2014 BEST-IN-SHOW WINNER: AtomoRapid HIV (1&2) integrated rapid antibody test. 54 finalists—33 Winners—11 Gold—1 Best-In-Show. The Best-In-Show Award honors the most innovative product submission. The Winner embodies the principles of the MDEA program by excelling in areas of design and engineering excellence; manufacturing and technological innovation; clinical efficacy; cost-effectiveness; as well as overall benefits to patients, end-users, and the healthcare industry. The AtomoRapid HIV tester hits all elements of an outstanding product and is earth-shaking in its potential significant impact on 3rd world detection of infectious disease, global public health, and individual healthcare. Manufactured and submitted by Atomo Diagnostics Pty Ltd. (Sydney, Australia). Supply and design credit to IDE Group Inc.(Newington, Australia).
Critical-Care and Emergency Medicine Products
1. GOLD WINNER: Hemolung RAS extracorporeal carbon dioxide removal system, manufactured and submitted by ALung Technologies Inc (Pittsburgh, PA). Hemolung RAS provides respiratory dialysis, a simple, minimally-invasive form of extracorporeal carbon dioxide removal (ECCO₂R) that acts as an alternative or supplement to mechanical ventilation in cases of acute respiratory failure.
2. SILVER WINNER: ARKON anesthesia delivery system, manufactured by Spacelabs Healthcare (Snoqualmie, WA). ARKON allows anesthesiologists to keep their patients in full view while simultaneously controlling and monitoring gas delivery using their preferred workflow. Entry submitted by and supply and design credit to Design Concepts Inc. (Madison, WI).
3. BRONZE WINNER: Isolibrium critical-care air support surface, manufactured and submitted by Stryker Medical (Portage, MI). Isolibrium aims to provide tools for nurses to care for patients while its advanced pressure redistribution systems helps prevent pressure ulcers in patients. Supply and design credit to Humphrey Products company (Kalamazoo, MI), Grand Rapids Foam Technologies (Grand Rapids, MI), Les Produits Plastitel Inc. (Laval, Quebec, Canada), Twisthink (Holland, MI), and Derby (South Bend, IN).
4. FINALIST: RP-VITA remote presence telemedicine robot, manufactured and submitted by InTouch Health Inc. (Santa Barbara, CA). RP-VITA enables increased access to specialist care through high-acuity telemedicine consults. It eliminates the need for telemedicine-specific staffing. RP-VITA’s intuitive, easy-to-use, and safety features encourage physician adoption and clinical use. Supply and design credit to iRobot (Bedford, MA).
4. FINALIST: TrueCPR coaching device, manufactured and submitted by Physio-Control (Redmond, WA). TrueCPR helps improve CPR performance by giving rescuers real-time feedback on the quality of chest compressions in accordance with current guidelines. It also provides instant post-event review, allowing rescue teams to debrief more efficiently. Supply and design credit to Plexus (Neenah, WI).
Dental Instruments, Equipment, and Supplies
1. GOLD WINNER: Solea CO2 dental laser system for hard and soft tissue, manufactured by Convergent Dental Inc. (Natick, MA). Entry submitted by HERNETICS (Chelsea, MA). At 9.3 μm, Solea is the first CO₂ laser system ever cleared by the FDA for hard and soft tissue ablation. Solea is fast, precise, virtually noiseless, and anesthesia-free for the vast majority of procedures. Supply and design credit to HERNETICS (Chelsea, MA), Tischler Resources (Acton, MA), and Sachem Engineering, R&D (Arlington, MA).
2. SILVER WINNER: Digit Power dispenser for Aquasil Ultra Cordless tissue managing impression system, manufactured and submitted by Dentsply International, LD Caulk Division (Milford, DE). The Digit Power dispenser enables dentists to precisely place Aquasil Ultra Cordless impression material directly into the sulcus. This system minimizes work time violiations and the use of retraction cord while providing significant time savings. Supply and design credit to Nordson EFD LLC (East Providence, RI), and Key Tech (Baltimore, MD).
3. BRONZE WINNER: Bluephase Style curing light featuring Polywave LED, manufactured and submitted by Ivoclar Vivadent AG (Schaan, Liechtenstein). Bluephase Style is a cordless high-performance LED curing light that polymerizes all light-curing dental materials. Its ergonomic and compact design enables it to fit comfortably into the user’s hand. Supply and design credit to Rigami Design (Diepoldsau, Switzerland).
4. FINALIST: Zoom! Teeth Whitening System, manufactured by Discus Dental Philips Oral Healthcare (Culver City, CA). Entry submitted by DeviceLab Inc. (Tustin, CA). Zoom! will change teeth color up to eight shades within 45 minutes. It has settings to avoid unpleasant feelings during and after the process. Supply and design credit to DeviceLab Inc. (Tustin, CA), and Solid Concepts (Valencia, CA).
Drug-Delivery Devices and Combination Products
1. GOLD WINNER: PROPEL and PROPEL mini mometasone furoate implants, manufactured and submitted by Intersect ENT (Menlo Park, CA). PROPEL and PROPEL mini dissolvable steroid-releasing implants reduce the need for additional surgical procedures and for oral steroids, which can have serious side effects, for patients suffering from chronic sinusitis.
2. SILVER WINNER: DebioJect intradermal drug delivery device, manufactured and submitted by Debiotech SA (Lausanne, Switzerland). The DebioJect was conceived to overcome the problems encountered with classical intradermal delivery techniques. The innovative microneedle allows both pain-free and precise injection of up to 500 μL in a few seconds. Supply and design credit to CEA-LETI (Grenoble, France), Mecaplast SA (Botterens, Switzerland), and the Royal Institute of Technology (KTH) (Stockholm, Sweden).
3. BRONZE WINNER: Auvi-Q epinephrine auto-injector, manufactured by Sanofi (Bridgewater, NJ). Entry submitted by Kaléo Pharma (Richmond, VA). Auvi-Q is a single-use epinephrine autoinjector used to treat life-threatening allergic reactions (anaphylaxis). It is the size and shape of a credit card, the thickness of a cell phone, and includes a unique voice instruction system. Supply and design credit to Kaléo Pharma (Richmond, VA), and Medivative Technologies (Indianapolis, IN).
