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Articles from 2004 In April


E-Health and Connectivity

Originally Published MPMN April 2004

SPECIAL SECTION

E-Health and Connectivity

Wired Wards, Wireless Devices

The e-health revolution is well under way. The first medical device equipped with Bluetooth wireless technology was approved by FDA last June. A central control system developed by Stryker Endoscopy, the Sidne establishes wireless connectivity with surgical instruments.

Many more wireless products are in the pipeline, according to Bill Saltzstein of Code Blue Communications. His company collaborated with Stryker and is involved in several other medical projects.

Meanwhile, wired wards are cropping up in hospitals around the globe. Patient records are increasingly called up on wireless laptops and handheld devices. Physicians, usually the last line of defense, are eschewing pen and pad to prescribe medication electronically. By some accounts, error rates have declined by 50% and patients are out of the hospital more quickly as a result.

Wireless products and the Internet are a boon to the home-care market, as well. It is poised to explode as aging baby boomers, who some call the worried well, clamor for remote monitoring devices.

This section profiles a sampling of companies that are behind the technology that is making these advances possible. Some have produced wireless systems for home-care use. Others have partnered with device OEMs to develop wireless hospital equipment. One firm has designed a product that allows plug-and-play data collection from more than 250 models of bedside monitors. In a sign of these globalized times, their headquarters are as likely to be in Noerresundby, Denmark, as Tucson, AZ.

"Making a medical device wireless is not a trivial matter," Pierre Landau, CEO of Polymap Wireless, told MPMN. It requires a body of technical and targeted regulatory expertise that may not be readily available within a medical device firm. Rather than invest time and money in recruitment efforts, he stressed, it simply makes sense to outsource that activity to a company with 
the required expertise. 

Norbert Sparrow


Cutting the Cord in the OR

Code Blue Communications recently introduced its second-generation Bluetooth-enabled product, which allows any device with an RS-232, RS-422, or 
RS-485 port to communicate wirelessly. 
The Serial Port Adapter is available as an OEM or external product.

Last June, FDA approved the first medical device using Bluetooth wireless technology. A central control system developed by Stryker Endoscopy, Sidne (Stryker Integrated Device Network) establishes wireless connectivity with surgical instruments via a Serial Port Adapter from Code Blue Communications (Woodinville, WA; www.codebluecommunications.com). You should expect to see many more Bluetooth-enabled healthcare products coming on the market this year, says Bill Saltzstein, president and founder of Code Blue Communications. Why now? Because Bluetooth has become boring.

"At a session at the Bluetooth Americas 2003 conference in December, one of the market gurus was trying to put some perspective on why attendance was down," recounts Saltzstein. "And his comment--which I totally agree with--was that Bluetooth has gotten boring. Well, hallelujah! That's exactly where we need to be to begin working on medical applications," he explains. "The device industry doesn't want flashy new things. It wants a solid technology that has all the bugs worked out, and which is gaining marketplace acceptance."

In addition to the Stryker device, Code Blue Communications supplies Bluetooth wireless capabilities to GE Medical's Achilles DexterQUS osteoporosis risk-assessment device. "It's designed for use in a doctor's office. The person being screened puts his or her foot in the ultrasonometry device, which sits on the floor. A Bluetooth-enabled PDA serves as the user interface, and it also sends the data to the printer. So you have three Bluetooth devices that are interacting, including the PDA, which is essentially acting as the front panel," says Saltzstein.

Code Blue Communications recently introduced its second-generation Serial Port Adapter, which allows any device with an RS-232, RS-422, or RS-485 port to communicate wirelessly. No software installation nor system changes are required. All of the necessary Bluetooth (at the full product level) and FCC approvals have been obtained.

The next evolution in Bluetooth technology, according to Saltzstein, is the 1.2 specification. "One of the new features is called adaptive frequency hopping (AFH), which allows Bluetooth and 802.11b, more commonly known as Wi-Fi, to coexist with zero interference. Bluetooth picks those frequencies where 802.11b is not." Bluetooth 1.2 is just beginning to ship in chip sets, adds Saltzstein.


Wi-Fi Module Connects with Device OEMs

A module that integrates 802.11b, or Wi-Fi, technology developed by DPAC Technologies has been specified for use in several medical device applications.

When DPAC Technologies (Garden Grove, CA; www.dpactech.com) introduced its drop-in Internet-enabled 802.11b module in September 2003, med-tech applications were at the front of the company's mind. "Our system design services group had several existing relationships with device firms," says Mike Grobler, director of wireless applications. When the product was under development, some of them signed on as beta testers. 

"The self-contained design of the Airborne Wireless LAN node module makes it very easy to integrate into a product," says Grobler. "It's based on a widely accepted standard, and there is a plethora of equipment to support it from an infrastructure point of view," he adds. A typical application might involve adding the module to an infusion pump. Prescription data are downloaded to the device from a PDA; the module also allows the device's operation to be monitored from a central nursing station.

"From that base wireless LAN module we have made derivative encapsulated products suited for use with legacy devices," says Grobler. The AirborneDirect family of products are designed to provide wireless local area network and Internet connectivity to installed-base OEM devices. Several makers of medical equipment are interested in the technology, according to Grobler.

AirborneDirect Serial, which the company introduced in January, is under review for use with a bedside monitor. To create a wireless connection between the monitor and a nursing station, "the product is simply plugged into the device's existing serial port." As with the module, much of its appeal lies in its simplicity. OEMs do not need RF or communications expertise, and there is no need to develop software.

AirborneDirect Serial also allows alerts to be sent from the system via the Internet to cell phones, pagers, and PDAs. 

The company is currently looking into enabling SpO2 devices. "The existing products have no local area network connectivity. The manufacturer wants to multiplex them so the data can be observed on a network. And he wants portability," adds Grobler.

