Medical Device Link.

CAD/CAM/CAE Exhibitors Flock to PDE Show to Answer Every Need

Pacific Design Engineering, colocated with MD&M West in Anaheim, CA, played host to a wide variety of CAD/CAM/CAE vendors, all of whom were demonstrating their software and seeking to "out-wow" the competition. The companies exhibiting at the January 18–20 show ranged from some of the biggest names in the business to fledgling start-ups, all offering the latest solutions to the age-old dilemma of how to make it quicker, better, and cheaper.

Visitors to Pacific Design Engineering were able to source an array of software ranging from products written for niche applications to general-purpose CAD/CAM solutions. Photo courtesy of Oscar & Associates

Products ranged from general-purpose, do-it-all suites that take users from conceptualization to molding or machining the final parts, to specialized niche applications written to fill a specific need. Finite-element analysis (FEA) is a growing area, and it was available both integrated into some of the bigger packages and as a stand-alone application.

Leading off with a one-two punch was Unigraphics Solutions (Maryland Heights, MO), which featured both the Unigraphics suite and Solid Edge. Unigraphics is a high-end modular package that offers 13 CAD modules, 15 CAM modules, and 4 CAE modules, in addition to literally dozens of task-specific add-ons for mix-and-match flexibility. A midrange package developed specifically for mechanical assembly design and drafting, Solid Edge also offers add-ons targeted specifically at sheet-metal and plastic-part design engineers, with process-specific commands to address the unique demands of each.

Structural Dynamics Research Corp. (SDRC; Milford, OH) offered a full range of high-end, Internet-enabled product development and data management solutions. The company's products include the I-deas Artisan and Master CAD/CAM/CAE series, Imageware modelers, and Metaphase product data management tools. Jan Brown, marketing communications manager, noted that the I-deas series' attributes include its scalability, integrated FEA, and data management capabilities. Brown went on to say that the company anticipates a May release for its upcoming version.

SolidWorks Corp. (Concord, MA) showed SolidWorks99, which offers powerful solid modeling capabilities and fully associative drawings—when the drawing is updated, the changes also appear in the 3-D model. The Windows-native application also includes a free viewer, enabling anyone with Internet access to receive and view models. SolidWorks representatives said that a new version is expected this month.

Among the CAD programs at the show, Vellum Solids, 3D, and Draft from Ashlar Inc. (Santa Clara, CA) were the "only professional-level CAD packages available for the Mac," according to national sales manager Gil Daerr. They "draw the way that you think," offering intuitive and easy-to-use tools. Vellum Draft is a 2-D CAD package, while 3D uses wire-frame, surface, and parametric techniques, and Solids is a hybrid modeler that combines wire-frame, surface, and solids modeling. Both Solids and 3D include multiple, adjustable light sources for rendering. The three, which were released in December, are also available for Windows.

Dual-hybrid modeler launched

Hot off the CD-ROM burner is Helix2000 from Microcadam Inc. (Burbank, CA). The product had its official launch at a press conference during PDE. Helix offers the company's new dual-hybrid modeling system, which integrates solids with surfaces and parametrics with topological modeling. The new version offers numerous improvements and includes an interactive-simulation tutorial to help get new users up to speed.

VX Vision from Varimetrix Corp. (Palm Bay, FL) introduces the company's second-generation unified parametric geometry kernel, which utilizes a combination of solid, surface, and wire-frame modeling techniques and a methodology the company calls proximity compliance tolerancing, which is said to be an improvement over adaptive tolerancing. VX Vision also offers a CAM module to ease tool programming for NC machining while maintaining the association and synchronization with the original 3-D model.

Structural Dynamics Research Corp. displayed its Internet-enabled I-deas products at Pacific Design Engineering. The company announced a May release for the updated version of its software. Photo courtesy of Oscar & Associates

A complete integrated CAD/CAM solution is available in Mastercam, from CNC Software Inc. (Tolland, CT). The company's modular approach includes applications from drafting and design through solid modeling and on to milling, lathing, and wire EDM.

EdgeCAM, from Pathtrace Systems Inc. (Ontario, CA) is a comprehensive suite of CAM tools to take a CAD design and turn it into a real part, from desktop to machine shop. Patrick Matthews, CEO of CAMforce Inc. (Upland, CA), an EdgeCAM distributor, said that one of the program's main strengths is in the number of CNC tools it supports. EdgeCAM is available as a stand-alone application, or as a plug-in for Autodesk's Mechanical Desktop.

