Medical Design articles from March 2005

Medical Design archives from March 2005

Is the FDA killing innovation?(medical edge)
March 1, 2005... The FDA announced last year that it's increasing its medical device user fees by about 16%. The Agency charges the fees to review medical technologies before can be sold. The announcement moves the cost of premarket approval (PMA) applications...

Tiny rails make for big improvements.(Brief Article)
March 1, 2005... Miniature linear bearings in a veterinary instrument assist in transferring precise volumes of blood, reagents, wash solutions, and calibration samples. The LaserCyte Hematology System, from Idexx Laboratories, Westbrook, Maine, accurately...

Sensors keep tabs on elderly and young.(Brief Article)
March 1, 2005... A sensor network of cameras, lasers, and smart devices could monitor the elderly and boost their quality of life. Engineers leading the research at Purdue University and Olympus Corp. envision smart devices worn by the elderly and impaired....

Image-analysis tool: handles multiple microscopes.(Brief Article)
March 1, 2005... Engineers with biomedical firm G Systems Inc., Piano, Tex., gsystems.com now use a single image-capture board to analyze images from several specular microscopes. After analysis, software stores results in accordance with FDA regulations. ...

Careful quality planning prevents headaches.(regulations and Federal Drug Administration)
March 1, 2005... Companies that develop their Quality Management Systems (QMS) around best practices are in good position to meet regulatory requirements. The transitional period for ISO 13485:2003 ends in April 2006 for Canada and July 2006 for the EU and...

FEA: guides design of blood pressure sensor.(Federal Energy Administration)(Brief Article)
March 1, 2005... A manufacturer of blood-pressure monitors used FEA to guide development of a sensor that reads out a continuous noninvasive, beat-to-beat signal. A critical part of the apparatus is a complex and flexible serpentine beam. By using the...

Redesign for the Stereo Microscope.(Innovations)(Olympus America Inc.)(Brief Article)
March 1, 2005... Engineering and styling are what managers wanted in their redesigned stereo microscopes at Olympus America Inc., Melville, N.Y. (www.olympusamerica.com). They also wanted the equipment to be compact but still accommodate the complex optical...

Burr begone.(Brief Article)
March 1, 2005... Small machined and formed metal medical parts often come out of production with burrs. Deburring them by hand is costly and time consuming. And some deburring processes generate too much scrap and rework. An alternative, ElectroBurr from...

10 tips for effective design controls: design controls may seem like a lot of paperwork, but they focus attention on a design where it's needed and thereby lead to safer devices.
March 1, 2005... Design controls are required for most medical devices marketed in the United States, Europe, and Canada. The "controls" are actually such as human-factors studies, risk analyses, and descriptions of how different disciplines in your company...

A few good sensors: the latest sensors can report pressures from 0 to 1 psi, provide different outputs, and some even check other sensors.
March 1, 2005... Sensors for medical applications must work at extreme temperatures, fit into tight spaces, and act quickly. The following looks at a few recent sensors and also reviews a new standard for analog sensors in digital networks. Is that sensor...

Finding fit, form, function, and fast: the cutting edge of rapid prototyping is in the operating room but fit, form and function still show what's right and what's wrong in the design cycle.
March 1, 2005... The original role for rapid prototyping was simply to confirm the shape and feel of concept products. But as the technology changes, so has its role in design. Surgeons, for example, are using rapid-prototype (RP) models of bone and tissue to...

Surface characterization: visualize the invisible: there are many different techniques for looking at coated surfaces. Atomic-force microscopes have nanometer resolutions and optical interferometers create color profiles. This closer look at several methods shows where they work best.
March 1, 2005... Improving the performance of a device through surface modification not only differentiates the unit in the marketplace, but it's often a requirement for market success. Sophisticated surface characterization provides fundamental information on...

Three steps to electronic records: getting caught unprepared for an FDA audit while implementing a product-information system can threaten the long-term viability of a company. A few steps, however, can give a better chance of passing the audit.
March 1, 2005... Medical device and equipment companies are challenged with controlling, managing, and distributing product information in a structured and secure environment. This is particularly true when a company keeps all records on paper. A product...

What should designers know about manufacturing?( )(Brief Article)(Editorial)
March 1, 2005... You should know as much as reasonably possible, especially [for the products you're shaping. There is a lot to know and that's why we've started this periodic supplement to Medical Design. It's focused on making medical devices with the latest...