At this year's MD&M West show in Anaheim, CA, DPAC showcased the use of its 802.11b module in a prototype intelligent hygiene management system. The i-Hygiene device wirelessly monitors compliance to corporate hand washing and other policies. An RFID badge worn by the user communicates with the system, which has an embedded wireless LAN node module from DPAC. Transmitted over the Internet, the data can be monitored in real time. Food preparation is one of the obvious target industries for the product, but hospitals and even industrial cleanroom environments can derive a significant benefit, says Grobler. 


Supplier of Wireless Systems Has a Unique Relationship with Medical Technology

The Polytel system wirelessly transmits encrypted data from a medical device to a remote location via the Internet.

A recently introduced drop-in Bluetooth system partly owes its existence to a medical device manufacturer. "We were initially approached by a device OEM who was looking for an off-the-shelf product that would provide connectivity," says Pierre Landau, CEO of Polymap Wireless (Tucson, AZ; www.polymapwireless.com). "Many, many years ago, I worked in the medical device industry," he adds. (In the early 1980s, Landau was involved in the development of the evoked potential monitor, which monitors neural activity during neurosurgical procedures.) "So, there was this natural interest on my part in fulfilling that need." That project led to the launch of the more broad-based Polytel product at the beginning of this year.

The Polytel system wirelessly transmits encrypted data from a device to the Internet. It can be integrated into any medical device with a serial port.

The system comprises a remote circuit board placed inside the device, an access point that plugs into a regular telephone line, an Internet service provider (ISP), and a wireless data center. The remote unit records, time-stamps, and saves data until it is within range of the modem. Bluetooth technology is used to transmit the data wirelessly to the modem, which dials up the ISP and sends the data to the center via the Internet. The unit was designed for the home-care market, but it can be used in other settings just as easily.

"What we call the access point, which is sort of a home hub, works with a regular telephone line. So you could say that the hardware is more suited to home use," says Landau. "But there's no reason to limit the device to that end. In fact, we are working with clients who want to connect different devices with a remote unit in hospital networks."

Polymap also offers custom Bluetooth-based products. It recently entered into an agreement with Zeevo, a supplier of system-on-chip components based in Santa Clara, CA, to expand these capabilities. "Some device manufacturers are interested simply in our built-in components," explains Landau. "They have another way of bridging the rest of the wireless link. Others already have the back-end system components, and we dovetail our [technology] with theirs."

The device industry has been cautious in its adoption of wireless technology, and rightfully so, notes Landau. "Making a medical device wireless from scratch is not a trivial matter. You have to understand RF propagation. You have to interact with regulatory bodies you might not normally deal with. And it can require a substantial up-front investment," says Landau. "With our solution, you drop the little unit into your device, and you're done. We offer medical device manufacturers, who may be reluctant to jump in and spend the kind of money that is required, an opportunity to avail themselves of this technology." 


Danish Company Embarks on Global Mission to Make Medical Devices Wireless

The Telehealth Gateway from RTX Healthcare wirelessly collects and transmits medical data to a remote server via the Internet. The product is marketed to device OEMs and system integrators.

Improving a patient's quality of life while reducing overall treatment costs could be considered the Holy Grail of medical device manufacturing. RTX Healthcare (Noerresundby, Denmark; www.rtx.dk) believes that integrating wireless communications capabilities with medical diagnostic equipment is a meaningful step in that direction.

RTX Healthcare is a subsidiary of RTX Telecom, which has completed more than 300 projects, developing everything from chip sets to finished products for global OEMs. RTX Healthcare (formerly Penell a/s) is dedicated to using its considerable resources in wireless connectivity to benefit medical products. "We feel that the healthcare market is immature in this regard," says marketing manager Jens Kofoed, "and our mission is to make medical devices wireless worldwide." The introduction of a family of OEM homecare products that incorporate Bluetooth technology represents the most recent milestone in this campaign.

The system's core components are devices that measure blood pressure and weight, and a Telehealth Gateway unit that collects and transmits the data to a remote server via the Internet. All of this is done wirelessly. The product line represents a "step up in the value chain for the company," notes Kofoed.

In the past, the company has followed a traditional outsourcing model by supplying electronics and subassembly design services to device manufacturers. This new line of products takes that business model in a new direction. The company now purchases technology in the form of basic devices, integrates wireless e-health capabilities, obtains the necessary product approvals, and markets the resulting products to device firms and system integrators. The underlying communications platform, which supports Bluetooth, GSM/GPRS, and LAN protocols, will also be offered for integration with other devices.

"One of the key features of the system is its simplicity," says engineering manager Niels Ole Andersen. "The user makes no adjustments.
The devices and the Gateway are configured prior to shipment. All the patient needs to do is plug it into a power source and a phone line," he explains.

Data are encrypted using the Secure Socket Layer protocol. It is implemented in the company's proprietary Callisto software platform that is part of the Gateway unit. Callisto also supports authentication on the client and server ends, and configuration options can be hidden behind two levels of user names and passwords. None of this will be visible to the patient. He or she sees only a sleek box adorned with a light-emitting diode to indicate that the device is working. "The data are delivered in XML," adds Andersen. "This gives the manufacturer maximum flexibility in displaying the information."

The price point is substantially lower than existing products that perform a similar function, he adds.

"When OEMs see this technology, they immediately begin thinking about a whole range of other applications," says Kofoed. (Indeed, several other medical devices that apply this technology are in RTX Healthcare's pipeline.) For instance, "there are a lot of potential wireless applications that simply involve capturing information," notes Andersen. He sees home care and its enabling technologies as a market that is on the verge of exploding. It's a wave that RTX Healthcare is well-positioned to ride, he adds. "We have the experience, knowledge base, and capabilities to meet the anticipated demand for high-volume products that comply with global regulatory standards."


