Originally Published MDDI April 2004

Cover Story

The winners of the 2004 Medical Device Excellence Awards represent a broad range of outstanding achievements. From the Algo 3i newborn hearing screener to the Zassi bowel management system, the winners meet the highest standards of design, engineering, and innovation. In our exclusive coverage on the following pages, the 28 winning products are announced for the first time.

Sponsored by MD&DI magazine, these awards are devoted specifically to recognizing innovation and excellence in the design of medical device products. The 2004 winning products and their suppliers are listed below. If a product is highlighted in one of the feature articles that follow, a page reference is provided in place of the product's detailed description.

Following the list of winners, three articles highlight more than half of the winning products, providing extensive details behind the designs. The people behind the products share the stories of how their passion for their concept led to an award-winning design. 

Ideally, products combine both innovation and great design. Innovation and Good Design: A Winning Combination takes a look at how products can achieve this balance. This article examines the design goals, methods, and execution of a few of the winning products.

Innovation is certainly a driving force behind the development of breakthrough devices. This key design element is the focus of Breakthrough Products Could Put Lesser-Known Firms on the Map. A few of the winning products are discussed to illustrate the critical connection between innovation and design excellence.

No matter how innovative, however, if a device isn't easy to use, it is unlikely that it will succeed in the marketplace. As described in Blending Form and Function: Good Design Starts with Usability, usability was noted as a major factor in the winning products. Although defining ease of use is subjective, the products featured in this article represent prime examples of the integration of this core design element.

All three articles provide different but equally important perspectives on how a winning product rises to a level of achievement that merits the coveted Medical Design Excellence Award.

The winners are selected by a panel of experts. A short biography of each juror is provided in Jurors Bring Wide Range of Expertise to MDEA Program.

Gold and Silver designations will be announced at the MDEA presentation on Wednesday, June 16, 2004, during the Medical Design & Manufacturing (MD&M) tradeshow at the Jacob K. Javits Convention Center. The ceremony is open to all show attendees. Winning products will be on display throughout the show.

For a closer look at how ingenuity and creativity make a winning product, just look below.

2004 Winning Products and Suppliers

Critical-Care and Emergency Medicine Products

Audicor cardiograph expansion system, manufactured by Inovise Medical Inc. (Newberg, OR).
Supply and design credit: Sirius Technol-ogy (McMinnville, OR), Andrews-Cooper Technology (McMinnville, OR), Oliver Products Co. (Grand Rapids, MI), and Long Beach Memorial Medical Center (Long Beach, CA).

LifePort kidney transporter, manufactured by Organ Recovery System (Des Plaines, IL). Entry submitted by IDEO (Palo Alto, CA). The LifePort kidney transporter perfuses kidneys with cold physiologic solution to improve organ condition during transport to transplant recipients.
Supply and design credit: IDEO (Palo Alto, CA). 

Dental Instruments, Equipment, and Supplies

BiteStrip disposable bruxism test, manufactured by SLP Ltd. (Tel Aviv, Israel).

PrepMaster disposable air abrasion instrument, manufactured by Groman Inc. (Margate, FL). The PrepMaster is a disposable air abrasion instrument that enables dentists to perform all classes of cavity preparation and therapeutic surface etching, yet has a low unit price that makes disposability feasible.
Supply and design credit: A&G Plastics Inc. (Hialeah Gardens, FL), The R&D Group (Coconut Creek, FL), Lasereliance Inc. (Longwood, FL), K-Tube Corp. (Poway, CA), and Global Thermoforming & Engineering (Miami). 

Finished Packaging

Dermabond topical adhesive ProPen XL, manufactured by Closure Medical Corp. (Raleigh, NC). 
Supply and design credit: GW Plastics Inc. (Bethel, VT). 


General Hospital Devices and Therapeutic Products

Algo 3i newborn hearing screener, manufactured by Natus Medical Inc. (San Carlos, CA). The Algo 3i new-born hearing screener is a portable, handheld device used to screen the hearing of infants between the ages of 34 weeks corrected gestational age and 6 months.
Supply and design credit: Pemstar/Pacific Consultants (San Jose), Seiko Instruments Inc. (San Jose), ACTiSYS (Fremont, CA), Elpac Power Systems (Irvine, CA), GCX Corp. (Suisun City, CA), Worldwide Manufacturing (San Bruno, CA), and SMAC/Bay View Funding (San Francisco).

