Originally Published MDDI April 2005

MDEA 2005

Keeping the Patient in Mind Leads to Outstanding Design

Manufacturers who considered a patient's comfort level lead the pack in the MDEAs.

Erik Swain

It is easy to get caught up in technological gadgetry when designing a device. But, chances are, a new product won't catch on unless it significantly improves benefits to patients. One of the most important criteria in selecting winners for the Medical Design Excellence Awards (MDEA) is patient benefit, and it is no surprise that many of the honored products provide that to a substantial degree.

Companies should ensure that patient benefits are realized, says MDEA juror Matthew B. Weinger, a professor of anesthesiology, biomedical informatics, and medical education at the Vanderbilt University School of Medicine (Nashville). They should “extensively involve end-users in the development process and use human factors engineering professionals in the user-interface design,” he explains. “Consider user interface and user documentation from the very start of the design process. Also, employ rigorous usability testing at multiple stages of the design, using functional criteria rather than preference or opinion.”

Also, says juror Eliot Lazar, principal of ElCon Medical (Buffalo, NY), “turn to physician and patient groups to get a sense of unmet needs and ideas for using products.”

What follows are profiles of several MDEA-winning products whose designers took that advice to heart. They came up with devices that significantly improve patients' comfort, quality of life, and chance for survival.

ConfiDose Disposable Autoinjector

The ConfiDose disposable autoinjector by PharmaPen Inc. (Athens, TX) administers subcutaneous or intracavernosal injections without the patient ever seeing a needle. It also automates needle insertion, dose delivery, and needle withdrawal with a single push-button operation. Its design makes needle stick injuries virtually impossible. The product won an award in large part because it makes self-injections more painless and less complex for patients.

“The benefit is the ability for a healthcare provider to offer a patient the means to self-inject a therapy,” says juror Mark S. Vreeke, senior partner at Rational Systems LLC (Houston). “The device can be set up for custom therapies and requires limited patient training. This is ideal for patients with either a limited injection routine or limited capabilities.”

The ConfiDose, PharmaPen's first product, was developed with needle-phobes in mind, says CEO Richard Winters. “Some people just react to needles with a visceral emotion, and that produces compliance issues,” he says. “Many newer drugs are very complex to manufacture and can't be taken orally, so injections are becoming more popular. We wanted to enable patients to take control of their own medical situation and make a difference in the quality of life.”

Designed to be custom-filled by a professional, “by the time the device gets to the patient, it is ready to go,” says Winters. “All you have to do is inactivate the safety function, wipe the injection site with alcohol, put the nose of the injector against your skin, and press a button. The difference with our product is that all three phases of the injection automatically follow from pushing the button. And the only time the needle is out of the device is when it's doing its job.”

An easy way to self-inject can also be cost-effective for patients. They can take their medication at home instead of needing to go to a clinic or hospital and paying to have it injected for them.

Insorb 20 Subcuticular Skin Stapler

The Insorb 20 subcuticular skin stapler provides a number of benefits to patients who have undergone surgery. Made by Incisive Surgical Inc. (Plymouth, MN), the Insorb has the potential to revolutionize skin closure. It combines the better cosmetic result of an absorbable suture with the fast closure times of metal skin staplers. It also ends the need to remove metal staples after an operation. Its significant increase of patient comfort and satisfaction merited it an award.

“This product provides an improved cosmetic result, a lower risk of infection, and may shorten operative time compared to other wound-closure methods,” says juror Jay Goldberg. He serves as director of the healthcare technologies management program at Marquette University (Milwaukee). “Use of resorbable staples eliminates the need for a secondary staple-removal procedure, reducing costs and avoiding the trauma associated with metal staple removal,” he notes.

A cosmetic surgeon, Joseph M. Gryskiewicz, came up with the idea for the technology in the early 1990s. But converting it into a product took a long time. After an initial concept failed, company management issued an edict to turn off the computers. “We started playing around with protein tissue and did everything empirically,” says John L. Shannon Jr., president and CEO. “We learned that you can't model human tissue in 2-D. We had to turn it into a 3-D project.”

Once the company worked up a new design, it quickly became apparent that it would succeed. “The first eight patients we ever used it on, we closed half the wound with metal skin staples and half with our staples. That was the best way to control for whether any issues were due to the patient or the device,” explains Shannon. “Every single one of those patients asked why we didn't close their whole wound with Insorb.”

The U-shaped staple is made from a blend of polylactic acid and polyglycolic acid and is absorbed after a few months. The stapler compresses the targeted skin tissue, advances a metal penetrator to capture a precise portion of dermis, and advances the staple with cleats to secure the tissue.

The product, initially targeted to the obstetrics and gynecology markets, has continued to draw raves from physicians and patients. In fact, one supporter, family physician Raina Young, has experienced it in both roles. “I was very happy with how [my wound] looked,” said Young, who had a Caesarian section. “The nurses commented about how good it looked, too. Also, if you want to get out of the hospital early, you don't have to worry about coming back to get your sutures removed.”

