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The Future of Medical Molding Begins to Take Shape

PRODUCT UPDATE

The Future of Medical Molding Begins to Take Shape
Micromolding, liquid silicone-injection molding, and two-shot molding are making their mark in the industry
Shana Leonard
This micromolded filter features more than 76-µm squares.
Though molding is a tried and true method for manufacturing many medical devices, the climate of the industry is shifting slightly. Whereas traditional injection molding has dominated the scene over the years, other molding processes are gradually gaining recognition. Micromolding is viewed as a method that will expand rapidly as devices shrink down to tiny proportions. Liquid silicone–injection molding, now popular in other countries, appears as though it may prosper domestically. And two-shot and multishot injection molding are taking center stage as consumers accept the appealing appearance and texture enabled by these processes.

Big Things Come in Small Packages

It seems as though the prefixes micro and nano are on every member of the medical community’s lips. The advent of nanotechnology, the popularity of minimally invasive surgery, and the efficacy of implantables in delicate body tissue are all spurring the shrinking of devices. And though prospects for the future appear exciting and wide-ranging, one pressing issue is much less discussed: the manufacture of these minute medical components.

Micromolding is recognized as a process capable of churning out some miniature products on the horizon. Already relied upon for many small applications, micromolding will most likely expand significantly in conjunction with the swelling demand for miniaturization.

Donna Bibber, vice president of sales and marketing for Miniature Tool & Die (MTD; Charlton, MA), attests to the rapid growth of the micromolding sector. “We have been in business for 34 years, doing micromolding for 8,” she says. “It was kind of frustrating at first, but we put in a lot of effort. About 6 months ago, the floodgates opened and I have barely been able to take a minute to breathe since!”

Despite a flourishing market, the industry is plagued by an inconsistency. Many companies disagree as to what constitutes a micromolded part. Some firms vaguely define one as having a mass of less than a gram. MTD defines a micropart as one molded from fractions of a pellet, weighing less than a gram, and featuring a wall thickness of 0.005–0.010 in.

MTD has made its mark in the industry, having laid claim to the smallest molded component in the world. The firm creates 520 of the parts per pellet, each with a weight of 0.00012. The firm has also released what it touts as one of the world’s smallest single-piece injection–molded filters. The micromolded filter features 76-µm squares with wall thicknesses of 0.006 in. and offers ranges of 18–36% open area for use in nylon and polypropylene filtration products. According to Bibber, the micromolding of the filter converted an eight-step process into a one-step process.

Beyond filters, MTD micromolds resorbable polymers for implantable materials. Despite a hefty price tag that can range from $3000 to $12,000 per pound, the materials are considered desirable because the implantable device market is thriving. Properties of the materials include heat and moisture sensitivity. They are designed to degrade in the body.

In addition to its use for small applications, micromolding boasts other advantages as well. “It is advantageous because you use a small amount of a very expensive material; in the medical market you can’t reuse or regrind materials,” says Bibber. “In big-scale molding you are basically throwing away material. Also, in a conventional press the mold is baking in a huge barrel, sitting there degrading and becoming brittle and losing its properties.”

The field of micromolding is growing by leaps and bounds. Right now, it is still somewhat of a niche field. However, as the trend toward miniaturization rolls onward, many more companies are likely to jump on the bandwagon.

Breaking the Mold

Liquid silicone–injection molding can enable reduced lead times and is suited for medical use due to the material’s biocompatible properties.

Though liquid silicone–injection molding has been a major player in the European molding market, it has yet to burst into the spotlight of the stateside arena. Its use has, however, begun to spread in the U.S. market and is increasing, according to Jim Meier, vice president of new business development for Scientific Molding Corp., Ltd. (SMC; Somerset, WI).

Inspired by its success in Europe and Asia, SMC adopted liquid silicone– injection molding capabilities. Since then, the firm has enjoyed its own success, attributing an estimated 10% of its business to the process. SMC acknowledges that this process is its fastest growing sector. “It has had a significant impact. As a matter of fact, within the last year the capacity of SMC has doubled,” Meier notes.

Rather than using conventional plastic pellets, liquid silicone–injection molding, as its name implies, forms parts from the liquid form of silicone. A two-part material, liquid silicone exhibits a consistency that Meier compares to motor oil or soft putty. The material is injected into a hot mold that serves as a curing element.

