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Articles from 2002 In May


Tactile Sensor Arrays Conform to Fit Human Needs

Originally Published MPMN May 2002

INDUSTRY NEWS

Tactile Sensor Arrays Conform to Fit Human Needs

Susan Wallace

A conformable sensor makes it possible to measure pressure and touch in places not previously possible, such as on the curved surfaces of the human body. Pressure Profile Systems Inc. (Los Angeles; www.pressureprofile.com) offers the T-2000 tactile sensor system that uses a conformable array of pressure sensors to quantify the sense of touch. The sensor bends and forms to fit complex shapes such as the human hand, tool handles, joystick controls, or feet.

Because it is a complete hardware and software system, the T-2000 is sensitive enough to acquire data such as the human pulse felt at skin level, and flexible enough to check the fit of a helmet, shoe, or prosthetic device.

The system is based on the company's proprietary TactArray technology, originally developed for use in tactile gloves for surgical data acquisition. The technology uses capacitive pressure sensors instead of resistive sensors, which require multiple calibrations during a single session. The T-2000 can continuously deliver reliable data after only one initial calibration. This results in fast, repeatable data collection.

A single T-2000 can be configured with 16 to 256 sensor elements in array sizes up to almost 6 sq in. System specifications include full-scale ranges of 3, 12, or 30 psi, 0.15% static noise, and 1.0% nonlinearity. Pressure sensitivity is controlled by the user.

Copyright ©2002 Medical Product Manufacturing News

Critical Industry Data Available on CD-ROM

Originally Published MPMN May 2002

INDUSTRY NEWS

Critical Industry Data Available on CD-ROM

Susan Wallace

For more than 20 years, the Medical Device Register (MDR) has been recognized throughout the industry as the leading directory guide to medical manufacturers and their products. The full directory is also offered as an interactive Windows-based CD-ROM—the Win MDR—whose summer 2002 release is now available.

The new release of the WinMDR brings the ease of use and functionality of a searchable CD-ROM format to a comprehensive manufacturer database. Manufacturer profiles include such information as company name, address, telephone and fax numbers; e-mail and Web site addresses; annual revenue and medical sales volume; method of distribution; registered trade names; quality system and CE mark compliance; U.S. federal procurement eligibility; type of ownership or parent company; number of employees; names of key executives; and a complete list of products, presented with their FDA codes and grouped by medical specialty area.

For the summer 2002 release, several new features have been added to the WinMDR's powerful search and retrieval capabilities. Subscribers can now search the database using fields such as company name, city, state, postal code, country, or phone number. Manufacturers can also be selected according to their revenue range, distribution method, or quality system adherence, while products can be located by product name, keyword, medical specialty, or trade name. A special function enables the creation of personnel mailing lists and labels.

Produced by MPMN's publisher, Canon Communications llc, the summer 2002 WinMDR can be purchased with a one-year license—which includes a six-month upgrade at no additional cost—for $369.00. A special package offer of the two-volume print edition of the 2002 Medical Device Register together with the summer 2002 WinMDR costs $469.00. Further information and ordering instructions can be obtained on-line at www.devicelink.com/bookstore/items/WINMDR-02.html or by calling 310/ 445-3746.

Copyright ©2002 Medical Product Manufacturing News

Companies Introduce Medical Manufacturing Equipment, Products for Global Market at German Show

Originally Published MPMN May 2002

INDUSTRY NEWS

Companies Introduce Medical Manufacturing Equipment, Products for Global Market at German Show

Norbert Sparrow

One thing is clear when you arrive in Stuttgart, Germany: Mercedes-Benz rules the roost. The iconic hood ornament looms from the roof of a building across from the terminal: it's impossible to miss as you line up for a taxi, which, in all likelihood, will be a Mercedes. And no visit to this industrial town in Germany's Southwest would be complete without a tour of the Mercedes-Benz museum, one of the prime tourist attractions. But the automotive industry--Porsche also has a factory here--is not the region's only economic driver. The capital of the state of Baden-Württemberg, Stuttgart is also a hub of European medical technology.

Germany is the largest manufacturer of medical equipment in Europe, and Baden-Württemberg is home to almost half of the country's medical device OEMs. More than 50% of the medical products consumed in Europe are made here, according to the GWZ-Baden-Württemberg Agency for International Cooperation. Thus it should come as no surprise that the first MEDTEC event to be held at the Stuttgart Messe March 5-7 exceeded expectations both in terms of the number of exhibitors and attendees. Organized by Canon Communications llc, which publishes MPMN, and modeled after the company's MD&M trade shows in the United States, MEDTEC 2002 featured several product introductions relevant to device manufacturers worldwide.

