Top Products and Services of 2013

MPMN continues the tradition of honoring the top products and services of the year, which were chosen using a survey sent out to our readers. For each of the categories below, the two most popular products were included. In the case of a tie for first or second place, three products were included. 

Pumps and Valves

Microfluidic valves 
Combining the proven rocker principle with an innovative actuator enables Twin Power microfluidic valves from Burkert Fluid Control Systems to maintain given levels of performance and reliability in a smaller valve design with lower power consumption. The dual-solenoid valves are available in 10-, 16-, and 22-mm sizes. They also exhibit the flow and pressure resistance typically found in larger valves, making them suitable for applications in which space is critical or strong performance is needed. The 10-mm valve comes with orifices sized up to 1.6 mm and with pressure resistance as high as 73 psi; the 16- and 22-mm models are available with a 3.0-mm orifice. Maximum pressure resistance is 29 psi for the 16-mm valve and 73 psi for the 22-mm valve.
Burkert Fluid Control Systems
IRVINE, CA

Piezoelectric diaphragm micropumps
Based on piezoelectric diaphragm pump technology, the self-priming micropumps in the MP-6 series from Servoflo Corp. deliver air, gases, or liquids in low-flow portable medical equipment applications, such as drug-delivery devices, infusion pumps, nebulizers, respiratory equipment, and point-of-care platforms. These stock pumps measure 30 × 15 × 3.8 mm, consume less than 200 mW of power, and are capable of cycling several-hundred times per second. Typical flow values are 18 ml/min maximum with 100-mbar backpressure for gas and 7 ml/min with 600-mbar backpressure for water. Custom pump modifications can be made to meet customer requirements. A polypropylene version is available for handling corrosive media. Evaluation kits are available.
Servoflo Corp.
LEXINGTON, MA

Cleanroom Manufacturing and Assembly

Production, assembly, and testing services 
Outsourcing partner MedPlast is a full-service custom medical device manufacturer equipped with Class 100,000 cleanrooms for molding and assembly. It also offers extensive product testing capabilities. Its in-house laboratory services include monitoring of the production environment for microbial contaminants that could compromise the final sterilized product. The company also performs bioburden and Limulus amebocyte lysate testing. In addition to lab tests, it conducts a variety of in-process and final testing during the manufacturing process, including customized pull testing, drop testing, leakage testing, flow testing, and electrical testing. The ISO 13485- and ISO 9002-certified and FDA-registered contract manufacturer offers capabilities in injection molding, blow molding, silicone materials, and silicone processing.
MedPlast
TEMPE, AZ

Cleanroom leasing 
A full-service medical device contract manufacturer registered with FDA and operating a facility certified to ISO 13485:2003 standards, Life Science Outsourcing Inc. has 10,000 sq ft of Class 10,000 cleanroom space used primarily for the manufacture of Class II and Class III devices. The company can lease cleanroom space to OEMs on a daily, weekly, or monthly basis, providing allocated spaces for confidential or special projects. The cleanroom houses equipment, tooling, and assembly fixtures for ultrasonic component cleaning, ultrasonic welding, tray sealing, and such microprocesses as soldering. Providing a turnkey outsourcing solution for both startups and large medical device companies, the company offers sterilization, packaging validation, and warehousing services as well.
Life Science Outsourcing Inc.
BREA, CA

Assembly Equipment

Ultraclean assembly robots
Compact VS-series six-axis robots from Denso Robotics are available in ISO Class 5 and ISO Class 3 cleanroom versions for use in medical device assembly applications requiring very high levels of contamination control. The high degree of flexibility inherent in the robots' articulated design and choice of end effectors, according to the manufacturer, makes them suitable for performing a variety of high-speed, high-precision assembly tasks and for carrying out such secondary operations as packaging, testing, and inspection. Assembly cycle times range between 0.37 and 0.33 seconds and repeatability between ±0.03 and ±0.02 mm. Offering reaches of 500 to 900 mm and payload capacities of 4 to 7 kg, the robots can be mounted on the floor, ceiling, or wall. They have ultraslim arms that facilitate production-line integration, and an optional bottom-side cable connection saves floor space.
Denso Robotics
LONG BEACH, CA

