Medical Device and Diagnostic Industry (MD+DI) announced the finalists in the 2012 Medical Design Excellence Awards (MDEA) competition in its April print issue. The award ceremony, which will take place on May 23, will also honor Thomas Fogarty with the 2012 MDEA Lifetime Achievement Award. Holding 150 patents on surgical instruments, Fogarty invented the Aneurx stent graft, now a Medtronic-branded product. He has also published roughly 180 scientific articles and textbook chapters on topics of general and cardiovascular surgery. The lifetime achievement award will be presented by Dean Kamen, an inventor, entrepreneur, and advocate for science and technology.
MDEA is the premier awards program for the medical technology community. It recognizes the achievements of medical device manufacturers, their suppliers, and the many people behind the scenes--engineers, scientists, designers, and clinicians--who are responsible for the groundbreaking innovations that are changing the face of healthcare. MDEA-finalist and winning entries excel in the areas of product innovation, design and engineering achievement, end-user benefit, and cost-effectiveness in manufacturing and healthcare delivery.
A comprehensive review of the entries was performed by an impartial, multidisciplinary panel of third-party jurors with expertise in biomedical engineering, clinical practice, diagnostics, human factors, industrial design, manufacturing, and medicine. The 2012 MDEA Jury selected 41 finalists in 10 medical product categories. The finalist products and manufacturers (alphabetical by cateory) are:
CRITICAL-CARE AND EMERGENCY MEDICINE PRODUCTS
- CARDIOHELP System for circulatory and pulmonary support. Manufactured by MAQUET Medical Systems USA (Wayne, NJ). Entry submitted by WCG (New York, NY).
- endOclear wiper device for the cleaning and visualization of endotracheal tubes. Manufactured by EndOclear LLC (San Ramon, CA). Entry submitted by Innovative Design LLC (Danvill, CA).
- The Freedom portable driver. Manufactured and submitted by SynCardia Systems Inc. (Tucson, AZ).
- King Vision video laryngoscope. Manufactured and submitted by King Systems (Noblesville, IN).
- LS-1 "suitcase" intensive care unit. Manufactured and submitted by Integrated Medical Systems Inc. (Signal Hill, CA).
- ProSim 4 Vital Signs Simulator. Manufactured and submitted by Fluke Biomedical (Everett, WA).
DENTAL INSTRUMENTS, EQUIPMENT, AND SUPPLIES
- 3-D Click Guide kit for dental implants. Manufactured and submitted by Idondivi Inc. LLC (San Francisco, CA).
- Elevance Dental Chair with Cantilever Forward design. Manufactured by Midmark Corp. (Versailles, OH). Entry submitted by Design Central Inc. (Columbus, OH).
- Identafi Oral Cancer Screening Device. Manufactured by DentalEZ Inc. (Malvern, PA). Entry submitted by M3 Design (Round Rock, TX).
- Waterlase iPlus All Tissue Laser. Manufactured and submitted by Biolase Technology Inc. (Irvine, CA).
- Scotchbond Universal Adhesive dropper vial. Manufactured and submitted by 3M Deutschland GmbH, 3M ESPE Division (Seefeld, Germany).
GENERAL HOSPITAL DEVICES AND THERAPEUTIC PRODUCTS
- Combitide Starhaler for asthma and COPD. Manufactured by Sun Pharmaceutical Industries Ltd. (Mumbai, India). Entry submitted by Cambridge Consultants Ltd. (Cambridge, United Kingdom).
- Edelvaiss Multiline paradigm-shifting manifold and I.V. line. Manufactured and submitted by Doran International (Toussieu, France).
- Safepole I.V. pole. Manufactured by SafePole LLC (Los Angeles, CA). Entry submitted by TEAMS Design (Chicago, IL).
- TissuGlu Surgical Adhesive. Manufactured and submitted by Cohera Medical Inc. (Pittsburgh, PA).
- TOBI Podhaler dry powder inhaler device with PulmoSphere technology. Manufactured and submitted by Novartis Pharmaceuticals Corp. (San Carlos, CA). TOBI Podhaler is not approved in the USA.
- Vasculaire Compression System. Manufactured and submitted by Venous Health Systems (Portola Valley, CA).