Doyen Medipharm Inc. (Barton, Cambs, UK; www.doyenmedipharm.com) displayed a fully integrated wound-care dressing fabrication and packaging line at its stand. The company showed dressings being fabricated on the PD120 machine, which were then transferred to the 4SS four-side-seal packaging unit. Fabrication speeds can attain 200 units per hour, and the servo-driven machines have a patented design that ensures control of all validated sealing parameters.

The firm also introduced several enhancements to its 4SS packaging machine that will minimize machine downtime and product waste, according to group chairman Alan Isaacs. Among the features cited by Isaacs are in-feed speed profiling to "prevent the dressings from bunching up" and electronic web tension control. The web-tensioning system reduces curling of the packaging and ensures that sealing characteristics remain identical regardless of reel size. A pressure adjustment system on the side seal rollers enables the operator to rapidly and precisely repeat settings during product changeover. The new features, which are standard on all 4SS machines, can also be fitted to existing machinery in the field.

Minimally Progressive

The KPL 5000 laser developed by Komlas GmbH is designed for microwelding and drilling applications in the medical device and electronics sectors.

A laser system designed for use in R&D and small-scale production was showcased by Berlin-based Komlas GmbH (www.komlas.de). The workstation integrates the KPL 5000 laser, a servomotor-driven x-y stage that achieves 5-µm resolution, and a stereomicroscope with through-the-lens miniature CCD video camera. The standard laser can be focused to a 100-µm spot; an advanced model allows the beam to be focused to a 50-µm area. The system is suited for welding and drilling miniature medical devices and electronic components.

French firm Arthesys (Gennevilliers, France; www.arthesys.com) has 15 years' experience developing and manufacturing catheters, noted Miroslav Secerov, director of marketing and sales. The company attended MEDTEC to demonstrate how it can adapt its PTCA catheters to suit the needs of OEMs, said Secerov. Balloon lengths and diameters as well as the positioning of radiopaque markers can be modified to meet specifications, and numerous options are available to match the products to a customer's existing range. Although it is currently focusing on Europe and parts of the world outside North America, Secerov hinted that Arthesys is eyeing the U.S. market with a PTCA catheter under development that does not infringe on current patents.

Stent and Deliver

As drug-eluting stents come to market and create further demand for the tiny scaffolds, suppliers of related services and equipment are redoubling efforts to get the attention of OEMs. Fortimedix (Berg en Terblijt, Netherlands; www.fortimedix.com) showcased its product development expertise and manufacturing equipment at MEDTEC. In addition to its ability to manage stent development from the design stage to the production of a finished CE-marked device, the company promoted its universal stent crimper. Incorporating patented automated crimping technology, the machine relies on a force- controlled process to maintain crimping until an equilibrium of forces has been reached. The company also builds a machine that reduces stent diameters prior to crimping and heat-set equipment for postcrimping operations.

The newest generation of stent-crimping equipment from Machine Solutions integrates several automation features.

Not to be outdone, Machine Solutions Inc. (Flagstaff, AZ; www.machinesolutions.org) launched its latest stent crimping unit at MEDTEC. The Series 1000 machine integrates advanced process monitoring features along with automation enhancements. It incorporates a PC-operated system, allowing users to create unique file structures for different size combinations that can be easily recalled. A load cell displays the force applied to the activation arms while using the mechanical stops. Other novel features include a vision assistance system to aid in precisely positioning the stent between catheter marker bands, an encoder for continuous monitoring of crimp diameters, and a laser micrometer that provides crimp profile measurements as the stent retracts.

Copyright ©2002 Medical Product Manufacturing News

On-Line Database Facilitates Plastics Sourcing

Originally Published MPMN May 2002

E-NEWS

On-Line Database Facilitates Plastics Sourcing

Zachary Turke

http://ides.com/products/pexpress.html

A plastics database maintained by IDES (Laramie, WY) may allow designers to source resins for new projects more rapidly. Located at http://ides.com/products/pexpress.html, the Prospector Express Web site provides OEMs with a comprehensive tool for locating and purchasing 38,000 plastic materials from almost 400 global suppliers. "Our Web site allows medical designers to cut hours out of their plastics search," says president Mike Kmetz. "With just a few mouse clicks, they can find a material, source it, get a price quote, and even place an order on-line," he says.

Designers navigate through the site using an intuitive search function that narrows the product listings to a few compatible resins. Among other factors, these searches can be performed using manufacturer name, generic plastic family information, product title, or plastics grade. Once a suitable material is located, relevant design guides, case studies, material safety literature, and product data sheets are provided. Output in HTML format, the product data sheets contain information on up to 1300 physical, mechanical, thermal, electrical, optical, and processing characteristics.

