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Articles from 2008 In November


The Future of Medical Device

This will allow doctors and surgeons to determine if the purchase of a new piece of equipment makes sense. Another prediction is that companies will move a âEURoeGreenâEUR business model that emphasizes reduction of medical waste. This trend will promote development of smart technology that can enable sterilization of previously single-use equipment (syringes, catheters, IV tubes). The business model could further development of biodegradable body navigation devices. In addition, the company cited other trends, as follows:

  • Movement of medical device from hospital to home.
  • Creation of smaller, handheld and protable devices.
  • Development of home diagnostics using microelectromechanical safeguards to prevent misuse and inaccurate readings.
  • Development of diagnostics that make use of very small fluid samples.
  • Increasing use of wireless technology that eliminates the need for expensive cables.

FDA Considers Gender Differences in Cardio Trials

The guidance document includes items that may affect medical device companies and others involved in the design and conduct of such studies. Speakers include Kathleen Uhl, MD, Director, Office of Women's Health, FDA, as well as various experts from industry, such as speakers from Boston Scientific, Maquet Cardiovascular, Medtronic, CardioMed Device Consultants, Thoratec (invited), and Abbott Vascular.

Ultrasound Waves Helping to Bust Blood Clots Faster

The study involved 37 patients (16 with DVT and 21 with acute in-situ arterial thrombosis) who were treated with a clot-dissolving drug and ultrasound. The technology was used to loosen proteins in the blood clots, which enabled a faster deliver of the drug to the clot. The patients with arterial thrombosis and all but six patients with DVT saw their clots completely dissolve.

Cook Medical Fares Well, Continues Double-Digit Growth

Cook Medical achieved double-digit growth and reached $1.5 billion in annual sales, and is continuing to build up its global reach with several manufacturing facility expansions and worldwide product launches. This year, the company made significant investments in its manufacturing sites in Ireland ($25 million euros), Australia, Denmark, and Shanghai, and is expanding Cook Pharmica by 100% and Cook Urological by 50%. Cook also opened new offices in Japan and acquired shonin, which enables the sale of the company's products in that country. The meeting focused on Cook's Peripheral Intervention and Aortic Intervention strategic business units (SBU). The company continues to achieve strong success by maintaining its basic core philosophy of working directly with physicians to create new products (as opposed to growth via acquisitions), said Rob Lyles, vice president and global leader of Cook's Peripheral Intervention SBU. For 2008, he projected up to 15% growth for the SBU and forecasted 20% growth for 2009. Within peripheral intervention, Cook holds the #1 and #2 place in inferior vena cava (IVC) filters (30% global market share), embolization coils, and accessory devices (29% global market share). The company's main competitors in this space are publicly-held Boston Scientific, Cordis, Abbott, Terumo, and Bard. Lyles sees a huge opportunity for Cook's convergent technologies in 2009. In September, the company completed enrollment for an international clinical trial involving its Zilver PTX, a drug-eluting peripheral vascular stent. While companies like Cordis and Abbott have expressed interest in this space, Lyles is confident that Cook will be the first to market and anticipates a product launch in Europe early next year. He called the 12 month data on the stent "awesome" and is awaiting the 18 month results. Another market opportunity for convergent technology is in the prevention of catheter-related bloodstream infections. With CMS no longer reimbursing for the condition (it is considered a "never event"), hospitals need to get serious about preventing these infections, said Lyles. He added that Cook's Spectrum PICC line (peripherally inserted central venous catheter) has the potential to be a disruptive technology in this area. Cook's hold on the endovascular aneurysm repair (EVAR) market remains strong as well. Of the $1 billion EVAR market, Cook has 35%, according to data cited by Phil Nowell, director and global leader of the company's Aortic Intervention SBU. Gore comes in second with 30% and Medtronic third with 27%. Although Cook holds the top spot in this arena, Nowell recognized several significant barriers to market--rising R&D and regulatory costs, issues related to royalties and intellectual property, and profitability challenges with the rising cost of manual production.

Waxman Replaces Dingell as Head of House Energy and Commerce

Waxman is notoriously critical of the pharmaceutical industry, and, to an only slightly lesser degree, the medical device industry. Waxman's promotion to chairman was the result of a vote during a closed meeting of the Caucus. The committee approved Waxman, 137 to 122. This change upsets the seniority system of the House.

GE's Digital IT Initiatives Launch New Age in Patient Care

It will also be present at developing hospitals in emerging countries. For example, Aspetar Hospital in Qatar is one of the first sites partnering with GE on the solution. The company's goal is to implement the program into more than 3000 doctor offices and new hospitals through 2012, giving access to a global network of healthcare groups. According to the president and CEO of GE Healthcare IT, Vishal Wanchoo, the initiative enables institutions, hospitals, and doctors to provide a model of best practice. 2. Collaboration with Intermountain Healthcare and Mayo Clinic Rochester. The goal here is to bring breakthrough medical research (that has been published) to patients sooner. Clinicians will have the most current information to help them in decision making. Based in Utah, Intermountain Healthcare is a network of 21 hospitals, clinics, and other healthcare sites. 3. IT Collaboration between GE Healthcare and its partners--Intermountain Healthcare, Montefiore Medical Center (New York), Mayo Clinic Rochester, and the University of California's San Francisco Medical Center (UCSF). These groups are collaborating to develop an open architecture healthcare IT system that will enable patients to be more active in their healthcare and seamlessly share data with clinicians. It will also help doctors share best practices. "Public expectations related to healthcare have radically changed in the last 10 years," said Michael Blum, MD, Chief Medical Information Officer at UCSF. He added that healthcare IT is at the cornerstone of meeting this expectation. Now the issue to tackle is, if the use of certain healthcare IT systems is doable, why aren't they being implemented? Jeff Immelt, chairman and CEO of GE, addressed where the company stands in these tough economic times (good--2008 could be one of GE's highest earnings year in its history) and the future of healthcare (again, improving quality at a lower cost). He named four important issues at the forefront of healthcare: - Improving access and the quality of healthcare for the uninsured - Transparency and choice--more will be known about the quality of healthcare, and early detection, along with the spread of information will be critical - Innovation--it's a growing part of gross domestic products (income) around the world, and strong pipelines are crucial to the future of healthcare - Systems efficiency and IT--it's not a technological challenge, but rather a workflow challenge. So, when considering the above factors and current economic conditions, how can a company play a strong role in the industry's future? Immelt named the ability to have staying power, a dedication to vision, good leaders within the company, instituting a marriage of good process capability with software, and collaborating with industry.

Allegations of Corruption Could Leave FDA in Turmoil

According to the letter, "misconduct reaches the highest levels of CDRH management including the Center Director and Director of the ODE." The accusations of coercion and intimidation have led Representatives John Dingell (D-MI) and Bart Stupak (D-MI) of the House Energy and Commerce Committee to begin a congressional investigation. They believe FDA experts were "ordered, intimidated, and coerced" to modify scientific reviews, conclusions, and recommendations on devices. The scientists claim they were forced to accept data that wasn't scientifically valid. Bloomberg News says that the scientists reported their concerns to von Eschenbach in May. While the agency's assistant commissioner for integrity and accountability, William McConagha, found "convincing'' evidence to support the allegations, no action has been taken, according to Dingell and Stupak. Look for more on this developing story in the Washington Wrap-Up section of MD&DI's January issue

MassMedic Showcases Newest Technology

(Cambridge), Smart Surfaces Inc. (Somerville), NMT Medical Inc. (Boston), and Confidisc Medical (Southampton). More than 400 venture capitalists and medical device business leaders attended the MassMEDIC event, which was held on Friday. Massachusetts has the second largest concentration of medical device development and manufacturing in the country. The state is home to more than 225 manufacturers, and its device exports total $2.4 billion.

