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Articles from 2005 In May


Pulling It All Together: A Look at Extrusion and Tube Processing

Originally Published MPMN May 2005

PRODUCT UPDATE

Pulling It All Together: A Look at Extrusion and Tube Processing

Extruders and tubing materials suppliers keep up with new trends

Corinne Litchfield

The Smart Driller LT from Technical Innovations is designed to perform computer-controlled, repetitive hole drilling and skiving patterns.
As medical technology becomes more advanced, medical manufacturers that provide equipment and services must rise to the challenge. Current developments include manufacturing small, complex products. This growing trend is particularly evident in extrusion and tube processing.

“Tubing is becoming tinier in size and more elaborate in configuration,” says Rikki Bauer, vice president of Medical Extrusion Technologies (Murrieta, CA). With a shift toward more minimally invasive surgeries, smaller incisions are required, which in turn requires smaller tubing and other materials. Companies specializing in extrusion and tube processing are developing machinery and other devices in order to meet these new demands. As Bauer puts it, “Equipment, technology, and R&D in the field of extrusion are becoming more important than ever.”

Hole-Punching Systems Create Multiple Hole Patterns


Automated catheter hole-drilling and hole-punching systems can store and recall 10 or more hole patterns. The Smart Driller LT and the Smart Puncher LT from Technical Innovations (Brazoria, TX) perform computer-controlled, repetitive hole-making, or skiving operations on single or multilumen tubing. The turnkey system has a pneumatic balloon grasper, a catheter guide made to application specifications, and an adjustable outboard stop. Target applications include high-volume, multiple hole pattern devices.

Porous PTFE Tubing and Extrusion is Offered

Porous polytetrafluoroethylene (PTFE) is a soft, flexible, fully fluorinated polymer with exceptional chemical resistance and temperature stability. International Polymer Engineering (Tempe, AZ) offers a porous PTFE that is 100% virgin and produced in a Class 10,000 cleanroom. The company has developed a line of microbore ePTFE and PTFE tubing and rod. Tubing sizes range from a 0.0366-in. inner diam with a 0.002-in. wall thickness, to a 0.068-in. inner diam with a 0.010-in. wall thickness. Rod sizes range from 0.008- to 0.038-in. outer diam. Extrusion capabilities include single- and multilumen tubing, profiles, and sheet. The company uses the latest polymer technology and automated extrusion techniques to reduce costs and shorten lead times.

Tubing Set Coiling Machine Also Works as a Winder

S-Y-M Products offers the Mini-Winder for coiling and packaging of tubing.

A tubing set coiling machine offered by S-Y-M Products Co. (Stamford, CT) can serve as a conventional winder. The Mini-Winder, used in the manufacturing and assembly of disposable medical tubing devices, coils and packages tubing sets three times faster than conventional methods, according to the company. The product’s contact surfaces are stainless steel or high-density plastic, making it suitable for use in a cleanroom environment. A length of tubing is placed on the winder’s mandrel, which rotates the exact number of turns necessary to make the coil. The speed, coil size, rotation amount, motor direction, and mandrel height are all adjustable. After a coil is completed, the mandrel retracts, enabling the operator to slide the finished product into a package without excess movement. The winder comes equipped with foot and hand controls.

Optical Gauge Analyzes and Measures Multilayer Tubing

A gauging instrument provides advanced multilayer tubing thickness measurement. The DI 330 OptiGauge thickness measurement system from Lumetrics Inc. (West Henrietta, NY) uses optical technology to measure absolute thickness to ± 0.004 mil accuracy. Because the thickness of every layer is measured simultaneously, many types of translucent multilayer tubing or coating can be analyzed in detail. With a measurement rate of 30 Hz, the system can easily conduct an on-line inspection of a fast-moving web. Off-line inspections can also be performed.

Extruder Series Features Nonreactive Components

The GMP twin-screw extruder series from Leistritz features stainless-steel, nonreactive components.

