MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Sitemap


Articles from 2003 In April


Microblasting: Expanding Options

Originally Published MDDI April 2003

COVER STORY: MACHINING

Uses for modern microblasting technology in medical device manufacturing are increasing as devices become smaller. 

by Garry Slemp and Colin Weightman

The defining term in microblasting is micro—very small. The technology is used to clean, texture, deburr, or otherwise process very small parts and hard-to-reach areas with extreme accuracy. 

The equipment propels a very fine dry-abrasive powder mixed with clean, dry, compressed air. The air is forced through nozzles with openings as small as 0.018 to 0.060 in., and the abrasive blast is pinpointed on the surface to be processed. Processing is always done in some type of enclosed work chamber. Because abrasive powders will clump if exposed to moisture, and because the process creates an abrasive dust, all microblasting systems must integrate an air dryer—or a dry-gas propellant such as nitrogen—and dust collection as a part of the system. 

This very basic description of the microblasting process and equipment is the framework on which all the latest in new design developments are based.

New Equipment Expands Applications

As medical devices have become smaller and more intricate, older methods of surface processing are becoming obsolete. Abrasive tumblers and grit blasting operations are less effective for processing miniature parts. Hand tools such as files, rotary tools, and knives are slow and prone to damaging parts. Microblasting has always addressed the small-sized product, and today new equipment developments take this technology into higher-production areas. This makes it widely applicable to low-cost and disposable-parts processing. Single-station and semiautomated capabilities also add a great deal of flexibility. 

New developments in microblasting technology include the addition of electronics and the redesign of the blasting systems for enhanced durability and reduced maintenance. A wider size range and the enhanced purity of abrasive powders have also increased the number of applications.

Equipment. More-powerful blasters with larger powder-storage tanks have made it viable to process larger areas and deliver abrasive through multinozzle arrays for multiple small-part abrading. In addition, many high-power systems have blasting-operation sensors whose data are exportable to external controllers, opening the door to automated requirements and production-level processing.

Abrasive Media. The sizing and purity of the media have tightened, giving more-controllable results. In the past, some abrasive powders were only available in 50–300-µm sizing. Today, they may be classified at 17.5, 25, or 50 µm. This smaller size means that it is possible to use smaller nozzles to pinpoint the abrasive pattern. The fine abrasives quickly remove oxide layers and contamination from part surfaces, and impart an even, matte finish.

This blaster configuration uses an automated nozzle array to texture parts that are presented on an x-y tray.

The most common abrasives include aluminum oxide and silicon carbide. These are aggressive, cutting abrasives; crushed glass, glass bead, walnut shell, and plastic media are less aggressive; sodium bicarbonate is the softest abrasive available. Peening abrasives such as glass beads are also available.

The best way to illustrate the wide range of modern microblasting in the medical device arena is to present specific applications. These range from manual to semiautomated systems, and cover the full spectrum of abrasive powders.

Tubing Applications

Cannula and Microtube Deburring. These raw tubes are made primarily from stainless steel or other metal alloys and are the basis for subdural insertion devices such as hypodermic needles. Microblasting technology is used to remove very fine burrs so that there are no sharp projections on the outside edge of the tube tip. Heel burrs are also removed. These are generated on the inside diameter of the tube point. This application benefits from the larger power and capacity of modern blasters because it is a volume process.
 
Cannulae are commonly arrayed either flat, with the tubes aligned next to each other, or in other mass configurations. They are typically processed in very high volumes. A blasting system will often use a multiple-nozzle array at a 90º angle to blast the tubes. Most tube-deburring applications use a glass bead abrasive. This media is available in 35- and 50-µm sizes. Glass beads will quickly remove fine burrs generated in the grinding process without altering the exacting tube tolerances.

Cannula Housing Texturing. When manufacturing hypodermic needles, a housing, hub, or component is often overmolded or bonded to the tube. This requires a textured surface on the circumference of the tube at the point of attachment. This selective texturing alters the surface to provide good adhesion between the tube and the molded or attached components. By using 50-µm aluminum oxide, microblasting provides a good surface finish without being too aggressive. Again, the volume and uniformity of this application suit it for automated systems with multiple nozzles.

Indication Band Texturing. In addition to texturing for component attachment, many production houses also use microblasting technology integrated with custom holding fixtures to texture a number of small, evenly spaced bands on the circumference of each tube. These provide the medical professional with a visual indication of how far the device has been inserted. A secondary benefit of the process occurs after a device has been inserted: the texturing permits medical personnel to easily locate the device when using electronic imaging systems. This type of banding is typically accomplished using 25- or 50-µm aluminum oxide media, often with spindle-type fixturing on the blasting equipment.

