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Articles from 2005 In March


Emerging Technologies

Originally Published MPMN March 2005

Special Section

Emerging Technologies

Every year, MPMN takes a look at some fascinating new developments in the world of medical device manufacturing. These new technologies often prove to be a preview what we’ll be seeing in the next generation of medical devices.

This year’s crop runs the gamut from diagnostic imaging software for osteoporosis screening to a new deposition process for surface treatment of devices. Terahertz radiation can provide imaging in 3-D, and may improve detection rates of diseased tissue. And a new wireless system for hearing aids likely will have hard-of-hearing patients smiling from e2e.

Early Detection of Osteoporosis Made Easier with Computer Diagnostics

OsteoGram diagnostic software analyzes x-ray images to determine the patient’s risk for osteoporosis.

According to recent figures from the National Institutes of Health, osteoporosis is a major public health threat for 44 million Americans, more than half of whom are women. Early detection of the bone disorder has usually relied upon dual x-ray absorptiometry (DXA) scans of the hip or spine, scans which may be inconvenient, if not expensive, to obtain.

However, a company specializing in computer-aided diagnostics technology has come up with a plan to provide osteoporosis screening to more women. CompuMed (Los Angeles; www.compumed.net) has filed a patent for the integration and use of its OsteoGram osteoporosis screening and diagnostic software system on digital mammography equipment.

Originally developed for use on standard or digital x-ray equipment, the software gives clinicians a cost-effective method of measuring bone-mineral density (BMD). Using a hand x-ray, the software uses measurements from the middle phalangeal bones of the index, middle, and ring fingers to analyze and produce the BMD report. The company has designed the OsteoGram software with a highly precise radiographic absorptiometry (RA) technique to measure BMD.

By incorporating the software into existing systems, women can be screened for both breast cancer and osteoporosis in one visit. After a routine mammogram, the woman would place her hand on the machine to generate an image suitable for BMD analysis.

In previous years, combining the OsteoGram software with analog-based mammography was not possible because of differences in penetration and inconsistent photon energy levels. “With traditional mammography, the equipment looks only at the tissue, not the bone,” explains CEO Jerry McLaughlin. But digital mammography machines regularly achieve and maintain peak photon energy levels, allowing deeper penetration in order to get clear images of tissue as well as bone.

CompuMed’s success in integrating the software into other platforms bodes well for its integration into digital mammography equipment, says McLaughlin. “It’s merely acquiring the image from another type of x-ray equipment,” he adds. The company hopes to make the technology available within six months.

Corinne Litchfield

Ear-to-Ear Wireless Technology Doubles Listening Pleasure

The new
e2e wireless technology
allows two independent hearing
instruments to function as one hearing system.

As recently as the mid- to late 1990s, digital chips in hearing instruments contained a few thousand transistors. Less than a decade later, integrated circuit technology has contributed to the dramatic increase in processing power. More than 2 million transmitters can presently be housed in a 1.3-V chip. Such power translates into additional features for medical products.

For example, gone are the days when hearing-aid users had to wear bulky instruments and tote around battery packs. Even worse, they had to turn down their volume and forego hearing conversations because of annoying feedback. Today’s instruments are powerful microstereo systems. They feature a microphone, amplifier, loud speaker, and battery in a package that may be as small as a cashew.

Siemens Hearing Instrument (Piscataway, NJ; www.usa.siemens.com/hearing) also incorporates a core digital-signal processing paradigm into all of its Acuris models, enabling a dynamic listening environment. With the use of directional microphones, a signal is transmitted that allows each ear to identify whatever it is hearing. Speech, stationary or fluctuating noise, music, or even silence is recognized. Multiple sounds and the direction from which they originate are also detected. For instance, the process makes it possible for a person in a car to hear a companion speak or to enjoy music, while noises entering through an open window are filtered. In other words, the signal processing analyzes the situation, and the rest of the signal is optimized. Additionally, information about the listening environment is continually sent from ear to ear.