IV Components

SPOTLIGHT

IV Components

Antimicrobial IV connector

Designed to be used with a catheter or IV tubing, a needleless IV connector is coated on its inner and outer surfaces with a silver antimicrobial agent. The VitalShield coating on the V-Link connector prevents contamination and growth within the device of six pathogens known to cause catheter-related bloodstream infections. Effective for up to 96 hours, the connector’s coating can kill 99.9% of these pathogens, including vancomycin-resistant Enterococcus faecalis (VRE) and methicillin-resistant Staphylococcus aureus (MRSA). Because VRE and MRSA can contaminate medical devices that deliver IV fluids and medications to patients, the connector valve is coated to specifically prevent the growth of these pathogens at the point of entry to the patient’s bloodstream. To aid proper aseptic technique at the IV insertion site and further reduce extraluminal contamination, the outside of the translucent connector has a flat, swabbable surface. In addition to the coating, the connector also features double-seal protection inside the device to prevent contamination in the fluid path.
Baxter International Inc., Deerfield, IL
www.baxter.com


Valves

A line of needleless swabbable products includes tube-end, bag-access, and stopcock valves. The tube-end valves have pockets that fit five tubing sizes: 2.0, 2.5, 2.8, 3.7, and 4 mm. Designed to attach directly to solution bags during manufacturing, bag-access valves can be a cost-effective way to convert any needle port on a bag into a needleless access site. The needleless access site can provide high flow or act as a closed system. Break-off valves are available in 6- and 6.8-mm sizes, while bag-access valves are designed to fit 6.8-mm-ID tube ports. Stopcocks in the product line also provide needleless access and closed-system functions. All of the products in the line are made from USP Class VI latex- and DEHP-free materials.
Halkey-Roberts Corp., St. Petersburg, FL
www.halkeyroberts.com


Cannula

The latest in a line of fluid management devices for arthroscopic applications, a cannula is designed to seal leaking portals during shoulder surgery. The ExtravaStopper can be easily loaded onto a 4-mm blunt switching stick so that it can be inserted into a portal and then connected to a suction device. When used to drain soft tissue, the cannula helps to reduce swelling and fluid overload to the patient. It also can prevent waste of irrigation fluid and eliminates the need for OR floor suction mats. In addition to preventing fluid loss from abandoned portals, the cannula can be used to control fluid extravasation, even in areas such as the anterior portal that are prone to swelling during surgery.
Cannuflow Inc., San Jose
www.cannuflow.com


Check valves

Offered in both low- and high-pressure versions, one-way check valves feature a sealing mechanism that is designed to prevent backflow without sacrificing forward flow performance. The check valves are available in a variety of materials, including lipid-resistant polycarbonate and ABS. They also are latex- and DEHP-free. Designed with critical infusion processes in mind, the valves are offered with tube port and luer lock configurations as well.
Filtertek Inc., Hebron, IL
www.filtertek.com


Small-bore connectors

Eliminating potential misconnections with luer fittings, a line of small-bore connectors provides leak-free connections. Featuring elastomeric seals with smooth, gap-free paths for enhanced flow characteristics, the SRC series of connectors provides confirmation of a secure connection with an audible click. Available in 9/32-, 1/8-, ¼-, and ½-in. sizes and in various configurations, the connectors allow tubing to rotate, which prevents kinking. The connectors can be used with compression therapy devices, negative-pressure wound therapy, gas applications, and blood or waste collection in addition to other IV applications.
Colder Products Co., St. Paul, MN
www.colder.com


Stopcocks

A supplier offers a line of stopcocks and IV components that is specifically designed to minimize potential infection. The supplier’s slit-septum needleless-access device eliminates the need for using a steel needle and protects against needlestick injuries. A closed, swabbable stopcock designed to reduce the risk of bloodstream infections can also lower overall costs by eliminating protective caps and add-on components. Another version of the stopcock features minimal dead space to prevent bacterial colonization. Also part of the line is the supplier’s antimicrobial stopcock, the B-Stop, which was created to reduce bacterial colonization on devices as well.
Elcam Medical Inc., Hackenack, NJ
www.elcam-medical.com

For more articles and information on IV components, go to devicelink.com/mpmn/ivfilter.


Copyright ©2008 Medical Product Manufacturing News

Making the Grade

HONOR ROLL OF PRODUCTS AND SERVICES

Making the Grade
As 2008 draws to a close, MPMN continues its tradition of highlighting some of the most memorable product and service descriptions that we ran during the past year. Determined by the most popular pages in the digital edition of MPMN, the 2008 Honor Roll of Products and Services begins below and continues throughout the issue.

Portable Coordinate-Measuring Machine

Offered in either six- or seven-axis models, an 8-ft portable coordinate-measuring machine (CMM) provides accurate measurement to within 0.0007 in. Operators guide the Quantum FaroArm’s touch-probe along the surface of the object to be measured. The CMM’s laptop computer illustrates the 3-D measurement on-screen, records all of the data, and then creates a 3-D blueprint. Features include Bluetooth cable-free operation; the company’s i-Probe, equipped with size recognition and built-in probe-temperature sensor; autosleep mode; universal quick mount; and an ergonomic handle. The machine is suited for performing inspections, tool certification, CAD-to-part analysis, and reverse engineering.
Faro Technologies Inc., Lake Mary, FL
www.faro.com


Ceramic Injection Molding

A service provider employs a five-step ceramic injection molding (CIM) process consisting of tool design and manufacturing, mixing, molding, debinding, and sintering, which yields high dimensional accuracy without the need for secondary operations. Suitable for projects where alternative fabrication methods may not be feasible or cost-effective, CIM enables the manufacture of small, intricately shaped components using such materials as aluminum oxide, zirconium oxide, and ZTA ceramic. Able to withstand high temperatures without suffering from thermal shock, these materials offer strength, toughness, wear resistance, and biocompatibility.
Ceradyne Inc., Costa Mesa, CA
www.ceradyne.com


Couplings

A company supplies a line of zero-backlash, low-wind-up, bellows-type flexible shaft couplings in stock sizes from 0.0903 to 0.5 in. Both metric and custom combinations of bores up to 1 in. can be supplied. Exhibiting no cyclic speed variations during 360° rotation, the couplings also exert low side thrust on the bearings. Set-screw or split-hub type ends are available. The standard couples will remain operational in temperatures up to 260°F, and enhanced couplings with joints welded to the hubs will operate up to 350°F. Suitable for encoders, stepper motors, and motion control feedback devices, the couplings can also be used in a variety of medical devices.
Servometer/PMG LLC, Cedar Grove, NJ
www.servometer.com


Custom Pressure-Sensitive Adhesives

To provide OEMs with adhesives that meet all of their application requirements, a provider of pressure-sensitive adhesives offers to customize its products based on three categories of adhesion: gentle hold, medium hold, and extreme durability. From these three categories, designers can specify the precise adhesion strength that works best for an application. Other customizable characteristics include quick tack, breathability, shear strength, and removability. Used to coat foams, films, and fabrics, the adhesives are suitable for medical device assembly in direct and nondirect skin-contact applications such as disposable electrode adhesive systems, surgical drape constructions, and wound-dressing adhesive systems.
MACtac, Stow, OH
www.mactac.com


