2017 Medical Design Excellence Award Finalist

Drug-Delivery and Combination Products

Corvida Medical
Halo Closed System Transfer Device

Halo® is a Closed System Transfer Device (CSTD) designed to protect healthcare professionals from exposure to hazardous drugs while they are compounding and administering chemotherapy. With its proven physical barrier, Halo acts as a leak-proof, airtight containment chamber for toxic liquids and vapors. With minimal parts and actions required, Halo is extremely easy to use.

Amgen
Neulasta® Onpro®

Neulasta® Onpro® kit includes a co-packaged single dose of Neulasta® and a single-use On-body Injector for Neulasta®, lightweight delivery system applied to the skin during your chemo appointment. It’s designed to automatically administer Neulasta® the next day, so that you may not have to return to the doctor just for a shot of Neulasta®.

West's SmartDose® platform is a single-use wearable injector that adheres to the patient’s body and is pre-programmed to deliver high volumes (<3.7mL) of viscous or sensitive drug products. This drug delivery system incorporates human factors and usability to deliver a patient-centric approach. The SmartDose platform affords home based self administration.

West Pharmaceutical Services, Inc.
West's SmartDose platform

On May 26, 2016, Probuphine, the first six-month implant to treat opioid dependence, received FDA approval. Declared a “game-changer” by the media, Probuphine aspires to revolutionize treatment options for patients with opioid dependence, a chronic disease that in 2015 took almost 80 American lives each day, according to the CDC.

Braeburn Pharmaceuticals
Probuphine

Novartis Pharma AG
Cosentyx Sensoready Pen

The Sensoready® Pen is a drug delivery device for COSENTYX® that maximises simplicity, confidence and ergonomics.

Implant and Tissue-Replacement Products

Beaver-Visitec International
I-Ring

The Visitec® I-Ring® is a new, single use pupil expansion device that safely and gently retracts the iris to view and access the lens during cataract surgery. Designed specifically for the increasingly common Intraoperative Floppy Iris Syndrome patient, the intrinsic safety features and remarkably soft material minimize risk to delicate tissues in these complicated cases.

NeuroStructures
Belvedere Lateral Plating System

Belvedere is an anterior lateral thoracolumbar bone plating system that features a simple low profile design with a unique adjustable self-locking gear mechanism. Belvedere's advantages include adjustable length for optimal placement, anatomically contoured to match the spine, low profile design to optimize patient comfort, and a simple one-step locking mechanism per level.

RIGIDLOOP™ Adjustable Cortical Fixation System is designed for soft tissue cruciate ligament reconstruction. Unique packaging with integrated graft prep and suture strand management allows users to easily mark the graft and suture loops. Unlike any other product, the card organizes sutures so the user has easy access to what they need when they need it.

DePuy Synthes Companies
RIGIDLOOP™ Adjustable Cortical Fixation System

Available for multiple indications from head to toe, the FlowerCube contains all of the implants and instruments needed for an orthopedic case. All implants are individually sterile packaged and all instruments are provided in sterile, single use kits.

Flower Orthopedics
Ready-For-Surgery FlowerCube

Radiological, Imaging, and Electromechanical Devices

HS-Design
VECTRA WB360 3D

VECTRA WB360 is the world's first 3D whole-body imaging solution. Designed for medical use, this innovative system images nearly the entire skin surface in macro-quality resolution with a single capture. The integrated software allows clinicians to map, measure and track pigmented lesions and to record and monitor distributed skin diseases.

Misonix
sonicVac

The sonicVac is the first device to combine low frequency direct contact ultrasound with aspiration. Its intended use is the surgical debridement of wounds including diabetic foot ulcers, burn wounds, pressure and venous leg ulcers. The sonicVac is a single use, sterile disposable device used in an OR setting.

Geri is the world’s first incubator that combines a low-cost imaging system within each individually controlled patient incubator chamber. Embryologists can assess embryo development without taking the embryo out of its optimal environment. High-quality time-lapse images are taken while the embryo remains safe within Geri.

Planet Innovation
Geri

The AmiCORE Apheresis System is an automated blood cell separator that collects a leukoreduced single or double dose of platelets by centrifugation using a single use disposable kit. The device collects the platelets and storage plasma through a single venipuncture site and returns the remaining blood components to the donor.

Fresenius Kabi
AmiCORE

Farm Design Inc.
Hologic Affirm Prone Biopsy Table

The Affirm™ Prone system is a total redesign of Hologic's widely used, 20-year-old breast biopsy platform. The Affirm Prone system is the world's first dedicated prone biopsy system for 2D or 3D imaging-guided biopsies. The system is designed to better target lesions, and offer significant user workflow improvements and an improved patient experience.

EYE TECH CARE
EyeOP1 Non-invasive glaucoma therapy

Glaucoma and ocular hypertension affects around 120 million people worldwide and is a leading cause of blindness. EyeOP1 from EYE TECH CARE is the only device based on focused ultrasound to reduce intraocular pressure and slow down disease progression. The 3 minute procedure is non-invasive and does not require surgical skills.

