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One Small Step for Medical Devices


Posted by mddiadmin on April 1, 2005

 

Originally Published MDDI April 2005

MDEA 2005

Design improvement means building on existing innovation, but this year’s MDEA winners took some leaps and bounds.

Originally Published MDDI April 2005

MDEA 2005

Design improvement means building on existing innovation, but this year's MDEA winners took some leaps and bounds.

Heather Thompson

Designers of medical devices have long been known for their ability to make improvements between each generation of products. They have been able to adopt cutting-edge technologies from other industries, introduce more streamlined features, and, ultimately, improve the way a device is used. These incremental improvements may seem like minor changes, but they serve a decidedly important role in blending design and function and making a good product better.

This year, there were several award-winning examples of designs that made impressive changes to existing devices. Some used existing technologies in a new way, or updated products that were long overdue. Most of all, they simply took the next logical step that proved to be a giant leap forward.

This One Goes to Eleven

Medical device designers strive to create the next generation of products that will go faster and be more efficient. And sometimes those designers have the right technology to do so. But faster is only better if the product can yield better results and ultimately help the patient and the user more effectively. That's where next-generation products really shine.

Medical Design Excellence Awards juror Jay Goldberg, who is the director of the healthcare technologies management program at Marquette University (Milwaukee), says that companies should make an effort to talk to customers and users about problems they may be having with devices. “When a company makes changes that solve a problem or meet customer needs, then it's a meaningful innovation,” Goldberg says.

The Somatom Sensation 64 computed tomography system from Siemens Medical Solutions renders isolated images like this one of the inner ear using autosegmentation.

Somatom Sensation 64 Computed Tomography System. The Somatom Sensation 64 from Siemens Medical Solutions (Malvern, PA) brings an impressive upgrade to the market of computed tomography (CT) scanners. Siemens's media relations manager, Andrea Naiman, says, “Siemens is constantly trying to advance and that involves having a partnership with our customers.” In fact, she says, “Most developments to our CT products are based on direct customer feedback gathered from our expert users.”

“From a clinical standpoint [the Somatom] is revolutionary,” says juror Eliot Lazar, president of ElCon Medical Consulting in Buffalo, NY. The 64-submillimeter-slice Somatom CT system has a gantry rotation time of 0.33 seconds. It also offers resolution down to 0.4 mm. Such a fast and accurate system has never before been available. Previous scanners only offered a maximum of 32 slices. Siemens used some innovative programs to create the device.

To improve the gantry rotation, Siemens employed its Straton x-ray tube. According to Siemens, it is an ultralight and small tube that increases the g-force. The resulting speed allows a temporal resolution of up to 83 milliseconds. In a case in which a patient has a high heart rate, the image capture could virtually freeze the heart's motion. Naiman explains that Siemens wanted to increase resolution and keep images clear, but did not want to compromise by increasing radiation. “Most companies . . . increase the amount of x-ray radiation or dose used,” she says. “Unfortunately, this also increases the amount of x-ray radiation to which the patient is exposed.”

The x-ray tube also incorporates Z-Sharp technology to obtain a 64-slice capability. The Z-Sharp technology enables two focal points in the anode by precise deflection of the electron beam within the x-ray tube. The deflection process generates two overlapping beams to pass the scan field. Because it essentially produces a double readout, spatial resolution is increased. The company's proprietary detector technology solved the problem of optimizing data acquisition speeds and x-ray detection.

“What's very impressive about the scanner,” says Goldberg, “is that it lets you display an image of an isolated organ system and get rid of everything else.”

Goldberg and other jurors were also intrigued with the high resolution of the rendered images. “I have seen segmented images like this before,” Goldberg says, “but it is my understanding that they were created manually. The autosegmentation feature of this scanner differentiates it from other scanners.”

The level of detail and the speed at which the images are produced gives clinicians a new way to study human anatomy, which may improve early diagnosis and treatment options.

The LifeSync Wireless ECG System by GMP Wireless Medicine Inc. uses Bluetooth to eliminate lead wires and trunk cables. It works with existing hospital equipment.

LifeSync Wireless ECG System. As the device industry moves into wireless communication, it is only natural that patients should be wireless as well. In a hospital setting, however, that has not always been an option. “Hospitals can spend millions of dollars on some of the ECG systems,” says Matthew Bross, art director for GMP Wireless Medicine Inc. (Fort Lauderdale, FL). “Once they do, they are less willing to change to a whole new system.”

Even so, MDEA juror Stephen B. Wilcox, principal for Design Science Consulting Inc. (Philadelphia), notes that several companies are working to create wireless devices in hospitals. “Many people who work in hospitals are asking ‘How do you get rid of all the spaghetti?'”

To answer that, GMP introduced the LifeSync wireless ECG system. The system was designed to eliminate lead wires and trunk cables between patients and bedside 12-lead or transport ECG monitors. All told, the LifeSync costs about $1400 for the monitor transceiver and $1400 for the patient transceiver. According to Bross, in terms of what hospitals usually spend on equipment, that's a bargain.

The LifeSync has two electronic components using Bluetooth technology that function as two-way radios. These radios collect and transmit ECG and respiration data to a hospital's existing ECG monitor.

