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Articles from 2005 In December


Products from the MPMN Mailbox

Originally Published MPMN January 2006

PRODUCTS

Products from the MPMN Mailbox

Rapid Soft Tooling

A manufacturer of plastic parts has introduced rapid soft tooling (RST). Micro Plastics Inc. (Flippin, AR; www.microplastics.com) offers the process for making washers, shoulder washers, and spaces. RST is suitable for fast-paced design engineering and low-volume production runs. According to the company, RST can be used to produce parts in one week. Part specification requirements include a maximum OD of 1 1/16 in., and maximum ID of 7/8 in. A minimum wall thickness of 1/32 in. for small parts and 3/64 in. for larger parts can be achieved.

Temporary Masking Resins

Temporary masks offer surface protection for orthopedic implants, implant hardware, surgical instruments, and medical devices. The Speedmask 7100 series of temporary metal masking resins from Dymax Corp. (Torrington, CT; www.speedmask.com) cure in seconds using UV light. Multiple viscosity ranges simplify dispensing and reduce mask application to a single-coat process. The resins leave no toxic residue on surfaces and resist acid and alkali cleaning and plating solutions. A range of adhesion levels are available for sealing and protecting surfaces during tumbling, peening, abrading, and cleaning processes. Blasting and peening masks eliminate external damage to coated and noncoated surfaces. The masks are available in both peelable and water-soluble grades. Peelable masks peel away from surfaces at room temperature or after a warm water soak at 120° F. Water-soluble masks wash off with hot water spray or in agitated baths ranging in temperature from 140° to180° F.

Rotary Encoders

Incremental rotary encoders can be used in harsh application environments. The RVI58 series encoders from Pepperl + Fuchs (Twinsburg, OH; www.am.pepperl-fuchs.com) have incremental measurement outputs up to 10000 ppr and an IP65-rated 58-mm diam aluminum housing. The encoders come standard with a shielded cable or round connector, and feature quadrature and index outputs or quadrature and index plus complementary outputs. Additional features include a servo or clamping flange, 6- or 10-mm diam shaft, alarm output, and 10–30 V dc or 5 V dc power capability.

Honing Machine

A vertical honing machine can be used for precision honing of 0.75 to 8 in. bores. The SV-10 vertical machine from Sunnen Products Co. (St. Louis, MO; www.sunnen.com) has two motors, one for the spindle and one for the stroker. The DH-series diamond hone has 16 points of cutting action. The mechanical stroke guarantees precision surface finish with consistent crosshatch angle in each cylinder. The machine also features a patented full bore profile display, which projects a real-time graphic of the bore cross-section. A zoom feature maximizes the bore view. During the cycle, the machine allows the operator to dwell the honing tool anywhere throughout the bore. The dwell pointer can be moved to the position where the bore is visually smaller and the tool will dwell there as long as necessary. Variable spindle rpm and stroke speed allows an infinitely variable crosshatch angle for any bore-diameter and cylinder-length combination.

Aseptic Dispense Valve

A precision dispense valve has an aseptic design that reduces the risk of contamination in sterile fluid–filling processes. The 754V-SS from EFD Inc. (East Providence, RI; www.efd-inc.com) uses a low-maintenance diaphragm design to provide fast, precise dispensing of most low- to medium-viscosity fluids. It can be cycled up to 500 times per minute, with shot size ranging from 0.5 μl to a continuous flow rate of 60 μl/sec. A fast, clean cutoff after each shot prevents drips and waste. To ensure sterility and simplify cleaning, the valve’s fluid path is smooth and free of areas where contaminants or bacteria could collect. Wetted parts are made of FDA-compliant 316L stainless steel and PTFE suitable for clean-in-place or sterilize-in-place processes. Instead of seals or O-rings, the valve uses an inert PTFE diaphragm, conservatively rated at 10 8 cycles, to isolate the fluid from the valve’s internal parts. The amount of fluid dispensed is determined by a combination of fluid pressure, flow rate, and valve open time, with open time regulated with a microprocessor-based ValveMate controller. Mounted near the valve, the controller simplifies system setup and allows open time to be adjusted in increments as small as 0.001 sec, for consistent and precise shots.


