Originally Published MPMN May 2005
The Medical Design Excellence Awards
In a field where physicians generally receive more attention than their tools, the Medical Design Excellence Awards (MDEA) perform an important job. They help give credit where credit is certainly due, but often slow in coming. “I think that the manufacturers, particularly the designers, don’t get much recognition,” says Matthew B. Weinger, MD, a perioperative health services researcher with Vanderbilt University School of Medicine (Nashville, TN) and an MDEA juror. “The primary recognition they get is whether their product sells.”
But lag time between when a medical device is designed and when it reaches the market can be significant. And commercial success is not always linked with good design, Weinger says.
The eighth annual MDEA awards program, organized by MPMN publisher Canon Communications llc, seeks to turn the spotlight on the design and engineering achievements that have produced some of the most impressive medical devices on the market. Each product’s user, patient, and business benefits; design and functionality; and contribution to the advancement of healthcare were evaluated by a team of judges from across the medical spectrum. They shared with us what made a few of the silver and gold award winners stand out.
Leaps in Technology
|The Somatom Sensation 64 computed tomography system from Siemens Medical Solutions features the industry’s highest resolution.|
Some products came to the forefront by way of technological leaps. One that most impressed the judges was the Somatom Sensation 64 computed tomography system, manufactured and entered by Siemens Medical Solutions (Malvern PA). Tor Alden, principal at HS Design Inc. (Gladstone, NJ), calls it a “paradigm shift in CT scanning technology” with the industry’s highest resolution. “Even though you could look at this product as an incremental improvement, it required very complex technology, engineering, and design with a lot of historical and logistical concerns,” Alden says. “Multidiscipline teaming makes this innovation stand out. The design is well thought out, simple, very friendly, and approachable.”
The images the device produces for cardiac, neurology, and body-scanning applications provide an astounding level of detail, and promise a new level of diagnostic ability to benefit patients, according to human factors consultant Michael E. Wiklund. And the device performs more quickly than its predecessors, improving throughput and potentially reducing patient cost. Despite these technological leaps, Siemens kept human factors in mind. “They’ve still managed to maintain a simple form factor,” says Wiklund.
One benefit is that the device allows the user to single out a particular organ and automatically remove all else from the image. With other scanners, the image must be manipulated manually. “The manufacturer probably identified this as a uncovered customer need, and found a way of providing a solution meeting this need,” says Jay Goldberg, PhD, director of the Healthcare Technologies Management Program at Marquette University (Milwaukee).
|The GeneChip Scanner 3000 with autoloader represents a technology that will someday allow drug dosage to be determined and adjusted based on a patient’s genetic makeup.|
The GeneChip Scanner 3000 with autoloader, manufactured by Affymetrix Inc. (Santa Clara, CA), also represents a vanguard technology—one that will someday allow drug dosage to be determined and adjusted based on a patient’s genetic makeup, according to Mark S. Vreeke, PhD, senior partner, Rational Systems LLC (Granger, IN). “It’s going to be one of those tools that has the potential to really revolutionize medicine,” he says. From a design standpoint, the device is well integrated, according to Vreeke. “The entire outside structure flows very well.”
“Gene-chip scanning creates the mental picture of a lot of equipment,” says Wiklund. But while the device reaches a new stage in terms of the technology, “this particular company has come up with a nice, streamlined system. You really couldn’t ask for anything more in terms of compactness,” he says.
Another impressive leap over existing devices was made by the cardioPAT perioperative autotransfusion system, manufactured by Haemonetics (Braintree, MA). “They took an existing product category and said, ‘How can we expand the value of these products?’” says Weinger. The device salvages red blood cells lost intraoperatively and postoperatively during cardiovascular surgical procedures. But unlike existing devices, which must have a much larger amount of blood to work with, this product can perform its task with just a 2-L/hr rate of fluids to salvage. The device also requires far less training and technical expertise to use than existing products.
Wiklund, who calls the device “a tour de force,” says it has the plug-and-play kind of character that would allow even a busy nurse to operate it effectively. “They provided the right level of automation, so it didn’t create more work,” he explains. The machine also offers a small footprint, ideal for the operating room environment, and can even be used in the recovery room.
