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Articles from 1999 In September

Sterile Medical Packaging Market Projected to Grow 5.3% Annually


Sterile Medical Packaging Market Projected to Grow 5.3% Annually

Study sees unit demand jumping to 7.2 billion

The sterile medical packaging market is expected to grow 5.3% annually to reach $1.4 billion by 2002, according to a report published by The Freedonia Group Inc. (Cleveland). The report, Sterile Packaging, attributes the growth to continuing attempts to raise infection control standards, an aging population, and demand for sterile packaging configurations designed to provide greater convenience, such as surgical trays.

The study predicts that the trend toward the use of disposables rather than reusables will continue. Sales and demand gains will slow, however, as a result of a decrease in the number of surgical procedures, a slower rate of disposable product replacements for reusable medical supplies and devices, and shorter hospital stays.

The report gives a breakdown of projected growth for specific segments within the sterile packaging market. The market for thermoformed trays will increase 6% through 2002, to $395 million, because of their use in surgical and diagnostic test kits. Blister packs and clamshells will see 7% market growth through 2002, to $115 million, primarily because of the demand for disposable contact lenses. Pouches and bags will see 5.7% annual market growth through 2002, to $336 million and $153 million, respectively. And growth in the market for parenteral containers such as plastic IV containers and vials will slow because of the maturing of this segment of the market. For more information on the report, which is available for $3300, call 440/684-9600.

Rapid Prototyping Market Shrinking

Report documents sharp decline in RP revenues

Rapid prototyping (RP) sales have gone from bad to worse, according to a report from Wohlers Associates Inc. (Fort Collins, CO). The report, titled Rapid Prototyping & Tooling, State of the Industry, notes that on the heels of a weak 1997, revenues from RP sales and services fell more sharply in 1998 than in any previous year. Last year, in fact, RP system sales actually declined from the previous year, marking only the second time in history such a decline has occurred. A bright spot for the industry is 3-D printers for concept modeling, which the report points to as a key to future sales growth. For more information on the report, which is available for $345, call 970/225-0086.

Business and Acquisition News

BEI Medical Systems Company, Inc. (Teterboro, NJ), has entered into an agreement with the University of Birmingham (Edgbaston, UK) and Janesh K. Gupta, a member of the Royal College of Obstetrics and Gynecology, for the worldwide rights to manufacture, market, and distribute the Gupta-Frank clamp, an instrument used in vaginal hysterectomies. Custom tubing extruder NDH Medical Inc. (St. Petersburg, FL) has announced plans for a new manufacturing facility and headquarters in Sevierville, TN. The 25,000-sq-ft, $1 million manufacturing facility will have a staff of 25 and will be expandable to 100,000 sq ft. CMS Hartzell (Richmond, KY; St. Paul, MN) and Global Tool & Engineering (Dallas) have completed their merger agreement. CMS Hartzell will combine its die-casting, sheet-metal stamping, and plastics injection molding services with Global Tool's engineering, prototyping and tooling, and short-run injection molding services. Infinite Group Inc. (Warwick, RI) has combined the recently formed company Express Pattern (Buffalo Grove, IL) with newly acquired plastics injection molder Osley & Whitney Inc. (Westfield, MA) and metallurgical firm Materials & Manufacturing Technologies Inc. (West Kingston, RI). Particle accelerator designer Ion Beam Applications (Louvain-La-Neuve, Belgium) has acquired SteriGenics International (Fremont, CA), a provider of high-quality contract gamma sterilization, microorganism reduction, and radiation processing services for $27 per share in cash. The company had previously acquired Griffith Micro Sciences (Chicago) in April of 1999. Eastman Chemical Co. (Kingsport, TN) has announced plans to acquire the ethylene methyl acrylate and ethylene butyl acrylate product lines of Chevron Chemical Company LLC (San Ramon, CA). The transaction should be finalized at the end of the third quarter of 1999. Motor, drive, and servo system manufacturer Kollmorgen (Radford, VA) has agreed to purchase New England Affiliated Technologies (Lawrence, MA), a company that designs and manufactures precision positioning and motion control products. HealthShield Technologies (Westport, CT) has entered into an exclusive licensing agreement with AK Steel (Middletown, OH). AK Steel will coat carbon and stainless-steel products with HealthShield, a silver-based antimicrobial agent. Custom injection molder Topcraft Precision Molders Inc. (Warminster, PA) was awarded Best Plant status by the Delaware Valley Industrial Resource Center. The award was given as a result of the company's success in rapid tool setup, team effectiveness, and space utilization.

