjected to, and this packaging system could lead to more applications with thermal control.”

NanoCool LLC designed the packaging system to maintain a temperature of 2°–8°C for 48 hours. The system combines insulated packaging with a lid that uses evaporative-cooling technology. “NanoCool has developed a new shipping system with a goal of maintaining the required temperature during shipment, every time, so that the patient receives their medical product within temperature specification. Creating a new shipping solution to improve drug and medical shipments versus conventional shippers is our primary goal,” says Hoffman.

The system is shelf stable until needed for shipping, when the packager fills the box and presses a button on the lid to activate cooling. “I like that the activation is indicated very clearly with a blue logo disappearing,” says juror Privitera. The company can adjust sizes and other components based on customer needs.

Hoffman explains that the NanoCool system is up to 70% lighter and smaller than existing boxes and is environmentally friendly. He says the company specifically focused on environmental considerations during design. “NanoCool's packaging technology can ship a product utilizing a much smaller shipper than conventional-type polystyrene boxes and ice packs. Since the cooling technology is built into the insulation, our shipping systems are considerably smaller, easier to handle, and create less product to dispose of after the shipment, which has a positive environmental effect in that less material is sent to landfills.”

In addition, Hoffman says the system does not use polystyrene, which in many countries is considered an unfavorable material because of theories about its decomposition. “In Europe, disposing polystyrene-type products is believed to have a negative effect on the environment,” he explains.

The adsorption cooling technique is quite different from other technologies, and the company holds several patents for the process. And while consumer goods opportunities do exist, says Hoffman, NanoCool's focus is decidedly on medical and healthcare segments.

Copyright ©2006 Medical Device & Diagnostic Industry

Miller’s Exit from Biomet Raises Speculation

Miller

Biomet's Miller: Abrupt departure.

The orthopedics industry is still reeling from the sudden resignation late last month of Dane Miller as chairman and CEO of Biomet Inc. (Warsaw, IN). Industry analysts were genuinely surprised by the move, which is now generally attributed to a rift between Miller, one of the original founders of Biomet, and the company's board about the future direction of the company. Daniel Hann, senior vice president, chief counsel, and secretary, was named interim president and CEO.

Noblitt

Biomet's Noblitt: A resounding endorsement.

Although some viewed Hann as a surprise pick, he received a resounding endorsement from Biomet board chairman Niles L. Noblitt. He described Hann as “a talented and results-oriented executive” with more than 17 years' experience at Biomet. “He knows the company intimately, shares our commitment to building shareholder value, and is well positioned to move the company forward,” Noblitt said.

Miller, who will remain with Biomet as a director and consultant, was one of the four founders of Biomet. He has been president, CEO, and a director of the company since its formation in 1977.

Scott Harrison, MD, lead director of the board, said that Biomet could not have achieved its current level of success without Miller's “extraordinary vision, talent, and leadership over the course of nearly three decades.”

Commenting on his departure, Miller said, “I believe in Biomet and its team members, and their ability to continue to deliver quality products and enhance shareholder value. As I begin a new stage in my life, I will always be grateful to have worked with the great people at Biomet and to have played a role in its growth and success.”

Many analysts speculated that the board's desire to have a CEO with a greater focus on “building shareholder value” was likely at the core of its disagreement with Miller.

Denhoy

Analyst Denhoy: Shocked by departure.

“Dane Miller was always more focused on his customers and technological advances in orthopedics than on Wall Street,” says Raj Denhoy, vice president and senior medical technology analyst with Piper Jaffray & Co. (Minneapolis). “In the end, that's what probably led to his sudden departure from the company he founded and led for almost 30 years.” Denhoy, who referred to Miller as “the senior statesman of the orthopedics industry,” characterized the sudden resignation as “hugely shocking.”

Engelhardt

Analyst Engelhardt: Lamenting the ‘last of a breed.'

John Engelhardt, CEO of Knowledge Enterprises Inc. (Chagrin Falls, OH) and founder of the Institute for Orthopaedics, described Miller's departure from Biomet as “the biggest event since we began tracking industry developments in 1992.” Engelhardt, who publishes the OrthoKnow and BareBones newsletters, concurs with speculation about a rift within the company's management. “Dane Miller would never have left the company the way that he did unless there was a major disagreement about its present course and future direction,” he says. Describing Miller as “the last of a breed . . . an orthopedics guy running an orthopedics company,” Engelhardt added, “The industry is increasingly run with a focus on marketing, sales positioning, and stock value.”

In the aftermath of his resignation, Miller was indeed faulted by some analysts for focusing too much attention on product engineering and technology at the expense of marketing and sales. Yet, at the same time, many of the same analysts were quick to note that Biomet's product-centric focus is generally credited as the reason the company has one of the highest product-loyalty rates among orthopedic surgeons.