Assembly fluid dispensers
Available from Nordson EFD, the high-precision Ultimus V and Optimeter dispensing systems for adhesives and other fluids used in critical medical device assembly processes have been designed to keep fluid quantities consistent as viscosity changes or the volume of fluid in the syringe decreases. The former dispenser models can store and then automatically adjust dispense settings to keep the volume of applied fluid constant in the case of fluids that undergo viscosity changes. To compensate for changing fluid levels when thinner fluids are used, the latter model automatically adjusts airflow to maintain uniform deposit size. The dispensers enable users to set dispense parameters in standard, metric, or SI units and to select among English, Chinese, French, German, Italian, Japanese, Korean, and Spanish as the language for menu displays and prompts.
Nordson EFD
EAST PROVIDENCE, RI

Cables and Connectors

Medical cable assembly services
A supplier of custom medical connection systems offers the value-added service of providing custom cable assemblies to fulfill medical device design requirements for complex diagnostic and therapeutic applications. Lemo USA Inc. can supply 100% tested and RoHS-compliant medical wiring and cable assemblies for such critical products as imaging equipment, surgical and other medical instrumentation, and orthopedic and prosthetic supplies and apparatuses. Not only does the company design systems to meet UL/IEC 60601-1 patient safety standards, but it also works in collaboration with the client during product development to ensure that these standards are met. The service provider employs sealed connectors for wet applications, stainless steel for longevity and hot sterilization, mixed configurations (fluidic and pneumatic subsystems in one connector), plastic materials familiar to the medical industry, and soaker caps for chemical sterilization.
Lemo USA Inc.
ROHNERT PARK, CA

Push-pull interconnect
The ultra-high-density MiniMax push-pull interconnect system from Fischer Connectors USA is a rugged miniaturized connector designed for smaller devices. An all-in-one 20-signal (0.5-A per signal) and 4-power (5-A) connector with 24 mixed contacts, the interconnect offers durability of better than 500 mating cycles. It has passed tests to establish suitability for use in harsh environments. The connector has a profile of less than 7 mm inside the box, a design that prevents power and signal from interfering with each other, and an unbreakable keying system that withstands more than 4 Nm of torque. It is delivered precabled.
Fischer Connectors USA
ALPHARETTA, GA

Extrusion Services

Custom extrusions
Teleflex Medical OEM offers services involving the extrusion of PTFE, FEP, EFEP, and other high-performance thermoplastics in dimensions ranging from microminiature through 35F. Equipped to handle challenging applications, the company produces heat-shrink and spiral heat-shrink tubing, multilumen tubing, coextrusions, and profiles, among other extruded items. Its capabilities additionally comprise standard and embedded marker bands, radiopaque fillers, and braid and coil reinforcement, including variable-pitch, continuously coiled shafts. The integrated, full-service contract manufacturer serves as a single-source provider of diagnostic and interventional catheters and sheath-dilator sets and kits.
Teleflex Medical OEM
JAFFREY, NH

Variable-flexibility extrusion technology
A provider of advanced extrusion services uses proprietary Taper-Tie continuous-extrusion technology to make variable-flexibility tubing for catheter shafts requiring high flexibility at one end for forward navigation and rigidity at the other to facilitate directional control by physicians. Specializing in the production of minimally invasive medical devices, Putnam Plastics Corp. designed the technology to replace traditional manual assembly of catheters with segmented shafts and eliminate associated labor costs. The continuous manufacturing method produces a catheter shaft that has variable properties along its length from the moment it is extruded. The process allows for quickly changing from rigid to soft grades of a designated polymer along the shaft while simultaneously reducing wall thickness during the extrusion.
Putnam Plastics Corp.
DAYVILLE, CT