At the other end of the spectrum were simple devices like the OptraGate disposable lip and cheek retractor, manufactured by SFS intec AG (Altstatten, Switzerland), which were nonetheless impressive. “It’s such a simple way of solving a problem,” says Jay Goldberg. The flexible plastic ring is used to keep the lips and cheeks out of the way during dental procedures. It replaces rigid metal retractors—which are complicated to insert and remove, and uncomfortable for patients—providing the same benefits. One of the judges tried on the device, recalls Wiklund. “I assure you I could see every one of his teeth to the back of his mouth,” he says.
Equally simple, and designed to perform functions that once required two separate tools, is the lighted ear curette, manufactured by Bionix Development Corp. (Toledo, OH). “This device illustrates how a simple device can be an elegant solution,” says Alden. A light source located in the handle is piped out into a “spoon” used to clean the ears. Previously, physicians had to use one hand to hold an otoscope and one to hold the curette, Alden explains.
The product fills a tremendous need, according to Denise M. Korniewicz, RN, DNSc, professor and associate dean for research, University of Miami School of Nursing (Miami). “It is designed very simply, and is engineered so that you can handle it very well,” she says, adding that the product is low cost, with practical, disposable tips.
Simplicity and safety also were designed into the Vicks baby thermometer, manufactured by Kaz Inc. (New York City). The rectal thermometer has a flexible tip to help prevent tissue damage, and is shaped to guard against overinsertion. “It is a completely new kind of form factor,” Wiklund says, adding that an easy-to-read display and a cover to protect the flexible tip were nice added features.
Aesthetics and Elegance
|The lighted ear curette from Bionix Development Corp.
has a light source located in
No matter how functional, well-designed medical products feature aesthetics and elegance as well. Devices that are overly large and noisy can be intimidating to patients, explains Weinger, adding that products can even be intimidating to clinicians if they appear especially complicated to use.
The Intelect Advanced and Mobile Electrotherapy range, manufactured by Chattanooga Group (Hixson, TN), was “easily the winner of the beauty contest,” says Wiklund. But he doesn’t take that lightly. “It is intended for use in health clubs, where attractiveness can lend credibility,” he explains. The system includes equipment for providing ultrasound/stimulator combination, dual-channel stimulator, EMG biofeedback, laser, and vacuum stimulator therapies in an integrated cart that is completely portable. It features a sleek design and an intuitive interface. “That was sort of the high-water mark in terms of industrial design and ergonomics,” Wiklund says.
The Savia 211 dSZ hearing system, manufactured by Phonak AG (Stafa, Switzerland), also stood out because of its aesthetics. The digital hearing aid, worn outside around the back of the ear, is actually offered in a range of bright and attractive colors. The manufacturer is attempting to move the users’ perception of hearing aids away from prosthetics and toward the image that glasses now have—as a fashion accessory that also provides performs a useful service function— or, as Goldberg puts in, a “hearing accessory.”
|The ClozeX wound-closure device uses a series
of adhesive tabs and strips with a laced design
to pull wounds closed.
And unlike previous digital hearing aids, which had features similar to those of analog models, this device can automatically sense and adjust to background noise. On other devices, the volume control requires so much pressure to operate that they have to be removed for adjustment. “This device gave us the impression that the designers were really taking advantage of the digital technology,” Stephen B. Wilcox, PhD, principal at Design Science Consulting Inc. (Philadelphia) says.
Ease of use is another critical element of good design. “If the clinician can’t use a device effectively, it’s at best ineffective for the patient, and at worst could be dangerous,” Weinger says. Out-of-the-box design was common to winners in the surgical category, such as the ClozeX wound-closure device, manufactured by Clozex Medical LLC (Wellesley, MA), according to Weinger. The ClozeX uses a series of adhesive tabs and strips with a laced design to pull wounds closed. This is achieved by adhering the strip first to once side of the wound, then to the other, and then lacing the wound closed and adhering the strips in place.
|The self-contained lifeline external defibrillator from Defibtech offers voice prompting to users and an intuitive interface.|
The three sets of tabs are color coded, to help clinicians use them in the proper order. “The designers had to create a fairly complicated application method, but they did a good job of color coding and communicating to the user,” Weinger says. “You want to design your product to be usable pretty much out of the box.”
