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For Award-Winning Devices, the Healthcare Future Is Now

Medical Device & Diagnostic Industry Magazine MDDI Article Index Originally Published July 2000   MDEA 2000 WINNERS The Medical Design Excellence Awards (MDEA) 2000 winners represent not only technological innovation and quality engineering but also major advances in healthcare. Leslie Laine

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published July 2000

Leslie Laine

The winners of this year's MDEA exemplify the highest standards of design engineering, technical innovation, and industry initiative. "Entrepreneurship is on the rise," says juror Corinna E. Lathan. Michael E. Wiklund, chair of the jury panel, adds that the competition suggests "there's still room in the marketplace for clinicians who have a bright idea and find a way to take a product that traditionally has been made in a certain way, put a tweak on it or go for a revolutionary change, and launch a business on that basis."

The MDEA jury members note that the award-winning devices are all remarkable in their overall design and consideration of human factors. In addition, the makers of these devices have found ingenious solutions to technical hurdles—such as miniaturization or materials sourcing—that have long thwarted other developers in their area of medical manufacturing. In some cases, these solutions represent novel applications of advances in related fields, such as consumer electronics; in others, the solutions are the result of completely new inventions and research.

Although the innovation and engineering behind the 10 gold and 19 silver award winners are extraordinary, such characteristics are only part of the reason that MDEA jurors selected these products from a great variety of original, high-quality entries. Lathan remarks that "There's really a systems-level integration of the products—of the environment, a person's lifestyle, the home environment, and the clinical environment. There's clearly a trend for the product design to bring into account the entire system of care." Other jurors note that designs are reflecting qualities that are more often found in consumer products. "We are coming to expect forms that feel good in the hand, are easy to use, and look great. And there's no reason why that can't trickle down to the medical device industry," one juror comments.

Winners were chosen in 10 categories: critical-care and emergency products; dental instruments, equipment, and supplies; general hospital devices and therapeutic products; implant and tissue-replacement products; in vitro diagnostics; finished packaging; over-the-counter and self-care products; radiological and electromechanical devices; rehabilitation and assistive-technology products; and surgical equipment, instruments, and supplies.

Although the winning products vary widely in terms of the clinical conditions they address—which range from infant feeding difficulties to diabetic foot ulcers—they all exemplify creative responses to some of today's most pressing healthcare concerns, such as greater use of preventive treatments, minimization of patient discomfort, point-of-care delivery of services, cost reduction, and environmental protection. The winning products may not be available at every doctor's office or hospital yet, but they offer a glimpse of the kinds of improvements that will benefit patients in the near future.

CRITICAL-CARE AND EMERGENCY PRODUCTS

Faster IV Access for Delivery of Vital Fluids. In situations involving shock, trauma, or cardiac arrest, administering vital fluids or medications quickly can be essential. Typically, these fluids are administered through IVs attached to peripheral veins, but because of the patient's condition, finding such a vein can be prohibitively time-consuming. In fact, a study conducted by the American College of Emergency Physicians in 1999 reported that in 12.4% of cardiac arrest cases, emergency personnel spent critical minutes trying but ultimately failing to establish an IV line.

Alternatives to accessing peripheral veins are to establish a central venous line, use the veins in the neck, or cut away the skin covering a peripheral vein. These methods require qualified personnel, however.

Pyng Medical Corp. (Richmond, BC, Canada; gold award winner) has developed an innovative solution with the FAST 1 adult intraosseous infusion system, which employs an introducer to insert an infusion tube into the manubrium (the top portion of the sternum) and a pump to ensure a steady and appropriate flow of fluid directly into the bone marrow. In clinical trials, the system was able to gain vascular access in an average of 60 seconds, with gravity flow rates of up to 80 ml/min and pump flow rates of 225 ml/min.

FAST 1 adult intraosseous infusion system (Pyng Medical Corp.)

The sternal access route is desirable because the infusion site will not collapse if the patient is experiencing shock, trauma, hypotension, or cardiac arrest. Also, the design of the device enables it to be transported and stored in cramped spaces, such as in ambulances.

Having viewed a presentation describing the use of the device, one MDEA juror states that "it looks like a fairly complex task. There are a lot of complicating factors, such as interfering with the site or contaminating the site. It seems impressive that, in one tray, they have all the pieces and a fairly coherent sequence of actions that lead you through what appears to be an effective use table."

Michael W. Jacobs, Pyng's chairman, states that, "The FAST 1 system is consistent with the time-honored trend of identifying a critical, unmet medical need and creatively addressing that need. Ergonomics and portability as well as cost-effectiveness have been constant drivers in the technological evolution of the FAST 1 system because of the need to make the system useful, beneficial, and effective for the hospital, prehospital, and military markets."