4. FINALIST: FOX Handheld Nebulizer, manufactured by and submitted by Vectura GmbH (Germany). The FOX inhaler is a fast and efficient handheld nebulizer for treatment of respiratory diseases. Its breathing control enables highly accurate drug delivery to the small airways, ensuring optimal therapeutic results of the inhaled liquid medications. Supply and design credit to Ian Mahaffy Industrial Design Ltd. (London, UK).
4. FINALIST: MedCenter pharmacy kiosk, manufactured and submitted by MedAvail Technologies Inc. (Mississauga, Canada). The MedAvail MedCenter enables a remote pharmacist in a call center to provide confidential, real-time professional advice and verify the automated dispense of prescription medications to patients at the kiosk. Supply and design credit to Squint Innovation & Branding Inc. (Toronto, Canada).
General Hospital Devices and Therapeutic Products
1. GOLD WINNER: LuViva Advanced Cervical Scan point-of-care, non-invasive cervical disease detection device, manufactured by Guided Therapeutics Inc. (Norcross, GA). Entry submitted by Big Bang (Decatur, GA). LuViva is a test for early detection of disease that leads to cervical cancer. It does not require a tissue sample. The test provides an immediate and objective result at the point of care, reducing false-positive and false-negative results. Supply and design credit to Big Bang (Decatur, GA), Seaway Plastics Engineering (Port Richie, FL), Gupta Permold Corp. (Pittsburgh, PA), and Herman Miller Inc. (Zeeland, MI).
2. SILVER WINNER: MetaNeb system, manufactured and submitted by Hill-Rom Services Pte. Ltd. (Singapore). MetaNeb is indicated for mobilization of secretions, lung expansion therapy, and treatment and prevention of pulmonary atelectasis. It can also provide supplemental oxygen when used with compressed oxygen.
3. BRONZE WINNER: MuV patient transfer system, manufactured by CEGA Innovations LLC (Sioux Falls, SD). The MuV system is lightweight and ergonomically designed to reduce patient stress and the physical toll on hospital workers during patient transfer, reducing workplace injuries and increasing efficiencies and reimbursement criteria. Entry submitted by and supply and design credit to Kablooe Design (Blaine, MN).
4. FINALIST: IsoGel AIR therapeutic support surface, manufactured and submitted by Stryker Medical (Portage, MI). IsoGel AIR assists in managing pressure, shear, and microclimate through its unique cover and open-column design those results in low air loss through its proprietary gel. Supply and design credit to Hilco Technologies (Grand Rapids, MI), Dartex Coatings Ltd. (Acton Close Nottingham, Nottingham, UK), and Tridien Medical (Corona, CA).
4. FINALIST: RENASYS Soft Port, manufactured and submitted by Smith & Nephew Inc. (St. Petersburg, FL). RENASYS Soft Port offers patient comfort and increased placement versatility (for difficult wound locations), and functions when folded or kinked. Due to the soft construction, the risk of pressure sores may be reduced. Supply and design credit to Ximedica (Providence, RI).
4. FINALIST: SmartSite VialShield closed-vial access device, manufactured and submitted by Yukon Medical LLC (Research Triangle Park, NC). The SmartSite VialShield is a needle-free closed system transfer device that protects clinicians from exposure to hazardous drugs during drug preparation and administration. The product is designed to optimize safety, simplify care and minimize costs. Supply and design credit to Gilero Biomedical (Research Triangle Park, NC), and Industrie BORLA S.p.A. (Moncalieri, Torino, Italy).
Implant and Tissue-Replacement Products
1. GOLD WINNER: GUIDE DBS programming planning and visualization system for deep brain stimulation (DBS), manufactured and submitted by Boston Scientific Corp. (Natick, MA). GUIDE DBS is a software program that creates a 3-D image of a patient’s deep brain anatomy and the relative location of the implanted lead. A model of the volume of activated tissue allows the clinician to intelligently optimize stimulation parameters.
2. SILVER WINNER: Eclipse soft tissue anchor, manufactured and submitted by MedShape Inc. (Atlanta, GA). The Eclipse offers an innovative, nonrotational approach for reattaching soft tissue to bone. It features an expandable sheath-and-bullet design that preserves tissue orientation while reducing surgical complexity and increasing confidence in the repair. Supply and design credit to Enginuity Works (Atlanta, GA), and Creature LLC (Atlanta, GA).
3. BRONZE WINNER: Codacs direct acoustic cochlear implant system, manufactured and submitted by Cochlear Ltd. (Sydney, Australia). The Codacs system meets an unmet patient need by mechanically stimulating the cochlea, bypassing the impaired middle and outer ear of people with severe to profound mixed hearing loss. Supply and design credit to Helbling Technik (Liebefeld, Switzerland).
4. FINALIST: Compressyn Band implant for sternal closure with Compressyn Band Tensioner, manufactured and submitted by Dallen Medical Inc. (San Clemente, CA). The Compressyn Band is intended for use in stabilization and fixation of anterior chest-wall fractures including sternal fixation. This knotless cerclage device uses a spring to supply dynamic compression to aid in bone healing. Supply credit to Velco Tool & Die (Lake Forest, CA).
4. FINALIST: Persona, the Personalized Knee System, manufactured and submitted by Zimmer Inc. (Warsaw, IN). Patient expectations of total knee replacement are increasing. The Persona Knee System was designed to minimize the compromises required with standard knee systems. The system supports unparalleled levels of personalization, empowering surgeons to restore the unique identity of every knee.
In Vitro Diagnostic Products and Systems
1. GOLD WINNER: AtomoRapid HIV (1&2) integrated rapid antibody test, manufactured and submitted by Atomo Diagnostics Pty Ltd. (Sydney, Australia). AtomoRapid HIV is the first integrated rapid test for detection of HIV 1&2 using blood. It replaces the need for existing test kits with multiple items that are complicated to use, thus reducing the inherent error rates found when using kits in the field. Supply and design credit to IDE Group Inc.(Newington, Australia).