“What strikes me about the product,” says Wilcox, “is that it doesn't require new monitors—it's retrofit.” That feature was a deliberate choice for GMP, explains Bross, both for economics and for easy installation. “The transceiver plugs into the back of most monitors and the monitor thinks that the transceiver is the lead wire.”

The transceiver then communicates with the LeadWear system that sits beside the bed or goes inside the patient's pocket.
Another feature of the system is a disposable cable that can help maintain a sterile environment. “Disposable is what hospitals want,” says Bross, because lead wires are notorious for causing hospital-acquired infections. “If we can get something that the nurse can slap on and then throw away, we're reducing the risk of transferring bacteria.”

The leads designed by GMP are flat and conductive. They are molded inside a clear, thin, semirigid membrane to promote faster and more-consistent placement on the patient.

By including features that complement existing machinery, use disposable parts, and make placement an easier process, the manufacturers demonstrated how easing the transition into a hospital setting is as important as using state-of-the-art technology.

The Cart before the Horse?

Several companies submitted products that used up-and-coming technology far beyond the next logical step. They offered highly advanced devices—without waiting for accompanying technology to appear on the market. Introducing something groundbreaking is always a risky venture for the manufacturers, but it can also enable other manufacturers to push their related products forward.

The GeneChip Scanner 3000 from Affymetrix Inc. incorporates desktop savvy with state-of-the-art diagnostics.

GeneChip Scanner 3000 with Autoloader. The GeneChip Scanner 3000 from Affymetrix Inc. (Santa Clara, CA) blends good design with technology that has the potential to change the way medicine is practiced. It is a desktop scanner that uses microarrays for genetic analysis. Affymetrix enlisted Design Continuum (West Newton, MA) to help create a flagship design for the scanner that would promote the company brand and bring the technology to the forefront. “The GeneChip scanner needed to address instrument reliability and some negative perceptions of corporate accessibility,” says Allan Cameron, who is the principal in industrial design for Continuum.

MDEA jurors were impressed by the scanner's design. “Most samples are not integrated with the design of a scanner; they are in a box next to the device,” says juror Mark Vreeke of Rational Systems LLC (Granger, IN). “The GeneChip microarrays have a nice integration with the analyzer, which makes it easy to use.”

The company put quite a bit of effort into making the scanner a fluid, easy-to-use system. According to the company, it is roughly one-fifth the size of previous scanners, which is a significant improvement considering the limited space allotted to clinical technicians.

Yet the scanner also yields high-resolution images and operates with a one-button start. The GeneChip Scanner 3000 features an autoload capability. The temperature-controlled environment inside the autoloader keeps the microarray chips viable for up to 16 hours during the processing of the complete carousel.

Besides its advanced design and capabilities, jurors were also swayed by the potential for use that the scanner represents.

“Genetic information will be the basis for personalized medicine,” Vreeke observes. He further asserts that such personalization would result in revolutionary changes for the IVD market.

Vreeke goes on to explain that by using the scanner as a diagnostic tool, clinicians could have the potential to assess a patient's genetic makeup. For example, he says, “A company already has a gene chip that analyzes P450, a gene that metabolizes drugs.” According to Vreeke, the gene helps identify people as slow, medium, or fast metabolizers, which could help personalize medicine dosage levels.

By putting the well-designed scanner on the market, Affymetrix has in fact created a market for more genetic screening applications.

The Z-View Aberrometer from Ophthonix Inc. uses wave-front technology and has a user-friendly design.

Z-View Aberrometer. The Z-View from San Diego–based Ophthonix Inc. blends a well-conceived design with technology that has untapped potential for the ophthalmology market. But the blending of design and technology did not come without its share of trouble.

For the design, the consultant firm DD Studio (Carlsbad, CA) had the job of integrating the technology into a user-friendly design. The design firm had to figure out how to get the technology into an approachable delivery system without compromising use. “It was the biggest challenge for the design team,” says Kevin Simmons, Implementation Director for DD Studio. "At first they [an independent engineering firm] just wanted to put the aberrometer in a rectangular box. We had to convince them to incorporate ergonomics so that it is optimal for both patients and users.”

To do so, DD Studio called upon Ophthonix's president and CEO Andreas Dreher, PhD, to help it meet the design challenges. “Having Andreas as our champion really helped us push through successfully,” says Simmons. “It's important to have someone at the top who is supporting your design ideas.”

The device uses wave-front technology that creates a 3-D map of a patient's unique optical fingerprint, thereby evaluating both lower- and higher-order aberrations. Juror Eliot Lazar says that the application of wave-front to medical devices is a completely new idea. “This is the same technology used to develop the Hubble telescope,” he says. “It's the first wave-front sensor technology designed for patient use.”

Ophthonix's Dreher says, “The technology has been used for aerospace and other engineering fields, but we felt we could make it simplified, reliable, and inexpensive enough for medical use.” After all, he says, it is fairly simple technology that results in the most accurate optical map available.

“The main reason that attempts to get accurate optical refraction failed in the past was because people were thinking of the eye as a perfect optical system; it's not,” Dreher adds.