Hann

Biomet's Hann: Exploring alternatives.

Shortly after announcing Miller's departure, the Biomet board reported that it had retained the services of financial services firm Morgan Stanley (New York City) to explore “strategic alternatives.” The announcement has led to widespread speculation that the company may now be for sale. “We believe that this review is a prudent exercise and is consistent with management's commitment to our shareholders and team members,” said interim president and CEO Hann.

Although analysts have frequently mentioned Medtronic Inc. (Minneapolis) as a potential suitor for Biomet, Engelhardt said such a purchase is highly unlikely. “Medtronic is only interested in top-tier players in any segment,” he said. “They don't buy the number five company.” Denhoy concurred, stating, “A Biomet acquisition would not be in line with Medtronic's growth objectives.”

Biomet manufactures a wide range of orthopedic products, including joint replacement devices, bone cements, and accessories; dental reconstructive implants; internal and external fixation products; electrical bone-growth stimulators; craniomaxillofacial implants and bone substitute materials; spinal stimulation devices, spinal hardware, and orthobiologics; and arthroscopy products and soft-goods bracing. Biomet products are available in more than 100 countries.

With 6100 employees worldwide, Biomet reported annual revenues of $1.9 billion for the year ending on May 30, 2005, an increase of 19% over year-earlier sales of $1.6 billion.

© 2006 Canon Communications LLC

Return to MX: Issues Update.

MDEA Jurors Bring Insight, Expertise to Awards

The Medical Design Excellence Awards couldn't survive without discerning adjudication. This year, 12 jurors brought an extensive range of knowledge and experience from across the medical device spectrum to the judging table. Areas of expertise include product design, clinical engineering, biomedical engineering, neuroscience, biomaterials research, nursing, human factors, and product development. These are the brightest and best, and we are proud to have them as MDEA jurors.

 

Tor Alden is principal and owner of HS Design Inc. (Gladstone, NJ), a full-service product development firm specializing in the medical and healthcare marketplace with a focus on user-driven design. His experience includes more than 15 years in product design and corporate branding, during which he has received more than 20 design and utility patents. He is active in the Industrial Designers Society of America, for which he currently serves as vice chair of the medical section.

Baura

Gail D. Baura is vice president for research and chief scientist for San Diego-based CardioDynamics, a company that makes noninvasive, continuous cardiac-output monitoring equipment. She manages projects that use system theory to improve device performance and invent diagnostic parameters for new markets. She also wrote the first textbook combining system theory and patient monitoring. A senior member of the Institute of Electrical and Electronics Engineers (IEEE), she belongs to IEEE's Signal Processing Society and Engineers in Medicine and Biology Society. Baura holds 13 U.S. patents and has another seven pending.

Butler

Jeff L. Butler is principal engineer at Sysmed Enterprises Inc. (Richardson, TX), a firm that offers clinical engineering consulting to surgery centers, hospitals, and other outpatient facilities. Before starting his private consulting practice, Butler served for 14 years as vice president and COO of Baylor Biomedical Services, a wholly owned subsidiary of Baylor University Medical Center. The firm is an FDA-registered medical device manufacturer and refurbisher in Dallas. Butler is a member of the National Society of Professional Engineers and the American College of Forensic Examiners.

David

Yadin B. David, PhD, is director of the biomedical engineering and television services department at Texas Children's Hospital (Houston). He is also the president of Biomedical Engineering Consultants (Houston), a firm that provides medical technology management, strategic technology planning services, and expert-witness services. David holds an academic appointment at the Baylor College of Medicine Department of Pediatrics and is an adviser to the World Health Organization. In addition, he has been a member of several FDA advisory panels.

Goldberg

Jay R. Goldberg, PhD, is director of the healthcare technologies management program at Marquette University and the Medical College of Wisconsin (Milwaukee). His experience includes development of new products in urology, orthopedics, GI, and dentistry. A licensed professional engineer, he holds six patents for urological medical devices. Goldberg also serves as chairman of the ASTM subcommittee on urological devices and materials.

Hyman

William A. Hyman, ScD, is professor and interim head of the department of biomedical engineering at Texas A&M University (TAMU; College Station, TX). He is also a faculty member in material science and engineering at TAMU and a participating faculty member in TAMU's sports medicine institute and the center for microencapsulation and drug delivery. He also holds a position as senior scientist in the biomaterials research center at the University of Texas at Houston. Hyman has served as a consultant for FDA, the National Science Foundation, and the National Institutes of Health. He serves on the ASTM committees on surgical implants and medical devices, sports equipment and facilities, and forensic sciences, and is a board member of the U. S. Board of Examiners for Clinical Engineering.

