Medical Device Link.

Originally Published MX July/August 2005

MDEA WINNERS

Medtech's premier awards program honors top achievements in medical product development.

Products representing significant advances in medical technology received their due in June at the presentation ceremony for the eighth annual Medical Design Excellence Awards (MDEA) competition.

An independent, multidisciplinary panel of jurors selected 30 products to receive gold and silver awards in the 2005 edition of the MDEA competition. The awards were presented at a ceremony held in conjunction with the Medical Design & Manufacturing East 2005 Conference and Exposition in New York City.

Products are judged according to an intense set of criteria, including product innovation, design and engineering excellence, end-user and patient benefits, and cost-effectiveness in manufacturing and healthcare delivery.

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

For additional information about the MDEA program, including instructions for entering the 2006 competition, visit the awards Web site at www.MDEAwards.com.

By category, gold () and silver () award-winning products and their manufacturers for 2005 are as follows.

Critical-Care and Emergency Medicine Products

Bill Gregory, director of engineering at GMP Wireless Medicine (Fort Lauderdale, FL), stands with the display of the company's MDEA-winning LifeSync wireless ECG system. The LifeSync entry was submitted by Design Continuum (West Newton, MA), and was presented a silver award in the category of critical-care and emergency medicine products. (click to enlarge)

EZ-IO intraosseous delivery device, manufactured by VidaCare Corp. (San Antonio, TX). EZ-IO is a powered intraosseous delivery device, used for delivering fluid resuscitation and administering medication when standard vein access cannot be readily achieved.

Lifeline (aka Reviver) automated external defibrillator, manufactured by Defibtech (Guilford, CT). The Lifeline automated external defibrillator is a self-contained defibrillator with voice prompting and intuitive user interface. Its real-world functionality enables both medical professionals and lay responders to provide lifesaving defibrillation.

LifeSync wireless ECG system, manufactured by GMP Wireless Medicine Inc. (Fort Lauderdale, FL). The LifeSync wireless ECG system is an electrocardiogram monitoring system that eliminates lead wires and trunk cables between patients and bedside 12-lead or transport ECG monitors, allowing freedom of movement throughout the hospital.

Dental Instruments, Equipment, and Supplies

OptraGate, manufactured by SFS intec AG (Altstatten, Switzerland). OptraGate enables dental professionals to easily and effectively enlarge the treatment field for dental and other oral procedures. The product is latex-free and flexible to improve patient comfort. Supply and design credit to Ivoclar Vivadent.

Waterlase MD dental therapy laser, manufactured by BioLase Technology Inc. (San Clemente, CA). Waterlase MD employs advanced dental laser technology for effective, highly precise, and safe treatment of hard and soft dental tissues with no pain, no need for anesthesia, no bleeding, and fast recovery time.

Finished Packaging

Posing with a display of the 2005 MDEA-winning 3M Foam adhesive dressing (from left): David Holm, product development specialist at 3M Co. (St. Paul, MN), with partners from Loparex (Willowbrook, IL) Peter Fernstrum, account manager, and Christopher E. Fisher, market manager. 3M Foam adhesive dressing won a silver award in the category of general hospital devices and therapeutic products. (click to enlarge)

RelyX Luting Plus cement, manufactured by 3M ESPE Dental Product Development Specialist (St. Paul, MN). RelyX Luting Plus cement in the clicker dispenser is a fluoride-releasing dental cement used by dentists to permanently affix crowns and bridges. The clicker dispenser ensures a precise 1:1 volume ratio of the two-part cement.

General Hospital Devices and Therapeutic Products

3M Foam adhesive dressing, manufactured by 3M Co. (St. Paul, MN). 3M Foam adhesive dressing is a bordered, highly absorbent foam dressing for treating moderate to highly exuding partial- to full-thickness dermal wounds such as pressure ulcers, neuropathic ulcers, abrasions, and first- and second-degree burns.

ALYX component collection system, manufactured by Baxter Healthcare Corp. (Round Lake, IL). ALYX is a portable automated system that rapidly collects and processes two transfusion doses of red blood cells, separating out the red cells on the spot and returning unneeded components to the donor with saline, thereby reducing donor side effects.