A twin-screw extruder series features precisely machined hardware and controls that meet FDA validation requirements. The Leistritz (Somerville, NJ) GMP series is suitable for tube extrusion, compounding, devolatilization, reactive processing, and foaming. Stainless-steel screws, barrels, and other parts that contact the processed materials are nonreactive, nonadditive, and nonabsorptive with the product being extruded. Screws and barrels are available in modular or one-piece designs, depending on the intended usage and required cleaning standards.

Extruder Produces Small-Diameter Tubing

Small-dimension medical and catheter tubing can be produced using a crosshead-type extruder from Wayne Machine.

Small, crosshead-type medical grade extruders from 1¼4- to 5¼8-in. sizes have been introduced. The extruders from Wayne Machine (Totowa, NJ) are appropriate for producing small-dimension medical and catheter tubing, as well as precision medical products such as medical fiber-optic cables and fine medical-grade insulated wire. Key features of the extruders are industry-standard, feed-end-design extruder screws, feeding of polymer, no dynamic seals that can leak or cause surging, double-reduction helical gearboxes as found on larger machines, heavy-duty thrust bearings, timing belt drive for speed range changes and long-life ceramic heaters. High-temperature models are available for processing FEP, PFA, ETFE, ECTFE, and engineering polymers. The extruders can be customized.

Copyright ©2005 Medical Product Manufacturing News

OutsourcingOutlook

Originally Published MPMN May 2005

Outsourcing Outlook

Extrusion


Custom Assembly and Packaging of Disposables Is Available


An FDA-registered contract manufacturer has core competencies in custom assembly and packaging of disposable medical devices, as well as in-house tube extrusion and RF welding. Assembly and packaging services are performed in Class 7 cleanrooms. The company works with its clients to customize process development and validation, specification review, and detailed work instructions. Device integrity testing, packaging development, and 510(k) filing assistance are also available.
Command Medical Products Inc., Ormond Beach, FL www.commandmedical.com


Automated Assembly Systems Can Be Customized

Over the past year, a company has shipped more than a dozen new safety product assembly machines to manufacturers of safety IV catheters, syringes, needles, and scalpels. Components such as springs, protective caps, locking devices, and self-destruct features that are currently being designed into medical devices of the future are all being assembled on the company’s machines. High-speed automation equipment for the assembly of IV products, catheters, blood collection products, syringes, needles, and tubing is offered. Custom, as well as standard, equipment can perform automated assembly and material-handling operations. Equipment design, fabrication, and validation with documentation through installation and service are provided at the customer’s facility. KahleUSA, Summit, NJ www.kahle.com


Merger Creates New Electronics Manufacturing Solutions Provider

An electronics manufacturing solutions (EMS) provider of highly complex and specialized medical devices, implantable technologies, and equipment has been created by the merger of two companies. The new firm also supplies a number of medical customers with electromechanical and board assemblies. It can provide not only highly complex SMT assemblies, but also global turnkey solutions including backplanes, cable assemblies, and fully integrated box build systems. Other services include design, cleanroom manufacturing, direct shipping, and supply chain management. The company has eight locations worldwide—in the United States, United Kingdom, Thailand, Singapore, and China. CTS Electronic Manufacturing Solutions, Glasgow, Scotland www.ctscorp.com


Outsourcer Uses Flexible Manufacturing Methods for Small and Irregular Batches

A medical device subcontract manufacturer offers assembly and packaging from its Class 10,000 cleanroom. Flexible manufacturing methods enable small and irregular batches to be handled, along with high-volume runs. Full sourcing of components is available. Sterilization options include EtO, gamma, and steam. Manual and semiautomatic packaging lines are offered for blister packs, peelable pouches, poly bags, and custom packaging. Soldering, ultrasonic cleaning, electronic assembly, and injection molding services are also provided. Wesley Coe (Cambridge) Ltd., Cambridge, UK www.wesley-coe.com


Fixturing and Automation Services Augment Medical Contract Manufacturing Operations

