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Articles from 2002 In April


Beyond the Daily Grind

Originally Published MPMN April 2002

EQUIPMENT NEWS: Metal Fabrication Equipment

Beyond the Daily Grind

New machining, drilling, and cutting technologies offer a range of benefits

Katherine Sweeny

By definition, medical device components require high precision and tight tolerances. Metal, a generally difficult material to work with, must be manipulated into forms that suit those standards. In response to increasing demands by manufacturers, metal fabrication technology developers are constantly updating their systems to meet the needs of the medical device industry. A long-life mold and die miller, a laser micromachining system, and an electrofission cutting and forming machine are some of the new products discussed in this article. These and other products with metal fabrication applications are included below.

Mold and die miller offers precision milling without thermal distortion

A vertical mold and die miller is designed to mill steel mold inserts, mold components, and die parts directly from a hardened block. The YBM-950V from Yasda Precision America Corp. provides high stock-removal rates, long cutter life, and excellent surface-finish results. According to the company, its stock-removal rates are as much as five times higher and its surface-finish results are as much as three times better than other machines in its class.

The YBM-950V from Yasda Precision America Corp. features a self-adjusting spindle and resists thermal deformation.
The YBM-950V features a self-adjusting spindle that enables stock removal with fine-finishing machining and is guaranteed to perform for 20,000 hours. Because the spindle system contains the largest exothermic parts, it suffers most from thermal deformation, which can cause inconsistent machine accuracy. The machine prevents deformation by circulating heat-exchange fluid through the spindle assembly and other main components to bring them to room temperature. This causes the machine to be suitable for finishing operations that require long durations with the same cutter. In addition, a direct-drive system includes a diaphragm coupling that enables accurate spindle rotation, isolates vibration and heat from the spindle drive motor, and enhances machining accuracy and surface finish.

A self-adjusting system provides an appropriate preload for a range of spindle speeds, whether for heavy-duty cutting at a low rpm or low heat generation for rotation at high speeds. The spindle and drive motor are connected coaxially by a diaphragm coupling to achieve high-precision rotation throughout the entire speed range. High-precision machining can be achieved even in tough machining conditions such as varied-directional cutting resistance machining, high-helix-angle end milling, and back-face machining.

A window-shaped, bridge-style construction employs an extra rib on the base of the bridge to improve the rigidity of the structure. The YBM-950V has a 40 x 20-in. table with an x-y-z travel of 30 x 20 x 14 in., a 1760-lb load capacity, a 20,000-rpm maximum spindle speed, an 800-items-per-minute maximum rapid feed, and a 500-items-per-minute maximum feed rate.

Portable plasma cutter offers speed and cost improvements

Hypertherm's Powermax 1000 G3 is a portable plasma cutter with voltage-sensing technology.
A portable plasma cutting system incorporates input sensing, which allows it to run on 200–600 V in one or three phases, or on 230–400 V in three phases without the need for manual linking. The Powermax 1000 G3 from Hypertherm uses the same power supply and torch technologies as the company's previous model, but offers more speed and efficiency. The 1000 G3 has a power supply that compensates for voltage variation. Its digitally controlled inverter delivers continuously adjustable constant current output from 20 to 60 A and permits high-quality cuts over a range of metal thicknesses. According to the company, the system's torches, T60 and T60M, feature electrodes that extend consumable life by as much as 10 times in tests against previous models. Nozzle wear is reduced by a dual-threshold pilot circuit. A coaxial-assist jet design boosts cutting speed by up to 20% and blow-back technology delivers a pilot arc without high-frequency interference. The system operates under harsh environmental conditions with a variety of options to respond to the specialized needs of different applications. >uses the same power supply and torch technologies as the company’s previous model, but offers more speed and efficiency. The 1000 G3 has a power supply that compensates for voltage variation. Its digitally controlled inverter delivers continuously adjustable constant current output from 20 to 60 A and permits high-quality cuts over a range of metal thicknesses. According to the company, the system’s torches, T60 and T60M, feature electrodes that extend consumable life by as much as 10 times in tests against previous models. Nozzle wear is reduced by a dual-threshold pilot circuit. A coaxial-assist jet design boosts cutting speed by up to 20% and blow-back technology delivers a pilot arc without high-frequency interference. The system operates under harsh environmental conditions with a variety of options to respond to the specialized needs of different applications.

