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Anticounterfeiting Technology Protects Device Data

BREAKTHROUGHS

Anticounterfeiting Technology Protects Device Data
Shana Leonard
The custom silicon chip, CryptoFirewall, made by Cryptography Research Inc., works to prevent the manufacture of counterfeit devices.

Encryption techniques have safeguarded against breaches of security in everything from consumer electronics to military and government communications. Now, Cryptography Research, a security consulting and technology licensing firm, is transferring its data-protection know-how to the medical device industry in order to prevent product cloning, thus ensuring patient safety.

Medical device cloning is a troubling phenomenon often targeting single-use patient-interface devices, such as probe kits, that are used in conjunction with diagnostic equipment, explains Benjamin Jun, vice president of technology for Cryptography Research. The company’s cryptography technology addresses the dangers associated with the remanufacture and cloning of consumables. It also can prevent the modification of the equipment verifier to permit the diagnostic system to accept a counterfeit disposable product.

“We have a technology that involves putting a security chip in the consumable itself—in the patient probe kit—as well as a chip in the piece of medical diagnostic equipment,” Jun says. “These two chips talk to each other and basically authenticate the consumable and also meter its usage.”

The consequences of device counterfeiting can be significant; not only can OEMs lose revenue, but patient safety could be seriously compromised through the use of these noncertified disposable products. In the past, defense against such dishonest practices has often entailed the use of holograms. However, this approach is flawed because medical care providers must actually open the package and study the hologram in order for it to be useful, according to Jun. He adds that the falling cost of manufacturing holograms could further reduce the efficacy of this security model.

“Most people just don’t know that you can apply cryptography in a more-advanced way. Our logic isn’t just something that can speak a password; it is designed to be resistant to certain kinds of attacks that are very common,” Jun says. “There are a couple of things that are designed to make our logic difficult to reverse engineer, difficult to tamper with, and difficult to extract secrets from.”

The company currently integrates its custom technology into both the existing application-specific integrated circuit (ASIC) in the single-use component as well as into the ASIC in the corresponding diagnostic equipment. However, the firm is working with several chip manufacturers to develop an off-the-shelf solution.

Cryptography Research, San Francisco
www.cryptography.com

Copyright ©2008 Medical Product Manufacturing News

AAMI Seeks Input on Human Factors Course

It will be designed for professionals working in or for medical device manufacturers that already have a basic understanding of the framework of quality management systems, particularly design control, risk management and CAPA activities, but need more in-depth information about the concepts, science, processes, methodologies, and practical applications of human factors. AAMI is asking people in the device industry to give input on what the course content and curriculum should be. To that end, it has set up a survey. To take the survey, go here.

Port for Bypass Surgery System Approved

Engineered Surface Inhibits Biofilm Formation

BREAKTHROUGHS

Engineered Surface Inhibits Biofilm Formation
Daniel Grace
Sharklet is a specially patterned surface designed to be inhospitable to harmful bacteria.

Not all medical advances are discovered in laboratories or manufacturing facilities—at least one was discovered at sea. Sharklet Technologies has introduced a surface technology that features a pattern inspired by shark skin, and is designed to be inhospitable to bacteria.

Tapped by the U.S. Navy, Anthony Brennan, professor of engineering at the University of Florida, endeavored to shed light on microorganisms that were colonizing on the surfaces of ship hulls and causing expensive damage. During his investigation, Brennan noticed that unlike most slow-moving sea animals, some shark species remain clean of barnacles and algae. He concluded that the topography of the sharks’ skin offers resistance to parasitic organisms. Applying this mechanical principle, Brennan and his team invented a solution to help reduce the costs associated with ship fouling.

With Sharklet, Brennan’s discovery has come ashore. Sharklet is an engineered surface designed to ward off harmful microorganisms—not from ships, but from medical devices. “It’s the first nontoxic, long-lasting, and no-kill surface to control the growth of harmful microorganisms,” says Mark Spiecker, vice president of operations.

