J&J Analysis Shows a One in Three Failure Rate for Metal Hip Implants after Five Years

An internal analysis by Johnson & Johnson shows that the company has been aware of high metal hip implant failure rates since 2011. According to a report by Bloomberg, the J&J analysis concluded that approximately 37 percent of DePuy Orthopaedics' ASR metal-on-metal hip implants would require replacement at five years. DePuy Orthopaedics is a subsidiary of J&J. The internal documents showing this high failure rate were revealed during the discovery process of a patient lawsuit. In 2011, the company circulated the analysis internally. During this time, a high-profile recall of its metal-on-metal ASR hip implants was underway. The recall led to approximately 10,000 lawsuits against the company. According to some analysts, the final costs from the faulty hip implants could cost the company up to $1 billion in liability damages. Paul Voorhorst is a biostatistician at DePuy. During pretrial hearings for an injury lawsuit, he corroborated the accuracy of the internal analysis. The internal study showed that out of 550 implant hips, approximately 37 percent would require replacement or revision after 4.6 years or less. J&J attempted to downplay concerns over the internal analysis. In prepared remarks, Loie Gawreluk, a spokeswoman for the company, stated that the 37 percent figure originated from "a small, limited set of data that could not be used to generalize the revision rate for ASR, unlike published data from national joint registries that include large numbers of patients and detailed revision information." References http://washpost.bloomberg.com/Story?docId=1376-MH21X407SXKX01-41DTEAUAQGRRCIC8EKSGQMCN7F Lesson Learned from the DePuy Recall: It's All Material Metal-on-Metal Hip Implant Controversy Escalates Lubricant Research Could Lead to Improved Metal-on-Metal Implant Alloys

Overcoming Engineering Challenges: Taming ‘-omics’ Data

Syapse (Palo Alto, CA), a startup trying to bring genomic data into routine clinical use, is developing a data-management platform to enable clinicians to sift through the mounds of data generated by "-omics:" genomics, proteomics, metabolomics, and transcriptomics to ultimately improve the diagnosis of a variety of potential illnesses. The end goal is, as a GigaOm article puts it, "to make mining omics data as simple for its users as Salesforce.com makes [customer relationship management] for its users." 

MPMN reached out to Syapse to get a sense of some technical perspective on how the company is going about doing that. Namely, we asked the company's chief technology officer, Tony Loeser what the company's primary engineering hurdles are (which are obviously software related, rather than mechanical) and how it has overcome them.

"An example challenge is the complexity of the content that we are dealing with. Biology and medicine are precise sciences, with tens of thousands of concepts and interrelationships between those," says the firm's chief technology officer, Tony Loeser. "There are dozens of public ontologies describing the structure of biomedical knowledge. Every company we work with sees this data landscape differently, and has different data integration needs. We need to be able to accommodate all of that within our application suite."

"Our approach has been to build our biomedical information store on a semantic, RDF (Resource Description Framework) back end. Working together with customers, we are able to craft ontologies that describe precisely their view of the data that they work with and interact with," Loeser continues. "Much of the functionality in the application is configured automatically based on the custom ontologies, providing a fully customized interface for each customer." For high volume -omic information that is not amenable to RDF storage, the company is building specialized data stores to allow both Big Data-style data manipulation and a semantic view of relevant subsets of the data, he explains.

"Looking ahead, we feel that this data architecture uniquely prepares us for the ever-present challenges such as data integration, customer-driven model customization, or precise management of data central to a collaboration."

Brian Buntz is the editor-in-chief of MPMN. Follow him on Twitter at @brian_buntz.

CryoPop, a Device for the Developing World Created with 3-D Printing

Score another point for 3-D printing. Momo Scientific, the developer of a low-cost medical device for use in developing nations, has been able to finish prototyping their innovative device thanks to high-resolution 3-D printing. Developed alongside Jhpiego, a John’s Hopkins University-affiliated NGO, Momo Scientific's device, the CryoPop, is aimed at providing pap tests in developing countries where such procedures are prohibitively expensive. By converting CO2 (which is available cheaply thanks to the soda industry) into dry ice, the CryoPop can treat cervical pre-cancerous lesions by freezing them. The company says the procedure is akin to freezing warts off of the skin. Moreover, the device is simple enough that trained nurses and midwives can be trained in the procedure – further reducing healthcare costs in regions of India and Sub-Saharan Africa, where nurses are often more available than doctors.

Marton Varady, CryoPop's project manager, discovered he would need a higher resolution 3-D printer than was currently available to him to create prototypes for the CryoPop. He found his answer with a printer being used by Potomac Photonics, a Maryland-based micro manufacturing company. In a press statement, Varady comments, “The resolution of this 3-D printer was much higher than what we had in our onsite lab. Working with tolerances in the 1 – 2 thousandths range gave us the parameters we needed to fulfill the design requirement. Plus, we could make the entire part in one piece, which increased robustness.”
While the final version of the CryoPop may not be manufactured entirely with 3-D printing, Varaday comments that 3-D printing played a large part in helping Momo Scientific move forward with the project. “3D printing can’t always do everything we need, but it is a great tool and has solved some tough problems in our project. It really helped move us toward saving women’s lives!”
The CryoPop is currently undergoing animals studies. Momo Scientific predicts it will be available to market in the next two years.
-Chris Wiltz is the Associate Editor of MD+DI

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MD&M West 2013 Product & Service Preview

The following selection includes products and services that will be offered by a range of exhibitors at MD&M West, February 12-14, 2013.

Precision Wire and Tube Bending
Specializing in prototyping and the use of custom tooling for material machining and forming, Marshall Manufacturing Co. offers services in automated and robotic precision wire and tube bending. Tubes 0.050 to 0.500 in. in diameter and wire in diameters of 0.050 to 0.375 in. can be formed. The ISO 13485-certified company assists clients with decisions about the materials and processes that will lead to the achievement of the best form, function, and manufacturability for any medical part. Using such techniques as electrical-discharge machining, flaring, swaging, and laser machining, the company manufactures parts from premachined wire and tubing. Premachining operations include precision cutoff, turning, and milling of special tips, such as trocar, bullet, barbed, pencil, and other types. These operations can also produce cross holes, grooves, and slots, all with precise tolerances. Premachined parts can be bent to orient their machined features on each end to a precise final destination using customized separators and indexing.
Marshall Manufacturing Co.
Booth #1191