Laser micromachines tiny features in hard materials

A new model in a series of industrial-grade diode-pumped solid-state lasers delivers 10 W on average and ≥100 GW/cm2 peak power intensity. Offered by Lambda Physik Inc., the PowerGator 355-10 microfabricates high-aspect-ratio features in hard materials measuring more than 1 mm thick. Short 15-nanosecond pulses and 355-nm wavelengths improve plasma penetration and reduce heat-induced effects, microcracking, and redeposition of material to produce high-quality surfaces. These capabilities make the machine suitable for manufacturing components out of difficult-to-machine materials that require drilling and cutting of micron-size features. High beam quality allows focusability for feature sizes less than 10 µm down to submicron levels. The PowerGator 355-10 can machine most materials including metal alloys, ceramics, silicon, and polymers. It is available in 1064- and 532-nm wavelength versions to enable further process optimization by matching spectral absorption characteristics of the material. Other features include a hermetically sealed laser head, RS-232 function control for hands-free operation, and remote and removable supply units.

Laser system features robust software package

A complete turnkey workstation marks, engraves, and cuts a variety of medical materials using laser technology. The Laser Mate II from Online Inc. can function as a stand-alone unit, or it can be mounted over an existing conveyor line in a cleanroom setting. Devices such as dials, conveyors, and indexers can be attached for high-volume applications via extra inputs and outputs on the system's periphery. A software package operates in a Windows format and enables users to import different types of files without converting them. Both raster and vector graphic images can be marked while controlling speed and power settings. In addition, industry-standard bar codes that can mark more than 150 characters per second with text smaller than 0.015 in. are included for marking and traceability.

Graphite-machining center works with small electrodes and intricate tooling

Datron Dynamics' M4 graphite-machining center offers high accuracy for machining intricate and tiny parts.

Equipped with sealed and pressurized linear guideways and ball screws, a high-speed graphite-machining center is suitable for working with small electrodes that requires intricate tooling. The M4 from Datron Dynamics also features intuitive control with look-ahead buffers and a 60,000-rpm liquid-chilled spindle with an automatic tool changer. The machine measures 48 x 50 in. and offers a 15.75 x 15.75 x 11.8-in. working envelope. Its solid one-piece construction provides structural stability and vibration dampening. The high-speed spindle, combined with intricate tools and a stable construction base, produces a high-quality surface finish and the accuracy required for intricate electrodes. The unit comes with a Pentium-based PC operating system that offers canned cycles. An accompanying handheld pendant is designed for easy access and operation. Customized for optimal airflow, its enclosure captures airborne dust and can be retrofitted to work with existing graphite-dust collection systems. A central lubricating system facilitates part replacement. An optional z-height precision sensor enables users to measure the contours of a workpiece in 3-D before running a job. The M4 is compatible with standard carbide tools and can be used with the company's line of microtooling products.

Vibration-free tooling minimizes breakage

The ML200 from TBT Automotive Div. precisely drills deep holes without external vibrations.

Able to handle bore diameters from 0.03 to 0.5 in., two numerically controlled drilling machines have maximum depths of 16–50 in. Available from TBT Automotive Div., the ML200 and ML250 use high-frequency controlled motor spindles with rotary oil couplings integrated into the motors to eliminate external vibration. According to the company, tools as small as 0.0315 in. running at speeds up to 24,000 rpm and oil pressure of 2400 psi can break with even the slightest vibration. Elimination of drive belts helps to make the spindles maintenance free. The feeds and speeds of the drills can be changed depending on the tool position in the workpiece. Process repeatability can be observed with spindle power consumption and coolant pressure indication. The machines are offered in 1-, 2-, 4-, and 6-spindle versions and have counterrotation for the workpiece to reduce bore runout. Field reliability can be as high as ± 96%.

Pressing systems offer precise operator control

The ServoPress from Schmidt Feintechnik Corp. allows in-process control and monitoring.

