Originally Published May/June 2000
After evaluating more than 100 products submitted to the 2000 Medical Design Excellence Awards (MDEA) competition, a jury of medical device industry experts has selected 29 finalists representing the competition's 10 categories. Now in its third year, the design competition rewards innovation and engineering excellence in medical product design and manufacturing. The awards program is organized by Canon Communications and sponsored by EMDM's sister publication, Medical Device & Diagnostic Industry magazine. And the finalists are . . . .
Critical Care and Emergency Products
FAST 1 adult intraosseous infusion system
Promotes rapid medication delivery in time-critical emergency situations
The system was created to provide safe, reliable, and rapid venous access for infusion of vital fluids and medications. As an alternative to a peripheral IV, the FAST 1 system employs an introducer to insert an infusion tube into the top bone of the sternum. The sternal access route is desirable because it will not collapse if the patient is experiencing shock, trauma, hypotension, or cardiac arrest. In clinical trials, the system was able to gain venous 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. Pyng Medical Corp., Vancouver, BC, Canada.
Infusion Dynamics Power Infuser portable infusion pump
Compact pump delivers fluids rapidly
Specifically for rapid IV administration of crystalloid and colloid IV fluids, the Power Infuser electronic infusion pump restores blood pressure and intravascular volume in patients suffering from clinical shock or hypotension. The device is outfitted with a number of safety features not typically available during rapid fluid administration, such as in-line air elimination membranes, a downstream occlusion sensor, and one-way valves to prevent backflow. The portable unit is suitable for use in operating rooms, trauma sites, and ambulances. In the hospital setting, the pump simplifies the task of fluid management by allowing precise control over flow rates and automated bolus delivery. Infusion Dynamics Inc., Plymouth Meeting, PA, USA.
Parker Flex-Tip endotracheal tube
Minimizes trauma to the airway
The centred, tapered, flexible distal tip of the Flex-Tip endotracheal tube minimizes intubation trauma to the human airway. When the tip hits the anatomical structures of the airway, it flexes gently upward and tends to slide harmlessly off of and past those structures on its curved backside. The tip's bevel angle and curvature allow better vocal cord visibility during conventional intubation with a rigid laryngoscope, resulting in less likelihood of misintubation into the esophagus. The device is appropriate for orotracheal use in hospital, prehospital, and alternate-site environments. Parker Medical, Englewood, CO, USA; Euromedical Industries, Sungai Petani, Kedah, Malaysia.
Dental Instruments, Equipment, and Supplies
Diamond Probe/Perio 2000 periodontal disease evaluation system
Quickly detects periodontal disease at the point of care
Developed to test for periodontal disease during routine dental exams, the system measures relative sulfide concentrations as an indicator of gram-negative bacterial activity and then reports immediate results. The system consists of a single-use disposable probe tip with microsensors that is connected to a main control unit. The probe is used exactly like a standard stainless-steel periodontal probe, so the device requires little training and can easily be incorporated into a clinician's exam routine. Diamond General Development Corp., Ann Arbor, MI, USA.
Altiva NTR Natural Tooth Replacement one-piece tooth replacement system
Decreases the complexity, discomfort, and time involved in tooth replacement
The Altiva Natural Tooth Replacement system reduces the tooth replacement process from a six- to eight-month procedure with numerous dental office visits to a one-day procedure with one follow-up visit. According to its manufacturer, the system is the first immediate-load, immediately functional implant tooth replacement system. The system consists of a threaded, self-tapping screw base that replicates the root of the tooth, and a tapered post that serves as the base for the tooth restoration or crown. The procedure for placing the prosthetic tooth directly through the gingival tissue does not require surgery and can be performed using local anesthesia. Altiva Corp., Minneapolis, MN, USA.
Finished Packaging
Dialpak III contraceptive tablet dispenser
Refillable, discreet compact reduces material use and fosters user compliance
Designed to resemble a cosmetic case, the Dialpak III is a reusable compact for dispensing birth control pills. The package features a mechanism to set the start day and orientation of the pill refill to ensure correct sequencing. The design also incorporates an "any day start" feature allowing the user to start taking the pills on any day of the week, which may help women take their pills properly. The new lighter-weight package represents a cost savings over previous packages. Because the compact is reusable for a year or more, it can reduce material use by more than 1,000,000 lb per year. Ortho McNeil Pharmaceutical, Raritan, NJ; Able Design, New York, NY, USA; McQuay, Watsontown, PA, USA.