Having successfully developed this digital-signal processing, Siemens sought to simplify the wearing process for hearing-aid users. The firm developed ear-to-ear (e2e) wireless technology, a binaural hearing system that permits two independent hearing instruments to function as one for the first time. The technology synchronizes the system’s core advanced digital-signal processing and wearer-operated controls. William Lankenau, president and CEO of Siemens says, “With 74% of hearing instrument fittings being bilateral, this is a huge step forward in terms of moving the industry to the next technological level. First, there was analog, then digital, and now e2e wireless.”

Until now, there was no integration or synchronization of a user’s left and right hearing aids. E2e enables the instruments to “talk to each other,” says Thomas Powers, PhD, chief research officer for Siemens. He notes that this technology restores critical input information that the brain and auditory systems require to make good decisions, and improves the wearer’s ability to hear in difficult listening situations.

Acuris automatically adjusts itself to the listening condition of the wearer, who can also use synchronized controls to adjust the volume or program on one instrument, which changes both simultaneously. Shortening the programming time for hearing instruments should benefit approximately 80% of the hearing-impaired population, who suffer hearing loss in both ears. People with limited arm movements will also find not having to alter two separate instruments advantageous. Powers says, “Only half of [the users’] effort is required to adjust the volume or program. And since the controls may be separated on the two instruments, they can avoid confusion when making adjustments.”

The core digital technology in Acuris is also suitable for monaural amplification. Acuris can easily be adapted for binaural wireless communication with a second hearing instrument at any time in the future.

Analee Zelaya

Advanced Breast Cancer Imaging TechnologyNears Market

Cambridge Consultants is working with TeraView
to establish the best market entry strategy for its advanced breast cancer imaging technology.

The death rates from breast cancer have declined considerably between 1992 and 1996. However, the American Cancer Society still estimates that 40,410 women will die from, and 211,240 women will be diagnosed with, breast cancer in the United States this year. Additionally, more than 1.2 million new cases were diagnosed in 2004 worldwide, according to the World Health Organization.

Two Cambridge, UK–based companies, Cambridge Consultants (www.cambridgeconsultants.com) and TeraView Ltd. (www.teraview.co.uk) have joined forces with leading international surgeons to determine the best strategic market entry for an advanced imaging technology for this type of cancer.

Spun out from Toshiba Europe’s Research Laboratory, TeraView is currently performing a series of studies, imaging healthy and cancerous tissues. The firm is devoted to the exploitation of terahertz radiation or t-rays, which lies at frequencies between infrared and microwave bands and is a yet unexplored region of the electromagnetic spectrum. Capable of imaging in
3-D and supplying spectroscopic information, t-rays can differentiate between unhealthy and normal tissue.

The potential benefits of the system include improved detection rates of diseased breast tissue during surgery. The system serves as a guide for the surgeon’s knife, ensuring that too much healthy tissue is not removed. Using this technology could lead to a decrease in the need for repeat surgeries, which have been quite high. While some studies indicate that 10–20% of patients have to reenter an operating room, others statistics point to 30%, according to Gerald Dunstan, PhD, senior business consultant at Cambridge Consultants.

In addition, TeraView’s technology could also translate into substantial worldwide healthcare savings, says Dunstan. He adds, “Lessening the need for a second procedure by using [terahertz] imaging technology in the initial surgery will not only provide considerable health economic benefits, but may also provide improved recovery rates and a reduction in the trauma of treatment for the patient at an already trying time,” he says. “By engaging with surgeons, we can develop, [analyze], and recommend a number of strategies to TeraView in order to help them achieve successful market entry for this exciting technology.”

TeraView’s CEO Don Arnone notes, “Our technology development is at a critical stage, and by performing this research study with Cambridge Consultants, we hope to see TeraView technology introduced into operating theaters within the next three years.”

Analee Zelaya

Material Structures Enhanced with IonicDeposition Process

Using Ionic Fusion’s plasma deposition process, a polymer’s substrate was infused with silver oxide for added antibacterial properties.