Jackson

Craig M. Jackson is president of Hemosaga Diagnostics Corp., a start-up company based in San Diego. Jackson has served as president and director of research and development for Reagents Applications Inc. and as scientific director for the American Red Cross Blood Services (Detroit), where he was also an adjunct professor of biochemistry at Wayne State University. He was a professor of biological chemistry and an associate professor of internal medicine at Washington University School of Medicine (St. Louis) prior to joining the American Red Cross. He is a member of Working Group 1 of the Joint Committee for Traceability in Laboratory Medicine (JCTLM).

Korniewicz

Denise M. Korniewicz, RN, DNSc, is a professor and senior associate dean for research at the University of Miami School of Nursing and Health Studies (Miami), where she also serves as director of the nursing school's research center. Her chief areas of expertise and responsibility include research, grant development, graduate student mentoring, and assistance to medical device companies in the development of patient-safety equipment. She gained experience in the management of critical patients as an emergency room charge nurse before undertaking an academic career that has included professorships at the Georgetown University schools of nursing and medicine and the University of Maryland. She is a registered nurse in Maryland, Michigan, and Washington, DC.

Privitera

Mary Beth Privitera is a principal of Mad Design USA (Cincinnati), a firm specializing in design consulting for the medical device industry. She is also a codeveloper and a faculty member in the Medical Device Innovation and Entrepreneurship Program at the University of Cincinnati. The program partners multidisciplinary student teams with physician innovators, creating and advancing intellectual property for commercialization. She is an assistant professor of biomedical engineering and an adjunct instructor of industrial design. An expert in the application of human factors in medical product design, she has also worked in industry since 1988. She is a member of the Industrial Designers Society of America and serves on its national educational council. She is also a member of AAMI.

Schollmeyer

Michael P. Schollmeyer is director of clinical research at CHF Solutions Inc. (Brooklyn Park, MN), a firm that makes an extracorporeal hemofiltration system to treat fluid overload in postsurgical or congestive heart failure patients. He is responsible for developing pre- and postmarket clinical trials and managing the postmarket clinical registry. Among the clinical research studies Schollmeyer has been involved in are the first cardiac and vascular stents, and the first implantable internal defibrillator. He developed the first investigational device exemption (IDE) trial for carotid stents, the first IDE trial on metabolic pacing, and the first IDE trial for use of urological stents in certain applications. He has received three patents for coinventions: two pacing leads and an electrosurgical blade.

Vreeke

Mark S. Vreeke, PhD, is senior partner at Rational Systems LLC (Granger, IN), a consulting firm that combines business knowledge and technical capabilities to implement IT and infrastructure changes to support business redesigns. In a related position, Vreeke is serving as vice president of research and development for Rational Biotechnology, a spin-off of Rational Systems, whose goal is to speed the adoption of personalized medicine through the development of combined IVD and drug therapy products. Before forming Rational Systems, Vreeke was a senior research scientist at Bayer Corp. (Pittsburgh), where he was responsible for new reagent development in Bayer's self-testing segment and coordinated efforts to incorporate new reagents into a next-generation sensor platform.

Weinger

Matthew B. Weinger, MD, is a professor of anesthesiology, biomedical informatics, and medical education at Vanderbilt University (Nashville) and a staff physician in the Middle Tennessee VA Healthcare System. At Vanderbilt, he is director of the Center for Patient Safety, director of the Center for Perioperative Research in Quality, and codirector of the Middle Tennessee Center for Improving Patient Safety. Weinger has also taught anesthesiology at Stanford University and the University of California at San Diego. He is cochairman of the human factors committee of AAMI.

Copyright ©2006 Medical Device & Diagnostic Industry

AdvaMed Proposes Standard for CRM Performance Reports

Responding to increasing concern about the safety and reliability of cardiac rhythm management (CRM) devices, industry association AdvaMed (Washington, DC) has released a draft proposal for pulse-generator product performance reports. According to the association, the proposal is designed to “improve communications between the manufacturers of cardiac rhythm management devices and patients, providers, and the public.”

Ubl

AdvaMed's Ubl: Better understanding.

AdvaMed president and CEO Stephen J. Ubl commented that the proposal “will help ensure these key stakeholders have a better understanding of the performance of these lifesaving medical technologies.”

The proposed reporting format is based on a standard compiled by the International Organization for Standardization (ISO; Geneva), Cardiac Pacemakers–Part 2: Reporting of Clinical Performance of Populations of Pulse Generators or Leads (ISO 5841-2:2000). The AdvaMed proposal establishes specific definitions, procedures, and requirements for medtech companies to follow when issuing performance reports on such CRM devices as implantable cardioverter defibrillators and cardiac pacemakers. The reporting standard would enable device performance comparisons among the various CRM manufacturers.

