Stay tuned to MPMN's Web site over the next few weeks as we continue to add to our coverage of the winners. Check out the May print issue of MPMN, which features our annual coverage of select MDEA winners, including case studies that contain interviews with the supplier companies and OEMs.
NEW: Watch coverage of the 2009 Medical Design Excellence Awards ceremony as well as the BMEidea competition, which recognizes university student biomedical innovations. A few of this year’s MDEA gold-distinction winners describe the challenges they overcame during development of their products.
Critical-Care and Emergency Medicine Products
Lifepak 15 monitor-defibrillator. The Lifepak 15 monitor-defibrillator is used in medical emergencies to provide defibrillation and a range of monitoring functions, so that emergency medical services and hospital personnel can provide timely and appropriate patient care.
Submitter and manufacturer: Physio-Control Inc. (Redmond, WA; www.physio-control.com)
"For the Lifepak 15 monitor/defibrillator, Physio-Control partnered with emergency services personnel to design an all-new platform, which led to several clinical and operational innovations," says Brian Webster, president of Physio-Control. "For example, the Lifepak 15 monitor is the only monitor/defibrillator to offer CO2 and methemoglobin monitoring capabilities, which can help measure the effectiveness of resuscitation efforts and exposure to certain drugs and chemicals, respectively."
LiquiBand Optima wound-closure adhesive. LiquiBand Optima is an advanced cyanoacrylate skin adhesive and applicator. Its no-sting, fast-set formulation is optimized for safe, quick, and easy use and application to close minor wounds in the emergency room.
Submitter and manufacturer: Medlogic Global Ltd. (Plympton, Plymouth, UK; www.medlogic.com)
"LiquiBand Optima is a preassembled skin adhesive device that can be used straight from the pack," says Gordon Schofield, marketing manager, Medlogic Global Ltd. "The unique winged actuator provides an easy 'click-and-use' functionality that ensures precision control. LiquiBand Optima enables the emergency room clinician to perform quicker, safer, and more-precise wound closure that helps achieve excellent cosmetic results. The Octyl-Blend cyanoacrylate technology, used within LiquiBand Optima, allows the product to be stored at ambient temperature using an optimized, no-sting monomer formulation."
ThermoSuit body-cooling system. The ThermoSuit system cools the core temperature of cardiac arrest, stroke, or heart attack victims to 33°C in 20 minutes or less. When cooled, vital organs operate more slowly and require less oxygen, reducing the chance of brain or heart damage.
Submitter: Ximedica (Providence, RI; www.ximedica.com)
Manufacturer: Life Recovery Systems (Waldwick, NJ; www.life-recovery.com)
Suppliers: Ximedica; Nexcore Technologies Inc. (Waldwick, NJ; www.nexcoretech.com); Dielectrics Inc. (Chicopee, MA; www.dielectrics.com)
"To our knowledge, it's the only [product] that cools with thin-film liquid convection," says Robert Schock, vice president of R&D at Life Recovery Systems. "We pump cold liquid-in this case cold water-over the body in a thin layer and move it to extract heat from the skin. This is a really effective way to extract heat from the body compared with conventional cooling blankets and ice cubes."
Dental Instruments, Equipment, and Supplies
Styla MicroLaser advanced dental laser system. The Styla is dentistry’s first microlaser, enabling dentists to perform soft-tissue procedures with little or no patient anesthetic, recession, bleeding, or pain. The unit is 6.9 in. long, and weighs just 1.9 oz.
Submitter: KRT Marketing (Lafayette, CA; www.krtmarketing.com)
Manufacturer: Zap Lasers (Pleasant Hill, CA; www.zaplasers.com)
"The biggest challenge developing Styla was also our smallest: How to compact a tabletop laser into a 6.9-in., 1.9-oz wire-free device?" says Alex Di Sessa, vice president of sales and marketing, Zap Lasers. "The result is not only a revolutionary tool that improves dentists' workflow, but also one that delivers better patient care."
Finished Packaging
UniDose glucose meter check control. Glucose meter check control in UniDose provides a simple-to-use, reliable, and robust container to provide and present a single drop of quality control solution to verify the performance of a blood glucose test system.