Specifically targeting the detrimental microbes is the key. Some microorganisms are harmless or are even beneficial, while others can accumulate and form biofilms that attack living cells and can cause patient infections. Since the two types live side by side, an ideal defense against destructive microbes would not impede the growth of beneficial ones, unlike many common disinfectants. Also used to combat biofilms, traditional antibiotics yield mixed results, and continual use can lead to bacterial resistance.

Sharklet represents the best solution yet available, according to the supplier.The Sharklet pattern consists of billions of tiny raised features arranged in diamond shapes. Each diamond measures 25 µm across and contains seven raised ribs of varying lengths. The surface’s tortuosity has been engineered for better control of settling microorganisms, and surface energy has been calibrated to affect the adhesion strength of microbes on the surface. Active agents can be surface-grafted to produce additional bioresponses.

In-house tests have shown that Sharklet is effective at inhibiting biofilm formation for up to 21 days. In contrast, formation on common biomaterial surfaces can occur within several hours. “It’s important to note that these results came from laboratory tests using petri dishes,” Brennan notes. “The surface is potentially capable of delaying [biofilm] formation in clinical settings indefinitely.”
Sharklet can be applied directly to the surface of catheters, patient monitors, and other medical products.

Sharklet Technologies, Alachua, FL
www.sharklet.com

Copyright ©2008 Medical Product Manufacturing News

Continuous Glucose Monitoring Proven to Work for Adult Diabetics

During the life of the 26-week study, adults (defined as those 25 and over) using continuous glucose monitors saw their blood glucose levels drop by an average of 0.5%, reports the Wall Street Journal. However, adults in the study who used traditional blood meters saw their blood glucose levels rise slightly during that time. If blood glucose levels drop 1%, that reduces the chance of future complications from diabetes by 40%. The same effect was not observed in children, because they were not as compliant about wearing their continuous monitoring devices.

Direct Metal Laser Sintering Speeds Prototype Development

ENGINEERING SOLUTIONS

Direct Metal Laser Sintering Speeds Prototype Development
DePuy Spine's use of a DMLS system reduced wait times and increased flexibility in producing surgical tool prototypes
A DMLS system allowed DePuy Spine to quickly present consulting doctors with multiple iterations of surgical tool prototypes, such as this plate bender.

As minimally invasive surgery becomes one of the fastest-growing areas in spine treatment, orthopedic surgeons are demanding increasingly sophisticated tools that must be designed for greater access and control through smaller incisions.

But getting these instruments to a surgeon who needs them—and coming up with new or customized models as techniques advance and materials evolve—can be an arduous process. DePuy Spine (Raynham, MA; www.depuyspine.com), a manufacturer of implants and instruments for spine surgery, found that prototyping, revisions, materials selection, cadaver testing, and manufacturing of surgical tools often amounted to total wait times of many months.

Hoping to reduce prototype lead times, DePuy acquired an EOSINT M 270 direct metal laser sintering (DMLS) machine, manufactured by EOS (Novi, MI; www.eos.info). Employing the machine during the past year has enabled DePuy to shrink lead times for surgical tool prototypes from several months to less than a week in some cases, according to Peter Ostiguy, DePuy staff team leader. “What has cut development time so dramatically lately is the capability of the M 270 to build multiple iterations of a tool prototype in a matter of days,” he says. The company has processed 2000 prototype parts of surgical equipment and devices on this type of machine in the first year of use alone.

The DMLS process begins with a CAD file of the product design, which defines each thin layer of a horizontal cross-sectioned model that is generated onto the work platform inside the machine. A first layer of 17-4 stainless-steel powder is deposited at a thickness of 20 µm onto the work platform and then sintered by a focused laser beam. The work platform is lowered and the process is repeated additively, layer by layer, until a 3-D metal part is produced with maximum dimensional limits of 10 × 10 × 8½ in. high. In this manner, extremely complex geometries are created automatically, directly from CAD data in just a few hours.

“In the early stages of DePuy’s product development, DMLS has helped by making new designs and functional prototypes available to their customer base of doctors much sooner,” says Andy Snow, EOS Northeast Area sales manager. “As a result, functional testing can be initiated quickly and flexibly. At the same time, these prototypes can be used to gauge the doctors’ acceptance.”