Copyright ©2005 Medical Product Manufacturing News

LED Manufacturer Brightens up Surgical Devices

E-Newsletter Exclusive

LED Manufacturer Brightens up Surgical Devices

A LED upgrade kit manufacturer has adapted its proprietary commercial product for use in medical and surgical applications. Terralux Inc. (Boulder, CO; www.terralux.biz) has designed a high-powered LED system for use in Class 1 medical devices. The system will be used to replace incandescent bulbs in handheld surgical instruments.

Founded in 2003, Terralux offers upgrade kits for use in portable lighting. The kits include an LED light engine designed to replace incandescent bulbs that usually burn out in a few hours. The unit couples an LED with an electronic component that regulates light output and optimizes power consumption. When used in place of an incandescent bulb, the unit emits pure white light and can operate up to 100,000 hours without a change in light intensity as the battery runs down. In addition, the product extends the battery life by using a proprietary PowerPush circuitry, which matches the LED to the power supply. Unlike incandescent bulbs, which break easily when dropped, the light engine is an extremely rugged, solid-state device that is almost impervious to shock and vibration.

Lighting used in medical and surgical equipment is often custom-made and, therefore, expensive to maintain. Terralux adapted its existing light engine technology for the medical OEM’s product, says CEO Anthony Catalano.“We coupled the light from the LED with an optical fiber cable and added some mechanical packaging,” he says. Since the company already mass-produces the light engines, the OEM was able to reduce costs associated with design development and prototyping. “By taking our technology and moving it over to the OEM’s product, we eliminated a lot of engineering hurdles,” adds Catalano.

Regularly used to enhance flashlights made by Mag Instruments, the light engines can be used in other medical applications.

Corinne Litchfield



Copyright ©2005 Medical Product Manufacturing News

Medtech Snapshot

Originally Published MDDI December 2005

Medtech Snapshot

Want to know what the future holds for the device and diagnostic industries? The snapshot notes key developments and projections for the coming years.

 

Copyright ©2005 Medical Device & Diagnostic Industry

Allergan Prevails in Contested Battle to Acquire Inamed

In a pitched and convoluted battle to acquire breast-implant manufacturer Inamed Corp. (Santa Barbara, CA), Allergan Inc. (Irvine, CA) has emerged as the victor.

Last March, Inamed accepted a $2.8 billion offer to be acquired by Medicis Pharmaceutical Corp. (Scottsdale, AZ), a manufacturer of prescription acne and skin medications. But in mid-November, Allergan suddenly upped the ante with a $3.2 billion bid. The situation was further complicated by an unsolicited and somewhat underpowered move from Inamed competitor Mentor Corp. (Santa Barbara, CA) to acquire Medicis for $2.2 billion.

Shacknai

Medicis' Shacknai: No bidding war.

The bid by Allergan, which currently develops pharmaceutical products for the ophthalmic, neurological, dermatological, and other markets, ultimately proved to be too rich for Medicis to counter. Citing the advice of the company's board, outside counsel, and financial analysts, Medicis chairman and CEO Jonah Shacknai said, “We have concluded that it is in the best interests of Medicis shareholders not to raise our offer for Inamed.”

2005 MEDTECH SNAPSHOT Manufacturing: Increased Sites Reflect a Healthy Device Industry

Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published MDDI December 2005

 

Nearly every state saw an increase in the number of registered device manufacturing facilities in 2005. Overall, the number of FDA-registered medical device establishments increased from 2004 (11,071) to 2005 (11,364). To submit registration and listing submissions, contact FDA at the following numbers: 240/276-0111; fax: 301/527-9187, or e-mail reglist@cdrh.fda.gov. For policy questions, contact CDRH at 240/276-0110; fax 240/276-0140; or e-mail rlprogram@cdrh.fda.gov.

Click images to enlarge:

FDA-registered medical device establishments, with the number of firms and percentage of U.S. total for each state. Establishments include manufacturers, contract manufacturers, repackagers/relabelers, and rebuilders/refurbishers. Percentages for each state are rounded to the nearest whole number. Source: CDRH establishment registration database.

Metropolitan areas with the highest concentration of biomedical engineering workers, 2004. Source: U.S. Department of Labor, Bureau of Labor Statistics.
States with the highest concentration of medical scientists for 2004. Source: U.S. Department of Labor, Bureau of Labor Statistics.
Metropolitan areas with the highest concentration of medical science workers. Source: U.S. Department of Labor, Bureau of Labor Statistics.
The number of FDA-registered medical device establishments in the United States in 2004 compared with 2005. Source: CDRH establishment registration database.
Medical device manufacturing, repackaging, and rebuilding operations, by state. Source: CDRH establishment registration database.