For products from suppliers with e-commerce capabilities, the site also allows users to solicit sample materials, request price quotes, and place purchase orders. "These features are particularly useful for smaller manufacturers that otherwise might not get the attention they deserve from larger suppliers," says Kmetz.

Copyright ©2002 Medical Product Manufacturing News

Motor Site Guides Users through Configuration Process

Originally Published MPMN May 2002

E-NEWS

Motor Site Guides Users through Configuration Process

Zachary Turke

www.hurstmfg.com

Designed for users with varying levels of motor knowledge, a Web page located at www.hurstmfg.com guides customers through the motor configuration process using a series of broad, application-based questions. "Many of our customers have limited motor expertise," says Nick Segobiano, director of sales and marketing for Hurst Manufacturing (Princeton, IN). "Our on-line motor design feature is a response for them, incorporating simple questions about a motor's application that help lead to specific motor designs."

Offering 6000 possible product configurations at the click of a mouse, the design feature works by prompting customers through the selection of preengineered modules that combine to create a customized motor and control. The process incorporates drop-down menus that ease use, and allows searching without the input of all key performance values. "This tool isn't just our catalog in electronic format," explains Segobiano. "It's a cyber motor expert that does the thinking for you when you don't know the right questions to ask or the specific information to request." Products that can be designed include brushless dc, stepper, hybrid stepper, linear actuator, synchronous, and induction motors.

In addition to allowing on-line motor design, the site also enables users to get a price quote and place and track orders, all without searching through catalogs or consulting engineers. As part orders are transmitted directly from the user's computer to the manufacturing floor, delivery time for motor samples is generally 48 hours.

Copyright ©2002 Medical Product Manufacturing News

My Favorite Bookmarks

Originally Published MPMN May 2002

E-NEWS

My Favorite Bookmarks

Ryan Pierce
Research and Development Engineer
Concentric Medical Inc.

Zachary Turke

Stanford Medical Device eSource (http://esource.stanford.edu) is a directory of on-line resources that specifically target medical device designers. Conceived as part of the university's biomedical engineering curriculum, this site helps to simplify the task of knowledge management that is often a problem for our profession. Combining a Web portal with customized content, the page is a one-stop clearinghouse for trade journals, intellectual property information, and engineering data.

Science Made Simple (www.sciencemadesimple.net/conversions.html) is where I go when I need a quick and convenient way of converting different units of measure. Of course as device designers, we all know that 3 Fr = 1 mm, but this site is worth bookmarking for less-memorable conversions. The page even includes a currency convertor, which comes in handy when preparing expense reports.

Merriam-Webster Medical Dictionary (www.intelihealth.com) is one of several useful medical dictionaries I've found on the Web. Hosted by InteliHealth, this dictionary has more than 35,000 entries, complete with pronunciation suggestions and hyperlinked cross-references when applicable. I have to read a lot of technical papers, and the convenience of this site leaves me no excuse for not looking up any unfamiliar clinical terminology I come across.

Medical Industry Today (www.medicaldata.com/mit) provides a free and concise report of the latest news on devices, diagnostics, biotechnology, market issues, corporate acquisitions, and world health. Available daily via fax or e-mail, this publication generally contains about 10 stories in both brief-synopsis and full-text formats. It only takes me a few minutes a day to scan the headlines, and I find it helpful for keeping in tune with what's going on in the industry.

Concentric Medical Inc. (Mountain View, CA; www.concentric-medical.com) creates novel treatments in the field of interventional neuroradiology, including devices for stroke and tumors. In addition to standard products such as guide catheters, microcatheters, and guidewires, the company develops thrombus and foreign-body retrieval devices and drug-delivering embolic particles.

Medical Product Manufacturing News is seeking design engineers to share their Internet expertise with our readers. If you or someone else from your company would like to participate in this column, please contact associate editor Zachary Turke by phoning 310/445-4268 or via e-mail at zachary.turke@cancom.com.

Copyright ©2002 Medical Product Manufacturing News

From Extruding to Boxing

Originally Published MPMN May 2002

EQUIPMENT NEWS: Extrusion and Tube Processing

From Extruding to Boxing

New devices offer improved efficiency and operator comfort

Katherine Sweeny

Tube fabrication and processing are essential parts of the medical manufacturing industry. Recent developments in these technologies enable manufacturers to extrude tubing more efficiently, automatically cut and store tubing, and blast chemical residue from finished products. These products and others are described in this section.

