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Report Says Electronics Are Key to Future Drug-Delivery Devices

A new report, based on input from industry experts, says that there is growing market potential for the integration of electronic functionality into drug-delivery devices. Published by Cambridge Consultants (Cambridge, UK), "2020: A New Drug Delivery Landscape" summarizes the proceedings of two workshops hosted by Cambridge Consultants and attended by experts from the drug-delivery and pharmaceutical industries, including representatives from giants such as Astra Zeneca, Novartis, and GSK as well as start-ups. Held in Boston and Leicestershire, UK, in April 2009, the workshops focused on the key issues and opportunities that will influence the drug-delivery industry over the next 10 years. According to the report, devices with advanced electronic functionality are expected to take an increasing share of the systemic delivery market in the next few years, constituting a major growth opportunity for innovative companies. A perspective prevalent in the United States is that complex electronics technologies are maturing, enabling regulators and pharmaceuticals companies to gain the confidence needed for broad acceptance. While upbeat on the prospects of incorporating new technologies into drug-delivery devices, delegates from Europe pointed to increasing regulation surrounding waste and environmental impact. Issues such as battery and microelectronics disposal will require specific measures if they are not to impede the proliferation of such advanced devices. Andrew Diston, Global Medtech Practice Leader at Cambridge Consultants, remarks, "The world of pharmaceutical delivery is poised to realize many of the benefits of technological advances from other industries, where standards are reaching towards the requirements for medical applications. These workshops identified much optimism in the market. Reliable microelectronics platforms may provide significant additional functionality and connectivity for new delivery devices, providing great opportunities for innovative pharma companies and new start-ups alike to play a part in this healthcare revolution." While delegates acknowledged that there is a severe short-term shortage of investment capital to fund such innovation, the long-term outlook is more hopeful. "Governments in Europe and the U.S. are carefully considering the impact of an aging population and increasing chronic disease on the future cost of healthcare," Diston says. "The result of this will be a renewed effort to make healthcare expenditure go further, which will mean a renewed focus on efficient systems that deliver better patient outcomes. The future leaders in this new market may be those companies that capitalize on the opportunity to significantly improve patient outcomes through enhanced device functionality."

Plastics Providers Respond to Demand for Supply Continuity and Sustainability

PRODUCT UPDATE

Plastics Providers Respond to Demand for Supply Continuity and Sustainability
New polymers feed a market hungry for enhanced performance characteristics, aesthetics, and sustainable resources
Stephanie Steward

PolyOne has launched biopolymer compounds for use in such applications as tubing, IV pumps, respiratory equipment, and medical device electronics housings.
Many plastics suppliers timed the release of new materials this year with NPE2009, the exposition produced by SPI, the Plastics Industry Trade Association (Washington, DC; www.plasticsindustry.org). And the buzzword of this year’s show was bioplastics, which reflects the increase in interest in materials that are derived from renewable resources. Additionally, new polymer materials reflect efforts of suppliers to meet customer demand for enhanced performance characteristics for applications ranging from valves to medical device packaging. Without sacrificing performance, OEMs are also seeking to enhance their products with coloring options, a trend that has as much to do with appealing to the consumers as it does with branding. The question for OEMs now is not what materials are available, but, as Larry Johnson, global marketing director, healthcare, for PolyOne (Cleveland; www.polyone.com) put it: What’s your objective?

The Biopolymer Bandwagon

The increased industry interest in bioplastics was reflected at NPE2009 by the nearly 40 exhibitors offering bioplastics-related technology, including resins, specially designed additives, machinery, and processed goods, as well as the more than 50 conference presentations on the subject, according to the show’s blog reports. Interest in biopolymers has been growing among medical device manufacturers, especially in the past year, along with the green manufacturing trend and the desire to be more environmentally conscious, according to Johnson. “But existing products haven’t had the right performance characteristics until now,” he says.