In creating this product, the company had very little previous research to build on. "Pyng uses a part of the sternum that, to a large degree, has not been used for venous access in the past," says Jacobs. "There was very little data to use in testing our design concepts. We now know more about the manubrium and its venous-access and fluid-flow characteristics than was previously available in the literature."

Smaller Infusion Pump to Fit Emergency Environments. Like the FAST 1 system, the Infusion Dynamics Power Infuser similarly addresses the problem of rapid fluid infusion for patients suffering from blood loss or dehydration. With its portable electronic infusion pump, Infusion Dynamics Inc. (Plymouth Meeting, PA) has focused on solving the problem of equipment space limitations in emergency situations.

Infusion Dynamics Power Infuser (Infusion Dynamics Inc.)

In the field, paramedics can place the small, battery-powered pump on or near a patient for life-saving infusion in situations where a lack of manpower or room to elevate an IV bag would normally impede treatment. The pump will restore blood pressure and intravascular volume in patients suffering from clinical shock or hypotension.

In the hospital setting, the pump enables precise control over flow rates and automated bolus delivery. The device also offers several safety features, such as in-line air-elimination membranes, a downstream occlusion sensor, and one-way valves to prevent backflow.

Paul Loughnane, president of Infusion Dynamics, notes that "Our pump is 80 to 90% lighter than most conventional infusion pumps, even though our maximum flow rate is 400 to 1100% higher. Miniaturization makes it possible for a new level of care to be delivered outside of the hospital. In our case, this means IV fluids can be delivered at the scene of an accident or in air or ground transport with the speed and safety that until now has only been possible in a controlled hospital setting."

"As an industry-wide trend," adds Loughnane, "miniaturization means that more care can be delivered at home and at alternate sites, lowering medical costs, enhancing patient comfort, and improving outcomes."

According to Loughnane, the miniaturization that makes the pump possible is due in part to advances in consumer electronics. "The product design would not have been possible without the miniaturization of electronic components and motors that has occurred over the last decade," he says. "In particular, the Power Infuser benefited from miniaturization of analog electronic components, which has been driven by the cell-phone industry."

Reducing the Trauma of Intubation. During an emergency, when healthcare personnel are focused on time-critical, life-saving measures, patients can often sustain lasting injuries not only from their wound or condition but also from the treatment. During intubation, for example, delicate airway structures can be traumatized by standard endotracheal tubes, which have relatively sharp, rigid tips. The tubes can cause vocal cord paralysis, laceration, hematomas, dislocations, abrasions, and perforations of airway structures. In some cases, the damage can be life-threatening.

Parker Medical (Englewood, CO) has developed its Parker Flex-Tip endotracheal tube to minimize the trauma of intubation.

Parker Flex-Tip endotracheal tube (Parker Medical)

The Flex-Tip tube has a centered, tapered, flexible distal tip that minimizes intubation trauma to the human airway. During intubation, when the tube tip encounters the anatomical structures of the airway, it flexes gently upward and slides harmlessly past.

The tip's beveled angle and curvature allow for better vocal cord visibility during conventional intubation with a rigid laryngoscope, resulting in less likelihood of misintubation into the esophagus. Also, in flexible fiber-optic intubations, the new tip travels downward parallel to and between the vocal cords, and is curved toward the fiber bundle, so there is minimal risk of the tube snagging on airway structures.

Jim Parker, president of Parker Medical, repeats the physician's mandate: "First, do no harm." Parker comments that "this statement is particularly relevant in today's litigious climate. Any effective new technology that can substantially eliminate the risk of harm from current medical procedures should become the new standard of care."

DENTAL INSTRUMENTS, EQUIPMENT, AND SUPPLIES

A One-Day Implant. For patients with tooth loss, implants offer functional advantages over dentures. Implanted teeth are maintained and behave just like natural teeth. They also actually stimulate bone growth in the jaw, which dentures do not. The typical procedure for receiving a tooth implant, however, involves as many as seven months of repeated visits and surgical procedures.

The Natural Tooth Replacement (NTR) system from Altiva Corp. (Minneapolis; gold award winner) reduces the lengthy process to a one-day dental procedure with a single follow-up visit. According to Mark Wagner, president and CEO of Altiva Corp., "If you go in for a conventional implant, it's going to take from four to seven months to do the whole thing. In the United States there are approximately 16 million restorative procedures done every year, and implants represent only about 2 to 3% of that. The reason why implants haven't had bigger penetration is because of that inconvenience."