Wiklund and several judges agree that the Insorb 20 subcuticular skin stapler, manufactured by Incisive Surgical Inc. (Plymouth, MN), offers an elegant mechanical solution and is an excellent example of mechanical engineering incorporating simple, intuitive operation. “Forgive me for waxing poetic,” says Wiklund, “but this one seems to perform mechanical ballet.” The device allows physicians to close wounds by placing resorbable staples underneath the skin. There are no puncture marks with the device, and no need for the patient to return for suture removal. And because it is simple to use, the device turns a formerly difficult procedure into something that physicians can master without long hours of training.
Sometimes what clinicians need is a bit more room to work with. The Vital Heat body temperature regulator, manufactured by Dynatherm Medical Inc. (Burlingame, CA), employs a slight vacuum and circulating hot water to restore and regulate a patient’s core body temperature during and after surgery. Existing products for this purpose include large, bulky warming blankets that must be heated in a microwave or connected to a machine, according to Korniewicz. The Vital Heat mechanism is no larger than a vital sign monitor, and the application covers only the patient’s hand, providing improved patient access for monitoring. “The smaller we get some of the equipment that we use in healthcare, the better,” says Korniewicz. “That gets me more turned on than some big machine.”
|The EZ-10 intraosseous delivery
device is used for administering resuscitating fluid and medication through a patient’s bone marrow, when access to the vein is impossible.
Cost factors come into play in device design because of the need to make technologies more accessible to clinicians and patients. The Lifeline automated external defibrillator, manufactured by Defibtech (Guilford, CT), has the potential to bring life-saving equipment to a greater number of locations because it is about half the cost of similar products. The self-contained defibrillator offers voice prompting to users and an intuitive interface. “Every aspect of it was beautifully designed,” Wilcox says. “It seems simple, but there are a lot of barriers to overcome to get it that simple. At the same time, the designers reducing the cost compared to the designers competitors.”
The EZ-IO intraosseous delivery device, manufactured by VindaCare Corp. (San Antonio), features low-cost elements that will make it accessible to a greater number of emergency responders. The tool is used for administering resuscitating fluid and medication through a patient’s bone marrow when access to a vein is impossible. The innovation is in a disposable catheter that fits at the tip of what appears to be a standard cordless drill. The drill allows for the cost savings. “It doesn’t look like a high-tech medical device, but it accomplishes what it is supposed to do at a lower cost,” says Goldberg. “It is very clever, but from a design standpoint it seems like something you’d get at the hardware store,” Wilcox says.
Of course, good design keeps the patient in mind as well. The Motiva interactive healthcare platform, manufactured by Philips Medical Systems (Milpitas, CA), brings healthcare into patients’ homes via a very familiar technology—television. The idea isn’t new, but this model has promise to extend the technology in new and beneficial directions, according to Wilcox. “This is one of the first that seems to be a workable, feasible system,” he says. The information and monitoring system for patients with chronic diseases integrates clinical software, vital-sign measurement devices, and a personalized interactive TV program in the patient’s home to facilitate communication with caregivers.
|The EnteraLite Infinity enteral feeding system gives patients more freedom of movement during feedings.|
Though it offers only limited applications at present, Wilcox says it is sure to develop further quickly. It allows patients not familiar with computers or the Internet—especially the elderly—access to many of the same functions, such as e-mail and video download on demand. “We felt like, boy, this is an amazing platform,” Wilcox says. “Treating it like just another television channel was inspired.”
The Sage oxygen therapeutic device, manufactured by Chad Therapeutics (Chatsworth, CA), helps patients on portable oxygen therapy by providing automatic adjustments to oxygen delivery. “This basically provides better therapy,” says Wilcox. The system uses a motion sensor and software algorithms to automatically increase or decrease delivery based on patients’ activity level. “It makes the portable oxygen more functional,” Wilcox says.
The EnteraLite Infinity enteral feeding system, manufactured by Zevex Inc. (Salt Lake City), gives patients—especially active children—more freedom of movement during feedings. The product works in any position, “so that if you were a child, you wouldn’t have to worry about sitting in one position to take your feeding,” says Korniewicz. The device is even simple enough for some children to use on their own. “It wasn’t a lot of work to put it together or to use,” Korniewicz adds.
Simple or complex, intended for use by patients at home or surgeons in the OR, the products that will take home medals from the 2005 MDEA program feature a tremendous amount of work in the design process. By providing new technology, improved functionality and accessibility, or new benefits for patients, these products will certainly improve the lives of patients—even those who know little about what went into creating them.
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