The consulting doctors can be very exacting about their requirements for tools such as blades, racks, tweezers, and calipers. “When they review the prototypes, they may ask for different handle angles or different spring strengths,” Ostiguy notes. “It’s very easy to adjust the CAD design and make another iteration. Laser sintering lets us make virtually anything they ask for.”

In addition to quicker prototype turnaround, the introduction of laser sintering into DePuy’s Development Center has also been a paradigm shift in the thought process for designing tools, according to Ostiguy. “We’re not designing for manufacturability any more, we’re designing for functionality,” he says.

Due to its success with DMLS for prototyping, DePuy recently purchased another M 270 for use with instruments for in vivo surgical applications.


Copyright ©2008 Medical Product Manufacturing News

New Ultrasound Receivers Could Boost Image Quality, Efficiency

The other, the AD9273, is the most power-efficient receiver for ultrasound systems, making them a fit for handheld systems, where efficient battery operation is so crucial. Both feature a serial port interface that allows system designers to customize the noise and power performance for any given imaging mode, probe, or power requirement. "One of the things we've been able to do is greatly reduce the number of components used in the receiver section of ultrasound systems," says Scott Pavlik, strategic marketing manager for the healthcare segment at Analog Devices. âEURoeThat means a reduction of space, cost, and power needed to process ultrasound signals without compromising imaging quality and system performance.âEUR

Tubing and Catheter Processing

FOCUS ON EQUIPMENT

Tubing and Catheter Processing

Fast Cycle Times Achieved by Catheter Manufacturing Equipment

A compact catheter manufacturing system is suitable for taper, radius, soft, closed-end, and dilator tips; flaring; neck-downs; butt, overlap, and braid-to-nonbraid welds; balloon tips and welds; marker band embedding and placement; and single- and multilumen applications. The semiautomated Saffire 4200 builds on the manufacturer’s Pirf technology while offering a variety of expanded features. Consisting of a generator and one of two forming platforms, depending on insertion force requirements, the system features proprietary inductive heating technology that allows for higher temperatures than previous equipment while extending the life of the heater. An improved cooling manifold reduces cycle times. Platforms can be used with various tipping, welding, and forming molds for a range of applications.
Sebra, Tucson, AZ
www.sebra.com


Automated Butt-Welding System Offers Repeatability

By providing automation of axial force, an axial compression bonder offers reliable and repeatable joint creation, which has been an engineering obstacle in the past owing to the inherently weak nature of butt welds, according to the system’s manufacturer. In addition, the bonder provides a hands-free means of butt-welding two faces of polymer tubing, including single- to multilumen braided shafts. The system can perform each butt weld within 5 to 30 seconds, depending on the size and material of the tubes, and produces weld areas as narrow as 1 mm. It features such parameter controls as grip pressure, heat duration, cool duration, and axial force. An optional vision system that employs an LCD display and video camera with variable magnification is available to assist with precise component positioning.
Beahm Designs Inc., Campbell, CA
www.beahmdesigns.com


Expander Processes Heat-Shrinkable, Small-Diameter Tubing

A company’s tubing expander processes heat-shrinkable tubing with ODs ranging from 0.01 to 0.38 in. by heating products while pressurizing the inside in order to induce expansion. Expanded tubing is then level-wound onto an output spool on a continuous basis. The tubing expander features heating and cooling systems, which the company says allow the machine to run at higher speeds while producing less waste and fewer tubing bursts. In addition, tubing can be sealed off by a pressure pinch for burst repair. Parameters such as pressure, temperature, speed, and pull ratios can be programmed via a touch screen and stored in recipes for easy editing and retrieval.
Engineering By Design, San Jose, CA
www.ebdesign.com