A company has expanded its capabilities by providing fixtures and automation equipment. Engineering, designing, development, and manufacturing services will be available for special fixtures and tabletop automation equipment. A hands-on approach will speed the process, starting with the actual components, therefore bypassing a lengthy specification and design phase. The company has experience in mechanical, electrical, and pneumatic applications for tabletop assembly, cooling fixtures, nests, inspection devices, end-of-arm tooling, precision drilling, x-y tables, and secondary operations tooling. Project integration and manufacturing, including industrial design, supply chain security and inventory management, validation and quality controls, packaging and labeling, and sterilization responsibility are systematically controlled. Processes are validated under rigorous qualifications, and full documentation is maintained. SMC Ltd., Molding and Manufacturing Div., Somerset, WI www.smcltd.com


Manual, Automatic, or Semiautomatic Assembly Services Are Offered

A full-service company provides assembly services to neurological, OB-GYN, surgical, and orthopedic device manufacturers. Engineering and design services are said to provide clients with product improvements and cost savings, both in materials used and in the assembly process. A machine shop on the premises allows in-house prototyping and fabrication services. Manual, automatic, or semiautomatic production is offered for full or subassemblies. The company has expertise in the use of adhesives, microspot and ultrasonic welding, and the machining and fabrication of metal and plastic parts. HPC MedX, Hanover, PA www.hpcmedx.com


Company Focuses on Assembly with Emphasis on Automation

Providing a full range of contract manufacturing services, a company features assembly capabilities, with specific expertise in automation. Complete or partial assembly of components is offered in facilities compliant with industry standards. Cleanrooms are Class 100,000 certified. Additional services include product design and development, global manufacturing, and distribution. Nypro Medical Products Group, Clinton, MA www.nypro.com


Molding and Assembly Services Include Catheter Production

Silicone injection molding and assembly services are offered in Class 100,000 and Class 10,000 cleanrooms. One of the company’s current assembly projects is a catheter for the treatment of benign prostate hyperplasia. The assembly of the device stretches over a few days. In addition to developing molds and moldings, the company sourced standard components and developed the production process according to ISO and GMP requirements. Medical Rubber, Horby, Sweden www.medicalrubber.com


Assembly Cells Create Mechanical and Electromechanical Housings

A company’s manufacturing and assembly services focus on single-point responsibility for mechanical and electromechanical housings and their components. Assembly cells are housed in a 16,000 sq ft air-conditioned facility organized to undertake simple subassemblies or comprehensive product programs integrating custom production and the procurement of stock materials, if required, for all product components, regardless of the process used to produce them. The company’s engineering and management team can recommend assembly efficiencies that can significantly reduce final unit costs. CWM Contract Manufacturing, Bensenville, ILwww.cwm-contractmfrg.com

Copyright ©2005 Medical Product Manufacturing News

On Printing, Labeling, and Marking

Originally Published MPMN May 2005

SPOTLIGHT

On Printing, Labeling, and Marking

Printing machines

A machine series is suitable for printing oblong components without having to give up the advantages of a sealed doctoring system. Because of the large printing surface, the possibility of setting the doctoring path to various cliché widths, as well as the cliché covers that are included as standard, allow the TSQ machine to be universally tuned to any product, such as catheters. The company’s RTI systems have the options of a horizontal or vertical operating rotary printing unit, which is especially useful in many types of automated systems. High-quality multicolor prints can be produced. Tampo Print International Corp., Vero Beach, FL www.tampoprint.com


Pad printers

Pad printers can mark from one to four colors using sealed or enclosed inking systems. Features include modular design, automatic pad cleaning, and viscosity control. A quick-change inking system accommodates multiple applications. Customized part fixtures and part-handling equipment are also available to provide the proper level of automation needed for cost-effective production. Automated Industrial Systems, Erie, PA www.padmark.com