Three FEA tools were demonstrated by Structural Research & Analysis Corp. (Los Angeles). "FEA is all we do, so we're very honed," said account manager Mike Buckley. Targeted at different segments of the market, the Cosmos series includes Works, DesignStar, and Edge, each of which is offered with three levels of functionality. All feature OpenGL support, and the Works packages offer complete integration with SolidWorks.

AutoFEA Software Company, LLC (Arcadia, CA) demonstrated Solid Analysis FEA Solution, a scalable modeling and FEA package available in multiple levels. Capabilities range from 2500 nodes with the affordable entry-level package to unlimited nodes with the top-of-the-line Architectural and Mechanical versions.

Software analyzes stress in implantable hinge

A complete set of FEA tools is offered in NE/Nastran from Noran Engineering Inc. (Los Alamitos, CA). The software has been used to analyze stresses in such diverse components as a titanium hinge for a spinal implant and the wing of an F-5E fighter jet, according to the company, and is available bundled with FEMAP.

DatapointLabs (Seattle, WA) was seeking CAE partners at the show for the company's TestPak Alliance Program, which aims to address the issue of materials representation in CAE simulations. The company offers a wide range of premade material datasets in their TestPaks, and also tests customer samples.

Engineers needing interactive collaboration over the Internet congregated at the CoCreate Software Inc. (Ft. Collins, CO) booth and had a look at the company's OneSpace application. The firm, a Hewlett-Packard subsidiary, also demonstrated WorkManager, a product development management application.

Centric Software Inc. (San Jose) said that their Pivotal Solutions suite comprises an "Internet-centric" collaborative virtual product development software solution.

Moldflow Corp. (Lexington, MA) showed a series of plastic-molding simulation applications. Three packages addressing a wide range of simulation needs, including hot-runner and cooling issues, were featured at the booth.

Metal-molding simulation was covered by Scientific Forming Technologies Corp.'s (Columbus, OH) Deform Systems, which provides metal-forming and heat-treating simulation in addition to helping identify a range of other potential metal-part manufacturing problems.

Additionally exhibiting at the show were numerous other vendors with products ranging from virtual reality conceptualization systems to applications enabling the platform-independent viewing of a wide range of CAD files.—Stephen C. Levy

Conference to Highlight Rapid Prototyping and Rapid Manufacturing Developments

A conference and exposition to be held April 11—13 in Rosemont, IL, will display a wide range of rapid prototyping and rapid manufacturing technologies, including materials, equipment, and software.

Peter Marks, managing director of Design Insight, will give a keynote speech titled "Rapid Prototyping in the New Economy." Marks says, "Many believe that rapid prototyping is at a crossroads, caught between extravagant projections for the future and current realities of slower growth for equipment manufacturers and service providers." His presentation will report on recent research suggesting that the near term belongs to a new breed of Web-centric rapid prototyping services. Terry Wohlers, president of Wohlers Associates Inc., will follow Marks's speech with a discussion of the most significant trends and developments in rapid prototyping.

More than 100 companies involved in rapid prototyping and rapid tooling plan to exhibit at the Rosemont, IL, show in April.

Among the 125 companies scheduled to exhibit are 3D Systems, Stratasys, CIBA Specialty Chemical, and Cubital America. The conference is sponsored by the Society of Manufacturing Engineers (SME) and the Rapid Prototyping Association of SME. For more information, contact SME at 800/733-4763.—Karim Marouf

Acutek International Acquired by Scapa Tapes

Acutek International (Inglewood, CA), a specialty converter of disposable devices, has been acquired by Scapa Tapes (Windsor, CT). Following a year of negotiations, the companies made the announcement in a joint press conference at the Medical Design and Manufacturing West 2000 show in Anaheim, CA.

Acutek specializes in the design and production of custom pressure-sensitive adhesive components. The company has converting operations in Inglewood and in Cornamona, Ireland, with sales offices located in Inglewood and Brussels. Following the acquisition, operations will continue uninterrupted at the company's manufacturing facilities.