Rehabilitation and Assistive-Technology Products

Eargo

Eargo utilizes patented Flexi Fibers to suspend a hearing device in the ear canal making it virtually invisible and allowing bass sounds to pass through creating a more natural sounding experience. Plus, our rechargeable battery means never having to replace batteries all the time saving both time and money.

Freedom Innovations, LLC
Kinnex

Freedom Kinnex is a microprocessor controlled hydraulic prosthetic ankle/foot system that monitors sensors to control plantar and dorsiflexion resistance. Apps available to both clinicians and patients allow for customization to suite each patient needs.

ENLITEN’s Open Area Support System (OASUS) provides users of all ages affordable, area mobility, fall prevention and body weight support. It allows unrestricted front and back, lateral, and rotational freedom to safely improve walking mobility and provide gait therapy assistance for both children and adults

ENLITEN LLC
OASUS - Open Area Support System

Linx is the first fully integrated, microprocessor-controlled lower limb system for above-knee amputees. Combining four microprocessors and seven situational awareness sensors for control and balanced limb loading, the knee and ankle units communicate continuously to adjust resistance and speed for ease of use, safety and stability.

Endolite
Linx

ER and OR Tools, Equipment, and Supplies

Perineologic
PrecisionPoint Transperineal Access System

The PrecisionPoint™ Transperineal Access System (PPTAS) is the first FDA cleared device allowing free-hand transperineal biopsy of the prostate. The PPTAS is intended to be used in conjunction with a transrectal ultrasound probe to provide guided access to the prostate via the perineum in an office setting under local anesthesia.

Misonix
sonicVac

The sonicVac is the first device to combine low frequency direct contact ultrasound with aspiration. Its intended use is the surgical debridement of wounds including diabetic foot ulcers, burn wounds, pressure and venous leg ulcers. The sonicVac is a single use, sterile disposable device used in an OR setting.

MicroCutter 5/80 is a surgical stapler that transects or joins tissue together by simultaneously deploying double staggered rows of staples while a knife cuts between the rows. Globally, it is used to surgically treat cancer in the lungs, colon, prostate, liver, spleen, and pancreas, for transplants and pediatric procedures, as well as general and bariatric surgery.

Dextera Surgical Inc.
MicroCutter 5/80 Surgical Stapler

Acumen Hypotension Probability Indicator (HPI) is a breakthrough technology that alerts clinicians to potential hypotension, or abnormally low blood pressure, in their surgical and critical care patients before it occurs. Studies have shown that even short durations of hypotension can be harmful to patients during both OR and ICU stays.

Edwards Lifesciences LLC,
Critical Care
Acumen Hypotension Probability Indicator Software

Medtronic plc
Signia Powered Stapling System

The Signia™ Powered Stapler is a modular, semi-reusable system designed to deliver the entire portfolio of Medtronic stapling reloads. Through the use of an advanced algorithm, Signia™ will provide surgeons active feedback about target tissues and adjust its firing speed to optimize staple formation.

Cianna Medical, Inc.
SAVI SCOUT

The FDA-cleared SAVI SCOUT® radar localization system is a zero-radiation and wire-free solution for breast tumor localization. SCOUT is designed to aid surgeons in locating target tissue during a lumpectomy or surgical biopsy procedure. This product represents the first time radar is successfully used in human tissue.

Nonsurgical Hospital Supplies and Equipment

Planet Innovation
Gavi

Gavi is the world’s first instrument to automate IVF vitrification, the process of freezing embryos for use in later cycles. By automating and standardising the process, historically a manual process subject to variability, Gavi aims to improve patient outcomes and the likelihood of patients taking home a healthy baby.

Hill-Rom, Inc.
Envella Air Fluidized Therapy Bed

The Envella™ Air Fluidized Therapy Bed is intended to help treat and prevent pressure injuries, and provides ideal support for patients with advanced pressure injuries, flaps, grafts, or burns. The Envella™ bed’s differentiated technology is clinically proven to help accelerate wound healing and limit complications and adverse events.

The Carebag bedpan and commode pail liner is equipped with a super absorbent pad for the safe collection, transport and disposal of potentially infectious body fluids. It is also green-friendly and anti-microbial effective against 26 pathogenic strains. 5 log reduction noted on C diff spores.

Cleanis Inc
CareBag bedpan and commode pail liner

The Tube-Evac device was invented as a result of God revealing how to make a device for clearing surgical drains. It has been used tens of thousands of times in various hospitals around the United States. It has patents in the US and overseas with several more overseas patents pending.

Godsdvc
Tube-Evac

ivWatch
ivWatch Model 400

The ivWatch Model 400 is a medical device that continuously monitors peripheral IV sites to aid in the early detection of infiltrations. A sensor uses visible and near-infrared light to detect changes in optical properties of tissue. The device analyzes the data and notifies clinicians if conditions suggest an infiltration.