Wide-Area-Network Services Provider Goes Vertical

"In the telemetry world, SkyTel Corp. [Jackson, MS; www.skytel.com] has always been a wireless services provider," says Donald Solar, director of telemetry services for SkyTel. This year marks something of a shift for the company, as it expands its scope in a vertical direction. "In the second quarter, SkyTel plans to offer an end-to-end service for machine-to-machine and people-to-machine applications." The objective, explains Solar, is to accelerate the development cycle for OEMs. "We are matching up a transceiver; microprocessor; and serial, digital, and analog ports. The Remote Access Device will make it very easy for OEMs to integrate our product with their equipment and begin transmitting information quickly and effectively."

Today, OEM-level wireless transceivers manufactured by Belgium-based Advantra International are approved to operate on the SkyTel network. The modules are based on ReFLEX technology, a narrow PCS band used by SkyTel. Advantra's AR200 OEM module, measuring 3.7 ¥ 1.9 ¥ 0.2 in., is designed to be a simple drop-in solution for existing products. The forthcoming Remote Access Device from SkyTel will further facilitate the integration of wireless capabilities.

SkyTel was recently involved in the development of a product that monitors patients with congestive heart failure. "The device sits in the patient's home," says Solar. "Four or five times a day, it wakes up and says it's time to take your blood pressure, step on the scale, take your temperature, and so forth." The built-in transceiver collects and sends the results, via the SkyTel network, to a database, where the data are monitored. "We are seeing steady growth for this application, month over month and year over year," says Solar. Nevertheless, he feels that the device industry's uptake of wireless wide-area network (WAN) technology is not what it could be.

The technology "has not gained significant acceptance in the medical device arena," says Solar. Local wireless technology, such as Bluefoot, is making substantial inroads to hospital equipment, he notes, but device OEMs have not yet fully grasped the "value proposition" of wireless WAN technology. That may be just a matter of time.

The firm is currently working with one of its customers to build an off-the-shelf system that will allow diabetics to take readings and send the results over the network. Mobility is a key factor, says Solar. "Patients can take the readings anytime and anywhere." When that product and the Remote Access Device become available, device OEMs may well decide that wireless WAN technology deserves a closer look.


French Connection Gets Devices Talking

Universal connectivity software from Capsule Technologie can collect data from more than 250 medical devices and send them to clinical information systems in a compatible format.

Capsule Technologie (Paris; www.capsuletech.com) has come a long way in a short time. A supplier of universal device connectivity software, the firm began development of its flagship DataCaptor interface in 2000. In early 2002, "interest in our product was beginning to stir among some of the key players in the industry," says CEO Nicolas Choussat. "By the end of that year, we had reached a milestone--ISO 9001 certification and 510(k) clearance--and business took off," adds Choussat. Since then, Siemens, GE Medical, Dräger, and Philips, among others, have integrated Capsule Technologie's product into their medical systems. With the recent launch of DataCaptor 4.4, featuring plug-and-play connectivity, the company is looking forward to even more stellar results.

DataCaptor provides an interface between stand-alone and/or networked medical devices, primarily bedside monitors, ventilators, and infusion pumps. It collects the medical data originating at a device's communication port, translates them into XML or HL7, and distributes them to clinical and hospital information systems. The company claims to have the largest library of medical device interfaces available, with built-in support for more than 250 different products. DataCaptor 4.4 adds unprecedented ease of use to the company's extensive interface capabilities.

The product integrates an Automatic Device Identification module. This allows users to connect and reconnect any of the medical devices supported by DataCaptor without reconfiguring the software. This can be beneficial in hospital settings where bedside monitors are frequently changed. "It was quite tricky fine-tuning the plug-and-play capability," says Choussat, who adds that the firm has succeeded in developing a completely reliable and rapid detection system. A fully functional version of DataCaptor 4.4 can be downloaded from www.capsuletech.com for a free 30-day evaluation.

Healthcare environments are still riddled with so-called islands of information, devices with proprietary data protocols that put up barriers to communication. But manufacturers are increasingly aware, says Choussat, that universal connectivity is the way forward. Third-party connectivity vendors, such as Capsule Technologie, represent the best option to get from here to there, he adds.

"Developing connectivity solutions is a time-consuming task that can be a tremendous drain on resources," says Choussat. This is especially true, he notes, when it is not a firm's core competency. "Why reinvent the wheel when a best-of-breed product is available?" he asks. "Many suppliers of clinical information systems are device manufacturers themselves," adds Choussat. "They would have to talk to their competitors, even ask them for help, to develop the drivers [that allow multiple devices and clinical information systems to communicate]. It's so much 
easier to go through a third party." 

Copyright ©2004 Medical Product Manufacturing News

Clearing the Air

Originally Published MPMN April 2004

PRODUCT UPDATE

Clearing the Air

Filters find many uses in medical device manufacturing

Susan Wallace

Polyester filter cartridges from Airguard can be washed and reused for plastics 
manufacturing applications. 

From clearing smoke from operating rooms to protecting sensitive electronics, filters are essential parts of medical devices. They are also used in manufacturing processes to help ensure sterility. What follows is a roundup of some advances in filtration technology. 

Polyester Filters Are Washable and Reusable

Dust cartridges from Airguard (Louisville, KY) are made with 100% spunbonded polyester media. They are used in pulse-jet dust collectors. Applications for such systems include situations in which there is residue from metalworking or chemical or plastics manufacturing. 

The spunbonded media have high initial efficiency, high filtration efficiencies on fine particulate, and good dust-cake release characteristics. The media are long wearing and highly resistant to abrasion. Cartridges are washable and can be used repeatedly. They resist most chemicals, including many acids, alkalis, oxidizing agents, and solvents. 

Specialized media, such as aluminized, are also offered by the company. Aluminized media are suitable for static dissipation, which is desirable for safety and facilitates material handling. They are also well suited for cartridges used in powder-coating operations.