Rigid Barrier Films

Optimized for medical device packaging applications, rigid barrier films typically supplied to the pharmaceutical industry offer high moisture-barrier properties and thermoforming characteristics. The Pentamed film product line—including Pentamed Aclar PA 300/12, PA 200/12, and PA 190/12—combines rigid PETG with high-barrier Aclar laminate specifically for packaging medical device components that are combined with moisture-sensitive pharmaceuticals, such as prefilled syringes. Sealable to most standard lid stocks, the films are sterilizable. Transparent, colored, and
high-gloss clear versions of the films are offered.
Klöckner Pentaplast of America Inc., Gordonsville, VA
www.kpfilms.com


LED Panel-Mount Indicators

A series of snap-in light-emitting diode (LED)–based panel-mount indicators includes high-brightness versions suitable for viewing under daylight conditions. Also included in the 559 series are 5- and 12-V indicators with integral resistors; low-current, high-efficiency indicators; and two- and three-lead bicolor indicators. The indicators are shock and vibration resistant, use 90% less energy than incandescent units, generate no heat, and typically operate for 100,000 hours. The indicators come with straight terminals for wire wrapping or lead wires for soldering, and their black UL 94V-0–rated housings enhance illumination contrast. Mounting holes range from 6.32 to 6.40 mm in diameter, and the indicators are suitable for panels 0.787 to 1.57 mm thick.
Dialight Corp., Farmingdale, NJ
www.dialight.com


Gearmotors

A manufacturer of custom-designed subfractional horsepower gearmotors offers an array of RoHS-compliant components. Among them are ac synchronous, dc, and hysteresis gearmotors. The company is vertically integrated and offers a range of in-house capabilities that include machining, molding, gear hobbing, and quick-change assembly. Many models can be used in medical equipment.
Autotrol Corp., Crystal Lake, IL
www.autotrol.com


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


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. 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.
Sebra, Tucson, AZ
www.sebra.com


Cable Strain Relief

A cable strain relief eliminates connection failure during critical medical procedures. The Wave strain relief combines the smooth, cleanable surface of a straight strain relief with the flexibility typically associated with chambered-style strain reliefs. The product can be manufactured using medical-grade silicone, PVC, polyurethane, or thermoplastic elastomer formulations.
C&M Corp., Wauregan, CT
www.cmcorporation.com


Tube-Processing Units

Tube-processing systems are used to apply high-precision heat during bonding applications for a variety of catheter systems. The bonding systems feature the Thinline thermal nozzle, which provides uniform heating characteristics. The thermal nozzle also minimizes the occurrence of hot or cold spots during the shrinking process more than flat or C nozzles, according to the manufacturer. Semiautomatic processing capabilities include multilumen welds, braided-to-nonbraided butt welds, and braided-to-braided butt welds.
Machine Solutions Inc., Flagstaff, AZ
www.machinesolutions.com


Contract Manufacturing

A contract manufacturer of medical devices based in Hong Kong serves clients in the United States, Europe, Japan, and other countries. The company operates a 30,000-m2, wholly owned facility in China that includes 1266 m2 of Class 100,000 cleanrooms. Contained in the cleanrooms are 35 injection molding machines, 4 blow molding machines, 4 extrusion machines, and a number of assembly lines. In addition, the plant features a metal-stamping shop, a sewing operation, bilingual documentation packages, and a maximum capacity of 1500 workers. The factory is certified to ISO 9001 standards.
Vincent Medical Manufacturing Co., Kowloon, Hong Kong
www.vincentmedical.com


Biomaterials Molding

A contract molder of implantable-grade biomaterials specializes in working with PEEK-Optima for medical applications designed to come in contact with blood or tissue for more than 30 days. Biocompatibility, stability, strength, and rigidity are among the material’s advantageous properties. The company can process the material using injection molding, extrusion, or compression molding techniques. It can also overmold PEEK with a sealing silicone. Class 10,000 cleanroom capabilities are available to customers in such markets as orthopedics, cardiac rhythm management, and surgical instrumentation.
Molded Rubber & Plastic Corp., Butler, WI
www.mrpcorp.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.
Omniflex LLC, Greenfield, MA
www.omniflexfilms.com


Plasma Welding System

Used for joining operations with small wires and tubes, a semiautomated plasma welding system can be used with 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.
Process Welding Systems Inc., Lavergne, TN
www.pwsweld.com


Two-Component Silicone Rubber

Composed of a base resin and a curing agent, a silicone rubber for medical applications can withstand repeated sterilization. Once cured, MasterSil 151MED is tough, flexible, and clear. The low viscosity of the elastomer compound enables it to completely fill in contours of complex product shapes. Demonstrating low rates of linear shrinkage and outgassing, the compound can be used for casting, potting, and encapsulating electronic components, and various optical systems. It provides elastic and transparent protection against adverse conditions, according to the manufacturer.
Master Bond, Hackensack, NJ
www.masterbond.com


Transparent Applicator Packaging

Thermoformed transparent packaging is designed to make selection of the correct applicator easier. Clear film on one side and durable paper labeling on the other ensures that contents are protected from contaminants. Applicators can be wrapped individually or in various amounts to enhance user-friendliness, to maintain sterility, and to reduce waste. Different types of applicators can be packaged together, and packages can be bar coded for inventory control.
Puritan Medical Products Company, LLC, Guilford, ME
www.puritanmedproducts.com


Tubing Expander

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 stored in recipes for easy editing and retrieval.
Engineering By Design, San Jose
www.ebdesign.com


Inlet Filters

A provider of EMI and RFI components has unveiled a family of IEC inlet filters engineered for use in devices and switching power supply units that require a high level of interference suppression, including medical equipment applications. Offering high asymmetrical and symmetrical attenuation performance, the FN9233 IEC inlet filter series provides a greater attenuation of 6 dB compared with the company’s FN9222 series. An optional earth line choke can reduce interference signals on the ground wire. The filters are designed for a maximum continuous operating voltage of 250 V ac and have a frequency range of dc to 400 Hz.
Schaffner EMC Inc., Edison, NJ
www.schaffnerusa.com


Bellows Couplings

Couplings employing a stainless-steel bellows exhibit very high torsional rigidity with zero backlash and flexibility across all three axes of possible shaft misalignment. The design of the compact BKC series allows high position repeatability to be maintained even under torsional loading, while only a very light restoring load is placed on shaft bearings under misalignment. To help ensure that the couplings fit mechanically in precision servo applications, the connection between the bellows and aluminum clamping hub is hidden within the fit-length of the hub itself, allowing for axial shaft engagement just like that of standard bellows but with a 15% shorter overall length.
R+W America LP, Bensenville, IL
www.rw-america.com


Optical Encoder

A company’s optical encoder features a 1.2-in. OD, an overall height just exceeding 1 in., and the stability of a bearing encoder design. Configured to potentially replace a modular encoder in an application, the QR12 offers increased versatility and an improved feedback solution, as well as performance upgrades, according to the supplier. It further claims that a flexible member enables greater tail-shaft run-out than can be tolerated by modular encoders; it also provides 30° of rotation for commutation timing. Outputs consist of a quadrature with index pulse and three-phase commutation.
Quantum Devices Inc., Barnveld, WI
www.quantumdev.com


Diaphragm Valves

Featuring high temperature and chemical resistance, a line of diaphragm valves is suitable for applications where temperatures fluctuate across a wide range, up to 80°C. The valves are constructed from virgin, unpigmented PVDF; physical properties of the material include abrasion resistance, impact strength, and a wide operating temperature range. A position indicator is incorporated, as well as a red snap-on handwheel to simplify installation. A lockable handle is optional. The valves can be pneumatically actuated for automated control.
GF Piping Systems, Tustin, CA
www.gfpiping.com