Plasma Welding System Suited for Use with Small Wires and Tubes

Designed for joining operations involving small wires and tubes, a semiautomated plasma welding system is suited for use with such medical products as guidewires, angioplasty wires, vascular closure wires, biopsy tubes, and aspiration tubes. A programmable logic controller and a DT-100 programmable weld controller regulate weld parameters, including time, pulsing, slopes, and preflow and postflow gases. Part clamping, movement to weld position, and retraction to unload the part are pneumatically controlled. To ensure proper weld alignment, x-y-z torch slides can adjust the position of the plasma welding torch. Furthermore, wire or tube that sticks out from the tooling can be set with micrometer adjustment; tooling is also available to accommodate different tube and wire sizes.
Process Welding Systems Inc., Lavergne, TN
www.pwsweld.com


Copyright ©2008 Medical Product Manufacturing News

Packaging & Sterilization

OUTSOURCING OUTLOOK

Packaging & Sterilization
Jody Birks, RA/QA manager, Eagle Medical Packaging and Sterilization Inc., Paso Robles, CA.

Medical device manufacturers have many choices available to them when selecting a sterilization method. Key considerations include device material compatibility (functional and cosmetic), packaging type, validation and production costs, and turnaround time. It is important to realize that all sterilization technologies have limitations, and to know the specific drawbacks of each one, some of which follow below. There is no perfect solution, and no “one size fits all.”

The majority of devices are sterilized by one of three general methods: heat/steam, irradiation, or by application of a chemical sterilant. Steam exposes devices to high heat and humidity, which can compromise the product in some cases. Gamma irradiation can change the molecular structure of plastics and silicones in an undesirable manner. And E-beam sterilization has product-penetration limitations.

Chemical sterilants work by inactivating organisms; ethylene oxide (EtO), for example, sterilizes by alkylation. The sterilant substitutes for hydrogen atoms on molecules needed to sustain life, and, by attaching to these molecules, EtO stops their normal life-supporting functions. However, EtO has residual toxicity issues, is costly and complicated to validate, and requires a long cycle time.

Whatever the method, a good contract sterilization firm should be willing to supply a wealth of information about a given technology in order to help the OEM find the most compatible solution for a specific application.

High-Barrier Packaging Protects Devices Sensitive to UV Light

A firm’s high-barrier aluminum foil laminate pouches are used to package and protect diagnostic tests, microtiter plates, and other medical devices that are sensitive to UV light, moisture, and oxygen permeation. Standard packaging types include films in roll-and-bag format and zipper bags for microplates. Offering packaging and converting services, the company is ISO 9001:2000 registered, and also offers die-cutting, printing, narrow web slitting, and subassembly capabilities.
G & L Precision Die Cutting, San Jose, CA
www.glprecision.com

Firm Specializes in Custom Thermoform Packaging

Specializing in custom thermoform packaging for medical devices, a company operates a 200,000-sq-ft facility that includes Class 10,000 and Class 100,000 cleanrooms. The firm can thermoform a variety of standard materials, including PET, PVC, HIPS, and HDPE, as well as specialty multilayered materials that provide increased oxygen and moisture barriers in order to meet FDA packaging requirements. In-house testing equipment ensures consistency, cleanliness, accuracy, and functionality.
OraTech, Salt Lake City, UT
www.oratech.com

Packaging Heads Up Company’s Turnkey Offerings

A company provides packaging and sterilization of orthopedic, spinal, cardiovascular, and neurological devices. Certified to ISO 11607 standards for packaging of terminally sterilized medical devices, the firm also offers package integrity testing per ASTM 1929 guidelines, and package strength testing according to ASTM F88-06 seal/peeling testing guidelines. The company assists customers with various sterilization services, including designing protocols, performing sterility validations, conducting routine processing, and overseeing quarterly dose audits. A recent facility upgrade doubled the size of the company’s manufacturing headquarters to 54,000 sq ft. The plant contains three Class 10,000 cleanrooms.
Quality Tech Services Inc., Bloomington, MN
www.qtspackage.com

Organization Provides Contract Packaging Services in Class 100,000 Cleanroom

An organization specializes in packaging FDA-registered medical products in a Class 100,000 cleanroom. Available packaging types include instant hot packs, instant cold packs, and instant reusable cold packs; in addition, a durable tape underwrap can be incorporated specifically for sensitive medical devices. Contract manufacturing and assembly of Class II medical devices are also available. A primary mission of the organization is to provide employment opportunities to disabled citizens.
Employ+Ability, Braintree, MA
www.workisgood.org