The company provides PTFE laminated media as well. PTFE cartridges are engineered specifically for dusts with high moisture content. 

So Smoke Doesn't Get in Your Eyes

Surgical-smoke filtration materials from W. L. Gore reduce the chance of smoke escaping the collection chamber.

Procedures such as electrosurgery or laser surgery release a certain amount of smoke into the air. These operations require a high-performance vent with filtration capabilities. Specialized media reduce the chance of contaminated smoke leaving a collection canister. 
Gore Medical Membrane Technologies (Elkton, MD) supplies a membrane for surgical-smoke filtration as an all-in-one, multifunctional laminate. The product combines a microfiberglass prefilter with a hydrophobic PTFE membrane and is offered in many forms. It combines high smoke-holding capacity and long life with a robust barrier to fluid penetration. 

Additionally, the high smoke-particle retention of Gore-Tex media may offer extended suction system life. And, according to the company, hydrophobic Gore-Tex ePTFE membranes have significantly higher resistance to leakage than other microporous membranes.

Diagnostic Wicks Have Highly Uniform Liquid-Flow Properties

Transorb wicks from Filtrona Richmond Inc. (Colonial Heights, VA) are used as wicking components in lateral-flow diagnostic devices such as midstream pregnancy and ovulation tests. They can also be used in other applications that require collection and transfer of sample liquids or reagents.

The company offers Transpad wicks as well. They are used for sample collection and transfer media in lateral-flow test strip formats. The low protein binding and highly uniform liquid-flow characteristics of this media make it suitable for this application. 

The products are custom designed to control the rate of flow and amount of liquid delivered to the test site. The wicks are constructed using continuous fibers to optimize uniformity of liquid transfer characteristics.

Synthetics--The Fabrics of Lifesaving Applications

Precision-woven synthetic fabrics are suited for medical and diagnostic applications. The SaatiCare fabrics from Saatitech (Somers, NY) are used for blood filtration in arterial, cardiotomy, and transfusion filters. They are also used for drug-infusion systems, flow control devices, moisture barriers, biopsy bags, and EMI and RFI shielding. 

SaatiCare fabrics have a narrow aperture-size distribution, ensuring accurate and predictable filtration. A proprietary finishing system ensures that the fabric will meet specified pyrogen levels and be in compliance with USP Class VI requirements. 

Diagnostic test strips use the company's screen membranes to ensure rapid and uniform spreading and precise prefiltration

The fabrics are available custom fabricated into slit rolls, stamped parts, tubes, pleated elements, bags, and various other forms. Ultrasonic cutting and welding, pleating, and laser and cold cutting are all performed in a Class 10,000 cleanroom under ISO 9001 guidelines. A variety of pore sizes, thicknesses, and flow rates, as well as special hydrophilic and hydrophobic finishes, are available. 

Filters Ensure a Tight Fit

MagnaFlex air filters, made by Universal Air Filter Co. (Sauget, IL), feature bend-to-fit flexibility. They have a magnetic installation method and sealing strip that ensures a tight fit for medical electronics enclosures.

The units are designed for medical enclosures that cannot accept a rigid air filter frame because of obstructions. The magnetic sealing strip eliminates mounting hardware and simultaneously locks the flexible filters in place. The resulting tight seal prevents unfiltered airflow from bypassing the air filter. 

Each filter is supplied in a flame-retardant, polypropylene frame. This makes it possible for the filter to follow a contour and bend around obstructions. Frames come in thicknesses ranging from 0.03 to 0.12 in. A solvent-resistant, two-part epoxy bonding material is used to securely unite frame and air-filter media.

Copyright ©2004 Medical Product Manufacturing News

Search Capabilities Improve Customer Access to Products

Originally Published MPMN April 2004

E-News

Search Capabilities Improve Customer Access to Products

Melody Lee

Click to go to site.

Hamamatsu Corp. (Hamamatsu City, Japan) now provides its U.S. Web site users with a search feature. Users of the English-language site have access to 95% of the company's product line. The revamp includes improved access to product information and data sheets, routing of Web form entries, and requests for quotes, samples, and demonstrations. The company offers a range of detectors, light sources, and imaging systems for medical use. Its Web site features products such as photodiodes, photo integrated circuits, position-sensitive devices, photomultiplier tubes, light sources, and x-ray products. 

Copyright ©2004 Medical Product Manufacturing News

My Favorite Bookmarks

Originally Published MPMN April 2004

E-News

My Favorite Bookmarks

Allan Knox, Program Manager FlexOne Technologies

Allan Knox

The number one site for me is definitely DigiKey (www.digikey.com). What is fantastic about this site is 
the search engine. DigiKey has done a masterful job of allowing the user to first find the component he wants quickly, then get price, availability, and technical specs with just a couple of clicks. For example, you type in "resistor" and a whole list of subgroups comes up. Select a subgroup, such as "chip resistors," and the next screen has all the parameters that might be associated with chip resistors. You can select the package style, power rating, packaging (bulk, tape-and-reel, etc.), vendor, resistance, tolerance, or any combination. 

You can also enter multiple selections if you know exactly what you're looking for, or "drill down" by first [choosing a specific size]. Select that and only the vendors, values, and parts that are available in that size are shown. If you select a value, only the vendors and parts that still meet your selection are shown. If you get to a point where there are fewer than 20 or so selections, all the information about price, vendor, and availability are shown. Click on the part number and you get quantity pricing. Click on it again and you get all the technical specifications.

Another really useful site is Martindale's Calculator (www.martindalecenter.com/calculators.html). Ever wonder how to figure interest on a loan? Convert Btu to kilocalories? How many pecks of apples will fit in a boxcar? If it's not on this site, it probably can't be done. There are more than 18,000 calculators here.