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Copyright ©1999 Medical Product Manufacturing News

Double-Blister Package Sets Surgical Device Apart

Double-Blister Package Sets Surgical Device Apart

Vinyl provides extra strength without breaking the bank

Manufacturers often use packaging to differentiate consumer products vying for attention on store shelves. But can distinctive packaging also give a boost to products sold to businesses and institutions?

This was the question posed by executives at Remington Medical Inc., a supplier of cardiovascular medical devices. Remington decided to give its vascular introducer set, which is used to implant pacemakers in hearts, a new double-blister package that's easier to handle and provides more assurance that sterility will be maintained in the operating room than the original single-blister package. The Alpharetta, GA, company is the first supplier of vascular introducers to use a double-blister style.

The complete double-blister package designed by Blue Ridge Packaging includes an inner package (shown sealed) and an outer tray (with the Tyvek lid pulled back).

The sealed inner tray holding Remington's vascular introducer set is manually placed into the outer tray, which is sealed by machine.

The new package, designed and made by Blue Ridge Packaging of Simpsonville, SC, includes inner and outer trays. The inner thermoformed tray, made of 25-mil clear vinyl Pentamed MD 557-00-16200 from Klöckner Pentaplast of America (Gordonsville, VA), includes compartments for each of the elements of the introducer set (dilator, sheath, guidewire, needle, and syringe) and is sealed with a Tyvek lid. The outside rectangular vinyl tray is also thermoformed and sealed with Tyvek. After the inner tray is sealed in the outer tray, the package is EtO-sterilized.

Material Switch

A specialist in packaging for medical and electronics applications, Blue Ridge also designed the original single-blister package, using Klöckner's 30-mil blue-tinted Pentamed PETG film. The decision to switch materials and downgauge was one of the keys to the new double-blister design. Both the old material and the new offer advantages, notes Larry Richards, Blue Ridge's designer. Blue-tint polyester makes it easier to visually check for breaks in the seal, but Remington wanted a stronger package than it had used in the past. "Vinyl can be downgauged and still be stronger than polyester," Richards explains. "Also, the double package costs considerably more than the single tray, so moving to vinyl helped to make this more-expensive package a bit less so."

During deliberations on what type of package to use, cost considerations took a back seat to market research showing that the new package design would be a hit with the nurses and technicians who would be handling it, according to Don Rosvald, president of Remington. Why? "It's simply a better package that is easier to open and more likely to maintain sterility," Rosvald says.

And so, in a sense, the package became the product. Remington's vascular introducers are very similar to those of its competitors, Rosvald notes, but no one else is using a double-blister package. "We had to differentiate ourselves," he says.

Locked in Place

In the old single-blister package, the elements of the introducer set were locked in place so that when the lid was removed, the parts wouldn't fall out if the tray were turned upside down. This arrangement was supposed to be safe from the standpoint of sterility, but it meant that a nurse or technician had to handle each item, which was a hassle and actually increased the likelihood that the introducer set would be contaminated.

When the items are sealed in the new double package, a nonsterile circulator nurse can open the outer package. Then a scrub nurse in a sterile field puts the inner package on a back table and removes the lid. No one has to unlock the items from the tray. Instead, the tray is simply inverted on the sterile surface and the items are ready to use.

"We've had excellent feedback from nurses and technicians about the ease of use of our new package," Rosvald reports.

Simpler Design

Besides being easier to use, the new package was also easier to design than its predecessor. In designing the single blister, the Blue Ridge designers first had to figure out how to fit all the items in as small a space as possible. Then they designed the tabs, ribs, and taper locks that were supposed to hold all the introducer items in position but not make things too difficult for the nurses who had to remove the items.

By contrast, the new package is a "pretty vanilla" creation, says Richards, the Blue Ridge designer. He and his colleagues lowered the ceiling of the inner package so that the Tyvek lid would hold the introducer items in their compartments without the locking components. Minimizing head space was also a primary concern in the design of the outer package, as was preventing the inner tray from riding up on the lip of the outer tray and interfering with its seal. To solve the latter problem, a 2- to 3-degree backdraft was designed into the thermoforming molds. This causes the flanges of the outer tray to turn down, which ensures that the inner tray can't ride up.

"At one point I even suggested that we thermoform in some grooves that would lock the inner tray into the outer tray," says Richards. "But Don [Rosvald] was adamant about getting rid of any locking mechanisms to keep the package easy to open and handle."