A line of pressing systems offer 100% in-process control and monitoring. The ServoPress systems from Schmidt Feintechnik Corp. are compact and precise, providing easy-to-understand and easy-to-use operator interfaces and flexible components. Each lectromechanical ServoPress module has a servomotor-driven press ram and a Windows-based PressControl 4000 system with CNC and PLC controls. The machines continuously perform precise assembly operations without mechanical stops in the components or tooling. This is achieved with the closed-loop control of the numerically given force, stroke, and ram feed-rate parameters. A dual-channel light-curtain control system, with a complete guarding of work area, protects the operator. The systems organize, administer, and graphically present production data. The PressControl 4000 can perform either random or simultaneous operations on up to six ServoPress units or other CNC-operated axes such as positioning devices and robots. Data communication is via the serial field bus CANopen, enabling problem-free integration of frequency convertors and I/O modules that meet the CANopen standard. All four ServoPress models function as modular units, and can be operated as single-station benchtop cell units, or integrated into existing systems.

Fiber-optic laser system suitable for welding applications

A pulsed Nd:YAG fiber-optic beam-delivery laser system covers a working range of up to 200 W. Provided by Lasag Industrial-Lasers, the SLS 200C-16 is an air-cooled system with a compact design that can be integrated into new or existing workstations. A real-time power supply makes the system suitable for peak-power controlled welding applications with high demands on precision, quality, and throughput. The SLS 200C-16 is available with up to six fiber outputs for energy and time-sharing with a pulsed-on-demand operation. Fibers are offered in 100-, 200-, 400-, and 600-µm core diameters. Other features include a completely sealed power supply with active water or air cooling, a PC interface and Windows-based software, and a modem for remote operation and diagnostics. The system is suitable for precision spot and seam welding, hermetic sealing of medical parts, cutting, and micromachining.

Electrofission cutting and forming machines eliminates extra tooling

Using an electrofission process, machines can cut and form wire and tubing without the need for tooling. Working with a range of alloys with diameters to 0.0787 in. for wire and 0.1 in. for tubing, the UDR-series units can cut lengths as small as 0.2 in. The series is supplied by a joint venture between Jouhsen Bündgens and Cold Header Machine Corp. The electrically powered UDR units heat the wire and perform a cutoff through one mobile slide and one stationary slide. With the parting of the heated wire, both ends of the cutoff are identical and slightly rounded. The machines can operate with tight tolerances at speeds of 500 parts per minute. Their electrodes prevent the need for extra tooling, thereby reducing cost. In tubing-cutting applications, the systems reduce the need for honing because there is little diameter reduction in the cutoff process.

Copyright ©2002 Medical Product Manufacturing News

Web Site Sheds Light on Laser Processing Questions

Originally Published MPMN April 2002

E-NEWS

Web Site Sheds Light on Laser Processing Questions

Zachary Turke

www.gsilumonics.com/sources

A new Web site maintained by GSI Lumonics (Billerica, MA) helps device manufacturers familiarize themselves with laser materials processing. Containing a range of information on laser welding, cutting, and drilling, the page features two services that allow users to submit sample parts for processing and to ask laser experts specific questions. "We are attempting to provide the visitors to our Web site with more information about laser processing and to help them understand the issues and benefits associated with this technology," says applications manager Tom Kugler.

Putting OEMs in direct contact with applications engineers, the "Ask an Applications Expert" section of the company's site allows users to submit laser processing questions via e-mail. Users are prompted to detail the application in question with all relevant process information, including part material, thickness, weld penetration requirements, case depth, and hole diameters, to ensure that a comprehensive answer can be provided. Drawings or photos can also be included with the query. GSI Lumonics will respond by e-mail or telephone within two business days of receipt of the inquiry.

Information about submitting sample parts for processing can be accessed under the "Get Samples Processed" portion of the Web site. Manufacturers seeking to take advantage of this service are required to submit an on-line form that describes the processing parameters. After the form is received, a representative from GSI Lumonics will contact the company to arrange the part exchange.

Copyright ©2002 Medical Product Manufacturing News

Doyen Unwraps On-Line Packaging Validation Seminar

Originally Published MPMN April 2002

E-NEWS

Doyen Unwraps On-Line Packaging Validation Seminar

Zachary Turke

www.doyenmedipharm.com

An on-line seminar offered by Doyen Medipharm Inc. (Lakeland, FL) details new concepts in the development and implementation of packaging validation plans. "In these challenging economic times, effective validation processes are of great importance to medical device manufacturers," says president Ray Johnson. "Our seminar highlights an approach to validation that satisfies the FDA requirement for zero critical defects and helps companies improve their bottom lines." Topics addressed in the seminar include focusing on the most critical concerns, generating planned maintenance and standard operating procedures within the validation framework, controlling change, designing meaningful tests, and complying with FDA regulations.