Self-Aligning Bearings

A coefficient of friction as low as 0.001 enables users of a line of bearings to employ smaller and more cost-effective motors, belts, gears, and ball screws than those used with high-friction bearings, according to the manufacturer. Offered in 16-, 20-, 25-, 30-, 40-, and 50-mm versions, the Super Ball Bushing bearings feature a self-aligning capability of up to 0.5° that automatically compensates for inaccuracies in base flatness or carriage machining. Acceleration rates up to 150 m/sec2 and steady-state travel speeds 3 m/sec can be achieved without the derating factors commonly required with linear guides. Adjustable open and closed configurations are offered. Lightweight wear-resistant polymer retainers and outer sleeves reduce inertia and noise. The company maintains that, when combined with its 60 Case shafting, the bearings can withstand three times the load of conventional bearings and can last 27 times longer.
Danaher Motion, Wood Dale, IL
www.danahermotion.com


Piezoelectric Actuators

Designed for applications requiring a small footprint, ultracompact piezoelectric actuators are suited for numerous motion control applications, including miniature valves, optical switching and scanning, and nanopositioning and nanoprobing. The flexure-guided components enable backlash- and friction-free motion. Measuring 8 × 10 × 17 mm, the FPA-80E model features a stainless-steel construction that mechanically amplifies the motion of the internal piezoelectric ceramic, yielding 80 µm of displacement range. Providing 180 µm of displacement range, a titanium version of the FPA-180E measures less than 8 × 9 × 26 mm.
Dynamic Structures and Materials LLC, Franklin, TN
www.dynamic-structures.com


Injection Molding

Conducting all of its injection molding processes under cleanroom conditions, a molder operates a Class 10,000 cleanroom equipped with 60 injection molding machines and 20 injection blow molding machines. Employing electric machinery, the company provides a clean and precise injection molding process that produces components with tight tolerances. Additional molding capabilities include insert, two-material, silicone injection, and overmolding. Accurate documentation and traceability are also provided.
Medisize, Hillegom, the Nehterlands
www.medisize.com


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


Switching Power Supply

Measuring 8 × 5 × 1.6 in., a 400-W switching power supply features universal ac input with active power factor correction and single outputs ranging from 2.5 to 58 V dc. The product also offers single-wire parallel, remote sense, remote voltage margining, current monitor, remote on-off, and power fail signals. Additional options include an end-mount fan cover, internal O-ring diodes, constant current operation for battery-charging applications, and medical safety-approved models.
Advanced Power Solutions, Pleasanton, CA
www.advpower.com


Adhesive Cartridge

Users can accurately and quickly dispense resins without making a mess by combining a dispensing gun with a company’s cartridge. The Sulzer coaxial two-component cartridge fits standard 380-ml dispensing guns and features a compact size. It can be employed with most manual, pneumatic, and battery-powered caulking tools. Accurate ratio control enables mixing of almost all chemical materials, including epoxies, polyurethanes, acrylics, polyesters, and silicones. In order to ensure adhesive compatibility, the product is offered in either polypropylene or nylon versions. A shutoff valve allows for precise on-off control of liquid flow.
Adhesive Packaging Specialties Inc., Peabody, MA
www.adhesivepackaging.com


Tube Manufacturing

Resins and tubing can be manufactured in a variety of configurations in a company’s Class 10,000 cleanrooms. The company specializes in fluoropolymer tubing for catheter applications, capillary tubing, multilumen tubing, microtubing with close tolerances, needle sheaths, and corrugated tubing for oxygen, gas, and fluid transfer. Designed to meet specific application requirements, all custom components are RoHS compliant, chemically inert, and nonleaching, and have nonstick surfaces. Drilling, flaring, flanging, slitting, scoring, hole punching, and cutting processes are available. Etching processes are also available to aid in bonding.
Parker-TexMed, div. of Parflex, Ft. Worth, TX
www.texmed.us


Titanium Machining Bar

A line of small-diameter titanium machining bar can be used for making small, intricate parts on Swiss-type automatic screw machines. Ultrabar works well with automatic bar feeders and moves efficiently through guide bushings so it can run at higher speeds and feeds than can industry-standard machining bar, according to the supplier. It is available in diameters ranging from 3 to 12 mm and in lengths up to 4.26 m. Medical grades offered include Ti 6Al-4V, Ti 6Al-4V ELI, Ti 6Al-7Nb, Ti CP grades 1–4, and Ti 15Mo. Conversion grinding operations are not necessary, owing to the tight dimensional tolerance and size consistency of the bar.
Dynamet, Washington, PA
www.cartech.com/dynamet


Micromanufacturing Services

A company produces dust-speck-sized parts and micro features on standard-size components through processes that occur in a Class 10,000 cleanroom. Precision capabilities enable the fabrication of assembled parts with micron-scale tolerances and mirror-finished optical surfaces. Micromanufacturing services include micromolding, microstamping, specialty plating, and single-point diamond turning; design services are also available. Examples of applications requiring these capabilities are minimally invasive surgical instruments, stent markers, microarrays, microfluidic chips, and neurological, cochlear, and ophthalmic implants.
MicroPep, Providence, RI
www.micropep.com


Programmable Flowmeter

Permitting accurate dosing and filling control across an array of flow-control applications, a continuous or batch-control flowmeter incorporates two 50-V-dc transistor outputs, which are freely programmable and can be configured as pure switching outputs for a valve or alarm. Additionally, the outputs can be configured proportionately to flow-rate volumes as pulse outputs with a maximum of 1250 Hz. Featuring a large graphic display, the Type 8055 flowmeter is programmed locally via three keypads or by PC.
Burkert Fluid Control Systems, Irvine, CA
www.burkert-usa.com


Check Valve

A one-way check valve provides free flow in the forward direction and minimal backflow leakage. The Supravalve is designed for medical applications where a reliable valve is needed to prevent solution backflow at a low pressure differential. Offering air purging in less than 3 seconds, minimal air entrapment, and checking and pressure integrity, the valve is compatible with standard 3.2-mm ID tubing. The silicone duckbill meets USP Class VI requirements.
Small Parts Inc., Miramar, FL
www.smallparts.com


Cyanoacrylate Adhesives

Cyanoacrylate adhesives used for bonding components such as connectors, tubes, and catheters are offered by a manufacturer of engineering sealants and adhesives. The cyanoacrylate adhesives cure in ambient temperatures and can bond to a range of flexible, rigid, porous, and nonporous materials and surfaces. Used as an alternative to solvent welding, UV-curable adhesives also provided by the manufacturer are formulated to reduce stress cracking in catheter and needle bonding.
Permabond, Somerset, NJ
www.permabond.com


Push-Pull Connectors

Engineered for quick mating and unmating, a series of push-pull aluminum-shell connectors is designed in compliance with IEC 61984. The nonsealed version of the connector is offered in a 12- or 16-mm housing with 2 to 12 contacts ranging from 1.0 to 2.5 mm in diameter. Sealed connectors feature a 10-, 12-, 16-, or 18-mm housing and have 2 to 14 contacts ranging from 0.8 to 2.5 mm in diameter. Both types of connector are available in box-mount receptacle, jam-nut receptacle, and straight plug styles. They have an operating temperature range of –40° to 100°C and provide signal and power interconnects in medical electromechanical instrumentation and process control applications.
Amphenol Industrial Operations, Sidney, NY
www.amphenol-industrial.com