2. SILVER WINNER: NIOX VERO airway inflammation monitor, manufactured by Aerocrine AB (Solna, Sweden). Entry submitted by Veryday (Bromma, Sweden). NIOX VERO enables clinical monitoring of airway inflammation and plays a critical role in the efficiency of diagnosis, treatment, and follow-up of patients with inflammatory airway diseases, such as asthma. Supply and design credit to Veryday (Bromma, Sweden), Panasonic Healthcare Co. Ltd (Tokyo, Japan), and IT Dr. Gambert GmbH Wismar (Wismar, Germany).
3. BRONZE WINNER: HYBRiD-XL fully automated continuous access analyzer, manufactured by DRG Diagnostics GmbH (Marburg, Germany). The DRG:HYBRiD-XL allows, for the first time, simultaneous measurement of immunoassays and clinical chemistry parameters including turbidimetric tests in one sample. Entry submitted by and supply and design credit to BIT Group (San Diego, CA).
MDDIonline.com Readers Choice Award
2014 READERS CHOICE WINNER: Persona, the Personalized Knee System, The entire community of MD+DI readers weigh in on their choice for the top MDEA finalist product. More than 4,300 readers voted...and the 2014 winner was Persona. Patient expectations of total knee replacement are increasing. The Persona Knee System was designed to minimize the compromises required with standard knee systems. The system supports unparalleled levels of personalization, empowering surgeons to restore the unique identity of every knee. Manufactured and submitted by Zimmer Inc. (Warsaw, IN).
Medical Product Packaging, Graphic Instructions, and Labeling Systems
1. GOLD WINNER: SoTube SoSafe double-sterile barrier packaging, manufactured and submitted by Selenium Medical (La Rochelle, France). SoTube/SoSafe are two innovative solutions, nested tubes based, for implants double-sterile barrier packaging. They ensure nurses and surgeons easy handling of package and implant as well as a pioneer “No Touch” approach right up to the point of surgery.
2. SILVER WINNER: Safe Label System (SLS) enterprise-wide electronic medication preparation safety system, manufactured and submitted by Codonics Inc. (Middleburg Heights, OH). SLS is an on-demand medication preparation-specific system that replicates pharmacy oversight at the point of care. It ensures TJC compliance with best practices and standards to improve patient safety, workflow efficiency, accuracy, and reduce drug errors. Supply and design credit to SIMS Lab and Partner’s Healthcare at Massachusetts General Hospital (Boston, MA).
3. BRONZE WINNER: DISK (Dispenser Integrated System Kit), manufactured and submitted by CleanCut Technologies LLC (Anaheim, CA). DISK is thermally bonded to an HDPE backer card and is intended to provide medical device product retention and protection during packaging, handling, sterilization, shipping, and use in medical environments.
4. FINALIST: ePAK Single-Use Delivery System featuring DVR Crosslock distal radius plating system, manufactured and submitted by Biomet Orthopaedics Inc. (Miami, FL). ePAK is a sterile, single-use delivery system designed to treat distal radius fractures. ePAK is always stocked and ready for every surgery, minimizing surgical delays because all components are new and fresh for every surgery.
4. FINALIST: IMS Signature Series cassettes, manufactured and submitted by Hu-Friedy Mfg. Co. LLC (Chicago, IL). Patent pending IMS stainless steel cassettes feature silicone rails to hold dental instruments in place from chairside through reprocessing. An open hole pattern and rail design facilitates cleaning and sterilization. Cassettes standardize procedures for increased safety and efficiency. Supply and design credit to Design Integrity (Chicago, IL).
Over-The-Counter and Self-Care Products
1. GOLD WINNER: AEROBIKA oscillating positive expiratory pressure therapy system, manufactured and submitted by Trudell Medical International (London, Canada). The AEROBIKA oscillating PEP device helps loosen and remove mucus build-up in the lungs. On exhalation, positive pressure holds the airways open, while oscillations thin and loosen mucus helping move it to the central airways where it can be coughed out. Supply credit to Silcotech (Bolton, Canada), and C&J Industries Inc. (Meadville, PA).
2. SILVER WINNER: Tria Age-Defying Laser handheld dermatological device, manufactured by Tria Beauty Inc. (Dublin, CA).). Tria Age-Defying Laser lets consumers achieve professional anti-aging results at home. The safe, effective skincare device uses fractional laser technology to smooth wrinkles, reduce discoloration, and improve the texture of all skin types. Entry submitted by and supply and design credit to IDEO (Palo Alto, CA).
3. BRONZE WINNER: FreeStyle Optium Neo blood glucose and ketone monitoring system (not available for sale in the United States), manufactured and submitted by Abbott Diabetes Care Inc. (Alameda, CA). FreeStyle Optium Neo guides patients through their diabetes and insulin management. Set up by a healthcare provider, the meter stores, displays, logs, and suggests insulin dose adjustments. It also notifies of high or low blood glucose levels and trends. Supply and design credit to Bridge Design (San Francisco, CA).
4. FINALIST: Tria Hair Removal Precision Laser handheld dermatological device, manufactured by Tria Beauty Inc. (Dublin, CA). Tria Hair Removal Precision Laser is an advanced diode laser used at home by consumers to permanently remove unwanted hair from small, sensitive areas of the body, such as the underarms and bikini line. Entry submitted by and supply and design credit to IDEO (Palo Alto, CA).
Radiological and Electromechanical Devices
1. GOLD WINNER: AIRO Mobile Computed Tomography (CT) System, manufactured and submitted by Mobius Imaging LLC (Ayer, MA). The AIRO Mobile CT integrates advanced imaging technologies into existing medical workflow and provides the clinician with procedural flexibility as well as real-time CT imaging information where and when it is needed. Supply and design credit to Varian Medical Systems (Salt Lake City, UT), Excelitas Technologies (Salem, MA), Hamamatsu Corp. (Bridgewater, NJ), Analog Devices Inc. (Norwood, MA), Rotek Inc. (Aurora, OH), Marlborough Foundry Inc. (Marlborough, MA), and Aved Electronics Inc. (North Billerica, MA).