Covert optical security feature

A covert optical watermark security feature can be used to authenticate and validate a product. AuthentiKey includes a hidden watermark that can be embedded in the graphics of any package and can be printed using flexographic, ultraviolet flexographic, or offset print technologies. Multiple watermarks can be embedded in the graphics and are detected using a lens key to unlock the embedded image. Different keys may be employed throughout the supply chain to ensure security and conformity of product. Tursso Co., St. Paul, MN www.tursso.com


Thermal-transfer printer

An in-line thermal traversing system can meet multiple package coding and bar code requirements on all horizontal form-fill-seal equipment. The EasyPrint MLP includes a printhead that moves on a linear rail to code up to 30 packages in one pass, eliminating the need for multiple coders. It has a print area of up to 5 in. in width. This traversing feature replaces hot-stamp ribbon and metal type. The unit is driven by a stepper motor that is program logic controlled and offers an E Prom cartridge, which eliminates the need for in-field programming. Bell-Mark, Pine Brook, NJ www.bell-mark.com


Ink-jet nozzle

A nozzle features field-replaceable components that can be easily cleaned or swapped out by in-house operators, eliminating the need to replace the entire nozzle assembly. To further reduce operating costs, the EZ Jet nozzle can accept all orifice sizes used with Videojet Excel–series printers from 36 to 120 µm. InkJet Inc., Willis, TX www.inkjetinc.com


Printer and label software

A company offers a printer and software for labeling. MaxiLabelV2 software includes more than 500 ANSI safety symbols for making OSHA-compliant safety labels and signs. The software also contains more than 600 general industrial and office symbols. The LabelShop 2010-PC printer connects to a laptop or PC with a USB cable and features a footprint that fits anywhere on a desk or a laboratory bench. Users can print custom labels with industrial-grade adhesive in 23 different color combinations from 1¼6 to 1 in. wide. Special shrink-tube labeling material can also be used in the printer for wire, cable, medical instrument, or personal item identification. K-Sun Corp., Somerset, WI www.ksun.com


Case-printing equipment

An in-line bar code printer is available for corrugated shipping containers. The Sidewinder uses a computer-generated printing stencil, which allows exact placement of very-high-resolution printing anywhere within the 2 ¥ 23-in. print area. The quality is sharp and brilliant at a maximum rate of 100 ft/min. The printer is suitable for average batch runs of 10,000 cases. Iconotech, Clinton, CT www.iconotech.com


Engraving and cutting systems

Air-cooled CO2 laser engraving and cutting systems are used for making labels for medical equipment and for marking medical devices. Laser systems cut, engrave, etch, and mark on a wide variety of materials from plastics and wood to stainless steel and marble. With standard graphic software such as AutoCad, one laser system functions like a printer from Windows XP and makes labels, identification tags, bar codes, and nameplates. Laser systems can mark metal directly with special optics. Systems range from 16 ¥ 12 in. to 48 ¥ 24 in., with power from 25 to 300 W to handle multiple laser processing applications. Universal Laser Systems Inc., Scottsdale, AZ www.ulsinc.com


Thermal printer

A rugged desktop printer has both thermal- transfer and direct thermal capabilities. The CLP-621 offers complete connectivity options, including internal Ethernet, along with a high-lift print mechanism. The unit uses an internal power supply. Citizen Systems America, Torrance, CA www.citizensystemsamerica.com


Label printer-applicator

A label printer-applicator is a lightweight, in-line unit. The Model 2600 offers a selection of thermal and thermal-transfer print engines. The units print 203- or 300-dpi text bar codes and graphic images at speeds up to 12 in./sec, and will dispense labels up to 4.5 in. wide and 6 in. in length. Labels are printed in a next-out mode and then immediately applied to cartons or products on the production or packaging line. Using the tamp-blow method of application, a printed pressure-sensitive label is peeled from its liner and is retained by vacuum on the applicator’s tamp pad. The pad is extended and the label is blown on to the surface from approximately 0.25 in. Weber Marking Systems, Arlington Heights, IL www.webermarking.com