Injection-Molded Components

A specialty manufacturer injection molds metal and plastic implants such as knee and acetabular cups, hip joint replacements, and dental appliances. It molds plastic parts from high-performance thermoplastic resins and also uses metal injection molding to produce highly detailed instrumentation components that can have shot weights of less than 1 g. High volumes of parts can be injection molded using multicavity tools and stringent process controls. Materials offered include PEEK, polypropylene, thermoplastic elastomers, and powder metal feedstocks of stainless steel, titanium, and cobalt chrome.
Polymer Technologies Inc., Clifton, NJ
www.polymertechnologies.com


Medical Hose

Wire-free hose for medical applications is crush, pull, and puncture resistant. The Type 252 hose is designed to immediately return to its original shape if stretched or crushed. Its smooth interior improves flow characteristics and enables quiet performance. Lightweight and flexible, the tubing is also available with injection-molded cuffs.
Hi-Tech Medical, Georgetown, MA
www.hitechmedical.net


UVA LEDs

Offering an environmentally friendly alternative to mercury-based lamps, light-emitting diodes (LEDs) are available for use in the UVA range. Suited for medical applications, the solid-state light sources have applications in spectroscopy as well as in phototherapy for skin conditions such as jaundice and psoriasis. They also have in vivo uses that were formerly not possible with mercury-based lamps, according to their manufacturer. The LEDs are offered in wafer, chip, and lamp formats.
The Fox Group Inc., Montreal, QC, Canada
www.thefoxgroupinc.com


Polyurethane Foam

Reticulated polyurethane foam suited for use in medical devices performs such tasks as filtering, absorbing, wiping, and padding in applications that include nebulizers, ventilators, oxygen concentrators, and air compressors. The foam begins as a network of open cells of polyester or polyether that are encapsulated by a thin membrane of polyurethane. The membrane is removed using heat and pressure, leaving an open-pore reticulated foam with a skeletal structure through which gas and fluids can easily pass. The pore size is precisely controlled within a range of 4–110 pores per inch. The foam can be made in various densities. In addition, it provides controlled permeability and can incorporate fungicidal or bactericidal additives or surfactant coatings.
Crest Foam Industries Inc., Moonachie, NJ
www.crestfoam.com


Converted Tubing

A company converts tubing into catheter-based delivery systems. Custom-designed delivery systems can be developed for a range of capabilities. Standard braid, variable pitch, and coil reinforcement design capabilities, as well as application-specific design services, are offered. Delivery system designs can include bonded tips, embedded marker bands, and insert molding. Tubing can be converted into delivery systems for applications such as TAA graft delivery and carotid and coronary stent delivery.
Teleflex Medical OEM, Kenosha, WI
www.teleflexmedicaloem.com


Flowmeters

Vortex-shedding flowmeters offer consistent flows of cooling water, water-based machine coolants, and water or glycol mixtures. The flowmeters are designed to measure and monitor the cooling flows in automated and robotic machining, molding, and fabrication operations. They are available in pipe sizes ranging from 0.25 to 4 in., providing 4- to 20-mA transmitter flow rates at 0.4 to 600 gal/min. CoolPoint models in 0.5- to 2-in. pipe sizes feature ±1% full-scale accuracy; ±2% full-scale accuracy is standard on all models, as is flow repeatability of ±0.25% of actual flow.
Universal Flow Monitors Inc., Hazel Park, MI
www.flowmeters.com


Lubricant Bearings

Employed in such medical applications as infusion pumps, a line of sealed lubricant bearings is available with inside diameters ranging from 1⁄8 to 1 in. Preinstalled oil-filled polymers lubricate the bearings with a film or oil. Because the oil-filled polymers contain approximately twice the amount of oil found in most greases, excess oil is available for lubrication, according to the company. As a result, the product is suitable for harsh environments or for equipment that requires frequent cleaning. Stainless- and chrome-steel construction is available for most sizes.
Sapporo Precision Bearings USA (SPB-USA), Sarasota, FL
www.spb-usa.com


Fittings

Metal-injection-molded (MIM) hose fittings made from Type 316L stainless steel are free from the design constraints that limit fabrication of such fittings by conventional metal-forming processes, according to their manufacturer. In addition, MIM technology allows stainless steel to be employed for larger parts, such as hose fittings, than could previously be injection molded from the material. The MIM fittings can have complex geometries, and their surfaces are clean and uniform enough to satisfy medical technology requirements. Their resistance to chemicals and extreme temperatures make fittings constructed from 316L alloy suitable for critical applications. The fitting line includes adapters, straight couplers, tee connectors, elbows, reduction couplers, and y connectors.
Eldon James Corp., Loveland, CO
www.eldonjames.com


Contract Laser Welding Processes

A service provider maintains that laser welding offers significant advantages over conventional gas tungsten arc and electron-beam welding methods for a number of critical applications, including medical device manufacturing. The 6 kW of peak power and tightly focused laser beam can yield aesthetic weld beads with a smaller heat-affected zone and a higher depth-to-width ratio than other welding techniques, according to the company. Process automation for diverse geometries is enhanced through the computer control of four axes of motion and the flexibility of a fiber-optically coupled welding head. Welding operations can be performed at high speeds in order to reduce lead times.
Fluid Automation Inc., Nottingham, PA
www.laser-weld.fluid-automation.com


Precision Molding Services

Touting itself as a one-stop shop for plastic parts, a company offers precision molding, in-house mold construction, insert molding, and complex assemblies. Sixteen automated molding machines ranging from 50 to 550 tn can mold materials from engineering-grade to high-performance resins in addition to filled materials and foamed parts. Difficult-to-mold materials, such as PPS, PEEK, Torlon, and Ultem, are a specialty. Moreover, the firm provides assembly, ultrasonic and spin welding, sonic stitching, pad-printing, silk-screen printing, hot-stamping, and heat-sealing services.
Diversified Plastics, Minneapolis
www.divplast.com


Medical-Grade 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


Net-Shape Electroforms

Advanced electroforming techniques are employed by a specialist company to mass-produce net-shape components from a proprietary nickel-based alloy that is comparable in mechanical and chemical properties to stainless steel. The company grows precision high-strength static and dynamic components from a solution of metal salts, forming them on a mandrel with high part-to-part consistency. Because little or no postmachining is involved, the method minimizes the labor and materials necessary to fabricate a part. Components and assemblies for medical, instrumentation, motion control, and other applications made by electrofoming are lightweight and exhibit corrosion resistance and good mechanical performance. They include miniature housings and enclosures, stress-free bellows, catheter tip–forming dies, microfluidic molds, and reflectors.
NiCoForm Inc., Rochester, NY
www.nicoform.com


Laser-Weldable Tubing

Medical tubing features an additive technology that enables it to be laser welded to transparent medical components used in applications such as intravenous therapy, hemodialysis, and catheterization. The Clearweld additive eliminates the need for solvent or adhesive bonding, which can leave behind residual bonding material. The ability to laser weld can also improve processing efficiency. Sure Bond tubing is composed of Natvar 252 trilayer coextruded tubing for the delivery of unstable medications. It has an inner layer of polyethylene to prevent absorption and a proprietary middle layer for adhesion. An outer layer of Eastman Ecdel elastomer ensures that the tubing maintains its clarity, joint stability, and weld strength. It can withstand EtO and gamma sterilization.
Natvar, a Tekni-Plex company, Clayton, NC
www.natvar.com


Rubber and Plastic Molding Capabilities

Complex medical assemblies are manufactured by a company with rubber and plastic molding capabilities. High-volume production occurs in Class 100,000 and Class 10,000 cleanrooms, and design assistance and materials engineering are available. The firm’s medical device manufacturing experience includes surgical instruments, diagnostic instruments, valves, pumps, connectors, diaphragms, seals, plunger tips, lab equipment, and disposables. Rubber-to-plastic and metal-to-plastic conversions are also offered.
Minnesota Rubber and Plastics, Minneapolis
www.mnrubber.com