Betadine PrepStick applicator
Easy-to-use antiseptic applicator avoids the mess of traditional methods
The Betadine PrepStick provides an alternative to presaturated, foil-wrapped swabsticks or crushable glass ampoules used to apply antiseptic. The PrepStick is a dry-handled swab that contains Betadine in the applicator handle. To use the swabs, clinicians squeeze the applicator handle, releasing the antiseptic solution into the foam tip. Design benefits include controllable flow and reduced packaging waste. Purdue Frederick Co., Norwalk, CT, USA.
Propyflex PVC-free bags
Cost-effective alternative to PVC bags
As an alternative to PVC medical fluid bags, Propyflex bags do not produce toxic dioxins or hydrogen chloride when incinerated. The bags are made from a three-layer coextruded flat or tubular film consisting of polypropylene and styrene ethylene butylene styrene. Like bags made with PVC, Propyflex bags are flexible and transparent, yet their improved water vapour barrier properties eliminate the need for overwraps. The bags are priced competitively with PVC bags, and because they do not need to be overwrapped, can reduce packaging costs. Sengewald Verpackungen, Halle, Germany; Pactiv, Amstelveen, Netherlands.
General Hospital Devices and Therapeutic Products
Ferris PolyMem wound-care dressings
Aids in healing numerous types of wounds while reducing costs and nursing time
PolyMem sterile wound dressings contain healing agents to help treat dermal ulcers, partial-and full-thickness burns, diabetic ulcers, acute wounds, skin tears, and other conditions. The dressings aid in wound cleansing, absorb exudate, exhibit permeability to facilitate moist wound healing, assist in autolytic debridement, and do not adhere upon removal. These features allow wounds to heal without requiring cleaning between dressing changes and eliminate the need for ancillary products such as absorptive agents, cleansers, moisturizers, and secondary dressings. Ferris Manufacturing Corp., Burr Ridge, IL, USA.
NC-Stat system for detection and assessment of repetitive stress injuries
Tests for carpal tunnel syndrome noninvasively at the point of care
The NeuroMetrix NC-Stat provides accurate, noninvasive diagnosis and monitoring of carpal tunnel syndrome and can screen workers who are at risk of developing repetitive stress injuries. The device replaces expensive medical instrumentation that is typically not available at the point of care and that requires invasive procedures. Clinicians can also use the device to identify appropriate treatment regimens and track progress of treatment plans. The unit consists of disposable biosensors, a handheld monitor, and a docking station. By stimulating a nerve, detecting the resulting bioelectrical response, and then analyzing the signal, the unit can display a number on an LCD screen that indicates the presence or absence of repetitive stress injuries. NeuroMetrix, Cambridge, MA, USA; Product Genesis, Cambridge, MA, USA.
SureSight vision screener
Detects vision problems in 10 seconds
Pediatricians, family physicians, and screeners in public health settings can use the Welch Allyn SureSight vision screener to accurately and quickly detect refractive error, the primary vision disorder in children. The unit is innovative for its handheld design, low cost, ease of use, and fast delivery of results. Whereas traditional large desktop units weigh about 20 lb and require 5 to 10 minutes to complete the screening, the SureSight handheld unit measures refractive error in both eyes in 5 to 10 seconds. The SureSight is operated about 14 in. from the patient and uses flashing lights and sounds to engage the child's attention during the test. Welch Allyn, Skaneateles Falls, NY, USA; David Cooper & Associates, Pittsford, NY, USA.
Implant and Tissue-Replacement Products
Amoena Luxa breast prosthesis
Offers a more-natural and comfortable option for women who have undergone mastectomy
The Amoena Luxa breast prosthesis adheres directly to the chest wall with a silicone adhesive, offering an alternative to traditional nonattachable devices that are held in place with a mastectomy bra. By attaching directly to the chest, the chest wall bears the weight of the prosthesis—rather than the bra shoulder strap and underband—and more closely resembles the weight of a natural breast. The adhesive can accommodate a variety of skin types and allows for comfortable and easy removal of the prosthesis. Coloplast Corp., Marietta, GA, USA.