In the past, silicone has been molded through a rubber vulcanization process, which entails a long cycle time. Liquid silicone allows for reduced compressed cycle times, resulting in reduced unit costs, says Meier. He adds that with this process, the firm was able to produce some tools in 6 weeks that typically would have taken 20 weeks.

Owing to its biocompatible, inert, and flexible nature, silicone is well suited for the medical industry. Among the advantages of silicone–injection molding are repeatability, limited contamination and human contact, flash-free precision, and rapid curing cycles.

“It’s the perfect material for the medical world,” Meier asserts. “When we combine the benefits of silicone with the process of liquid–injection molding, the results in terms of components, and especially in terms of economies, is very beneficial to our customers.”

Along with liquid silicone–injection molding capabilities, SMC also specializes in two-shot injection molding. Two-shot molding is performed for enhanced aesthetic and textural value. Because tools with features such as flexible grip handles are often preferable to users, demand for two-shot and multishot injection molding is on the rise, according to Meier.

“The user demand, in most cases, is from surgeons in an operating room or clinic that are holding on to a surgical device,” says Meier. “And if there’s a better feel or grip imparted to a product by using two-shot elastomeric compounds, that creates more sales for the producer and more two-shot molding applications for us.”

The availability of bright colors and different textures may not be vital to the use of a product. However, aesthetics differentiate products and appeal to the senses, hence the growing popularity of two-shot injection molding. And the cost effectiveness and repeatability of the process are added incentives.

Copyright ©2006 Medical Product Manufacturing News

Prototyping and Rapid Prototyping

OUTSOURCING OUTLOOK

Prototyping and Rapid Prototyping
John Bannayan, executive vice president, Glebar Company, Inc., Franklin Lakes, NJ
Rapid Prototyping

A prototype component machined for a medical device manufacturer needs to be produced in the shortest amount of time at the highest quality possible. The process also needs to be duplicated reliably.

This presents a challenge to a contractor, since these components cannot be made on just any machine. As an example, guidewire cores are made on custom-built CNC grinding machines. Recently, more-stringent geometric features with very tight tolerances and extremely small diameters have been the standard. Wire diameters up to 0.0008 in. over a length of 20 in., with varying geometric features, are common. This narrows down the types of machinery that can be used to make these prototypes.

In order to produce high-quality prototypes, contract manufacturers need to choose raw materials carefully. With increased demand for smaller precision components, experimentation and process development is necessary. This can invariably extend lead times, sometimes making the prototype far from rapid. Both contractors and OEMs need to understand the fabrication process at the prototype level, as it is critical to successful medical device development


Process Development Services Enable Rapid Product Launch

As a machine-tool builder for the medical device industry, a firm can supply prototype components and process development expertise to enable its customers to rapidly implement a product launch. Turnkey grinding and inspection systems are specifically configured to meet customer’s requirements. By running production on equipment on a contractual basis in its plant, the firm’s process development team faces the same issues its customers would normally face on a new product launch. The company is then able to debug the process, provide technical training, supply start-up production volume, and address process issues before the technology transfers to the customer’s site.
Glebar Company, Inc., Franklin Lakes, NJ
www.glebar.com


Prototyping Service Accelerates Fluid-Handling Product Development

A refined rapid response prototyping process accelerates product development cycle times, allowing quick, iterative design changes to meet any dispensing, transfer, circulation, or dosing application. The firm uses Design for Six Sigma and other processes to integrate a wide selection of fluid-handling components and assemblies into a system’s architecture.
Micropump Inc., Vancouver, WA
www.micropump.com/pr


High-Quality Prototypes Reduce Product Development Time

Contract services are available that are meant to help clients bring their new products to market quickly. The First to Market program emphasizes the delivery of high-quality prototypes in the fastest manner possible, thus reducing product development time. The firm specializes in precision machining of a variety of materials such as polymers, metals, and glass, with feature sizes as small as 1 µm. All that is required is a CAD file from the customer and prototypes can be available in as little as 24 hours.
Potomac Photonics, Lanham, MD
www.potomac-laser.com