PolyOne, an exhibitor at NPE, launched six new products at the show, two of which were biopolymers. Offering high impact performance, Resound biopolymer compounds are one of PolyOne’s product lines engineered to provide a functional biopolymer for the medical device market. Designed for durability, the compounds are suited for use in manufacturing medical device housings, most of which typically contain electronic components, according to Johnson. “These biopolymers have a higher heat resistance than past materials,” he explains. Resound compounds combine engineering thermoplastics with such biobased polymers as variations of polyhydroxybutyrate and biopolyesters. These compounds have the necessary heat resistance and processing capabilities to be used to make parts for IV pumps as well as respiratory, anesthesiology, and patient-monitoring equipment.

“Many manufacturers want to be able to say they have biopolymer content, but they need to maintain the same physical properties of the current materials they’re using in their applications,” Johnson says. In response to that need, PolyOne also created its Versaflex Bio thermoplastic elastomers (TPEs), which have 70% renewable content with no loss of such performance characteristics as heat resistance or clarity, according to the company. With enhanced performance and processing characteristics, TPEs are now being regarded by OEMs as functional materials in such applications as molded-in seals, gaskets, and living hinges, Johnson notes.

In Living Color

Biopolymers not only offer the sustainability that some medical device OEMs are seeking, some also offer the benefit of being compatible with material colorants. “There is an increased interest in masterbatches and UV additives for coloring products, and biopolymers are a good base polymer for those applications,” Johnson says.

While some niches, such as the catheter market, use colors for identification, there is also an emerging trend toward using color for company and product branding, as well as to appeal to end-users. To meet these demands, some suppliers, such as PolyOne, are making a point of incorporating colorability into the performance characteristics of its products. As part of its Geon product line, for example, PolyOne recently introduced new grades of metallic, precolored Geon vinyl compounds that are offered to help product designers improve aesthetics while eliminating environmentally unfriendly and costly painting options.

Similarly, The Dow Chemical Co. (Midland, MI; www.dow.com) offers custom and stock precolored options for its Calibre polycarbonate (PC) and Emerge PC/ABS blends, as well as other highly colorable polyethylene products. Its Health+ polymers, which were launched at NPE2009, also have the potential to accept some form of colorant. The increased interest in coloring options can be partly attributed to the increase in home healthcare and the changing way in which people interact with medical devices, suggests Jason Eckel, market development manager, rigid packaging and health and hygiene, for the North American basic plastics division of Dow. “Home healthcare is becoming more like other consumer markets,” he says. “People didn’t used to want others to know they had a glucose monitor, for example. But now they want them in a color they choose, like iPods or laptops,” he adds.

Fluid Delivery

While some market niches, such as glucose monitors, are pursuing enhanced aesthetics in materials, fluid-delivery applications continue to require improved functionality and antimicrobial features. “The driver behind the need for chemical resistance and antimicrobial features is the increased presence of infection in healthcare environments and Medicare and Medicaid’s decision last year to no longer provide reimbursement for hospital-acquired infections,” says Jill Martin, senior development specialist, North American basic plastics, Dow Chemical.

Most of the polymers in the Health+ platform are high-density polyethylenes that offer chemical resistance and can be blended with other polymers to enhance such performance characteristics, according to Martin. Not only do the polymers have the potential to accept colorants, but they also feature different melt index and density ranges for manufacturing such medical products as fluid-delivery kits, syringes, and breathing treatment and tubing systems. They also could potentially be used in medical device packaging.

Plastomer Technologies offers a high-purity PTFE material that can be used in valves, diaphragms, and pumps.
Plastomer Technologies (Houston; www.plastomertech.com) also has recognized the continuing demand for polymers that can be used in such fluid-delivery applications as valves, diaphragms, and pumps. These products require a high level of purity and fluid-transfer cleanliness, explains Roxanne Dittrich, business manager for Plastomer Technologies.

The company recently introduced a high-purity polytetrafluoroethylene (PTFE) material, Texolon Style 8764HP, that offers chemical inertness and antistick properties. It is processed in a controlled environment to help eliminate contamination that is often found in PTFE moldings, Dittrich says. Offered only in pure, virgin PTFE form, the material provides wear and corrosion resistance necessary for critical medical and electronic applications.