To avoid confusion about what constitutes a problem with a CRM device, the standard seeks to establish “the most objective, feasible representation of device performance.” If further clarification or judgment is required regarding device performance, the standard would require manufacturers to disclose their techniques fully so that the goal of comparison among manufacturers can be practically achieved. If a manufacturer finds it cannot conform to the international standard, the company's product performance report should clearly disclose the nonconformance.

The AdvaMed proposal was developed with the help of FDA and the Heart Rhythm Society (HRS; Washington, DC). Last September, HRS sponsored the Policy Conference on Pacemaker and ICD Performance, held in Washington, DC. The conference proceedings are available from the HRS Web site at www.hrsonline.org/positionDocs/HRS-device_conference.pdf. As a follow-up to the conference, HRS commissioned a task force to develop more-effective ways of gathering and disseminating information about CRM device performance. According to The New York Times, HRS plans to issue the report of its task force on May 2.

AdvaMed says that its member companies have begun preparing and evaluating reports based on the new format in consultation with various stakeholder groups. The draft of AdvaMed's proposed Requirements for Uniform Reporting of Clinical Performance of Pulse Generators is available via the AdvaMed Web site at www.advamed.org/publicdocs/PPR_proposal_030306.pdf.

© 2006 Canon Communications LLC

Return to MX: Issues Update.

Tomorrow’s Design in Today’s Healthcare

MDEA 2006

Outstanding medical devices can represent tremendous leaps forward or can advance a technology in small but significant ways. They can foster innovations in high-profile fields or in obscure ones. They can be sold around the world in millions of units or serve a low-volume but crucial niche.

That kind of diversity is represented among the winners of the 2006 Medical Design Excellence Awards. Yet despite obvious differences, the winners had some common threads among their accomplishments.

“Many of the award-winning devices had both new clinical or technical innovation coupled with obvious considerations of the users. Within each category there were a number of next-generation devices that demonstrated progress of improved healthcare delivery, as well as a few breakthrough or novel technologies,” says juror Mary Beth Privitera. She is assistant professor of biomedical engineering for the University of Cincinnati's Medical Device Innovation & Entrepreneurship Program. “Also, there is a trend in developing image-guided systems to eliminate errors in surgical techniques for therapies in the OR as well as in ancillary facilities.”

Products are judged on five criteria: design and engineering innovations, functional and user-related innovations, patient benefits, business benefits, and improvement to overall healthcare. Twenty-six entries were deemed worthy of awards. The following pages show you why.

Some could be revolutionary for their sectors. Ranging from a new approach to CT scanning to a test that can detect quickly a serious infection outbreak, these products represent paradigm shifts that could influence future designs.

Others bring improvements on a smaller scale. Whether designing trocars or nebulizers, the companies that make these products found ways to make established technologies better, less expensive, easier to use, and safer.

And some bring needed advances to underserved markets. From a cot that makes it easier for emergency medical technicians to lift patients to a battery technology that could promote hearing-aid use in Third World nations, these products bring solutions to places that don't get enough attention.

“I think the need for a safer product, the human factors associated with the product, and the unique characteristics of the product for the patient population” were among the factors that distinguished winning products, says juror Denise Korniewicz. She is a professor and senior associate dean for research at the University of Miami (FL) School of Nursing.

A list of the products, the stories behind them, and profiles of the jurors follow. MD&DI's coverage is the best place to learn about them until June 7, 2006, at the Medical Design & Manufacturing East show in New York City. That day, winners will be honored at a ceremony, and whether they won gold or silver awards will be revealed.

Fisher Scientific Seizes Opportunity in Molecular Diagnostics

In March, during a presentation at the Lehman Brothers Global Healthcare conference, Paul Meister, vice chairman of Fisher Scientific International Inc. (Hampton, NH), reiterated a claim that has been often repeated among in vitro diagnostics (IVD) industry observers. “The quest for drugs that enhance and prolong our lives is driving a shift toward protein-based drugs and the promise of personalized medicine,” he said.

In light of this, Fisher's announcement a week later that it was investing nearly $300 million in the molecular diagnostics market came as little surprise. The company announced that it was purchasing test developer Athena Diagnostics Inc. (Worcester, MA) from Behrman Capital for $283 million in cash. In addition, Fisher said that it would buy a 9% stake in Nanogen Inc. (San Diego) for $15 million in cash. Fisher plans to work with Nanogen to expand Athena's markers and tests. Athena's menu of genetic markers is focused on neurological disorders, such as epilepsy, amyotrophic lateral sclerosis, and Alzheimer's disease.