Bioabsorbable Polymer
Lactoprene SMC7, a lactide-based bioabsorbable polymer, is part of a suite of proprietary customized polymers from Poly-Med Inc. The material maintains an extended mass-loss profile of one to two years based on the final device construct and enables constructs to retain strength for much longer than typical glycolide-based absorbable materials, according to the manufacturer. A copolymer composed of FDA-accepted monomers, it has a long shelf life and can be extruded into a variety of constructions. The material is used in such medical devices and applications as sutures, meshes, and coatings that are best made from a longer-term absorbable material.
Poly-Med Inc.
Booth #731

Product Design Services
Specializing in product design services, Precision Tool & Die focuses on creating practical device solutions that take into account the client's requirements for production speed, efficiency, and economics. The company offers such services as concept generation, design input, design planning, analytical study and design refinement, 3-D drawings, prototyping, cost estimations, and design review. Capabilities in plastic injection molding, mold design, mold manufacturing, prototyping, short- and long-run production, contract assembly, and value-added services for medical device manufacturers are all offered at a single location.
Precision Tool & Die
Booth #1495

Heat-Sealing Machine
Designed to support medical device packaging productivity in short-run production and laboratory and resealing applications, the Aergo 1M one-station heat-sealing machine from Sonoco Alloyd has a single manually operated nesting tray that slides out for loading and in for sealing. The tray features a sealing area measuring 12 × 18.5 in. Precise, reliable seals can be produced with a single 3.9-kW heater platen that provides operating temperatures up to 550°F. Standard machine features include a dual-readout digital temperature controller, a digital timer for heat-seal dwell contact, a digital cycle counter, and design elements that promote operator safety and convenience. Available with an array of accessories and options, the system can be delivered in a cleanroom-compatible version. The 600-lb machine can be mounted on a cart for mobility. Volume capacity ranges between 1000 and 2000 packages per shift.
Sonoco Alloyd
Booths #604, 5039

Machined Fluidic Components
Swiss Productions Inc. manufactures screw-machined parts for fluidic systems. Capable of machining plastic or metal components in prototype quantities to long runs, the company operates a facility equipped with more than 50 screw machines that can produce components ranging in size from 2.5 in. in diameter down to syringe tips measuring 0.019 in. in diameter. Capabilities include the production of Teflon and ultra-high-molecular-weight syringe tips for premium-quality syringes, the creation of precision sealing surfaces, and the maintenance of tight tolerances to ensure seal integrity. In addition to plastic and metal medical syringes, the service provider machines valve and pump components, PEEK and CTFE connectors, and more.
Swiss Productions Inc.
Booth #2898

Suction Filters
A line of hydrophobic vacuum protection filters designed to help guard suction systems against bacterial, viral, and biohazardous contamination and preserve system performance have BFE and VFE ratings above 99.999%. Available from the developer AG Industries in several sizes and port configurations, the specialty filters additionally provide low pressure resistance. The manufacturer offers custom systems in addition to standard suction filters. Its vertically integrated manufacturing capabilities facilitate custom filter design, with variously configured housings, end fittings, and filter media being strategically combined to satisfy the customer's specific flow and filtration requirements. Durable construction from hypoallergenic materials makes these vacuum filters suitable for use in aspirators, equipment for negative-wound-pressure therapy, and gas sampling systems.
AG Industries
Booth #1429

Tube Measuring System
An integrated QC system for accurately measuring the critical dimensions of plastic medical tubes and tubular products consists of the UltraScan ultrasonic gauge, AccuScan laser-based scanner, LaserSpeed noncontact encoder, DataPro process controller and data management system, and BenchMike system for measuring tubing cut lengths. Beta LaserMike supplies the system to manufacturers of IV components, catheters, and similar products that need to maintain a high level of production control to meet stringent industry requirements for product quality and safety. Measuring the wall thickness and concentricity of medical tubes with precision, the ultrasonic gauge is equipped with patented technology for automatically setting up measurement parameters and efficiently tracking product variations. The laser scanner measures product diameter and ovality, the encoder measures product length and speed, the process controller monitors system gauges, and the tabletop measures cut tubing.
Beta LaserMike
Booth #2637

Precision Ceramic Parts
Ceramaret S.A. manufactures precision components for medical devices and analytical instruments from very hard high-purity ceramics, including 99.9%-pure alumina and TZP zirconia. It also employs 96%- and 99.7%-pure alumina and zirconia-toughened alumina. Suited for use as insulators, flow-control components, blades, feed-throughs, and other parts, the materials are inert, biocompatible, and insulative and resist high temperatures and aggressive solvents. The 99.9% alumina and TZP zirconia meet applicable international standards for implantable devices. The manufacturer uses single- and double-effect pressing, cold isostatic pressing, and hot isostatic pressing techniques to form parts with near net shape from compacted ceramic powder. It produces parts in-house, from generation of the powder to the finished component. CNC machining, centerless grinding, lapping, and honing are offered for secondary processing.
Ceramaret S.A.
Booth #1427

Small-Bore Connectors
Secure, leak-free SnapQuik connectors offer a safe option for small-bore connection of medical tubing in air-driven devices and other applications. Developed by Colder Products Co., these fluid connectors are designed to provide a more-reliable alternative to luer fittings. By not mating with standard luer fittings, they reduce the chance of misconnections that can lead to patient injury or death. Featuring a streamlined exterior and a special internal-latching mechanism that makes them easy to clean, the connectors reduce the risk of dirt buildup and thus help minimize the potential for patient infection. The connection produces an audible click, and disconnection is effected quickly and simply using a breakaway latch mechanism. Designed for 3/32- and 1/8-in. tubing, the connectors deliver high-flow fluid transfer in a small profile. They are suited for such applications as air-inflated cuffs, surgical devices, and monitoring equipment.
Colder Products Co.
Booth #2455

Bluetooth Serial-Port Modules
The dual-mode OBS421 Bluetooth serial-port module and single-mode OLS425 and OLS426 Bluetooth low-energy serial-port modules from medical wireless system supplier connectBlue Inc. are self-sufficient Bluetooth low-energy modules with the UART interface. All three products are a complete embedded stack and are suited for replacing serial cables or accessing Bluetooth low-energy UART devices through the manufacturer's low-energy serial-port service. The single-mode modules offer a long battery lifetime, and the dual-mode module provides compatibility support for both low-energy Bluetooth and Classic Bluetooth. The OLS426 module is interchangeable with Classic Bluetooth modules made by the same company.
connectBlue Inc.
Booth #1385

Chamber-Cleaning Tool
The EasyReach cleaning tool has been designed by Contec Inc. for use in cleaning and disinfecting isolators, laminar-airflow hoods, cabinets, and gloveboxes. Made from lightweight stainless steel and featuring a 360° pivoting mop head, the autoclavable product enables users to swab walls, corners, ceilings, and otherhard-to-reach areas single-handedly and with minimal effort. The cleaning tool can be used with a variety of sterile, presaturated, and nonsterile disposable cleaning pads available from the supplier. It works with a quick-connecting mop system consisting of a 7.5-in. stainless-steel mop-head frame and a choice of several complementary handles. One available handle is 16 in. long and made of stainless steel. Two others--one in anodized aluminum and one in stainless steel--are also 16 in. long but can extend to a potential length of 30 in.
Contec Inc.
Booth #1924