Submitter and manufacturer: Bionostics (Devens, MA; www.bionostics.com)
"Quality control liquid [for blood glucose test strips] can expire after two to three months. If users want a new package, they have to order it because no one keeps it in stock. We developed a single-use packet that allows a manufacturer to put a packet of quality control solution in with a package of test strips to verify the strips are working accurately. Current bottles of the liquid are too big. This product provides a control in a ready-to-use form. It had to be small, intuitive to use, reliable, and made of a material that contains the liquid so that it doesn't evaporate. The single-use UniDose packet preserves the solution for up to 24 months," says Randy Byrd, chief technical officer, Bionostics.
General Hospital Devices and Therapeutic Products
Envision E700 wound surface. The Envision E700 wound surface addresses five key factors affecting pressure ulcer healing: pressure, shear, friction, patient immobility, and microclimate management. It can be reconfigured for any type of sleep deck: step-deck, V-deck, or flat deck.
Submitter and manufacturer: Hill-Rom Co. (Charleston SC; www.hill-rom.com)
Medigenic infection-control keyboard. The Medigenic infection-control keyboard addresses studies showing hospital keyboards to be a source of bacterial cross-contamination. The Medigenic keyboard helps monitor its own cleaning status, and allows for high-speed data entry and quick cleaning.
Submitter and manufacturer: Esterline Advanced Input Systems (Coeur d’Alene, ID; www.advanced-input.com)
"The major feature is the cleaning alert system that we built into [the Medigenic infection-control keyboard]. What good is a cleanable keyboard if no one is going to clean it? It comes factory preset at 12-hour intervals, but the user can adjust that. Hospital high-risk areas tend to set it at shorter intervals. The main challenge in developing this product was to have a surface that was totally flat, yet gave the user a good tactile response in terms of the feel of the keys. This was achieved by incorporating full-travel keys under a silicone elastomeric cover," says Randy Noland, director of marketing for Esterline Advanced Input Systems.
Rad-87 pulse CO-oximeter. The Rad-87 is a pulse CO-oximeter with optional built-in 802.11a/b/g radio for bidirectional wireless communication with a remote-monitoring and clinician-notification system. It allows for easy activation of features with a single touch.
Submitter and manufacturer: Masimo (Irvine, CA; www.masimo.com)
"Masimo product managers and industrial designers relied heavily on clinician input to gather, analyze, and prioritize clinical necessities and desires in order to identify the top functions used most often," says Steve Cebada, Masimo senior product manager. "The Rad-87's quick-access front panel buttons-representing the most frequently used clinical actions identified by practicing clinicians-are a key feature during times when quick interaction and decision-making are pivotal. The Rad-87 introduces the concept of a device profile that allows the monitor settings to be customized for a particular care area and enables a specific color to be assigned to that profile, e.g. a neonatal setting can be set to orange. Color association allows clinicians to immediately confirm if the settings have been correctly assigned and to identify the appropriate location for the device."
S3 medical-surgical hospital bed. The S3 medical-surgical hospital bed is a patient-support platform incorporating many safety, patient-centric, and nursing-efficiency features that are simple to use and reliable.
Submitter and manufacturer: Stryker Medical (Portage, MI; www.stryker.com)
Suppliers: Hilco Technologies (Grand Rapids, MI; www.hilcotech.com); Advantage Sintered Metals Inc. (Battle Creek, MI; www.advantagesintered.com); Eimo Technologies (Vicksburg, MI; www.eimotech.com); Quality Tool and Stamping (Muskegon Heights, MI; www.qtstamping.com); Cascade DieCasting/Great Lakes (Sparta, MI; www.cascade-cdc.com)
"As a feature of the bed that is used most often by clinicians and patients, the side rail system was the focus of the S3 product design team," says Richard Derenne, associate engineering product manager, R&D, for Stryker Medical. "Every detail was considered-from increasing patient coverage, to meeting the latest entrapment guidelines, to developing a one-handed release, to balancing the weight of the side rail with multiple springs for effortless motion. [The team also incorporated] an easy-to-clean design [and] the only-in-class intermediate patient egress position."
"Our experiences and talents were put to the test in working with the part designs of the Stryker S3 program," says Jet Perelli, president, Advantage Sintered Metals Inc. "The geometries were very challenging. The final designs required all of our expertise to achieve the several different levels through molding, sintering, vibrator finish, as well as machining, steam-treating, and assembly operations."
