MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

ITC Investigates Global Competition

It will compare regulatory condition in Japan with those of other foreign markets for domestic-made products exported to those countries. ITC will hold a public hearing about its investigation on July 11, 2006. It is accepting written submissions for the record. Comments must be received no later than July 25, 2006. Although the ITC investigation is a factfinding investigation only, industry should take the time to comment. In this era of global trade and harmonization, itâEUR(TM)s up to us to ensure a level playing field. Industry must watch out for its own interests.

The Curse of the Mad Cow

EDITOR'S PAGE

The Curse of the Mad Cow
On March 13, 2006, the U.S. Department of Agriculture confirmed the presence of bovine spongiform encephalopathy (BSE) in a cow in Alabama. This was the eighth confirmed case of BSE in North American cattle; the second one just this year.

BSE, or mad cow disease, is a progressive neurological disorder in cattle. And strong evidence indicates that BSE can be passed to humans. To date, 190 cases of its human variant, Creutzfeldt–Jakob disease, have been reported.

Most of the cows found to have BSE in the United States have not been destined for the human food chain. That’s good news for the carnivores among us. But vegetarians are not off the hook. Beef by-products are used in many other ways.

For example, plastic products, including many used in medical devices, employ derivatives of beef tallow as lubricants in the manufacturing process. These products, called stearates, comprise 100–200 ppm in raw polyethylene. They are inexpensive and work well.

But it’s difficult to know whether the prions that are thought to cause BSE are present in stearates. Prions are virtually indestructible, so normal sterilization methods won’t kill them.

Because of the risk of contamination, worldwide healthcare agencies recommend that plastics suppliers document that their products containing stearates do not come from countries known to have BSE-positive cows. This involves a lot of extra work on the part of the manufacturer. Further, it appears the number of BSE-safe countries is dwindling.

So why not just get rid of the risk altogether? Why not just find other materials to do the job? Some suppliers are doing just that.

Value Plastics (Fort Collins, CO) offers animal-free polypropylene and polycarbonate fittings and connectors. “Polypropylene is by far the most widely used resin for flexible tube fittings in the biopharmaceutical industry,” says Bruce Williams, the company’s CEO. “Our new animal-free polypropylene significantly reduces our customers’ BSE-related paperwork by completely eliminating the documentation requirement for fittings made with this material.”

Another company, TC Tech (Maple Plain, MN), certifies its products are animal-free.

It makes films used in the construction of bioprocess bag chambers as well as tubing, fittings, and connectors used with bags and for other fluid-transfer applications.

According to Thomas J. Murphy, PhD, and John K. Schmitz of STI Components Inc. (Raleigh, NC), substitutes for animal-based polymer additives are not hard to find. The challenges are in sourcing these materials and converting processing lines.

Those challenges are well worth pursuing. Value Plastics and TC Tech have the right idea in moving away from animal by-products. Today’s recommendation could become tomorrow’s regulation.

Susan Shepard, Editor

Copyright ©2006 Medical Product Manufacturing News

IPO Market Slowing Down

By contrast, the mergers and acquisitions market remained strong. Let's hope we're not returning to the days when the only way for investors of a device start-up to cash out was to sell the company.

Modular Ac-Dc Switching Power Supplies Are Digitally Controlled

HOTLINE

Modular Ac-Dc Switching Power Supplies Are Digitally Controlled

Corinne Litchfield
A digitally controlled ac/dc switching power supply can be programmed for specific parameters.

A new line of switching power supplies features advanced digital management capabilities. The iMP series of ac-dc switching power supplies from Astec Power (Carlsbad, CA) includes a range of hardware modules. Single-, dual-, and triple-output modules, in power ratings from 600 to 1500 W, allow designers to build custom solutions. Modules can be configured in a selection of four customizable MP cases. Cases can hold up to seven modules, with a choice of outputs ranging from 2 to 60 V dc. Input voltages of 85–264 V ac or 120–350 V dc are available.