Digital Pressure Sensors
Digital ultra-low-pressure sensors in ranges down to 25 Pa full scale use a special compensation technology to achieve long-term offset stabilities better than 0.1% in measuring air and gases. Supplied by First Sensor AG, these Sensortechnics LDE flow-based differential-pressuresensors include a microcontroller for precision digital-signal conditioning and can attain high levels of accuracy. They are offered with a digital SPI bus and analog output. The sensors are based on a sensitive thermal mass-flow-measuring principle and provide high-resolution signals. Because the flow channel and sensing elements are integrated within the silicon sensor chip, gas flows in very low volume. This design effectively immunizes the sensors against dust contamination and humidity and allows the use of long connecting tubes and input filters without loss of their calibrated accuracy, the company says.
First Sensor AG
Booth #419

OEM Dispensers and Pumps
Fluid Metering Inc. supplies precision low-flow dispensers and metering pumps with a valveless, one-moving-part design to the medical device OEM market. The OEM line of products for use in medical diagnostic and analytical instrumentation includes fixed- and variable-displacementoptions. Standard models are available in a range of output volumes from 500 nl per dispense to 1.28 µl per revolution. Custom models can be designed to meet specific application requirements. Performance capabilities include flow coefficients of 0.5% or better and ±1% accuracy, along with good chemical resistance. The manufacturer offers stepper control kits ranging in sophistication from basic Quick Start control to advanced programmable stepper development for precision fluid control.
Fluid Metering Inc.
Booths #2283, 2383

Multiple-Channel Liquid Dispenser
Available from IVEK, the Multiplex multiple-channel dispensing system for sterile filling applications is able to deliver liquid volumes ranging from less than a ?l up to 4 ml in a single stroke. The three-piece positive-displacement ceramic pump modules are engineered to eliminate particulate contamination while exhibiting high accuracy and repeatability. Designed to be hard and abrasion resistant, they keep the dispensing system from showing wear even after hundreds of millions of cycles, according to the company. Each piston-cylinder set has a ceramic rotary valve that is separately controlled, allowing the pumps to be individual enabled or disabled. The pumps are easily removed from the actuator for cleaning or autoclaving. Applications include sterile filling, syringe filling, and form-fill-seal systems.
IVEK Corp.
Booth #3311

Hemostasis Valve Y-Connector
Qosina catalog item 80448, a one-handed hemostasis valve y-connector that allows independent manipulation of several guidewires, is offered with two wire-lock adapters, item numbers 80449 and 80450. These adapters work in conjunction with the valve in applications involving multiple guidewires. With the single-handedcontrol-lever action, light fingertip pressure enables users to lock and release the connectors, leaving the valve open, semiopen, or closed. A solid click clearly identifies the valve position through tactile as well as acoustic feedback. The connector housing, made from polycarbonate and polyoxymethylene, exhibits both high clarity and resistance to extreme temperature. Aiding in the control of backflow, the silicone valve fits guidewires measuring 0.118 in. and smaller in diameter.
Booth #2121

Small Thermistors
Designed for use in applications in which long lead length, small size, or consistency of tip size are important, E300-series miniature and microsize thermistors from Quality Thermistor Inc. are incorporated in catheters, skin temperature monitors, and hypodermic and other housings. The tips of these thermistors measure 0.023, 0.031, and 0.037 in. in diameter. Their leads are solid nickel or copper, with polyesterimide or polyurethane insulation, and are sized at 32 or 38 AWG. The overall part length ranges from 3 to 36 in. The series operates at temperatures between 0° and 70°C, features a typical time constant in still air of 3 to 4 seconds, and has a typical dissipation constant of 0.2 to 1 mW/°C in still air, depending on the model. RoHS compliant, these resistors are available in point-matched and interchangeable tolerances.
Quality Thermistor Inc.
Booth #746

Biomedical Textile Engineering Services
Secant Medical Inc. offers custom engineering services to manufacturers of cardiovascular, neurovascular, orthopedic, and other types of medical implants. The company partners with OEM development teams to design and manufacture components made from advanced polymeric, metallic, and resorbable biomaterials such as polyesters, polyethylenes, polylactides, polyglycolides, polyaryletherketones, stainless steel, nitinol, and titanium. It can shape implantable medical fabrics--including low-profile options--into planar, tubular, or complex component structures that exhibit specified functional behaviors and performance characteristics. Helping device manufacturers design biomedical textiles that satisfy custom requirements, the company provides services that involve biomaterials research, engineering collaboration, custom product design, prototyping, and advanced manufacturing.
Secant Medical Inc.
Booth #1743

Balloon Catheter Coating System
Offered by Sono-Tek Corp., the fully enclosed and programmable MediCoat BCC system is used for coating common sizes and types of balloon-mounted catheters with drugs for delivery during in vivo medical procedures such as angioplasty. Fitted with either MicroMist or AccuMist ultrasonic atomizing nozzles, the system generates a low-velocity soft spray and uniform micron-sized droplets to ensure good adherence to balloon surfaces without any overspray, cracking, or peeling of the coating. The subsequent drying procedure is automated, according to coating requirements. Ultrasonic spray technology enables thin functional coatings to be created reliably and repeatably at low flow rates and with good control of spray characteristics.
Sono-Tek Corp.
Booth #1440

Ultrasonic Air-Bubble Sensors
Compact Sonocheck ABD07 clamp-on ultrasonic sensors for quick, reliable contactless air-and gas-bubble detection in liquid-filled tubes are supplied by Sonotec Ultraschallsensorik Halle GmbH to manufacturers of miniaturized and portable medical devices. Measuring 25.40 × 19 mm and 15.75 mm high, the minisensors offer performance comparable to much larger conventional air bubble detectors, according to the manufacturer. Bubble-size sensitivity and other parameters can be specified by the user. The manufacturer can also produce custom devices as necessary. Equipped with a programmable microcontroller, the sensors additionally perform liquid-level monitoring and full-empty detection. Their measurement cycle is 200 microseconds, typical response time is 1 millisecond, and guaranteed detection capability extends down to bubbles sized at one-third of any tube's inner diameter.
Sonotec Ultraschallsensorik
Halle GmbH
Booth #3593