"We currently produce the following castings for the S3 bed: upper and lower transmission housings, brake rings, side rail carriers, and support plates," says Jim Moran, vice president, sales and marketing, Cascade Die Casting Group Inc. "We became involved with Stryker's technical teams early in the development of these components and worked together to provide designs that both fit the intended application and, at the same time, provided for a robust and repeatable manufacturing process. By assisting with the design development, we were able to jointly drive down the cost of the casting components by eliminating machining and non-value-added operations, thus optimizing the casting design for fit, form, and function. Die designs were developed and produced locally, which offered quick lead times and outstanding die construction. The castings are produced on 880T UBE high-pressure die-casting machines with the use of process monitoring to ensure product consistency and excellent manufacturing control and reliability."
Implant and Tissue-Replacement Products
InterFuse interbody fusion device. The InterFuse device is an interbody fusion device for the spine that provides a customized fit for each patient using a minimally invasive approach. Its unique rail-and-slot design locks up to six small modules together into a solid, large construct.
Submitter and manufacturer: Vertebral Technologies Inc. (Minnetonka, MN; http://vti-spine.com)
Suppliers: Invibio Inc. (Woodbury, MN; www.invibio.com); Minnesota Rubber and Plastics (Centerville, MN; www.mnrubber.com); Rochester Medical Implants (Rochester, IN)
"The device provides support and stability at the intervetebral disk space," says Mark Rydell, design engineer for Vertebral Technologies. "It also allows for fusion across the disk space through fenestrated areas in the implant that are filled with autologous bone."
"For the InterFuse device, we provided a biomaterial that is mapped to the specific needs of this minimally invasive spinal device, considering mechanical performance, the device's design requirements, and the delivery approach," says David Hawks, Invibio business development manager.
iUni and iDuo (unicompartmental and bicompartmental) knee-resurfacing devices. The iUni and iDuo (unicompartmental and bicompartmental) are personalized knee-resurfacing implants that provide patients and surgeons with an early intervention option for osteoarthritis of the knee.
Submitter: Racepoint Group (Waltham, MA; www.racepointgroup.com)
Manufacturer: ConforMIS Inc. (Burlington, MA; www.conformis.com)
"The traditional, off-the-shelf approach to knee osteoarthritis treatment still has clinical drawbacks that leave an equal number of patients-particularly early-intervention patients-without an attractive option," says Phil Licari, COO, ConforMIS. "ConforMIS's minimally invasive, patient-specific iUni and iDuo implants were developed to improve patient clinical benefits, simplify surgical technique, and increase hospital efficiencies associated with partial knee replacements. Each implant is designed from an individual patient's CT scan and is precisely sized and shaped to match the 3-D topography of the patient's bone surfaces."
Merlin.net patient-care network (PCN). Merlin.net PCN is an integrated system enabling telemetry transmissions from patients’ implanted medical devices from home. The Internet portal and real-time alert management extends the reach of healthcare from the clinic to the home.
Submitter and manufacturer: St. Jude Medical Inc. CRMD (Sylmar, CA; www.sjm.com)
Suppliers: Insight Product Development (Chicago; www.insightpd.com); IBM (Glendale, CA); Plexus Services Corp. (Neenah, WI; www.plexus.com)
"Finding innovative ways to respond to our customers' feedback was the most challenging and, at the same time, most fun aspect of working on Merlin.net patient care network (PCN)," says Amy Jo Meyer, manager, public relations, corporate relations for St. Jude Medical Inc. "For example, we heard over and over again how much time each day was taken up with routine tasks, like calling patients to remind them of their follow-up appointments. We needed to find a way to free up that valuable clinic time without compromising the level of service patients rely on and expect. So, we came up with DirectCall message, an automated system that makes up to four types of routine calls to patients in as many as 22 languages and which can be set up with a couple of clicks of a mouse."
"The Plexus design team was involved throughout the product development lifecycle, from initial specification through manufacturing release," says Michael Running, vice president, Plexus Technology Group. "[Our] engineers contributed to the radio transceiver, electrical, mechanical, and software platform designs. Plexus produced prototype and beta units and worked closely with St. Jude to complete verification testing of the product. The Merlin@home Transmitter is currently being manufactured by Plexus. [The company's] nearly 30 years of experience in the design, development, and manufacture of medical devices was instrumental in the success of our partnership with St. Jude Medical, and in the successful release of the Merlin@home Transmitter."