Testing and Diagnostic Products and Systems

DIAGNOSTICS FOR THE REAL WORLD LTD
SAMBA

SAMBA is a diagnostic tool for monitoring HIV treatment efficacy and early infant diagnosis for patients in resource-poor settings where the burden of HIV is greatest. It is an accurate and simple to use “sample in – result out” system enabling patients to receive same-day results and treatment at remote clinics.

Abbott Laboratories
FreeStyle Libre

Abbott's FreeStyle Libre system, available and approved across Europe, measures glucose for people with diabetes removing the need for routine finger pricking and unburdening people with diabetes from the pain and inconvenience of finger pricks.

Our tests use a drop of blood to test for a variety of conditions, illnesses and diseases with results in minutes. We say "our lab - at the tip of your finger" because what used to happen in a complex lab can now happen in the palm of your hand.

NOWDiagnostics
ADEXUSDx hCG Test

GenMark's ePlex system is a sample-to-answer instrument designed to perform multiplex molecular testing for infectious disease diagnostic in high-risk patients. Physicians can quickly and effectively identify bacterial, viral and fungal infections and antibiotic resistance markers to aid in determining the appropriate treatment with the goal to improve patient care.

GenMark Diagnostics, Inc.
ePlex

Gastrointestinal and Genitourinary Devices

Boston Scientific Corporation
Dakota™ Nitinol Stone Retrieval Device with OpenSure™ Handle

Dakota is the first single use kidney stone retrieval device able to claim capture of stone fragments as small as 1 mm and as large as 10 mm. Dakota also incorporates the OpenSure handle, a first-of-its-kind feature allowing urologists to easily drop large, complex fragments that may otherwise get trapped.

Perineologic
PrecisionPoint Transperineal Access System

The PrecisionPoint™ Transperineal Access System (PPTAS) is the first FDA cleared device allowing free- hand transperineal biopsy of the prostate. The PPTAS is intended to be used in conjunction with a transrectal ultrasound probe to provide guided access to the prostate via the perineum in an office setting under local anesthesia.

The Resolution 360™ Clip’s innovative design enables the physician or nurse/technician to provide hemostasis with controlled clip placement designed for procedural efficiency and accuracy.

Boston Scientific Corporation
Resolution 360™ Clip

The NURO External Neuromodulation System is an office-based, non-surgical method to treat patients with Overactive Bladder (OAB) and associated urinary urgency, frequency, and incontinence. The device provides gentle nerve stimulation (neuromodulation) to restore patients’ natural ability to control their bladder, improving quality of life for those affected by OAB.

Creature Product Development
NURO Percutaneous Tibial Neuromodulation system

Design Concepts, Inc.
Eclipse System bowel control therapy

Accidental Bowel Leakage disrupts many women’s lives. The Eclipse System, which consists of a vaginal insert and handheld pump, is a simple, discreet solution. Women are fitted for an insert during an office visit. It’s easy to place and remove as desired. It’s also effective – 8 in 10 reported success during a clinical trial.

Digital Health Products and Mobile Medical Apps

TowerView Health
TowerView Health Medication Management

TowerView helps chronically ill patients manage complex medication regimens by sending patients presorted medication trays that insert into TowerView's proprietary connected pillbox that senses missed doses and sends reminders. Health coaches use TowerView's software to provide outreach for nonadherent patients. TowerView partners with payors so patients receive its service for free.

Level EX
Airway EX

Airway EX is a mobile application that physician specialists can use to perform life-like virtual surgeries and perioperative procedures using video game technology — delivered through a free mobile application. Airway EX is designed to advance physician education/training to improve surgical outcomes.

BETACONNECT is the first and only fully-electronic autoinjector approved in the U.S., for assisting people diagnosed with Multiple Sclerosis in performing self-injection of Betaseron. BETACONNECT is a unique service offering provided free of charge to Betaseron patients which has highlighted the excellent long-term reputation of Bayer and our ongoing commitment to patients with MS.

Phillips-Medisize Corp
BETACONNECT

Utilizing a neuroscience-based approach, the Levo System is a digital medical device for providing personalized nightly sound therapy designed to improve the quality of a tinnitus patient’s daily life.

Otoharmonics
The Levo System

Ascensia Diabetes Care
Contour Next Diabetes Meter and App

The CONTOUR™NEXT ONE meter and the CONTOUR™DIABETES app create an integrated and simplified diabetes management system. The user’s blood glucose (BG) results are captured throughout the day and are automatically synced and logged in the app. This digital diary provides the tools for users to make informed decisions about their health.

Companion Medical Inc.
InPen Smart Insulin Delivery

Companion Medical has developed a smart insulin pen that provides the benefits of an insulin pump to pen and syringe users, including a dose calculator, dose alarms, and an e-logbook. InPen allows patients and physicians better control over insulin therapy and is a new mode of therapy to inform and improve the management of diabetes.