Copyright ©2005 Medical Product Manufacturing News

Fillers & Dispensers

Originally Published MPMN May 2005

SPOTLIGHT

Fillers & Dispensers

Vial filler

An automated vial filler and sealer can produce filled containers of liquid at a rate of 80 units per minute. Liquid fill volumes vary from 1 to 100 µl and can be adjusted. Different styles of containers, closures, seals, and pumps may be outfitted for total flexibility. Closed-loop sensing of product and component status ensures a reliable output. An operator interface displays settings, error messages, and the requisite counters to ensure efficient operation. Quickpouch, Ronkonkoma, NY
www.quickpouch.com
 


Custom dispensing

A system integrates filling, tipping, capping, sealing, labeling, and robotic offload into boxes. With all of these functions in one machine, significant reductions in floor space are realized. The machine dispenses reagents and compounds in fill ranges from 5 to 480 ml with accuracy ±0.1%. Zero porosity pumps provide controlled programmable fills with no shedding. Rapid change out features make it suitable for use in a Class 100 environment. All fluid-handling devices are quickly removable for autoclaving. AMS Filling Systems Inc., Honey Brook, PA www.amsfilling.com


Solvent dispenser

A solvent dispenser is equipped with a vapor conveyor system to ensure a complete removal of solvent vapors from the working area. The DS2/ls also has a level sensor that gives indication of the solvent quantity in the dispenser reservoir by means of an LED signaling system. While working, the green LED remains on if there is enough solvent in the dispenser. When the solvent goes below a preset level of 20 cm3, the green LED turns off and a red LED turns on. The special shape of the unit's dispensing bushes allows them to dispense solvent on the internal or external surface of tubing, conical surfaces, soft and rigid drip chambers, needles and various types of connectors, and components made of medical polymers such as PVC, ABS, polypropylene, and polycarbonate. TechnoMed Inc., Wallace NC www.technomedinc.com


Epoxy-dispensing robot

A complete solution for two-part meter-mixing applications is available. The system offers an integrated control head that accommodates most standard two-part meter-mixing cartridges and tubes. The robotic system is self-contained and features an integrated digital valve controller working in real time with the robotic motions. Enhancements such as preprogrammed dots and fills are provided, as well as diagnostics and a production-history display. Applications include potting, gasketing, and sealing. Dispense Works Inc., McHenry, IL www.dispenseworks.com


Fluid-dispensing system

A dispensing system applies consistent amounts of adhesives, cyanoacrylates, silicones, and other assembly fluids used in medical device production. The compact Ulta 1400 has a microprocessor-controlled timer that enables operators to automatically apply the correct amount of adhesive on every part. This eliminates the waste, mess, and quality problems associated with inconsistent fluid application. Dispense time can be adjusted in increments as small as 0.001 seconds for extremely precise control over the amount of material applied. The operator places the dispense tip in position and taps an electric foot pedal to deposit an identical amount of material on every part. An adjustable vacuum control prevents dripping between shots. EFD Inc., East Providence, RI www.efd-inc.com


Liquid-filling system

A single-head filling unit uses a preassembled sterile disposable filling module. The Acerta DS1 dispensing system is designed for final sterile injectables and diagnostics. The system is suitable for cytotoxic and gene-therapy products. The single-use module eliminates autoclaving, steam-in-place, and clean-in-place procedures and reduces validation efforts. The equipment can be configured easily for manual filling, as well as integrated into existing or new filling lines. It can perform up to 40 fills per minute, and dispenses from 0.2 to 10 ml consistently within ±0.5%, even at small volumes. Millipore Corp., Billerica, MA www.millipore.com

Copyright ©2005 Medical Product Manufacturing News

Breaking Sound, Weight, and Battery-Life Barriers

Originally Published MPMN May 2005

PROFILE

Breaking Sound, Weight, and Battery-Life Barriers

A rotary scroll compressor helps oxygen concentrator offer new level of independence and quality of life for breathing-impaired patients

The InogenOne concentrator uses a rotary scroll compresssor from Air Squared as its prime mover.