Cycloolefin Polymers

Suited for parenteral packaging applications, a line of cycloolefin polymers (COPs) can be molded to obtain various sizes of prefilled syringes, pen injector cartridges, vials, and bottles. Characteristics of Zeonex COPs include low water absorption, chemical resistance, and high transparency of 92% in the visible range of 400 to 800 nm, which allows easy visual checks of drug level and quality. Tougher than cyclic olefin copolymer plastics, COPs are less prone to breakage during molding operations and are lighter and easier to handle than glass, according to the material supplier. The materials can withstand steam, EtO, and gamma sterilization.
Zeon Chemicals, Louisville, KY
www.zeonex.com


Double-Coated Adhesive Film

A copolyester film is coated with 6 ml of a skin-friendly silicone gel adhesive on one side and 2 ml of an acrylic adhesive on the other. The acrylic adhesive coating, Bioflex Rx1268S, bonds to nonwovens, films, and foams easily. When used as a double-coated tape for applications such as neonatal care, medical device attachment, wound care, and hypertrophic scar management, the film can be removed without causing skin trauma. The silicone is also water resistant.
Scapa North America, Windsor, CT
www.scapamedical.com


Laser Welding Services

Laser welding services are available from a contract manufacturer serving medical device OEMs primarily in the surgical tool and implant markets. Specializing in joining both similar and dissimilar materials, the company welds platinum, tantalum, gold, and stainless steel in a variety of sizes for a range of medical applications. Microjoining capabilities are also offered. The company is ISO 9001:2000 certified.
Pulse Systems, Concord, CA
www.pulsesystems.com


Plastic Push-Pull Connectors

Modified versions of a plastic push-pull electronic connector come with a metal housing. Tested to withstand more than 2000 mating cycles and able to meet requirements for gamma and autoclave sterilization of medical devices, Medi-Snap connectors can be configured with 2–26 contact points. They are 100% touchproof and incorporate a special push-pull locking mechanism that ensures a secure connection. The metallic connectors are available in watertight, disposable, and reusable models. They can be supplied with color coding and keying; with solder, crimp, and print terminations; and with straight or right-angle plug housings.
ODU-USA Inc., Camarillo, CA
www.odu-usa.com


Panel Fasteners

Self-clinching stainless-steel panel fasteners are designed to install permanently and flush in thin stainless-steel sheets. The spring-loaded assemblies are available in a variety of screw lengths and in thread sizes of #4-40 through #10-32 and M3 through M5. Constructed from Type 400 stainless steel in an easy-to-install captive-screw design, the Type PFC4 fasteners are suitable for use in stainless-steel sheets as hard as 88 HRB and can provide corrosion resistance similar to that of zinc-plated steel. The RoHS-compliant fasteners can attach metal sheets as thin as 0.060 in. Installation is accomplished by inserting the fastener into the properly sized punched or drilled hole and, once the mounting hole is positioned over the fastener’s shank, squeezing with a press until the shoulder of the retainer comes into contact with the sheet material.
PennEngineering, Danboro, PA
www.pemnet.com


Heat-Resistant Epoxy

Designed for bonding applications requiring temperatures up to 250°F, a high-performance epoxy adhesive is resistant to heat and chemicals. The thixotropic paste, HP 250, has a viscosity of 105,000 cP and does not run when used on vertical or inverted surfaces. Used for gap filling, the adhesive produces strong, nonshrinking bonds with metals, glass, ceramics, plastics, and composites. It has a working time of 65 minutes and a functional cure time of 24 hours at room temperature. Tensile shear strength of the adhesive as tested on steel is 3200 psi.
Devcon, Danvers, MA
www.devcon.com


Thermoset Plastic Tubing

Thermoset plastic tubing is manufactured with tighter tolerances than conventionally extruded tubing using a proprietary process, according to the manufacturer. Flexible and kink resistant, the polyimide tubing is intended for use in applications requiring maneuverability within small profiles, including neurological and fiber-optic devices, intravascular drug delivery, and balloon angioplasty. The sterilizable tubing is chemically inert, smooth, and transparent. A selection of colors is available.
MicroLumen Inc., Tampa, FL
www.microlumen.com


Custom-Molded Parts

A service provider partners with OEMs to design custom-molded products and manufacturing processes to meet specific project requirements. A specially developed automatic molding press located in the company’s Class 10,000 cleanroom is used for compression and transfer molding operations. The press is computer controlled and monitored to maintain consistent conditions in order to ensure duplication of products through multiple molding cycles.
Da/Pro Rubber Inc., Tulsa, OK
www.daprorubber.com


Braille Application System

An electronic Braille code pattern controller and an adhesive melter provide precise, high-speed dot placement for the application of Braille coding to packaging. The proprietary e.dot electric guns and ProBlue adhesive melter, in conjunction with the pattern controller, can interpret multiple languages and convert them into Braille code. In accordance with European directives requiring that pharmaceutical packaging be imprinted with Braille for the visually impaired, the system produces dots at the regulated height of 0.5 mm. Using a clear adhesive that does not interfere with packaging graphics, the system’s dot guns provide consistent and repeatable imprinting at up to 98 ft/min.
Nordson Corp., Duluth, GA
www.nordson.com


Microminiature Cable

Enhanced microminiature round cable is available for medical device applications in which size and electrical integrity are critical, such as electrophysiology probes and small-diameter flexible endoscopes. Made from high-strength toughened fluoropolymer (HSTF) and low-dielectric-constant expanded-PTFE materials, the cable maintains the desired level of performance through device flexure, abrasion occurring during routing, and tracking and sterilization. HSTF is an advanced biocompatible dielectric material that offers good electrical properties and such mechanical advantages as strong resistance to scrape abrasion and cut-through and enhanced pinhole-free performance in ultrathin profiles.
Gore, Elkton, MD
www.gore.com


Three-Layer Extrusion Head

Designed for three-layer extrusion, an extrusion head can be easily converted for single- and dual-layer applications with multiple striping options. The Tri-Die crosshead can be used to produce a range of products that include microbore medical tubing, with minimum diameters of 0.015 in. It also provides die centering from the front and uses spiral helicoids with all-melt flow channels designed to maintain balanced flow throughout operation. Helicoids with multi- and spiral-channel designs are also used.
Genca, St. Petersburg, FL
www.genca.com


Solenoid Valve

Providing a flow rate that is linearly proportional to the input current, a single-stage solenoid valve has a capacity that exceeds 200 standard liters per minute over an inlet-pressure range of 30–90 psi. Typical maximum power consumption at full flow is 11 W. Friction is eliminated due to the valve design, which incorporates a suspended armature and a sealed poppet. Low hysteresis and bubble-tight sealing enable high repeatability. Response times are approximately 20 milliseconds at 10–90% flow capacity. The valve is currently available in 5-, 12-, or 24-V dc versions for manifold mounting in liquid or gaseous systems.
South Bend Controls, South Bend, IN
www.sbcontrols.com


Conductive Thermoplastics

Blending polycarbonate and acrylonitrile butadiene styrene thermoplastic polymer alloys with conductive fillers has yielded a conductive thermoplastic that exhibits EMI shielding up to 85 dB. To obtain an evenly dispersed fiber matrix within the polymer, fibers are treated with a proprietary dispersion agent technology, resulting in uniform shielding throughout a complex part’s geometry. Unlike with many traditional shielding products, parts molded using Premier plastics do not require secondary operations. Weighing less than metal in some cases, the material can be used for handheld devices.
Chomerics, div. of Parker Hannifin Corp., Woburn, MA
www.parker.com/chomerics