A typical workstation allows an operator to work in a well-lighted chamber that is cleaned by continual dust collection.

Medical Electronics Applications

Medical electronic devices, particularly implants and internal probes, have coatings that must be processed very carefully. This is typically a manual or semimanual blasting application because of the variety of device configurations. A common application is processing the coated wires or leads that are attached to an implantable defibrillator. A silicone covering on the defibrillator leads must be removed in selected areas. The microblasting process uses a sodium bicarbonate material to accomplish this without damaging the underlying coil.

Implant Applications

When orthopedic implants are manufactured, their surfaces may be too smooth for proper tissue adhesion. For this reason, they are often processed with abrasive media to roughen the surface. On some larger parts, a grit blast cabinet may be used. For the more-intricate areas, however, the precision and control of microblasting is advantageous.

Microblasting benefits prosthetic hip assemblies, ball-joint assemblies, bone screws, dental implants, and similar devices in two ways: it removes undesirable surface features that may reduce the device's acceptance by the body, and, by abrading the implant surface, it produces a finish that is conducive to tissue growth. When tissue adheres to the implant, it prevents undesirable movement.

Self-expanding stents are implantable devices typically made of nitinol. They range from very small outside diameters of 0.100 to 0.120 in. to 1.5 in. The shape-memory properties of nitinol make it ideal for this application. The manufacturing process starts with cutting an intricate pattern into a tube of nitinol. The shape of the pattern will dictate the expansion properties of the material. 

To obtain the exacting dimensions, the tube is cut using a laser process. This process will leave an oxide layer on the surface of the stent and remelt on the sides of the struts, as the laser beam becomes more diffuse. 

Microblasting can remove both the oxide layer and the remelt. This requires a precise process: too much abrasion will weaken the joints and cause premature device failure. The process is often controlled by measuring the amount of weight, in thousandths of a gram, that is removed from the stent.

The properties of laser processing cause most remelt to occur on the inner diameter of the stent. Often, the most effective means of removing this is to use an extended right-angle nozzle that blasts from the inside of the stent outward. The normal exit point of the nozzle is sealed off and then a slot or hole is formed in the nozzle tube at a right angle to the nozzle axis. This allows the abrasive to strike the inner diameter of the stent. In most circumstances, the stent is rotating as the nozzle traverses back and forth within it.

For this application, 17.5-µm aluminum oxide has become fairly standard because of its sharp cutting ability. It is able to reach all the nooks and crannies of the stent. Another medium commonly used on stents is silicon carbide, which is more aggressive. Abrasive selection is dependent upon the amount of residue or burrs to be removed.

This automated stent-cleaning assembly integrates three blasting nozzles with a spindle design.

User Customization. Customized blasting systems are common in the proprietary area of stent design and manufacture. With primary blasting components, the medical device company will typically use a nozzle array with automated or semiautomated fixturing customized to meet its specific design requirements. The basics of abrasive type, blast pressures, and nozzle sizes are the constants in the system. Advanced blasters with few internal parts and integrated electronics make in-house customization easier to do than in the past.

Medical-Part Injection Mold Applications

Processing New Molds.
Molds and micromolds are made of tool steel, and are typically created using an electrical-discharge machining (EDM) or laser process to cut mold cavities into the steel material. Such molds are used to manufacture a variety of medical parts. Some create polymer implantable devices that have small, delicate enclosures for electronics, such as miniature cochlear implants. Others may be used to mold a range of medical disposables. Micromolds for electronics and implant assemblies can be as small as 1¼8 by 1¼16 in., with very delicate internal geometries. The parts produced can have a cross section as small as 0.010 in.—about the thickness of a business card. Whether a standard small molded part or a micromolded part is being created, retaining the exact mold geometry is essential. 

The EDM process uses graphite electrodes to create the mold cavities. Graphite residue is sometimes left in the cavity during this process, and must be removed. With a soft abrasive, the microblasting technique easily removes residue without damaging the cavity surface. 

When a laser is used to cut the pattern of the device into the steel, it leaves remelt, commonly known as laser slag. This must be removed without compromising the tolerances within the mold. When the laser slag builds up, it case-hardens, becoming more brittle than the tool steel itself. The abrasive process used to remove remelt is much more aggressive than that used with EDM. This type of mold is usually blasted using aluminum oxide. This is a harsh abrasive, but the precision and control of the blasting process prevent damage to the cavity surface; the unwanted material is quickly removed.

