MDEA WINNERS

The medical technology community's leading innovators stepped forward to claim their gold and silver at the presentation ceremony for the annual Medical Design Excellence Awards (MDEA) competition.

Now in its 10th year, the MDEA competition is the premier awards program for the medical technology industry, recognizing contributions and advances in the design of medical products. The awards, presented in June at a ceremony held in conjunction with the Medical Design & Manufacturing East 2007 Conference and Exposition in New York City, are testament to the tireless efforts of the many individuals who contribute to the development of healthcare's groundbreaking innovations.

Winning products in the MDEA competition undergo a comprehensive review by an impartial, multidisciplinary panel of third-party jurors with expertise in biomedical engineering, human factors, industrial design, medicine, and diagnostics. In their assessment of candidates, jurors look for entries that reflect clear achievements in product innovation, design and engineering excellence, end-user and patient benefits, and cost-effectiveness in manufacturing and healthcare delivery.

The 2007 jury selected 35 gold and silver award winners in 10 medical product categories. The product categories are as follows.

For additional information about the MDEA program, including instructions for entering the 2008 competition, visit the awards Web site at www.MDEAwards.com.

By category, gold () and silver () award-winning products and their manufacturers for 2006 are as follows.

Critical-care and emergency medicine products

Cool-Cap neonatal head-cooling system, manufactured by Olympic Medical Corp. (Seattle, WA). Entry submitted by Natus Medical Inc. (San Carlos, CA). The Cool-Cap system enables neonatologists to provide selective head cooling as a treatment option for full-term infants with clinical evidence of moderate to severe hypoxic-ischemic encephalopathy, thereby reducing long-term neurological damage.

Impella 2.5 circulatory support system, manufactured and submitted by Abiomed Inc. (Danvers, MA). The Impella 2.5 is the world's smallest ventricular-assist device. It provides increased circulatory support during catheterization laboratory procedures such as high-risk angioplasty.

Organ Care system, manufactured by Transmedics Inc. (Andover, MA). Entry submitted by Farm Design Inc. (Hollis, NH). The Organ Care system is designed to maintain transplantable organs in a warm, functioning state outside the body in order to optimize their health and permit continuous clinical evaluation.

Dental instruments, equipment, and supplies

EtchMaster dental air abrasive etching instrument, manufactured and submitted by Groman Inc. (Margate, FL). EtchMaster is a disposable micro air abrasion tip for localized intraoral etching of tooth surfaces and prosthetics. Each EtchMaster tip is prefilled with abrasive powder and is powered and controlled by air via a simple chairside adapter.

Ezlase diode dental laser system, manufactured and submitted by Biolase Technology Inc. (Irvine, CA). Ezlase is a dental laser system that uses semiconductor diode technology; a unique wavelength; and sterile, single-use fiber tips to perform soft-tissue clinical procedures with minimal bleeding and maximum patient comfort.

Orthoralix 8500 panoramic dental x-ray unit, manufactured by Ka Vo Dental Corp., Gendex Dental Systems (Des Plaines, IL). Entry submitted by Cesaroni Design Associates Inc. (Glenview, IL). The Orthoralix 8500 is a panoramic x-ray unit used to take dental x-rays. The panoramic system provides superior mechanical performance while producing excellent diagnostic image quality.

Thermoplastic Drill Template Set, manufactured by Institut Straumann AG (Basel, Switzerland). Entry submitted by Applied Dental Inc. (Mountain View, CA). The Thermoplastic Drill Template Set enables a dental surgeon to fabricate an accurate radiographic and surgical guide in minutes. It marks the desired site of implantation and enables precise use of the cutting instrument during implant bed preparation.

Finished packaging

Ospol dental implant system packaging, manufactured by Ospol AB (Malmö, Sweden). Entry submitted by Avalon Technology AB (Solna, Sweden). Ospol dental implant system packaging is used to organize and handle the Ospol implant system at dental clinics, providing safe and easy use in a sterile environment. It fits together with all parts and supports all phases of the Ospol implant system.

General hospital devices and therapeutic products

Episure AutoDetect epidural syringe, manufactured and submitted by Indigo Orb Inc. (Irvine, CA). The Episure AutoDetect epidural syringe is a spring-loaded, loss-of-resistance, 10-cm³ syringe used during epidural anesthetic procedures. The device is intended for use with an epidural needle to verify placement of the needle tip in the epidural space.