In Vitro Diagnostics
Bactec FX microbial detection system. The Bactec FX is a microbial detection system used for growing and detecting microorganisms in clinical specimens. The product’s ergonomically optimized design offers an efficient work flow and high-capacity output with a small footprint.
Submitter: Bresslergroup Inc. (Philadelphia; www.bresslergroup.com)
Manufacturer: Becton, Dickinson and Co. (Sparks, MD; www.bd.com)
Suppliers: Bresslergroup; Crescent Industries Inc. (New Freedom, PA; www.crescentind.com); CW Thomas Inc. (Philadelphia; www.cwthomas.com)
"Our big accomplishment was reducing the footprint by 50%. We also added a circular light indicator that tells lab technicians that they have a positive detection that they need to respond to. The indicator is a prominent light that they can see across the lab," says Mike Flanagan, director of marketing for Bresslergroup Inc.
Benchmark Ultra immunohistochemistry and in situ hybridization staining instrument. The Benchmark Ultra is an immunohistochemistry and in situ hybridization staining instrument with advanced features that improve usability, streamline laboratory work flow, and result in faster reporting of patient test results.
Submitter and manufacturer: Ventana Medical Systems Inc. (Tucson, AZ; www.ventana.roche.com)
Suppliers: Flextronics Inc. (Jesus Maria, Aguascalientes, Mexico; www.mx.flextronics.com); SMC Corp. of America (Tempe, AZ; www.smcusa.com); Baymar Solutions (Lutz, FL; www.baymarsolutions.com); Intuition Design Inc. (Chesapeake City, MD: www.intuitiondesign.com)
"Helping to specify products that would meet engineers' needs and also keep the purchasing department happy was possible due to SMC's wide product spread and internal engineering support. We were able to combine SMC's standard products and custom-engineered assemblies to streamline Ventana's production. The use of our 2-mm fittings and tubing was a real space saver," says Bill Ferguson, factory representative, SMC Corp. of America.
"Through the whole product launch, Ventana allowed us the freedom to implement manufacturing documentation and fixture designs different from what they were currently using on other product lines," says Andrew McCutchen, president and CEO of Baymar Solutions. "One of the reasons Baymar could do this successfully is that we can deliver a turnkey package, which includes change order documentation, validations, and anything else required to fully implement the design."
"Intuition Design provided industrial design and product development support throughout the development of the Benchmark Ultra," says Rob Bernstine, president, Intuition Design Inc. "Our focus was on the cabinet and user interaction points. Services provided included creating product concepts, model making, part design, hardware specification, prototype fabrication, and documentation. We provided support in design management, industrial design, mechanical engineering, graphic design, mechanical design, illustration, and model making."
eSensor XT-8 system for warfarin sensitivity testing. The eSensor XT-8 system for warfarin sensitivity testing detects multiple genetic variations that identifies patients at risk for warfarin sensitivity and thus allows estimation of the optimal and safe warfarin dose.
Submitter and manufacturer: Osmetech Molecular Diagnostics (Pasadena, CA; www.osmetech.com)
Suppliers: Aubrey Group Inc. (Irvine, CA; www.aubreygroup.com); Aline Inc. (Redondo Beach, CA; www.alineinc.com)
"The eSensor system is the first FDA-cleared microarray product based on electrochemical detection of DNA hybridization for personalized medicine applications," says Robin Liu, director of system development, Osmetech Molecular Designs. "It fuses two novel technologies together: electrochemical detection and integrated microfluidic lab-on-a-chip. It offers clinical laboratories the following features that are different from the other platforms: small footprint; medium- to high-throughput capacity with random-access operation; disposable cartridges; simple three-step workflow; rapid test turnaround time of four hours; and high accuracy and specificity. The platform provides a simple method to allow genetic tests in a near patient setting and provides results in less than a few hours."
"[Warfarin sensitivity testing] is just the tip of the iceberg. [This product] is like a PC with a basic platform and you can use different cartridges for several genes. One potential application is the detection of cystic fibrosis genes to help determine the likelihood of a child having cystic fibrosis based on the parents' genetics. It's so simple to use, so fast, and the applications are so varied," says Vytas Pazemenas, president and CEO, Aubrey Group Inc.
"The journey with Osmetech in the development of the microfluidic recirculating pump in the XT-8 eSensor was an amazing validation of the value that microfluidics brings to these newer, pioneering, multiplexed diagnostic products," says Leanna Levine, president and CEO of Aline Inc. "It also validated our unique approach to microfluidic prototyping using polymer laminate technology."