Avalon CTS cordless fetal transducer system, manufactured by Philips Medizin Systeme GmbH (Boeblingen, Germany). The Avalon CTS cordless fetal transducer system provides for continuous, cordless patient monitoring in the antepartum period and during labor and delivery.
Supply and design credit: Kunststoff Christel GmbH & Co. (Bad Durrheim, Germany), and W. L. Gore & Associates GmbH (Putzbrunn/Munich, Germany). 

Syndeo patient-controlled analgesia syringe pump, manufactured by Baxter Healthcare Corp. (Round Lake, IL). The Syndeo patient-controlled analgesia syringe pump is designed for the safe and precise delivery of analgesic, sedative, and anesthetic solutions in hospital or in alternative medical environments.
Supply and design credit: Herbst LaZar Bell Inc. (Chicago) and Insight Product Development (Chicago). 


System 100 fluid removal system, manufactured by CHF Solutions Inc. (Brooklyn Park, MN).
Supply and design credit: YY Design (New York City), IN Inc. (Los Alamitos, CA), John Smith Medical Device Engineering (Oceanside, CA), MJL Engineering & Manufacturing Inc. (Escondido, CA), Smtek International Inc. (Marlborough, MA), EAD Motors (Dover, NH), Introtek (Edgewood, NY), Integrated Power Design (Wilkes-Barre, PA), Harding Energy (Norton Shores, MI), Genesis Medical Technology (Owings Mills, MD), Sonny Behan Consulting (Duluth, GA), DataKey Electronics Inc. (Minneapolis), TriVirix International Inc. (Belfast, Northern Ireland, UK), Indulgent Technologies (Stow, MA), Donbar Industries (Long Valley, NJ), CarTika Medical (Plymouth, MN), Dunn Industries (Manchester, NH), Grove Engineering (Buskirk, NY), Bunzl Extrusion Massachusetts Inc./Pexco Medical Products (Northborough, MA), Spectrum Laboratories Inc. (Rancho Dominguez, CA), Quality Mold and Design (Londonderry, NH), Merit Medical Systems Inc. (South Jordan, UT), Minnetech (Minneapolis), Pelham Plastics (Pelham, NH), Method Associates Inc. (Keyport, NJ), Venetec International Inc. (San Diego), Colder Products Co. (St. Paul, MN), InterV/Manan Medical Products Inc. (Wheeling, IL), B. Braun Medical (Plymouth, MN), and Halkey-Roberts (St. Petersburg, FL).

Zassi bowel management system, manufactured by Zassi Medical Evolutions Inc. (St. Louis). 
Supply and design credit: Yeungnam University Medical Center (Daegu, South Korea), Yushin Medical Co., Ltd. (Bucheon City, South Korea), Command Medical Products (Ormond Beach, FL), Jamak Fabrication Inc. (Weatherford, TX), Parylene Coating Services (Katy, TX), and Cycles Inc. (Sterling, MA).

Implant and Tissue-Replacement Products

Bion microstimulator, manufactured by Advanced Bionics Corp. (Valencia, CA). 
Supply and design credit: The Alfred Mann Foundation (Valencia, CA), Quallion (Sylmar, CA), and the Al Mann Institute for Biomedical Engineering, USC (Los Angeles). 


In Vitro Diagnostics

CellTracks AutoPrep system, manufactured by Immunicon Corp. (Huntingdon Valley, PA). The CellTracks AutoPrep system is used with immunomagnetic reagents that capture target cells and labeling reagents that differentiate them. The first application is based on isolation and characterization of rare circulating tumor cells.
Supply and design credit: HS Design Inc. (Gladstone, NJ) and Astro Instrumentation LLC (Strongsville, OH). 

Paradigm Link blood glucose meter, developed jointly by BD Medical, Diabetes Care (Franklin Lakes, NJ), Medtronic MiniMed (Northridge, CA), and Nova Biomedical (Waltham, MA), and manufactured for BD Medical, Diabetes Care and Medtronic MiniMed by Nova Biomedical. The Paradigm Link blood glucose meter is the world's first untethered wireless glucose meter that provides bidirectional communication between a glucose meter and insulin pump.
Supply and design credit: Nova Biomedical, Medtronic MiniMed, and Herbst LaZar Bell (Chicago).

ThinPrep imaging system, manufactured by Cytyc Corp. (Boxborough, MA). Entry submitted by Battelle Healthcare Products (Columbus, OH). 
Supply and design credit: Battelle Healthcare Products (Columbus, OH).