Combining pictures, text, animation, and audio commentary, the seminar is presented in a slide format that mimics the company's live presentations. Viewers can access the information 24 hours a day and navigate through the pages at their own speed. Created using both Flash animation software and HTML coding, the seminar runs directly from the user's computer without download delays. Templates, technical documents, and other free resources can also be accessed on the company's Web site.

Copyright ©2002 Medical Product Manufacturing News

My Favorite Bookmarks

Originally Published MPMN April 2002

E-NEWS

My Favorite Bookmarks

How-Lun Chen,
Assistant Design Engineer
Ethicon Endo-Surgery Inc.

Zachary Turke

MatWeb (www.matweb.com) is a helpful page that contains information on more than 26,000 plastics, metals, ceramics, fibers, and other engineering materials. Each listing details basic material properties, including elastic modulus and tensile and yield strength, that are useful when performing finite-element analysis and mold-flow simulations. The best aspect of the site, though, is its powerful search engine that allows browsing by trade name, manufacturer, material type, or even by desired material composition or properties.

The CancerWeb On-Line Medical Dictionary (http://cancerweb.ncl.ac.uk/omd/) is a free resource that offers help with the often-confusing vocabulary of cell biology, biochemistry, and other medical sciences. I have to write many reports as part of my job, and I find this site useful for finding correct spellings and explaining unfamiliar terms. The page contains 46,000 listings that are cross-referenced with each other through hyperlinks to ease understanding. There is even a section that explains how to use the dictionary as your word processor's spell-checking resource.

Laparoscopy.com (www.laparoscopy.com) is a Web site that specializes in information related to laparoscopic surgical procedures. My company produces many of the minimally invasive devices used in these operations, and this is an interesting resource for learning about the manner and conditions in which the tools will actually be used. With movies and pictures of real procedures, this site has given me a better understanding of surgeons' needs, information I can apply when designing new products.

MicroPatent (www.micropatent.com) is an intellectual property resource that I find helpful when searching for patent information. The site has a powerful search engine that uses proprietary software to provide fast and comprehensive searches. Offered in pdf format, the patent listings are available in both complete and abstract forms, and come complete with diagrams when applicable. Regular data updates ensure that the information on the site is accurate and timely.

Ethicon Endo-Surgery Inc. (Cincinnati; www.ethicon.com) produces single-patient-use and other instruments for minimally invasive and traditional surgical procedures. Servicing the urology, breast care, and pain management markets, the company works with surgeons to develop procedure-enabling products.

Medical Product Manufacturing News is seeking design engineers to share their Internet expertise with our readers. If you or someone else from your company would like to participate in this column, please contact associate editor Zachary Turke by phoning 310/445-4268 or via e-mail at zachary.turke@cancom.com.

Copyright ©2002 Medical Product Manufacturing News

In Brief

Originally Published MPMN April 2002

INDUSTRY NEWS

In Brief

Katherine Sweeny

White Electronic Designs Corp. (Phoenix) has received a third follow-on order to provide display module assemblies for medical monitoring systems. The company supplies semiconductor products that support network systems, switches, base stations, and other hardware platforms....Producer of flexible film and sheet products Tyco Plastics (Minneapolis) has been placed up for sale by Tyco International Ltd. (Pembroke, Bermuda). Tyco International will reorganize its businesses into four operating units....BarcoView (Kortrijk, Belgium) has signed a long-term contract with Agfa-Gevaert N.V. (Mortsel, Belgium) for delivery of a range of Barco medical gray-scale displays, graphics controllers, and calibration software. Afga-Gevaert will integrate Barco's products into its current line....Amicon Plastics and UFC Fluorogreen (both of Houston) have announced the appointment of Hartwell Associates Inc. (Newtown, PA) as their manufacturing representative in New England, New York State, the mid-Atlantic states, and eastern Canada. The two companies have also formed an alliance with American Plastic Molding Corp. (Scottsburg, IN) to offer injection molding capabilities along with hot stamping, insert molding, sonic welding, subassembly, and prototyping services.... Provider of water-based coatings for medical devices AST Products Inc. (Billerica, MA) has signed licensing agreements with Bioteque Corp. (Taipei, Taiwan), Conceptus Inc. (San Carlos, CA), and Neich Medical Company, Ltd. (Shenzhen, China). AST offers a specialty coating that is environmentally friendly....Teknor Apex (Pawtucket, RI) has received ISO 10993 biocompatibility approval for a series of its TPV elastomers. The Uniprene 7010 series grades are formulated for use in medical applications in which the parts are constantly in flex....Elcam Plastic (Merom Hagalil, Israel) has established a subsidiary that will operate as Elcam Medical out of Phoenix. The new unit will provide venture business and product development services for the company, which manufactures products used in IV therapy, critical care, and pressure monitoring....Producer of medical wire Fort Wayne Metals (Fort Wayne, IN) has announced an agreement with IDA Ireland (Dublin, Ireland) to increase its European presence and build a 25,000-sq-ft facility in Castlebar, Co. Mayo, Ireland....MedSource Technologies Inc. (Minneapolis) has announced that it has filed a registration statement with the SEC for an initial public offering of its common stock. The company offers engineering and manufacturing services to the medical device industry....Bausch & Lomb Inc. (Rochester, NY) has selected custom injection molder Courtesy Corp. (Buffalo Grove, IL) as its Supplier of the Year for 2000 for Courtesy's ability to keep production pipelines filled in the face of a raw material supply shortage.