The NTR is a one-piece tooth replacement, with a threaded, self-tapping screw base that replicates the root of a tooth and a tapered post that serves as the base for a tooth restoration or crown. The implant can be placed directly through gingival tissue, using local anesthesia.

Says Wagner, "Dentists can complete the implant procedure in one day and put a temporary crown on so that the patient has immediate functionality and aesthetics. The next and only other visit is four weeks later, when a permanent crown that has been made by the lab is placed."

According to Wagner, the procedure not only benefits the patient by minimizing the pain and inconvenience of the implant procedure, but also represents a major benefit to overall dental care and affordability. "It's significantly less chair time," says Wagner. "Dentists can have more time to see more patients."

Instant Diagnosis of Periodontal Disease. Periodontal disease is often undetected in routine dental examinations because of the difficulty and expense of measuring the problem.

Diamond General Development Corp. (Ann Arbor, MI) has developed a product, the Diamond Probe/Perio 2000 system, that enables the easy measurement of periodontal disease, ensuring that more people will be diagnosed in the early stages of the condition.

Diamond Probe/Perio 2000 (Diamond General Development Corp.)

"The dental field is changing in terms of its understanding of the importance of periodontal infections," says Donald Musinski, vice president at Diamond General. "In the past, those infections weren't considered to be so important, but there is a growing sense that there are big risk factors in the management of such major conditions as heart disease, low birth rates and early labor, diabetes, and strokes. In fact, it was only about two years ago that these systemic risk factors of periodontal infections were documented by the American Academy of Periodontology. There's a real paradigm shift taking place within the dental community."

The Diamond Probe system, which consists of a main control and a disposable probe tip connected to the control unit with a handle and cable, measures relative sulfide concentrations as an indicator of gram-negative bacterial activity and reports results immediately. It was designed to be identical in shape, size, stiffness, tactile feedback, strength, and patient comfort to a standard stainless-steel periodontal probe so that it would require little operator training and be easily incorporated into a clinician's exam routine.

GENERAL HOSPITAL DEVICES AND THERAPEUTIC PRODUCTS

Vision Screening for Preschoolers. Although preschoolers should be screened for vision disorders, it is difficult to test young children, which often prevents them from getting the treatment they need.

The SureSight Vision Screener from Welch Allyn (Skaneateles Falls, NY; gold award winner) is designed to encourage the screening of very young children, explains Drew Kugler, the company's manager of research and development. The SureSight device represents "a focus on wellness and prevention," he says. "You can prevent loss of vision approximately 90% of the time if abnormalities are detected early enough," Kugler adds. "Yet most problems are not detected until the patients are teenagers, and by then it is often too late."

SureSight Vision Screener (Welch Allyn)

According to Welch Allyn, vision disorders are the most prevalent handicapping conditions that children have, and, in preschoolers, the majority of these disorders go undetected. Untreated, they often result in amblyopia or "lazy eye," the leading cause of monocular blindness in North Americans younger than 70. Amblyopia leads to a dramatically higher chance of vision loss in the other eye, and frequently is the cause of learning delays and ultimate limitation of career options.

Two-thirds of those who develop amblyopia have abnormal refractive error. Refractive error occurs when the eye's optics do not clearly focus images on the retina. When this risk factor is detected and treated by age four, 90% of patients have their vision saved and avoid lifelong effects. The current standard of care is to test for refractive error using an eye chart, but this can be difficult and inaccurate with preschoolers. In the United States, 72% of amblyopia cases are not detected until after adolescence.

The SureSight Vision Screener accurately and quickly detects refractive error. Unlike traditional desktop units that weigh approximately 20 lb and require 5 to 10 minutes to complete a screening, the handheld SureSight measures refractive error in both eyes in just 5 to 10 seconds. Results are detected automatically, so there is no need for subjective interpretation. It is operated about 14 in. from the patient and uses flashing lights and sounds to engage the child's attention during the test.

Juror Tom Marsh notes that the product's design makes it appealing to use in a number of environments and that the device appears to be easy to use. He adds that, "Its real advantage seems to be that it gives reliable testing to adolescents and toddlers that heretofore was unavailable."

Dressings that Minimize Trauma. For the most traumatic wounds—such as dermal ulcers, partial- and full-thickness burns, diabetic ulcers, and acute skin tears—the need for numerous wound cleanings and dressing changes not only causes expense and delays in the healing process but is also tremendously painful for the patient.