“Fisher's acquisition of Athena is consistent with our strategy to expand our offering of high-value, high-margin products and services in growing markets,” said Gia Oei, a spokesperson for Fisher. “While Athena has been focused on neurology, it does have a small offering in nephrology and endocrinology, which can be expanded. Athena also has opportunities to develop new tests for the clinical trials–testing market based on its portfolio of genetic markers. In particular, Athena's genetic tests can help pharmaceutical companies better identify which patients may respond more effectively to specific drugs during clinical trials. The company also has opportunities to expand internationally—beyond its existing footprint in North America.”

Through a variety of purchases over the past five years, Fisher has transformed itself into one of the world's largest scientific research and clinical laboratory suppliers. In 2003, the company bought Perbio Science AB for about $714 million. The following year, Fisher merged with Apogent Technologies Inc. in a deal worth approximately $3.9 billion. For 2005, Fisher recorded $1.3 billion in revenues for its healthcare products and services division, which markets IVD kits, reagents, and related products. Although the company sells a variety of diagnostics to laboratories, most of its recent efforts have been focused on expanding its consumables business. According to Meister, consumable products constitute about 80% of Fisher's projected 2006 sales of $5.9 billion. Consumables represent an even higher percentage of sales among its clinical products, he said.

In addition to updating and broadening its IVD offerings, the company's latest investments will complement its consumables products. “Fisher is currently a large provider of many of the tools used in molecular diagnostics, such as reagents and other consumables used in sample collection, sample preparation, and DNA amplification,” Oei said. “Information gained through gene-based testing can ultimately be used to develop tools and consumables for use in research into therapeutics that directly address the genetic basis of disease.”

As it produces these new tests, Fisher will have access to Nanogen's NanoChip electronic microarray platform. The automated system allows multiple patient samples to be placed on the same chip. Nanogen says that by doing so, labs can dramatically reduce the cost of running molecular tests—a recurrent concern among providers of genetic testing. “We believe the opportunity for growth in this market will come as the menu of molecular tests expands to replace older methods and as more laboratories are able to bring these methods in-house for routine use,” said Bob Proulx, vice president of marketing at Nanogen. “The fast growth of the molecular diagnostics market makes it attractive to the larger IVD players that have been strong in other segments, like clinical chemistry or immunodiagnostics. Crossover to the molecular market is likely and will create a challenging competitive marketplace.”

© 2006 Canon Communications LLC

Return to MX: Issues Update.

Medical Tubing: Dimensions Aren’t Everything

Extrusion

Figure 1. Various interactions take place during the extrusion process. A combination of these interactions can result in material degradation.
Figure courtesy of Chris Rauwendaal and Rauwendaal Extrusion Engineering (Auburn, CA)
(click image to enlarge)

Most specifications for medical tubing consist of a drawing of a tube that lists its material, dimensions, and tolerances. For single-lumen tubing, the dimensions usually include two of the following three dimensions: inner diameter (ID), outer diameter (OD), and tubing wall thickness, along with their associated tolerances. The tube length and tolerance would also be specified unless the tubing is to be provided in a continuous length on a spool. Other notes that may appear on tubing specifications include packaging requirements, a sampling plan for inspection of the dimensional tolerances, and a note regarding tubing cleanliness, such as “No dirt, grease, oil, etc. to be present on the tubing surface.” Very few specifications include other tubing attributes or process parameters associated with producing tubing.

It is a common misconception that as long as tubing is made from the proper material and meets the dimensional requirements, each lot will be the same, regardless of which supplier extrudes it. Although this may be true, there is also a good chance that tubing lots may differ from one another. These differences are not always obvious or easily recognizable, even when inspected by incoming quality control. Often, the process parameters and the equipment used to extrude the tubing are as important as, or even more important than, the dimensions of the tube. Therefore, it is important for both extrusion providers and OEMs to understand the process of extrusion as well as the implications of those parameters for different materials used to make tubing.

Extrusion and Degradation

The process used to produce medical tubing can be extremely important in the high-end diagnostic and therapeutic catheter markets. Market pressures have driven catheter manufacturers to design ever smaller devices with increasingly thinner walls. Examples of tubing applications include high-pressure catheter tubing, tubing used in angioplasty and stent-delivery catheters, and balloon tubing used in medical balloons, especially high-pressure angioplasty and stent-delivery balloons. They also include tubing that will be implanted or inserted in the body and other applications in which the tubing's mechanical, physical, chemical, electrical, or thermal properties are critical to the function of the finished device.

Degradation during extrusion can greatly affect the properties of the end-use medical tubing. Polymers are very large molecules that derive their unique and useful properties from their size, or molecular weight. The process of these large molecules breaking down is called degradation. At some point, polymer degradation changes tubing properties such as tensile strength, brittleness, flexibility, and discoloration. To understand degradation, it is important to understand the various interactions that take place during the extrusion process. Figure 1 provides an overview of these interactions.