Surface-treatment processes have made great strides in the last 20 years through ion-based deposition procedures.

The ionic plasma deposition processes combine materials on an atomic level, such as plastics with metal alloys, to create products that retain core properties but have additional qualities such as hardness, corrosion resistance, and lubricity.

Yet there may be limitations with some of these procedures. Chemical vapor deposition (CVD) can only work at extremely high temperatures. Sputtering, another well-known ionic deposition technique, may not have consistent rates of deposition.

Ionic Fusion Corp. (Longmont, CO; www.ionicfusion.com) has developed an ionic plasma deposition (IPD) process for surface treatment. The patented process is performed in a vacuum and uses low temperatures to infuse materials into most material substrates. The high-energy deposition process creates an impregnated surface that has better adhesion and better
substrate penetration.

Click to enlarge .

The process came about as a result of the company’s work with silver oxide deposition on polypropylene and spunbonded polyolefin. Once the firm began work on refining the ionic deposition process, as well as finding other metal alloys for the application, “we found remarkable characteristics as a result,” says president Joe Ryan. Tantalum, platinum, and gold are among the metals that can be processed using IPD technology.

The multiple alloy and precious metal combinations can also be stacked in multiple layers to create complete wear- and corrosion-resistant systems. The entire surface of the material substrate is evenly coated to ensure adherence to close-tolerance specifications.

Use of IPD technology in medical devices ranges from imbuing prosthetics with titanium for added strength and wear resistance to tantalum-coated stainless-steel stents for postimplant visibility. Other medical device implants have been impregnated with silver oxide, a metal alloy known for its antibacterial qualities, for use in preventing infection.

Corinne Litchfield

Copyright ©2005 Medical Product Manufacturing News

Packaging and Sterilization Wrap-Up

Originally Published MPMN March 2005

PRODUCT UPDATE

Packaging and Sterilization Wrap-Up

Susan Wallace
Ultraclean nylon bags from Degage Corp. are suitable for the critical packaging needs of medical and electronic parts.


Medical device packagers have a very important job. The best device in the world won’t save any lives until it’s in the hands of a healthcare professional. And it can’t get there safely unless it’s been properly packaged. It also may do harm unless it’s been sterilized so that it will not introduce any contaminants into the patient.

Following is a roundup of some of the latest innovations in the medical device packaging and sterilization industries.
.

Medical-Grade Nylon Packaging Available for Critical Devices

Ultraclean nylon bags and films are available for the packaging of critical medical and electronic parts. The nylon and antistatic bags from Degage Corp. (Terrell, TX) are fabricated in a vertically integrated, federally certified 209e cleanroom. Applications include medical instruments, orthopedic devices, spinal products, and neurosurgical devices, as well as ceramics, thin films, and fiber optics.

The company also manufactures thin-gauge, narrow-width, zero-tolerance tubing for the packaging of catheters and other critical medical devices. Its Clean-Tuff film is as strong in 2 mil as most 4-mil films, according to the firm. The company’s vertical integration allows it to achieve shipping times of 2 weeks.

Polymer Packaging Can Be Customized

Sud-Chemie’s polymer packaging solutions can
be molded
into any shape or size. Information can be printed on the packages in up to six colors.

A company’s polymer packaging can be molded into virtually any shape or size. The line from Sud-Chemie Performance Packaging (Belen, NM) includes both standard and customized products such as tubes with a dessiccant stopper, flip-top tubes for diagnostic test strips, dosers, and dispensers.

Another type of packaging, the 2AP dessiccant polymer, offers advanced moisture protection, enabling moisture-sensitive components such as the caps of fertility-test kits or complete IVD housings to be molded from dessiccant material. Also by using the polymers, manufacturers can streamline workflow by eliminating the need for dessiccant insertion, foil pouching, or carton packaging.