The Ferris PolyMem sterile wound-care dressing, from Ferris Manufacturing Corp. (Burr Ridge, IL), contains healing agents designed to reduce pain and swelling even as the device helps decrease costs and nursing time.

PolyMem sterile wound-care dressing (Ferris Manufacturing Corp.)

The dressing keeps wounds clean, absorbs exudate, exhibits permeability to facilitate wound healing, assists in autolytic debridement, and does not adhere upon removal. It eliminates the need for wound cleaning between dressing changes, for exposing the wound to air to dry it, and for ancillary products such as absorptive agents, cleansers, moisturizers, and secondary dressings. It is also designed to be easy enough to use so that, in most cases, the patient or a family member can apply or change the dressing themselves. This holds true even for some severe wounds, which traditionally are handled by skilled clinicians.

"Clinical studies indicate that wounds are healed in far less time with Ferris PolyMem," says Roy Carr, vice president and general manager at Ferris. "Clinicians can save time and money with our product and the patient experiences far less pain and recovers faster."

Immediate Diagnosis of Carpal Tunnel Syndrome. According to statistics from the Centers for Disease Control and Prevention, more than 2.4 million visits to physician offices and clinics in 1996 were related to carpal tunnel syndrome. It is estimated that the condition costs United States' industry more than $20 billion per year in healthcare services and lost productivity.

The traditional diagnostic method, an electromyograph, is an invasive procedure that is considered painful to the patient. Because of this discomfort, patients undergoing treatment are typically not retested to ensure that the treatment is efficacious, and those who are merely at risk for developing the condition are often not tested early.

With the goal of providing an improved diagnostic modality, NeuroMetrix (Cambridge, MA) developed the NeuroMetrix NC-stat, which offers accurate, noninvasive diagnosis and monitoring of repetitive stress injuries of the hand and wrist.

NC-stat (NeuroMetrix)

The unit comprises disposable biosensors, a handheld monitor, and a docking station. After stimulating a nerve, detecting the resulting bioelectrical response, and analyzing the signal, the device displays a number on an LCD that indicates the presence or absence of repetitive stress injuries.

Richard Thomas, president of NeuroMetrix, says that the company "had to develop technologies sophisticated enough to detect the bioelectric signals in a simple and reliable manner within a primary-care setting. This was a substantial challenge. Every aspect of the product—from the microprocessor-based instruments to the biosensors to information management systems—reflects the state-of-the-art in engineering and neurophysiology."

According to Thomas, the NC-stat is helping to empower clinicians at the point of care. "Our product moves the power of electrodiagnostic medicine from a specialized hospital laboratory to a primary-care physician's office," Thomas says. "The conventional methods are expensive, require significant technical expertise, and can be painful for the patient. NC-stat is cost-effective and can be operated by a nurse or technician."

IMPLANT AND TISSUE-REPLACEMENT PRODUCTS

Reducing Back Pain and Preserving Mobility. For patients with unresolved lower back pain, options for relief are limited. In a diskectomy, pain is reduced by removing a portion of the disk nucleus and relieving pressure on the nerve root, but this procedure does not restore disk height and may actually destabilize the spine and accelerate continued degeneration of the disk.

Another common surgical treatment is fusion of the vertebra above and below the disk, which relieves pain by restoring the disk height. This procedure reduces range of motion, however, and may accelerate degeneration of the adjacent disks because the fused joint can no longer contribute as part of the load-distribution system of the spine, resulting in higher loads on the adjacent disks.

For those patients who are candidates for a standard diskectomy or a lumbar vertebral fusion procedure and who meet a specific set of criteria, a new source of relief may soon be the Raymedica Prosthetic Disk Nucleus (PDN) from Raymedica Inc. (Minneapolis; gold award winner). The device is a long-term prosthetic implant that relieves back pain while preserving a normal range of motion. Commenting on the device, Corinna Lathan notes that the company has "presented very compelling clinical outcomes data that indicate that this may be a very viable alternative to current treatments for degenerative disk disease—specifically fusion and diskectomies."

PDN Prosthetic Disk Nucleus Implant (Raymedica Inc.)

The PDN is constructed of a structural hydrogel core encased in a woven, high-strength polyethylene jacket. It is implanted in pairs within the patient's disk space following removal of the disk nucleus. After removal of the disk nucleus and implantation of the dehydrated PDN devices into the disk space, the hydrogel core absorbs moisture from the surrounding tissue, expands, and restores disk height and proper biomechanical function to the affected area of the spine. The patient's pain is relieved and he or she retains the range of motion that would have been lost in a spinal fusion procedure.