Mobile Clinical Assistant, manufactured by Intel Corp. (Beaverton, OR). Entry submitted by Whipsaw Inc. (San Jose, CA). The Mobile Clinical Assistant is a tablet computer for the healthcare industry. It is used by doctors and nurses to organize, store, and process patient information. It is also a diagnostic tool, used to retrieve and analyze test results.

Odor Absorbing Hydrocolloid wound dressing, manufactured and submitted by Avery Dennison Medical (Turnhout, Belgium). The Odor Absorbing Hydrocolloid dressing captures wound malodors and absorbs exudate from lightly to moderately draining wounds. It provides a protective, occlusive barrier that facilitates autolytic debridement, granulation, and epithelization.

Pinnacle total parenteral nutrition management system, manufactured and submitted by B. Braun Medical Inc. (Bethlehem, PA). The Pinnacle total parenteral nutrition management system uses advanced bar coding and software technology—including a Windows browser-based user interface—to increase caregiver productivity while also protecting patient safety.

SureSkin central catheter and IV dressing, manufactured and submitted by Euromed Inc. (Northvale, NJ). SureSkin is a transparent, caregiver-inspired hydrocolloid central catheter or IV dressing with a one-step application. It adheres securely yet gently, providing a waterproof barrier against contaminants and a conformable fit in challenging locations.

Symbiq infusion system, manufactured and submitted by Hospira Inc. (Lake Forest, IL). The Symbiq infusion pump is a state-of-the-art medication management system that combines ease of use, reliability, and advanced technology, and incorporates MedNet patient safety software to increase safety and usability.

Vest airway clearance system, model 205, manufactured and submitted by Hill-Rom Company, Inc. (Charleston, SC). Designed exclusively for acute- and long-term-care environments, the Vest airway clearance system, model 205, uses high-frequency chest wall oscillation to remove retained secretions due to acute and chronic respiratory conditions.

Implant and tissue-replacement products

Gynecare TVT Secur system for treating stress urinary incontinence, manufactured and submitted by Ethicon Inc. (Somerville, NJ), a Johnson & Johnson company. The Gynecare TVT Secur system is a pubourethral sling for treating female stress urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

OrthoGlide medial knee implant, manufactured and submitted by Advanced Bio-Surfaces (Minnetonka, MN). OrthoGlide is a cobalt-chrome medial knee compartment implant that reduces pain in osteoarthritic patients by providing a low-friction articulating surface. It can be implanted through minimally invasive outpatient surgery, with no bone cutting.

StimLoc deep-brain lead immobilizer, manufactured and submitted by Image Guided Neurologics (Melbourne, FL). StimLoc is a permanent implant used to immobilize electrical leads used for deep-brain stimulation for the treatment of Parkinson's disease, essential tremor, and dystonia.

In vitro diagnostics

Piccolo Xpress chemistry analyzer, manufactured and submitted by Abaxis Inc. (Union City, CA). The Piccolo Xpress is a point-of-care blood chemistry analyzer for use in medical or veterinary applications. It can provide up to 14 different blood chemistry values from a 100-µl sample in approximately 15 minutes.

Symphony one-touch histology slide preparation system, manufactured and submitted by Ventana Medical Systems Inc. (Tucson, AZ). The Symphony system automates the preparation of hematoxylin- and eosin-stained histology slides, resulting in high-definition slides that improve diagnostic visualization and provide exceptional discrimination of microanatomic detail.

UltraCrit hematocrit measurement device, manufactured by Separation Technology Inc. (Altamonte Springs, FL). Entry submitted by Key Technologies Inc. (Baltimore, MD). Intended for use in the blood banking industry, the UltraCrit device uses ultrasound technology to quickly and accurately quantify hematocrit levels in human whole blood for the purpose of screening blood donors.

Over-the-counter and self-care products

Conveen Optima silicone urisheath, manufactured and submitted by Coloplast A/S, Urology and Continence Care Div. (Kokkedal, Denmark). The Conveen Optima is a silicone urisheath for males suffering from urinary incontinence. Designed for easy application by gloved caregivers or by users with reduced hand dexterity, the device is appealing for both professional and personal-care markets.

Easypod subcutaneous injection device, manufactured and submitted by Merck Serono International SA (Geneva, Switzerland). Easypod is an electromechanical device for subcutaneous injection of medicinal products, and is marketed for both adult and pediatric self-administration of growth hormone.