The company can print important information on the polymer packages in up to six colors. Unlike tubes that are injection molded with integral lids, Sud-Chemie’s flip-top tubes are made in two separate pieces. This allows for easy printing of the tubes prior to assembling the flip-top lids.

Manufacturers can use the polymer products in their high-speed packaging or filling lines. For instance, the company’s flip-top tubes feature a hinge design that allows the hinge to be removed and reattached without altering the functionality of the product.

Materials Supplier Offers New Packaging Capabilities

A company provides two new packaging services. Packaging size customization from Nusil Technology (Carpinteria, CA) enables customers to dispense and discard process-specific packaging. This eliminates waste. Submicron filtration helps lower costs by improving user efficiencies.

“Specialized, ready-to-use packaging has multiple benefits to multiple industries, even more so when the technology is customizable for specific applications,” says Richard Compton, the company’s cofounder and CEO. “With dedicated space and increased expertise in final processing and packaging, our in-house team of material experts can engineer custom packaging solutions based on each customer’s unique property requirements.”

Multiple Sterilization Facilities Minimize Transportation Costs

Steris Isomedix Services offers comprehensive contract sterilization services to the medical device industry.

A company offers gamma, EtO, and E-beam sterilization services. Steris Isomedix Services (Mentor, OH) has a keen understanding of supply chain management, and works with its customers to improve turnaround time, reduce inventory, and enhance time to market. It has a network of 16 North American facilities to help achieve this goal.

Gamma processing using dosimetric release protocol enables products to be shipped immediately after sterilization. This can be done in 24 to 48 hours or less, from processing to outbound shipping. This method is suitable for single-use medical supplies such as syringes, catheters, IV sets, gloves, and face masks.

Another company, Centurion Sterilization Services (Howell, MI), has three facilities to handle logistics for every region in the country. On-site full-service laboratories allow samples to be tested immediately. This eliminates extra expense or transportation delays. Only medical devices are tested, no powders, talc, or seeds.

Copyright ©2005 Medical Product Manufacturing News

New Dispensing Products Complement One-, Two-, and Three-Component Systems

Originally Published MPMN March 2005

E-News

New Dispensing Products Complement One-, Two-, and Three-Component Systems

Analee Zelaya

www.sealantequipment.com
(click to go to site).

An ISO 9001:2000– certified producer of precision-engineered metering, mixing, and dispensing systems and fluid-dispense valves offers more than two dozen new products on its updated Web site. Sealant Equipment & Engineering Inc. (Plymouth, MI) also designs and integrates systems and equipment
that supply, proportion, and control one-, two-, and three-component adhesives, sealants, lubricants, and other process materials. Users can access the company’s latest product information and technical data for many items, including supply pumps, tanks, and accessories. They can learn about the company’s product design principles and system-integration capabilities.

On-line forms are available for submitting orders for equipment, valves, and parts, and service requests.

Copyright ©2005 Medical Product Manufacturing News

Lower Resin Prices or Firm Waives Fee

Originally Published MPMN March 2005

E-News

Lower Resin Prices or Firm Waives Fee

Analee Zelaya

www.resinpros.com (click to go to site).

Resin Technology Inc. (RT; Fort Worth, TX) offers a Web-based service, called RT intelligence, that may help firms to reduce resin costs. Complementing RTi’s consultation service, RTintelligence provides news, data, charts, and trend analysis for the resin industry. However, the company does not make, sell, or broker resin. According to RTi’s president, Garland Strong, this fact gathering and reporting tool ensures that “clients don’t have to wait for a status report. They get it when they want.”

RTintelligence is used to establish specific goals and the direction of a supervised program. Each client receives an RTintelligence section, containing proprietary information in a secure setting, which allows predetermined savings goals to be tracked. A client’s resin purchasing pattern in comparison with the market, supply and demand factors, overall inventory levels, and real-time pricing benchmarks are among other available features. Also, each commodity purchased has a chart showing savings balance and average price. “By setting the goals with a client, we’ve established a benchmark that provides quantification of the customer’s program,” states Strong. “We enable the customer to actually see the progress.”