Laser tube processor is efficient and user-friendly

A laser system cuts tubing with a diameter ranging from 0.25 to 1.125 in. The Pro Stent-2 system, available from Stent-Cil Inc., incorporates the Lasag 246FC laser source, which is designed for fine cutting operations. It was developed with the goal of producing a reliable, highly accurate, and user-friendly turnkey system for the cutting of small-diameter tubing. The system enables a single operator to monitor and operate up to three systems. An efficient assist-gas usage design minimizes laser energy during the cutting process. This low energy level, combined with cooling water, translates to less heat being applied to the part and, in turn, a smaller heat-affected zone than is possible with a conventional laser cutter.

Additionally, the captured process allows tighter tolerances to be kept when processing small-diameter tubing. Parts coming off the machine typically do not have dross or slag left over from the cutting process, which means less time in the electropolishing postprocess.

Written with a graphical interface, the system's motion control software provides visual feedback of laser parameters and program parameters, video feedback of the cutting surface, system-status messages, parts counts, and timers, all on a single LCD screen. The software runs industry-standard NC code to drive the motion system and interact with the auxiliary controls for assist gas, water flow, and laser control.

Applications include the manufacture of stents, catheters, suturing devices, auditory-canal implants, and specialized hypodermic needles. The most common types of tubing that can be cut are stainless steel and nitinol, however the system can be used to cut many other types of metallic tubing. "Users need only supply stock to cut, attach the water source, and tell the system what part to cut and how many," says vice president of marketing Shane Kirk. "The system then automatically indexes and manipulates the stock throughout the manufacturing cutting process."

Tubing shrinker is suitable for cleanroom use

The Glo-Ring from Eraser Company, Inc., uses infrared heating to shrink tubing.

A single-element bench unit with solid-state heat controls can shrink long lengths of heat-shrink tubing and other materials on cable assemblies and wire harnesses. The Glo-Ring from Eraser Company, Inc., radiates focused infrared heat at temperatures of up to 1500°F, and features a temperature controller for variable heat intensity. It can be fitted with ½, 1-, 2-, or 3-in.-diam gold-plated plug-in quartz elements, with special element configurations also available. Heating elements open and close by activating the electrical foot switch. Quartz elements are protected by guards for safety and to prevent accidental damage. According to company spokesperson Nancy Shenker, the Glo-Ring was "initially developed for use in the manufacturing world as a substitute for heat guns; the medical industry picked up on it because it does not require the use of hot air, making it suitable for cleanroom use." The unit measures 4½ x 5 x 9 in. A triple-element bench version and a handheld unit are also available. Applications include medical tubing for catheters and IVs.

Tubing cutter box loads short-length tubing

Vulcan Machinery's cutter also box loads elastomeric tubing.

A tubing cutter is designed for high-speed box loading of FPVC medical tubing up to 120 in. long. Offered by Vulcan Machinery Corp., the tubing cutter can be configured to fill three in-line boxes at 80 cycles per minute, and production throughput rates up to 240 pieces per minute are achieved. A three-axis servo-driven in-feed, rotary indexing, mechanical discharge, and automatic box-oscillating system replace standard pneumatic discharge units. Typically, pneumatic discharge, system cycle rates are limited to less than 60 pieces per minute, requiring large volumes of compressed air and higher maintenance. "FPVC tends to retain a set as it continues to cool after accumulation," says company spokesperson Bryan Friend. "By decreasing the overlapping that occurs with common discharge systems, higher quality standards are achieved."

The servo-driven mechanical discharge and accumulation system significantly minimizes these problems and increases production efficiency. Also, the automatic box exchange and oscillation system reduces labor, improves product distribution, and delivers increased end-product quality. Process parameters are entered using a software-driven, four-line LCD with soft-touch keypad entry. As the operator scrolls through various password-protected set-up menus, current variables are displayed and new values may be entered.

The machine cuts tubing to a desired length, discharges it pneumatically from a conveyor at the end of the line into an adjacent plastic-lined box, and transports it to a final assembly area for attachment of fittings, coiling, and tying. The tubing lengths are automatically and evenly distributed. The efficiency derived from the mechanical collection and uniform delivery to bulk containers eliminates the need for intermittent bursts of air, resulting in an economical and potentially cleaner performance.

Vacuum sizing system quickly and efficiently creates tubing

The 2.0 PVS from RDN Manufacturing Company, Inc., cools and sizes small-diameter tubing.

A vacuum sizing system is designed for cooling and sizing small-diameter tubes. The design allows close-tolerance sizing of nonsilicone medical materials, such as flexible PVC and urethanes, which are difficult to vacuum size. The Model 2.0 PVS from RDN Manufacturing Company, Inc., vacuum sizes these materials at higher rates than extrusion process techniques, according to the company. A vacuum is created through the use of a blower. "Instead of free-sizing tubing or using a direct-acting liquid-ring vacuum pump for conventional sizing, we use a regenerative-blower vacuum system to equalize vacuum pressure between our top sizing tank and our lower reservoir tank," says vice president of sales Tom Malec. "We also use a solenoid to constantly monitor and correct vacuum fluctuation and measure vacuum in inches of water rather than mercury."