Copyright ©2002 Medical Product Manufacturing News

DuPont Divides to Conquer

Originally Published MPMN April 2002

INDUSTRY NEWS

DuPont Divides to Conquer

Norbert Sparrow

If you buy medical packaging materials or fabrics from DuPont Corp. (Wilmington, DE; www.dupont.com), it's time to update your Outlook. The firm has announced a reorganization of its businesses into five groups, or growth platforms, as the company calls them. In addition, it plans to spin off its textiles businesses, which have diverted R&D resources from more-profitable sectors and come under increasing competitive pressure in recent years.

The five market- and technology-focused businesses are electronic and communication technologies, performance materials, coatings and color technologies, safety and protection, and agriculture and nutrition. The restructuring will enable faster execution and improved capability for innovation and shareholder value creation, according to DuPont chairman and CEO Charles O. Holliday Jr.

Medical packaging and Sontara fabrics, which are used in gowns and drapes, will join the safety and protection platform as part of the nonwovens group. Surlyn materials now fall under the performance materials platform.

Copyright ©2002 Medical Product Manufacturing News

Rapid Manufacturing Partnership Formed

Originally Published MPMN April 2002

INDUSTRY NEWS

Rapid Manufacturing Partnership Formed

Susan Wallace

Early adopters of rapid manufacturing—those who make medical devices such as customized hearing aids, dental devices, and prosthetics—will soon benefit from an agreement recently signed by 3D Systems Corp. (Valencia, CA; www.3dsystems.com) and Raindrop Geomagic (Research Triangle Park, NC; www.geomagic.com). The companies have signed a development, marketing, and sales agreement to provide turnkey hardware and software solutions for rapid manufacturing. They already provide key technology components for a rapid manufacturing process for individually designed orthodontic devices at Align Technology (Santa Clara, CA).

Products scheduled to be created by the partnership will include a 3-D scanner for data capture, software for product design, stereolithography solid imaging systems for rapid development, and stereolithography materials used to produce the end product. Consulting and training on processes, products, and technology will also be made available.

"This agreement reflects a cutting-edge vision of rapid manufacturing," says Grant Flaherty, senior vice president of worldwide sales and marketing for 3D Systems. "We are providing a solution that can significantly reduce the time and cost of getting our customers' products to market."

Copyright ©2002 Medical Product Manufacturing News

Bluetooth and Medical Devices: Vital Signs Are Robust

Originally Published MPMN April 2002

INDUSTRY NEWS

Bluetooth and Medical Devices: Vital Signs Are Robust

Norbert Sparrow

The connectBlue serial port adapter with Bluetooth 1.1 wireless technology was used to demonstrate the transmission of electronic data from patient monitors at a recent conference.

Bluetooth wireless technology has experienced delays and sundry growing pains, but Code Blue Communications Inc. (Woodinville, WA; www.codebluecommunications.com) believes it showed the technology's potential for the device industry at the recent Bluetooth Developers Conference. During the December event in San Francisco, the firm demonstrated the wireless transmission of electronic data from patient monitors and a patient-worn device using a Bluetooth 1.1–approved interface.