EnteraLite Infinity enteral feeding system, manufactured by Zevex Inc. (Salt Lake City). EnteraLite Infinity allows tube-fed patients to be physically active, without being held back by their feeding pump. Designed for hospital and alternate-care use, the device offers simplicity, accuracy, and portability that promote physical activity.

Mark Vandlik of Baxter Healthcare Corp. (Round Lake, IL) poses with the MDEA-winning ALYX component collection system in the company's booth at the Medical Design & Manufacturing East exposition. The ALYX system was presented a gold award in the category of general hospital devices and therapeutic products. (click to enlarge)

F.A.S.T. (Facilitated Aspiration/Suction Thrombectomy), manufactured by Genesis Medical Interventional Inc. (Redwood City, CA). F.A.S.T. employs a funnel catheter and suction to remove blood clots from the access grafts of dialysis patients, reducing the possibility that clots might move where they could cause death.

The Lighted Ear Curette, manufactured by Bionix Development Corp. (Toledo, OH). The Lighted Ear Curette combines a bright white light-emitting diode (LED) with a clear plastic ear curette, enabling physicians to perform cerumen removal safely under direct visualization in what had previously been considered a blind procedure.

Vital Heat body temperature regulator, manufactured by Dynatherm Medical Inc. (Burlingame, CA). Vital Heat employs a slight vacuum and circulating hot water to restore and regulate a patient's core body temperature during and after surgery. The device provides a simple and intuitive user interface, thereby reducing the risk of user error.

Implant and Tissue-Replacement Products

Axxess neurostimulation leads, manufactured by Advanced Neuromodulation Systems (Plano, TX). Axxess trial and permanent leads are the world's smallest-diameter neurostimulation leads. Their small size and unibody design provide surgeons with better control and more placement options, resulting in less-invasive insertion.

In Vitro Diagnostics

Posing with 2005 MDEA jury chair Michael E. Wiklund (front row, right) is the product development team for the gold-award-winning Lighted Ear Curette by Bionix Development Corp. (Toledo, OH). Front row (from left): Susan Brangham, product development coordinator; Jamie Schlorff, product development engineer; Jim Huttner, MD, PhD, medical director and vice president, new product development. Back row (from left): Ed Markewitz, product development engineer; Andrew Milligan, PhD, president and CEO; and Josh Noble, product development engineer. (click to enlarge)

Alegria multisample random-access ELISA analyzer, manufactured by Orgentec Diagnostika GmbH (Mainz, Germany). The Alegria is a multisample random-access ELISA analyzer developed for processing SMC-Technology-based test strips as an aid in the diagnosis of autoimmune diseases. The Alegria is intended for in vitro diagnostic use only.

GeneChip Scanner 3000 with autoloader, manufactured by Affymetrix Inc. (Santa Clara, CA). The GeneChip Scanner 3000 is a desktop device that provides genetics researchers with sensitive, high-resolution, state-of-the-art scanning of GeneChip brand microarrays used for complex genetic analysis.

Niox Mino, handheld FENO analyzer, manufactured by Aerocrine AB (Solna, Sweden). Niox Mino is a handheld device for measuring exhaled nitric oxide (NO), a marker of airway inflammation. This non-invasive method makes it easier to diagnose asthma and measure response to treatment, and can give early warning of loss of asthma control.

Over-the-Counter and Self-Care Products

ConfiDose disposable auto-injector, manufactured by PharmaPen Inc. (Athens, TX). ConfiDose is a disposable autoinjector that can inject a drug without the recipient ever seeing a needle; insertion, delivery, and withdrawal are completed with a push of a button. The needle retracts fully, thus averting the risk of needle stick injury.

Humatrope reconstitution device, manufactured by Eli Lilly and Co., Pharmaceutical Delivery Systems (Indianapolis). The Humatrope reconstitution device is used to mix a diluent (liquid) with a human growth hormone powder. The subsequent solution is used for injection. This Humatrope device makes the reconstitution process significantly easier.

Vicks Baby Thermometer, manufactured by Kaz Inc. (New York City). The Vicks Baby Thermometer is designed for safer and easier rectal temperature measurement of babies. Its compact, ergonomic design is easy to hold and control, while the large display makes viewing easy. The short probe helps guard against over-insertion.