Custom Adhesive Tapes

A supplier of pressure-sensitive adhesive tapes offers a range of custom foam bonding tapes suitable for sound attenuation and vibration damping in such applications as medical electronics. Viscoelastic properties of the tapes create structural-borne wave interference and refraction when placed between two sheets of material, which reduces the amount of vibration and sound. The adhesive tapes can bond to a variety of synthetic and natural materials. The supplier also provides acrylic and rubber adhesive systems as well as acrylic/rubber hybrid products.
Adchem Corp., Riverhead, NY
www.adchem.com


Oxygen Flowmeters

Available for use with oxygen, flowmeters feature a tube and a hood molded from impact-resistant, medical-grade Lexan material, and a machined brass base plated with a high-gloss, chrome-like finish. A durable stainless-steel stem valve ensures control throughout the flow range and provides positive flow shutoff. O-ring seals eliminate leakage, and meters are calibrated at 50-psig inlet pressure for accurate flow measurement under a variety of operating conditions.
Cole-Parmer, Vernon Hills, IL
www.coleparmer.com


Mezzanine Connectors

Designed for applications with high-pin-count devices on mezzanine cards or module printed circuit boards (PCBs), a company’s board-to-board connectors eliminate the need for large multilayer boards in systems, thus conserving PCB real estate. The connectors offer signal clarity with ample bandwidth for high-speed designs, simplify PCB routing, and, by employing the company’s solder-charge technology for surface-mount attachment, enable better process yields and lower applied costs compared with comparable ball-grid-array products, according to the manufacturer. Allowing for stack heights ranging from 16 to 38 mm, the HD Mezz connector features data rates as high as 12.5 Gb/sec, guide elements for gatherability in blind mating, and a high contact density.
Molex Inc., Lisle, IL
www.molex.com


UV-Curable Resin

Formulated to adhere to a variety of substrates, a UV-curable resin can be used to bond metals and plastics commonly used in medical devices. Recommended for use with stainless steel, aluminum, copper, and other materials such as glass, PVC, and nylon, the UV Cure 60-7114 clear urethane adhesive can be used for insulation in electronic assemblies. It provides moisture and chemical resistance. The resin does not require any mixing, and it cures within seconds when exposed to light from a UV Cure 100 Spot Cure system.
Epoxies Etc., Cranston, RI
www.epoxies.com


Micropump

A pump is designed to minimize the adverse load applied to motors without compromising precision. Measuring 28 × 28 × 120.5 mm, the pump’s backlash is between four and five pulses, depending on the model. Ten standardized models are available and all can be modified to meet custom applications. The plunger seal is capable of lasting 1,500,000 cycles, according to the company.
Sanwa Tsusho Co., Tokyo
www.sanwatsusho.com


Fiber Material

A company claims that its PEEK-and-carbon-fiber material is 50% lighter than aluminum, 85% lighter than steel, and can be fabricated into complex geometric shapes. For example, the Orthtek BF material is suitable for forming customized, contoured 3-D components such as the tibia guide shown here. Traditionally, a metal would be required to fabricate such a part, according to the company. The radiolucent material remains stable after hundreds of autoclave cycles and resists swelling or degrading from exposure to steam up to 135°C.
Greene, Tweed & Co., Kulpsville, PA
www.gtweed.com


PEEK Injection Molding

A full-service contract manufacturer has honed its capabilities to offer injection molding using medical-grade PEEK. The material can be difficult to mold since it requires high temperatures and specialized equipment. However, the service provider has undergone on-site training with the material manufacturer, acquired specialized equipment, and hired experienced toolmakers in order to serve this niche market. The firm operates a 50,000-sq-ft facility equipped with a Class 100,000 cleanroom.
PEDI—Plastics Engineering and Development Inc., Carlsbad, CA
www.pediplastics.com


Butt-Welding System

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.
Beahm Designs Inc., Cambell, CA
www.beahmdesigns.com


Composite Tubing

Thin-walled composite tubing is made out of continuous fiberglass filaments. Polymed tubing has a high strength-to-weight ratio, is lightweight, sterilizable, and can maintain precise tolerances. The tubing also features radiolucent and dielectric properties. Applications include endoscopic or laparoscopic procedures that require devices to be electromagnetically transparent or to provide radiolucency. Composite tubing can also be used in suction and irrigation devices, electrosurgical devices, and catheters and needle sheaths.
Polygon Co., Walkerton, IN
www.polygoncompany.com


Soft Liquid Silicone Rubber

A raw-materials manufacturer has introduced a line of low-durometer soft liquid silicone rubber (LSR) products for healthcare applications. The Silbione line of LSRs offers strong physical attributes and can be processed at Shore A hardnesses of 5, 10, and 25. With a Shore A hardness of 10, LSR 4310 provides higher elongation and 50% greater tear strength than competing products, while 25-durometer LSR 4325 features high tear strength, elongation, and resiliency, according to the supplier. These properties make the latter material suitable for stretch-and-return applications such as balloon catheters.
Bluestar Silicones, East Brunswick, NJ
www.bluestarsilicones.com


Isolation Transformers

Designed to achieve high levels of creepage and hipot up to 3750 V ac between windings, two series of isolation transformers feature a split-bobbin construction with a shroud. The 804-series units have a PC-mount package and can handle up to 36 VA, while the 805-series units can achieve up to 153 VA in a chassis-mount package. Both types are engineered for 50/60-Hz operation.
West Coast Magnetics, Stockton, CA
www.wcmagnetics.com


Medical Elastomers

Consisting of 30 different material options, a family of high-purity thermoplastic elastomers does not contain animal-derived materials, vinyl, phthalates, latex, or any additives that are not required for medical applications. The Medalist series of elastomers encompasses compounds that are designed to be versatile as well as heat and chemical resistant. Products formulated for overmolding can adhere to various substrates. The supplier of the TPEs offers product support to device designers in the form of test data, design and processing guidelines, property tables, and regulatory compliance information.
Teknor Apex Co., Pawtucket, RI
www.teknorapex.com


Medical Cable

Offering whip-free characteristics, cabling for medical wire features an open-center working channel with an inside diameter ranging from 0.007 to 0.045 in. and an outside diameter from 0.011 to 0.085 in. The Helical Hollow Strand cable can also be supplied in smaller-diameter versions with continuously extruded coatings. Employing wire drawn by the supplier, the product is manufactured according to customer specifications for tension, compression, and torque and pitch direction. The cabling is offered in single- or dual-layer versions and can be used for its electrical and mechanical properties. Applications include endovascular devices, bioconductors, and urological tools.
Fort Wayne Metals, Fort Wayne, IN
www.fwmetals.com


Insert Molding

Insert molding can replace such processes as heat-staking and solvent bonding for the manufacture of medical devices, according to a company experienced in the operation. The company’s competencies include design recommendation through mold tooling fabrication, prototyping, full-scale production medical molding, and transfer of a system to a customer’s facility upon request. In addition to offering insert molding services, the firm designs and builds integrated insert molding systems for the manufacture of medical devices. Production cells typically employ vertical molding presses with rotary tables and custom mold tooling, enabling such delicate inserts as cannulae, extrusions, and guidewires.
Aberdeen Technologies Inc., Carol Stream, IL
www.aberdeentech.com


Machined Springs

Springs machined in the form of a curved-beam helix offer the performance capabilities of that shape combined with the elastic properties of the high-strength steel, aluminum, or titanium from which they are formed. Machined springs have features and functional potential that more-traditional types of springs do not, says the manufacturer. The springs with the Heli-Cal flexure design provide precise deflection rates for compression, extension, torsion, lateral bending, and lateral translation spring functions.
Helical Products Company, Inc., Santa Maria, CA
www.heli-cal.com