Agilent, formerly Hewlett Packard, has a site called "Educator's Corner" (www.educatorscorner.com/index.cgi), with a wonderful set of tools for engineering education. It has experiments, lectures, and slide shows about all sorts of topics, as well as links to similar sites, book listings, and project suggestions. They even have an engineering cartoon.

Kemet, a capacitor vendor, also has a very good site (www.kemet.com). 

Not only is it easy to locate product specifications, but the site also has a wonderful selection of technical articles. There are papers on virtually every aspect of capacitors, including failure, leakage, aging, and interpretation of all the various specifications. It's a great way to educate yourself if you use capacitors frequently.

Williamson Labs (www.williamsonlabs.com) is another great conglomerate site with articles, reference materials, project suggestions, and even humor, all relating to electronic engineering. It has a wealth of useful information, such as suggestions on building and testing prototype circuits, and anecdotal references to noise and electromagnetic interference problems and how to prevent them. It's sort of a candy store for electrical engineers.

Everything PCB (www.everythingpcb.com) is another one-stop site for technical details, links to vendors and suppliers, and manufacturing information about printed circuit boards. This site includes industry forums where people and companies can exchange and debate technical details. There is also an offer for free classified advertisements. This has to be one of the best bargains on the Web.

There are also some really amusing Web sites that only an engineer could truly love. Bert's Quarter Shrinking and Can Crushing Gallery (http://205.243.100.155/frames/shrinkergallery.html) is the site on shrinking quarters, a fascinating application of high technology for its own sake. After all, with inflation already nibbling away at our savings, do we really need a quarter the size of a dime? This is one site 
you have to see to believe, and even then you wonder.

In a shameless bit of self-promotion, I also am fond of the Knox Associates Design site (www.knoxassociatesdesign.com). This site has a links page that includes many of the previously mentioned sites. Among the links there is a heavy emphasis on two areas--tutorials and wireless sites, specifically those pertaining to IEEE802.11.

FlexOne Technologies (San Jose, CA; www.flexone.com) is a small contract manufacturer in the Silicon Valley specializing in prototypes and low- to medium-volume production. The company provides printed circuit layout, electronic design services, parts procurement, 
and design review for manufacturability and reliability.

Melody Lee

Copyright ©2004 Medical Product Manufacturing News

IN BRIEF

Originally Published MPMN April 2004

INDUSTRY NEWS

IN BRIEF

Rubber Industries (Shakopee, MN; www.rubberindustries.com) has expanded its capabilities to include liquid injection molding . . . MEC, Milwaukee Electronics Co., (Milwaukee) is celebrating its 50th anniversary in 2004. . . Nusil Technology (Carpinteria, CA; www.nusil.com) has acquired Morehouse-Cowles (Fullerton, CA; www.morehousecowles.com) from MFIC Corp. Morehouse-Cowles is a manufacturer of equipment and technology for milling, mixing, and dissolving and will continue operating in Fullerton as a wholly owned subsidiary of Nusil. . . Dow Corning Corp. (Midland, MI; www.dowcorning.com/healthcare) and Rohm and Haas Co. (Philadelphia; www.rohmhaas.com) have formed a strategic alliance that will create materials and services to address unmet needs in wound care, transdermal, and related medical device applications. . .Beta LaserMike (Dayton, OH; www.betalasermike.com) has received a patent for its Snap Technology software contained within its ultrasonic wall thickness measurement system. . . Fluid sensor manufacturer Gems Sensors Inc., (Plainville, CT; www.gemssensors.com) has acquired Venture Measurement Company, LLC (Spartanburg, SC; www.venturemeasurement.com). 

Copyright ©2004 Medical Product Manufacturing News

Stent-Crimping and -Loading System Takes Up Residency in Catheterization Labs

Originally Published MPMN April 2004

INDUSTRY NEWS

Stent-Crimping and -Loading System Takes Up Residency in Catheterization Labs

Norbert Sparrow

Designed for crimping and loading stents with living tissues in catheterization labs, the HV100 comprises a sterilizable base and disposable segmental crimping mechanism.

Segmental compression technology is at the heart of a line of equipment that fully or partially automates catheter and stent production processes. The proprietary crimping mechanism developed by Machine Solutions Inc. (MSI; Flagstaff, AZ; www.machinesolutions.org) provides an even, repeatable radial compression for stent-crimping and balloon-folding applications. MSI has adapted the technique to a new device that crimps and loads living-tissue products. The firm launched the product at MEDTEC in Stuttgart, Germany, in March.

Minimally invasive surgery (MIS) has made great strides in recent years. It will continue to progress as patients demand the use of less-invasive techniques. Minimally invasive stent placement procedures used today also will drive innovation, says James P. Kasprzyk, director of global marketing. "Several leading clinical investigators in the United States and Europe rely on labor-intensive hand loading to place stents with living-tissue components attached," he says. The HV100 crimping mechanism offers an alternative.

The device precisely reduces the diameter of large stents that have living tissue attached to them. To preserve tissue integrity, the instrument operates partially submerged in a saline solution. The stent is crimped and loaded into a delivery system in the catheterization lab prior to the procedure. Precise stent and tissue reduction is critical to the success of the operation. It also ensures that the stent expands evenly when it has been placed in the patient.

The HV100 provides consistent, repeatable radial compression and can be operated by a single person. Its small footprint makes it suitable for use in laboratory and bedside settings. The base unit is sterilizable, while the segmental compression mechanism is designed for single use.

MSI's initial customers likely will match the size of the disposable mechanism with their living-tissue stent products and package them together, says Kasprzyk. "We anticipate that this will be similar to the way in which stent and catheter companies currently sell accessory products such as inflation devices and y connectors." The sterilizable base will be sold directly to catheterization labs, he adds, probably by device OEMs.