Adhesive Dispensing and Curing Equipment

Dispensing pump

The fully programmable VMP electronic variable-displacement metering pump accurately dispenses ultraviolet (UV) radiation-sensitive fluids, including UV-curable assembly adhesives. Available from Fluid Metering Inc., the dispenser features a precision stepper motor that controls the pump speed and employs the manufacturer's patented CeramPump valveless piston pump design. Made of Type 316 stainless steel or opaque PVDF, its pump head keeps UV light from affecting process fluids in transit. A second stepper motor electronically adjusts the piston displacement; by varying the length of the piston stroke, dispense quantities can be finely tuned. This dispenser can be programmed for a variety of functions via a user-friendly touch screen interface that can control up to 16 pumps on a single bus; up to 128 metering devices can be controlled using a PLC or computer.
Fluid Metering Inc.
SYOSSET, NY

Valve dispensing systems
Utilizing a pneumatic, normally closed diaphragm valve, Dymax Corp.'s Model 475 valve dispensing systems accurately dispense low- to high-viscosity fluids. The design of the internal diaphragm and adjacent parts prevents migration of fluid into the actuating section within the valve. The toughness of the diaphragm, along with the selection of appropriate materials for component construction, ensures long diaphragm and valve life between maintenance schedules. These features make these valve systems suitable for dispensing light-curable materials and such reactive materials as cyanoacrylates, anaerobics, and solvent-based products. Accurate, repeatable performance is achieved by using the valve's stroke adjustment knob to dial in a desired shot volume. And a 25-µm air filter regulator permits only clean, dry, particulate-free air to pass, ensuring the system's long and continuous life. The regulator includes an integrated shutoff valve and pressure exhaust to quickly and safely depressurize the system, eliminating the need for the operator to open and close the regulator.
Dymax Corp.
TORRINGTON, CT

Wound Care Technologies

Breathable polyurethane film
Medifilm 426, a breathable polyurethane film on a removable carrier, is available for use in skin-contacting applications such as IV-site dressings, wound-care dressings, and incise drapes. Manufactured by Mylan Technologies, the product can be supplied with hypoallergenic pressuresensitive adhesives. It consists of the extruded polyurethane film on a paper/polypropylene liner and has a thickness between 0.5 and 10 mil, a thickness range that is standard with all the films in this line of wound-care and ostomy devices. The film has a medium-level coefficient of friction and moisture vapor transmission rate. It can also be customized by the inclusion of pigments such as flesh tones, embossed matte or gloss finishes, antistatic agents, and other options.
Mylan Technologies
ST. ALBANS, VT

Custom adhesives
A manufacturer of pressure-sensitive adhesive (PSA) tapes provides custom adhesive technologies for wound-care products and other skin-contacting medical devices. For long-term-wear applications requiring an aggressive adhesive, Adhesives Research Inc. supplies a medical-grade acrylic adhesive technology that offers high moisture-vapor transmission rates (MVTR) for breathability, good wear properties, minimal edge lift, and tolerable removal with no adhesive residue left on the skin. This adhesive supports dressings intended for wound sites posing potential adhesion difficulties and can be tailored to bear the weight of skin-attached medical devices and pump patches. Also available is a low-trauma-adhesive (LTA) platform for gentle skin removal. This customizable, high-MVTR PSA technology maintains reliable skin contact for up to three days and allows removal and reapplication without the adhesive bonding to itself. The gamma-sterilization-compatible LTA formulation leaves no residue and is biocompatible, noncytotoxic, and nonirritating or sensitizing to the skin.
Adhesives Research Inc.
GLEN ROCK, PA

Packaging services:

Custom packaging
Offering full-range medical device packaging services, CleanCut Technologies specializes in manufacturing compliant device packaging systems in a controlled environment. The company operates ISO Class 7 and Class 8 cleanrooms in its ISO 13485-certified facility and offers full traceability of the raw materials it uses. In order to ensure full performance effectiveness, the service provider develops and designs packaging in consultation with customers. For example, it offers a patented clipless dispenser that protects guidewires and catheters while minimizing the environmental impact of packaging materials.
CleanCut Technologies
ANAHEIM, CA