Rapid Membrane Switch Prototype Service Is Available

A rapid prototyping service for membrane switches is a stand-alone operation designed to quickly produce working mock-ups. Parts produced are conceptual in nature but appear and function as the envisioned production parts. The Instant Intaq service enables customers to verify their design with functional prototypes in three days or less for overlays and laser-cut blanks, or within 10 days for most membranes.
GM Nameplate, Seattle, WA
www.gmnameplate.com


Coming up in the May 2006 issue of MPMN, Outsourcing Outlook on Surface Treatment
Copyright ©2006 Medical Product Manufacturing News

Getting Down to the Wires

ELECTRONICS OUTSOURCING

Getting Down to the Wires
Corporate changes and regulations on hazardous materials affect how EMS firms do business
Corinne Litchfield

Medical OEMs are still feeling their way through the process of outsourcing product design and development projects to electronics manufacturing service (EMS) companies. Recent figures from industry experts suggest that anywhere from 13 to 25% of all medical electronics are outsourced. This article talks about how product content regulations affect EMS providers and the OEMs they serve, as well as the impact of corporate buyouts and changes in business models on medical electronics manufacturing.

Getting the Lead (and Other Harmful Materials) Out

The hot topic for many EMS firms is how to comply with regulations aimed at eliminating hazardous waste. On July 1, 2006, the European Union’s directive, Restriction of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS), will take effect. RoHS bans the sale of electronic-based products containing more than 0.01% of specific hazardous materials, including cadmium, mercury, lead, hexavalent chromium, polybrominated biphenyls (PBBs), and polybrominated diphenyl ether (PBDE). The Waste Electrical and Electronic Equipment (WEEE) directive took effect in August 2005 and is intended to ensure that electronic products are properly disposed of or recycled after use.

Similar laws are being adopted in California. The state’s Electronic Waste Recycling Act is already in effect and affects anyone who sells covered electronic devices. “If a company sells a product containing an LCD panel, monitor, plasma display, or CRT that’s greater than four inches diagonal, the firm has to pay a fee,” says Mike Kirschner, president of Design Chain Associates (San Francisco; www. designchainassociates.com). In addition, six states have enacted or are considering legislation barring the use of hazardous materials in electronic products. California’s RoHS law is leading the pack, as it goes into effect on January 1, 2007. It specifically references the EU’s directive, which currently exempts medical devices. “And since medical devices are excluded from the EU, they are excluded from California as well,” explains Kirschner.

A digital x-ray scan module by Maxtek Components Corp. uses chip-on-board technology with a flex attachment for interconnect with the x-ray sensor.  

By looking to the EU to chart the course for medical devices and RoHS compliance, California has set an unusual precedent. According to the EU commission, a 10- to 12-month study needs to be performed on medical devices to see if RoHS regulations are applicable. “This could push the decision to include medical devices well into late 2006, with deadlines extending to 2008 or longer,” says Geoffrey Bock, engineer and RoHS program manager at TUV Rheinland of North America Inc. (Plymouth, MI; www.us.tuv.com). Medical electronics manufacturers and other medical OEMs are lobbying to keep the exemption, as the potential impact of the RoHS directive could be costly and time-consuming. There is also room for debate over which—and where—medical products are exempt. “Since the EU’s directives on medical devices have yet to be tested, there’s the potential for EU member states to define the scope differently,” Kirschner warns.

While materials such as PBB or PBDE are rarely seen in electronics anymore, lead-bearing solder is still used to bond components onto PCBs. This poses a challenge for many suppliers to the medical electronics industry. “Right now we’re still in the experimentation phase,” says Eric Hodges, marketing manager for Maxtek Components Corp. (Beaverton, OR; www.maxtek.com). “We’re identifying parts that are on the leading edge of being converted to lead- or cadmium-free. Then we build up components with alternative, compliant materials and begin testing them.”

Even though medical devices are still exempt, EMS providers are encouraging their medical OEM customers to conform to RoHS. One key reason is availability of materials. As the consumer industry moves toward compliance, demand for noncompliant materials may drop dramatically. As a result, leaded solder and other materials may become unavailable. “Whatever happens on the consumer side will affect the entire market,” says Hodges. “The medical device industry needs to think about how the directives will impact the overall electronics market and sourcing of materials.”