Special DLLs say goodbye to: NC postprocessing.(dynamic linked libraries)
March 1, 2005... A manufacturing group at Brigham Young University says they have developed a machining system that combines master model CAD geometry with toolpaths in one file. It also uses DLLs (dynamic linked libraries) to drive particular machine tools in...

Short-wavelength laser: tightens submicron tolerances.(News)(JP Sercel Associates)(Brief Article)
March 1, 2005... A fluorine gas laser that produces a 157-nanometer wavelength can cut micron-scale features and sub-micron tolerances in ordinarily difficult to machine materials. The capabilities in the UV laser come from developer J P Sercel Associates,...

Software automates electrode design.(News)(PS-Electrode from Delcam Inc.)(Brief Article)
March 1, 2005... Electrode design software, PS-Electrode, customizes a tool's shape and then simulate its operation. The software from Delcam Inc., Windsor, Ontario, Canada, (delcam.com) includes several catalogues of blanks and holders. The software lets users...

Equipment assists in new Heart-Valve replacement.(Machine Of The Month)(HV100 from Machine Solutions Inc.)(Brief Article)
March 1, 2005... Repairing faulty heart valves requires gruesome surgeries that start by cracking open the chests of patients. That may soon be history, thanks to much less invasive techniques that use a stent with living tissue attached delivered with a...

SME forms tech group to guide scanned 3D data.(News)(Society of Manufacturing Engineers)(Brief Article)
March 1, 2005... The Society of Manufacturing Engineers has established a technology group to develop, store, and disseminate ideas regarding 3D data captured from digital and laser scans, and reverse engineering. The group mission is to advance industry...

What designers should know about chemical milling: they're not as flashy as lasers, but photoetching and electrochemical micromachining can turn out fine detail on thin and small parts.(Medical Manufacturing)
March 1, 2005... The chemical milling of medical parts often gets overshadowed by the high-tech aura of more recent methods, such as wire EDM and laser cutting. However, the 50 year old chemical milling process has been developed to the point where many...

Arizona supplier lands multiple customers via e-marketplace.(Case Study)(Action Machine, LLC)
March 1, 2005... Action Machine, LLC, a machine shop located northwest of Phoenix, has recently secured a number of new customers as a member of the First Index. Lead Generation Service. Action Machine specializes in aerospace parts, but is flexible enough to...

Scientific approach to molding.(Products)
March 1, 2005... C. Brewer Company's Scientific Molding techniques takes advantage of the physical properties of plastic to deliver a repeatable system for consistently moving the same volume of material at a tightly controlled velocity. The company has...

Three machines for medical production.(Products)
March 1, 2005... The EDM Wire FA10S combines Mitsubishi's programmable flushing system with a fine-finish power supply and non-isolated workpiece table for unmatchable speed and surface finish. PM4 control works with the inverter-driven flushing system for 20...

Catheter tube marking system.(Products)
March 1, 2005... An FDA-approved catheter robe marking and engraving software package provides a flexible and easy-to-use machine for placing high quality marks on medical grade plastics. System configurations include a multi-use manual load/unload system for...

System spot cures medical adhesives.(Products)
March 1, 2005... A spot-curing adhesive dispensing machine. OmniCure Series 2000 UV/Visible Spot-Curing System, is for medical devices, microelectronics, add optoelectronic manufacturing. The Series 2000 delivers repeatable cures through closed-loop feedback...

Colorless no-clean flux.(Products)
March 1, 2005... A colorless no clean flux is ready for use in EFD's PrintPlus and SolderPlus solder paste lines. The flux leaves a clear residue for a perfect cosmetic joint finish. Printing or dispensed solder-paste deposits retain shape through the reflow...

Benchtop mill cuts prototypes.(Products)
March 1, 2005... MDX-500 and MDX-650 benchtop milling machines quickly and inexpensively turn CAD files into 3D prototypes. Powered by ac servo motors on all three axes, they use feed-forward processing to mill ABS, modeling wax, aluminum, brass, and other...

A guide to manufacturing costs.(Products)
March 1, 2005... Design for Manufacture and Assembly, DFMA 2005A, guides product developers through cost-management practices during design. The software combines DFA Version 9.2 and DFM Concurrent Costing V2.1, and identities major cost drivers associated with...