Devices used in ophthalmologists' offices today can only diagnose lower-order aberrations, such as near-sightedness, far-sightedness, and astigmatism. Higher-order vision problems can include seeing double images, having glare sensitivity, or experiencing image fuzziness—which previously could not be corrected.

Once the measurement of the eye has been taken with the Z-View, the results can be applied to laser corrective surgery, to intraocular lens implants, or to contact lenses. Although contact lenses and other devices that go along with the scanner are not yet available, Lazar believes they soon will be. As he points out, “This is the kind of device that pulls accompanying technology into the market.”

Old Technology Gets New Blood

Blood collection and transfusion systems have long needed some process improvements. Blood has a short shelf life and is difficult to work with. Blood collection is expensive, requiring trained staff to monitor and assist donors. What's more, the pool of blood donors is getting smaller, and the yield from donors is never enough to meet the need.

Transfusion is also an expensive process, even under the best circumstances. Much of the blood collected is unusable or mistreated and therefore wasted. The technology for autotransfusion has had few innovations since its inception in the 1970s. Several MDEA entrants decided to tackle some of the issues that plague this part of medicine by improving portability and flexibility and by reducing expense.

Baxter Healthcare introduced the ALYX component collection system for the global market.

ALYX Component Collection System. The collector, manufactured by Baxter Healthcare Corp. (Round Lake, IL), is a portable automated system that rapidly collects and processes two transfusion units of red blood cells. “We found that when donors give whole blood, there is only one unit of red blood cells suitable for use and that's just not enough,” says Jay Radovich, senior director of ALYX Engineering.

The ALYX is unique in that it separates out the red cells on the spot and returns unneeded components to the donor with saline, all in the same process. “We took the centrifuge that has been used in separation for years and shrunk it down to a small size so we could take it out to donors,” says Radovich. And according to Radovich, on-site component separation and leukoreduction (the filtration of white cells) reduces labor costs and delays in the preparation of blood products.

The result is twice the collection with reduced donor side effects. The system also incorporates a continuous draw and return that enables the double donation to be made in only 22 minutes, compared with 45 minutes for the competition.

Another feature Radovich is particularly proud of is the user interface. The graphic instructions are presented on a touch screen to cut down on training time. It does not include textual instruction, so it can be adapted for use in other countries. “We designed this for the global market,” Radovich says.

Radovich has been working on the ALYX system for nearly six years and is dedicated to seeing it succeed. “I was the first donor to use it, and I've given [blood] numerous times since then.”

MDEA jurors cited the portable design, the user interface, and the reduced blood collection time as the main reasons they identified the ALYX as a winner. “It's an innovative improvement in the essential task of blood collection,” says juror William A. Hyman, a professor and interim head for the department of biomedical engineering at Texas A&M University (College Station, TX). “It has increased speed and attention to error reduction.”

The CardioPAT perioperative autotransfusion system is designed to process small amounts of blood for critical use with less waste.

CardioPAT Perioperative Autotransfusion System. According to Alec Bobroff, the director of product marketing for Haemonetics Corp. (Braintree, MA), “Autotransfusion has been a mature market for nearly 30 years.” He adds, “There hasn't been anything new for a long time.”

Haemonetics decided to meet that challenge with its CardioPAT system. The CardioPAT is designed to provide perioperative autotransfusion for patients undergoing cardiovascular surgery. “The unique thing about it is that it's designed to be used in a wider range than traditional perioperative self-savers,” says juror Matt Weinger, MD, who is with the Vanderbilt University School of Medicine, Division of Perioperative Health Services Research, in Nashville, TN.

The designers used a small, portable Dynamic Disk separation chamber that batches fluid rather than a traditional flow-through chamber that is relatively large and cumbersome. Bobroff explains that the Dynamic Disk is a “simple elastic diaphragm that can change volumes to better accommodate the way post-op patients lose blood.” He says that average patients bleed up to six hours after an operation, but that the amounts are very small. The company needed a way to avoid wasting those small, but important amounts. In the past, says Bobroff, “a lot of blood was thrown away.” By processing fluid in small 100-ml batches, the product is able to move blood quickly and effectively.

Weinger notes that for currently used systems, operators must preselect the amount of blood they will recycle. If they guess wrong, the blood is wasted, because there is too much or not enough saline in the mix. “The CardioPAT allows some flexibility because it adapts to multiples of 100 ml,” says Weinger.

The system consists of an electromechanical device and a sterile single-use disposable set, which together collect and process red blood cells lost during and after surgery. It is used in the operating room to recycle blood lost during cardiovascular surgical procedures and in the recovery room to recycle blood lost after surgery. Haemonetics also made the CardioPAT a small, portable system that mounts on an IV pole. “We wanted the system to be able to travel with the patient,” says Bobroff.

To make the device even more portable, the company put bags on the outside, rather than in an enclosed box. This also made manufacture a less-expensive process, but some jurors noted that it did compromise on the aesthetics of the device. “It's not as elegant a design as it could be,” says Weinger, “but it is certainly in keeping with other operating room devices, and I think in this case the benefits of the technology outweigh presentation.”

Copyright ©2005 Medical Device & Diagnostic Industry


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