Code Blue Communications' connectBlue serial port adapter, which incorporates Bluetooth 1.1 wireless technology, enabled the Welch Allyn Propaq CS portable monitor to transmit waveforms for a full set of patient parameters, including multiple ECG channels and respiration. Code Blue also demonstrated the wireless transmission of oxygen saturation, and pulsed and continuous waveform data from a wearable sensor developed by Nonin Medical to a stand-alone monitor. Both device OEMs are currently investigating the feasibility of integrating Bluetooth technology into their products.

"We are exploring the combination of our oximeter solution with Bluetooth technology to dramatically improve patient mobility and to simplify the monitoring of oxygen saturation," says Nonin Medical president and CEO Gary Tschautscher. "Bluetooth technology is a perfect fit and extension to our small, low-power pulse oximetry technology."

The serial port adapter technology has Bluetooth 1.1 and FCC approvals, notes Code Blue Communications president Bill Saltzstein. These approvals "pass through to device manufacturers, allowing them to focus their resources in other areas while incorporating this industry-standard wireless technology into their products," he adds. The devices demonstrated at the conference using Bluetooth wireless technology have not been approved by FDA.

While early hype regarding Bluetooth's performance and subsequent delivery delays bred skepticism in some quarters, stable products and components are now shipping, notes Saltzstein. Interoperability issues with pre-1.1 Bluetooth specifications caused problems for early devices from different manufacturers.

Saltzstein recognizes that these issues led to some negative press coverage and delays in program plans. But the 1.1 spec is solid, he adds, and products shipping with 1.1 approval "interoperate nicely. One minute, I use my iPAQ with an Anycom Bluetooth CF card to connect via GPRS using an Ericsson phone to a Web site," says Saltzstein, "and the next I connect to a prototype medical device with a connectBlue serial port adapter. Different manufacturers, several different profiles, and vastly different applications . . . and they all work easily together."

The product demonstrations at the developers conference, stresses Saltzstein, "demonstrate the capabilities of Bluetooth in the medical market and validate the concept of a patient area network."

Copyright ©2002 Medical Product Manufacturing News

LED Monitor Backlights May Mean Lights Out for Fluorescent Lamps

Originally Published MPMN April 2002

INDUSTRY NEWS

LED Monitor Backlights May Mean Lights Out for Fluorescent Lamps

Zachary Turke

Luxeon LEDs from Lumileds Lighting offer tunable white points and increased brightness in monitor backlighting applications.

High-flux LEDs that offer improved color fidelity and increased product lifecycles may replace cold-cathode fluorescent lamps (CCFLs) in monitor backlighting applications. Produced by Lumileds Lighting (San Jose, CA; www.lumileds. com), Luxeon diodes facilitate more-accurate diagnoses in a range of medical applications by providing users with tunable white points and adjustable color spectrum control. "With these diodes, you can dynamically control and tune in colors to get just the image perspective that you want," says director of corporate communications Doug Silkwood. "And unlike CCFL products, LED-backlit monitors allow this color manipulation without requiring a reduction in gray-scale levels."

In addition to providing enhanced control, Luxeon diodes also offer display manufacturers the ability to produce a greater range of colors. According to company estimates, monitors backlit with these diodes generate 120% of the NTSC color spectrum; conventional displays typically produce only 70%. Other product benefits include the capability to generate twice the brightness levels of some liquid-crystal displays, and the ability to calibrate different monitors to the same white point to ensure a common view when the same image is viewed at multiple locations. LED-backlit monitors also last longer, adds Silkwood. "With no tubes to break or degrade, these devices have a 50,000-hour life expectancy."

Though primarily marketed for 15- to 18-in. monitors, the LEDs are suited for use in displays ranging in size from 5 to 20 in. FIMI S.r.l. (Saronno, Italy; www.fimi.philips.com) will be the first company to take advantage of this novel technology when it begins production of a 15-in. medical display in the third quarter of 2002.