Start-up company Inogen Corp. has developed a new oxygen concentrator that is not only truly portable, but also nearly triples the time respiratory patients requiring supplemental oxygen can move about freely. According to the company, the Inogen One concentrator creates a new class of independent oxygen devices by providing three key quality of life benefits for patients. They are: light weight, long battery life, and low noise.

Inogen achieved these goals largely by breaking away from the industry-standard piston pump and selecting a rotary scroll compressor as the concentrator’s prime mover, says Geoff Deane, Inogen’s vice president of engineering/CTO. Developed by Air Squared (Cincinnati; www.airsquared.com) and licensed exclusively to Inogen for use in oxygen concentrators, the scroll compressor delivers more than 80% volumetric efficiency, while drawing less than 40 W. The Inogen One operates in the sub-40-dBa range, a fraction of what’s considered acceptable in the industry, Deane stated.

Existing products for patients with chronic obstructive pulmonary disease (COPD) are almost exclusively stationary, designed for in-home use. Though they are reliable and low-cost, they sacrifice on quality of life in the areas of noise and vibration. The only portable device available previously had a battery life of less than 50 minutes and a noise level of 55 dBA, and required overhaul at 3000 hours.

“To achieve the kind of miniaturization and reliability we were targeting, we had to optimize each subsystem, starting with the compressor, which consumes about 80% of the energy,” says Deane. “We spent a lot of development effort to attain higher efficiency in the pressure swing adsorption cycle. And we invested in development of a very sensitive conserver, as well as miniaturization of the electronics and the software we use to manage operation of the device. This is all with the goal of reducing the amount of work the machine has to do.”

Critical performance criteria for the compressor included low noise and vibration, long life, oil-free operation, light weight, low energy use, and ability to deliver precise flow and pressure. Deane says the team researched more than a dozen alternatives including helical, rotary vane, and piston pumps. “Until we came upon Air Squared’s rotary scroll compressor, a piston pump was the only device that came close in the pressure and size range we needed, and it would have required work to isolate the noise and vibration caused by valves and balance issues,” Deane added.

Scroll gives new spin to compressor technology

The scroll compressor design is based on a 1900-era patent and 1970s refrigeration compressor technology. Under development by Air Squared, it has evolved into a new kind of air compressor that runs quietly and oil-free. The operating elements of a scroll compressor consist of two identical involutes, which form right- and left-hand components. One scroll is indexed or phased 180° with respect to the other to allow the scrolls to mesh. This indexing creates crescent-shaped gas pockets, bounded by the involutes and base plates of both scrolls.

In operation, one scroll remains fixed; the other is attached to an eccentric, driven by an electric motor. As the moving scroll orbits around the fixed scroll, the pockets formed by the meshed scrolls follow the spiral toward the center and diminish in size. The compressor inlet is at the periphery of the scrolls. The entering gas is trapped in two diametrically opposed gas pockets and compressed as the pockets move toward the center, where the discharge port is located in the fixed scroll. No valves are needed because the discharge port is isolated from the inlet. This reduces noise and improves the durability of the unit.

Because scroll compressors use true rotary motion, they can be dynamically balanced for nearly vibration-free operation. Air delivery is continuous, which virtually eliminates inlet or discharge pulsation and associated noise. Reliability is inherent, because there are only two primary moving parts, with no inlet or discharge valves to break or make noise, and no associated valve losses.

“We researched the scroll compressor in depth, and determined it could give us a big advantage right off the starting line because we had very little noise or vibration to isolate,” says Deane. “Air Squared conducted additional development and customization for us to reduce energy consumption of the compressor by 40% through tweaking the manufacturing process and through a proprietary technology–now patented–that greatly improved the sealing of the oil-free machine.” Air Squared also developed a way of fine-tuning the discharge flow of the compressor so that each unit delivered the set rate with an accuracy of ±0.2 L/min.

