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Medical Edge August 19, 2008

Aug 19, 2008 2:26 PM

MED_Medical Edge_: Managing medical data on the battlefield

August 19, 2008

Foreign FDA offices a good idea. But who pays?

It's easy to get frustrated with the FDA because it is usually slow acting and risk-adverse. So now comes news the Agency is setting up offices and labs in China, India, and other locations to monitor products headed our way. One has to wonder: What, a proactive FDA? After recovering from the shock, you realize this action is exactly the right thing to do.

Paul Dvorak

Articles

Managing medical data on the battlefield

After the Gulf War, thousands of service members returned from duty without proof of combat-related illnesses and injuries, resulting in loss of benefits. In 1997, Presidential and Congressional mandates called for a medical tracking system and a lifelong electronic medical record for all service members. MC4 is the response
Full Article

Get more from offshoring than just a component

Medical-device designers are continuously challenged to find ways that reduce time and cost in their design and manufacturing tasks. Offshore sourcing of product development and manufacturing is one way to lower the unit costs. However, the lowest unit cost is often not the lowest total cost, particularly when the hidden cost is increased time to market.
Full Article

Combination products challenge their packaging

One begins to appreciate the difficulty and importance of protecting medical devices when you consider that a failed package is sufficient reason to toss a $2,000 drug-coated stent. For more insight to recent challenges in medical packaging and a peek at new developments, especially for combination products, we posed several questions to Edward L. Haedt, vice president of marketing for Perfecseal Inc., Oshkosh, WI, (perfecseal.com). The company develops and manufactures healthcare and pharmaceutical packing.
Full Article

Good bye titanium, hello PEEK

A material incompatibility problem in a surgical head restraint led designers to swap a PEEK-based material for costly titanium. Performance Plastics Ltd. (PPL), Cincinnati, (performanceplastics.com) shaped the restraints with a PEEK (polyetheretherketone) compound from RTP Company, Winona, Minn., (rtpcompany.com) because it was structurally sound and nonmagnetic
Full Article

New Products

Cool lithium cell capable of 2,600 mAh

The CGR26650A, a high rate lithium ion cell, uses a nickel manganese-based cathode material to deliver higher discharge rates and better temperature stability than comparative cells. In addition, a heat resistance layer provides safer operation. The cells are suitable for multi-cell applications. Features include a high discharge rate of up to 40 Amps, a typical capacity of 2,650 mAh, and a high recharge rate capacity, most of which is recovered in 20 min.
Panasonic Electric Works Corp., 1701 Golf Rd, Suite 900, Rolling Meadows, IL 60008, pewa.panasonic.com
Full Article

Power supplies for rough environments

The LS50 (50W) through LS150 (150W) series of ac-dc single-output power supplies cover widely used output voltages including 3.3, 5, 12, 15, 24, and 36V. In some medical applications, ac input-line quality is poor. Factory equipment, for example, can cause fluctuations in input voltages and generate high-voltage spikes. Such line transients and disturbances can reduce the life of power supplies designed only for use in offices. Available in power ratings of 50, 75, 100, and 150W, the enclosed units carry the CE Mark and meet UL/EN/IEC60950-1 safety agency specs. The units have a withstand voltage of up to 1.5kVac input to ground, 3kVac input to output, and 500Vdc output to ground. The units also conform to the immunity standards of EN61000-4-X and the EMC/EMI standards of EN55011-B, EN55022-B and FCC-Class B. All models meet the Power Factor and Harmonic Correction requirements of EN61000-3-2 and are RoHS compliant. Other features include a voltage adjustment potentiometer, a Green LED "On" indicator and screw terminal connections. All units carry a three year warranty. The convection-cooled operating temperature range is from -25 to 70C with deratings above 50C. The LS50 through LS100 series can operate with a universal ac input of 88 to 264Vac, and a switch on the LS 150 selects 115 or 230Vac. The supplies range in size from 3.9 x 3.8 x 1.4 in. up to 7.8 x 3.9 x 1.5 in. and are available now with prices starting from $18.44 each in 100 unit quantities.
Lambda America, 3055 Del Sol Blvd, San Diego, CA 92154, (619) 575-4400, lambdapower.com.
Full Article

Think Cartesian motion for medical assembly and inspections

A version of cartesian motion systems, the camoLine (camo=cartesian motion) provides a modular design for applications such as, medical assembly, material handling, pick-and-place, palletizing, and inspections. The system includes electromechanical and pneumatic axes, bolt-together connections, and aluminum framing. Users select from pneumatic, ball screw, and belt-drive actuators for high positioning accuracy or fast travel speeds. Customers can also choose among servomotors, side drives with timing belts, or planetary gears to complement a variety of design requirements.
The building-block approach of the camoLine makes it flexibile because users can locate holes as needed, work within broad configuration parameters, select from three types of actuators, and change the configuration quickly and easily. Simple bolt-together connections streamline assembly while providing benefits of T-slotted aluminum frames. Brackets and cable management are standardized, which further simplifies design and construction tasks.
Bosch Rexroth Corp, 14001 South Lakes Dr, Charlotte, NC 28273, (800) 739-7684, boschrexroth-us.com
Full Article

Industry Update

Cleveland Clinic Innovation Summit slated for November 10 to 12, 2008

Register now for the early-bird discount.
www.clevelandclinic.org
Witness the innovation revolution, invest in the future of medicine, and envision the limitless possibilities.
Join Robert Rubin from Citigroup, Jim Tobin from Boston Scientific, Tim Ring from CR Bard, Karen Licitra with Johnson & Johnson, Senator Ron Wyden (D-OR), Tommy Thompson, former Secretary of the Department of Health and Human Services and other leading experts in the field at the 6th Annual Medical Innovation Summit. The exciting lineup of speakers, panel discussions, and clinical presentations will reveal the latest trends in medical innovation.
The Summit provides an unrivaled perspective on the newest medical technologies and the financial drivers behind those innovations. It is dedicated to providing singular insights, networking opportunities and actionable take aways for all participants. A few highlights include:

Candid exchanges with leaders shaping the future of medical technology

First hand analysis on new directions for supporting innovation post the historic 2008 election

World leaders who are shaping health care opportunities in important international markets

Detailed insights into the newest innovations in the fast growing urology and gynecology markets including live, interactive surgery

Top 10 Medical Innovations for 2009

www.clevelandclinic.org