Contract Injection Molding
Sunny Medical Device (Shenzhen) Company, Ltd., supplies OEM, ODM, and customized medical devices and assembly components on a contract basis to customers worldwide. Specializing in such interventional cardiology and radiology devices as balloon inflators, guidewires, angiographic needles, manifolds and stopcocks, pressure lines, hemostasis y-valve kits, angiographic control syringes, pressure transducer kits, heparin caps, and stoppers for guide catheters, the company offers capabilities in plastic injection molding, assembly, packaging, and EtO sterilization. It offers custom versions of the enumerated devices and of others as well. The service provider can develop new molds based on customer samples. All production procedures are conducted under conditions certified to ISO 13485, and all finished products are CE certified. Both sterile and nonsterile products are available on an OEM basis.
Sunny Medical Device (Shenzhen) Company, Ltd.
Booth #3095

Laser-Processing System
The fully automated Accu-Lase V200 laser-processing system, part of the line of low-maintenance catheter and guidewire processing equipment supplied by Syneo, is designed to optimize users' process capability in the production cutting of polyimide tubing, the making of complex holes, and the marking of polymer components. Pioneering a new generation of machine technology from the manufacturer, the system embodies proprietary motion control and handling knowledge combined with precision laser-based material processing methodology for catheters and guidewires. To help customers incorporate laser technology into their manufacturing processes, the equipment company offers comprehensive laser technology support services in accordance with Six Sigma; education and training, maintenance, service calls, and repair services are available.
Booth #3315

Wound-Care Components, Adhesives
Vancive Medical Technologies provides components and systems for developers, manufacturers, and converters of temporary adherent medical devices. Products include the InteliShield DEHP-free barrier film for ostomy applications, the BeneHold securement and wound-care solutions platform, a thin absorbent skin adhesive (TASA) platform, and pressure-sensitive adhesives in single- and double-coated, self-wound, and transfer tape constructions. The multicomponent plastic barrier film is made without PVC, PVDC, or plasticizers and with an optional nonleaching antimicrobial inner surface. The wound-care platform includes thin, conformable dressings that manage lightly to moderately exuding chronic and acute wounds, and the securement components and finished products include medical-tape strips and a tube-fixation device. The TASA platform delivers fluid-handling performance that supports extended wear time for dressings.
Vancive Medical Technologies
Booth #712

Pumps for Surgical Ablation
The OEM pumps in the 400RXMD family have been specifically designed by Watson-Marlow Pumps Group for the surgical ablation market.  The pumps are suited for equipment employing radio-frequency ablation. They can also be used to pump cooling fluid for precise temperature control in surgical systems for the treatment of cardiac arrhythmia, cancer, and other procedures. The pumps are offered in a range of precision pressure settings to suit specific applications, feature a mechanism engineered to improve flow accuracy as compared with that of a predecessor line, and have a tube holder that ensures correct positioning of a newly loaded tube each time the safety lid is closed. Available in 10 variants, the pumps provide flows up to 500 ml/min at 550 rpm and deliver pressures up to 8 bar. The offer of two stepper motors and one brushless-motor option enables pump users to set pressure, flow, and rotation direction.
Watson-Marlow Pumps Group
Booth #1713

Conductive Pad-Printing Ink
AG-1074 silver conductive ink for pad-printing high-definition fine-line traces in hard-to-print areas of electronic medical devices is offered by Conductive Compounds Inc. Providing design engineers with flexibility in creating circuits, the ink is designed to print well in recessed areas of hard-plastic device substrates and on raised surfaces, unlike screen printing and other conventional printing processes that cannot access contoured surfaces, according to the manufacturer. Solvents can be adjusted for compatibility with specific substrates or medical-grade silicone pads. The ink also enables design engineers to incorporate electronic circuit traces into molded parts more easily.
Conductive Compounds Inc.
Hudson, NH
Booth #1447

Filter Vents
Donaldson Company, Inc., provides filter vents made with proprietary Tetratex expanded-PTFE membranes for a variety of medical device applications, such as devices requiring acoustic and protective vents, drainage bags, IV-administration sets, ostomy bags, urine bags, and device packaging. The vents are hydrophobic, toxicity-tested to USP Class VI standards, clean and nonshedding, chemically inert, and thermally stable. They feature high particulate and bacterial removal rates and high rates of airflow, and are designed to minimize extractables. Oleophobic and acoustically transparent materials are optionally available. Equipped with design and filtration-material expertise, the manufacturer offers custom systems that are easily integrated into the customer's device or application.
Donaldson Company, Inc.
Booth #974

Automatic Tubing Cutter
The Model WC601B benchtop automatic rotary-blade cutter is engineered to cut flexible tubing and sleeving to a programmed length and number of pieces easily and accurately without crushing processed material. Manufactured by the Eraser Company, Inc., the unit is suited for processing tubing to tight specifications. The minimum cut length is 0.100 in. while the maximum tube size accommodated is 0.500 in. OD. Ten variable feed rates allow the operator to choose the best rate for a given material in order to optimize productivity and cut-length repeatability and accuracy. A batching feature enables users to program all variables for as many as 99 different frequently run jobs, and a kitting feature allows users to cut multiple pieces of different lengths within a single batch.
The Eraser Company, Inc.
Syracuse, NY
Booth #2264

Ultrasonic Punching and Welding Machine
The HiQ MPW ultrasonic punching and weld-sealing machine has been designed by Herrmann Ultrasonics to save medical device manufacturers material and steps in the production of plastic components with integrated filter membranes. Supplied as a manual workstation or integrated into an automation line, the modular system can punch and weld at the same time. In a single step, the unit transports the membrane by conveyor, punches the membrane contour, and welds the membrane onto the part in a weld cycle time of less than 2 seconds. Downstream optical quality control is not needed because the system has its own vacuum monitor to check whether the membrane is correctly punched and positioned. The machine control features gentle conveyor transport with a splice check to minimize other sources of error and thus production downtime.
Herrmann Ultrasonics Inc.
Bartlett, IL
Booth #3235

Synthetic Latex
Cariflex IR latex, a synthetic latex alternative to natural rubber for surgical gloves, medical bandages, catheters, tube connectors and other applications requiring high levels of purity, user protection and comfort, and product quality, exhibits the high tensile strength and tear resistance of natural rubber without the impurities that cause discoloration, odor, and allergic reactions. Kraton Performance Polymers Inc. produces the versatile polyisoprene material in a precisely controlled environment in solid and latex forms, without employing organic solvents. The latex version it supplies is able to be processed by manufacturers on production lines designed for natural rubber when process parameters have been adapted. Used in gloves, the latex not only provides protection against reactions to rubber proteins, but also can enhance comfort and minimize hand fatigue.
Kraton Performance Polymers Inc.
Houston, TX
Booth #618