The merits of the new package aside, is this ultimately a story about a company that made too big a fuss about a relatively small matter? Not in the opinion of Gary Slate, president of Blue Ridge. "It's not like packaging candy," Slate says of the Remington project. "If there's a problem with a medical device used for something like heart surgery because of a defective package, you don't get a second chance to get it right. Quality is what counts."

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Copyright ©1999 Medical Product Manufacturing News

Binding posts

Electronic Connectors

Binding posts

Binding posts are available in a variety of colors to ensure easy circuit and polarity identification. All current-carrying parts are gold-plated, finely machined brass and provide maximum conductivity and resistance to corrosion. Miniature fluted nut types are rated for 15 A, 1000 V working, while standard hex- nut and fluted-nut types are rated for 30 A, 1000 V working. Hex- and fluted-nut types with larger studs are also available. Plastic parts are selected for good resistance to corrosive atmospheres, heat, oil or grease, abrasion and impact, and chipping and cracking. Warner Electric, 383 Middle St., Bristol, CT 06010.

Connector junction boxes and wiring system

A connector junction box and a wiring system reduces mounting requirements and wiring costs. The four- and eight-port junction boxes use 8-mm Pico connectors to achieve significant miniaturization benefits. According to the manufacturer, the boxes are the smallest available in the market. Light weight makes them beneficial in robotic applications. A connector ratchet locknut ensures good shock and vibration protection. Lumberg Inc., 14121 Justice Rd., Midlothian, VA 23113.

Power-entry module

A power-entry module incorporates up to six different functions in a package designed to save space, speed assembly, lower parts counts, and facilitate EMC testing and compliance. The GRM-series module features a square configuration, and it is only 26 mm deep. Features include ac inlet, on/off switch, RFI filter, and fuse holder. A metal shield between the inlet and the panel opening provides protection against radiated emissions. Flexible steel contact points make continuous contact with the chassis to reinforce the ground connection. Continuity in the path ensures that damaging EMI is properly routed and does not pass through the equipment. Schurter Inc., P.O. Box 750158, Petaluma, CA 94975-0158.

Nonmetallic shell connectors

Designed for medical applications requiring nonconductive components, lightweight connectors with nonmetallic shells are offered in three keying configurations that are mainly designed for durability. Multiple keying options are available to prevent accidental cross mating of otherwise identical connectors. The shells, molded from PEEK, can accommodate up to seven contacts. PEEK can withstand temperatures of –60° to 230°C and is highly resistant to chemicals. Lemo USA, P.O. Box 11488, Santa Rosa, CA 95406.

Connectors with lightweight shells

A series of 0.025-in.-centerline connectors are available with optional lightweight metal shells for increased durability and mechanical integrity. The new metal shells, which house the traditional plastic connector, offer greater design flexibility and mounting options. The Nano series of ultrahigh-density connectors are available in single- and dual-row packages, and as surface mount, through-hole, and wire-to-wire terminations. Omnetics Connector Corp., 7260 Commerce Cir. E., Minneapolis, MN 55432-3103.

PCB terminal blocks

Pluggable PCB terminal blocks use insulation-displacement connection technology to achieve a fast connection. With the QUiX-Combicon terminal blocks, no wire preparation is required. The wire is simply inserted, and thus wiring time is reduced by 60%, the manufacturer says. Using a 5.08-mm pin spacing, the terminal blocks mate with all industry-standard 0.200-in. PCB-mount headers. The terminal blocks are available with 2 to 16 positions. An additional option includes a screw flange for additional security to the mating header. Phoenix Contact Inc., P.O. Box 4100, Harrisburg, PA 17111-0100.

Coaxial contacts

Low-insertion-force coaxial contacts provide more than 25,000 insertion/extraction cycles. The 50- contacts are rated at 1.20:1 maximum VSWR at 3 GHz. Its low insertion force and long-life performance make this contact system suitable for high-pin-count assemblies as well as portable computers, test equipment, and wireless applications. Hypertronics Corp., 16 Brent Dr., Hudson, MA 01749-2904.

Connector for surface-mount applications

Wire-to-board, disconnectable IDC connectors have a pitch of just 1.0 mm and are only 2.0 mm high and 4.5 mm thick. The IDC section that connects to each wire has dual U-slots to provide redundancy for reliable connections even under adverse environmental and mechanical stresses. A three-point insulation grip provides strain relief for further interconnection integrity. The header is designed for vacuum pick-and-place robotics. J.S.T. Corp., 1957 S. Lakeside Dr., Waukegan, IL 60085.