Copyright ©2004 Medical Product Manufacturing News

Parker Hannifin Launches Life Sciences Business Unit

Originally Published MPMN April 2004

INDUSTRY NEWS

Parker Hannifin Launches Life Sciences Business Unit

Linear stages and motion control electronics developed by Parker Hannifin Corp. are suited for use in high-density microarray systems. By forming a life sciences business unit, the company hopes to cut time to market.

Global manufacturer of motion and control technologies Parker Hannifin Corp. (Cleveland; www.parker.com) has formed a life sciences business unit. The announcement was made in February.

The business unit will offer "OEMs a single point of access to Parker's motion and fluid control competencies," says president and CEO Don Washkewicz. Parker Hannifin views life sciences as a fast-growing market segment. By integrating its range of technologies, the firm hopes to streamline the delivery of application-specific systems. OEMs will benefit from collaborative engineering, faster time to market, and improved design and systems integration.

The business unit is based in Hollis, NH, at the firm's Pneutronics division. It will work with customers in the development of enabling technologies and integrated systems involving miniature solenoid valves and diaphragm pumps, motion controllers, stepper and servomotors, and related products.

Mike Portela has been named business unit manager. Rob Howard is the sales and marketing manager and Paul Horvat is the business development manager. The technical staff is led by senior scientist Thomas Londo and senior systems engineer Paul Grippo.

Copyright ©2004 Medical Product Manufacturing News

Stent Advances Pavethe Way for Drug-Eluting Coating Suppliers

Originally Published MPMN April 2004

INDUSTRY NEWS

Stent Advances Pave the Way for Drug-Eluting Coating Suppliers

Melody Lee

A stainless-steel coronary stent is coated with Hemoteq's polymer matrix containing Paclitaxel.

Drug-eluting stents may have only been commercially available in the United States for about a year, but the facts already point to a huge demand. According to Cordis (Miami Lakes, FL; www.cordis.com), nine months after FDA approval, its Cypher stent has been used in nearly 60% of U.S. coronary stent procedures. Recently, Cordis and Guidant Corp. (Indianapolis; www.guidant.com) reached an agreement regarding the marketing of Cypher. Guidant, a developer of cardiac and vascular treatment, will promote the stent. In addition, the companies will develop another version of the device that uses Guidant's Multilink vision stent-delivery system. 

Following closely in the race to market drug-eluting stents is Medtronic (Minneapolis; www.medtronic.com). It has begun the third phase of clinical trials for its Endeavor drug-eluting coronary stent. If its stays on track, the company predicts product approval in the United States in late 2005.

The movement toward this market among OEMs did not go unnoticed by suppliers, as the key to the success of drug-eluting stents may be in finding the right coating. With the right surface treatment, a stent can more effectively prevent restenosis, or the reclogging of arteries. The first six months after stents are inserted are critical, as 10-20% of balloon angioplasty patients experience restenosis. Several companies offer potentially lifesaving coatings, while others are still in the research phase.
 
Nanocoating firm Hemoteq (Würselen, Germany; www.hemoteq.com) has been offering Ouverture since the end of 2002. The polymer matrix combines two coatings that are hemocompatible and reduce the risk of reclogging. Nearly any metallic stent material and design can be processed with the drug-free coating. 

The coating on Angiotech's Taxus Express stent demonstrates drug-eluting properties.

After the first few months postsurgery, "there is no real need for a drug or any coating," says Ingolf Schult, marketing manager for Hemoteq. "Many doctors feel more comfortable with a bioresorbable coating that will disappear after the drug-eluting phase. That is why Hemoteq selected biodegradable polymers for Ouverture." Schult adds that some of the biostable polymers that are being used for stent coatings are not really biocompatible and may interfere with antirestenosis therapy. 

STS Biopolymers Inc. (Henrietta, NY; www.stsbiopolymers.com), recently acquired by Angiotech Pharmaceuticals Inc. (Vancouver; www.angiotech.com), also offers a drug-eluting coating technology. The Medi-Coat system consists of drugs trapped in a mix of hydrophilic and hydrophobic polymers.

Following the recent acquisition, the coating system will be offered to manufacturers with an added advantage. Historically, STS Biopolymers was approached by OEMs wanting a certain drug to be released from a device. The company would then combine its coating formula with the provided drug. Angiotech plans to continue doing so, but also hopes to provide the manufacturers with the drug itself. "We want to go to the manufacturer and say, 'Here is what we think the clinical problem is, and here is the drug that we think will work,'" says Bill Hunter, president and CEO of Angiotech. "We're providing the complete packaging and bringing the drug and the coating." 

An advantage of using Medi-Coat "is its flexibility," adds Hunter. "It isn't just one coating that suits all purposes. Medi-Coat is a blend of several different polymers. That means that there's usually one polymer in the combination that's suitable for delivering the certain drug, and you can use more or less of that particular polymer [when making the coating]."

An ionic plasma deposition (IPD) process is used by Ionic Fusion Corp. (Longmont, CO; www.ionicfusion.com) to give stent makers another choice in antirestenosis and drug delivery. It currently lays down FDA-approved materials for radiopacity on stents or other surface coatings to improve stent characteristics. The company is also involved in advanced research work to improve the drug-eluting properties of its coatings. 

Medtronic's Endeavor stent is in its third phase of clinical trials with expected approval in late 2005.

According to the company's president and COO Joe Ryan, the IPD process has several characteristics that make it distinctively different from traditional coating methods. One advantage is that the process can be done at room temperature on any substrate. For example, this enables a metal made of stainless steel, nickel, or another alloy to retain its mechanical or tensile strength or any inherent properties. 

"Because we're actually impregnating the metal ions into the substrate of the stent, the adhesion is extraordinary," says Ryan. "It literally becomes a part of the substrate material. This has been proven by work with NASA and MIT. In NASA's case, the metal ions went into the material up to 13 microns."