Digital Temperature Sensor
Suitable for many electronic systems, the Model TSYS01 digital temperature sensor from Measurement Specialties Inc. encapsulates a temperature sensing chip and a 24-bit analog-to-digital convertor in a QFN16 package. Its technology provides onboard factory calibration coefficients that deliver accurate temperature information accompanied by high measurement resolution. For enhanced application-specific performance, the manufacturer can perform custom calibration upon request. The sensor draws less than 12.5 ?A during normal operation and under 0.14 ?A in standby mode. Because of its small size, expansive operating temperature range of -40° to 125°C, and ±0.1°C accuracy, it can serve as a replacement for thermistors. Integration with microcontrollers is achieved via an I2C or SPI interface.
Measurement Specialties Inc.
Hampton, VA
Booth #430

Self-Sealing Porous Media
Porex Corp., a specialist in sintered porous plastic components for medical device applications, makes sintered self-sealing porous media capable ofblocking a range of polar organic solvents and acidic solutions. These porous self-sealing media have high gas permeability and good bacterial filtration capability. Additionally, the media can be manufactured with an indicator that changes color when it is exposed to a liquid. They are offered to help support the prevention of contamination and infection, especially in fluid-management applications.
Porex Corp.
Fairburn, GA
Booth #2915

High-Purity TPV Elastomers
Teknor Apex Co. has added two high-hardness grades to its Medalist MD-200 series of thermoplastic vulcanizate (TPV) elastomers: compound MD-240 at 87 Shore A and MD-245 at 43 Shore D. The latter grade has a durometer roughly equivalent to 93 Shore A. Designed and qualified to replace rubber in medical device applications, the line of resilient, high-purity, nonhygroscopic compounds now includes grades ranging in Shore A durometer from an ultrasoft 15 to the newly introduced hard compounds. Their rubber-like properties include low long-term compression set, high fatigue resistance, prolonged flex life, stability at high temperatures, abrasion resistance, and long-term sealability. Suitable for extrusion, injection-molding, and blow-molding processes, the hard grades can be used for the production of peristaltic tubes; collection and drainage tubes; vial, cap, and plug stoppers; seals and gaskets; device handles; ergonomic soft grips; valves; and diaphragms.
Teknor Apex Co.
Pawtucket, RI
Booth #2526

Notified Body
The technical service organization TÜV SÜD America Inc. is a large-scale medical device notified body and testing laboratory. The company provides a suite of services that includes CE-marking and CB Scheme, as well as electrical, electromagnetic-compatibility, functional safety, and biocompatibility testing. It serves as a notified body for the EU Medical Devices Directive, Active Implantable Medical Devices Directive, and In Vitro Diagnostic Directive. In addition, the organization provides FDA 510(k) reviews and third-party inspections and certifies medical device manufacturing enterprises to ISO 9001, ISO 14001, ISO 13485, and CMDCAS standards.
TÜV SÜD America Inc.
Peabody, MA
Booth #1852

Electronic Manufacturing
With recently added manufacturing capacity, electronics manufacturing services provider Valtronic offers medical device industry customers expanded capabilities in surface-mount (SMT) manufacturing, assembly, and testing. The larger and more-efficient SMT area is equipped with 12 SMT machines. In addition, a larger cleanroom is now available for sensitive products. Flow-based production cells are in place for projects of all types, with IPC-A-610 inspectors assigned to each of them to ensure that quality standards are met through every step of the manufacturing process.
Solon, OH
Booth #1586

Developing Improved Biomaterials: Increasing Tissue Growth, Decreasing Infection, and Inhibiting Inflammation without Drugs

Thomas J. Webster, department chair, chemical engineering at Northeastern University (Boston), will speak on "Developing Improved Biomaterials: Increasing Tissue Growth, Decreasing Infection, and Inhibiting Inflammation Without Drugs" at the MD&M West MedTech Innovate Seminar taking place on Tuesday, February 12.

MPMN: Which themes do you intend to cover in your presentation at the MedTech Innovate Seminar, and why are these themes important?

Webster: One of the important emerging medical device areas is the use of nanotechnology. Nanotechnology is often defined as the creation of materials--be they particles, grain, or tubes--that have at least one dimension less than 100 nm. When you make such small materials, they essentially have much different properties than larger materials, such as micron-sized particles, grains, or tubes. The size range of nanomaterials provides unique properties, one of which is superhigh surface energy. When you think of medical devices, surface energy is a critical property for interacting with cells, tissues, and the body, since the body is primarily composed of water. If you have materials with high surface energy, you have materials that will interact better with the body.

A key feature of my presentation will be a discussion of what is happening with the field of nanotechnology and medical devices. This is a quickly changing field; there is a lot going on. FDA is incredibly interested in what this new size range of materials is doing for tissue growth, what is happening in terms of safety, how to manufacture nanomaterials, and how they are being used to help everything from hip implants to catheters. That's a lot of what my talk will summarize. Of course, the reason why I'm talking about it is because many companies and researchers at universities are reporting increased tissue growth through the use of nanomaterials--these high-surface-energy materials.

The excitement surrounding nanomaterials is also being transferred to old materials. Such older-type materials as titanium, which has been used as a hip-implant material for decades, are getting a new lease on life and being received with a new burst of excitement as manufacturers are beginning to make them out of nanoparticles or fabricate them with nanofeatures. Associated with the use of such materials is increased tissue growth, including bone growth.

MPMN: For cardio, orthopedic, or other medical device applications, what are some of the challenges facing designers and developers of biomaterials?

Webster: This is another thing I'll discuss at the seminar. An area that we have not conquered in the medical device sphere is infection control. If you look at the statistics, the entire globe is seeing an increased number of infection cases caused by medical devices. Thus, whether you're talking about orthopedics or such cardiovascular applications as stents, heart patches, or catheters that are used over a long period time, infection is a big problem. And as we know, the way we've tried to combat this problem thus far is by developing antibiotics. But bacteria are proliferating so quickly that it's easy for them to evolve and mutate, enabling them to resist antibiotics. We are constantly behind the curve. We're constantly trying to develop new antibiotics, but by the time we bring them to market, the bacteria have begun to develop resistance to them, and they aren't effective anymore.

Thus, one of the challenges that still remains and for which I'll highlight some approaches is medical device-related infection. This is an issue that we really have to get a hold on because we're spending so much time and effort in developing better orthopedic or cardiovascular implants only to see them cause infections.