Cord sets

Class I molded C19 cord sets and power cords supply up to 20 A to power system equipment. The cord sets are available in seven colors and can be configured in three angles—straight, left, and right. They can be molded onto nonshielded SJT, STO, and SEOW, 14/3 and 12/3 AWG cable. Small or large NEMA 5-15 plugs terminate the cord sets, but other plug configurations are also available. Panel Components Corp., P.O. Box 115, Oskaloosa, IA 52577.

Interconnect systems

A manufacturer of high-speed, high-density interconnect systems has expanded its range of products designed for use in medical devices. Such products include miniature thermistor and welded thermocouple assemblies, as well as termination to flex circuits, microribbon, and coaxial cables. The company also produces high-density 1-mm connector systems and assemblies and a variety of custom interconnects. InterCon Systems Inc., 2800 Commerce Dr., Harrisburg, PA 17110-9310.

Forty-pole connectors

Forty-pole metal- and plastic-shell connectors intermate to provide design flexibility. The metal-shell 105-series and the plastic-shell 405-series connectors are available with up to 40 gold-plated contacts in 18-mm-diam bodies. They are designed and manufactured in accordance with ISO 9001 standards. Sealed connectors are rated up to IP68. The connectors are supplied with integral shielding for EMI/RFI-sensitive applications, and they meet EMC 92, which helps OEMs conform to worldwide electromagnetic compatibility standards. Fischer Connectors Inc., 115 Perimeter Court Pl., Ste. 1060, Atlanta, GA 30346.

Custom connectors

Custom-molded connectors are available for the device and hearing-aid industries. The manufacturer's capabilities include custom keying, miniaturization, modular tooling, no-touch safety connectors, shrouded connectors, and radiotranslucent carbon contacts. A variety of molding materials is available. The manufacturer's in-house design, extrusion, tooling, molding, and terminating capabilities allow it to produce cable connector assemblies to exacting customer specifications. Minnesota Wire & Cable, 1835 Energy Park Dr., St. Paul, MN 55108.

Push-pull connectors

A series of miniature cylindrical connectors features precision push-pull locking. Shells are matt chromated and available in various sizes. The inserts are made of various materials including PEEK, LCP, PBT, and Teflon. Steam autoclaving is possible with connectors having PEEK or LCP inserts. A broad range of contract arrangements is available. Contacts include signal, power, coax, fiber optic, and air and fluid coupling. ODU-USA Inc., 451 Constitution Ave., Unit A, Camarillo, CA 93012.

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Cover Products

Cover Products

From the September '99 issue of Medical Product Manufacturing News

Form-Fill-Seal Machine

The Delta 3000D cam, an electronic horizontal form-fill-seal packaging machine from Ilapak Inc. (Newtown, PA), features multiaxis wrapping with misplaced product detection, online gas monitoring, and hermetic sealing rates of up to 240 packs/min.


NuSil Technology (Carpinteria, CA) offers high-consistency elastomers that can be used for silicone extrusion, molding, and calendering. VeraSil elastomers feature an adjustable cure rate and table life, and Shore A hardness from 30 to 70.

Position Sensors

MTS Systems Corp. (Cary, NC) makes noncontacting magnetostrictive position sensors that offer low cost thanks to automated manufacturing. Auto-SE sensors do not wear, are easily protected from fluids and debris, require little maintenance, and have long life expectancy.

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Copyright ©1999 Medical Product Manufacturing News

Production and assembly equipment

Production and assembly equipment

Converting system

A converting system incorporates the following technologies: 18-in. web widths, 5 unwinds/rewinds, 2 unwinds with in-line steering, 2 low-tension butterfly dancers, 2 transducer tension controls, web and die registration sensors, 2 flexographic printing stations, 2 infrared/impinged hot-air dryers, 2 single-rotary die stations, and a double-rotary die station. Features include a heavy-duty cabinet design with thick-aluminum mounting front faceplate, as well as integrated third-party equipment using analog, discrete, serial, and networking protocols. The system also uses machined pads with a cone-locating system for accurate tramming of multiple cabinets. Delta Industrial Service, 11501 Eagle St. N.W., Coon Rapids, MN 55448.