Specialized Thermoplastics

A plastics provider has unveiled a portfolio of engineered polymer materials that comprise both thermoplastic elastomers and engineering thermoplastic compounds. Customizable, the Trilliant HC family is suited for use in structural, antimicrobial, surface engineering, conductive and antistatic, thermal management, precolored, and flame-retardant applications. Within this family of products, PbF specialty materials are lead-free polymer-metal composites engineered to replace lead in diagnostic equipment and CT scanners. The materials have demonstrated shielding efficacy that is equal to or better than lead, according to the supplier.
PolyOne Corp., Avon Lake, OH
www.polyone.com


Extrusion Head

A supplier of extrusion tooling offers an extrusion head capable of producing tubing finer than a strand of human hair. The MediFlow system head and in-line dies are engineered for applications with minimum tolerances of 0.002 in. and other applications requiring tiny tubing, such as minimally invasive arthroscopic surgical procedures. A patented face spiral design enables the production of close-tolerance, thin-wall, multilayer tubing. The passage flow in the body can have a split flow or the manufacturer’s single-flow feed. If a tip is damaged or bent, the head’s two adjustable hypotube tip styles can be fixed by replacing an insert, which can take only a minute, rather than an entire tip.
Guill Tool & Engineering, Warwick, RI
www.guill.com


Vacuum-Chamber Sealer

To provide precise validation, a vacuum-chamber machine has a temperature-regulated seal bar, which enables control over all parameters of the sealing process. Chamber machines typically use an impulse sealer; however, a higher degree of control and validation is required for medical device packaging. The C400 TC single-chamber machine reaches a maximum vacuum of 1 mbar for a low residual oxygen level.
Multivac Inc., Kansas City, MO
www.multivac.com


Silicone Injection Molding

A designer, developer, and manufacturer of medical device components and subassemblies offers injection molding of medical-grade silicones in a Class 100,000, ISO 13485–certified facility. The facility also houses Arburg injection molding machines, advanced material-handling equipment, and automation and cold-runner technology. Applications for its injection molding services include such thermoplastic and silicone parts as injection sites, membrane products, and gaskets. The company specializes in mid- to high-volume thermoplastic manufacturing capabilities.
APEC, a div. of Helix Medical LLC, Baldwin Park, CA
www.apecplastics.com


Roller Pinion System

Enabling engineers to incorporate accurate linear and rotary motion control functions with zero backlash and speeds up to 11 m/sec, a roller pinion system (RPS) can be used in such large medical equipment as MRI, PET, and tomography units. In applications requiring high speed, accuracy, and low noise, the RPS can be used in lieu of typical rack and pinions, linear motors, spur gears, chain and belt drives, and ball screws. The system consists of a drive pinion with bearing-supported rollers that move along the face of the rack or gear-tooth profile, producing low noise, vibration, and wear.
Nexen Group Inc., Vadnais Heights, MN
www.nexengroup.com


Connectors for ElectroSurgical Applications

Building on its established Redel brand of connectors for minimally invasive electrosurgical applications, a company has introduced the R series. Features of the product include an ergonomic push-pull latching technology, a dense field in a semirectangular format, and the same keying offered in the company’s existing connectors. The series has a set of interchangeable mixed-signal contacts. Signal contacts have four-point-indent crimp technology with a typical wire gauge of 22 to 26 AWG for the 0.7-mm crimp contact; optional reduced crimp-barrel contact is available for wires down to 32 AWG.
Lemo USA Inc., Rohnert Park, CA
www.lemo.com


Liquid Silicone Rubber

A line of liquid silicone rubbers (LSRs) has been developed for use in short-term implantable devices designed for contact with the body for up to 29 days. In addition, the materials are suitable for disposable applications in IV sets and catheters, as well as for a variety of components, including valves and O-rings. With chemistry similar to that of the supplier’s existing LSRs, the S40, S50, and S70 LSRs also incorporate most of the same polymers but optimize the chemistry from a molecular level to achieve a stronger, more-consistent material. The company says that these materials attain their ultimate physical properties upon initial cure with no drift.
Dow Corning, Midland, MI
www.dowcorning.com


Stainless-Steel Fasteners

Fasteners made of Type 18-8 and Type 316 stainless steel, along with thousands of standard inch and metric fasteners, are stocked for medical equipment manufacturers by a distributor. The company is authorized to sell Avdel, Cherry, Bollhoff, and Pop rivets; HeliCoil threaded inserts; IRW Fastex plastic fasteners; Loctite adhesives and thread lockers; and Tamperproof screws, among other branded products. Its stock also includes steel, nylon, silicon bronze, brass, and aluminum nuts, bolts, screws, and washers.
Atlantic Fasteners Company, Inc., West Springfield, MA
www.atlanticfasteners.com


Microwelding Capabilities

Specializing in laser energy and automation, a service provider has advanced its laser welding operations to address miniaturization and precision. On disparate materials, the company’s microwelding process can achieve spot welds on disparate metals smaller than 0.004 in. It enables attachment of platinum coils and electrodes, and machine components to copper, nickel, and nitinol conductors and core wires with diameters as small as 0.003 in.
Avicenna Technology Inc., Montevideo, MN
www.avicennatech.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.
NuSil Technology, Carpinteria, CA
www.nusil.com


Ultraminiature Ball Screw

A company has introduced what it claims is the world’s smallest commercially available stainless-steel ball screw. Featuring a diameter measuring only 3 mm, the product comes in a choice of 1- or 0.5-mm pitch. The supplier also offers a range of miniature stainless-steel screws with diameters ranging from that of the ultraminiature screw up to 16 mm. Offered with or without preloading, the screws are outfitted with one of four types of ball nuts. Applications include surgical robots and fluid-dispensing pumps, among others.
Steinmeyer Inc., Burlington, MA
www.steinmeyer.com


Short-Run, Low-Volume Molding

Specializing in short-run, low-volume molding, a company can provide production runs as low as 50 injection-molded parts. Horizontal injection molding machines are used, as are vertical molding machines for insert molding processes. The company’s equipment can produce parts from both high-temperature and commodity-grade plastics. In addition to molding, the company offers machining and packaging services, 3-D rapid prototypes, and thermo vacuum forming of trays.
Plastic & Metal Center Inc., Laguna Hills, CA
www.plastic-metal.com


Miniature Connectors

Microminiature circular connectors feature electrical contact terminations with insulated wires, which provide secure connections even in severe shock and vibration environments. Employing twist-pin microminiature contact technology, the connectors feature a 0.635-mm contact pitch, which enables them to be lighter and consume less space than conventional microminiature connectors, according to the manufacturer. The connectors are supplied with up to 266 contacts and are available in a variety of layout configurations and terminations. In addition, the connectors have a contact rating of 1 A and a life span of 500 mating cycles.
ITT Interconnect Solutions, Watertown, CT
www.ittcannon.com


Hysteresis Brakes

Engineered with the manufacturer’s patented Cog-Buster to automatically smooth braking torque, hysteresis brakes can be used in the winding process employed in the manufacture of stents and wire-reinforced medical tubing. Precision wire tension can easily be maintained, even on open-loop systems, according to the company. Torque is smooth—even near zero rpm—owing to the production of frictionless torque via internal magnetic fields, rather than contact between parts. Units are available with torques from 0–11 to 250 oz-in. and heat dissipation to 110 W.
Placid Industries Inc., Lake Placid, NY
www.placidindustries.com


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