We'll talk about strategies for combating this problem. One such strategy that appears to be working and that does not involve the use of antibiotics is using nanomaterials to change the surface energy of implant materials. For example, I'll highlight a study in which we have taken a catheter made from a material that is frequently associated with infection. We have created nanoscale surface features on the catheter that change the surface energy so that the device can repel bacteria. Fortunately, we are seeing no cases of infection from these catheters with nanoscale features. This is a nondrug, nonantibiotic approach; we are using surface properties to improve the functionality of the medical device.

MPMN: What do you see as the role of tissue ingrowth for fighting infection and inflammation?

Webster: Unfortunately, bacteria will proliferate if they're present in the area of the medical device. In addition, they will grow much quicker than tissue and mammalian, or tissue-forming, cells. Thus, in a sense, we're already a couple of steps behind in the competition. The bacteria will beat mammalian cells to the surface and grow.

One of two things can happen if bacteria are present on the medical device. Either they will grow at an incredible rate and form a biofilm, preventing tissue from growing. Or, if they grow at a slow rate, tissue will grow in the midst of the bacteria, causing tissue infection. And if bone gets infected, it becomes very weak. Thus, if someone has a hip implant and the bacteria on the implant intermingle with the bone, you will have very weak bone surrounding the implant. That's most likely where the bone will fracture, forcing the patient to undergo replacement surgery. Unfortunately, the current solution to an infection is to remove the implant. That's the last-resort situation you want to be in, but that's commonly what has to happen because we have no way of stopping the bacteria from growing once they reach a certain population density.

Combating this problem is where approaches such as nanotechnology are really needed. We need to keep bacteria from attaching to medical devices in the first place, but if they do attach and grow on the medical device, can we use nanoparticles to combat them? Yes, we can actually direct nanoparticles to go into the biofilm, into the bacteria, and kill them without having to remove the implant. We're seeing indications that we can create nanoparticles that could be injected around an infected implant to kill the bacteria and remove the infection so that you don't have to ask the patient to go through a costly, time-consuming, and detrimental surgery. This is another topic that I will cover in my presentation.

MPMN: How close to commercialization are the nanotechnology applications you are addressing here? And what about the potential cytotoxicity dangers associated with nanotechnology?

Webster: Let me preface this by saying that many of us in this field view nanotechnology as having two parts. One part is nanoparticles. Many people are using nanoparticles to fight cancer or improve disease detection. That's one part of nanotechnology. Another part that is actually closer to commercialization is using nanotechnology to create nanofeatures on implants. This application does not have to involve nanoparticles. There are ways that you can create nanodimensional features on existing implants that do not involve the use or the shedding of nanoparticles.

One such nanotechnology surface-modification technique is called anodization. Already employed in the medical device community, anodization is a process that manufacturing companies often use to color code their medical devices. It's an electrochemical process that changes surface roughness. Thus, an orthopedic screw can have a greenish tint if it's anodized one way and a blue tine if it's anodized a different way. What people are doing in the nanotechnology field is changing this electrochemistry so that you produce nanofeatures rather than micron-size features that change the color of an object.

Furthermore, anodizing orthopedic implants to create nanofeatures is close to commercialization. There are a couple of efforts in which companies have submitted applications for FDA 510(k) approval because they are not changing chemistry by using this approach. They still start with titanium, but they're changing its roughness characteristics, and that's a much easier way to get FDA approval.

In terms of commercialization, I might also add that we have tested a silicon nitride product with nanoscale features offered by a company called Amedica (Salt Lake City). This product almost looks as if it has little blades of grass growing on the surface. We performed a number of animal and in vitro studies showing that this material does a better job of improving bone growth than titanium. But more importantly, it decreases bacterial function, and it does this without the use of antibiotics. The material's surface energy and surface roughness decrease bacterial function. Amedica is selling this material commercially, and it's being used in spinal implantations. In addition, FDA recently granted the company expanded claims for antiinfection properties. It's the first FDA-approved material that I know with an antiinfection claim that does not involve releasing a drug.

MPMN: What conclusions do you hope attendees at the MedTech Innovate Seminar will draw from your presentation?

Webster: One conclusion that I hope attendees will draw from my talk is that we don't have to give up on the materials that we are inserting into the body today. Many companies, academicians, and clinicians think that we need brand-new chemistries to improve the performance of our medical devices. I don't think that this is true. By highlighting this new material size, by highlighting nanotechnology, we open the door again to all of the chemistries that we've been inserting into the body for a long time. However, we may need to change small things about them to make them perform better. I think that's a valuable thing for people to hear. At the same time, this approach can also accelerate the process of commercializing new medical implant technologies.

One criticism of nanotechnology and regenerative medicine is that the next material that we will develop, get approved, and use in people is still decades away. But again, by concentrating on the old chemistries and using old materials with different dimensions, we can speed up the FDA approval process, accelerate commercialization, and really help people faster.

Using Risk Management to Successfully Deploy Wireless Medical Devices

Ken Fuchs, senior principal architect, Enterprise Systems at Mindray (Mahwah, NJ), will speak on "Using Risk Management to Successfully Deploy Wireless Medical Devices" at the MD&M West MedTech Innovate Seminar taking place on Wednesday, February 13.

MPMN: What do you intend to cover in your presentation at the MedTech Innovate Seminar?

Fuchs: My topic is about risk management and how to apply it within a hospital setting. The presentation will try to improve awareness among both hospitals and device manufacturers that there is a shared responsibility between them when they deploy medical devices on the hospital's internal IT networks.

Historically, many medical devices were deployed on networks, but most of them were on isolated networks. Thus, in the case of patient-monitoring or infusion devices, the vendors would come in, install their own hardware, run their own cables sometimes, connect everything together, and basically have a locked-down network rather than connect the devices to anything else in the hospital.

Then at some point, people decided that they needed some data from these systems, and this was accomplished by building gateways that sat across the networks. Thus, you had a PC of some sort with two different network interface cards. Data from the medical device was collected from the closed network provided by the vendor and then shipped to clinical information systems or electronic medical records systems using the hospital's IT network.

More recently--especially with the advent of wireless--there has been greater demand to merge all of these separate networks into one network and not duplicate the infrastructure. But this effort has led to new issues facing vendors. Previously, they owned the whole network and knew what they were getting from it, but now they are sharing it with other, probably unknown systems and devices, and now there is some onus of responsibility that moves from the vendor to the hospital's IT organization.
First, the vendors and hospitals have to be aware of this situation, and second, they have to try to manage the corresponding risk, especially since we're talking about medical devices that can cause patient safety issues if they don't operate properly.

MPMN: Are these vendors medical device OEMs or suppliers of wireless connectivity solutions and software?