RTi reviews its site several times daily and does not charge a fee unless its client saves money on resin purchases.

Copyright ©2005 Medical Product Manufacturing News

My Favorite Bookmarks

Originally Published MPMN March 2005

E-News

My Favorite Bookmarks

Jim Brown, Medical Business Unit Manager
Colder Products Company

Jim Brown

The Engineering Toolbox (www.engineeringtoolbox.com) is a refresher course for all those terms you learned in college engineering and science classes. This site provides some interesting tidbits of information, resources, and useful tools for a range of engineering and scientific fields. It is a great reference for a broad spectrum of topics, including air psychrometrics, fluid dynamics, process control, and thermodynamics, among others. The information can be easily translated into several European languages.

The International Society of Pharmaceutical Engineering
(www.ispe.org) provides education, training, and technical publications for life science professionals. This multilingual site is a resource for regulatory and industry news, as well as reference materials. It also has a suppliers directory featuring relevant products. Discussion forums are available to the public for those interested in exploring industry topics. The site also provides a global events calendar.

How Stuff Works (www.howstuffworks.com) explains how things work, from M1 tanks to kitchen blenders to the muscles in one’s body. Included are topics such as health, science, computers, and electronics. The site is a veritable cornucopia of the functioning behind many of the things we engage in daily.

Global Spec (www.globalspec.com) is one of the most complete engineering search engines available, with links to more than 90 million Web pages. Searches can be narrowed to the most specific of details, including product specifications, patents, material properties, and standards.

Colder Products Co. (St. Paul, Minnesota; www.colder.com) provides controlled performance connections to industrial, biopharmaceutical, medical, chemical, and packaging markets.

Corinne Litchfield

Copyright ©2005 Medical Product Manufacturing News

New Process Created to Manufacture Li-ion Batteries

Originally Published MPMN March 2005

INDUSTRY NEWS

New Process Created to Manufacture Li-ion Batteries

Susan Wallace

The Massively Parallel Modular Battery architecture produces large battery modules from many small cells.

Modular Energy Devices Inc. (Westerly, RI; www.modenergy.com) has developed a system for manufacturing large Li-ion batteries from small, safe commercial Li-ion cells. The Massively Parallel Modular Battery technology combines many small cells in parallel and series to achieve a specified capacity and voltage. Then multiple modules are connected in series to obtain the desired battery pack voltage.

Embedded electronic circuitry reliably balances the capacities of the individual cells in the module. A supervisory battery-management system enables the user to properly interface the battery to the application bus. Control circuitry can disable a section of a module that contains a failed cell with only minor loss in capacity, thus providing a high level of reliability.

The process has many advantages. It compensates for cell differences; allows for individual cell failure without severe loss in system performance, which increases module reliability; and leverages the low cost of mass-produced commercial cells to provide a price reduction for large Li-ion batteries.

Copyright ©2005 Medical Product Manufacturing News

Welding Sleeve Production Services Offered

Originally Published MPMN March 2005

INDUSTRY NEWS

Welding Sleeve Production Services Offered

Susan Wallace

The production of welding sleeves is one of several contract manufacturing services now offered by Interface Associates Inc. (Laguna Niguel, CA; www.interfaceusa.com). Welding sleeves are small consumable items used to produce catheters. Their purpose is to contain small and fragile components and to provide compressive load during fuse-welding operations, such as attaching polymer balloons to catheter shafts.

The welding sleeves are precision-cut pieces of thin-wall, heat-shrink tubing, with an internal diameter closely matched to the size of the components being welded. To facilitate removal of the sleeve from the weld area, each has an axial slit that runs down the middle of the sleeve.

Producing welding sleeves manually, with the required degree of precision, is a very time-consuming and laborious task. Therefore, Interface has developed a robotic tube cutter and slitter system, Model RTC-100. The unit processes a wide range of tube sizes and produces many combinations of weld tube lengths and slit lengths. The complete operation is performed in a matter of a few seconds per sleeve. Interface Associates believes that this service, among others, provides its customers the flexibility to focus their efforts on more-important areas of operations.