IMPLANT AND TISSUE-REPLACEMENT PRODUCTS
- ConforMIS iTotal CR Knee Replacement System. Manufactured by ConforMIS Inc. (Burlington, MA). Entry submitted by Racepoint Group (Waltham, MA).
- GORE Hybrid Vascular Graft. Manufactured and submitted by W. L. Gore & Associates Inc. (Flagstaff, AZ).
- KAMRA Corneal Inlay. Manufactured and submitted by AcuFocus Inc. (Irvine, CA).
IN VITRO DIAGNOSTICS
- Myla microbiology middleware system. Manufactured and submitted by bioMerieux Inc. (Durham, NC).
- Simplexa Direct and Simplexa Universal Direct assay kits. Manufactured and submitted by Focus Diagnostics (Cypress, CA).
- SnapPath 1000 biomarker testing system. Manufactured by BioMarker Strategies (Baltimore, MD). Entry submitted by HS Design Inc. (Gladstone, NJ).
OVER-THE-COUNTER AND SELF-CARE PRODUCTS
- New prefilled insulin injection pen. Manufactured by Novo Nordisk A/S (Hillerod, Denmark). Entry submitted by ESP Bioscience (Crowthorne, Berkshire, United Kingdom).
- Vibrance Kegel Device. Manufactured and submitted by Bioinfinity (M) Sdn Bhd (Kuala Lumpur, Malaysia).
RADIOLOGICAL AND ELECTROMECHANICAL DEVICES
- BodyTom portable, full body, multi-slice CT scanner. Manufactured and submitted by NeuroLogica Corp. (Danvers, MA).
- Carestream CS 7600 imaging plate system. Manufactured and submitted by Carestream Health Inc. (Rochester, NY).
- DermScope imaging accessory for the iPhone. Manufactured by Canfield Scientific Inc. (Fairfield, NJ). Entry submitted by HS Design Inc. (Gladstone, NJ).
- NOMAD Pro handheld x-ray system. Manufactured by Aribex Inc. (Orem, UT). Entry submitted by IQMS (Paso Robles, CA).
- Planmed Verity extremity scanner. Manufactured and submitted by Planmed Oy (Helsinki, Finland).
REHABILITATION AND ASSISTIVE-TECHNOLOGY PRODUCTS
- BiOM Ankle prosthetic device. Manufactured and submitted by iWalk Inc. (Bedford, MA).
- Breathe NIOV Ventilation System. Manufactured and submitted by Breathe Technologies Inc. (Irvine, CA).
- Neptune sound processor. Manufactured by Advanced Bionics LLC (Vlencia, CA). Entry submitted by Product Creation Studio (Seattle, WA).
- Niagara Foot field-adjustable prosthetic device. Manufactured and submitted by Niagara Prosthetics and Orthotics International Ltd. (Fonthill, ON, Canada).
- RT600 Functional Electrical Stimulation (FES) stepper ergometer featuring SAGE smart stimulation system. Manufactured and submitted by Restorative Therapies Inc. (Baltimore, MD).
- SIM (Smart Incontinence Management). Manufactured and submitted by Simavita Pty. Ltd. (North Sydney, Australia).
SURGICAL EQUIPMENT, INSTRUMENTS, AND SUPPLIES
- The ActiViews CT-Guide navigation system. Manufactured and submitted by ActiViews Inc. (Wakefield, MA).
- Alair Catheter for Bronchial Thermoplasty procedures. Manufactured by Asthmatx (Sunnyvale, CA). Entry submitted by Bridge Design (San Francisco, CA).
- Catalys Precision Laser System. Manufactured and submitted by OptiMedica Corp. (Santa Clara, CA).
- EndoSerter Corneal Endothelial Delivery Instrument. Manufactured by Ocular Systems Inc. (Winston-Salem, NC). Entry submitted by Cathtek (Winston Salem, NC).
- FMwand Ferromagnetic Surgical System. Manufactured and submitted by Domain Surgical (Salt Lake City, UT).
The 2012 MDEA-finalists, and their suppliers, will be honored for their innovative contributions to the medical device industry.
Up to one Bronze, one Silver, and one Gold-winning product will be announced in each category. One Gold-winning product will be awarded "Best-in-Show."