2. SILVER WINNER: NvisionVLE Imaging System, manufactured by NinePoint Medical (Cambridge, MA). The NvisionVLE Imaging System is the first and only volumetric optical coherence tomography device cleared by FDA for endoscopic imaging and imaging of esophageal tissue microstructure. Entry submitted by and supply and design credit to Farm Design Inc. (Hollis, NH).
3. BRONZE WINNER: LumaGEM Molecular Breast Imaging (MBI) system, manufactured and submitted by Gamma Medica (Salem, NH). LumaGEM is an effective adjunct to standard mammography. It is a patient-friendly and cost-effective tool for detecting early-stage cancers in dense breast tissue. Supply and design credit to Farm Design Inc. (Hollis, NH), and Sunrise Labs (Auburn, NH).
4. FINALIST: Atomlab 960 thyroid uptake system, manufactured by Biodex Medical Systems (Shirley, NY). Atomlab 960 is a multipurpose spectrum analysis instrument for diverse nuclear medicine applications. Uptake studies, wipe tests, and other tasks are accomplished using this fully computer-controlled instrument and comprehensive selection of software. Entry submitted by and supply and design credit to Integrated Design Systems Inc. (Oyster Bay, NY).
4. FINALIST: DRX-Revolution mobile x-ray system, manufactured and submitted by Carestream Health (Rochester, NY). DRX-Revolution helps medical staff generate high-quality digital X-ray images to treat seriously ill patients. A collapsible column allows enhanced visibility and safety, and a long tube head allows for easier exams even in the presence of bedside medical equipment.
Rehabilitation and Assistive-Technology Products
1. GOLD WINNER: Vector Gait and Safety System, manufactured and submitted by Bioness Inc. (Valencia, CA). The Vector Gait and Safety System is a ceiling-mounted robotic technology designed to improve patient mobility and functional independence by tracking movement and offloading a precise amount of body weight during rehabilitation. Supply and design credit to D&K Engineering (San Diego, CA).
2. SILVER WINNER: Carevo shower trolley, manufactured by ArjoHuntleigh Innovation Center (Malmö, Sweden). The Carevo is a modern shower trolley for therapeutic showering and bathing. It offers comfort and dignity to patients during daily hygiene care and enables caregivers to work close to patients, reducing static stress. Entry submitted by and supply and design credit to Veryday (Bromma, Sweden).
3. BRONZE WINNER: Hercules Patient Repositioner, manufactured and submitted by The Morel Company (Batesville, IN). The Hercules allows a single caregiver to safely reposition a patient up in bed in less than ten seconds with the simple push of a button.
4. FINALIST: Aircast AirSelect Elite advanced pneumatic walking boot, manufactured by DJO Global (Vista, CA). The Aircast AirSelect walking boot has an integrated air-cell support system that lets patients customize the fit to maximize comfort and minimize edema. SoftStrike technology absorbs shock, while the lab-tested rocker sole encourages a natural gait. Entry submitted by and supply and design credit to Farm Design Inc. (Hollis, NH).
4. FINALIST: Quantum Securement System, manufactured by Q’Straint (Fort Lauderdale, FL). Entry submitted by Jim Best ID (Hewitt, NJ). The Quantum is a fully automatic, rear-facing wheelchair securement station. It allows wheelchair passengers to board a bus or train and simply push a button to safely secure themselves during transport. Supply and design credit to Jim Best ID (Hewitt, NJ), Input Creative Group (Leonia, NJ), and Lucas Technical Services LLC (Philadelphia, PA).
4. FINALIST: Snug Vest deep pressure therapeutic garment, manufactured and submitted by Squeezease Therapy Inc. (Vancouver, Canada). Snug Vest is a therapeutic garment that inflates to provide a firm hug known as deep-pressure therapy. It regulates the sensory system and relieves anxiety in individuals with autism and sensory disorders. Pressure is adjustable and user-controlled.
Surgical Equipment, Instruments, and Supplies
1. GOLD WINNER: Zip Surgical Skin Closure, manufactured and submitted by ZipLine Medical Inc. (Campbell, CA). Zip is a noninvasive skin closure alternative to sutures and staples for surgery and lacerations, offering time-savings, better cosmesis, lower infection risk, and greater patient comfort. It is easy to apply and patients can remove it at home. Supply and design credit to Innovative Drive LLC (Redwood City, CA)
2. SILVER WINNER: INTUITION Instruments for DePuy ATTUNE Knee System, manufactured by DePuy Synthes, Joint Reconstruction (Leeds, UK). INTUITION instruments combine the surgical process with the implant options to allow surgeons to balance the soft tissue as well as control the implant position and fit for each patient. Entry submitted by and supply and design credit to DePuy Synthes, Joint Reconstruction (Warsaw, IN).
3. BRONZE WINNER: ASSIST Silver low-adherent antimicrobial graft cover dressing, manufactured and submitted by Milliken Healthcare Products LLC (Spartanburg, SC). ASSIST Silver is a graft cover dressing that combines Active Fluid Management technology with a low-adherent layer to provide optimal moisture balance, eliminate the need for additional low-adherent layers, and provide 7-day antimicrobial protection. Supply and design credit to Haywood Vocational Opportunities Inc. (Waynesville, NC).
4. FINALIST: ENSEAL G2 Articulating Tissue Sealers, manufactured and submitted by Ethicon Endo-Surgery Inc. (Cincinnati, OH). ENSEAL G2 Articulating Tissue Sealers are sterile, single-patient-use surgical instruments for coagulating and transecting vessels up to 7mm in diameter, as well as lymphatics. They are the first articulating sealers compatible with a 5mm port.
4. FINALIST: MicroCutter XCHANGE 30 stapler, manufactured and submitted by Cardica Inc. (Redwood City, CA). MicroCutter XCHANGE is the smallest-diameter articulating stapling device available today. At less than half the size of competing models with nearly twice the articulation, surgeons may be able to access anatomy not possible with other staplers.
4. FINALIST: POWEREASE System of spine surgery instruments, manufactured by Medtronic (Memphis, TN). Entry submitted by IDEO (Cambridge, MA). POWEREASE is a system of powered surgical instruments used by OR surgeons to drill, tap, and drive specialized implants during spinal surgeries, including open and minimally invasive procedures, and final construct assembly. Supply and design credit to IDEO (Boston, MA), C&A Tool Engineering Inc. (Churubusco, IN), NGI Cutting Instruments (Warsaw, IN), Tegra Medical (Hernando, MS), and Engineered Medical Systems LLC (Bartlett, TN).