Cleanroom packaging, pouch sealing
Already equipped with several ISO Class 8 and ISO Class 7 cleanrooms for molding, assembling, and packaging plastic components, Plastics One Inc. has added independent cleanrooms for medical device packaging and medical pouch sealing. These cleanrooms are certified to ISO Class 7 standards for sterile barrier packaging and molding. The service provider works directly with customers worldwide to create advanced package designs. Its ISO 13485-and ISO 9001-certified facility includes an in-house design department using 3-D software, a fully equipped mold-making shop, and current injection molding technology. The company additionally offers a dedicated R&D team, enabling it to provide contract packaging services extending from product concept to creation.
Plastics One Inc.
ROANOKE, VA

Testing, measurement, and inspection equipment

High-definition camera

The IK-HR2D high-definition camera from Toshiba Imaging Systems Div. can be used to add full-motion, live video output to microscopes employed for inspecting circuit boards, assembling devices, and performing other inspection, testing, and measurement tasks in which real-time, high-resolution, high-quality color imaging is critical. Besides being in high resolution, the images captured exhibit good contrast and clarity. Supporting ergonomic and efficiency objectives, the one-piece, compact CMOS high-definition camera measuring 1.73 × 1.73 × 3.17 in. offers live-image data capture at speeds up to 60 frames per second and includes both DVI-D and USB outputs. User-selectable video output formats include 1080p/720p at 60 fps and 1080i at 30 fps. Video frames can be output at up to 10 fps via the built-in USB port for convenient transfer of live images to a computer without the use of a frame grabber.
Toshiba Imaging Systems Div.
IRVINE, CA

Tabletop universal testers

The EZ Test EZ-X series of compact tabletop test systems has been designed by Shimadzu Scientific Instruments to provide high levels of test force measurement precision, control precision, and test speed. The universal testers can be configured into 29 models that are designed to meet small-capacity testing requirements for the medical device industry. They offer ±0.5% accuracy over a range of 1/500 of load capacity to full capacity and allow data sampling at speeds up to 1000 measurements per second. A high-speed, long-stroke model features a 3000- mm/min return speed that minimizes the wait between tests. To extend the range of possible test applications, the manufacturer offers a selection of specialized jigs for sample preparation and evaluation of device properties. This series of test units can inspect such items as syringes, adhesive bandages, and packages for physical characteristics and other performance criteria.
Shimadzu Scientific Instruments
COLUMBIA, MD
www.ssi.shimadzu.com

Leak/flow-testing instruments

Leak-testing flexibility is built into the Med75 Combo instruments for medical device leak and flow testing from InterTech Development Co. These leak testers perform a range of functions: leak and flow testing for medical products, pressure-decay and mass-flow leak detection in combination, and leak and flow testing for catheters. Several options, including as many as four independent channels, allow users to conduct the tests that best suit the application. The several test circuits operate independently, with individual pressure regulators, valves, and calibration ports. A touch screen control panel, dual USB ports, Ethernet connectivity, and embedded Web pages all facilitate data management. The leak detectors can be employed as stand-alone instruments, or they can be interfaced with a PC or an external programmable logic controller, through which setup is automatic.
InterTech Development Co.
SKOKIE, IL

IV components, tubing connectors, and couplings

Medical-grade polypropylene connectors
LinkTech Couplings' polypropylene couplings are now available in Legacy Almond and Modern Cool Grey colors. These color combinations allow customers to choose their preferred coupling color, improving their device aesthetics. Both color combinations are available in 20PP Series (1/8-in. flow size) and 40PP Series (¼-in. flow size), are produced from animal-free medical grade polypropylene, and can be Gamma sterilized. With more than 300 different styles and configurations, the company offers couplings that are well suited for use on durable and disposable medical equipment and analytical devices. Its couplings interconnect with other similar thumb-latch couplings and are available in more than 1000 styles and configurations.

