The gold standard in medical design excellence

  • MDEA 2018 gold winners collage

    The winners of the 20th annual Medical Design Excellence Awards (MDEA) were revealed during a reception at the co-located Medical Design & Manufacturing (MD&M) East and PLASTEC East event on June 12. From a field of dozens of finalists in nine categories, judges awarded gold, silver and bronze awards to the most outstanding products. In this slide show, we present the gold winners along with the best-in-show device.

    For a recap of the finalists, go here, and for complete coverage of the awards ceremony, including the winners of bronze and silver awards, go here.

    PLASTEC East and MD&M East are part of the largest advanced design and manufacturing trade show and conference on the East Coast. The event is held in New York, NY, from June 12 to 14, 2018. 

  • MoMe Kardia ambulatory electrocardiograph (ECG) monitoring wearable

    Cardiovascular Devices

    Gold winner: MoMe Kardia system, manufactured by InfoBionic (Lowell, MA)

    Design and supply credit: DDStudio

    The MoMe Kardia ambulatory electrocardiograph (ECG) monitoring wearable is designed for patients with transient symptoms of cardiac arrhythmia. It acquires, stores and sends ECG and other related data, which is continuously transmitted and can be flagged for physician review on a web-based portal. The body of the device is molded from medical-grade polycarbonate, which has been biocompatibility tested to meet the requirements for prolonged contact duration (24 hours to 30 days) as per ISO10993-1.

  • SURGICEL Powder Absorbable Hemostat from Ethicon US LLC

    Drug-delivery and Combination Products

    Two devices tied for gold in this category: Pictured here is the SURGICEL Powder Absorbable Hemostat from Ethicon US LLC (Somerville, NJ), with Jarden Plastics and Oliver Healthcare Packaging credited for design and supply assistance; and Eli Lilly Taltz Injection Devices, manufactured by Eli Lilly and Co. (Indianapolis, IN) with design help from IDEO. That device is shown in the following slide.

    The SURGICEL Powder Absorbable Hemostat stops continuous, broad-surface oozing and bleeding fast, even on friable or raw tissue, when other conventional methods are impractical or ineffective. The structure of the powder penetrates the surface of the blood to get to the sources of bleeding and is proven bactericidal against pathogens. The device is constructed primarily of injection molded polypropylene components and a blowmolded EVA bellows.

  • Eli Lilly Taltz Injection Device

    Drug-delivery and Combination Products

    Taltz injectors are designed to treat people with moderate to severe plaque psoriasis and psoriatic arthritis with Eli Lilly and Co.'s Taltz medication. The devices come in both autoinjector and prefilled-syringe form. It tied for gold in this category with the SURGICEL Powder Absorbable Hemostat from Ethicon US LLC (Somerville, NJ), shown in the previous slide.

  • VersaOne fascial closure system

    ER and OR Tools, Equipment and Supplies

    Gold winner: VersaOne fascial closure system, Medtronic Inc. (North Haven, CT)

    The VersaOne fascial closure system serves as a trocar and fascial closure device to deliver consistent port-site closure, added procedural efficiency and ease of use. The system enables the trocar to remain within the patient while closing the defect, allowing for tissue alignment. Much of this product leverages the materials and processes of the company’s existing trocar offering, including injection molding, ultrasonic welding, semi-automated assembly and EtO sterilization, said Medtronic in the submission form.

  • AeroForm Tissue Expander System

    Implant and Tissue-Replacement Products

    Gold winner: AeroForm Tissue Expander System, AirXpanders (Healdsburg, CA)

    The AeroForm Tissue Expander System is a needle-free, patient-controlled, wireless tissue expander system for women who choose to have reconstructive surgery following a mastectomy. Inspired by a carbon dioxide bicycle pump canister, AeroForm is inserted underneath the chest muscle and activated by a wireless controller that triggers a micro-valve to release small amounts of carbon dioxide within the expander to gradually stretch the breast tissue to make room for a permanent implant. A silicone elastomer, ABS and thermoplastic elastomer are among the materials used to fabricate the tissue expander and dosage controller.

  • Equashield Pro Pharmacy Robot

    Nonsurgical Hospital Supplies and Equipment

    Gold winner: Equashield Pro Pharmacy Robot, Equashield (Port Washington, NY)

    The Equashield Pro automates manual drug compounding through the use of a high-throughput robot designed around manufacturing concepts. It does not rely on human hands, unlike current robots on the market. Human arm motion is not efficient for automated drug preparation, notes the company. Equashield Pro is designed with “manufacturing process” methodology much like an assembly line with various stations that compound drugs. This allows the robot to be designed with arms that move in linear directions only (x, y and z). This reduces cost, increases reliability and reduces arm breakdown, all while protecting the healthcare worker. 

  • Willow Breast Pump

    Over-the-Counter and Self-Care Products

    Gold winner: Willow Breast Pump, Willow (Mountain View, CA)

    Design and supply credit: IDEO

    Willow is an all-in-one breast pump that fits inside a bra. It was designed to be mobile, discreet and hands-free. The pump is composed of a few simple pieces that snap together: the pump, flange, flexible tube and milk bag. Willow is easy to assemble, use, and clean, with dishwasher-safe parts and spill-proof milk bags (sealed with an innovative, one-way valve) that can be stored in the fridge or freezer. Willow is connected to an app that syncs data from each pump, enabling moms to track their milk volume in real time while the pump stays hidden inside their bra. Through the app, moms can also keep tabs on past pumping sessions, access help videos and stay updated on their progress through alerts.

  • Exablate Neuro

    Radiological, Imaging, and Electromechanical Devices

    Gold winner: Exablate Neuro, Insightec (Tirat Carmel, Israel)

    Exablate Neuro is an FDA-approved device used to treat essential tremor, a neurological condition that causes uncontrollable shaking and affects 42 million people worldwide. Exablate Neuro uses MR-guided focused ultrasound to perform surgery deep in the brain with no incisions.

  • Obi, DESĪN

    Rehabilitation and Assistive-Technology Products

    Gold winner: Obi, DESĪN (Bloomfield Hills, MI)

    For those ages 5 and older living with disability or disease affecting their upper extremities, Obi increases the diner’s independence and confidence by providing choice among four compartments of food and when food is delivered to a region in front of their mouth. This device automates smooth motions simulating normal human arm function during a meal. Through use of a robotic arm, the device becomes an extension of the user, conducting his or her intent of what and when to eat.

  • Sterrad Velocity Biological Indicator System

    Testing and Diagnostic Products and Systems

    Sterrad Velocity Biological Indicator System, Advanced Sterilization Products (ASP), part of Johnson & Johnson Medical Devices Companies (Irvine, CA)

    Design and supply credit: Worrell

    The Sterrad Velocity Biological Indicator System is a hydrogen peroxide biological indicator that confirms proper sterilization of reprocessed surgical instruments within 30 minutes. The reader integrates with Sterrad sterilizers and uses optical measurement technology. It includes automated record keeping, compliance checks and on-screen instructions. 

    The product consists of a snap fit cap and vial with a breakable ampule inside. When the cap is depressed, the ampule breaks, exposing the biomaterial to the environment. The cap is a high-volume injection-molded ABS blend. The vial is made of medical-grade polycarbonate. 

  • AeroForm Tissue Expander System

    Best in Show: AeroForm Tissue Expander System, AirXpanders (Healdsburg, CA)

    The gold winner in the Implant and Tissue-Replacement Products category, the AeroForm Tissue Expander System, was also named Best in Show by the panel of judges. It is a needle-free, patient-controlled, wireless tissue expander system for women who choose to have reconstructive surgery following a mastectomy.

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