Degradation during extrusion can be attributed to a number of causes. Improper drying or overheating the material (i.e., running the polymer at too high a temperature) may cause degradation. Overshearing the material (i.e., running the polymer at too high a screw speed or using the wrong screw design) or keeping the polymer in the molten state too long (i.e., long residence time) may also be to blame. Property changes occur primarily because these factors affect polymers' chemical composition. Some polymers, such as polyethylene terephthalate (PET), are very sensitive to process parameters and can degrade easily, while other polymers, such as polyethylene, are very forgiving. Degradation makes most polymers brittle and reduces the tensile strength and usable life of the finished product.

Another cause of degradation in extrusion is multiple melting process steps. For example, some materials used to make medical tubing must be precompounded. In other words, the base material is melted and mixed with other materials, such as colorants, radiopaque fillers, stabilizers, and processing aids. The precompounding often requires a separate extrusion operation to ensure good dispersion and distribution of the components. This process step results in heat and shear histories, in addition to the heat and shear histories that will be created in the tube extrusion process. If either step is carried out incorrectly, the tubing may degrade.

Figure 2. A typical medical tubing extrusion line.
Figure courtesy of Advanced Polymers Inc. (Salem, NH)
(click image to enlarge)

Extrusion Overview

An extrusion line comprises several pieces of equipment. The major elements of a medical extrusion line include a resin-drying system, an extruder, a die, a cooling tank, a take-up device (puller), and a cutter or winder (see Figure 2).

Drying. Often, the first step in the extrusion process is to dry the polymer. Polymer drying is a critical process in extrusion. Many polymers used in the medical device industry are hygroscopic, meaning they absorb moisture readily from the environment. Hygroscopic polymers must be carefully dried before being melt extruded or compounded.

Different materials require different drying methods, and the temperature at which the material is dried depends on what the material can withstand. Generally, drying temperatures range from 120Þ to 350ÞF, and drying times are 1–4 hours or more. Some materials are extremely sensitive to moisture content and must be dried very carefully. For example, the drying method used with PET is critical to the extrusion process, because any amount of moisture can ruin PET. Others are easier to dry and do not need much oversight.

Drying a material for too short a time or at too low a temperature can result in underdrying. Residual moisture in the polymer can cause hydrolysis during extrusion. Hydrolysis is a degradation process that results in significantly lower molecular weight. Underdrying of polymers often occurs in medical extrusions when processors run multiple materials each day through only one or two dryers. In such cases, the materials will likely not be sufficiently dried, based on the short drying time they would receive. Manufacturers often request the same sizes of tube to be provided in multiple grades or durometers of materials. If the processor does not have three separate dryers available to predry all three materials, then the second and third materials may not be dried properly before extrusion. If that happens, a manufacturer may evaluate partially degraded material and make the wrong choice for the application.

Overdrying is another problem when extruding medical tubing, because many medical extrusion lines run at very low throughputs, or at a low rate of between 1 and 10 pounds per hour. Many commercial resin dryers for medical extruders are oversized. Therefore, the material can stay in the dryer for 24 hours or more. If not properly monitored, materials may become overdried, which can cause thermal degradation in some materials. Many polymers, such as nylon and polycarbonate, are sensitive to overdrying.

Most resin manufacturers specify minimum drying times and temperatures for their materials. These recommendations must be followed very carefully so that materials are dried properly before extrusion. Normally, desiccant-type dryers are used to achieve proper drying. These dryers must be well maintained, cleaned, tested, and calibrated periodically to ensure that they are functioning properly.

The Extruder. An extruder is a melting and pumping machine. It converts solid pellets into a uniform, molten state and forces the material through the die at a constant rate. The frictional heat generated from the mechanical work of the screw and heat conducted from the heated barrel of the extruder melt the material.
Extrusion Die. An extrusion die sits at the end of the extruder and forms the initial shape of the tube. The die is the point at which the polymer exits into a cooling tank. A tubing die typically consists of two major components: a mandrel or tip that forms the tube ID, and a die, or ring, that forms the tube OD. The die and mandrel are contained inside the extrusion head. There are literally dozens of firms that manufacture extrusion heads and tooling, and many extrusion companies have developed their own proprietary head, die, and mandrel designs. The design of these components plays a critical role in the extrusion process and the ability to produce precise dimensions and maintain proper physical properties of the material. The relationship between the die and mandrel dimensions and the finished tube dimensions is referred to as the draw-down ratio (see Figure 3).

Figure 3. The extrusion process that creates the draw-down ratio.
Photo courtesy of Advanced Polymers Inc.

Very-small-diameter medical tubing with very thin walls can be difficult to extrude through a standard extrusion head and die. Often, the viscosity of the materials in the die is so high and the die gap is so small that the operator must increase the polymer temperature. This reduces the viscosity of the material so that the flow through the die is sufficient. But heating up a polymer can dramatically alter its properties.