"The demand for the product is a result of the magnitude and severity of human suffering from degenerative disk disease and the recognized disadvantages of the current surgical options," says Britt Norton, director of research and development at Raymedica. "Surgeons want a more natural solution to the problem than that provided via spinal fusion. The desire for reduced invasiveness and solutions that provide greater restoration of natural function seems to reflect the attitude of the larger medical device industry."

As Norton explains, "The goal of the Raymedica PDN is not only pain relief, but restoration of function of the degenerated lumbar intervertebral disk. The concept of functional restoration of this joint, as opposed to fusion, is part of a trend experienced in the past for treatment of painful joints such as hips. Fusion of the hip joint was once seen by orthopedic surgeons as the final option for treating patients with debilitating hip pain, but the side effects of altered biomechanics, gait, and lifestyle led innovators to develop artificial hip joints in order to restore function and movement. The PDN device continues this trend in the biomedical device industry toward restoration of normal function to degenerated joints."

Comfortable and Secure Breast Prostheses. Among those who wear a breast prosthesis, the most common cause of complaint is a sensation of too much weight, because the device is typically supported by the bra shoulder strap and underband. Some weight is important in maintaining symmetry in the skeletomuscular structures, however; if it is absent or significantly reduced, back and neck pain become problematic as the body attempts to correct for the imbalance.

Traditional breast prostheses also have a tendency to wander in mastectomy bras despite design features to guard against this. Prostheses can fall away from the body when the user bends over, causing discomfort and awareness of the product.

The Amoena Luxa Contact breast prosthesis from Coloplast Corp. (Marietta, GA) addresses the problems of weight and movement of the prosthesis by adhering directly to the chest wall with a strip of silicone adhesive.

Amoena Luxa Contact breast prosthesis (Coloplast Corp.)

The prosthesis is made up of two layers of silicone gel: a firm, pigmented layer that creates the outside front shape and support structure, and an inner back layer composed of a very soft gel. By attaching directly to the chest, the weight of the device is borne by the chest wall rather than by the bra shoulder strap and underband, closely resembling the support of a natural breast. The product is made possible by a self-adhering and reusable silicone-gel adhesive that has sufficient tack to ensure the placement of the device without fully bonding to the skin. The gel retains its desired properties through at least one year of wear and daily cleanings.

"One of the trends in the post breast surgery market is toward providing the most comfortable products to the end-users," says Anne Roesler Becker, design and market research manager at Coloplast. "The biggest complaints about these products are that end-users feel hot and the breast forms are perceived as feeling heavy. In designing the Luxa Contact, Coloplast has tried to answer both complaints. When the breast form is worn attached, most of the weight is transferred back to the chest wall and away from the bra shoulder strap, thus feeling lighter. When worn unattached, the Luxa Contact can be used with a CoolPad on the back, which is designed to absorb perspiration and make the end-user feel cooler and more comfortable."

IN VITRO DIAGNOSTICS

Blood Tests at the Point of Care. Typically, blood analysis requires lengthy delays and high costs because it requires the intervention of a centralized laboratory.

The Careside Analyzer blood-testing system from Careside Inc. (Culver City, CA; gold award winner) delivers test results within 12 to 15 minutes at the point of care. The device has the potential to sever the dependence on centralized laboratories for routine blood testing for many healthcare sites.

Careside Analyzer blood-testing system (Careside Inc.)

"It is beautifully designed," explains MDEA juror Craig M. Jackson. "Although not intended to be portable, it is small enough and light enough to be readily moved by most individuals. This meets needs that traditional instrumentation with this capacity cannot meet."

The system can perform tests in four categories: chemistry, electrochemistry, coagulation, and immunochemistry. It has a footprint of less than one square foot and is designed for easy use.

During operation, a few drops of blood are placed into a disposable cartridge for each test ordered. The cartridge is inserted into the analyzer, which processes the sample, reports the results, and ejects the cartridge into a self-contained receptacle for safe disposal. Results are reported on the screen and stored internally, and can be printed out or transferred to a networked data system.

Eliminating Finger-Stick Pain for Diabetics. Patients with diabetes who practice regular self-monitoring of blood glucose have much more positive health outcomes than those who do not. The pain of the traditional finger-stick method of blood monitoring, however, is a major barrier to regular testing for many patients.

The AtLast blood glucose monitoring system from Amira Medical (Scotts Valley, CA) eliminates the painful finger-sticks commonly associated with blood glucose testing by gathering samples from a patient's forearm, thigh, or upper arm, which have far fewer nerve endings than do the fingers.

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