2014 BEST-IN-SHOW WINNER: AtomoRapid HIV (1&2) integrated rapid antibody test. 54 finalists—33 Winners—11 Gold—1 Best-In-Show. The Best-In-Show Award honors the most innovative product submission. The Winner embodies the principles of the MDEA program by excelling in areas of design and engineering excellence; manufacturing and technological innovation; clinical efficacy; cost-effectiveness; as well as overall benefits to patients, end-users, and the healthcare industry. The AtomoRapid HIV tester hits all elements of an outstanding product and is earth-shaking in its potential significant impact on 3rd world detection of infectious disease, global public health, and individual healthcare. Manufactured and submitted by Atomo Diagnostics Pty Ltd. (Sydney, Australia). Supply and design credit to IDE Group Inc.(Newington, Australia).
1. GOLD WINNER: Hemolung RAS extracorporeal carbon dioxide removal system, manufactured and submitted by ALung Technologies Inc (Pittsburgh, PA). Hemolung RAS provides respiratory dialysis, a simple, minimally-invasive form of extracorporeal carbon dioxide removal (ECCO₂R) that acts as an alternative or supplement to mechanical ventilation in cases of acute respiratory failure.
2. SILVER WINNER: ARKON anesthesia delivery system, manufactured by Spacelabs Healthcare (Snoqualmie, WA). ARKON allows anesthesiologists to keep their patients in full view while simultaneously controlling and monitoring gas delivery using their preferred workflow. Entry submitted by and supply and design credit to Design Concepts Inc. (Madison, WI).
3. BRONZE WINNER: Isolibrium critical-care air support surface, manufactured and submitted by Stryker Medical (Portage, MI). Isolibrium aims to provide tools for nurses to care for patients while its advanced pressure redistribution systems helps prevent pressure ulcers in patients. Supply and design credit to Humphrey Products company (Kalamazoo, MI), Grand Rapids Foam Technologies (Grand Rapids, MI), Les Produits Plastitel Inc. (Laval, Quebec, Canada), Twisthink (Holland, MI), and Derby (South Bend, IN).
4. FINALIST: RP-VITA remote presence telemedicine robot, manufactured and submitted by InTouch Health Inc. (Santa Barbara, CA). RP-VITA enables increased access to specialist care through high-acuity telemedicine consults. It eliminates the need for telemedicine-specific staffing. RP-VITA’s intuitive, easy-to-use, and safety features encourage physician adoption and clinical use. Supply and design credit to iRobot (Bedford, MA).
4. FINALIST: TrueCPR coaching device, manufactured and submitted by Physio-Control (Redmond, WA). TrueCPR helps improve CPR performance by giving rescuers real-time feedback on the quality of chest compressions in accordance with current guidelines. It also provides instant post-event review, allowing rescue teams to debrief more efficiently. Supply and design credit to Plexus (Neenah, WI).
1. GOLD WINNER: Solea CO2 dental laser system for hard and soft tissue, manufactured by Convergent Dental Inc. (Natick, MA). Entry submitted by HERNETICS (Chelsea, MA). At 9.3 μm, Solea is the first CO₂ laser system ever cleared by the FDA for hard and soft tissue ablation. Solea is fast, precise, virtually noiseless, and anesthesia-free for the vast majority of procedures. Supply and design credit to HERNETICS (Chelsea, MA), Tischler Resources (Acton, MA), and Sachem Engineering, R&D (Arlington, MA).
2. SILVER WINNER: Digit Power dispenser for Aquasil Ultra Cordless tissue managing impression system, manufactured and submitted by Dentsply International, LD Caulk Division (Milford, DE). The Digit Power dispenser enables dentists to precisely place Aquasil Ultra Cordless impression material directly into the sulcus. This system minimizes work time violiations and the use of retraction cord while providing significant time savings. Supply and design credit to Nordson EFD LLC (East Providence, RI), and Key Tech (Baltimore, MD).
3. BRONZE WINNER: Bluephase Style curing light featuring Polywave LED, manufactured and submitted by Ivoclar Vivadent AG (Schaan, Liechtenstein). Bluephase Style is a cordless high-performance LED curing light that polymerizes all light-curing dental materials. Its ergonomic and compact design enables it to fit comfortably into the user’s hand. Supply and design credit to Rigami Design (Diepoldsau, Switzerland).
4. FINALIST: Zoom! Teeth Whitening System, manufactured by Discus Dental Philips Oral Healthcare (Culver City, CA). Entry submitted by DeviceLab Inc. (Tustin, CA). Zoom! will change teeth color up to eight shades within 45 minutes. It has settings to avoid unpleasant feelings during and after the process. Supply and design credit to DeviceLab Inc. (Tustin, CA), and Solid Concepts (Valencia, CA).
1. GOLD WINNER: PROPEL and PROPEL mini mometasone furoate implants, manufactured and submitted by Intersect ENT (Menlo Park, CA). PROPEL and PROPEL mini dissolvable steroid-releasing implants reduce the need for additional surgical procedures and for oral steroids, which can have serious side effects, for patients suffering from chronic sinusitis.
2. SILVER WINNER: DebioJect intradermal drug delivery device, manufactured and submitted by Debiotech SA (Lausanne, Switzerland). The DebioJect was conceived to overcome the problems encountered with classical intradermal delivery techniques. The innovative microneedle allows both pain-free and precise injection of up to 500 μL in a few seconds. Supply and design credit to CEA-LETI (Grenoble, France), Mecaplast SA (Botterens, Switzerland), and the Royal Institute of Technology (KTH) (Stockholm, Sweden).
3. BRONZE WINNER: Auvi-Q epinephrine auto-injector, manufactured by Sanofi (Bridgewater, NJ). Entry submitted by Kaléo Pharma (Richmond, VA). Auvi-Q is a single-use epinephrine autoinjector used to treat life-threatening allergic reactions (anaphylaxis). It is the size and shape of a credit card, the thickness of a cell phone, and includes a unique voice instruction system. Supply and design credit to Kaléo Pharma (Richmond, VA), and Medivative Technologies (Indianapolis, IN).