The reservoir tank separates the air and water, and the vacuum level is equalized with the upper tank for stability. The front end of the tank features a quench chamber to precool the tubing and seal the vacuum compartment, and a vacuum sizing sleeve is mounted on the entrance within a water well to provide a film of water on the tube as it enters the tank. The system has a soft-touch keypad with digital readouts for easy viewing of vacuum and temperature levels.

Tubing expander suitable for elastomeric tubing

The 875AC from Lakeview Equipment Inc. is capable of expanding elastomeric tubing.

A tube expander operates pneumatically for dependability and efficiency. The 875AC from Lakeview Equipment Inc. is suitable for vinyl, polyurethane, and other elastomeric tubing with durometer ratings ranging from 35 to 90. The unit is supplied with a nonmarring base and a foot pedal with a regulator and gauge. Cam-operated jaws provide controlled expansion. Jaw sets may be used in combination with any cam for flexibility while maintaining fixed tube expansion.

Blaster eliminates material residue from tooling

Available from Comco Inc., the MicroBlaster removes material residue from tooling.

A blaster can be used to clean tooling employed in the tubing extrusion process and in postprocessing of the extruded product. Prior to the physical extrusion of the tubing, microabrasive blasting is used to remove material residue from extrusion tooling. Its use prevents the residue that can result from chemical cleaning processes. The focused abrasive stream of the MicroBlaster, provided by Comco Inc., enables removal of molding residues without compromising or damaging the delicate and complex geometries of this type of tooling.

In postextrusion applications, the MicroBlaster is used to prepare surfaces of the product to impart a texture or roughen the surface. This surface alteration promotes bond adhesion and integrity for components that are added to the tubing or catheter. In a majority of these applications, a soft, water-soluble abrasive media is used, eliminating the hazards and complexities associated with using harsh chemicals to accomplish the task.

Microabrasive blasting is suitable for deburring and texturing of hypodermic needles and cannulae, surface preparation for bond adhesion, and deburring and cleaning of stents.

Automated tester finds defects in catheters and insulated wire

A catheter fault detector (CFD) finds exposed metal braid in plastic-jacketed catheters and identifies flaws in insulated wire. Offered by ASG, the CFD is a fully automatic tester that operates at rates up to 20 in. per second. It can be used as a stand-alone tester or integrated into automated processing and testing systems. Catheter feeders and sorters can be supplied to automate the testing process. The machine generates an electromagnetic field, which it couples into the test specimen. It then detects voltage fluctuations in this field around the insulation defect.

According to company spokesperson Paul Ogden, the machine was developed because "the common approach using conventional microscopic inspection is expensive and not completely effective in detecting small defects such as voids, pits, and frayed wires."

Servo cutter precisely measures tubing

A servo cutter designed for manufacturing tapered tubing combines precise cycle control with process functionality. Supplied by Davis-Standard, the cutter's user-friendly operator interface features a graphic representation of an entire bump-tube cycle. Processors can take advantage of 25 set points per screen for exacting ramp-up and -down control, and cut points can be selected at any stage throughout the cycle. Extruder and melt-pump output can also be controlled. The cutter can be operated in either on-demand or flywheel mode, and has a maximum cut capacity of 1 in. OD. A low-pressure air regulator provides a steady source of stable air for rapid cycling within the entire range of the bump profile.

Extruder mixes plastic with additives

Traditionally, tubing made from plastics with colorants, radiopaque materials, and other additives requires compounding before it is extruded. This can raise costs as well as damage PVC and other heat-degradable plastics. A single-screw extruding system avoids these problems by compounding plastic in a single pass. The Mixtruder from Harrell Inc. can introduce additives to plastic by performing a rough tumble-mix at room temperature. It then places the mixture into a hopper and can also add materials to the plastic via a multicomponent weigh feeder that introduces the appropriate proportions of each component to the hopper. The system's mixing screw enables elogational mixing and reentrant flow. The Mixtruder is also capable of extruding powder feed stock.

Copyright ©2002 Medical Product Manufacturing News

Perspectives on Outsourcing

Originally Published MPMN May 2002

PRODUCT UPDATE

Perspectives on Outsourcing

The qualities you seek in a supplier should be dictated by the type of device under development

Norbert Sparrow

Bill Wood, Colorado MEDtech
Sourcing a supplier of contract services, in some respects, is no different from selecting a plumber or a roofing contractor. Applying some basic principles of common sense can go a long way toward building a mutually beneficial relationship. In all instances, you want to be sure that the person you hire is reliable, has the expertise and resources to do the job properly, and that the rate is competitive. Of course, the analogy has its limits, not the least of which are the technological challenges and regulatory requirements that a supplier to the device industry must master.