INRatio2 blood-coagulation monitor. The INRatio2 enables patients to test blood coagulation parameters—prothrombin time and international normalized ratio—at home. Results are obtained in 1 minute using a single drop of blood, thereby improving care and increasing patient convenience.
Submitter: IDEO (Palo Alto, CA; www.ideo.com)
Manufacturer: Hemosense, Inverness Medical (Hayward, CA)
Supplier: IDEO
"[Collaborating] with Inverness from concept through production allowed us to achieve the aggressive project goals and improve the ease of use," explains John Lai, senior design strategist, IDEO. "[It also allowed us to] create a simple nonthreatening appearance that fit the company brand, create an icon-based interface that is informative and easy for seniors to use, reduce the overall product size, and help specify components and processes that significantly lower the cost of goods. The result is a device that is financially accessible for patients and will hopefully have positive impact on their health."
Spectra MRSA chromogenic-plated medium. Spectra MRSA is a chromogenic-plated medium intended for the primary isolation of MRSA from nasal swabs with conclusive results in 24 hours. It provides a reliable, economical solution to control and reduce the spread of MRSA.
Submitter and manufacturer: Thermo Fisher Scientific (Lenexa, KS; www.thermofisher.com)
"The design of Spectra MRSA combines the simplicity of microbiological culture media with the high-value and accuracy expected from a diagnostic test," said Tom Floyd, president, microbiology products, Thermo Fisher Scientific. "It is truly a practical, high-performing solution to a pathogen that is causing serious public health concerns."
TearLab osmolarity system. The TearLab osmolarity system is a point-of-care in vitro lab-on-a-chip diagnostic device for eyecare enabling analysis of less than 50 nanoliters of tear fluid, making tear collection and analysis safe, simple, and rapid.
Submitter: Invetech (Mt. Waverly, Australia; www.invetech.com.au)
Manufacturer: TearLab Corp. (San Diego; www.tearlab.com)
Supplier: Invetech
"Our engineering team, led by Dr. Benjamin Sullivan and Steve Zmina, along with our dedicated partners, Minifab and Invetech, worked tirelessly to overcome the many challenges of establishing a product capable of precisely measuring a diagnostic marker in 50 nl of tears within seconds while maintaining a simple user interface for a technician to achieve repeatable results in an office setting," says Eric Donsky, CEO, TearLab Corp.
True2go portable glucose monitor. True2go is the world’s smallest glucose meter. Suited for on-the-go use, the reusable meter attaches to the strip vial, gives results in as little as 4 seconds from a 0.5-μl sample, and self-calibrates using coding technology embedded on each test strip.
Submitter and manufacturer: Home Diagnostics Inc. (Fort Lauderdale, FL; www.hdidiabetes.com)
Suppliers: Integrated Engineering Technologies (Tacoma, WA; www.ietek.net); Texas Instruments Inc. (Maitland, FL; www.ti.com); CSP Technologies (Amsterdam, NY; www.csptechnologies.com)
"The True2go is a removable, reusable meter that is covered under insurance with most other glucose meters," says Brent Modzelewski, director of engineering, research, and development for Home Diagnostics Inc. "To create a no-code system, HDI chose to embed strip lot-specific information into the test strip during the manufacturing process."
"An MSP430 microcontroller was the natural choice due to the platform's ultralow power consumption and impressive array of onboard analog," says Charles Hadsell, catalog microcontroller unit marketing director for TI.
Vitros 5600 integrated system. The Vitros 5600 integrated system is a high-capacity clinical laboratory system uniquely designed to integrate clinical chemistry and immunoassay testing into a single instrument.
Submitter and manufacturer: Ortho Clinical Diagnostics (Rochester, NY; www.orthoclinical.com)
Supplier: Priority Designs (Columbus, OH; www.prioritydesigns.com)
"After researching laboratories around the world, Ortho Clinical Diagnostics learned many integrated solutions that link testing systems together with tracks or aliquotting modules don't always improve turnaround time-and the need to split or move samples could lead to an increased risk of erroneous results," says Bob Geen, workwide marketing manager for Ortho Clinical Diagnostics. "So the first technical challenge in creating the Vitros 5600 integrated system was to find a way to integrate three processing centers into a single analyzer. This is like combining three musicians, who are each playing a different time signature and different key, into one integrated, harmonious three-piece band. The challenge was met by applying lean principles during development. For example, each processing center was given unconstrained access to the sample, reagents and consumables, so the analyzer can get as many tests incubating as possible without delay."