Raymedica PDN long-term prosthetic disc nucleus implant
Relieves back pain and restores range of motion
Patients with degenerative disc disease now have an additional treatment option with the introduction of the Raymedica PDN prosthetic disc nucleus implant. The device is for patients with unresolved back pain who are candidates for a standard discectomy or a lumbar vertebral fusion and who meet specific criteria. Created as a long-term implant to replace a patient's disc nucleus, the PDN is constructed of a structural hydrogel core encased in a woven high-strength polyethylene jacket. The PDN device relieves back pain by restoring the disc height and retaining the range of motion—often not possible with other methods—thereby reducing the risk of accelerated degeneration in the treated disc or adjacent discs. Raymedica Inc., Minneapolis, MN, USA; Charles D. Ray, MD, Williamsburg, VA, USA.
In Vitro Diagnostics
AtLast blood glucose monitor
Eliminates painful fingersticks
Patients with diabetes can safely and accurately check their blood glucose levels without sticking their fingers to get blood samples. The AtLast blood glucose system combines a sampler and meter in one unit that can be used on a patient's forearm, thigh, or upper arm, which all have fewer nerve sites than the fingertip. By eliminating fingerstick pain, the device has the potential to encourage patients to check their blood glucose levels more frequently and manage their disease more responsibly. Amira Medical, Scotts Valley, CA, USA.
Careside Analyzer blood testing system
Delivers almost instant test results
With its capability to provide accurate point-of-care blood test results within 12 to 15 minutes, the Careside Analyzer decentralizes lab operations and eliminates the traditional 2- to 24-hour turnaround for test information. The system performs chemistry, electrochemistry, coagulation, and immunochemistry tests, and can conduct haematology tests when connected to a separate device. The compact unit has a footprint of less than one square foot and features a graphical user interface designed for simple operation by nontechnical operators. Careside Inc., Culver City, CA, USA; Hauser Inc., Westlake Village, CA, USA; UMM Electronics, Indianapolis, IN, USA.
Over-the-Counter and Self-Care Products
Dr. Brown's Natural Flow baby bottle
Provides a steady flow of milk or formula without air bubbles
Designed to emulate breast feeding, Dr. Brown's Natural Flow infant feeding system bottle keeps air bubbles and air from contaminating formula and prevents vacuum formation inside the bottle and middle ear. An internal venting tube in the bottle facilitates continuous positive pressure during the entire feeding cycle, simulating the flow of breast feeding. The manufacturer's user research found a significant reduction in colic and ear infections, when compared with use of conventional bottles and bag systems. Handi-Craft Company Inc., Bonne Terre, MO, USA; Mt. Zion Family Care, Mt. Zion, IL, USA.
Personal Lasette blood sampling laser device
Laser extracts blood without piercing skin
By using a laser instead of a traditional lancet, the Personal Lasette obtains capillary blood samples for glucose monitoring in a less painful manner. When the laser pulse is directed at a small area of the finger, it creates a tiny hole from which the blood is extracted via a precise, accurate beam of light that penetrates the skin without tearing it. Because the unit does not contain a lancet or medical sharp, it does not present the risk of accidental needle sticks or cross-contamination. The compact, battery-powered device has 16 power level settings to accommodate varying skin thicknesses. Cell Robotics, Albuquerque, NM, USA; Hauser Inc., Westlake Village, CA, USA.
Radiological and Electromechanical Devices
Cypress portable ultrasound system for cardiac imaging
Unit weighs less than 20 lb.
Cardiologists can use the Acuson Cypress ultrasound system to obtain real-time images of the heart in critical-care and emergency settings, as well as in remote clinics and rural areas. According to its manufacturer, at less than 20 lb, it is the smallest phased-array system ever built and it provides all of the capabilities of units that weigh more than 400 lb and cost more than $150,000. Because of its light weight, it can easily be carried to the patient's bedside. Built-in connectivity features allow networking of images, and its onboard modem permits users to send studies via e-mail. Acuson Corp., Plymouth Meeting, PA, USA; EDGE Product Development Corp., Newtown, PA, USA.