Tubing coiler

Designed for medical tubing, a coordinated, fully programmable coiling machine allows quick coiler response. The dual-axis, ac servo drive system allows for ratios in excess of 2000:1. The dual-axis servomotor-driven spindle and traverser provide quick computer communication between these two axes, allowing not only the closing of the velocity loop on the drive, but also the closing of the position loop. This enables the traverser to place the extrudate in a precise circumferential pattern at the flange with either instantaneous or delayed traverse patterns. Because the coiler is a software-based system, any conceivable traversing pattern that may be required can be entered into the system either from the manufacturer or in the field. This requires only the replacement of a memory chip in the controller. Vulcan Machinery Corp., 20 N. Case Ave., Akron, OH 44305.

Assembly press

The stroke-return lock on an assembly press ensures that every time a manual assembly or pressing operation is performed, the selected ram stroke has been completed by the operator within ±0.002 in. The ram-locking mechanism prevents a partially completed assembly by not allowing the ram to be returned to its fully retracted position should the operator inadvertently cut the ram stroke short. Thus, the assembly cannot be removed from the nesting fixture and the operator is forced to move the press arbor to its full preset position. Schmidt Feintechnik Corp., 230 Executive Dr., Cranberry Township, PA 16066.

Tape dispenser

A dispenser feeds and cuts strips of cohesive tape for the assembly and packaging of medical devices. The tape length is set using a dial knob on the side of the machine. When the operator pushes a button to cut the tape, the dispenser automatically feeds the next piece. It uses 120/240-V line voltage and requires no air. An optional tape cradle and a foot-switch control are available. Special electronics for conversion into batch mode are also available for continuously producing large quantities of strips. S-Y-M Products Co., P.O. Box 112160, Stamford, CT 06911.

Orbital head-forming machine

An orbital head-forming machine is used for product assemblies not using fasteners. Machined, semipierced, die-cast, or molded studs, pins, tabs, and bosses are flared out to secure the mating part without using rivets, screws, or other fasteners. There is no need for separate hardware. Blanked ridges, protrusions, and integral projections of malleable material, including stainless-steel grades and many thermoplastics, can be formed out to anchor components in position. The Model T-321 features precisely controlled and infinitely adjustable cycle time (speed) and heading pressure. Taumel Assembly Systems, Rte. 22, Robin Hill Corporate Park, Patterson, NY 12563.

Cut-to-length machine

A guillotine cut-to-length machine feeds, measures, cuts, and counts product as instructed by operator commands. The Model SS-4 eliminates the need for compressed air, which is often undesirable in cleanroom environments. It operates at higher speeds and lower noise than compressed-air units. Medical test strips, membranes, flat latex rubber products, films, foils, and papers can be cut with the machine. AZCO Corp., 385 Falmouth Ave., Elmwood Park, NJ 07407.

Modular assembly cell

High-accuracy dispensing and automated assembly of human implantable and microminiature medical products is made possible with a modular assembly cell. The Biocell 9000 is portable, modular, and flexible. Hideaway touch screen controls permit display and adjustment of dispense rates, volumes, and assembly insertion forces. Modular parts trays and removable tools allow access for cleaning and quick reconfiguration. An optional conveyor transport ties multiple machines together for fully automated manufacturing. Assembly & Manufacturing Systems Inc., 2222 Shasta Way, Simi Valley, CA 93065.

Narrow-profile assembly system

When interfaced with the manufacturer's Dynamic process controller, the Model 220 assembly system allows the user many options of control and functionality that can be customized to meet the needs of specific assembly applications. The Model 220 is available as a thruster system, which can be interfaced with custom and automated assembly systems, or it can be assembled with a press support package and an ergonomic base as a manual-press system. Dukane Corp., Ultrasonics Div., 2900 Dukane Dr., St. Charles, IL 60174.

Dipping system

A dip-molding and dip-coating system is useful for small-scale production and research formulation work. Compared with an earlier model, Navigator II features an expanded table for larger tanks, rugged construction, and a control system with software design incorporating the use of Microsoft Basic. In addition to vertical axis and pallet rotate motion, the system can also be supplied with former axial spin. ACC Automation, P.O. Box 569, Akron, OH 44309.

Automation machines

Cost and design time for special applications in the manufacturing arena can be prohibitive for companies seeking to automate assembly and testing for part or all of their production processes. A manufacturer of custom automation machines uses modular automation to reduce such delivery lead times and costs. It has designed and used many units, such as pick and place, adhesive dispensing, fastening, staking, welding/soldering, drilling/tapping, and leak testing, which can be integrated into a system, thereby reducing the design and build time. The company says that this is not a quick shortcut fix for special machines. Rather, it means that much of the basic preliminary tasks do not have to be repeated, thereby reducing costs and fabrication time. Automation Engineering & Manufacturing Inc., 834 S. Sherman St., Longmont, CO 80501.