And providing more contract services is one of the company’s major plans for the future. In fact, over the past year, it has seen a 156% increase in contract manufacturing. With this in mind, the company will undergo an expansion of its ISO 9001–certified facilities in April 2005.

“Every balloon is different,” says Josef Stupecky, the company’s president. “Start-up companies keep coming up with new ideas for applications and they need balloon development.”

The new 1900-sq-ft cleanroom and development lab will double existing manufacturing space. The company intends to focus its efforts on R&D for balloon manufacturing. It has added more engineers to its staff and has also started a department for materials R&D.

Copyright ©2005 Medical Product Manufacturing News

IN BRIEF

Originally Published MPMN March 2005

INDUSTRY NEWS

IN BRIEF

Susan Wallace

Adchem Corp. (Riverhead, NY; www.adchem.com), manufacturers of adhesive tape systems, has established a public warehouse in Industry, CA, to better serve western U.S. customers… Interplex Industries (Flushing, NY; www.interplex.com), a provider of molded components, assemblies, and design services, announced the establishment of Interplex Medical, a full-service contract manufacturer of medical devices… Foster Corp. (Putnam, CT; www.fostercorp.com) expanded its Las Vegas facilities to 18,500 sq ft, which will include a warehouse and logistics center to allow for manufacturing-operations growth within the biomedical firm… Unimark Plastics (Greenville, SC; www.jardenplasticssolutions.com) has changed its name to Jarden Plastics Solutions… Moll Industries Inc. (Dallas; www.mollindustries.com), a plastics injection molder and contract manufacturer of healthcare products, has purchased InteSys Technologies (Donegal, Ireland) and the assets of the firm’s divisions in Empalme, Mexico, and Costa Mesa, CA… AC Hoffman Engineering (Riverside, CA; www.achoffman.com) has merged with Hi-Tech Rubber Inc. (Anaheim, CA; www.hitechrubber.com) and plans to build a 50,000-sq-ft facility in Riverside.

Copyright ©2005 Medical Product Manufacturing News

Coating Facility Opens in China

Originally Published MPMN March 2005

INDUSTRY NEWS

Coating Facility Opens in China

Susan Wallace

Specialty Coating Systems, a business unit of Cookson Electronics (SCS; Indianapolis), has opened a full-service parylene conformal coating facility in Shanghai. The expansion into China came about with the purchase by SCS of its former service partner, Cycad Specialty Coatings Technology Company, Ltd.

The company’s Shanghai staff includes 20 experienced employees. “With the continued growth of the electronics industry in China, the new SCS operation will support the electronics, medical device, and other growing markets with custom paryl-ene coating services,” says SCS senior vice president and general manager, John Fry.

The Shanghai facility is DIN/EN/ISO 9001:2000 certified. SCS also operates coating facilities in the United Kingdom and Ireland, and has four locations in the United States.

Copyright ©2005 Medical Product Manufacturing News

Display Company Awarded ISO 13485 Certification

Originally Published MPMN March 2005

INDUSTRY NEWS

Display Company Awarded ISO 13485 Certification

Susan Wallace

Pick-and-place machines at the TFS Redmond, WA, facility can support customer needs from prototype through high-volume product builds.

Three-Five Systems Inc. (TFS; Redmond, WA; www.tfsc.com) has achieved ISO 13485:2003 certification from TÜV America Inc. for its Redmond facility. The electronic manufacturing services firm expects to expand its product offerings beyond the current level of components to finished medical devices.

Jack Saltich, the company’s president and CEO says, “Receiving this ISO certification is a great accomplishment and an important milestone for TFS and specifically for our Redmond facility. With this world-class endorsement of our high-quality standards in hand, we plan to deliver a broad range of services to a growing group of medical customers in the northwest and across the United States.”

Copyright ©2005 Medical Product Manufacturing News