Copyright ©2002 Medical Product Manufacturing News

Tool Kit Simplifies Web Site Design While Satisfying Regulatory Requirements

Originally Published MPMN April 2002

INDUSTRY NEWS

Tool Kit Simplifies Web Site Design While Satisfying Regulatory Requirements

Norbert Sparrow

Establishing and maintaining a presence on the Internet traditionally has required an investment in in-house information technologies or reliance on the services of a Web agency. In addition to funding an activity that can suck up resources, device manufacturers must take into consideration thorny regulatory issues that may arise. A new software tool kit developed by m2e2.net (New York City), Ticto gives nontechnical staff without programming experience the tools to build and maintain Web sites or intranet content. Because it also addresses security and documentation needs, Ticto has gained a growing number of converts among device OEMs.

"Ticto is designed for companies or departments that do not have internal IT expertise, or for situations where IT resources are being deployed elsewhere," says m2e2.net CEO Lauren Andersen. "Because it is provided as a service, there is no software installation or integration required—it works through an ordinary browser window. In fact, Ticto is no more complicated to use than a word processor, and anyone with a basic understanding of computers can learn to produce Web pages within minutes," she adds.

The service can be accessed from anywhere in the world via the Internet, making it suitable for distributed organizations. There is no need for a broadband connection; in fact, a Web site can even be edited over a mobile phone. An additional feature is that sites can be built in most foreign languages without additional software or plug-ins. Ticto accommodates a wide variety of character sets including Japanese and Chinese.

Archiving Feature Allays Regulatory Concerns

These user-friendly features were not developed at the expense of appropriate safeguards, however. Ticto has version control, which means that it keeps an archive of historical versions of a Web site that is accurate to the second. The archive enables a previous Web site to be restored instantly with no technical intervention or special training. It also supports workflow management: Web pages can be signed off by marketing, then queued for approval by a regulatory affairs manager.

The importance of archiving should not be underestimated. Nancy Singer, special counsel at AdvaMed and executive director of the association's Medical Technology Learning Institute, says that medical device companies "are often placed in difficult situations, because FDA has not issued specific detailed guidance on advertising and promotion practices." In particular, she notes, "it is unclear what companies can and can't do to promote products on their Web sites, and FDA has said that no such guidance is on the table." She adds that, until the agency provides some clarification on this issue, "a company's best defense is to ensure its regulatory department signs off all Web promotional material before it goes live, and to keep an archive of all changes to its site."

Money Matters

In the current economic climate, financial hurdles may seem more pressing than legal ones, and Ticto offers many benefits in terms of cost savings, says Andersen. "Users can significantly reduce the cost of maintaining a site by moving regular editing and updating tasks in-house (or in-department)," she says. Ticto can be purchased outright or rented on a monthly basis, thereby spreading the cost over multiple years. This approach can help to reduce risk on a project. The service is compatible with all existing Web site formats, so the cost of switching to Ticto is minimal, adds Andersen.

Guidant Europe in Diegem, Belgium, is using Ticto in its training department to maintain and build its e-learning Web site. The process of updating text and graphics through the company's Web agency had become cumbersome. Ticto allowed Guidant to bring this editorial work in-house, speeding up the process and lowering maintenance costs significantly. Mattie Baker, manager, radiation training, says, "Ticto has given my department direct editorial control over a major e-learning site. I estimate that the investment in this tool will pay for itself in less than three months."

Guidant is also using Ticto to create and maintain its various European country– specific Web sites.

In addition to editorial control, cost savings, and documentation, Ticto offers a number of other useful features. A built-in Web site traffic statistics feature enables users to find out how many visitors have viewed their Web site, which are the most popular pages, what sites visitors go to afterward, which keywords visitors use to search for the site, and more. All this information is available in real time, from anywhere in the world, without programming skills or technical assistance. This helps to alleviate the problem faced by many marketing managers: having to ask their IT department or Web agency for access to site traffic statistics.

Ticto also includes project management tools that allow users to assign individuals responsibility for specific sections or pages. Thus, a company can solicit feedback from its whole team on a draft Web site before it is launched, and that interaction will be confined to one place that is accessible to all team members. Project-related events such as conference calls and deadlines can also be scheduled on-line.

Unlike consumer HTML editing software, the program preserves functionality created by IT staff or by a Web agency. The software includes an automatic change history so that companies can see who has modified which files, and when. Ticto makes it unnecessary to give users direct access to Web servers—a step that could compromise security. All data for a company's Web pages are stored on secure servers, which are backed up continually to prevent loss. Ticto is supported by a multiple redundant server architecture with a history of 100% uptime.

Copyright ©2002 Medical Product Manufacturing News