“Plastomer realized there was a need for PTFE that would be processed and packaged for high-purity applications, such as those required in medical, electronics, or filtration, and developed this product to fill this requirement,” she says.

Notification of Change

Following such trends as colorability and sustainability can be a good business decision for both suppliers of materials and the OEMs who use them, but the slightest change to a material or component of a device can result in costly redesigns or testing for an OEM. Because of the potential redesign consequences, some suppliers are now increasing their efforts to keep OEMs informed of any changes or potential changes in formulation or availability of their materials.

“What we think is a minor change may be huge to a medical device OEM,” Eckel says. “They need the distinction between the original and new versions of a material to be known and [they need to understand] the impacts of those changes.”

In response to this need, Dow has launched a Notification of Change initiative for its products included in the Health+ polymer platform. The service is designed to help alleviate the stress on OEMs that are concerned with supply continuity, especially because raw material changes require recertification from FDA, says Eckel. “The Notification of Change guarantees a minimum notification regarding the discontinuation of a product or product composition changes.”.

For more information and articles on plastics and elastomers, go to www.devicelink.com/mpmn/materials

Copyright ©2009 Medical Product Manufacturing News

Testing Services Provider Has Roots in Product Design

MD&M MIDWEST 2009: FIRST-TIME EXHIBITORS

Testing Services Provider Has Roots in Product Design
Stephanie Steward

Specializing in orthopedics, Empirical Testing Corp. provides mechanical and wear testing services for such applications as knee and hip replacement devices.

Prior to becoming president and CEO of Empirical Testing Corp. (ETC; Colorado Springs, CO), Dawn Lissy spent years working on spinal implant product design and development teams as an engineer. During that time, she repeatedly faced the problem of working with testing houses that demonstrated limited knowledge of the medical device industry, developed inadequate test methods for her products, and delivered unreliable results. After much frustration, Lissy finally decided she could provide a better standard of testing services for product engineers like herself.


Since Lissy launched the company 10 years ago, ETC has provided orthopedic medical device testing services for such applications as knee and hip replacement devices based on ASTM and ISO standards or customer-driven protocols. And, as orthopedics manufacturing has expanded, so have the company’s services. “Ten years ago, polyaxial screw systems were the ‘new technology;’ now, there are four different categories of nonfusion devices for spinal indications,” Lissy says. To keep up with industry changes, as well as such new and emerging technologies as small joints and dental implants, the company is involved with several ASTM subcommittees and round-robin studies.

The company prides itself on working closely with its customers to provide services that meet all of their testing needs. Because of that practice, the company listened when its customers expressed a desire for a one-stop shop for hip and knee mechanical and wear testing. It has brought a hip and knee wear testing consultant on board to meet that demand. “In order to bring the same high level of quality to each project, it made sense to hire the consultant with years of experience in testing in both the hip and knee markets,” Lissy says.

In addition to broadening its expertise, the company has grown in terms of physical space and equipment. Working out of a 10,000-sq-ft facility, the company has added eight test frames in the past year to its existing 26 frames and two wear simulators. “By adding the additional frames, [we were able to] decrease queue time for our customers from approximately six to eight weeks after receiving their components to one to three weeks, depending on the time of year and scope of test job,” Lissy says. “The two six-station wear testers allowed for ETC to be able to support the extensive testing required for nonfusion spinal devices.”

Not limited to wear testing, the company offers load-included subsidence testing, as well as analysis of screw and rod interconnection properties. The company also provides a range of testing services for a variety of discs, stabilization devices, shoulder and elbow replacement devices, and lumbar and cervical fusion and occipital cervical systems.

While the equipment is essential to its mission, the company believes that its method of partnering with customers has also helped to improve its services. The company initiates communication with its customers at least once a week and occasionally engages in site visits. These visits present opportunities for the company to suggest enhancements to customers’ processes in order to help them meet production and regulatory requirements. Additionally, the company provides what it calls “best of” technical reports that can be used as guides during R&D and when assembling regulatory submissions.