4. FINALIST: FOX Handheld Nebulizer, manufactured by and submitted by Vectura GmbH (Germany). The FOX inhaler is a fast and efficient handheld nebulizer for treatment of respiratory diseases. Its breathing control enables highly accurate drug delivery to the small airways, ensuring optimal therapeutic results of the inhaled liquid medications. Supply and design credit to Ian Mahaffy Industrial Design Ltd. (London, UK).
4. FINALIST: MedCenter pharmacy kiosk, manufactured and submitted by MedAvail Technologies Inc. (Mississauga, Canada). The MedAvail MedCenter enables a remote pharmacist in a call center to provide confidential, real-time professional advice and verify the automated dispense of prescription medications to patients at the kiosk. Supply and design credit to Squint Innovation & Branding Inc. (Toronto, Canada).
1. GOLD WINNER: LuViva Advanced Cervical Scan point-of-care, non-invasive cervical disease detection device, manufactured by Guided Therapeutics Inc. (Norcross, GA). Entry submitted by Big Bang (Decatur, GA). LuViva is a test for early detection of disease that leads to cervical cancer. It does not require a tissue sample. The test provides an immediate and objective result at the point of care, reducing false-positive and false-negative results. Supply and design credit to Big Bang (Decatur, GA), Seaway Plastics Engineering (Port Richie, FL), Gupta Permold Corp. (Pittsburgh, PA), and Herman Miller Inc. (Zeeland, MI).
2. SILVER WINNER: MetaNeb system, manufactured and submitted by Hill-Rom Services Pte. Ltd. (Singapore). MetaNeb is indicated for mobilization of secretions, lung expansion therapy, and treatment and prevention of pulmonary atelectasis. It can also provide supplemental oxygen when used with compressed oxygen.
3. BRONZE WINNER: MuV patient transfer system, manufactured by CEGA Innovations LLC (Sioux Falls, SD). The MuV system is lightweight and ergonomically designed to reduce patient stress and the physical toll on hospital workers during patient transfer, reducing workplace injuries and increasing efficiencies and reimbursement criteria. Entry submitted by and supply and design credit to Kablooe Design (Blaine, MN).
4. FINALIST: IsoGel AIR therapeutic support surface, manufactured and submitted by Stryker Medical (Portage, MI). IsoGel AIR assists in managing pressure, shear, and microclimate through its unique cover and open-column design those results in low air loss through its proprietary gel. Supply and design credit to Hilco Technologies (Grand Rapids, MI), Dartex Coatings Ltd. (Acton Close Nottingham, Nottingham, UK), and Tridien Medical (Corona, CA).
4. FINALIST: RENASYS Soft Port, manufactured and submitted by Smith & Nephew Inc. (St. Petersburg, FL). RENASYS Soft Port offers patient comfort and increased placement versatility (for difficult wound locations), and functions when folded or kinked. Due to the soft construction, the risk of pressure sores may be reduced. Supply and design credit to Ximedica (Providence, RI).
4. FINALIST: SmartSite VialShield closed-vial access device, manufactured and submitted by Yukon Medical LLC (Research Triangle Park, NC). The SmartSite VialShield is a needle-free closed system transfer device that protects clinicians from exposure to hazardous drugs during drug preparation and administration. The product is designed to optimize safety, simplify care and minimize costs. Supply and design credit to Gilero Biomedical (Research Triangle Park, NC), and Industrie BORLA S.p.A. (Moncalieri, Torino, Italy).
1. GOLD WINNER: GUIDE DBS programming planning and visualization system for deep brain stimulation (DBS), manufactured and submitted by Boston Scientific Corp. (Natick, MA). GUIDE DBS is a software program that creates a 3-D image of a patient’s deep brain anatomy and the relative location of the implanted lead. A model of the volume of activated tissue allows the clinician to intelligently optimize stimulation parameters.
2. SILVER WINNER: Eclipse soft tissue anchor, manufactured and submitted by MedShape Inc. (Atlanta, GA). The Eclipse offers an innovative, nonrotational approach for reattaching soft tissue to bone. It features an expandable sheath-and-bullet design that preserves tissue orientation while reducing surgical complexity and increasing confidence in the repair. Supply and design credit to Enginuity Works (Atlanta, GA), and Creature LLC (Atlanta, GA).
3. BRONZE WINNER: Codacs direct acoustic cochlear implant system, manufactured and submitted by Cochlear Ltd. (Sydney, Australia). The Codacs system meets an unmet patient need by mechanically stimulating the cochlea, bypassing the impaired middle and outer ear of people with severe to profound mixed hearing loss. Supply and design credit to Helbling Technik (Liebefeld, Switzerland).
4. FINALIST: Compressyn Band implant for sternal closure with Compressyn Band Tensioner, manufactured and submitted by Dallen Medical Inc. (San Clemente, CA). The Compressyn Band is intended for use in stabilization and fixation of anterior chest-wall fractures including sternal fixation. This knotless cerclage device uses a spring to supply dynamic compression to aid in bone healing. Supply credit to Velco Tool & Die (Lake Forest, CA).
4. FINALIST: Persona, the Personalized Knee System, manufactured and submitted by Zimmer Inc. (Warsaw, IN). Patient expectations of total knee replacement are increasing. The Persona Knee System was designed to minimize the compromises required with standard knee systems. The system supports unparalleled levels of personalization, empowering surgeons to restore the unique identity of every knee.
1. GOLD WINNER: AtomoRapid HIV (1&2) integrated rapid antibody test, manufactured and submitted by Atomo Diagnostics Pty Ltd. (Sydney, Australia). AtomoRapid HIV is the first integrated rapid test for detection of HIV 1&2 using blood. It replaces the need for existing test kits with multiple items that are complicated to use, thus reducing the inherent error rates found when using kits in the field. Supply and design credit to IDE Group Inc.(Newington, Australia).