Logiq 700 Expert Series ultrasound system
Advances image quality to unprecedented levels
By moving to an all-digital system design, the Logiq 700 provides an expanded view into the human anatomy and can accurately transport images using networking technology. While ultrasound systems traditionally produce a 2-D cross-sectional image of the anatomy, the Logiq 700 acquires 3-D images of the body. Using 3-D views of the anatomy, radiologists can improve surgical planning and diagnosis. A coded transmission and detection technique improves direct visualization of blood flow. GE Medical Systems, Milwaukee, WI, USA.
SonoSite 180 hand-carried ultrasound system
Offers image quality comparable to a 300-lb system in a 5.4-lb hand-carried device
The SonoSite 180 brings high-quality digital ultrasound imaging to the point of care, previously not possible because of the size and cost restraints of traditional high-performance ultrasound. The unit's smaller size and lower price make ultrasound imaging more accessible in settings such as emergency rooms, postoperative environments, Ob/Gyn offices, rural areas, and military deployments. Using the SonoSite 180, physicians have rapid access to patient information and can bypass expensive ultrasound outsourcing. The product consists of a display unit that houses the system electronics and user interface, and a transducer that transmits and receives acoustic energy. Sonosite Inc., Bothell, WA ; IDEO Product Development, Palo Alto, CA, USA.
Rehabilitation and Assistive-Technology Products
Health Hero Network Health Buddy System for collecting and transmitting patient data
Internet technology allows physicians to monitor changes
The Health Buddy System combines a device for patients to report health information with a patient database that physicians access using a Web browser. The patient system consists of a backlit LCD screen, a built-in modem, a simple screen interface, and a built-in serial port for connecting health-monitoring devices such as glucose meters, weight scales, and blood pressure meters. At periodic intervals the system asks patients a series of questions about their medication, state of well-being, and eating habits, and then sends responses to a service center for evaluation. The initial target population for the Health Buddy includes patients with heart failure, Parkinson's disease, diabetes, and advanced-stage renal failure. Health Hero Network Inc., Mountain View, CA; IDEO Product Development, Mountain View, CA, USA.
Interactive Healthcare Services daily communication link
Electronically connects patients and physicians
By engaging patients as active participants in their own care and providing physicians and nurse case managers with daily access to timely, accurate, and relevant patient data, the Interactive Healthcare Services system strives to improve the management of heart failure disease. Patients receive a set of portable, easy-to-use devices that measure and transmit vital signs from their home to their healthcare provider's computer. The devices include a scale, a blood pressure unit, heart rhythm strip recorder, and a unit to transmit the data using the patient's phone line. In a user study, patients using the system had a hospital readmission rate of 0.21 visits a year, compared with an average of 1.9 for patients not using the service. Agilent Technologies, Palo Alto, CA, USA.
Natura digital hearing device
Processes sound up to 90% faster than traditional hearing aids
With a powerful, tiny chip that processes sound 50—90% faster than traditional hearing aids, Sonic Innovations's Natura hearing aids make it possible for users to hear virtually at the speed of sound. The device has nine frequency bands that can be adjusted to the user's hearing loss. Sonic Innovations supplies audiologists with 3Com Palm Pilots to record the settings of each patient's Natura unit and then relay the information to the manufacturer to custom build each device. To address the cosmetic concerns of users, the unit was designed to be nearly invisible when worn in the ear. Sonic Innovations, Salt Lake City, UT, USA; Brigham Young University, Provo, UT, USA; University of Utah, Salt Lake City, UT, USA; California Institute of Technology, Pasadena, CA, USA.
NuPulse mechanical compression device
Aids healing of foot ulcers
The NuPulse mechanical compression device enhances lower-extremity circulation for patients with arterial or diabetic foot ulcers. The device consists of a pump that is connected to foot wraps that inflate to mimic the normal action of walking and promote blood flow. Because its compressor unit is specifically adapted for the therapeutic application of cyclic pressure, the device delivers more-precise control over the pressure. The unit is designed for simple operation to ensure that patients of all abilities are able to safely and effectively use the unit in their homes. Kinetic Concepts Inc., San Antonio, TX, USA; Aerotek, San Antonio, TX, USA.