Empirical Testing Corp.
www.empiricaltesting.com
Booth #4128


Copyright ©2009 Medical Product Manufacturing News

Charge-Neutral Compound Optimizes Dosage for Asthma Inhaler

ENGINEERING SOLUTIONS

Charge-Neutral Compound Optimizes Dosage for Asthma Inhaler
Use of an antistatic polymer prevented static buildup from compromising patient care in a valve holding chamber

67718.tif
The use of an antistatic compound with high optical clarity helped to improve the design of an asthma product.
Often employed by such demographics as children and the elderly, valve holding chambers (VHCs) are designed for asthma patients who have difficultly coordinating their inspiration with the activation of an aerosol inhaler. But while VHCs assist patients in properly administering medication, many of them are vulnerable to static buildup, which can hinder administration of consistent dosages. And, in the case of drug-delivery devices, ensuring that patients receive consistent dosages is essential to successful treatment.

Desiring to improve drug delivery and patient care for its OptiChamber Advantage II VHC, Philips Respironics (Murrysville, PA; www.respironics.com) sought to overcome this common design flaw. To do so, Philips partnered with custom compounder RTP Co. (Winona, MN; www.rtpcompany.com), with whom it had a long-standing relationship, to develop a charge-neutral material for the product.

Use of a charge-neutral material would eliminate the product’s primary drawback: VHC housings can attract and hold residual amounts of medication due to static buildup. Because of this problem, the products also require the added inconvenience of washing and air-drying to reduce static prior to inhaler use. Moreover, the need for static-free VHCs has increased recently in response to a new class of inhalers on the market that have replaced chlorofluorocarbon (CFC) propellants with hydrofluoroalkane (HFA) ones.

“The use of a charge-neutral material in our VHC was vital to meeting the needs of healthcare providers and their patients through improved design,” says Robert Koshinskie Sr., product manager for Philips Respironics.

In order to achieve the neutral charge for the chamber, Respironics worked closely with RTP engineers to find a conductive material that would eliminate static buildup. Furthermore, it was essential to maintain physical properties, most notably the high optical clarity desired for a nearly water-clear appearance to aid in the product’s operation.

Research conducted by RTP in partnership with Philips Respironics showed that the substitution of a PermaStat 600-series all-polymeric, permanently antistatic ABS compound for the original material would greatly improve drug-delivery consistency. Such consistency results in better treatment for patients using the OptiChamber Advantage.

“ABS materials in general have good impact properties, which make them ideal for use on handheld items like inhalers,” notes Josh Blackmore, global healthcare manager, RTP. “Additionally, RTP Co.’s PermaStat ABS family of materials has been proven to pass biocompatibility, leachability, and drug-interaction testing, which makes them suitable for use in the drug flow path of inhalers.” The material’s low resistivity also provided Respironics engineers with just the right amount of static dissipation to optimize the chamber’s functionality.

“By addressing static attraction, the product offers consistent and reliable delivery on first use out of package, whether washed or unwashed,” states Koshinskie. “This material gave us a great balance of low resistivity, high clarity, and strength, which was key to the success of our product.”.

For more engineering solution stories, go to devicelink.com/mpmn/engineering

Copyright ©2009 Medical Product Manufacturing News

Use of Organic Molecules Between Silicon and Metal Promises to Miniaturize Switches

switching-molecules

The flip-chip lamination method creates an ultrasmooth gold surface, which allows organic molecules to form a thin, even layer between gold and silicon. Image courtesy of Mariona Coll Bau, NIST