Fuchs: These vendors often include manufacturers of patient-monitoring equipment, infusion devices, and imaging systems. In the case of imaging equipment, considerable amounts of data are typically transferred in bulk but with moderate time sensitivity. In the case of infusion devices and patient monitoring systems, much of the data are 'real time' data, bearing in mind that 'real time' means different things to different people. In such cases, if you're pushing waveform data or parameter data across these networks and something comes along that clobbers the network for whatever reason, an unsafe condition such as a delayed alarm can arise.

MPMN: In terms of regulatory requirements and standards, what are the challenges and hurdles to expanding wireless technologies for medical device applications while rendering them safer and more secure?

Fuchs: An international standard called IEC 80001 was developed to try to address the issue of placing medical devices on the hospital IT network. It was developed by a team of vendors, healthcare providers, and regulators--including FDA. The resulting standard places much of the burden on the health-delivery organization and encourages the organization to use risk-management approaches. In contrast to such standards as IEC 60601, to which medical device vendors must conform if they're going to create a medical device, IEC 80001 is not currently a mandatory standard. In the United States, one of the reasons that it is not mandatory is that it applies not to vendors but to health-delivery organizations, which are not normally regulated by FDA. Potential adoption paths include hospital-certification groups such as the Joint Commission. In any case, the standard doesn't currently have real regulatory status, and compliance is voluntary.

Vendors that wish to comply with this standard must disclose the issues and risks associated with their systems so that the hospital can be cognizant of those risks and attempt to mitigate them. For example, the vendor is supposed to inform the hospital whether a particular system needs a minimum bandwidth of x Mbit per second per device and that the hospital must provide this bandwidth at all times. The vendor is also supposed to tell the hospital if the latency on the hospital network must be y milliseconds or if the system can't run properly in a radio-resource management environment. Radio-resource management is a scheme in the wireless world in which devices are taken off line for a 'short' period of time to determine what else is out there, such as rogue devices. Unfortunately, employing this scheme may affect the wireless performance of some medical devices.

MPMN: What standards and strategies regulate risk management related to medical devices?

Fuchs: Vendors should try to disclose all the risk issues that they can foresee. To a certain extent, they should work with the hospital in helping it understand what the issues are and try to work with it to mitigate them. Now, it's on the hospital's side to work through these issues and perform an analysis that is similar to what the vendor would normally do in its risk analysis to understand the risks and get them down to an acceptable level. Part of this effort is that the hospital needs to understand that there are risks. It needs to look at what those risks are and make a decision as to whether the risks, after they try to mitigate them, are worth the deployment of the system. In other words, does the benefit outweigh the risk?

MPMN: What, specifically, are some of the risks that might arise?

Fuchs: Alarm-annunciation systems that go to cellphones or pagers are popular today. Although most vendors probably do not suggest that hospital organizations rely solely on such systems, if a hospital nevertheless decides to do so for whatever reasons, it has to understand that there may be a risk that someone may not receive a page. Perhaps they will have to look at the technology in question and understand what the probability is that someone will not receive the page. Or perhaps they will develop an escalation scheme in the event that someone doesn't respond to the page. Will the page go to someone else? Hospitals and vendors have to look at the overall systems design to feel comfortable that a device is good enough to put on the hospital's wireless infrastructure and deploy it.

Other risk issues relate to bandwidth management. If the vendor says that a device requires a certain amount of bandwidth, the hospital can turn to its infrastructure vendor to determine whether there are mechanisms for allocating different bandwidths to different types of applications. Is there a Quality of Service or prioritization scheme in place to improve the priority of safety-critical versus noncritical data, such as data from downloading a Netflix video? After all, IEEE 802.11 wireless networks are being used for all sorts of wonderful things.

MPMN: What do you hope attendees will come away with from your presentation?

Fuchs: I'm hoping that they'll come away with an awareness of IEC 80001 and its availability. In addition, I hope that they will gain awareness of how they should work in a cooperative manner with their potential customers--healthcare-delivery organizations--and become aware of the standard, how it applies to them, and how it may apply to the hospital. They should also understand that there's a framework in place that they can refer to if the need arises. I don't expect the attendees to be experts, but they should at least know a little about the standard so that they don't look totally puzzled when someone brings it up.

Engineering a Non-Invasive Device for Treating Headaches (Interview)

J.P. Errico, the CEO and founder of the medical device firm ElectroCore, has an interesting background. He holds a degree in aeronautical engineering from MIT and and a mechanical/materials engineering degree from Duke University. At Duke, Errico also earned a law degree and he later became a patent attorney.

In an interview with MPMN, Errico shed light on the engineering process behind the development of ElectroCore's non-invasive technology, which stimulates the cervical branches of the vagus nerve to treat headaches as well as respiratory problems. The company's GammaCore device, which is on the market in Europe and Asia, can be used to treat chronic migraines and for cluster headaches. The company's AlphaCore device was designed for respiratory applications such as bronchoconstriction.

MPMN: Could you provide an overview of how ElectroCore's technology works?

GammaCoreIf you step back for a second, the vagus nerve is one of the cranial nerves. It is comprised of two fibers: A and C fibers. Most of the information that is carried along that nerve is carried in the afferent direction, meaning it is going up to the brain. It primarily acts as a sensor for the brain to know how the body is functioning. What we do is we intervene along that line at the cervical level and we depolarize the A fibers, enabling us to influence a certain response in the brain: causing the release of inhibitory neurotransmitters.

The treatment is patient administered. A patient would place the device up against their neck, turn it on and you modulate the level of the signal that they are experiencing. At the end of 90 seconds, they have received a single dose.

Vagus nerve stimulation has been around for 20 years, largely used to treat epilepsy. Cyberonics just announced that they have implanted their 100,000 patient with their device. The vast majority of that is for epilepsy but they do have an approval for depression. It has a lot of different potential applications, but Cyberonics has primarily gone after epilepsy and depression at this point.

What we found is that their device, which once implanted might be on for 30 seconds to 2 minutes and off for 5 minutes. Then it cycles back on, repeating that sequence forever. What we have found is that is a substantial overdose of vagal stimulation. The vagus nerve does not need to be stimulated that frequently to provide a significant benefit.

MPMN: What was the biggest engineering challenge the company faced when developing the technology and how did you overcome it?

ElectroCore's GammaCore (above) and AlphaCore (below) devices offer a non-invasive treatment option for headaches and respiratory problems respectively. 

It probably falls squarely in the area of making a noninvasive device that can be used in so many different ways. We had a moment of inspiration when we saw that vagus nerve stimulation could be used to treat bronchoconstriction. That is an area where we had a sort of flash of brilliance. Then we set about proving it using some off-the-shelf technology. But figuring out how to turn that technology into something that was noninvasive was a gigantic intellectual program that we were successful at. When I look back on it, I'll say that was such an important component of what we did and that we spent a long time working on it and making it right.