The company is creating "more highly porous surfaces that would allow for greater volumes of drugs to be held by the stent, both on the inner and outer diameters," adds Ryan. "This process allows us to put different surface characteristics on [different parts of the stent]."

Copyright ©2004 Medical Product Manufacturing News

Machining

Originally Published MPMN April 2004

Outsourcing Outlook

Machining

Inspection Process Enhances Machining Services

With the aid of CNC equipment, a company provides machining services to OEMs with capabilities complemented by 3-D CAD software. Milling, turning, electrical-discharge machining, grinding, gun drilling, heat-treating, blasting, anodizing, and electropolishing are on the list of services. A team of biomedical engineers and designers works directly with programmers and operators to develop machining processes for custom instruments and components. A three-stage inspection process includes assessments during the first-article and final phases as well as in-process checks. Treatable materials include stainless steel, titanium, aluminum alloys, plastics, phenolic, and silicone. Gauthier Biomedical, Grafton, WI www.gauthierbiomedical.com 


Component Manufacturer Offers Metal Fabrication


Metal fabrication services are available from a manufacturer of medical device components. Capabilities include centerless grinding, swaging, bending, laser welding, needle assembly, electrical-discharge machining (EDM), CNC flaring, and tip reducing. EDM services feature tubing with outer-diameter ranges of 0.020 to 0.202 in., and hole sizes starting at 0.010 in. Laser welding, suitable for applications such as hypodermic tubing, minimizes the effect of heat in the welded area. Burr-free grinding and cutting are available for tube lengths starting at 3¼8 in. with standard tolerances of ±0.010 to ±0.005 in. The company can process materials including stainless steels, brass, nitinol, titanium, platinum, aluminum, Inconel, and Hastalloy. Popper & Sons, New Hyde Park, NY www.popperandsons.com 
 








Machining Technology Produces Precision Parts

Advanced technology is applied to produce precision-machined parts. Updated CAD and CAM software is networked to the manufacturer's CNC and electrical-discharge machining centers. Tolerances on machined parts are as low as 0.0005 in. The company processes metallic and nonmetallic materials to meet customer requirements. Located in a 100,000-sq-ft facility, the company manufactures customized parts, including clamps, nuts, O-rings, washers, and brackets. Seastrom Manufacturing Company, Inc., Twin Falls, ID www.seastrom-mfg.com 




Software Aids in Quick Prototype Turnaround

Using Solidworks 3-D modeling software speeds up the process of producing prototypes. A manufacturer of sheet-metal prototypes offers 2- to 10-day delivery of parts to mechanical engineers who use the CAD software. The company can use the files as the basis for manufacturing quick-turnaround parts and will generate the flat pattern from the 3-D file. Materials such as aluminum, cold-rolled steel, and stainless steel can be used to create chassis, enclosures, brackets, panels, 19-in. racks, and weldments. Rapid Sheet Metal Inc., Nashua, NH www.rapidsheetmetal.com  


Fabrication Department Meets Machining Demands 

With more than 1000 different mold sizes and a press capacity of more than 350 tn, a molding and machining company offers tight-tolerance machining of most plastic materials. The company handles a wide range of fluoropolymers and Amilon compounds, such as virgin and modified polytetrafluoroethylene blends with carbon and glass. Nonmetallic materials can be folded, bent, shaped, and welded into housings, containers, support brackets, and fixtures. Ultrasonic welding, insert molding, heat staking, hot stamping, pad printing, and assembly are performed within a Class 1000 cleanroom. The company can advise on design and material selection to fit applications requiring chemical resistance, thermal cycling, and high temperature. Amicon Plastics, Houston, TX www.amiconplastics.com 


Manufacturing Equipment Covers Range of Machining Needs

available for customers seeking precision components, such as surgical products, hypotubing, needles, battery contacts, wire forms, and electromagnetic and radio-frequency interference shielding. The company's toolroom equipment includes wire electrical-discharge machines (EDM) with autothreading for unattended operation, a submersible cutting tank, and five programmable axes. In addition to surface grinders and drill presses, a vertical machining center with 20-hp spindle torque is also on-site. The 12,000-sq-ft facility also houses a CNC and EDM microhole drill for holes from 0.004- to 0.256-in. diam. Peridot Corp., Pleasanton, CA www.peridotcorp.com 


Machining Available for 3-D Surfaces

Manufacturers are offered precision machining of surgical instruments, implant devices, and equipment parts. Providing services from prototypes through production, the company incorporates CAD and CAM Unigraphics software for machining and engineering. Capabilities include machining of 3-D surfaces within close tolerances of 0.001 in. on metals, including stainless steel. CNC turning equipment features a full c-axis, live tools, and four y-axis machining, with capabilities for 12 ¥ 25 in., up to a 3-in.-diam through spindle. Precision CNC milling systems handle up to 20 ¥ 40 in. with high-speed machining. BEM CNC, Bensenville, IL www.bemcnc.com 
 


Grinding Machines Produce Intricate Parts

Internally engineered and built grinding machines are used to develop high-quality intricate wire and tubular components. The medical wire component manufacturer offers tolerances within 0.0001 in., tip sharpness of less than 0.00005 in., surface finishes of less than 6 rms, and ground diameters as small as 0.005 in. The equipment is suitable for most metals and plastics with durometers greater than 56. In-house manufacturing services include taper and form grinding, cutting, bending, coining, coating, end-rounding, and laser marking. New England Precision Grinding, Holliston, MA www.nepg1.com 


Prototype Department Expands Range of Services

In order to provide more extensive manufacturing services, an in-house prototype department has expanded to include five-axis CNC milling. Capabilities also include CNC screw machining, wire electrical-discharge machining, laser marking, vacuum heat-treating, and passivation. 