Many custom extruders overcome the problems of producing tight-tolerance, small-diameter thin-walled tubing by using high draw-down ratios. This significantly improves dimensional tolerances, increases line speed, and makes tooling (dies and mandrels) much easier to fabricate. Unfortunately, running a high draw-down ratio also imparts significant orientation and residual stress and strain in the finished tubing. Such orientation can significantly increase the tensile strength and reduce the elongation of the tubing in the machine direction. It may also reduce the tubing burst pressure because of the loss in hoop strength. The residual stresses from high draw-down ratios can cause problems during subsequent thermal processing and sterilization and in the course of natural or accelerated aging. Thermal processing can release the stresses built in during extrusion, causing the tubing to shrink in length and increase in diameter and wall thickness.

Cooling. The extrusion cooling process is the next critical step. Polymer cooling is important. Significant changes in physical properties and morphological structure can result from different cooling conditions. For example, many polymers are semicrystalline; in other words, they contain amorphous regions and crystalline regions. When the polymer exits the die and cools, rapid cooling and quenching tend to retard crystallization or completely eliminate it. However, slow cooling can cause a higher degree of crystallinity or very-large-crystal formation. In some medical applications, such as balloon manufacturing, the extruded tubing must be amorphous prior to the balloon-forming process. Therefore, it is important to verify that the cooling parameters used will not cause crystallization in the tubing during extrusion.

In other applications, such as PEEK tubing extrusion, the PEEK tubing must be crystallized when extruded. That ensures that the tubing possesses the thermal, physical, and mechanical properties that PEEK is capable of attaining. In materials such as polyethylene and polypropylene, it is desirable for some applications to minimize the crystallinity in the tubing for improved clarity and softness. In other applications, increasing the amount of crystallinity improves stiffness and lubricity.
Most processors cool the polymer in a water-filled cooling tank as it exits the die. This is typically done in free extrusion or through a vacuum sizing tank. However, in both methods, contact with the water in the tank cools the polymer. The water temperature, circulation of the water in the tank, length of the cooling tank, and line speed can all affect the cooling process and thus the physical properties of the resulting tubing.

Water temperature control in the cooling tank is critical in many applications. However, many processors do not use temperature controllers at all; some have crude temperature control of their cooling water. A lack of control can result in significant variations in polymer cooling rate from one lot to another, as well as from the beginning to the end of a lot. Processors that use tap water for cooling can see incoming water temperatures change 30°F or more from season to season. In addition, hot spots can be created in the cooling tank, especially in the area where the polymer first enters. Indeed, proper circulation of the water in the cooling tank is important, even if precise temperature controllers are used. If there is insufficient flow in the water tank, hot spots can develop over time and be unknown to the processor.

Many medical extrusion lines are sold with very small, undersized cooling tanks that may not be well suited for long production runs or for extruding large-diameter or thick-wall tubing, or for extruding small, thin-wall tubing at high line speeds where there is insufficient time in the tank to cool the tube properly. High line speeds or short cooling tanks can result in insufficient residence time in the cooling tank. If the tube exits the extrusion process early and the inside of the tube is still warm, the cooling process may start reversing itself. This means the tube will rewarm itself from the inside out, since the center of the tube was not sufficiently cooled. This cooling reversal can create varying physical properties in the tube.

Extrusion Equipment and Its Importance

It is extremely important that purchasers make sure their tube manufacturer has the expertise and equipment to manufacture a high-end tube for use in medical devices. In the past five years, many industrial extrusion houses have entered the medical extrusion business because they see higher profit margins than are available in industrial applications. However, often these manufacturers have extruders that are too large for the production of tubing used in the medical industry. Using an oversized extruder to make a medical tube can result in very long residence times. In many materials, excessively long residence time will lead to thermal degradation of the polymer.

In addition, some tubing manufacturers use old equipment or equipment that may not be maintained to the standards desired in the device industry. Many older extrusion lines do not have state-of-the-art controls and, therefore, processing temperatures and other parameters can vary widely. Such variation can cause inconsistent thermal history, and as a result, inconsistent properties can occur within a run or from run to run. The same can be true for equipment that is properly designed but not well maintained, or for equipment that is not properly calibrated. For example, a temperature controller on an extrusion line may operate in temperatures ranging from 300Þ to 600ÞF or more. A temperature controller that is off by 1% equates to 5Þ at 500ÞF. If it is off by 5%, that equates to 25Þ at 500ÞF. With some materials, a process change of 10Þ can result in a dramatic difference in tube properties.