“This new breed of switching power supplies uses integrated digital resources to provide smart communication,” says Astec product marketing director Chris Jones. “The control features in the iMP series will enable designers to fine-tune power during the development process.” In addition, the onboard microprocessor allows engineers to adjust such factors as voltage, current, fan speed, and sequencing.

Users can set key features on each output. Voltage, enable and sequencing module, inhibit and enable polarity, dc okay thresholds, current limit set-point and type, and overtemperature thresholds can be programmed using the iMP- series intelligent I2C control. The systems can also capture configuration and parametric data for each output.

Copyright ©2006 Medical Product Manufacturing News

Shareholders Approve Guidant/Boston Scientific Deal

Starkey's Story Is Heard

Voltmeter Enables Contact with Minimal Charge Transfer

HOTLINE

Voltmeter Enables Contact with Minimal Charge Transfer

Shana Leonard
An ultra-high-impedance voltmeter performs contact measurements with virtually no charge transfer to or from the ESD-sensitive item.

Electrostatic discharge (ESD) has the potential to destroy a device. And yet, most products intended to measure site-specific voltage on ESD-sensitive devices actually transfer charge upon contact. Though the ESD riddle has continually gnawed at the industry, one company claims to have the answer

Trek Inc. (Medina, NY) has introduced an ultra-high-impedance voltmeter designed to perform contact measurements with virtually no charge transfer to or from the measured ESD-sensitive item. The Model 800 Infinitron features a high input impedance of more than 1016 Ω and low input capacitance measuring less than 10–15 F. ESD transfer is averted because the ultrahigh resistance offers infinite impedance loading.

The company cites the need for contact ESD measuring in real time as one of the motivations behind constructing the voltmeter. With a response time of less than 3.5 millisecond for a 100-V step change, the product is equipped to operate in real-time situations. The firm also notes that accurate and site-specific measurements may help determine causes and effects of ESD issues, leading to improved and more resilient products.

“Using the Infinitron, our ability to accurately measure voltage at a surface, by contact, without affecting the charge of the surface, and without causing an ESD event, has generated true excitement in the electrostatic community,” says Bruce Williams, chief designer of the product.

The voltmeter features a handheld contact probe configured to measure voltage on the ESD-sensitive object. Probe tips are available in round, flat, and pointed shapes, while tip sizes range from 1.27 to 0.76 mm. Measurement capabilities range from 0 to ±100 V dc, or peak ac at ±0.1% accuracy.

Additional features of the voltmeter include an LCD screen with LED back light that shows readings along with time and date, a zero button that provides zeroing of the input, and a hold mode that retains LCD information.

Copyright ©2006 Medical Product Manufacturing News

Rubber Latex Is Safe for People Suffering from Allergies

HOTLINE

Rubber Latex Is Safe for People Suffering from Allergies

Susan Shepard
A natural rubber latex is safe for people with Type I latex allergy.

A natural rubber latex material is made from a desert plant, called guayule, grown extensively in the southwestern United States. The product, developed by Yulex Corp. (Carlsbad, CA), is safe for people with Type 1 latex allergy. According to the company, it also outperforms both synthetic and imported natural rubber latex.

“The market potential for the material is enormous, as 8 to 12% of healthcare workers and their patients suffer from tropical-latex allergy,” says Jeffrey Martin, CEO and president of Yulex. “Previously, there was no natural alternative to make medical devices safe for people with latex allergy.”

Yulex and its network of growers are cultivating proprietary, high-yield lines of guayule. These commercial farms feed the Yulex processing facility near Phoenix, where a patented processing system is used to extract the latex.

The company has signed a distribution agreement with Centrotrade USA and its sister company, Centrotrade Deutschland GmbH, to provide the material to medical device manufacturers.

Primary markets include medical products such as surgical gloves, condoms, and catheters.