The company assists customers in tracking the development and testing phase of precision-machined medical implants and devices from prototype phase to full production. Assembly, packaging, and sterilization services are part of the overall package. Specialized Medical Devices, Lancaster, PA www.specializedmedical.com 

Copyright ©2004 Medical Product Manufacturing News

Molding Equipment and Services

Originally Published MPMN April 2004

SPOTLIGHT

Molding Equipment and Services

Two-stage ejector

A two-stage ejection system provides cut-to-length adaptability to varying mold-base sizes and plate thicknesses. The equipment features internal installation to avoid interferences with water-line connectors and externally mounted components. With bottom-last and top-last styles of ejection, the system comes in diameters of 20, 26, and 32 mm, accommodating most metric or inch standard mold bases. The stroke range for each ejection stage is achieved by cutting the center rod to the desired length and by cutting a threaded sleeve to length. The system controls the movement of two sets of ejector plate assemblies inside the mold box. Both the first- and second-stage strokes can be set independently. D-M-E Co., Madison Heights, MI www.dme.net  


Precision components

An outsource developer and manufacturer of finished, disposable medical devices has injection molding capabilities for precision components. Thirteen facilities with Class 10,000 and Class 100,000 cleanrooms also provide mold design and building capabilities. Depending on the location, the company's injection molding machines handle a tonnage capacity ranging from 22 to 360 tn. The company also offers full product life-cycle management from design to finished sterile goods. Avail, Fort Worth, TX www.availmed.com 


Vertical injection molding machine

A 37.8-tn injection molding machine is designed for fully automated molding of inserts as well as for continuous production lines. The 35 vertical series features a clamping unit equipped for vertical injection. Molding shot sizes range from 0.95 to 2.29 oz. Available models include the 35 A VV with a color interactive touch screen Procan CT microprocessor control, and the 35 M VV with a backlit flat-panel Procan MD microprocessor control. The machine is suitable for precision molding and can be equipped for liquid silicone rubber parts. A two-platen clamping unit offers a 90° rotation so that insert-molded parts will not slip during the clamping stage. Open space on the rear table permits the addition of auxiliary equipment such as robotics and automation cells. The overall dimensions are 108.7 ¥ 33.9 ¥ 74.8 in. Boy Machines Inc., Exton, PA www.boymachines.com      




Custom injection molding

A full-service custom injection molder offers quality assurance and ongoing bioburden checks and verifications to ensure contaminate-free products. The company's 100,000-sq-ft facility comprises Class 10,000- and Class 100,000-certified cleanrooms and a general molding room. Secondary operations performed within cleanroom environments include assembly, serialized bar coding, and packaging. New-tool construction and tool maintenance are performed in an in-house tool room. Trademark Plastics Inc., Riverside, CA www.trademarkplastics.com  




Molding services

With a specialty in molding engineering-grade thermoplastic and elastomeric materials, a supplier offers micromolding, machined metal component fabrication, and liquid silicone injection molding. The company's capabilities include complete design and engineering services, in-house CAD- and CAM-based tooling design and fabrication, insert molding, overmolding, and white-room molding. In addition to Class 10,000 and Class 100,000 cleanroom assembly, contract manufacturing services are available for assembly, machining, welding, and packaging. 
Donatelle Plastics, New Brighton, MN www.donatelleplastics.com     






Compression molding press

Providing 50 to 6000 lbf of clamp force, a compression molding press offers precision control through a proportional pneumatic pressure-control system. Model PS3H-8-CLX is suitable for vacuum-chamber compression molding of plastics and rubber requiring precise low-pressure force control, including testing, prototyping, and production applications. Fully programmable computer-based controls provide for data storage and dictate operating parameters, including temperature and pressure. The equipment features with an integral vacuum chamber and 8 ¥ 8-in. electrically heated and water-cooled platens. Standard electrically heated platens are available in sizes up to 18 ¥ 18 in. Wabash MPI, Wabash, IN www.wabashmpi.com  





Steel prototype production

A designer and builder of injection molds for plastic- and metal-injection molding offers steel prototypes with turnarounds in as few as 3 days. The company can produce a small amount of parts from a hand mold or a production-capable tool. The prototypes are accurate replications of results from a production tool and can be welded or plated. The full-service tooling company also provides part design and refinement, solid modeling, first-article inspection, in-house sampling, and mold construction. B A Die Mold, Aurora, IL www.badiemold.com  


Electric injection molding

A series of molding machines feature a controller permitting high-speed control of a 100-millisecond injection-scanning time. The Nex-series electric injection molding machines provide clamping compression, in-mold processing, and a variety of control programs. To minimize scrap, a protection function opens the mold if the sensing element detects any foreign matter during clamping. The series has a lineup of 22 models with nine types of mold-clamping mechanisms and 13 types of injection units. The units are suitable for a variety of applications, from small-sized precision parts to multicavity molding. Injection shafts are provided with a liquid lubrication-type ball screw to ensure high precision and high durability. Lissei America Inc., Anaheim, CA www.nisseiamerica.com  


Plastic and rubber forming 

Processing both plastic and silicone rubber, a molding service provider can meet customer requirements for applications from complex assemblies to implantable silicone devices. The company's services cover the process from conception to the final product. Design expertise includes CAD and 3-D model prototyping combined with flexible manufacturing technology. Additional supporting facilities include Class 10,000 cleanrooms, a microbiology testing laboratory, a tool room for mold maintenance, and printing services. Bibby Sterilin, Staffordshire, UK www.bibby-sterilin.com  



Insert molding machine

A molding machine uses a vertical clamp and vertical injection configuration with a multistation rotary table for insert placement. Medi-Molder uses book molds to enable molded parts to cure during travel, an advantage when processing long-cure-time materials such as liquid silicone. The press can also run different molds at the same time with adjustable parameters at each station. The company offers mold tooling for needle production. CA Lawton Co., DePere, WI www.calawton.com     


Copyright ©2004 Medical Product Manufacturing News