Bill J. Wood, senior vice president, product development and technology, at Colorado MEDtech Inc. (Boulder, CO), presented a paper titled "Developing and Maintaining the Outsourcing Partnership" at this year's MD&M West show. During that session, he addressed both common sense and industry-specific issues that are built into the OEM-supplier relationship. He agreed to expand on some of the points he made at the conference during a recent telephone interview with MPMN.

The reasons to outsource are legion, notes Wood. Drivers may be a loss of confidence in internal capabilities, speedy access to a QSR-compliant process or leading-edge technology, accelerated ramp-up, an overall reduction in costs, or a combination of these and other factors. "The decision to outsource is situational," sums up Wood. It is also an evolutionary process, as illustrated by the changing attitude of device OEMs toward the use of externally developed technologies.

The medical device community used to be behind the curve in terms of striking up outsourcing agreements to leverage leading-edge technologies, notes Wood. "It was pretty scary to them," he says. "That has changed during the past five years. With aerospace falling apart and technologists moving to the device sector, the medical device industry has become more progressive and aggressive. Gaining access to advanced technology is a very valid reason to outsource today," says Wood.

The demands of the marketplace, including accelerated time to market and shrinking product life cycles, continue to push device OEMs to outsource design and manufacturing operations. According to some recent studies, medical companies have more products in the pipeline than they can actually make themselves, notes Wood, "so faster start-up and the ability to produce more products at lower risk is a key factor in outsourcing."

Contract manufacturers benefit from reduced layers of bureaucracy and more streamlined procedures. "When customers ask us at Colorado MEDtech how long it takes to turn around an engineering change order," says Wood, "frankly, I think three days is a long time. In their facility, they may be lucky to turn around an ECO in a month." Blame it on signoff authority and corporate culture, says Wood. "I know of large corporations that reward those who are agile at company politics versus getting new products to the market." This is not always true, adds Wood, who cites Boston Scientific as a large company that is both nimble and aggressive. "But you're not going to find that at some of the older, larger, more conservative companies."

Finding the right fit

The more than 50,000-sq-ft medical device production facility at Colorado MEDtech includes a Class 10,000 cleanroom.

The qualities you are looking for in a supplier are in large part dictated by the type of product you're working on. A derivative device calls for a solid manufacturing base and a successful track record with similar products. On the other end of the spectrum, a breakthrough product requires an innovative and flexible supplier with a technological edge and clinical experience, notes Wood. Companies that specialize in breakthrough devices may, in fact, have a history of projects that don't make it out the door, and that is not necessarily a bad thing.

"These companies are challenged to be absolutely hot on the engineering end," says Wood, and the inability to bring a product to market may not be their fault. "Someone came to Colorado MEDtech several years ago with a project to build an infusion pump that would sell for $150," recalls Wood. "We came up with some interesting solutions, but ultimately we couldn't meet their price point." OEMs should focus on the percentage of products that do make it to market, says Wood. "When you're looking at breakthrough products, the metric has to be taken with some sort of filtering." Conversely, when evaluating a supplier for the manufacture of a derivative product, all of the devices should make it to market, adds Wood.

Bad beginnings

Miscommunication and indecision can often derail a partnership at the beginning of the process. A common occurrence, according to Wood, is a sloppy preapproval process that results in a fundamental misunderstanding of the nature of the device at the outset. Later on, "when there is a full and open discussion with the client, the team suddenly realizes that the instrument it thought it was going to make is different from what the OEM had in mind," says Wood. "Then the question becomes, can we rethink the solution?" Not an auspicious start for a project.

Long delays between sourcing a supplier and actual start-up can also have unfortunate consequences. "The outsourcer may go ahead and prepare a project profile for the lead engineers, name the engineers assigned to the project, and even introduce them to the client. The OEM may take an extremely long time finalizing the decision, and by the time he does, there may be a set of different people around the table," says Wood. That could be a critical issue if the company was "banking on the chemistry of the team," he notes. OEMs must recognize that custom developers measure their pipeline, says Wood. "They can't have a team just sitting around waiting for the next project to come through the door and still stay in business."

Single-source versus niche suppliers

Gaining access to advanced technology, faster start-up times, and reduced manufacturing costs are among the key reasons that device manufacturers outsource production.