As a result, many EMS firms are working with their own suppliers to determine what types of materials are being used. CTS EMS Inc. (Moorpark, CA; www.ctscorp.com/ems) offers product evaluations to its customers. “We look through the materials that are documented to see if any of the hazardous substances are already incorporated,” says David Prunier, director of North American business development. “If there are substances that need to be changed in order to be compliant, we give OEMs information on pricing, lead time, and availability of replacement materials.”

As the deadlines loom, more OEMs are becoming concerned about the time frame. “It’s not a question of cost,” explains Prunier. “It’s a question of being able to implement the regulations and adhere to timelines. Companies also have to consider what they will do with any excess inventory of noncompliant materials,” he adds. “We’re working to get those supplies down. We’re seeing more activity the closer we get to the deadlines.” Larger firms, both OEMs and EMS providers, may not have as many challenges in creating RoHS-ready components. Kirschner suggests that it has to do with what’s at the company’s disposal. “It’s the vertically integrated companies that will find it the easiest to comply,” says Kirschner.

Paragon Innovations provided several services, including electronic design, in developing the Vigilance cardiac output monitor shown here.

In the end, though, it’s up to the customers as to how much energy they want to expend on meeting the requirements. “We’re telling our customers about the regulations and making RoHS-compliant versions if the customers say they want it,” says Mike Wilkinson, CEO, Paragon Innovations (Plano, TX; www. paragoninnovations.com). Prunier agrees. “We can’t force our customers to change. As we get closer to the date, it’s interesting to see how people will adapt to the regulations.”

Mergers and Acquisitions: Business as Usual?

Recent headlines about Boston Scientific’s bid to acquire Guidant have put acquisitions and mergers at the forefront of conversations about the medical device industry. While there may not be motivation or money to buy an entire EMS firm, the purchase of another firm’s product line can add to a company’s overall value. Larger companies with electronics divisions may benefit the most from continuing on a path of vertical integration. A recent example of this is 3M Electronics (Austin, TX; www.mmm.com) and its purchase of Siemens Ultrasound Division’s flexible circuit manufacturing line. “Adding Siemens’s flexible circuits expands 3M’s business in the ultrasound and medical imaging markets,” says Frank R. Little, division vice president at 3M Electronics.

One trend that has been taking place seems rather Darwinian in nature: small, specialized EMS firms purchased by midsized EMS companies. This strategy is often used to either expand the customer base or add technical expertise. “Lately there have been cases where a tier-two niche player gets bought by another microelectronics packaging provider,” says Hodges. “Such a move enables them to access new market segments or applications, purchase technology instead of internally developing it, or add complementary services.”

For EMS firms, acquisitions can mean a loss of business...or business as usual. “It really depends on the OEM,” says Wilkinson. He mentions one medical OEM that stopped out-sourcing once it pur-chased an EMS firm that had design capabilities. However, EMS companies shouldn’t despair, he says. “For every company that stops outsourcing, a new one starts.”

A Zevex-designed organ transportation device can be used to transport a kidney from donor to recipient.

While being part of a larger EMS firm has its benefits, much experience can be gained by being autonomous. Maxtek’s history illustrates the point well. In 1970, Tektronix, a manufacturer of testing and measurement products, created the Hybrid Components Organization (HCO) to supply high-performance components for its high-speed test equipment. More than 20 years later, the captive organization was spun out as a joint venture with an electronics firm and renamed Maxtek. “All of the skills HCO had developed to serve Tektronix fit very well with other applications, including medical,” says Hodges. As a separate entity, Maxtek worked with medical OEMs that needed its expertise with signal integrity and thermal management. Reacquired by Tektronix in 2000, the firm now serves its parent company in addition to external customers. Hodges says it’s a win-win situation. “Because of our external customer base, we’re a source of growth and revenue for Tektronix,” he explains. “And since our capabilities can be applied to markets such as medical, we’re also able to support the next-generation needs of our customers by working on technologies that have the greatest impact for both our internal and external clients.”

ODMs: Manufacturing with a Twist

A blood-processing system sensor designed by Zevex monitors several channels for air and blood components.