It has long been known that organic switching molecules would be cheap to produce in large numbers. They would also perform faster than larger silicon-based switches and use much less energy. However, while progress has been made toward creating such molecules, they tend to be damaged irreparably when subjected to a particularly stressful step in the chip-building process: attaching them to electrical contacts. Now, a research team from the National Institute of Standards and Technology (NIST; Gaithersburg, MD) and the University of Maryland (College Park, MD) has found a simple method for sandwiching organic molecules between silicon and metal. This crucial step toward miniaturizing electronic components could lead to applications beyond chip design, such as novel biosensor designs. Metal forms many of the contacts in chip circuits, but getting metal onto a chip involves heating it until it evaporates and then allowing it to condense on the silicon. "Imagine what hot steam would do to your arm," says Mariona Coll Bau, a materials scientist at NIST. "Evaporated metal is much hotter, and organic switching molecules are very fragile--they can't stand the heat." To avoid overheating the molecules, Coll Bau's team has discovered a way to cover a surface with a nonstick material before condensing gold on top of it, allowing the metal to cool to an ultrasmooth surface. They then laminate the gold surface with the plastic used in overhead transparencies. The laminated gold is as easy to remove from the nonstick layer as peeling off plastic wrap. Adding the organic molecules is then comparatively simple: They are attached to the gold, after which the whole assembly is flipped onto a silicon base, with the organic molecules sandwiched neatly inside. Although scientists have attempted to make sandwiches of this sort before, Coll Bau says that their first-ever use of an imprinting machine finally made it possible to assemble the ingredients effectively. "The machine allows us to press the three layers together so the organic molecules contact both the silicon and gold, but without smashing or otherwise degrading them," she explains. This process of "flip-chip lamination" could spur the development of new biosensors, which depend on the interaction between organic materials and electronics. "The technique may prove useful as a fabrication paradigm," Coll Bau says. "It's hard to make small things, and this might be an easier way to make them."

Automation and Robotics

FOCUS ON EQUIPMENT

Automation and Robotics
Gantry Robots Do Not Require Conveyors, Free Up Floor Space

Combining a ceiling-mounted flexible SCARA robot with a long-stroke Cartesian robot, a series of compact gantry robots offers high efficiency.
The XR-series four-axis robots use up to 40% less factory floor space than conventional SCARA robots, according to the supplier. Moreover, they can function in many applications without the need for a conveyor. For such operations as assembly, material handling, and parts feeding, this capability can result in reduced equipment costs. The high-speed robots have a reach of 200 to 300 mm and an x-axis stroke ranging from 850 to 1660 mm. With a payload capacity of 3 kg, the robots feature a cycle time of 0.53 seconds and repeatability of ±0.015 mm. Programming software, controllers, and teaching pendants are also offered with the robots, including 3-D simulation software that allows for off-line programming and remote monitoring of robot operations.
Denso Robotic
Long Beach, CA
www.densorobotics.com


Automated System Enables In-House Electropolishing

A compact system is designed to enable manufacturers of metallic medical devices and components to electropolish their products in-house in order to maintain control over production quality. In addition to electropolishing, the system can sharpen, deburr, and passivate such parts as surgical drills, stents, and screens. The system can also help manufacturers reduce reliance on outside vendors, thereby decreasing chances of quality inconsistencies and delayed deliveries, according to the supplier. Featuring a secure, menu-driven PLC, the system offers part and lot traceability and includes more than 10 preprogrammed recipes for treatment cycles. Capable of handling parts measuring up to 8 × 8 × 4 in., the enclosed system can process up to 30 loads per hour, depending on parts and materials.
MetFab Technologies Inc.
Warwick, RI
www.metfabtech.com


Automated Assembly System Built for Cleanroom Use

Capable of integrating up to 26 processes, a standardized linear assembly machine is built for use in cleanroom environments. The QuickLink linear indexing system features several modules for incorporating ultrasonic welding, UV bonding, flow testing, laser inspection, and other operations necessary for small-part assembly applications. Using smart programming, the machine is capable of self-diagnosing problems and determining the best course of action to resolve a production error. In response to such an event, the machine can sound an alarm, retry the failed procedure, slow the production pace, or use an instant-stop function to deactivate all systems. Available with a 2- or 4-m working zone, the unit features an over/under-style chain conveyor, hardened-steel shot pins and replaceable bores, and a steel-welded frame with an aluminum work surface.
Adaptive Manufacturing Technologies
Ronkonkoma, NY
www.amtautomation.com