Cleanup of new molds is typically a manual abrasive process, sometimes requiring a magnifying device. The latest high-performance nozzles, typically in the range of 0.018 to 0.046 in. ID, are beneficial in such cases. 

Cleaning Production Molds. Molding-material residue builds up in mold cavities over a period of time. This is easily removed using the microblasting process. Also, some molded medical disposables actually contain abrasive materials—glass-filled nylon or mineral-filled polymer materials, for example. These are produced in multiple-cavity molds to create components and disposables in vast quantities. The product material is aggressive, and it tends to alter the surfaces of the mold cavities. 

Frequently, molds will start out with a slightly textured finish, what is sometimes called an EDM finish. As parts are molded continuously, the textured cavity surfaces become smoother, making it difficult to eject the parts from the tooling. A smooth surface tends to adhere to a part, whereas a textured surface aids in ejecting the part.

It is important to be able to retexture this interior surface without changing any of the actual dimensions of the mold; otherwise, the subsequent product would be ruined. In this case, the pinpoint pattern of the latest nozzles combined with one of a wide variety of micron-sized abrasives can resurface the inside of a mold without changing dimensions. Glass beads, crushed glass, and sodium bicarbonate are the most common abrasives used. When cleaning a mold that has been treated with a titanium nitride coating, walnut shell or plastic media can be used to remove contamination without damaging the underlying coating.

A before-and-after photo of thermocouple tips, which require the removal of magnesium oxide insulation before use in electronic medical devices.

Wire and Catheter Applications

There are two areas where microblasting is used to process wires and catheters: to texture wires in preparation for the application of a coating, and to remove coatings from catheters in preparation for bonding or welding.

To prepare metal alloy wires to accept a coating, the process involves roughening the wire surface. Typically, the coating is either a PTFE or polyurethane.

In preparation for bonding, it is advisable to abrade the surface for secure attachment. Since most polymer material used in catheters is extruded, it often has a high lubricity. When attempting to bond a balloon or other component to such a material, or to a metal tube, the surface must be roughened very lightly to promote bond adhesion. This is normally a manual operation, often incorporating simple part-holding fixtures and using a soft abrasive like sodium bicarbonate. The goal is to provide sufficient texturing without damaging the catheter tube.

Catheters are commonly inserted with guidewires. Removing a coating from a guidewire that is only 0.005–0.020 in. in diameter is a very delicate task. Guidewires differ from tubes in that they are usually much finer and can have a variety of configurations. They can be made from solid wire with a fair degree of rigidity, yet still be flexible. Some examples include springs coiled at the ends. Coatings are often applied to allow easier insertion into arteries, veins, or other subdural areas. It's fairly common to see guidewires coated with a Teflon or PTFE material. 

This coating material must be removed to expose the bare wire before bonding or attaching other components. This typically means abrading selected areas along the length of the coated wire, using multiple-nozzle microblasting configurations for good coverage. Sodium bicarbonate, glass beads, or crushed glass are commonly used.

Surgical Instrument Applications 

Scissors, saws, knives, scalpels, hemostats, etc.—such tools are becoming too expensive to throw away after one use. They are typically refurbished and reused several times, using irradiation and autoclaving to sterilize them. This has created an expanding industry of what might be referred to as medical device job shops. 

These companies specialize in refurbishing medical and surgical tools. Many use microblasting technology because it can get into tight crevices, such as hinge spaces, to remove built-up debris and residue. A soft or peening abrasive is typically used. Sodium bicarbonate is the first choice because its particle structure promotes efficient cleaning, yet it is soft enough to do this without damaging the actual structure of the tool or instrument. Glass-bead abrasives are used to restore the original finish to the instrument because their round-particle form does not cut, but pummels the surface, providing peening action for a like-new finish.

Conclusion 

Microabrasive blasting is the right choice for many medical manufacturing operations because it is cost-effective, versatile, and environmentally friendly. As production requirements grow, the process can be easily expanded to accommodate the increase. 

In some cases, if the process or design limits the amount of recast present, electropolishing alone can remove surface contaminants. Also, where product manufacture does not need a highly precise deburring, finishing, or other surface processing, basic batch finishing can be accomplished using conventional cabinet or broadcast blasting. Much depends on the type of medical device and how it will be used. 

Microblasting technology suits applications that require high precision for parts or features that are extremely small and must be processed without introducing anything that will slough off. Microblasting equipment can remove material in fractions of grams. This precise control, even in array processing, is what the new forms of microblasting equipment and media offer. It is only one step in the extensive process of medical device manufacturing, but it is a step to consider when the end result must be a pristine device that is suitable for insertion or implantation, or whenever there is a need to give longer life to the molds and tools that create these medical parts and devices. 