Surgical Equipment, Instruments, and Supplies
AutoSonix ultrasonic cutting and coagulating system
Small-diameter device allows surgeons to decrease incision size
The AutoSonix System for ultrasonic cutting and coagulating includes the first 5-mm-diam family of ultrasonic instruments, according to its manufacturer. Their smaller diameter allows surgeons to replace a 10-mm access port with a 5-mm one, resulting in better patient cosmetic outcomes. The system includes three disposable instruments: a ball probe, a hook probe, and Ultra Shears. The Ultra Shears instrument rotates 360°, allowing the surgeon to maintain direct visualization of the inferior portion of the knife blade at all times. The instrument also features a multiplane cutting capability that results in faster haemostatic cutting than competitive devices, according to the manufacturer. U.S. Surgical, North Haven, CT, USA.
InterGel adhesion prevention solution
Solves a difficult problem that can occur in complex surgical procedures
InterGel is a liquid gel that is poured directly into the wound site at the end of gynecological surgery to facilitate the reduction of abnormal scar formations, known as adhesions. The gel is made from a natural biopolymer that is nontoxic and absorbs into the body within one week. Its use prevents debilitating and costly complications including pain, bowel obstruction, and infertility. Application of the gel is designed to be intuitive to surgeons. Lifecore Biomedical, Chaska, MN, USA; Ethicon Inc., Somerville, NJ, USA; University of Southern California, Los Angeles, CA, USA.
Saufera bacteriostatic PVA sponge
Prevents postoperative problems associated with traditional foam sponges
PVA foam sponges used in surgery as internal wound dressings can promote microorganism growth when they are left in the body to aid postoperative healing. The Saufera bacteriostatic sponge has organic dyes bound to the foam to prevent the sponge from being a host for microorganisms for up to seven days. The bacteriostatic sponge prevents the growth of Staphaureus, and can remain effective in the presence of blood, which can render some germicides ineffective. Hydrofera LLC, Willimantic, CT, USA.
Sew-Right SR-5 and Ti-Knot TK-5 hand instruments
Simplifies minimally invasive procedures
Designed to improve upon current laparoscopic suturing procedures, the Sew-Right allows a physician to remotely place sutures to approximate soft tissue precisely and with minimum trauma. The Ti-Knot device securely crimps sutures together using a compressible sleeve (called a Titanium Knot) around the suture and cuts the excess suture tails. The Titanium Knot can be placed much more rapidly than tying more-traditional laparoscopic knots. The Sew-Right and Ti-Knot are designed to feel comfortable in either hand and to be completely operational using only one hand. LSI Solutions, Rochester, NY, USA.
Weck Hem-o-Lok polymer ligation clip
Enhances the surgeon's speed and reduces surgical procedure time
The Weck Hem-o-Lok polymer ligation clip system performs the same function as sutures and is used intraoperatively to cause haemostasis through vessel ligation. The three components of the system are a polymer ligating clip for occluding vessels or tissue structures, a cartridge for storing the clips, and a clip applier that transfers the clips from the cartridge to the surgical site. By penetrating and locking through multiple layers of tissue, the system minimizes the amount of dissection and reduces the surgical procedure time. The engaging clip-latching mechanism allows the user to feel and hear the clip close when visibility is limited within the surgical field. Weck Closure Systems, Research Triangle Park, NC, USA; Baxter, Laguna Hills, CA, USA.
About the AwardsA nine-member jury with expertise in biomedical engineering, human factors engineering, industrial design, medicine, nursing, packaging, and diagnostics evaluated more than 100 products submitted to the 2000 Medical Design Excellence Awards (MDEA) competition. They selected 29 finalists representing 10 categories. Corporate sponsorship for the 2000 MDEA competition is being provided by DuPont Tyvek (Wilmington, DE, USA), a supplier of sterile packaging materials for medical products; Eastman Chemical Company (Kingsport, TN, USA), a supplier of medical-grade resins, plasticizers, and packaging materials; and Medsource Technologies (Minneapolis, MN, USA), a firm that specializes in full-service outsourcing and complete project management for medical device manufacturing. The winning products will be displayed at the Medical Design & Manufacturing East Exposition, June 6—8, 2000, in New York City. For more information about the competition, call Canon Communications at +1 310 9969434. |