Automatic O-Ring Installation Machines Offer Speed, Flexibility

Designed for medical device manufacturing and packaging applications, a line of O-ring and seal installation equipment can achieve rates of more than 50 installations per minute, which is significantly faster than manual methods, according to the supplier. In addition to increased efficiency, the machines offer reliability and an ergonomic design to reduce operator force. Standard automation modules can be integrated into multistation assembly lines or adjusted for semiautomatic operation. The machines can be augmented with optional tooling features to run a variety of parts and O-rings. Because the O-ring is placed onto the part and is not twisted or rolled, no damage can occur to the O-ring, according to the manufacturer. In addition to silicone seal feeding and installation, the machines can handle special seal configurations and applications requiring medical-grade lubrication. The machines can also be customized to accommodate stainless-steel medical packaging and cleanroom applications, seal-placement verification, and Teflon coating.
Automated Industrial Systems
Erie, PA
www.asporing.com

For more information on automation and robotics, go to devicelink.com/mpmn/equipment

Copyright ©2009 Medical Product Manufacturing News

Vesta Expands Its Manufacturing and Assembly Services

Vesta Inc. (Franklin, WI), a contract manufacturer for medical device components and finished device assembly, has announced several facility infrastructure investments that will enable the company to grow its business and expand its offerings. The company will expand its Franklin, WI, plant, which focuses on the manufacture and assembly of silicone-based medical device components. The expansion, scheduled for completion in October, will double the supplier's manufacturing space and will allow for the introduction of Vesta Innovations, a service that will support early-stage product development for medical device OEMs. The company intends to consolidate the operations of its Portage, WI, facility into the newly expanded Franklin facility by the end of 2009. In another expansion, the company plans to consolidate its thermoplastic extrusion facilities currently located in Placentia and Temecula, CA, into a new manufacturing facility in Corona, CA. The new facility will support the production operations of Vesta's Extrumed business, which the company acquired in March. This move will enable Extrumed to expand its secondary service offerings and will support the company's focus on best-practice manufacturing of precision thermoplastic extrusions. The Corona facility is scheduled for completion early next year. The current Extrumed facility in Livermore, CA, will continue to operate, focusing on quick-turn extrusion projects.

Metal Fabrication

OUTSOURCING OUTLOOK

Metal Fabrication
Aaron Lahann, senior process engineer, Airtronics Metal Products Inc., San Jose.
Once skittish about outsourcing, most medical device OEMs today consider outsourcing vital to success. They know that contracting out metal fabrication to a precision supplier can help them improve product design while reducing production costs. Metal fabricators stay up to date on metal trends and technologies, such as laser cutting, machining, milling, stamping, surface treating, and testing. Below are some tips on how to select a metal fabrication provider:

Check credentials.
Not all metal fabrication shops are created equal. The OEM should ensure that the prospective partner is certified to the standards required for the application. For most OEMs, this means ISO 9001 and/or ISO 13485 certification.

Tour the shop.
Is the facility clean and orderly? Is the manufacturing equipment up to snuff and is the work flow smooth and efficient? The supplier should use a paperless enterprise resource planning (ERP) system to manage production, scheduling, pricing, and quality. It should also use the latest 3-D modeling software to verify the form, fit, and function of devices.

Meet the engineers.
An experienced and collaborative engineering team is vital to good product development. The outsourcer’s team should be eager to share ideas, find mistakes, and suggest design for manufacturing (DFM) changes to improve product design. The team should assist through all phases of production, including concept, prototyping, qualification, validation, and full-scale production.

Check quality and capabilities.
The OEM should ask the vendor about past and current clients and projects. Has the vendor manufactured for a medical device OEM before? Does it perform most or all of the work in-house, or does it outsource? The supplier should accommodate both the OEM’s rapid prototype and finished production schedules.

Take a tool inventory.
Once the OEM has selected a fabrication partner, it should research the company’s tool inventory. Using the vendor’s tools can expedite the project.