Hydrogen Peroxide Sterilization Offers Fast Cycle Times

Benefits of gas plasma (vaporized hydrogen peroxide) sterilization are fast cycle times, the absence of toxic residuals, and a low-moisture environment not exceeding 50ºC, according to the only provider of this sterilization method on the West Coast. The company’s service boasts material compatibility with 95% of metal and nonmetal devices, including fiber-optic, electronic, and microsurgical products, as well as medical devices sensitive to heat and moisture. Operating a facility certified to ISO 13485:2001 standards, the firm also provides additional services such as packaging design, packaging seal-strength testing, packaging integrity testing, cleanroom assembly, ultrasonic cleaning, irradiation, and bar coding.
Eagle Medical Packaging and Sterilization Inc., Paso Robles, CA
www.eaglemed.com


Copyright ©2008 Medical Product Manufacturing News

Wound-Care Technologies

SPOTLIGHT

Wound-Care Technologies

Silicones

Designed to protect wounds and promote healing, a line of silicones is suited for use in wound-care applications. In addition to its biocompatibility, purity, and performance characteristics, Silpuran liquid silicone rubber features good vapor permeability that yields breathable medical dressings. Silicone-based dressings can be removed without inflicting trauma on the wound and can prevent wounds from reopening, according to the silicone supplier. By preserving the skin’s elasticity and preventing tissue from drying out, the material can also enable beneficial treatment of scars. The silicone is compliant with USP Class VI standards and select ISO 10993 tests.
Wacker Chemical Corp., Adrian, MI
www.wacker.com


Low-melt-point polyurethane films

Designed to expedite the heat-lamination process by requiring less heat for joining materials, a line of low-melt-point polyurethane films can be bonded to other plastic substrates, wound contact layers, and hydrophilic foams. Suited for medical dressings, the most recent addition to the manufacturer’s Inspire portfolio of products features a smooth bacterial-barrier outer surface and does not require an additional pressure-sensitive adhesive for the bonding layer. This latter characteristic of the film can enable better breathability and may increase the lifetime of the dressing, according to the company.
Exopack Advanced Coatings, Wrexham, UK
www.exopackadvancedcoatings.com


Infection-control films

A supplier of medical films has incorporated a partner’s infection-control technology into its films to combat the bacterial growth of methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococci, and various other infectious microorganisms. Applications include IV site dressings, transdermal patches, and thin-film dressings. Natural Elements infection-control technology has been integrated into the supplier’s Vacuflex and Transport families of waterproof-breathable and barrier medical films, which are available in thicknesses ranging from 5 to 50 µm. Because it can regulate the activation and strength of the infection-control agent, the company maintains that cytotoxicity concerns are eliminated.
Omniflex LLC, Greenfield, MA
www.omniflexfilms.com


Hydrophilic foams

Provided with thicknesses ranging from 0.04 to 1.0 in., a selection of medical-grade hydrophilic foams is available for use in disposable wound-care products. The open-celled foams absorb and retain exudates, and are compatible with such active ingredients as pharmaceuticals, antimicrobials, hemostatic compounds, and odor-control agents. Depending on a customer’s application, impregnations can either stay in the foam or be released in the presence of moisture. Absorbency, density, cell size, degree of softness, and surface characteristics can be customized.
Rynel Inc., Wicasset, me
www.rynel.com


Tacky silicone gel

A clear silicone tacky gel is designed for casting and potting, and can be cured onto various substrates, including fabric backings. Suitable for use in transdermal, wound-care, and hypertropic and keloid scar-management applications, among others, the MED-6345 gel features temporary adhesive qualities that allow the product to gently adhere to the skin while enabling easy removal and reapplication. Its polysiloxane structure is permeable to gases, resulting in a soft, breathable, water-resistant cover. Materials are manufactured in ISO-certified facilities, and many of the silicone biomaterials are tested to all USP Class VI requirements.
NuSil Technology, Carpinteria, CA
www.nusil.com


Copyright ©2008 Medical Product Manufacturing News