VersaTrek automated microbial detection system, manufactured by Trek Diagnostic Systems Inc. (Cleveland). Entry submitted by Plexus Technology Group (Neenah, WI). The VersaTrek automated microbial detection system is a clinical laboratory instrument that combines blood culture, sterile body fluid culturing, mycobacterial detection, and mycobacterium tuberculosis susceptibility testing in a single platform.
Supply and design credit: Plexus Technology Group (Neenah, WI) and Mayville Engineering Co. (Mayville, WI). 

Over-the-Counter and Self-Care Products

HealthWear weight loss system, developed and manufactured by BodyMedia Inc. (Pittsburgh) and marketed by Roche Diagnostics Corp. (Indianapolis). 
Supply and design credit: K Development Inc. (Erie, PA), Millennia Technologies Inc. (Cheswick, PA), Nypro ADC (Elmhurst, IL), and Theron Inc. (Carmel, IN). 

Vicks underarm thermometer, manufactured by Kaz Inc. (New York City). Entry submitted by Smart Design (New York City). The Vicks underarm thermometer accurately and comfortably takes the axillary temperature of children aged 2 to 7 years. It is especially suited for children too old for rectal measurements, yet too young to hold an oral thermometer.
Supply and design credit: Smart Design (New York City). 

Radiological and Electromechanical Devices 

Cardiac CryoAblation Catheter and CryoConsole, manufactured by CryoCath Technologies Inc. (Montreal, QC, Canada). Entry submitted by Morelli Designers (Montreal, QC, Canada). The Cardiac CryoAblation Catheter and CryoConsole system achieves cryotherapeutic temperatures as low as –75ÞC, providing electrophysiologists with a precise, minimally invasive solution for treating cardiac arrythmias.
Supply and design credit: Morelli Designers (Montreal, QC, Canada). 

CT Exprés advanced contrast media delivery system, manufactured by Swiss Medical Care, SA (Lausanne, Switzerland). 
Supply and design credit: Debiotech, SA (Lausanne, Switzerland), LRE Technology Partner GmbH (Nordlingen, Germany), and Medisize (Letterkenny, County Donegal, Ireland). 

Partner Rhythm Assistant, manufactured by Guidant Corp. (Indianapolis). Entry submitted by Worrell Inc. (Eden Prairie, MN). 
Supply and design credit: Worrell Inc. (Eden Prairie, MN). 

Secca fecal incontinence treatment system, manufactured by Curon Medical Inc. (Fremont, CA). 
Supply and design credit: Ambrit Engineering Inc. (Santa Ana, CA), MOS Plastics (San Jose), D & N Precision Inc. (San Jose), Watson-Marlow Pumps (Wilmington, MA), and Innerstep (Fremont, CA). 

Rehabilitation and Assistive-Technology Products

Hand Mentor rehabilitation system, manufactured by Kinetic Muscles Inc. (Tempe, AZ). 
Supply and design credit: Arizona State University (Tempe, AZ). 

Omega T-Ring CAD tool, manufactured by Ohio Willow Wood (Mount Sterling, OH). 

Storm Series TDX5 power wheel-chair, manufactured by Invacare Inc. (Elyria, OH). 

Surgical Equipment, Instruments, and Supplies

Diego powered dissector, manufactured by Gyrus ENT LLC (Bartlett, TN). Entry submitted by IDEO (Palo Alto, CA). Supply and design credit: IDEO (Palo Alto, CA). 

Endoscopic Full-Thickness Plicator, manufactured by NDO Surgical (Mansfield, MA). Entry submitted by Item New Product Development (Providence, RI). The Endoscopic Full-Thickness Plicator is designed to grasp, retract, fold, and fixate tissue near a weakened lower esophageal sphincter as a treatment for gastroesophageal reflux disease.
Supply and design credit: Item New Product Development (Providence, RI), DaTuM 3D (Watertown, MA), Optimum Technologies (Southbridge, MA), and BarenBoym Co. (Framingham, MA). 

Indigo Optima laser system, manufactured by Ethicon Endo-Surgery Inc. (Cincinnati). The Indigo Optima laser system consists of a diode laser and unique diffusing fiber optics to provide office-based, minimally invasive treatment of benign prostatic hyper-
plasia. The system uses a thermotherapy process known as interstitial laser coagulation.
Supply and design credit: Plexus Corp. (Neenah, WI), and Elcan Optical Technologies, a Raytheon Co. (Midland, ON, Canada). 

MicroTargeting Platform System, manufactured by FHC Inc. (Bowdoinham, ME). 
Supply and design credit: StarFix Inc. (Portland, ME), Aerohydro Inc. (Southwest Harbor, ME), Z-Kat Inc. (Hollywood, FL), IVS Solutions AG (Chemnitz, Germany), and Harvest Technologies (Belton, TX).

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