Copyright ©2003 Medical Device & Diagnostic Industry

PCB Fabrication versus Solid Part Modeling

Originally Published MDDI April 2003

PRODUCT DEVELOPMENT INSIGHT

Printed circuit board (PCB) fabrication successfully crossed the threshold to paperless fabrication about 10 years ago. Now virtually all PCBs are fabricated directly from a digital file, with no accompanying drawing. For parts designed using solid modeling, however, the transition has been more difficult. A comparison of the two helps explain why. 

The first reason that PCB fabrication has been able to go to an all-digital format is that PCB design rules are highly standardized worldwide. Important design characteristics such as tolerances and relationships between features are the same, whether the PCB is in a child's toy or an ECG machine. PCB design software enforces these standards through a rigorous set of internal design rules. The resulting PCB design output from the application usually meets these international design standards. Consequently, both engineer and supplier are confident that there will be few, if any, problems producing the PCB.

For the typical part designed with 3-D CAD, however, the tolerances and relationships with other parts are not standardized. Critical dimensions and tolerances are different in every part designed. This is the major weakness of solid modeling: The virtual model gives equal emphasis to all dimensions, although some dimensions on a part are much more important than others, and the virtual model ignores tolerances completely. Consequently, understanding critical relationships between features and identifying critical tolerances is difficult for the vendor.

This is important because it would be prohibitively expensive and almost impossible to design a mold to make a part that would exactly match the virtual solid model. Creating an injection molding tool or a sheet-metal die is a painstaking process done by real people who make large and small mistakes, which take time and money to correct. The toolmaker is also faced with the reality that the plastic may shrink or the metal might bend in unpredictable ways. The key to successful mold design is to identify those dimensions and tolerances that are critical on the part drawing, and then control them. Mark Vaughan, director of engineering, at Bayer Healthcare's Diagnostics Division, notes a typical situation. “One problem we have had when working with vendors from solid models during fast-paced, concurrent development,” he says, “is that there have been generic dimensions that turned out to be important, but were not called out as critical on the initial revisions of the drawing.”

The second reason that PCB fabrication has gone all-digital is that the file formats used by PCB layout software have themselves become highly standardized. The photoplot and drill files created by the PCB layout software are well-defined and created specifically to be loaded into typical sets of PCB fabrication machines. 

The fabrication of parts from solid models, on the other hand, has just begun to get to that point, because of the variety of solid-model packages, and the equally large variety of often-incompatible fabrication software used by the vendors. 

According to Charles Deschenes, mechanical engineering manager at Abbott Laboratories, MediSense Products, the key to saving time with solid models is compatibility of file systems. “It has taken a lot of years, and it still takes a lot of hand holding [with the vendor] before you cut steel.” Norm Desmarais, a mechanical engineer at Bayer's Diagnostics Division, went into more detail on this problem. “When vendors use different software systems, the construction of the CAD model can become important. Certain methods of constructing the 3-D model geometry in the original CAD system do not always translate cleanly when imported to the vendor's CAD/CAM system. Time and effort are needed to sort out the resulting confusion when it happens.”

Copyright ©2003 Medical Device & Diagnostic Industry

UTI Expands Contract Manufacturing Services

Originally Published MPMN April 2003

INDUSTRY NEWS

UTI Expands Contract Manufacturing Services

Norbert Sparrow

To boost its already considerable contract manufacturing capabilities, UTI Corp. (Collegeville, PA; www.uticorporation.com) has acquired Venusa Ltd., a firm based in El Paso, TX. Venusa is a medical device manufacturer concentrating on proprietary OEM products and private-label fluid disposables. Its product markets include parenteral and enteral therapy, endoscopy catheters, and minimally invasive therapeutic devices. The company's services include injection molding and assembly technologies.

"Venusa has a proven track record of servicing major medical device OEMs with assembly facilities in Mexico and the United States," says Drew Freed, chairman and CEO of UTI. In addition to enhancing UTI's contract services, Venusa's "high-quality assembly capabilities will provide a tremendous advantage to our customers," says Freed.

UTI is a fully integrated supplier of finished devices, assemblies, and metal and plastic components to medical device OEMs worldwide. Its capabilities include product design and development, prototyping, production, assembly, and supply chain management.