Custom welded and cast stand-offs.(Products)
March 1, 2005... Custom welded and cast stand-offs are available in carbon steel and aluminum for most industrial applications, and in stainless steel for medical and semiconductor automation processes. Stand-offs mount peripheral devices. Automation cells...

Vertical machining center swiftly swivels.(Products)
March 1, 2005... The FZ08KS tilt vertical machining center uses a swivel-head spindle for single set-up machining of complex parts. It has a swiveling range of -20 to 115[degrees], and it only takes a second to swivel from 0 to 90[degrees]. The 6-axis machining...

Custom tubing in almost any shape.(Products)
March 1, 2005... The die facility at Eagle Stainless produces tubing with cross sections that are oblong, rectangular, square, egg shape, hexagonal, with creases, and of course, round. The company manufactures seamless and welded tubing in a range of diameter...

Retrofit brings precision to tube shrinking.(Products)
March 1, 2005... Thermal Traverser AC-480, a hot air system accessory, assists catheter device manufacturers. The unit retrofits to existing Beahm Hot Boxes to eliminate tedious operator-dependent processes. Precise speed and distance control along with...

Tubing sets speed assembly.(Hoses & Connectors)
March 1, 2005... Pre-assembled tubing sets let manufacturers simplify product assemblies, eliminate assembly errors, ensure leak-free connections, reduce assembly time, and shorten inventory management tasks. Tubing sets made with PTFE tubing in 1/16-in. and...

Tubing parts eliminate leaks, improve flow.(Hoses & Connectors)
March 1, 2005... Custom molding tubing parts are manufactured from PVC-based plastisol. The dip-molded parts eliminate potential leaks, and reduce labor costs. The design means users purchase and stock only one finished product instead of separate tubing,...

Silicone tubing holds up to high pressure.(Hoses & Connectors)
March 1, 2005... HelixMark reinforced tubing is intended for increased-pressure and high-temperature applications. The tubing has strong polyester braiding between extrusions of platinum-cured silicone (65 Shore A), and is marked with an easily identifiable...

Tiny tube for tiny spaces.(Hoses & Connectors)
March 1, 2005... TU/M miniature polyurethane tubing comes in 2-mm OD (1.2-mm ID) size. Seven standard colors are available in 20-meter rolls. A minimum bending radius of only 4mm lets the tubing fit into tight spaces. Maximum operating pressure is 116 psi and...

Products seen at MD&M West.(Design Solutions)
March 1, 2005... Medical Design & Manufacturing (MD&M) West in Anaheim ran January 10 to 12 and attracted over 1,100 exhibitors. The show is held annually to showcase products and services from suppliers of CAD/CAM/PDM software, automation technology,...

2,800 luers and connectors.(Design Solutions)
March 1, 2005... A catalog of precision fluid management components includes luers and connectors for blood-pressure measurements, tube-to-tube tasks, large bore tubes, and threaded units for laboratory jobs. The catalog includes product data, photos, list...

Ready-to-use silicone packaging.(Design Solutions)
March 1, 2005... Silicone packaging features size customization and submicron filtration. Packaging-size customization lets users dispense and discard process-specific packaging, thereby eliminating waste. Another new capability, submicron filtration, helps...

Syringe driver works alone or with 15 others.(Design Solutions)
March 1, 2005... The PSD/2 module is an integrated, self-contained syringe-drive module that works alone or daisy chained in a system of up to 16 units. The rigid one piece cast aluminum chassis provides a rugged platform for system components that results in...

Liquid injection molding.(Design Solutions)
March 1, 2005... A molder of liquid-injection-silicon parts says its electric molding machines can control the clamp cycle so parts come out flash free. Several other advantages of the process include a curing system that uses platinum for faster cycle times...

High-power inlets and outlets.(Design Solutions)
March 1, 2005... High Power inlets and outlets are IP 44-67 rated for dust and splashing water, and can be used on equipment rated from 16 to 32-A with service at 120-250 VAC. Three-pin connectors have 16 to 20-A or 30 to 32-A ratings, come in yellow or blue,...

Cable assemblies save space.(Design Solutions)
March 1, 2005... Flat flex cable assemblies save space and install easily. The cable is ideal for board-to-flat panel display and board-to-board connections. Standard features include 31 and 41 position Hirose DE 9 male and female connectors, optional ZIF ends...