Copyright ©2005 Medical Device & Diagnostic Industry

Boston Scientific Makes Bid for Guidant

In early December, less than three weeks after Johnson & Johnson Inc. (J&J; New Brunswick, NJ) thought it had finally put the wraps on its nearly year-long ordeal to acquire Guidant Corp. (Indianapolis), who should emerge to put the whole deal on ice but rival cardiac device maker Boston Scientific Corp. (Natick, MA).

Boston Scientific's sweetened bid of nearly $25 billion quickly garnered the interest of Guidant management and shareholders. It was about $4 billion more that J&J's renegotiated offer, which Guidant appeared to accept reluctantly following months of damaging disclosures and recalls of nearly 300,000 of its implantable cardioverter defibrillators (ICDs) and cardiac pacemakers.

The bid is only $400,000 less than J&J's original $25.4 billion offer, and was made just days after Boston Scientific was itself rumored to be a takeover target.

Regulatory: Alphabet Soup: MDUFMA, PMAs, and 510(k)s

Originally Published MDDI December 2005

 

2005 MEDTECH SNAPSHOT

The dramatic increases in the user fees mandated by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) have sparked much discussion and controversy during the last few years. In response, FDA prepared a report that examines the unit costs of the agency's medical device review process. The unit costs are, in effect, the average costs for FDA to review various types of applications during a particular period of time.

Other user-fee programs, such as the Prescription and Animal Drug User Fee Programs, differ from MDUFMA significantly, according to the report. Those user-fee pricing mechanisms have resulted in lower fees per application because the majority of fee revenue is collected from other mechanisms, including manufacturing establishments and product and sponsor fees. MDUFMA user fees, however, are derived solely from applications.

Fees collected as a percentage of program cost. User fees as specified in MDUFMA are not cost-based, and the user fee is a relatively small supplement to, rather than a replacement for, appropriations. Source: FDA Unit Costs for the Process of Medical Device Review.
Medical device manufacturing, repackaging, and rebuilding operations, by state. Source: CDRH establishment registration database.
Office of Regulatory Affairs (ORA) costs for the process of the review of device applications. The costs include total process costs, including costs paid from appropriations and fee revenues. Source: FDA Unit Costs for the Process of Medical Device Review.
CDRH distribution of costs for general support functions for reviews. Source: FDA Unit Costs for the Process of Medical Device Review.
Average review time for original premarket approval (PMA) applications increased from 221 days in 2003 to 285 in 2004. Non-FDA approvals increased from 70 days to 143 days. Source: ODE annual report.
The increase in the number of 510(k) submissions reviewed by third parties can be attributed to FDA's implementation of MDUFMA's user-fee provisions during FY 2003. The provisions required applicants to pay a fee when submitting 510(k)s without a third-party review. Source: ODE annual report.

Copyright ©2005 Medical Device & Diagnostic Industry

Clarus Closes $500M Fund for Life Sciences Investment

Wheeler

Wheeler: C-level experience.

Clarus Ventures (Cambridge, MA), a new venture capital firm focused on life sciences, has closed its inaugural fund of $500 million. The fund will provide capital and resources for portfolio companies primarily in the biopharmaceutical and specialty pharma sectors, but will have a secondary focus on medical device manufacturers and companies developing biotechnology platforms.

According to Clarus, the fund will invest up to $50 million per company, with a preferred investment size of between $20 million and $30 million. The company plans to begin pursuing investment opportunities in early 2006.

Galakatos

Galakatos: Creating company value.

Clarus was founded by a group of investment professionals with varied backgrounds in the healthcare arena, as well as experience in research and development, commercialization, business development, and management. Among its managing directors is Kurt C. Wheeler, founder and former CEO of InControl (Redmond, WA), a publicly traded cardiac device company that was acquired by Guidant (Indianapolis) in 1998.

“Each member of the Clarus team has a track record of consistently building companies that are emerging leaders in their sectors,” says Nicholas Galakatos, PhD, a Clarus managing director. “The Clarus partnership has the breadth and depth required to create significant value by investing at any stage of a life sciences company's growth.”

© 2005 Canon Communications LLC

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