LinkTech Couplings
VENTURA, CA

PVDF tubing connectors

Offered by Colder Products Co., the FitQuik line of quick-disconnect connectors for plastic tubing includes more than 100 options in PVDF as well as the previously existing configurations in nylon, polypropylene, and polycarbonate materials. PVDF is characterized by high levels of purity, chemical compatibility, and resistance to ultraviolet radiation. Fittings made from this material offer robustness and the ability to tolerate aggressive media and environments. Molded from Kynar 720, the PVDF fittings comply with the FDA 21 CFR 177.2510 requirements, are certified animal-free, and meet USP Class VI requirements. Designed for tubing sized from 1/16 to 3/8 in. OD and including a variety of threaded configurations, the precision-molded fittings, which are free of parting lines, are designed to ensure a secure, leak-free fit in demanding fluid-handling applications in medical diagnostics and analytical instrumentation.
Colder Products Co.
ST. PAUL, MN

Molding services

Custom miniaturized components

An ISO 13485:2003-certified supplier of high-volume molded medical  device parts can provide custom miniaturized components in a range of   advanced iso 10993- and usP class Vi-compliant polymeric materials.   Minnesota rubber and Plastics molds miniature components for such devices as fluid-delivery systems, along with numerous other static and   dynamic applications, using custom blends of Peek, polycarbonate, polysulfone, nylon, polyethylene, and polypropylene. components   characterized by sterilizability, chemical compatibility, biocompatibility,  toughness, durability, and hydrolytic stability at elevated temperatures  can be as small as 1 mm in diameter and weigh under 1 g.
Minnesota Rubber and Plastics
MINNEAPOLIS

Contract molding and assembly

Medbio, a contract manufacturer specializing in injection-molding components and assembling medical and biotechnology devices, is  equipped with four modular Arburg swivel-clamp molding machines that enhance the contractor's flexibility. the latest purchase is a 28-tn hydraulic molding machine that offers a range of working positions. using the machines, the molder can run a variety of precision molded parts, performing overmolding and insert molding using a vertical clamp position or automatic molding with a horizontal clamp position.
Medbio Inc.
GRAND RAPIDS, MI

Accelerated tooling service

The full-service medical device contract manufacturer Sil-Pro offers Jet tooling, a service designed to produce mold and extrusion tooling and functional prototype parts from silicone or thermoplastic material in a few days. the ISO 9001:2008- and ISO 13485:2003-certified specialist has a dedicated tool shop, and a five-axis machining cell with robotic support for around the-clock production gives it high-speed capabilities. a fast tooling service features an in-house inventory of originally hard and hardened stainless-steel inserts, offers an extensive material selection, can supply bridge tooling to preproduction and small production runs, and enhances design for manufacturability.
Sil-Pro
DELANO, MN

Catheter and stent manufacturing equipment

Balloon-bonding system

The Model 620B multiwelder from Beahm Designs Inc. is used to perform catheter shaft or balloon bonding. Providing an alternative to laser welding technology, the system combines multiple process steps and stabilizes the process of bonding thermoplastic components, essentially eliminating the risk of operator error. To create smooth, seamless transitions along a shaft, traditional catheter tube-bonding methods require the use of a hot-air station for preshrinking and a radial compression bonder to create the tube joint. In contrast, this tube-bonding system has the ability to preshrink the sleeve and then bond or fuse two components via an automated single-cycle sequence. Its split-die technology allows the generation of high-precision bonds in a range of widths and diameters, including narrow weld profiles of the sort typically produced with lasers. As a result, the system fulfills the requirements of demanding applications such as short balloon bonds and ultrasmooth lap joints.
Beahm Designs Inc.
LOS GATOS, CA

Linear assembly system

The LS 280 linear palletized assembly system available from Weiss North America Inc. can be the versatile foundation of plant assembly systems customized for the manufacture of a variety of medical devices, such as catheters, hypodermic needles, inhalers, diagnostic pens, and blood-sugar test kits. The system features a robust design, with workpiece carriers being transported and interlocked on a cylindrical cam that combines positioning precision of ±0.03 mm in the x- and y-axes and ±0.06 mm in the z-axis with stable interlocks. Pallet indexing times of half a second are typical. One of the company's straight-line assembly systems based on this modular transfer concept is 12 m in length and incorporates 15 processing stations and 42 circulating pallets. System modules are delivered to assembly line creators complete with a solid-steel machine base so that customers do not have to build a frame. In addition, the footprint is designed to accommodate assembly cell control cabinets and a master programmable logic controller.
Weiss North America Inc.
WILLOUGHBY, OH