Vicks Forehead thermometer, manufactured and submitted by Kaz Inc. (New York, NY). The Vicks Forehead thermometer is a noninvasive infrared thermometer for children and adults. It takes accurate readings by sweeping the probe across the temple. The product features a large color-changing display, backlight, and memory tracking.

Radiological and electromechanical devices

Halo³⁶⁰ esophageal tissue ablation system, manufactured by BÂRRX Medical Inc. (Sunnyvale, CA). Entry submitted by Stellartech Research Corp. (Sunnyvale, CA). The Halo³⁶⁰ system is an esophageal tissue ablation device comprising a radio-frequency generator, sizing balloon, and ablation catheter. It removes precancerous esophageal epithelium in a short, well-tolerated endoscopic procedure.

LandmarX Element endoscopic image guidance system, manufactured by Medtronic Navigation (Louisville, CO). Entry submitted by Medtronic ENT (Jacksonville, FL). The LandmarX Element endoscopic image guidance system is designed for use in functional endoscopic sinus surgery. The system provides an automated software flow and navigation instruments with rotating arrays.

RT Vue retinal imaging system, manufactured by Optovue Inc. (Fremont, CA). Entry submitted by Whipsaw Inc. (San Jose, CA). RT Vue is a diagnostic tool for creating highly detailed images and measurements of the retina, retinal nerve fiber layer, and optic disk. It is used by ophthalmologists to diagnose and manage retinal diseases such as glaucoma and diabetic retinopathy.

Rehabilitation and assistive-technology products

Ness L300 leg neuroprosthesis, manufactured by Ness Ltd. (Ra'anana, Israel). Entry submitted by Bioness Inc. (Santa Clarita, CA). The Ness L300 is a noninvasive neuroprosthesis that delivers electrical stimulation to nerves and muscles in the leg, improving gait in those suffering from foot drop associated with central nervous system injury or disease.

Pilot Walker enhanced mobility aid, manufactured by Full Life Products LLC (Moorestown, NJ). Entry submitted by Definitive Design (Langhorne, PA). The Pilot Walker is an enhanced mobility aid designed and engineered to meet the needs of patients with special mobility challenges.

Proprio Foot motor-powered prosthesis, manufactured and submitted by Ossur (Reykjavik, Iceland). The Proprio foot is the first artificially intelligent, motor-powered prosthetic foot. Suited for below-knee amputees, it offers physiological benefits such as automatic ankle flexion that are as close as current prosthetics can get to the human foot.

Xtensor upper extremity therapy device, manufactured and submitted by Clinically Fit Inc. (Melville, NY). The Xtensor is a portable therapeutic conditioning device for correcting upper extremity disorders. It fully stimulates the extensor muscles, tendons, and finger joints, improving range of joint motion and reducing hand stiffness due to arthritis.

Surgical equipment, instruments, and supplies

Mammotome MR breast biopsy system, manufactured and submitted by Ethicon Endo-Surgery (Blue Ash, OH). The Mammotome MR breast biopsy system is a vacuum-assisted breast biopsy system specifically designed for use under magnetic resonance imaging guidance.

NexFrame deep-brain trajectory guidance system, manufactured and submitted by Image Guided Neurologics (Melbourne, FL). The NexFrame is a skull-mounted trajectory guide used to implant electrical leads for deep-brain stimulation. It is a single-use device delivered to the customer prepackaged and EtO sterilized.

Pascal photocoagulator, manufactured and submitted by OptiMedica (Santa Clara, CA). The Pascal photocoagulator is an integrated semiautomatic pattern-scan laser photocoagulation system designed to treat retinal diseases using a single shot or a predetermined pattern array of up to 56 spots within 0.6 second.

Stryker Precision Saw, manufactured and submitted by Stryker Instruments (Kalamazoo, MI). The Stryker Precision Saw is an oscillating-tip surgical saw for cutting bone, typically in total-knee arthroplasty. The design permits the surgeon to hold the stationary component of the blade, resulting in unprecedented control and precision.

Prepare Now for the 2008 MDEA Competition

For information about entering the 2008 MDEA competition, medtech manufacturers and suppliers should visit the MDEA Web site at www.MDEAwards.com.

All products to be entered in the 2008 MDEA competition must be commercially available—able to be ordered or purchased—by December 31, 2007.

For the 2008 competition, the early-bird entry deadline is November 12, 2007, and the standard deadline is December 17, 2007.

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