The scroll compressor inside the Inogen One weighs just 2 lb, including its motor, and measures 4.5 ¥ 3 ¥ 3.3 in. The entire concentrator weighs less than 10 lb, including its battery, and measures about 12 ¥ 6 ¥ 12 in.

Its pulse-dose delivery system delivers 1–5 L/min in nine flow settings, varying the speed of the compressor from 1500 to 2700 rpm to meet demand. A lithium-ion battery provides 2–3 hours of independent use on a 3-hour recharge, with ac and dc capability for stationary and mobile operation, while concurrently charging the battery.

Inogen received FDA marketing clearance for its new oxygen concentrator in May 2004, and began shipping in October.

Copyright ©2005 Medical Product Manufacturing News

Web Store Supports the Life Science Market

Originally Published MPMN May 2005

E-News

Web Store Supports the Life Science Market

Analee Zelaya

www.advancedbiosciences.com

In addition to supplying information about its products and services on-line, Rohm and Haas Advanced Biosciences (Philadelphia) also features a store on its Web site. Researchers at universities, government agencies, and private institutes are able to purchase a selection of merchandise in various quantities. Products from the Amberchrom line include ion-exchange resins for acetate conversion, as well as reversed-phase chromatography resins for capture, purification, and polishing. Amberlite offerings are ion-exchange resins for conversion, color removal, or vitamin purification, as well as XAD adsorbents for capture and concentration.

Jean-Francois Ferraro, the firm’s global business manager, states, “[The Web] sales site is an important part of our overall effort to make Rohm and Haas products easier to purchase and use by researchers. We will continue to increase our applications support to the life science market to enhance our customers’ product and process development efforts.”

Users can track their order status on-line and print invoices. New products will be introduced via this medium. The company plans to offer this service outside the United States at a later date.

Copyright ©2005 Medical Product Manufacturing News

Free Training Tools Available for Plastics Industry

Originally Published MPMN May 2005

E-News

Free Training Tools Available for Plastics Industry

Analee Zelaya

www.traininteractive.com

A training service provider for the plastics industry has improved its Web site. A. Routsis Associates Inc. (Dracut, MA) offers free training tools, including a downloadable demonstration. Other features include an updated clients-only section, and training tips for plastics manufacturers seeking skilled, confident employees.

“I’m very excited about our [Web site],” says company president Andy Routsis. “The improvements include even more free training tools and advice than we had on our previous site, with even better tips for helping plastics companies train their employees.”


Copyright ©2005 Medical Product Manufacturing News

My Favorite Bookmarks

Originally Published MPMN May 2005

E-News

My Favorite Bookmarks

Tim Leba, Vice President of Product Development
PurePouch LLC

Tim Leba

The U. S. Patent and Trademark Office (www.uspot.gov) is a good reference site that allows users to look up patents by number or description. The site has information on filing for patents, describes the patenting process, and defines terms used in patents. It also covers information on trademarks. If nothing else, it is interesting to see some of the unusual ideas people have come up with over the years.

When you need to figure out where you’re going, Yahoo Maps (www. maps.yahoo.com) can help. The point-to-point driving directions are a great time-saver for me. Accurate directions, miles driven, and estimated travel time are all listed. You may need to take rush hour and weather conditions into account when planning your trip, however.

McMaster-Carr Supply Co. (www.mcmaster.com) distributes all sorts of hardware parts and supplies, and 98% of the items sold are shipped from stock. I use this site to purchase components when working on prototype equipment. I don’t have to buy a whole case when I only need one item, and I have it the next day.

When you have some downtime, a fun Web site to visit is the Urban Legend Reference Pages (www.snopes.com). Referred to as Snopes, the site specializes in tracking and investigating common fallacies, misinformation, old wives’ tales, strange news stories, rumors, celebrity gossip, and similar items. So the next time you receive a seemingly unbelievable e-mail, you can go to this site to help you sort out the facts.