Scapa Tapes is a leading manufacturer of pressure-sensitive adhesive films and tapes. The company provides medical OEMs with both critical component materials and converted products. Critical component materials include coated and laminated films, foams, and fabrics. Medical applications for the company's products include wound care, device fixation, and transdermal drug delivery. The acquisition of Acutek will expand Scapa's converting capabilities to include precision rotary die-cutting with island placement, flexographic printing, and custom multilayer laminating. Markets served by these technologies include pulse oximetry, wound care, drug infusion therapy, diagnostic testing, and consumer medical devices.

Speaking at the press conference, Stuart Ganslaw, president and general manager of Scapa Tapes, said that the acquisition is a further step in establishing the company as a fully integrated global supplier of medical components. "We will now be able to do it all, from the compounding of the adhesive to the delivery of the converted product to the healthcare community," he said. The union of the adhesive compounder with a converter was described by the two companies as a milestone in the medical tape industry.

The new company will join the Scapa Medical Group and retain the name Acutek International. The company will focus its efforts on seven strategic sectors of industry, including medical tapes, a market that Scapa values at $2.6 billion. This is the eleventh acquisition made by Scapa Tapes in the past 13 years.

For more information, call Scapa Tapes at 860/688-8000.—Benjamin Lichtman

Report Touts Development of Antibacterial Polymer for Use with Implants

A team of reseachers from the University of Washington in Seattle has developed a polymer that gradually releases antibiotics, making it possible to develop implants and other medical devices that remain infection-free. It is hoped that the material might be used in devices such as catheters, pacemakers, heart valves, coated stents, or virtually any polyurethane device.

Buddy Ratner, a professor of bioengineering at the university and leader of the study, says that "commonly used devices like catheters account for about 50,000 hospital deaths in the United States a year, many of them because of infection. Once the bacteria get on the device, they are extremely difficult to remove and are very resistant to treatment." According to Ratner, "it can take 100 times the concentration of antibiotic to kill the bacteria when they are attached as it takes to kill them when they are free."

The polymer counteracts the attachment process by slowly releasing the antibiotic. Consisting of a combination of antibiotic ciprofloxacin and polyethlyene glycol mixed with the polyurethane commonly used in medical devices, the original version of the polymer released material too quickly, according to Ratner. To remedy this, the team used a plasma process to coat the material with a 10–20-atom-thick layer of butyl methacrylate. Fluids pass through this layer, which dissolves the polyethylene glycol and makes the polyurethane porous. The antibiotic then leaches out of the polyurethane, with the coating controlling the rate of dispersion.

A plasma process used to coat a polymer with butyl methacrylate has enabled researchers to effectively control an antibiotic's rate of dispersion.

The researchers say that the system killed bacteria for 5 days. There is another potential advantage of the polymer—the high concentration of the antibiotic prevents the development of drug-resistant organisms, which occurs when bacteria exposed to an antibiotic survive. The researchers are also working on a similar development for silicone devices, Ratner says.—David Bowen

3M Creates Drug Delivery Division

3M (St. Paul, MN) has announced the creation of a new division dedicated to the drug delivery market. 3M Drug Delivery Systems Div. (St. Paul, MN) was launched recently to supply inhalation, transdermal, and transmucosal technology to the global pharmaceutical market. The division provides both systems development and components for metered dose inhalers and transdermal patches. In addition to supplying valves and canisters for metered dose inhalers (MDIs), the business unit offers contract filling and packaging services that can be used to produce market-ready products.

Ed Erickson, who heads 3M Drug Delivery Systems as vice president, explains that the division was formed from the company's larger pharmaceutical division, in recognition of its significant and unrealized potential for growth as an individual business. "We have always been one of the largest suppliers of drug delivery technology in the world," he says, "and the creation of 3M Drug Delivery Systems will afford us more autonomy and the opportunity to grow on our own merits." Describing the field of transmucosal drug delivery as "embryonic," Erickson suggests that the division's expansion plans will be focused in this area and indicates that the company is considering acquisitions.

In the past, 3M's drug delivery business has focused its energies in the inhalation and transdermal markets. According to Erickson, the creation of a dedicated division will allow the company to explore alternative drug delivery technologies and to venture outside its traditional activities.

One sector of activity for the new 3M business unit may include partnerships with manufacturers to develop device-based technologies for drug delivery.

