Medical Device Link.

Originally Published EMDM May/June 2005

2005 Medical Design Excellence Awards

The Best in Med-Tech Design

Judges at the 2005 Medical Design Excellence Awards found a lot to like among this year’s winning products, from a surgical stapler that performs a “mechanical ballet” to image-conscious hearing aids.

Christina Elston

In a field where physicians generally receive more attention than their tools, the Medical Design Excellence Awards (MDEA) programme performs an important job. It helps to give credit where credit is certainly due, but which is often slow in coming. “I think that the manufacturers, particularly the designers, don’t get enough recognition for excellent design,” says Matthew B. Weinger, MD, a perioperative health services researcher with Vanderbilt University School of Medicine (Nashville, TN, USA) and an MDEA juror. “The primary recognition they get is whether their product sells.”

The eighth annual MDEA programme, organized by EMDM 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. Members of the judging panel shared with us what made a few of the silver and gold award winners stand out.

Leaps in Technology

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, entered by Siemens Medical Solutions’s US operations in Malvern, PA. Tor Alden, principal at HS Design Inc. (Gladstone, NJ, USA), calls it a “paradigm shift in CT scanning technology” with the industry’s highest resolution. “It is [based on] 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-imaging 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 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 example 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 customer need, and found a way of meeting this need,” says Jay Goldberg, PhD, PE, director of the Healthcare Technologies Management Program at Marquette University (Milwaukee, WI, USA).

The GeneChip Scanner 3000 with autoloader, manufactured by Affymetrix Inc. (Santa Clara, CA, USA), 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, USA). “It’s going to be one of those tools that has the potential to really revolutionize medicine,” he says. Considering it 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.”

Another impressive leap over existing devices was made by the cardioPAT perioperative autotransfusion system, manufactured by Haemonetics (Braintree, MA, USA). “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 a 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 smaller 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 provides the same benefits as rigid metal retractors, which are complicated to insert and remove, and uncomfortable for patients. One of the judges tried on the device, recalls Wiklund. “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, USA). “This [product] illustrates how a simple device can have 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, FL, USA). “It is designed very simply, and is engineered so that you can handle it well,” she says, adding that the product is low-cost, with practical, disposable tips.

Simplicity and added safety were designed into the Vicks Baby Thermometer, manufactured by Kaz Inc. (New York City, NY, USA). 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-read display and a cover to protect the tip were added features.

No matter how functional, well-designed medical products feature aesthetics and elegance as well. Devices that are 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, USA), was “easily the winner of the beauty contest,” says Wiklund. It’s not an expression he uses lightly. “The device is intended for use in health clubs,” he explains, “where attractiveness can lend credibility.” The portable cart integrates equipment for ultrasound/stimulator combination, dual-channel stimulator, EMG biofeedback, laser, and vacuum stimulator therapies. It features a sleek design, and an intuitive interface.

The Savia 211 dSZ hearing system, manufactured by Phonak AG (Stfa, Switzerland), also stood out because of its aesthetics. The digital hearing aid, worn around the back of the ear, is offered in a range of attractive colours. The manufacturer is attempting to change the perception of hearing aids toward the image of a fashion accessory that provides a useful function. It’s more of a “hearing accessory” than a prosthetic device, explains Goldberg.

The 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. “These people gave us the impression that they were really taking advantage of digital technology,” says Stephen B. Wilcox, PhD, FIDSA, principal at Design Science Consulting Inc. (Philadelphia, PA, USA).

Ease of use is another critical element of good design. “If the clinician can’t use a product effectively, it will at best be ineffective for the patient, and at worst could be dangerous,” Weinger says. Out-of-the-box design usability was common to winners in the surgical category, such as the ClozeX wound-closure device, manufactured by Clozex Medical LLC (Dagsboro, DE, USA), 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 to each side of the wound, and then lacing the wound closed and adhering the strips in place.

The sets of tabs are colour coded to help clinicians use them in the proper order. “They ended up having to design a fairly complicated application method, so they used colour coding and labeling to improve ease of use,” Weinger says. “You want to design your product to be usable pretty much out of the box.”

Several judges agree that the Insorb 20 subcuticular skin stapler, manufactured by Incisive Surgical Inc. (Plymouth, MN, USA), offered an elegant mechanical solution and was an excellent example of mechanical engineering incorporating simple, intuitive operation. “Forgive me for waxing poetic,” says Wiklund, “but this one seemed 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, it 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 in. The Vital Heat body temperature regulator, manufactured by Dynatherm Medical Inc. (Burlingame, CA, USA), 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 or connected to a machine, according to Korniewicz. The Vital Heat mechanism 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.”

Price Points

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, USA), has the potential to bring lifesaving 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. “It seems simple, but there are a lot of barriers to overcome to get it that simple. At the same time, [the company] reduced the cost compared with its competitors,” Wilcox says.

The EZ-IO intraosseous delivery device, manufactured by VindaCare Corp. (San Antonio, TX, USA), features low-cost elements that will make it accessible to a greater number of emergency responders. The tool is used for administering fluid resuscitation and medication through a patient’s bone marrow. 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 didn’t look like a high-tech medical device, but it accomplished what it was supposed to do, at a lower cost,” says Goldberg. “It was so clever, but from a design standpoint it seemed like something you’d get at the hardware store,” Wilcox says.

Patient Benefits

Of course, good design keeps the patient in mind as well. The Motiva interactive healthcare platform, manufactured by Philips Medical Systems (Milpitas, CA, USA), brings healthcare into patients’ homes via a familiar technology—television. The idea isn’t new, but this model has promise, 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-signs-measurement devices, and a personalized TV programme in the patient’s home to facilitate communication with caregivers.

Though it offers 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. “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, USA), 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 levels. “It makes the portable oxygen system more functional,” Wilcox says.

Simple or complex, intended for use by patients at home or surgeons in the OR, products that took home medals from the 2005 MDEA programme featured a tremendous amount of work in the design process. Using new technology or enhanced functionality and accessibility, these products will improve the lives of patients—even those who know little about what went into creating them.

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