Medical tube manufacturers typically have very small extruders. But medical devices often require larger-diameter tubing than these small extruders were actually designed to produce. In these cases, processors may be running the extrusion lines at their maximum output with high screw speeds. This can be detrimental to many polymers that are shear sensitive. Shear-sensitive polymers that are run at a high screw rpm can suffer the same type of degradation found when a polymer is heated for too long or at too high a temperature. It is important to recognize that numerous interactions take place during an extrusion process.

Quality Issues

The OEM should determine what tests it should conduct on incoming tubing, as well as what tests it will specify the processor to conduct. The tests, if any, should be dependent on the end-use requirements of the product.

Any extrusion house that manufacturers choose to partner with should be ISO 9001:2000 or ISO 13485 registered. But ISO registration does not guarantee that high-quality tubing will be produced. Rather, ISO is a quality management system that ensures that a company is operating at some minimum standard. Still, an OEM should investigate an extruder's level of expertise. OEMs should also make sure the company has state-of-the-art manufacturing equipment and highly trained personnel, and they should guarantee that the extruder has in place the appropriate processes for manufacturing the product.

Conclusion

A tube's dimensions can affect the performance characteristics of extruded medical tubing. However, process parameters, equipment, and material characteristics also play an important role in determining the end properties of an extruded tube. When choosing a tubing supplier, OEMs should take into account the requirements of the tube in the finished device. They should also consider how important the tube's performance characteristics are in ensuring the proper device function. Since it is not possible or practical to specify every critical characteristic of a given tube, OEMs should seek out suppliers that have a demonstrated history extruding similar materials in similar sizes that are used in similar applications. The tubing supplier also should have appropriate levels of understanding, process controls, and expertise for the intended tube application and materials.

Mark A Saab is the founder and coowner of Advanced Polymers, Inc. in Salem, NH. He may be contacted by phone at 603-327-0600.

Copyright ©2006 Medical Device & Diagnostic Industry

Investor Group Bids to Take Gambro Private

In recent years, Swedish medical supply giant Gambro AB (Stockholm) has been something of a troubled company. In 2004, the company's U.S. dialysis business ran afoul of federal healthcare fraud charges. And earlier this year, FDA cited the company for quality systems violations. But apparently none of those problems have been enough to dissuade determined investors.

On April 3, Gambro's board of directors recommended that its shareholders accept a buyout offer from Nordic investor group Indap AB, a joint venture of Investor AB and EQT IV. At the time of the offer, the bid of 38.26 billion Swedish kronor (nearly $5 billion) represented a more than 30% premium over the company's average share price over the past three months, according to Indap.

Shortly after the bid was announced, Gambro's stock price surged to a value higher than the offered price, leaving some analysts to speculate that shareholders may see a higher bid. However, Investor CEO Borje Ekholm was quoted by AFX News as saying the company had no intention of raising its bid and that “the Gambro offer is fair.”

Indap reports that Investor is the largest shareholder in Gambro, with 19.9% of the company's share capital and 26.3% of the voting rights. It has committed to transferring its shares to Indap. The company's offer is conditional upon it being accepted to an extent that Indap takes control of more than 90% of the total shares of Gambro.

“By strengthening our ownership in Gambro, we can facilitate the execution of growth-orientated value creation measures,” said Ekholm. “This is more-easily implemented in a private setting as it enables the owners and management to take a longer-term investment horizon. The transaction also has a direct positive effect on Investor's financial position.”

The acceptance period for the offer, which stands at SEK 111 per share, is expected to run until May 10. Since the bid was announced, Gambro's share price has ranged between SEK 110 and 113.5.

von Koch

EQT's von Koch: Promoting privatization.

“We believe that Gambro, in this stage of its life cycle, will benefit from being privately owned, and that Investor and EQT are well suited to accelerate the development of the group,” said Thomas von Koch, senior partner at EQT Partners AB, the company's investment division.

In 2004, Gambro agreed to divest its U.S. dialysis clinics business, Gambro Healthcare U.S., to DaVita Inc. (El Segundo, CA), the largest independent provider of dialysis services in the United States, for approximately $3.05 billion in cash. The move came after Gambro Healthcare pled guilty to felony charges and agreed to pay $350 million in criminal and civil fines to resolve federal healthcare fraud charges. The company's renal products and blood-component business units were unaffected by the divestiture.

Earlier this year, Gambro reported that it had received a warning letter from FDA related to its monitor-manufacturing facility in Medolla, Italy. The letter reflected FDA's concerns about the safety of the company's Prisma kidney hemodialysis systems and the adequacy and effectiveness of the production unit's quality systems. In addition to the letter, FDA issued an import alert that called for the detention of Gambro's monitor products—Prisma, Prismaflex, and Phoenix—shipped into the United States. Gambro reports that its senior executives recently met with senior FDA officials to address the agency's concerns.

© 2006 Canon Communications LLC

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