With proven success in the computer and consumer electronics industry, original design manufacturers (ODMs) could well stand poised to take over the medical electronics market. Medical devices designed for end-users, such as blood glucose meters and digital thermometers, are ripe for ODM involvement. However, more complex medical devices may never make the transition, suggests Prunier. “When it comes to Class 3 devices—life-critical or life-sustaining devices—there will be a lot of aversion to buying off-the-shelf,” he says. Wilkinson agrees. “There are two types of medical devices: consumer-based, where there’s a lot of competition but not much margin; and high-tech, research-intensive products,” he says. “ODMs can play in the first category, but not in the second.”

Air-bubble and liquid-level detectors from Zevex are used in a variety of medical devices, including volumetric infusion pumps, hemodialysis units, and cardiopulmonary bypass units.

Many EMS firms will modify proven platforms in order to come up with innovative electronic solutions. Zevex (Salt Lake City; www.zevex.com), a maker of surgical ultrasound devices, fluid management systems, and sensors, teams up with medical OEMs to create products such as surgical ultrasound handpieces. “We use our proprietary technology to develop products for our customers,” says Phil Eggers, vice president of research and development. “Based on what the customer needs, we’ll either create a new system or customize an existing device.”

The resulting medical devices are the deciding factor as to whether the ODM model works for the industry. “It all comes down to execution,” says Hodges. “Whether a company relies on various outside suppliers, internal production, or an ODM to provide key components, it really is a matter of execution.”

They’ve Got the Power

Despite any challenges that come from new laws or shifts in business practices, EMS firms are available to offer their expertise to the medical OEMs that need them. The goal remains the same: to communicate effectively with customers in order to build high- quality medical devices. As Eggers puts it, “The real power of electronic outsourcing is when an OEM’s market knowledge is combined with a supplier’s capabilities to create technology that builds excellent products."


Copyright ©2006 Medical Product Manufacturing News

Medicare Payment Cut Proposals Raise Industry Ire

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Filters

SPOTLIGHT

Filters

Pleated panel filters

Pleated panel filters with self-supported media offer high strength and moisture resistance, and eliminate the need for an expanded metal backing. The inherent strength and stiffness of the X-Treme media result in a consistent pleat shape, spacing, and height. The filters are resilient and snap back to their original shape if damaged or deformed, with no loss of structural integrity. The frame and media pack are bonded with a water-repellent adhesive to maintain structural integrity; even when wet, the filters will not delaminate, buckle, or collapse.
Airguard, Louisville, KY
www.airguard.com


Vial adaptor and filter

A vial adaptor and filtration component system facilitates medication access, reconstitution, and transfer. The unit can be used with vials ranging in size from 5 to 50 ml that are fitted with a standard 20-mm vial closure. The design is suitable for use with needle-free access product lines.
Filtertek
, Hebron, IL
www.filtertek.com

All-metal process filters

HyPulse HyLine filters are suitable for process applications that require small-scale filtration solutions. The products perform as small process filters, with backwash and blowback capabilities. A threaded element connection allows high-efficiency filtration without the limitations of gasket-sealed cartridge filters, and is available in a single- or multitube design. The porous metal media are permanent and cleanable, and can withstand high temperatures and corrosive environments. Filters are available in various media grades and in alloys including titanium, nickel, Hastelloy, Inconel, and 316L stainless steel.
Mott Corp.
, Farmington, CT
www.mottcorp.com


Centrifugal filter

A centrifugal filter device provides ultrafast high-recovery purification and concentration of specific proteins such as macromolecules found in human specimens such as serum, urine, spinal fluid, and other biological fluids. Sample volumes up to 15 ml can be concentrated in 10 to 15 minutes with neglible loss of sample. The Amicon Ultra-15 has a regenerated cellulose membrane that minimizes adsorption of the macromolecules and provides high recovery of fully functional proteins. The filter is compatible with most rotor types and allows for direct pipettor access, which eliminates the need for an extra processing step. The product is available in packs of 8, 24, and 96 filter units.
Millipore Corp., Billerica, MA
www.millipore.com/amicon
Copyright ©2006 Medical Product Manufacturing News

Medtronic Gets Approval for Revolutionary Diabetes System

The system has a sensor that relays glucose readings to the pump every five minutes. It is a step toward an automated system that would function like a human pancreas. FDA so far has been hesitant regarding any system that takes an action automatically.