"We were responsible for providing the external covers, doors, and cabinetry that interacted with the internal systems," explains Linda Siders, design engineer for Priority Designs. "One challenge was that we had to observe minimum-clearance issues. [Ortho Clinical Designs] wanted to keep the overall size of the machine small. We had a very narrow margin to work within to achieve aesthetic appearances and express Ortho's brand identity. We also incorporated ergonomics and access points to accommodate the widest range of users possible," adds Joseph Lehman, Priority Designs senior industrial designer.
Over-the-Counter and Self-Care Products
Bunion Aid splint. The Bunion Aid hinged splint is designed to correct mild to moderate hallux valgus mal-positioning to normal values. The day/night splint consists of a medical-grade plastic hinge and antibacterial metatarsal toe straps and pads.
Submitter and manufacturer: Alpha Orthotics Corp. (Tiburon, CA; www.alphaorthotics.com)
Suppliers: Hallufi AG (Munich; www.hallufix.de); Office of Dr. Klaus A. Milachowski (Munich); Fraunhofer-Gesellschaft zur Forderung (Munich; www.fraunhofer.de)
"The Bunion Aid splint is a combination of a medical-grade plastic splint and Velcro fastening metatarsal and toe straps," says Andrea Fuller, public relations director for Alpha Orthotics Corp. "The plastic portion of the splint is hinged and fastened along the inside border of the foot with a toe and metatarsal strap. The straps and the splint provide three-point correction of the bunion deformity though-out the gait cycle. The metatarsal arch is optimally stabilized, the bunion relieved, the mal-positioning of the toe corrected, and the foot brought back and held in its natural position. [The device] relieves pain, allows return to an active lifestyle, and can be worn during the day or at night."
Radiological and Electromechanical Devices
Accu-Right CT marker device. The Accu-Right CT marker device is a safety innovation that labels the right side in computed tomography images with a capital letter R to distinguish it from the left side. This recyclable CT accessory may reduce wrong-side surgery.
Submitter and manufacturer: Accu-Right Correct Side Solutions LLC (Los Angeles; www.correctside.com)
Suppliers: ProAction Products (Van Nuys, CA; www.proactionpd.com); HLB (Chicago; www.hlb.com); VIP Rubber and Plastic Products Inc. (La Habra, CA; www.viprubber.com)
"The Accu-Right CT marker device was created to correctly designate the right side of a patient in CT images," says Kevin Mackey, president of Accu-Right Correct Side Solutions. "Currently, labeling the right and left side of an image depends on the technologist pushing the correct button on the CT console when performing a procedure. The CT scanner does not know if the patient is facing head first or feet first on the table, which determines which side of the gantry is assigned right or left. If the wrong button is pushed, the images are forever mislabeled."
Aquilion One dynamic volume computed tomography system. The Aquilion One dynamic volume computed tomography system reduces diagnosis time from hours or days to minutes. It can image up to 16 cm in a single rotation, and can show dynamic movement. Its comprehensive exam reduces the need for other tests.
Submitter and manufacturer: Toshiba America Medical Systems Inc. (Tustin, CA; http://medical.toshiba.com)
"The Aquilion One scans an entire organ in a single pass and produces 4-D videos that show an organ's structure, its movement, and blood flow," says Doug Ryan, senior director, CT marketing, for Toshiba America Medical Systems. "In comparison, a 64-slice, 128-slice, or 256-slice CT scan can only capture a portion of an organ in a single pass, requiring physicians to 'stitch together' multiple scans of an organ to get a full image. The new technology helps reduce multiple exposures to radiation and exam time."
NeuroStar TMS therapy system. The NeuroStar TMS therapy system is an FDA-approved, noninvasive therapeutic device for the treatment of depression. It operates by applying a focused, pulsed magnetic field that inductively stimulates cortical neurons associated with depression.