Think slim for small electronics packages.(Design Solutions)
March 1, 2005... System level integration and miniaturization (Slim) is a method for IC packaging design, and assembly. Miniaturization also involves an architectural perspective concurrent with product design choices. The company offers designs, methods, and...

Dot pattern adhesive for direct-skin contact.(Design Solutions)
March 1, 2005... The MACdots coating system lays down adhesive in a dot formation on the liner, instead of the full gum layer of adhesive. Each pressure-sensitive adhesive can be tailored for a specific application based on adhesion, breathability, and pattern....

How to inspect and measure small parts.(Design Solutions)
March 1, 2005... A Quick Image 2D noncontacting video measurement system uses a telecentric lens for a wider field of view and greater depth of focus than conventional methods. It requires less focusing effort and that translates into error suppression and...

Embedded ICs make connectors smarter.(Design Solutions)
March 1, 2005... A Smart connector system seamlessly integrated into cabling and connectors links minimally invasive surgical (MIS) and diagnostic equipment generators to surgical hand pieces, patient electrodes, and transducers--instruments that are the...

Nonmagnetic connectors for MRI environments.(Design Solutions)
March 1, 2005... A range of high-performance nonmagnetic connectors is ready for use in MRI environments where magnetic properties of connector components can obscure the results of MRI scans. The standard magnetic field strength of MRIs is typically 0.5 to 3...

Dispenser works with speed and precision.(Design Solutions)
March 1, 2005... The DispenseJet DJ-9000 assists constructing assemblies for medical devices and biotech products through precise, high-speed delivery of a wide variety of fluids, including UV-cure adhesives, encapsulates, conductive epoxies, and under fills....

Tubing shrinks 4:1.(Design Solutions)
March 1, 2005... A line of PFTE 4:1 shrink-ratio heat shrinkable tubing conforms to the size and shape of the object being covered for easy application on various fittings. The tubing features a thin wall for easy installation over irregular shapes, fittings,...

Circular 405 nm violet laser diode module puts out 50 mW.(Design Solutions)
March 1, 2005... An IQ laser-diode module yields 50mW of circularized violet output at 405 [+ or -] 10 nm. The instrument-quality unit has advanced beam shaping for excellent beam quality and circularity. The module features a precision current source and a PID...

Surface treatments.(Design Solutions)
March 1, 2005... A compact surface-modification system called the PJ is ready for laboratory and production use in several configurations. It's well suited for surface treatment, and cleaning and removing organic contamination from substrates, such as metals,...

No-backlash, no-maintenance helical couplings.(Design Solutions)
March 1, 2005... A product brochure for flexible couplings details the variety of materials, coil configurations, bore diameters, and attachment methods available for the Helical line. Helical couplings compensate for shaft misalignment and work at high speed...

Small character inkjet printer.(Design Solutions)
March 1, 2005... The PB series continuous ink jet printer provides a simple, low cost, 2-line printer for entry-level applications. The printers have an 8.9-in. monochrome LCD touch panel with full intuitive screen menus. The PB series' ink circulation system...

Hybrid linear actuator.(Design Solutions)
March 1, 2005... The compact Size 8 hybrid external linear actuator measures 2 l-ram square, and replaces four different components--a motor, coupling, leadscrew, and nut. A rotating Acme stainless-steel leadscrew is incorporated into the motor rotor,...

Mount multiple regulators on manifold.(Design Solutions)
March 1, 2005... Up to 4 QB3 electronic pressure regulators can be mounted to a manifold which offers a common supply and exhaust port with individual controlled outlet ports to minimize plumbing. The QB3 electronically controls pressure or vacuum by accepting...

Dental and medical bearings.(Design Solutions)
March 1, 2005... A line of bearings offers a variety of retainer materials and designs for quiet and smooth operation of hand tools. The bearings can withstand standard sterilization techniques, and temperatures in excess of 250[degrees]F (121[degrees]C)....

Heavy reserves lead to faster shipments: forget lean inventories.
March 1, 2005... For a good part of our 45-year history, Elpac subscribed to the typical, lean inventory approach. But the scheme called for continually hedging against sales forecasts and bracing for invariable high-quantity purchases. The 1990's, however,...