Contractor Supplies Chemical-Machined Medical Parts

Using a process called chemical machining—also known as etching or milling—a supplier manufactures prototype and production quantities of metal parts featuring complex geometries. In addition, the company performs all secondary operations, including forming, passivation, electropolishing, and plating, on a variety of metals such as titanium, nitinol, zirconium, stainless steel, and copper. An ISO 9001:2000–certified contract manufacturer, the company also offers radio-frequency and EMI shielding, as well as metal-stamped parts with thicknesses ranging from 0.002 to 0.135 in.
Fotofab
Chicago
www.fotofab.com


Vendor Offers Metal Fabrication Services

A manufacturer provides an array of metal fabrication services, including photochemical machining, metal stamping, electroplating, and passivation. Specializing in the processing of light-gauge metals as thin as 0.0007 in., the company offers circuit-board-level EMI shielding for medical electronics and sieves, screens, filters, gaskets, and washers for medical applications. In-house capabilities range from quick-turnaround prototype runs to production-level manufacturing.
Orbel Corp.
Easton, PA
www.orbel.com


Manufacturer Provides CNC Machining of Implants and Instruments

Offering CNC machining and orthopedic implant and instrument assemblies, a supplier specializes in spine, joint-replacement, fracture-management, hand and extremity, and endoscopy applications. Its services include five-axis CNC milling, CNC turning, 12-axis CNC Swiss-screw machining, CNC wire and plunge EDM, and assemblies. Using titanium, cobalt chrome, stainless steel, and other materials, the
ISO 13485–registered company offers prototyping, product launching, full-scale production, and project management. Additional support services include vendor-managed inventory, and nonsterile packaging and labeling.
Marox Corp.
Holyoke, MA
www.marox.com


Supplier Specializes in Contract Machining and Turning Services

Fabricating small to large metal parts in volumes ranging from a few pieces to large production runs, a contract manufacturer supplies base and side plates for biomedical test and analysis equipment, pump and compressor components and bodies, and parts for imaging equipment. The company manufactures parts from a variety of materials, including aluminum, carbon steel, ductile iron, stainless steel, and titanium. Certified to ISO 9001:2000 standards, the manufacturer processes materials using vertical machining centers, bridge mills with pallets, horizontal machining centers with and without pallet pools, and turning centers.
TCI Precision Metals
Gardena, CA
www.tciprecision.com


Outsourcer Manufactures Sheet-Metal Components

A full-service sheet-metal design, engineering, and manufacturing company serving the medical device industry offers design and mechanical engineering support, prototyping, precision fabricating, CNC machining, laser processing, painting, silk screening, and final assembly. The ISO 9001:2000–certified vendor provides custom engineering and value-added manufacturing using CAD design software; machining, milling, stamping, and other types of production equipment; and enterprise resource planning (ERP) systems. Quick-turnaround manufacturing capability allows the supplier to deliver prototypes and first articles, expediting confirmation of design concept and integrity.
Airtronics Metal Products Inc.
San Jose
www.airtronics.com

For more information on such contract manufacturing services as metal fabrication, go to www.devicelink.com/mpmn/cm

Copyright ©2009 Medical Product Manufacturing News

Implant Coating Characterization System Gets Cash

Nightingale-EOS Ltd. (Wrexham, Wales, UK) has received funding from Mercia Technology Seed Fund (Birmingham, UK) and Finance Wales to complete development of a laser-based technology that nondestructively measures coatings applied to medical implants. The company is also receiving funds from the Welsh Assembly Government. The technology under development, beam profile reflectometry, is designed to characterize thin coatings applied to cardiac stents, replacement joints, and related devices. Using a single measurement to determine both coating thickness and composition, the technology can be used for in-line QA inspection and laboratory testing. It also provides medical device manufacturers with a low-cost method for complying with the FDA's Process Analytical Technology initiative. The company's development center will open an applications laboratory and sales office at the Coventry University Technology Park in England, where the West Midlands Manufacturing Measurement Centre is also based. "There are clear benefits for medical device manufacturers in adopting technology such as this to streamline their production processes, reduce cost, and improve quality," remarks company chairman Alistair Taylor. "This investment enables the company to bring the technology to its customers in time for the next generation of devices."