Submitter and manufacturer: Neuronetics Inc. (Malvern, PA; www.neuronetics.com)
Suppliers: Juliana Design Group Inc. (Exton, PA); Sparton Medical Group (Strongsville, OH; www.sparton.com); Molex Corp. (Napersville, IL; www.molex.com); Gharieni GMBH (Moers, Germany; www.gharieni.de); HS Design Inc. (Gladstone, NJ; www.hs-design.com); Enser Corp. (Cinnaminson, NJ; www.enser.com); Edge Medica (Newtown PA; www.edge-pdc.com); Syncro Technology Corp. (Langhorne, PA; www.syncro-tech.com)
"It seemed to be that the technical and human factors requirements were in a constant tug-of-war for that would stump the designers," says Vince Juliana, principal industrial designer, Juliana DesignGroup. "In the end, these intense challenges only helped strengthen the result. The device is helping people. Long-term sufferers of major depression have finally been given a real solution. They are getting their life back. How powerful is that?"
Rehabilitation and Assistive-Technology Products
Lyric hearing aid. The Lyric hearing aid is an invisible, extended-wear hearing device. Its unique design and deep canal placement provides natural sound quality for up to 120 days at a time.
Submitter and manufacturer: InSound Medical Inc. (Newark, CA; www.insoundmedical.com)
Supplier: Center for Medical Device Innovations Inc. (Dublin, CA; www.centermdi.com)
"The start-up team at InSound Medical determined that the best path to a deep-canal device was to produce one that was worn continuously for months at a time," says Susan Whichard, vice president of marketing, InSound Medical. "While designing Lyric, the world's first extended-wear deep-in-the-canal hearing device, the team had to overcome many difficult technical challenges, including the development of a long-life battery with a unique elliptical shape and a low-power sound-processing circuit. [The team also overcame challenges] with materials and a design that could continuously reside in the hostile environment of the ear canal for months at a time. After five years of focused research and development, patients now wear this breakthrough hearing device that allows them to 'just hear better' 24/7."
NuStep T5XR recumbent cross trainer. The NuStep T5XR recumbent cross trainer is a rehabilitation-exercise machine that combines a comfortable, safe position with total body motion for rehabilitation and fitness at healthcare facilities, at home, and in wellness and fitness centers.
Submitter and manufacturer: NuStep Inc. (Ann Arbor, MI; www.nustep.com)
Suppliers: Sundberg-Ferar Inc. (Walled Lake, MI; www.sundbergferar.com); DeForest Engineering (Ann Arbor, MI); Griswold Engineering Inc. (Plymouth, MI; www.griswoldengineering.com); Humantech Inc. (Ann Arbor, MI; www.humantech.com); Keystone Product Development (Kalamazoo, MI; www.keystone-pd.com)
"The work we did with NuStep's design team in making the T5XR Recumbent Cross Trainer validated the important role ergonomics can play in responding to the needs of the medical and healthcare communities and ultimately the patients that they serve," says Josh Kerst, vice president, Humantech Inc.
Provent professional sleep apnea therapy. Provent is a prescription treatment for obstructive sleep apnea. Attached over the nose using a hypoallergenic adhesive, the device uses a novel valve mechanism to create expiratory positive airway pressure, which helps to keep the airway open.
Submitter: Lunar (San Francisco; www.lunar.com)
Manufacturer: Ventus Medical Inc. (Belmont, CA; www.ventusmedical.com)
Supplier: Lunar
"The pressure created by this unique valving system eliminates the need for the cumbersome and uncomfortable blower, tubing, and mask system used in continuous positive airway pressure therapy," says John Edson, president of Lunar. "Optimizing the design of the valve and the materials used was very important to achieve the desired inspiratory and expiratory resistances."
Whiz Freedom hygienic urine director. The Freedom hygienic urine director is a hydrophobic, antibacterial, and eco-friendly device that enables women to urinate standing or sitting, indoors or outdoors, without undressing. It is suitable for use by incontinent or mobility-impaired users.
Submitter and manufacturer: Jbol Ltd. (Oxford, UK; www.jbol.co.uk)
Surgical Equipment, Instruments, and Supplies
ClearCut Oval Burrs, ClearCut Round Burrs, and ClearCut SLAP Burrs. ClearCut Burrs are a line of single-use, rotary instruments that provide flush cutting and dual-suction pathways for precise resection of target bone while maintaining visibility during arthroscopic shoulder and knee surgery.