The proliferation of companies positioning themselves as single-source suppliers to device OEMs might, at first glance, suggest that the days of niche activities are over. Not so fast, says Wood. "It depends on the economics of your instrument. If your priority is to accelerate time to first revenue or time to profit, then a custom development company that also has manufacturing capabilities makes a lot of sense," he says. "You can never transfer a project from a development house to a contract manufacturer without suffering a loss in time."

On the other hand, parceling out the project may be beneficial from a cost perspective. "If you're willing to take the time, you can play off companies against each other up front and at the manufacturing stage," says Wood. "That can be to your advantage in terms of pricing."

A third scenario that is not uncommon involves signing up a company with an innovative bent to provide engineering and manufacturing expertise for the first year or two of a product's life cycle. Once the product is on the market and the OEM is under cost pressure, he can move manufacturing to another supplier, suggests Wood. "Clients in that situation need to be careful, though, and know what the exit strategies are. The nonrecurring engineering cost to transfer the product to another manufacturer can be significant," cautions Wood.

Whatever outsourcing strategy best suits your needs—and it's important to note that the strategy may shift as new products come through the pipeline and existing products mature—we hope that you find the Buyers Guide on contract services starting on page 48 to be a useful tool in your search for a perfect partner.

Copyright ©2002 Medical Product Manufacturing News

Vision Sensor Improves Measurement of Suture Cuffs

Originally Published MPMN May 2002

PROFILE

Vision Sensor Improves Measurement of Suture Cuffs

A system provides 100% inspection at high speeds

Susan Wallace

The In-Sight vision sensor transfers images to a vision-processing unit, where image analysis tools are used to gauge the part.

Surgical sutures contain metallic cuffs that feature three inwardly bent tabs that act as a catch for capture needles as they pull the sutures through arteries.

To manufacture these parts, a company was measuring the diameter of the cuff openings manually. This process entailed skilled operators pushing upper- and lower-diameter limit pins through the opening. While this technique was capable of determining which parts were in and out of tolerance, it also had some disadvantages. It could take an operator up to 30 seconds per part. Also, tabs could inadvertently be opened up if an operator was not careful when inserting the pins, causing the damaged part to be scrapped.

To improve the process, Levin Engineering was asked to implement a machine vision system that would provide 100% inspection at higher speeds. According to company founder Steven Levin, ease of use was the primary factor in selecting a system for the job. "This was my first flight with [a] vision [system], and I wanted to find a product that didn't require writing code to develop the application," he says.

Levin selected the In-Sight from Cognex Corp. (Natick, MA). In-Sight is a high-performance vision sensor featuring an industrial-hardened vision-processing unit, a separate high-speed digital camera, onboard light control, built-in discrete input/output, and a standard VGA display output. To simplify application development, the vision sensor can be configured through an intuitive spreadsheet interface. The process involves selecting vision tools and parameters from drop-down menus using a handheld control pad. The spreadsheet then automatically generates tool results into worksheet cells, which are then linked together to perform measurement of the cuff openings.

The vision sensor is integrated along with a PC onto a tabletop bending machine. During the manufacturing process, each cuff is manually loaded with tweezers into a fixture. The machine first bends the three steel tabs inward as the part is positioned in place. At that point, a PLC triggers the vision camera, which looks axially at the cuff to capture an image of its opening. The image is immediately relayed to the vision-processing unit, where image analysis tools are used to gauge the part.

"Essentially, we're looking for a circle inscribed within a triangle formed by the three tab ends," says Levin. "The sensor's EdgeFind tool worked best in terms of accurately measuring the diameter of the cuff opening, which again is critical, since this end of the opening is what needs to catch the needle as it removes a suture."

If the opening diameter falls within the specified tolerance, the vision sensor displays a green LED on the user interface screen and the part is retrieved and transported to an assembly station. If the part fails the inspection, an audio alarm controlled by the PLC is sounded, alerting operators to retrieve and discard the part.

Since the sensor was installed in early 2001, it has been running for 16 hours per day without any failures. In addition to providing 100% inspection of the components, Levin notes a significant throughput improvement. "These parts are quite small, and it takes operators quite a bit of time to manually gauge the holes," he says. "With the vision sensor, it's really less than a second per inspection versus 30 seconds to do it manually." Levin also credits the sensor for its ability to provide exact measurement data for the holes, whereas pins can only provide information about upper and lower limits.

Copyright ©2002 Medical Product Manufacturing News

Spotlight on Fillers and Dispensers

Originally Published MPMN May 2002

SPOTLIGHT

Spotlight on Fillers and Dispensers

Precision filling

A dispense valve is suitable for precision filling applications. The 725HF-SS accurately dispenses up to 12 oz of low- to high-viscosity materials without overfilling, underfilling, or waste. Wetted parts are made from stainless steel or inert polymer for compatibility with a wide range of materials. A fast, clean cutoff prevents dripping or drooling. Typical applications include filling pouches, foil packs, bottle, and sample containers. EFD Inc., 977 Waterman Ave., East Providence, RI 02914-1378.