Material-transport system

Workstations, machines, and testing stations can be interconnected by a modular monorail material transport system with self-propelled pallets. The Montrac system features shock-free and impact-free transport, cleanroom compatibility, safe discharge of electrostatic buildup, stepping ability with high accuracy, and good flexibility. Montrac LLC, 10430 Harris Oaks Blvd., Ste. K, Charlotte, NC 28269.

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A sterilizer can use various processes to sterilize products, including circulating water, a steam-air mixture for water-sensitive products, and high vacuum for soft-wall packaging. The Triplex system can sterilize product batches from 100 to several thousand at a time, making it suitable for both R&D and production runs. The sterilizer allows for adjustment of processing parameters and is self-documenting for regulatory compliance. The manufacturer provides cycle development service for difficult applications. Getinge/Castle Inc., 1777 E. Henrietta Rd., Rochester, NY 14623.

X-ray sterilization system

Designed for terminal sterilization of large volumes of medical products, an x-ray sterilization system has an energy rating of 7 MeV and a power rating of 190 kW. The Rhodotron x-ray machine has an extra beam line with ratings of 10 MeV and 200 kW that can be added to provide the option of processing in the E-beam mode. Full turnkey systems can be installed; installation and training are included with the purchase of the system. IBA, 11 Lafayette Ln., P.O. Box 37, Liberty Corner, NJ 07938.

In-chamber monitoring system

Using three sensors packaged in a single housing, an in-chamber gas monitoring system measures EtO, relative humidity, and temperature levels within the sterilization chamber. The ICM-310 features sensors that are UL, CSA, and EU listed as intrinsically safe for use in explosive-mixture sterilizers. Data are shown in continuous, real-time graphs on a custom-designed computer, which can be accessed on a network or operated locally. Other capabilities include the option to attach up to 64 sensors and the use of a dual Pentium computer system for added security. APL Group International LLC, 862 McMeekin Pl., Lexington, KY 40502.

Gas plasma sterilization

Combining hydrogen peroxide with radio waves, a sterilization system creates gas plasma that sterilizes the products without leaving toxic residues. The Sterrad 200 GMP sterilization system uses programmable control software, allowing designated personnel to selectively modify sterilization sequences and parameters to match product, packaging, and load configurations. Other features of the system include a double-door configuration, polished stainless-steel paneling, and GMP monitoring and parametric release capability. Advanced Sterilization Products, 33 Technology Dr., Irvine, CA 92618.

Irradiation system

A batch-type irradiator uses dry source storage rather than traditional pool storage to facilitate transferability and reduce installation time. The MicroCell's shield is made of preassembled steel and covers less than 170 sq ft of floor area. The system's design makes it suitable for small volumes of product. The product revolves on a carousel around the irradiation source for even dose distribution. SteriGenics International Inc., P.O. Box 5030, Fremont, CA 94537.

Pulsed-power sterilization

A sterilizer uses a pulsed-power system to drive an inert gas lamp that emits broadband white light pulses approximately 20,000 times more intense than sunlight. The process, which emits wavelengths in the UV, visible, and near-IR parts of the spectrum, produces no significant heat and can penetrate many types of clear packaging and fluids. Products are exposed for a short period of time, reducing the potential for material degradation. The manufacturer provides assistance to customers by allowing experiments to be conducted in its laboratory, thereby identifying sterilization equipment suitable for integration into the production process. PurePulse Technologies, 4241 Ponderosa Ave., San Diego, CA 92123.

Sterilizer control system

Designed for use with both remanufactured and new sterilizers, a sterilization control system includes a 16-color liquid-crystal display, a 10-key data-entry pad, 12 preprogrammed function keys, and a 40-column impact printer. The Frontier 2000 system is FDA GMP compliant and comes with a 12-in. chart recorder that provides independent monitoring and recording of cycle parameters. A prevalidation support package is available with each unit. ARS, 12900 Lakeland Rd., Santa Fe Springs, CA 90670.

E-beam irradiation system

An E-beam irradiation system uses microwave technology to sterilize single-use medical equipment. The Betaline system process, which takes approximately 1 hour, sterilizes one piece of equipment at a time, creates low levels of radiation, and uses no hazardous chemical additives. According to the company, it is the smallest irradiation system on the market, taking up only one-tenth the space occupied by traditional systems. Scanditronix Medical AB, Stålgatan 14, S-754 50 Uppsala, Sweden.