Submitter and manufacturer: Arthrex Inc. (Naples, FL; www.arthrex.com)
Suppliers: B&M Precision (Ruskin, FL; www.bmprecision.com); Somerset Plastics (Middletown, CT; www.somersetplastics.com); Sabic Innovative Plastics (Pittsfield, MA; www.sabic-ip.com)
"The primary challenges in developing the ClearCut burs were to provide an optically clear hood for improved visibility in arthroscopy over prior models, a method for securing the clear hood to the mating tube, and selecting a medical-grade clear plastic suitable for gamma sterilization," explains Ken Adams, engineering manager, shaver systems, for Arthrex Inc. "Arthrex Inc. introduced the ClearCut design by tapping into the strengths of B&M Precision for precision metal-forming capabilities, Sommerset Plastics for its expertise in injection and insert molding, and Sabic Plastics for the optimal material selection. The innovation and collaboration exhibited by all those involved has resulted in a unique line of arthrocopic instruments that is revolutionizing the way surgeons see anatomy."
Mic and Mic-Key introducer kit. The Mic and Mic-Key introducer kit enables physicians to safely and efficiently place Mic and Mic-Key balloon-retained enteral feeding tubes, which are used to deliver nutrition and medication to patients requiring long-term nutritional support.
Submitter: Three Atlanta (Atlanta; www.3atlanta.com)
Manufacturer: Kimberly-Clark Health Care (Roswell, GA; www.kchealthcare.com)
"One component of the kit that we are very proud of is the Saf-T-Pexy gastrointestinal suture anchor system," says Lanita Cox, associate marketing director, Kimberly-Clark Health Care. "One of the challenges was to create a preloaded needle system with passive safety features to improve ease-of-use and eliminate loading steps for physicians. The multi-functional, preloaded needle protects clinicians from inadvertent needle sticks by blunting the needle tip at the same time the T-fastener is deployed. We also incorporated resorbable sutures, which eliminates the need for suture removal, promotes enhanced stoma tract healing and minimizes the risk of infection. Lastly, we designed the bolster to provide a simple locking mechanism to secure the suture connection as well as being washable to promote daily hygiene, further minimizing the risk of infection."
Polar Wand endoscopic cryotherapy system. The Polar Wand endoscopic cryotherapy system offers a simple, cost-competitive, versatile, and effective treatment modality for diffuse mucosal lesions of the GI tract.
Submitter: Bolt (Charlotte, NC; www.boltgroup.com)
Manufacturer: G. I. Supply (Camp Hill, PA; www.gi-supply.com)
Suppliers: Bolt; Nexcore Technologies (Waldwick, NJ; www.nexcoretech.com)
"The modalities that are out there today are not at all that simple," says Monty Montague, principal for Bolt. "But blowing a cryogen through a series of solenoids to an exact amount is a pretty complex thing. So, making the complex simple was a big part of the design."
"Due to the Joule-Thomson effect, which is a rapid expansion of gas from a high pressure to a low pressure, there's a drop in temperature," explains Frank Carter, president of G.I. Supply. "It's what enables us to be less expensive: [The CO2] is at room temperature until it comes out of the end of the catheter. You don't have to add insulation or worry about storage of a cryogen such as liquid nitrogen."
Pulsar generator and PlasmaBlade disposable surgical cutting and coagulation devices. The surgery system includes the Pulsar generator, which generates pulsed plasma energy, and the PlasmaBlade family of disposable cutting tools. It is designed to provide the control of a scalpel and the bleeding control of traditional electrosurgery.
Submitter: California MedTech LLC (San Diego; www.calmedtech.com)
Manufacturer: Peak Surgical Inc. (Palo Alto, CA; www.peaksurgical.com)
Supplier: California MedTech
"The PEAK Pulsar Generator was one of the most challenging products we've ever developed," says Brian Kelleher, president and CEO of California MedTech. "It combines all of the cut, coag., and blend modes of a traditional electrosurgery instrument with PEAK's proprietary plasma-cutting mode. The plasma mode operates at a higher frequency than electrosurgery systems, and therefore careful attention was required during the design phase to prevent internal electrical cross-talk and to minimize patient leakage current."
"The PEAK surgery system is able to provide surgeons with the cutting precision of a scalpel, the bleeding control of their traditional electrocautery, but without all the associated thermal tissue damage," says Andre Bessette, vice president, marketing, Peak Surgical Inc. "This is something surgeons have desired for decades."