Radiological and Electromechanical Devices

At the presentation ceremony for the 2005 Medical Design Excellence Awards (from left): MDEA juror Eliot Lazar, president of elCon Medical (Buffalo, NY), with Patty Lebner and Michael Lebner, president of Clozex Medical (Wellesley, MA), whose ClozeX wound-closure device won a silver award in the category of surgical equipment, instruments, and supplies. (click to enlarge)

Intelect Advanced and Mobile Electrotherapy range, manufactured by Chattanooga Group (Hixson, TN). The Intelect Advanced and Mobile ranges are fully integrated suites of clinical electrotherapy equipment used to administer a comprehensive range of physiotherapy treatments.

Somatom Sensation 64 computed tomography system, manufactured by Siemens Medical Solutions (Malvern, PA). The Somatom Sensation 64 is the world's fastest 64-slice computed tomography system. It offers the fastest gantry rotation time (0.33 seconds) and delivers optimal image quality in cardiac, neurology, and body-imaging applications.

Z-View aberrometer, manufactured by Ophthonix Inc. (San Diego). The Z-View aberrometer offers comprehensive and accurate diagnosis of optical imperfections. Lenses created using a Z-View-generated prescription provide high-definition corrective vision non-surgically with improved clarity, crispness, and acuity.

Rehabilitation and Assistive-Technology Products

Representatives of the patient division of Haemonetics Corp. (Braintree, MA) pose with 2005 MDEA jury chair Michael E. Wiklund (right) after receiving a gold award in the category of surgical equipment, instruments, and supplies for the company's cardioPAT perioperative autotransfusion system. From left: Kevin Molloy, manager, new platform development; Douglas Dione, lead electrical engineer; Phillip Dolliver, project manager, cardioPAT; Philip Goyette, mechanical engineer. (click to enlarge)

Motiva interactive healthcare platform, manufactured by Philips Medical Systems (Milpitas, CA). Motiva is a healthcare information and monitoring system for people with chronic diseases. It uses clinical software, vital-sign measurement devices, and a personalized interactive TV program (in the home) to connect patients to their caregivers.

Sage oxygen therapeutic device, manufactured by Chad Therapeutics (Chatsworth, CA). The Sage oxygen therapeutic device is a pulsed oxygen delivery device that incorporates a motion sensor, software algorithms, and integrated memory to recognize and deliver according to a patient's oxygen needs based on activity level.

Savia 211 dSZ hearing system, manufactured by Phonak AG (Stäfa, Switzerland). The Savia 211 dSZ is a hearing instrument intended for persons experiencing hearing loss (approximately 10% of the Western population and 28 million in the United States alone). One Savia device is worn on each ear to improve hearing.

Surgical Equipment, Instruments, and Supplies

cardioPAT perioperative autotransfusion system, manufactured by Haemonetics Corp. (Braintree, MA). The cardioPAT is a perioperative autotransfusion system that salvages red blood cells lost intra- and postoperatively during cardiovascular surgical procedures in which the expected rate of processing salvaged fluids is no more than 2 L/hr.

Principal engineer Tony Pantages and his wife, Suzanne, pose with the MDEA trophy presented for the StarClose vascular closure system by Abbott Vascular Devices (Redwood City, CA). The StarClose system won a silver award in the category of surgical equipment, instruments, and supplies. (click to enlarge)

Cassi Rotational core biopsy device, manufactured by Sanarus Medical Inc. (Pleasanton, CA). The Cassi device is an automated large-core biopsy device used in the diagnosis of breast disease. Cassi's patented Stick-Freeze technology is used to immobilize the target tissue, making it unnecessary to purchase capital equipment.

ClozeX wound-closure device, manufactured by Clozex Medical LLC (Wellesley Hills, MA). ClozeX is a coaptive wound-closure device that replaces sutures, staples, and glues, providing dramatic improvements in speed, precision, cosmesis, comfort, and cost-effectiveness.

Insorb 20 subcuticular skin stapler, manufactured by Incisive Surgical Inc. (Plymouth, MN). The Insorb 20 subcuticular skin stapler is a patented absorbable skin-closure product that combines the cosmetic result of an absorbable suture with the rapid closure time of metal skin staplers, eliminating the need for postoperative staple removal.

StarClose vascular closure system, manufactured by Abbott Vascular Devices (Redwood City, CA). The StarClose vascular closure system delivers a nitinol clip to close femoral artery puncture sites following percutaneous catheterization procedures.

Copyright ©2005 MX