Molding

SPOTLIGHT

Molding

Tight-tolerance molding services

Specializing in tight-tolerance medical device molding, a company offers component and device manufacturing services using a variety of engineered and commodity resins. Equipped with 21 injection molding machines ranging from 35 to 400 tn and featuring robotic mechanization, the company can produce shot sizes ranging from 3 to 55 oz for part manufacturing. It can support concept development through its engineering and tooling center, as well as mold design, build, modification, and repair requirements using its in-house mold shop. Insert and overmolding, blow molding, and cleanroom manufacturing services are also offered. The company is equipped to provide ultrasonic welding, hot stamping, and packaging services as well.
Specialty Plastics Inc.
St. Peters, MO
www.specialtyplasticsonline.com


Cleanroom molding capabilities

Equipped with expanded cleanroom facilities, a contract molding services provider can offer Class 100,000 and Class 10,000 molding and assembly operations. Specializing in production of medical and surgical disposables, the company offers production for thermoplastic and elastomeric component applications. The company can mold such parts and devices as syringes, drip chambers, luer adaptors, and other components used in fluid- and IV-delivery systems. Maintaining linear injection, compression, and transfer molding machines, the company provides real-time process monitoring of all operations and can accommodate designs requiring molding of multiple materials.
MedPlast Inc.
Tempe, AZ
www.medplastgroup.com


Micromolding services

Offered as an alternative to machined parts, micromolded components and subassemblies are produced by a company for use in medical devices for minimally invasive surgery applications. Micromolding can also be used to combine dissimilar components, eliminating the need for bonding and welding operations. Such manufacturing changes achieved by using micromolding can reduce the number of components, overall size, and assembly complexity. It also reduces time required to manufacture devices under a microscope while obtaining an acceptable production yield, according to the company. Micromolding processes can be used to accurately mold components weighing less than 0.1 g with dimensional tolerances of ±0.005 mm. Wall thicknesses as small as 0.08 mm also can be achieved using micromolding, which can sustain a shot-to-shot volume consistency of 0.001cm³.
Mikrotech
Kenosha, WI
www.mikrotech.com


Molding and prototyping services

A company offers molding services for medical device concept design and production requirements. The company maintains 44 molding machines ranging in capacity from 5 to 300 tn. It also performs molding operations in cleanroom environments and monitors all processes with a software system that interfaces with the primary processing equipment to ensure optimum throughput. Specializing in molding of thermoplastic and elastomeric materials, the vendor can provide liquid silicone injection, micro-, insert, and overmolding, as well as assembly services in its cleanrooms. Additionally, the company offers design, engineering, R&D, and prototyping services, as well as in-house CAD/CAM–based tooling design and fabrication.
Donatelle
New Brighton, MN
www.donatelle.net


Nanomolding services

Using a nanomolding machine with a shot range of 0.08 to 0.35 g, a company offers nanomolding services for processing bioabsorbable polymers. The Sesame nanomolding machine is designed to injection mold medical devices with part volumes ranging from 0.10 to 100 mm³, which is too small for standard screw-design micromolding machines to accommodate, according to the supplier. The nanomolding machine’s screwless design is suited for high-speed machine-tool applications for molding tiny devices and components with complex geometries. Capable of handling thermoplastic, thermoset, and bioabsorbable materials, the machine is engineered to avoid processing complications and waste of materials. In addition to production services, the supplier offers assistance with bioabsorbable polymer selection, device design, and testing.
Medical Murray
North Barrington, IL
www.medicalmurray.com


Molding validation software

Training and software are offered to help medical device manufacturers improve validation processes. The supplier offers eDart software that simplifies the task of moving molds by providing machine-independent process setup information. The software features universal setup sheets that can reduce the cost of revalidation required when transferring molds to new machines or locations. To ensure the same process is set up at the new locations, the software system can be used to create a template that moves with the mold. When the software is installed on a network, plant managers can use the advanced system overview to check process setups at a glance. Providing historical data of every shot produced, the software can also be used to identify root causes of production problems. Optional digital cavity pressure and temperature sensors can be incorporated into a molding system to provide quality assurance. The software automatically recognizes the sensors and integrates them into the mold process being run.
RJG Inc.
Traverse City, MI
www.rjginc.com


For more information on molding services and equipment, visit devicelink.com/mpmn/molding

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