Discovering the fact that a single 90-second treatment could be effective in terms of acute and prophylactic aspects was something that was just a fact of nature. As a result of discovering it, we were able to make the noninvasive viable from a commercial perspective.

Figuring out how to make it a noninvasive device is really key--not just from my perspective but the perspective of the physicians that we are working with. That has been the thing that made them say: 'wow, how did they do that? That is really cool'

Several years ago, we call up the first neurologists [to discuss] using the device to treat headache. None of them were surprised that vagus nerve stimulation worked to treat headaches. In fact, they pointed us to places in the literature where it had been tried with implantable devices and it was very positive; most patients had significant success with it. They were surprised that it could be made noninvasive.

Cyberonics are the pioneers who came up with the idea of using vagus nerve as a venue for therapy. I have nothing but respect for what they've done. I think we got lucky in some things that we've found and it was somewhat serendipitous that we did. If you look at it from their perspective: they believed that the device needed to be on all of the time. They never would have tried to make something noninvasive. If you need to use the device every five minutes, then you are going to want to have it as an implant.

What we found is that you can change the need and that enabled us to be inventive in the area of making it noninvasive.

Brian Buntz is the editor-in-chief of MPMN. Follow him on Twitter at @brian_buntz.

J&J May Sell Ortho Clinical Diagnostics Business

Johnson & Johnson, one of the largest healthcare products manufacturers in the world, announced that it is considering the sale or spinoff of its Ortho Clinical Diagnostics business. The potential sale of the diagnostics division is part of CEO Alex Gorsky's strategy to streamline the company. According to information from Bloomberg, the diagnostics division at the company earned approximately $2.16 billion in total sales in 2012. This represented 3.3 percent of Johnson & Johnson's total earnings. In total, its medical device and diagnostics segments pulled in $27.4 billion, making MD&D the largest segment of the company. However, its Ortho Clinical Diagnostics unit yielded $100 million less than expected targets. Gorsky is under pressure to drive growth in its medical device and diagnostics division. With its recent $21 billion purchase of Synthes, the company is looking to cut divisions that are stagnating or have limited future potential growth. The Ortho Clinical Diagnostics unit, which develops blood screening supplies for use in transfusions, may be the first to go. In a prepared statement, Gorsky said, "As we look to the future we're advancing innovative new products in our pipeline, continuing to take a disciplined approach to managing our portfolio and adapting our business to the changing marketplace." References http://washpost.bloomberg.com/Story?docId=1376-MGSNKS0YHQ0X01-56POALG1LJ3C4A87Q31S7F82O5

Abbott Brings Dissolvable Scaffolds to Trial

Abbott Brings Dissolvable Scaffolds to Trial

The Bioresorbable Vascular Scaffold is made of polylactide, which has been used in other dissolvable medical devices. Photo provided by Abbott Vascular.  

Whereas metal mesh coronary stents have been the more traditional path for angioplasty, with the option for drug-eluting devices, the Absorb Bioresorbable Vascular Scaffold (BVS) is intended to dissolve into the system within a year to allow the artery to return to normal functioning. Currently available in 35 countries, including those in Europe, Latin America, and Asia, Abbott is now starting a clinical trial with 2,250 patients who have coronary artery disease.

The scaffold is made of polylactide, a material that has been used in its technological predecessors, such as dissolvable sutures. The only exception is two pairs of tiny metal markers, which indicate to the physician where the device was placed. The product is also drug-eluting, delivering everolimus to the system as the artery recovers and the scaffolding breaks down. Abbott spent ten years trying to figure out the proper materials and engineering that would be needed for the device, which, although it is like a stent, it is not classified as one because it is intended to be temporary.

Steve Kelly, senior public affairs manager for Abbott Vasular, says that this technology is considered by the company to be the fourth revolution in the treatment in coronary artery disease, preceded by angioplasty, bare metal stents, and drug-eluting stents. “With no permanent metallic stent remaining, the vessel has the potential to return to a more natural state,” Kelly says. “It is free to move, flex, pulsate and dilate similar to a natural vessel in response to normal activities such as exercise.”

Although the company also produces both bare metal and drug-eluting stents, one of its long-term goals was to create a temporary artery scaffolding to potentially replace them. During the trial, Abbott will be putting the BVS against its own XIENCE, a drug-eluting metallic stent.

The BVS mirrors the multilink design found on Abbott’s metallic coronary stents, which provides similar flexibility to a normal stent. Unlike the metallic stent, the dissolvable nature of the BVS may produce fewer long-term complications, including late stent thrombosis, prolonged usage of anticlotting medications, and interference with medical diagnostic equipment such as MRI and CT scans.

The primary endpoint for the trial is target lesion failure, or a combination of safety and efficacy. Other endpoints, such as vasomotion, or a measure of how much natural motion returns to the vessel as the BVS dissolves into the arterial tissue, will also be examined in a handful of the patients. The company’s goal is to complete the trial to get the BVS in front of FDA for approval by 2015, and to make it available for the commercial market shortly after. 

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CDRH Answers Slowness Critics on Patient Blog

“We understand the kind of burden that diabetes management presents to patients and we weren’t completely surprised to hear the community voice concern over the length of time it takes us to review and approve new, innovative diabetes technology,” their guest post said. “Central to this conversation was the need for researchers, manufacturers and the FDA to work closely and collaboratively in the earliest possible stages of device development. For it is in the early stages that we can all best think creatively about what kind of studies and data will be necessary to support the successful approval of new technology in the shortest timeframe.”

The CDRH officials said the Center is exploring other ways to expedite innovative device development of new and innovative devices. For example, a recent guidance provides development recommendations for an artificial pancreas. And the Center has “consolidated the artificial pancreas review under a single management chain reducing internal inconsistencies and providing clearer priorities for that team,” they said. “FDA’s recent quick approval of a new continuous glucose monitor sensor, the Dexcom G4 sensor, and approval of the first outpatient studies of an artificial pancreas device are both positive examples of FDA’s efforts to expedite the device development process.”

The post also touched on a policy being developed for mobile medical apps for smartphones and tablets that likely will impact diabetes management. “By working with a wide range of groups, the FDA is developing a policy for mobile medical apps that will assure that those apps that present the greatest patient risk receive the appropriate agency review,” they wrote. “We want to make sure that our regulation is as smart and as nimble as the technology it is designed to cover.”
Additionally, CDRH plans to work more closely with patient groups, according to the officials. “Directly connecting to the patient community—and not just those with diabetes—helps us better accomplish our public health mission. To that end, you will be hearing from us and hopefully see us more often.”

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FDA-Industry Consortium to Speed Device Reviews