Solvent and adhesive dispensers

A line of dispensers are compatible with traditional medical-grade solvents and UV adhesives and provide a safe, reliable, rapid, and consistent bonding procedure, independent of operator variability, for all types of medical polymers such as PVC, ABS, polypropylene, and polycarbonate. The special shape of the units' dispensing brushes enables 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. Solvent is dispensed by inserting the tubing or component into the relevant port and immediately pulling it back. TechnoMed Inc., 59 Stiles Rd., Salem, NH 03079.


Pump and bottle

A bottle is approved for flammable liquid dispensing by Factory Mutual Research Testing. The 35306 has a one-touch pump providing for one-handed operation and eliminates spraying and splashing. A cam-lock hinge keeps the lid open or closed securely and reduces odor. Neither silicone nor latex is used in the product. Menda, 3651 Walnut Ave., Chino, CA 91710.


Industrial dispense pump

A dispense pump offers maintenance-free, precision fluid control. The IDS 2000 features a valveless design, with only one moving part—a single rotating and reciprocating piston made of dimensionally stable, chemically resistant ceramics. The pump design accomplishes all fluid control functions while eliminating valves that can clog, fatigue, and fail, causing accuracy drifting and pump failure over time. The pump will deliver from microliters per dispense up to 1 L/min while maintaining a dispense precision of 0.5% for millions of dispenses without recalibration or downtime. Fluid Metering Inc., 5 Aerial Way, Ste. 500, Syosset, NY 11791.


Meter, mix, and dispense valves

Two-component dispense valves have balanced inlet and outlet spool assemblies that do not displace material during the shift from the reload to the dispense position. This feature enables pressure feeding of the right- and left-side components at up to 1200 psi during reloading while the materials are isolated from the mixer inlet. After the valves are returned to the dispense mode, an accurate volume of each component is injected into the disposable mixer inlet by rod displacement metering technology. The PosiDot valves are available in a 2-in. metering stroke size with pneumatic drives, programmable electric stepper drives, or servo-driven motors. Liquid Control Corp., 8400 Port Jackson Ave. N.W., North Canton, OH 44720.


Filler and dispenser controller

A controller for fillers and dispensers can be placed in inaccessible areas and still be programmed and operated via Ethernet with its embedded Web server. Because the remote console model is dc powered, it can be powered from its standard Devicenet communications port or an external dc source. A power and diagnostics LED is located on the front panel, rather than a keyboard and liquid-crystal display. The IR port has been retained to allow wireless communications and control with a PDA. Inputs for three additional load cells are included to eliminate the need for an external junction box. An environmental rear cap is available for both the remote and full console versions, giving each a NEMA 4X/IP66 rating and providing protection from dust and hose-directed water. Hardy Instruments, 3860 Calle Fortunada, San Diego, CA 92123.


Dispense valve

A valve precisely dispenses silicones, mastics, or plastisols. The 2200-727 Snuf-Bak is designed for use with filled or abrasive materials and provides drip-free control of high-viscosity materials. The valve features a hardened needle-and-seat assembly coupled with tough, wear-resistant seals. An all-aluminum body can handle high-pressure operations and double-air operation and a readily fixtured housing make it suitable for high-volume applications. Sealant Equipment & Engineering Inc., 45677 Helm St., P.O. Box 701460, Plymouth, MI 48170-0965.


Syringe pumps

Standard and custom syringe pumps are available for precision filling and dispensing applications. The VersaPump series offers syringe volumes ranging from 10 µl to 50 ml, with three-way to eight-way valve capability. Pumps can be daisy-chained for continuous-flow applications. They offer chemically inert fluid paths of Teflon, Kel-F, and borosilicate glass. Resolutions from 6000 to 48,000 steps are available for better than 1% accuracy and precision. Kloehn Ltd., 10000 Banburry Cross Dr., Las Vegas, NV 89144.


Dispensing valve controller

Two dispensing valves can be controlled simultaneously with pneumatic logic that provides a continuous-off state to any valve designed for four-way operation. The valve-off state is always active until a signal is received to switch to the valve-on mode. The valve-on state can be activated from a remote robotic device when the automatic timer on the unit is off. When the timer is on, the valve-on state can be activated at intervals ranging from 0.01 to 30 seconds. I & J Fisnar Inc., 2-07 Banta Pl., Fair Lawn, NJ 07410.

Copyright ©2002 Medical Product Manufacturing News