Rising sterilizer door

A manufacturer has introduced a vertical rising sterilizer door technology that can be customized for various applications. The door takes up 40­50% less floor space than traditional horizontal sliding or hinged-opening doors, according to the manufacturer. The equipment that powers and feeds the sterilizer can be installed above the machine, minimizing the need to enter the containment area. The door is available in sizes up to 146 in. wide, comes equipped with fail-safe features, and offers a choice of either an AB or Siemens PLC control system. Environmental Tectonics Corp., 125 James Way, Southampton, PA 18966.

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Water-Jet Cutter Requires Minimal Training


Manufacturing Equipment

Water-Jet Cutter Requires MinimalTraining

Suitable for short-run parts

COMBINING A MOTION CONTROLLER, high-pressure pump, abrasive jet delivery system, and two-axis machining table, the JetMachining Center from Omax Corp. (Auburn, WA) is designed for the production of precision parts. The system cuts nonconductive, reflective, and hardened materials and can perform CNC mill cutting and boring. Finished parts are free of burrs, stresses, and heat-affected zones.

The unit's motion control system combines CAD/CAM and motion control software to facilitate complex part machining using automatic tool path creation and a built-in cutting model. Icon-driven menus and on-line assistance make this system suitable for users with minimal training. Optional software modules include Nester LT for nesting complex parts and Translator for translation of a variety of CAD formats.

Tool paths are entered into the top-mounted, IBM-compatible computer and then sent to the abrasive jet delivery system, which accelerates prepressurized water through a small sapphire jewel within the self-aligning nozzle at 2500 ft/sec. An abrasive is mixed with the water in a ceramic tube, and a stream of abrasive-laden water exits the nozzle at 1000 ft/sec.

Mounted to the cutting table is an x-y-axis whose drive mechanisms include tool-grade linear bearings, brushless servomotors, and high-precision ball screws.

For more information, call Omax Corp. at 800/838-0343.

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Product Development

Automatic Writing Device Draws Thick-Film Electrodes

Features a pen that 'floats'

ARE YOU A MAKER of dc-heater-type cauterizers who is looking for more uniform product performance and higher manufacturing yields? The MicroPen precision writing system from OhmCraft Inc. (Honeoye Falls, NY) may help you reach your goals. MicroPen automatically draws thick-film electrodes in uniform widths as small as 2 mil and as thick as needed. No hand operations or hard tooling are involved.

Under CAD control, MicroPen performs dependably on substrate materials ranging from metal to ceramics to glass. Substrate configuration and fragility don't present problems. A patented dynamic pen control arrangement causes the pen to actually float on the line it's writing. This means that multiple layers of conductor and dielectric can be drawn before a single firing. The long-nosed pen can draw lines within grooves, over surface irregularities, and in helical patterns on cylindrical probes.

When developing new products, designers need only change computer instructions to make incremental changes in conductor patterning and line dimensions. After a single firing, the series of prototypes can be tested with the assurance that their performance will be identical to that of the production units, since the same process is used for manufacturing.

For more information, call OhmCraft Inc. at 716/624-2610.

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Polymer Meets Needs of Implant Products

Designed for long-term implants

MEDICAL OEMs now have an advanced biomaterial to specify in implant products and other high-performance applications.

Designed to meet stringent medical product performance criteria, PEEK-Optima LT polymer is the newest member of the PEEK polymer family of polyaryletherketone resins from Victrex USA Inc. (West Chester, PA). Compared to other plastics available for this market, PEEK-Optima LT polymer is stronger, can stand up to more aggressive environments, performs better in steam, and maintains impact properties over a broader range of temperatures, according to Victrex.

Since the company tailors the stiffness of the polymer to match that of human bone, the material can be used in long-term applications such as hip, spinal, and dental implants. In addition, the polymer's inherent lubricity helps prevent implants from cavitating on the bone, which is especially important for hip implants.

PEEK-Optima LT can fill very thin walls in products such as heart valve components. Because of its combination of strength and stiffness, manufacturers can use less of it than other plastics to achieve the same stiffness, Victrex claims.

For more information, call Victrex USA, Inc. at 800/842-8739.

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Copyright ©1999 Medical Product Manufacturing News

Entering the Japanese Medical Device Market

Originally Published September 1999


Ames Gross

In the past decade, Japan's economy has experienced very slow growth or actual recession. Despite this, opportunities in Japan's medical device market—currently valued at $21 billion, the second largest in the world—have grown for foreign medical companies. This growth is a product of several factors, such as an increased desire to find cost-effective treatments to reduce burgeoning healthcare expenditures, a more favorable regulatory and registration environment for foreign medical companies, and a rapidly aging population whose healthcare needs are soaring.