2. SILVER WINNER: NIOX VERO airway inflammation monitor, manufactured by Aerocrine AB (Solna, Sweden). Entry submitted by Veryday (Bromma, Sweden). NIOX VERO enables clinical monitoring of airway inflammation and plays a critical role in the efficiency of diagnosis, treatment, and follow-up of patients with inflammatory airway diseases, such as asthma. Supply and design credit to Veryday (Bromma, Sweden), Panasonic Healthcare Co. Ltd (Tokyo, Japan), and IT Dr. Gambert GmbH Wismar (Wismar, Germany).
3. BRONZE WINNER: HYBRiD-XL fully automated continuous access analyzer, manufactured by DRG Diagnostics GmbH (Marburg, Germany). The DRG:HYBRiD-XL allows, for the first time, simultaneous measurement of immunoassays and clinical chemistry parameters including turbidimetric tests in one sample. Entry submitted by and supply and design credit to BIT Group (San Diego, CA).
2014 READERS CHOICE WINNER: Persona, the Personalized Knee System, The entire community of MD+DI readers weigh in on their choice for the top MDEA finalist product. More than 4,300 readers voted...and the 2014 winner was Persona. Patient expectations of total knee replacement are increasing. The Persona Knee System was designed to minimize the compromises required with standard knee systems. The system supports unparalleled levels of personalization, empowering surgeons to restore the unique identity of every knee. Manufactured and submitted by Zimmer Inc. (Warsaw, IN).
1. GOLD WINNER: SoTube SoSafe double-sterile barrier packaging, manufactured and submitted by Selenium Medical (La Rochelle, France). SoTube/SoSafe are two innovative solutions, nested tubes based, for implants double-sterile barrier packaging. They ensure nurses and surgeons easy handling of package and implant as well as a pioneer “No Touch” approach right up to the point of surgery.
2. SILVER WINNER: Safe Label System (SLS) enterprise-wide electronic medication preparation safety system, manufactured and submitted by Codonics Inc. (Middleburg Heights, OH). SLS is an on-demand medication preparation-specific system that replicates pharmacy oversight at the point of care. It ensures TJC compliance with best practices and standards to improve patient safety, workflow efficiency, accuracy, and reduce drug errors. Supply and design credit to SIMS Lab and Partner’s Healthcare at Massachusetts General Hospital (Boston, MA).
3. BRONZE WINNER: DISK (Dispenser Integrated System Kit), manufactured and submitted by CleanCut Technologies LLC (Anaheim, CA). DISK is thermally bonded to an HDPE backer card and is intended to provide medical device product retention and protection during packaging, handling, sterilization, shipping, and use in medical environments.
4. FINALIST: ePAK Single-Use Delivery System featuring DVR Crosslock distal radius plating system, manufactured and submitted by Biomet Orthopaedics Inc. (Miami, FL). ePAK is a sterile, single-use delivery system designed to treat distal radius fractures. ePAK is always stocked and ready for every surgery, minimizing surgical delays because all components are new and fresh for every surgery.
4. FINALIST: IMS Signature Series cassettes, manufactured and submitted by Hu-Friedy Mfg. Co. LLC (Chicago, IL). Patent pending IMS stainless steel cassettes feature silicone rails to hold dental instruments in place from chairside through reprocessing. An open hole pattern and rail design facilitates cleaning and sterilization. Cassettes standardize procedures for increased safety and efficiency. Supply and design credit to Design Integrity (Chicago, IL).
1. GOLD WINNER: AEROBIKA oscillating positive expiratory pressure therapy system, manufactured and submitted by Trudell Medical International (London, Canada). The AEROBIKA oscillating PEP device helps loosen and remove mucus build-up in the lungs. On exhalation, positive pressure holds the airways open, while oscillations thin and loosen mucus helping move it to the central airways where it can be coughed out. Supply credit to Silcotech (Bolton, Canada), and C&J Industries Inc. (Meadville, PA).
2. SILVER WINNER: Tria Age-Defying Laser handheld dermatological device, manufactured by Tria Beauty Inc. (Dublin, CA).). Tria Age-Defying Laser lets consumers achieve professional anti-aging results at home. The safe, effective skincare device uses fractional laser technology to smooth wrinkles, reduce discoloration, and improve the texture of all skin types. Entry submitted by and supply and design credit to IDEO (Palo Alto, CA).
3. BRONZE WINNER: FreeStyle Optium Neo blood glucose and ketone monitoring system (not available for sale in the United States), manufactured and submitted by Abbott Diabetes Care Inc. (Alameda, CA). FreeStyle Optium Neo guides patients through their diabetes and insulin management. Set up by a healthcare provider, the meter stores, displays, logs, and suggests insulin dose adjustments. It also notifies of high or low blood glucose levels and trends. Supply and design credit to Bridge Design (San Francisco, CA).
4. FINALIST: Tria Hair Removal Precision Laser handheld dermatological device, manufactured by Tria Beauty Inc. (Dublin, CA). Tria Hair Removal Precision Laser is an advanced diode laser used at home by consumers to permanently remove unwanted hair from small, sensitive areas of the body, such as the underarms and bikini line. Entry submitted by and supply and design credit to IDEO (Palo Alto, CA).
1. GOLD WINNER: AIRO Mobile Computed Tomography (CT) System, manufactured and submitted by Mobius Imaging LLC (Ayer, MA). The AIRO Mobile CT integrates advanced imaging technologies into existing medical workflow and provides the clinician with procedural flexibility as well as real-time CT imaging information where and when it is needed. Supply and design credit to Varian Medical Systems (Salt Lake City, UT), Excelitas Technologies (Salem, MA), Hamamatsu Corp. (Bridgewater, NJ), Analog Devices Inc. (Norwood, MA), Rotek Inc. (Aurora, OH), Marlborough Foundry Inc. (Marlborough, MA), and Aved Electronics Inc. (North Billerica, MA).
2. SILVER WINNER: NvisionVLE Imaging System, manufactured by NinePoint Medical (Cambridge, MA). The NvisionVLE Imaging System is the first and only volumetric optical coherence tomography device cleared by FDA for endoscopic imaging and imaging of esophageal tissue microstructure. Entry submitted by and supply and design credit to Farm Design Inc. (Hollis, NH).