Copyright ©2003 Medical Product Manufacturing News

Conductive Shielding Material Offers Product Design and Processing Advantages

Originally Published MPMN April 2003

INDUSTRY NEWS

Conductive Shielding Material Offers Product Design and Processing Advantages

Norbert Sparrow
Industry's first electrically conductive EMI and RFI shielding material supplied in wide, continuous rolls was introduced by Rogers Corp. to medical device 

As electronic devices get smaller and operate at higher frequencies, EMI and RFI shielding must meet ever-more- stringent demands. Acceptable tolerances for even the smallest gaps, seams, or slots in electronic equipment continue to shrink. Rogers Corp. (Rogers, CT; www.rogerscorporation. com) recently introduced what it claims is the first electrically conductive EMI and RFI shielding material supplied in wide, continuous rolls. Described as one of the thinnest and softest such materials on the market, the Bisco EC-2000 series of conductive silicones also features good compression-set resistance, shielding effectiveness, and high yields. The material was presented to the medical device industry at the recent MD&M West show in Anaheim, CA.

The shielding material can be supplied in very thin layers, with cross-sections down to 0.020 in. thick, says Nicole Ouellette, senior product specialist. Available in durometers between 30 and 40 Shore A, the Bisco EC-2000 conductive silicones can replace fabric-over-foam materials in many thin, intricately shaped applications.

EC-2000 silicones are reportedly softer and more compressible than alternative products, making it easier to obtain a good mechanical seal by compressing the gasket. Because it is available in wide, continuous rolls, the material facilitates processing by converters and OEMs. In particular, the wide-roll format eliminates the need to seam molded sheets, thus improving yield. The material is also easy to die-cut, resulting in improved design versatility and decreased time to market.

The conductive silicones are suitable for any device requiring shielding, adds Ouellette, with the exception of products that must use a USP Class VI-rated material. Key medical uses include diagnostic and analytic devices. 

Copyright ©2003 Medical Product Manufacturing News

ISO and EN Medical Packaging StandardsInch toward Harmonization

Originally Published MPMN April 2003

PRODUCT UPDATE

ISO and EN Medical Packaging Standards Inch toward Harmonization

The standards' different scopes have eased progress

by Norbert Sparrow

Michael Scholla, senior consultant for DuPont Medical Packaging and a U.S. delegate to the ISO 11607 revision committee, is cautiously optimistic that the two main medical packaging standards may be partially harmonized by 2005.

Manufacturers with global ambitions currently have to wrestle with two medical packaging standards: EN 868 for Europe and ISO 11607 for the rest of the world. The good news is that these standards may be at least partially harmonized in the years ahead, according to Michael Scholla, senior consultant for DuPont Medical Packaging and a U.S. delegate to the ISO 11607 revision committee. Scholla presented a progress report on revisions that are being introduced to ISO 11607 at a private meeting in February during Medical Design & Manufacturing West in Anaheim, CA.

Fortunately for manufacturers, the rival medical packaging standards crafted by the International Organization for Standardization (ISO) and the European Committee for Standardization (CEN) have rather different scopes. ISO 11607 deals with process validation, as well as materials and design, whereas EN 868 covers only the selection and testing of materials that make up the packaging. The complementary nature of the standards has allowed OEMs to achieve global compliance without excessive difficulty. However, there is sufficient overlap in the materials area to create confusion. Scholla cites the methods used to test a material's porosity as one example.

Different tests are favored in Europe and the United States to rate porosity, and neither group is about to switch, says Scholla. To further complicate matters, in the Bendsten test, which is specified by the standard developed by CEN, the greater the porosity, the higher the resulting number. In the Gurley Hill test used by U.S. OEMs, the opposite is true. To achieve consensus, the ISO document lists a number of test methods that can be used to meet requirements. After all, notes Scholla, there is no single best way to test every package; it all depends on what's inside.

Scholla remarks that the second edition of the ISO standard includes notations, where applicable, informing manufacturers of what they need to do differently to comply with EN 868. This will allow companies designing packaging for a global market to reference a single document rather than jumping back and forth between two standards. This revised standard has been approved and is awaiting publication.

To take things to the next level and lay the groundwork for harmonization, the draft third edition of ISO 11607 has been divided into two parts: Part 1 for materials and design, Part 2 for processes. Conventional wisdom has it that EN 868 will not cover processing validation, since quality systems are under the purview of other standards, according to Scholla. "It's still not entirely clear that a CEN standard can't deal with processes," notes Scholla. "After all, problems and recalls rarely crop up because of the packaging . . . they are usually process related." Nevertheless, by introducing two parts into the ISO standard, a potential obstacle to harmonizing the two standards has been eliminated, and the selection and testing of materials can now proceed regardless of whether or not EN 868 integrates process controls.