One of the main changes spurring growth in the Japanese market is increased deregulation of the distribution sector. In the past, Japan's distribution system has been a tremendous obstacle to foreign companies.

Street Beat

Originally Published September 1999


Thomas J. Gunderson

Over the past two years, Wall Street has been conducting a very public love affair with large-cap stocks. The repercussions of such focused attention to market cap have been magnified among medical technology companies.

Consider the U.S. Bancorp Piper Jaffray medical technology indices (see Figure 1). Year-to-date, the large-cap stock index has increased 11.24%, while its small-cap counterpart has declined 0.4%. Performance over the trailing 12 months is even more one-sided: large-cap med-tech companies are up 24.2% versus the 5.5% decline of their small-cap counterparts. To put these numbers in perspective, the technology-heavy NASDAQ index increased 27.4% and 44.0% over the same respective periods.

Figure 1. The U.S. Bancorp Piper Jaffray medical technology indices for January through June 1999 illustrate Wall Street's current favor toward large-cap companies.

What's The Frequency?

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

An MD&DI September 1999 Column


In another example of issues raised by the expanding technological base of medical devices, the advent of digital TV is crowding the airwaves.

Picture yourself in the intensive care unit, with your cardiac function and respiration transmitted via a wireless monitor to the nurses' station around the corner. Just as your caregiver is furrowing his or her brow at an unusual breath or a slight dip in systolic pressure, your vital signs on the screen are suddenly replaced by . . . a wrestling match, or maybe a rerun of Mister Ed.

Although the last image is a bit fanciful, something along these lines took place not long ago in Texas, when a local television station began testing its digital TV (DTV) system in a previously unassigned frequency band. The band was the same one being used at a nearby medical center for its telemetry system, which the DTV tests effectively shut down. Fortunately, no one was injured and the problem was quickly rectified, but the incident served as a wake-up call for FDA, the Federal Communications Commission (FCC), healthcare providers, and manufacturers of wireless telemetry equipment.

Until recently, telemetry systems have functioned according to a kind of "squatters' rights" arrangement. Conventional—that is, analog—television stations were each assigned a second channel to be employed for future DTV services. Because these channels have generally remained vacant during the slower-than-anticipated development of DTV, they are often selected for transmissions by telemetry device users. Now that DTV technology is progressing, however, the potential for interference with ongoing telemetry operations has increased as stations actively test new digital systems.

In March 1998, FCC's Office of Engineering and Technology issued a fact sheet that in essence counseled TV stations and healthcare facilities to make nice and share, under the assumption that "interference can be avoided by appropriate planning and exchange of information." The idea was that the stations would inform hospitals of their DTV plans, the telemetry device manufacturers and installers would inform users about possible interference, and the users would then inform themselves about which channels were actually vacant and either continue operating on a still-vacant channel, switch to a different vacant channel, or replace nonretunable devices with new ones.

If the above reads like a run-on sentence in need of pruning, FCC evidently came to the same conclusion regarding its policy. On July 14 of this year, following consultation with a task force organized by the American Hospital Association, FCC adopted a notice of proposed rule making that would create a separate Wireless Medical Telemetry Service to operate on a "blanket-licensed, interference-protected basis" over specified frequency bands. The proposal would also establish an FCC-designated frequency coordinator, just to make sure that nobody's transmission gets squelched.

FDA, which participated in the task force and supports the FCC action, has noted in a July 29 letter to manufacturers that "this initiative marks the first time in the U.S. that wireless medical telemetry will have primary or co-primary status for use of the airways." FDA is encouraging companies that market devices based on wireless technology to submit comments on the proposed rule to FCC before the October 16, 1999 deadline.

The fretting over frequency is another example of the unanticipated technical and regulatory repercussions that can arise from ever-more-complex devices. Citing what he called the "challenge of new technology," CDRH director David Feigal stated in a July 27 presentation that the center had 763 applications under review or pending for artificial intelligence and visual recognition programs, data interpretation, software-operated miniaturized devices, and software-driven monitoring devices with alarm function for critical care. Though not all of these are wireless, they will nevertheless require manufacturers and regulators alike to stay tuned for the next episode.

Jon Katz

Copyright ©1999 Medical Device & Diagnostic Industry