3. BRONZE WINNER: LumaGEM Molecular Breast Imaging (MBI) system, manufactured and submitted by Gamma Medica (Salem, NH). LumaGEM is an effective adjunct to standard mammography. It is a patient-friendly and cost-effective tool for detecting early-stage cancers in dense breast tissue. Supply and design credit to Farm Design Inc. (Hollis, NH), and Sunrise Labs (Auburn, NH).
4. FINALIST: Atomlab 960 thyroid uptake system, manufactured by Biodex Medical Systems (Shirley, NY). Atomlab 960 is a multipurpose spectrum analysis instrument for diverse nuclear medicine applications. Uptake studies, wipe tests, and other tasks are accomplished using this fully computer-controlled instrument and comprehensive selection of software. Entry submitted by and supply and design credit to Integrated Design Systems Inc. (Oyster Bay, NY).
4. FINALIST: DRX-Revolution mobile x-ray system, manufactured and submitted by Carestream Health (Rochester, NY). DRX-Revolution helps medical staff generate high-quality digital X-ray images to treat seriously ill patients. A collapsible column allows enhanced visibility and safety, and a long tube head allows for easier exams even in the presence of bedside medical equipment.
1. GOLD WINNER: Vector Gait and Safety System, manufactured and submitted by Bioness Inc. (Valencia, CA). The Vector Gait and Safety System is a ceiling-mounted robotic technology designed to improve patient mobility and functional independence by tracking movement and offloading a precise amount of body weight during rehabilitation. Supply and design credit to D&K Engineering (San Diego, CA).
2. SILVER WINNER: Carevo shower trolley, manufactured by ArjoHuntleigh Innovation Center (Malmö, Sweden). The Carevo is a modern shower trolley for therapeutic showering and bathing. It offers comfort and dignity to patients during daily hygiene care and enables caregivers to work close to patients, reducing static stress. Entry submitted by and supply and design credit to Veryday (Bromma, Sweden).
3. BRONZE WINNER: Hercules Patient Repositioner, manufactured and submitted by The Morel Company (Batesville, IN). The Hercules allows a single caregiver to safely reposition a patient up in bed in less than ten seconds with the simple push of a button.
4. FINALIST: Aircast AirSelect Elite advanced pneumatic walking boot, manufactured by DJO Global (Vista, CA). The Aircast AirSelect walking boot has an integrated air-cell support system that lets patients customize the fit to maximize comfort and minimize edema. SoftStrike technology absorbs shock, while the lab-tested rocker sole encourages a natural gait. Entry submitted by and supply and design credit to Farm Design Inc. (Hollis, NH).
4. FINALIST: Quantum Securement System, manufactured by Q’Straint (Fort Lauderdale, FL). Entry submitted by Jim Best ID (Hewitt, NJ). The Quantum is a fully automatic, rear-facing wheelchair securement station. It allows wheelchair passengers to board a bus or train and simply push a button to safely secure themselves during transport. Supply and design credit to Jim Best ID (Hewitt, NJ), Input Creative Group (Leonia, NJ), and Lucas Technical Services LLC (Philadelphia, PA).
4. FINALIST: Snug Vest deep pressure therapeutic garment, manufactured and submitted by Squeezease Therapy Inc. (Vancouver, Canada). Snug Vest is a therapeutic garment that inflates to provide a firm hug known as deep-pressure therapy. It regulates the sensory system and relieves anxiety in individuals with autism and sensory disorders. Pressure is adjustable and user-controlled.
1. GOLD WINNER: Zip Surgical Skin Closure, manufactured and submitted by ZipLine Medical Inc. (Campbell, CA). Zip is a noninvasive skin closure alternative to sutures and staples for surgery and lacerations, offering time-savings, better cosmesis, lower infection risk, and greater patient comfort. It is easy to apply and patients can remove it at home. Supply and design credit to Innovative Drive LLC (Redwood City, CA)
2. SILVER WINNER: INTUITION Instruments for DePuy ATTUNE Knee System, manufactured by DePuy Synthes, Joint Reconstruction (Leeds, UK). INTUITION instruments combine the surgical process with the implant options to allow surgeons to balance the soft tissue as well as control the implant position and fit for each patient. Entry submitted by and supply and design credit to DePuy Synthes, Joint Reconstruction (Warsaw, IN).
3. BRONZE WINNER: ASSIST Silver low-adherent antimicrobial graft cover dressing, manufactured and submitted by Milliken Healthcare Products LLC (Spartanburg, SC). ASSIST Silver is a graft cover dressing that combines Active Fluid Management technology with a low-adherent layer to provide optimal moisture balance, eliminate the need for additional low-adherent layers, and provide 7-day antimicrobial protection. Supply and design credit to Haywood Vocational Opportunities Inc. (Waynesville, NC).
4. FINALIST: ENSEAL G2 Articulating Tissue Sealers, manufactured and submitted by Ethicon Endo-Surgery Inc. (Cincinnati, OH). ENSEAL G2 Articulating Tissue Sealers are sterile, single-patient-use surgical instruments for coagulating and transecting vessels up to 7mm in diameter, as well as lymphatics. They are the first articulating sealers compatible with a 5mm port.
4. FINALIST: MicroCutter XCHANGE 30 stapler, manufactured and submitted by Cardica Inc. (Redwood City, CA). MicroCutter XCHANGE is the smallest-diameter articulating stapling device available today. At less than half the size of competing models with nearly twice the articulation, surgeons may be able to access anatomy not possible with other staplers.
4. FINALIST: POWEREASE System of spine surgery instruments, manufactured by Medtronic (Memphis, TN). Entry submitted by IDEO (Cambridge, MA). POWEREASE is a system of powered surgical instruments used by OR surgeons to drill, tap, and drive specialized implants during spinal surgeries, including open and minimally invasive procedures, and final construct assembly. Supply and design credit to IDEO (Boston, MA), C&A Tool Engineering Inc. (Churubusco, IN), NGI Cutting Instruments (Warsaw, IN), Tegra Medical (Hernando, MS), and Engineered Medical Systems LLC (Bartlett, TN).