Copyright ©2006 Medical Product Manufacturing News

Rubber Latex Is Safe for People Suffering from Allergies : Voltmeter Enables Contact with Minimal Charge Transfer : Modular Ac-Dc Switching Power Supplies Are Digitally Controlled


HOTLINE


Rubber Latex Is Safe for People Suffering from Allergies

A natural rubber latex material is made from a desert plant, called guayule, grown extensively in the southwestern United States. The product, developed by Yulex Corp. (Carlsbad, CA), is safe for people with Type 1 latex allergy. According to the company, it also outperforms both synthetic and imported natural rubber latex.

Read more...


Voltmeter Enables Contact with Minimal Charge Transfer

Electrostatic discharge (ESD) has the potential to destroy a device. And yet, most products intended to measure site-specific voltage on ESD-sensitive devices actually transfer charge upon contact. Though the ESD riddle has continually gnawed at the industry, one company claims to have the answer

Read more...


Modular Ac-Dc Switching Power Supplies Are Digitally Controlled

A new line of switching power supplies features advanced digital management capabilities. The iMP series of ac-dc switching power supplies from Astec Power (Carlsbad, CA) includes a range of hardware modules. Single-, dual-, and triple-output modules, in power ratings from 600 to 1500 W, allow designers to build custom solutions. Modules can be configured in a selection of four customizable MP cases. Cases can hold up to seven modules, with a choice of outputs ranging from 2 to 60 V dc. Input voltages of 85–264 V ac or 120–350 V dc are available.

Read more...

Copyright ©2006 Medical Product Manufacturing News

Sensor Provides Control for Noninvasive Disc Procedure


HOTLINE

Sensor Provides Control for Noninvasive Disc Procedure

Shana Leonard

Surgical options to treat Degenerative Disc Disease-the erosion of invertebral discs-are relatively limited. Operations such as spinal fusions can be very painful and require a lengthy recovery period. However, a minimally invasive procedure that employs sensor technology may alleviate pain without the discomfort of major surgery.

The MTS Systems Corp., Sensors Div. (Cary, NC) C-series linear sensor was incorporated into a surgical tool to ensure controlled release of essential elements. The Dascor disc arthroplasty system provides patient relief by removing the damaged nucleus of an invertebral disc and replacing it with an artificial one.

In order to do this, a minor incision is made in the outer rim of the disc and the damaged nucleus is extracted. Then, a two-part curable polymer is injected into the disc and bonds with an expandable polyurethane balloon to form a faux nucleus. The implant restores the disc to a healthy position and serves to minimize back pain.

However, early iterations of the system delivered the two-part polymer to the disc site pneumatically. Surgeons were concerned with the difficulty of controlling the amount of polymer injected into the disc. The integration of the MTS Temposonics sensor into a reconfigured microprocessor-based unit enabled controlled dispensation of the polymer. The revamped surgical tool design depends on sensor monitoring of a ball screw driven by a brushless motor for measured release of the polymer.

"Temposonics was chosen because of its no-wear nature, no drift-over-time, no required calibration, and ease of connection to the mechanical system," says MTS Temposonics commercial product marketing manager Jesse Russell.

In addition to its application in a minimally invasive surgical tool, the Temposonics sensor also boasts the claim of smallest magnetostrictive sensor available. At 36 mm, the product measures 45% smaller than its predecessors, according to the company. "Its small size, enhanced sensitivity, and automatic-adjustment features make it ideal for this application," Russell says.

Other features include a 4-mm shaft diam, an 18-mm dead zone, and a 21-mm null zone. The sensor has a repeatability of ±25 µm and an operating temperature ranging from -40° to 75°C.

Additional medical applications for the sensor include its use in medical beds, grippers, filling mechanisms, and dispensing tools. The Dascor disc arthroplasty system has been approved for use in Europe and is currently undergoing U.S. clinical trials.

Copyright ©2006 Medical Product Manufacturing News