OptraGate

Everyone who has undergone a lengthy dental procedure knows how uncomfortable they can be. Ivoclar Vivadent AG (Schaan, Liechtenstein) sensed the need for a device to keep a patient's mouth open for long periods without pain or discomfort. Previously, a dental assistant had to retract the lips and cheeks with hand instruments. Otherwise, a lip expander made of a hard material was used. The former option was cumbersome, and the latter uncomfortable. As a result, the company developed the OptraGate, made of a soft, flexible plastic material. Its ability to improve patient comfort attracted the award jurors' attention.

“All available expanders and retractors are made of either hard plastic or stainless steel. Therefore all products that have been available for the last decade are stiff and inflexible,” says Diego Gabathuler, international product manager for Ivoclar Vivadent. “These products have not been used very frequently because they were very uncomfortable and sometimes painful to the patient. The OptraGate is the first and only product that is made of an elastomer, and therefore is anatomically flexible in all three dimensions.”

The device is made of two polypropylene rings and a soft thermoplastic elastomer that connects them. It has no latex, which can cause allergic reactions in some patients. The inner ring retracts the lips and cheeks. The soft elastomer enables the device to adapt to different mouth anatomies and enhances patient comfort.

“With the OptraGate, the retraction forces are distributed evenly around the whole mouth,” says Gabathuler. “With conventional instruments, high forces occur on selected spots, and the corners of the mouth can be harmed.”

Another advantage, says juror Goldberg, is that “it improves access to and visibility of the treatment field, enabling quicker, safer procedures.”

Savia 211 dSZ Hearing System

The Savia 211 dSZ is a hearing aid that offers improvements in both function and aesthetics to patients. The device is made by Phonak AG (Stafa, Switzerland).

“As the parent of a hearing-impaired child, I can appreciate the benefits provided by this new product, not only to the user, but to caregivers who maintain and insert the device,” says Goldberg. “Features such as automatic scene analysis, dynamic feedback cancellation, cancellation of reverberated signals and wind noise, and remote controls for changing programs and volume allow the device to adapt to a variety of conditions.”

After a hearing test is done, a hearing-care professional programs the Savia 211 using a PC with special software. The hearing aid can be programmed to fulfill the personal and specific needs of the patient. The custom programming is likely to reduce returns of hearing aids, which occur as often as 20% of the time.

The aid is worn behind the ear, and sound is transferred into the ear using a customized tube with an ear mold. The device is fully automatic, and manual interventions are usually not needed. However, patients can change the volume and hearing program using controls on the device or a remote controller. The device also collects data that the hearing-care professional can use to optimally reprogram it. Innovations in chip programming enable more processing power and less current consumption than previously available systems.

Juror Stephen B. Wilcox, founder and principal of Design Science Consulting Inc. (Philadelphia), was impressed by the use of new algorithms to improve audio quality. “It really takes advantage of digital technology to improve hearing,” he says. “It also breaks the paradigm of existing aids by making it more of a fashion item, like glasses.”

The aid is designed to be worn comfortably without generating pressure marks, even when worn with glasses. Users can choose a fashionable color combination and wear their aid like an accessory. Or, they can choose a hair or skin color and hide it behind the ear. Also advantageous to patients is its cost. Priced at $2000 to $3000, the Savia 211 is less expensive than most high-end hearing aids.

Vital Heat Body Temperature Regulator

The Vital Heat body temperature regulator is a small, portable, easy-to-use means of allowing patients to recover their body heat after surgery. Unlike alternative products, which require a patient's entire body to be covered, the Vital Heat works by simply placing the patient's hand into a chamber. The manufacturer is Dynatherm Medical Inc. (Burlingame, CA).

“Patients in postsurgical intervention who are unable to thermoregulate their temperature stand to benefit from the use of this device,” says juror Yadin B. David, director of biomedical engineering and television services for Texas Children's Hospital (Houston). “It is based on a combination of innovative technology and simplicity of application. Caregivers need to treat and examine the patient's surgical-site wounds, and in doing so, they have to remove the warm blanket. This compromises the patient's core temperature. However, with this device, the need to place warming blankets on top of the patient may be eliminated, allowing caregivers increased ability to access patient wounds.”

The hand is placed into the chamber, sealed, and attached to a paddle unit. A PVC film provides a barrier between the hand and the paddle, keeping the hand chamber sterile. A low-wattage pump moves 43°C water through an aluminum heat sink under the chamber. A 1-psi vacuum in the chamber makes the hand's blood vessels dilate, enabling warmed blood to be returned to the body core. Normal body temperature can be restored as quickly as six times faster than with any other noninvasive technique.

Dennis Grahn is a researcher in Stanford University's department of biological sciences. He discovered in 1998 that the capillary bed in the palm of the hand could quickly transfer large amounts of heat to the body core. He also found that pulling a vacuum tricked the blood vessels into dilating. Grahn patented the technology and licensed it to Dynatherm, which enlisted Whipsaw Inc. (San Jose) to help design a device. “It was a long, iterative process,” says Tom Keegan, director of marketing at Whipsaw. “We did more than 200 mock-ups and tried them on lots of patients, who had to be observed the entire time.”

The chamber, which is completely transparent so blood circulation in the hand can always be monitored, is designed to accommodate a wide range of hand sizes. Even if left unattended, the device will turn off automatically and never allow the water to be heated over 43°C.

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