Redefining Medical Packaging

Defining packaging in a medical context was a critical step to moving forward during these discussions, says Scholla, and this has produced some fundamental changes to the ISO document. "One of the things that makes medical packaging unique," he says, "is that it must be sterilizable and must maintain sterility until the point of use." The ISO draft reflects this property by precisely defining four terms: sterile barrier systems, preformed sterile barrier systems, protective packaging, and packaging systems.

Defining primary medical packaging as a sterile barrier system was something of a breakthrough, and the term is being embraced around the world. For example, the European Sterilization and Packaging System, a trade association representing medical packaging manufacturers and converters, is reportedly changing its name to the European Sterile Barrier Association.

During the talk, Scholla also drew attention to a requirement in Part 2 of ISO 11607 that mandates process validation for preformed sterile barrier systems. This has not always been done, says Scholla, but it should be. "The device firm has to validate its sealing process; why shouldn't the company that's responsible for three out of the four package seals?"

Looking Ahead

The working draft of the revised ISO standard has been distributed to experts of the ISO and EN technical committees on medical packaging. Comments from the international members will be compiled prior to a meeting in Frankfurt, Germany, in June. "The comments will be resolved, country by country," says Scholla, "and a revised document will come out as a committee draft." He stresses that each step of the process has to be affirmed by ISO and CEN members for harmonization to proceed. Following more comments and revisions, and accounting for translation time, a draft international standard (DIS) will then be issued. The best-case scenario, according to Scholla, is for balloting to begin in the fall of 2004, with publication of the standard in 2005.

"This is something we have wanted for 10 years," says Scholla, "and I'm pretty excited about seeing the light at the end of the tunnel." Everyone has become comfortable with standards, notes Scholla, and the fits of pique about who is responsible for what have fallen by the wayside. "Most of the arguments surrounding medical packaging have been hammered out during the past 10 years," says Scholla, citing the heated debate over expiry dating that divided the United States and Europe. With time has come the awareness that posturing is counterproductive. "In the end, it simply costs medical device companies more when standards are not harmonized," says Scholla.

Copyright ©2003 Medical Product Manufacturing News

Radiopaque Imprinting Enables Alternative to Angioplasty

Originally Published MPMN

April 2003

PROFILE

Radiopaque Imprinting Enables Alternative to Angioplasty

Markings on fabric substrate of device allow precise positioning

Zachary Turke

This angioplasty-alternative device from CryoVascular Systems was imprinted with a radiopaque ink from CI Medical that allows precise positioning within a blood vessel.

For four years, CryoVascular Systems (Los Gatos, CA; www.cryoinc.com) has worked to develop cryotherapy devices, a group of angioplasty-alternative products that revascularize arteries while simultaneously treating them with cold temperatures. This technology would inhibit restenosis and eliminate the need to permanently 
implant a stent, but researchers were having difficulty accurately viewing the placement of the cryotherapy catheters under fluoroscopy. Realizing that imprinting the devices with a radiopaque ink could solve this problem, the company turned to CI Medical (Norton, MA; www.cimedical.com) for help.

"The imprinting aspect of this project was vitally important to the product"s eventual success," says Cryo- Vascular Systems project engineer Keith Burger. "Although radiopaque ink had never been imprinted on a fabric layer like the one we use in our device, we knew that CI Medical had extensive experience with these kinds of inks and excelled in solving medical-device-imprinting problems," he adds.

Specializing in the development of medical-grade inks and imprinting technology, CI Medical was up for the challenge. Noting a growing interest in the use of radiopaque inks in the medical field, the company had developed a special formulation and proprietary imprinting process that allowed it to mark with clarity on numerous substrates, including fabric. Working closely with CryoVascular Systems" design engineers, the company fine-tuned this technology to produce the required imprint size, definition, ink thickness, and opacity.

The resulting product exceeded both companies" expectations. With the device"s fabric layer repeatedly imprinted with tight-tolerance markings, practitioners could easily track the device under fluoroscopy and place it accurately within a patient"s blood vessel. The imprinted pattern, which changes shape when inflated or deflated, also allows them to determine when the device can be removed safely. 

Cryotherapy devices from Cryo-Vascular Systems are already commercially available in Europe. The company expects to reach the American market with this technology in the first quarter of 2003. CI Medical is pleased to see its customer doing well and believes it could do the same for others. "This is a perfect example of how we can interface with design engineers in the early stages of development," says CI Medical engineering manager Bruce Mahan. "Imprinting is often a critical factor for a product's success and should be addressed early on in development," he adds.