PurePouch LLC (Minneapolis; www.purepouch.com) has developed a machine to open, load, and seal chevron pouches on rollstock. Medical supply and other manufacturers needing an easy- open package and a sterile presentation can use pouches from their current vendors on the PurePouch machine to improve packaging throughput and reduce labor costs. Thermal-transfer and print-and-apply labeling options are available.

Corinne Litchfield

Copyright ©2005 Medical Product Manufacturing News

In Brief

Originally Published MPMN May 2005

INDUSTRY NEWS

In Brief

Comet North America (Stamford, CT; www.comet.ch), a supplier of x-ray, radio frequency, and dosimetry systems, and Feinfocus products, has relocated to a 12,000-sq-ft facility featuring two application labs, enhanced testing and repair services, more than 6000 sq ft of warehouse capacity, and additional meeting and office accommodations. The previous headquarters of Feinfocus USA was chosen as the new site for Comet’s operations… BIT Analytical Instruments Inc. (Boston; www.bit-instruments.com), a full-service company that carries out contract development, manufacturing, and after-sales service on equipment for medical OEMs, is a member of the MEC Group, which has been acquired by the Messer Group (Germany; www.messergroup.de). The firm plans to offer its services on a global scale… ACS Group (www.acscorporate.com), a supplier of auxiliary equipment to the plastics processing industry, is relocating and expanding to a New Berlin, WI facility…FutureLogic Manufacturing (Phoenix; www.futurelogic-inc.com), an ISO 9001:2000–certified supplier of thermal printers, has expanded its lead production site to encompass 30,000 sq ft… Reell Precision Manufacturing (St. Paul, MN; www.reell.com), a manufacturer of custom and standard constant-torque hinges and precision-wound springs, has received the Outstanding Supplier Award from Porter Engineered Systems Inc. (Westfield, Indiana; www.porteres.com)… Davis-Standard (Pawcatuck, CT; www.davisstandard.com) and Jorgenson Machinery (Houston; www.jorgensonmachinery.com) have partnered to form Killion Laboratories, a 4350-sq-ft lab. The new Houston-based R&D facility will provide Davis-Standard’s customers with a more centralized location for laboratory systems process development and customer trials.

Copyright ©2005 Medical Product Manufacturing News

Semiconductor Firm Assists in Design of Implantable Devices

Originally Published MPMN May 2005

INDUSTRY NEWS

Semiconductor Firm Assists in Design of Implantable Devices

Corinne Litchfield

A developer of digital, mixed-signal, and sensor products has joined forces with a manufacturer to design implantable defibrillators. AMI Semiconductor (AMIS; Pocatello, ID; www.amis.com) recently announced its technology design and supply agreement with Interventional Rhythm Management Inc. (IRM; Research Triangle Park, NC; www.synecor.com).

Founded in 2003 by medical technology firm Synecor LLC, IRM has been focused on developing new ways of managing patients with cardiac arrhythmia. The company’s initial product is an intravascular implantable defibrillator (IID) designed for the primary prevention of sudden cardiac arrest, an event that has a survival rate of only 5% without a defibrillator.

IRM teamed with AMIS to add features to the IID that would extend the product’s life cycle without compromising functionality. AMIS’s proprietary ASIC technology uses mixed-signal, low-data-rate wireless communication to reduce power consumption. AMIS equipped the defibrillator with a sniff mode that periodically sends out a signal or “sniff” to detect RF energy or data that may require monitoring. Once the sniff finds significant data, a quick-start oscillator powers up the device and prepares it to communicate the data to an outside source, says AMIS account manager Scott Carson.

No major surgery is required to insert the IID under the skin. “The IID represents a major technological breakthrough for the significantly underserved patient population of defibrillator candidates,” says IRM president Richard S. Stack. “A cardiologist will now be able to implant this life-saving device in less than 15 minutes. Patients will no longer need to deal with the permanent implantation of a metallic box under their skin.”

Copyright ©2005 Medical Product Manufacturing News