Erickson also highlights the growing significance of drug delivery technology in the pharmaceutical sector, predicting that as more compounds are discovered in vitro using mechanism-based assays, innovative technologies will be called on to transport them to their active sites. "I think we'll see more synthetic molecules that have desirable clinical effects but need to be delivered through alternate routes," he says. Although the core activities of 3M Drug Delivery Systems will be concentrated on the pharmaceutical sector, Erickson notes that the division is also considering partnerships with manufacturers to develop device-based technologies for drug delivery.—Benjamin Lichtman

Quality Marks on Firing Line at Global Medical Device Conference

European industry, regulatory officials, and private testing and certification companies have been at loggerheads for more than a year over the use of quality marks on medical products in addition to the mandatory CE mark. Prominent industry associations and some government officials have vehemently opposed the marks, saying that they cloud the meaning and legitimacy of CE marking in the minds of consumers. The debate continued at the Global Medical Device Conference in Cancún, Mexico, in January.

Speaking on behalf of TÜV Product Service Inc. (Danvers, MA), Martin Leighton reiterated his company's claim that CE marking is not an ironclad guarantee that devices conform to all of the safety requirements. While medical devices sold within the European Union must bear CE marking to show that the products have met the essential requirements of the appropriate medical device directive, low-risk devices are, in fact, self-certified, he noted. These require little or no oversight from a third-party conformity assessment body. CE marking indicates that "prerequisite essential regulatory and safety requirements have been met and it serves as a passport to the European market," Leighton said, "but it is not a quality mark." There are markets beyond the EU where CE marking is not recognized, Leighton added, and TÜV's distinctive octagonal mark enables manufacturers to clearly display testing and certification information.

Leighton also stressed that quality marks such as the one marketed by TÜV (other certification and testing houses offer their own marks to customers) respond to the needs of the global market. Prohibiting the use of quality marks other than the CE mark within member states of the European Union is a regional and thus retrograde approach, he intimated.

Response from industry came fast and furious. Michael Baker, director general of the pan-European association EUCOMED, began the volley by objecting to the "arrogance of companies such as TÜV" that are sowing confusion over the merit and meaning of CE marking. "TÜV has made a considerable amount of money placing CE marking on products, and now they want industry to invest in yet another mark." The multiplication of quality marks and the consequent diminishment of the CE marking actually works against the objective of global harmonization, he added.

U.S. director of medical operations at TÜV Product Service Inc. Martin Leighton defended the use of private quality marks at the recent Global Medical Device Conference.

John Place, director general of the European Diagnostic Manufacturers Association, objected strongly to TÜV's assertion that CE marking was not a guarantor of quality. "The directive clearly states that it is a criminal offense to place CE marking on a product that does not meet the essential requirements," he noted, echoing the position of the German ministry of health. That body has threatened to outlaw the use of private certification marks on medical products placed on the German market.

Members of industry attending the session objected to the fleeting competitive advantage the quality mark may afford. One attendee pointed out that if he were to place the TÜV mark on his product, his competitive edge would have a life span of approximately one month. "That's how long it would take my competitors to affix the TÜV mark to their products," he said. "At that point, it becomes yet another quasimandatory mark that you have to have because everyone else has it."

While the European Commission remains officially neutral on this issue, the head of the medical devices sector, Antonio Lacerda, told attendees that a distinction can be made between quality marks that do offer the consumer some element of added value and those which are nothing more than a marketing ploy.—Norbert Sparrow

Furon and Norton Performance Plastics Form Saint-Gobain Performance Plastics

Saint-Gobain (Paris) has combined the operations of its wholly owned subsidiary, Norton Performance Plastics (Wayne, NJ), with recently acquired Furon Co. to create a new business unit, Saint-Gobain Performance Plastics. The company, which employs approximately 5400 people, is expected to have annualized sales of about $830 million, according to the company. The sale was completed at the end of October.

A source familiar with the company said that the merger stemmed from each company's desire to expand its geographic reach, with Furon looking to expand outside of the United States, and Norton, which already maintains a presence in Europe and Asia, wanting to further grow its business. The combined company, which manufactures engineered plastic products including fluoropolymers, silicones, and high-temperature thermoplastics, is now the world's largest processor of high-performance polymers, according to Robert C. Ayotte, chairman and CEO of the new unit.—David Bowen