Copyright ©2003 Medical Product Manufacturing News

Teach Your Children Well

Originally Published MPMN

April 2003

EDITOR'S PAGE

Teach Your Children Well

With the aging of America, the medical device industry, like U.S. manufacturing in general, may soon be facing a crisis in its workforce. The National Association of Manufacturers (NAM) reports that even in today's weak economy, 80% of all U.S. manufacturers report a moderate to serious need for qualified, trained workers. The organization further says that more than 60% of manufacturers can't meet production levels to satisfy customer demand. 

Without an influx of new employees, the situation will only get worse. The average worker is approximately 58 years old, NAM reports. As these people retire, the manufacturing sector will need to hire 10 million new people in the next 20 years, according to NAM estimates.

Employers must wage a public relations campaign to recruit highly skilled and motivated young people to fill these vacated positions in manufacturing environments. In order to attract the high-quality workers that will be needed, "we must do a better job of telling the world that manufacturing is a noble profession," says Richard E. Dauch, Manufacturing Institute chairman, and also cofounder, chairman, and CEO of American Axle & Manufacturing Inc. 

To help manufacturers achieve this goal, NAM is sponsoring the tentatively titled Manufacturing Careers Campaign. Its mission is to create a positive public image through a national advertising program, which may include print media and television and radio commercials. 

Individual manufacturers need to be involved, too. They can have a huge impact on the local public, especially the young people who will likely become their employees. Under the program, executives are encouraged and coached by NAM on writing editorials for local newspapers and being booked on talk shows. 

Companies can become involved with students and public schools to teach young people about the realities of careers in manufacturing. They can also conduct tours of their facilities for community organizations and the media. 

The program is admirable for at least two reasons. If it achieves its stated purpose, manufacturing will benefit from a highly skilled, dependable workforce. The reverse is also true. Because of the very public nature of the campaign, it will force manufacturers to run the kinds of operations that talented young people will want to join. Both manufacturer and worker will be well served.

As Dauch says, "We must change the perception that manufacturing is a dirty, dark, dead-end industry. In reality, manufacturing is a high-tech field with interesting and useful opportunities and excellent compensation."

Susan Wallace, Managing Editor

Copyright ©2003 Medical Product Manufacturing News

E-Health and Connectivity

Originally Published MPMN

April 2003

SPECIAL

E-Health and Connectivity

How to Manage the Inevitable Push toward Device Networking

by Zachary Turke

For many manufacturers, the question is not whether to network-enable their devices, but how to do so most cost-effectively. Recent developments in the healthcare industry have made the need for networked devices readily apparent. From the current nursing shortage to industry consolidation to the expanding use of outpatient treatment, health professionals are increasingly required to acquire more information in a shorter time with fewer staff. Network-enabled devices are the obvious solution to help them balance the scales. 

But even if this transition wasn't quickly becoming a necessity, there are many reasons manufacturers should think about incorporating networking capabilities voluntarily. Networked devices facilitate a mobile workforce and enable information sharing between providers. They support paperless operations and accelerate billing and referral times. They also allow for the detailed analysis of pre-event situations and expand use in markets like home care. In the competitive medical marketplace, a device that can offer any of these value-added services to a customer has a competitive advantage over other products.

ConnectBlue Bluetooth Serial Port adapters from Code Blue Communications Inc. are examples of board-level solutions for network-enabling 
a device.

Different Solutions for Different Requirements

So if the push toward connectivity is both needed and desirable, how can you go about making your machine network most cost-effectively? To answer this question, you must first decide at which level you want to integrate networking functionality into the device. Chip, board-level, and external solutions are the three options currently available. Each solution has unique benefits that may make it the best choice for your device.

For devices that are already on the market and have an established user base, an external solution is probably best. This method generally involves the highest per-unit cost, but is also the quickest and easiest way to get a device to market. Plugging into an existing serial port, this product is a stand-alone unit that has a DB9 or DB25 connector on the serial side and a 10/100Base-T or a 10Base-FL connection on the Ethernet side. Also called a device server, it is a prepackaged hardware and software product that eliminates the need for a manufacturer to develop the components individually.

Board-level solutions are slightly more intrusive. Requiring motherboard space, an available serial port, and a power supply, these solutions generally have a lower per-unit cost than external products. They do, however, require a slightly greater level of development resources. Board-level components generally include a processor, a real-time operating system, a TCP/IP stack, a Web server, a network connection, and all of the other elements needed to successfully achieve device connectivity.

Network devices like this Catella workstation from American Medical Sales Inc. help physicians acquire more information in less time.