Diagnostics Arena Changing, For Better and Worse

This will have to be looked at on a case-by-case basis, though. For every genomic-based test that's nothing more than an excuse to pad profits, there will probably be several that represent real improvement, saving costs in the long run.    

Machining

SPOTLIGHT

Machining

Swiss-type lathes

A series of lathes are equipped with full servo axes and advanced technologies that enable fast machining operations while reducing noncutting idle time by 40% compared with the company’s earlier models. All L-20 models include a Mitsubishi Meldas 720 control. Another feature is a TFT color LCD screen. The monitor provides a sharp image of a part during specific machining operations and allows the operator good visibility. The 720 control enables the lathe to be started and shut down instantaneously.
Marubeni Citizen-Cincom Inc., Allendale, NJ
www.marucit.com

Multitasking center

The x-, y-, and z-axes on a multitasking center move independently, preventing problems associated with axis-on-axis stacking. The three axes on the TB-25-LYMB series are 90° to each other and do not require movement of two axes to enable y-axis motion. The design makes the unit a turning center and a four-axis machining center in one. The single-spindle machine has a 10-in. chuck with a swing of 21 in. and a turning length of 24 in. It has a bar capacity of 2.5 in. and a full travel tail stock.
Tong-Tai Seiki USA Inc., Cottage, NY
www.tongtaiusa.com


Benchtop prototyping mill

A three-axis mill has 8.3 in. of x travel, 5 in. of y travel, and 6.25 in. of z travel. The unit comes with stepper motors, drivers, cables, and a computer with preloaded software. The stepper motors will resolve linear movement to 0.000125 in. and the machine can hold tolerances of less than 0.001 in. overall. Applications include developing working prototypes and machining molds for small plastic parts.
Sherline Products Inc., Vista, CA
www.sherline.com

Machine tool probe
Created specifically for small machining centers, an optical probe measures 40 mm in diam, and 50 mm in length. The OMP400’s size allows small machine users to benefit from strain gauge technology. The probe is suitable for use on machines with short z-axis travel and spindles as small as HSK32. The unit is sealed to IPX8 and built to withstand harsh environments. Battery life provides up to 50 hours of continuous use.
Renishaw Inc., Hoffman Estates, IL
www.renishaw.com


Hard turning lathe

A modular machine has one spindle, one turret, and one robot. The FUJI ANS-3100P is a rigid, hard turning lathe that offers built-in automation with a four-axis rack-and-pinion swing arm robot. The unit is equipped with a Fanuc control with five-place decimal control. It comes with a 12-pallet work stocker and other auxiliary loading options. The machine operates at a maximum of 3500 rpm, has an eight-position turret, and hard turns with a 20-hp spindle motor.
Fuji Machine America Corp., Vernon Hills, IL
www.fujimachine.com

Gang tool lathe

A gang tool lathe with two spindles offers complete part machining of complex bar products in a single setup. The BX-26S has a 3-D linear turret and traverse-type identical left and right spindles, both with 5 hp. This ensures stable cutting from end to end. High-speed turning of 8000 rpm maximum is made possible by built-in spindle motors and high-rigidity linear guides. Ease of operation and setup is enabled by y- and c-axes on either spindle with eight revolving tools.
Miyano Machinery USA Inc., Wood Dale, IL
www.miyano-usa.com


High-precision CNC machining

A global manufacturer offers high-precision CNC machining with wire EDM, milling, turning, and grinding, Custom machining includes sizes ranging from 0.1 to 28 × 15 in., with tolerances of ±0.0001 in. Complete in-house tooling, MasterCam programming, and SolidWorks design are also provided, as well as mechanical assembly.
Johnson Matthey, Temecula, CA
www.jmmedical.com

Five-axis rotary table

A company’s horizontal machining centers are available with a five-axis rotary table as a designated option. This feature is suitable for manufacturing applications that require maximum throughput and reliability. The 5XR option can help any sized operation concentrate machining processes for multiface jobs, intricately shaped parts, and for machining the cutter body.
Makino, Mason, OH
www.makino.com
Copyright ©2006 Medical Product Manufacturing News

EU Approves Boston Scientific-Guidant Deal