When long development times are not an issue, chips are likely to be the most cost-effective option. These devices have the lowest per-unit cost but require the most time and resources to achieve connectivity. Also called Ethernet-controller integrated circuits, they are available with various levels of integration. Units on the simple end of the spectrum include just a media-access controller or physical-layer-interface electronics. More-advanced chips incorporate multiple interfaces, a processor, memory, and more. Some chips are supplied with a variety of software and tools to reduce product development times. 

More:
Embedded Device Server Slashes Development Times
Where to Look for Help

Copyright ©2003 Medical Product Manufacturing News

My Favorite Bookmarks

Originally Published MPMN April 2003

E-NEWS

My Favorite Bookmarks

by Chris Herman, Director of Engineering Vasclip


PDFzone.com (www.pdfzone.com) is a great source for tricks and tips on creating and manipulating documents in .pdf format. We use these kinds of files for internal documentation, quality systems literature, and training materials, and this site helps to ensure that they look their best. You can access more than 700 time-saving tools here or get free advice from the knowledgeable users in the discussion groups.

Template Central (www.template central.com) contains templates for almost any document you might need, including brochures, e-mails, forms, reports, newsletters, presentations, and Web sites. Compatible with PowerPoint, Word, Dreamcaster, FrontPage, GoLive, and Outlook software, the templates really speed things up and can be accessed for a nominal fee.

How Stuff Works (www.howstuff works.com) is a page that uses clear-cut editorial content and helpful illustrations to explain how a variety of devices function. As an engineer, I find it's useful to be well-informed on a variety of technologies, and this site covers everything from CD burners to aircraft carriers. All the entries are cross-referenced, so you'll never have to worry about running across an unfamiliar term.

Snopes.com (www.snopes.com) is useful for debunking those rumors and urban legends that are always floating around via e-mail. It's amazing sometimes just how much disinformation can be waiting for you in your in box, but now there's finally a tool for separating fact from fiction. Just go here, enter some keywords, and the page will tell you whether the information is true or not, and where it originated from.

Vasclip (Roseville, MN; www.vasclip. com) designs and manufactures medical devices for the urology and men's health markets. The firm's product line includes the Vasclip implant, a miniature device that serves as an alternative to the traditional vasectomy procedure, reducing procedure time, pain, and complications.

Copyright ©2003 Medical Product Manufacturing News

E-Health and Connectivity

Originally Published MPMN

April 2003

SPECIAL

E-Health and Connectivity

Embedded Device Server Slashes Development Times

by Zachary Turke

An embedded device server from Lantronix (Irvine, CA; www.lantronix. com) cuts the internal development-cycle time for adding networking capabilities to a device from 6 to 9 months to as few as 60 days, according to company estimates. Housed in an RJ-45 package that is roughly the size of your thumb, the XPort server is a complete network-enabling solution designed to make it easy for OEMs with limited experience in this field to add communication capabilities to their products.

"Manufacturers no longer need to spend many months and hundreds of thousands of dollars becoming an expert on Ethernet systems and writing an IP stack when they can simply purchase an integrated solution from us," says marketing vice president Geoffrey Boyce. "We have taken the complexity out of developing a network-enabling solution and made it simple by doing it all for them," he adds.

The XPort unit contains everything needed to successfully network a device, including a 10Base-T/100Base-TX Ethernet connection, an operating system, an embedded Web server, flexible firmware, and a full TCP/IP protocol stack. To allow more-effective remote monitoring and management, the server also features components that enable e-mail notification when a device encounters a prescribed event or alarm. "Real-time notification of alarms is critical in responding quickly to any problems or interruption of service," says Boyce.

Another feature built into the device is security. "Safely transmitting information to and from a networked device is extremely important," says Boyce. "For this reason, we've built Rijndael encryption and password protection directly into the XPort server to prevent unauthorized access." The Rijndael algorithm is an advanced encryption standard that is often used by the government in networked devices.

According to Lantronix, the XPort server is suited for any circuit-board device to which a manufacturer would like to add network capabilities with minimal engineering. In the medical market, these products could include multiparameter patient monitors, in vitro diagnostics, cardiovascular monitors, infusion pumps, ventilators, defibrillators, chemistry analyzers, and ultrasound devices.

An XPort development kit is available to OEMs who want to evaluate this technology. Serving as a cost-effective way to begin the development process, the kit includes an XPort unit, a circuit-board assembly, a power supply, status LEDs, and a RS-232 serial interface. Reset and timer circuits are also available by request.

More:
How to Manage the Inevitable Push toward Device Networking
Where to Look for Help

Copyright ©2003 Medical Product Manufacturing News