PRODUCT UPDATE

Software

From product design to the management of regulatory data, increased efficiency and productivity are often dependent on investing in appropriate software systems.

Nobert Sparrow

"Information technology (IT) is helping to reduce the cost and time of research and development ...over time, IT will improve efficiency of manufacturing and distribution channels and at the same time improve the service [companies] provide to all customers around the world."

Those are among the conclusions of a recent global survey conducted by Deloitte & Touche and Deloitte Consulting (London), 1998 Vision in Manufacturing, which examined strategic developments and trends in manufacturing. While this particular report focused on the pharmaceutical industry, much of its content is equally relevant to medical device manufacturing, especially in the realm of IT.

Examining the impact IT will continue to have on industry, the report goes on to say that "executives are leveraging information technology to strip cost out of the supply chain, reduce lead times, and to better understand their customers. They foresee technology as a way to better coordinate with regulatory organizations as well as increase the speed of developing and bringing products to global markets." Software designed to help companies achieve these goals is featured in this section.

Constraint-Free Design

The product design process, for one, has been fundamentally changed by software that frees engineers from a host of constraints that their predecessors wrestled with on a daily basis. For example, I-DEAS, developed by SDRC (Hitchin, Herts, UK), makes it exceptionally easy to integrate design changes. Designers work with the part on-screen much as they would on a workbench, says SDRC marketing manager for design products Chris Cheek. "If you want to move a hole or shave an edge, you go in there and do that with the cursor," says Cheek. The system's variational geometry technology enables designers to perform these operations without first having to find and change dimensional values.

Helping manufacturers accelerate their product's time to market is one of the primary goals at Materialise (Leuven, Belgium). The company, which develops prototyping processes and related software, has harnessed the resources of the Internet to accomplish just that. Manufacturers can send 3-D CAD data to the company's Web site and receive a stereolithography concept model by the next day.

Managing Regulatory Data

In addition to design and manufacturing issues common to all sectors of industry, device manufacturers must comply with stringent regulatory requirements. Several companies have developed software that manages regulatory-related documents while reducing the potential for data-entry error.

Makromed (Rome), for example, offers software that enables companies to design, implement, and maintain an employee training programme in accordance with US FDA's good manufacturing practices and ISO 9000. Ease of use is the touchstone at the company, says president Barry Ashar, because the assumption is always that the user of the product knows more about quality and regulatory issues than he or she does about computers.

Tracking equipment calibration is another requirement built into most quality systems, and Blue Mountain Quality Resources (State College, PA, USA) has designed a programme to perform that function effectively and efficiently. One of the many features of the software is a measurement data template that enables calibration personnel to simply enter "as-found" and "as-left" values, and let the programme do the rest. Not only does it save time, but automating the process helps to minimize data-entry errors, according to marketing manager Denise Evans.

"You would be surprised by the number of companies that are still tracking this type of information manually," says Evans. Clearly there's a better way. The companies profiled in this section are able to provide software solutions to enhance productivity and contain costs across a spectrum of disciplines.

SDRC UK Ltd.

"Our I-DEAS software allows discrete manufacturing firms to conceptualize, develop, design, and test their product digitally before going to the shop floor and building a prototype," says Chris Cheek, marketing manager for design products at the US headquarters of SDRC UK Ltd. (Hitchin, Herts, UK). The benefits are obvious, Cheek adds. "It reduces the cost of manufacture because designers can uncover problems early in the process and discover ways to make the design more innovative early in the process when it is least expensive."

One of SDRC's key technologies is variational geometry (VGX), which allows engineers to produce a design or make changes with a minimum of constraints. "Variational geometry allows a designer to sketch out a concept and create a 3-D object without having to put all the dimensions on the geometry, ensure that all the angles are correct, that everything is properly documented, and so forth," says Cheek. The company recently extended variational geometry throughout the entire product line, introducing its ease of use to downstream operations. Once a part or an assembly has been created, any member of the project team can move a hole, for example, without being concerned with how it was created, who put it there, and how it was constrained. "It allows the user to work in a true virtual environment," says Cheek. "You work with a part on-screen much like you would on a workbench. If you want to move a hole or shave an edge, you just go in with the cursor and do that. You don't have to go back to a text window, look for a dimension value, and change it."

VGX technology, which has been extended into the company's part modelling and assembly modelling systems, will be incorporated into analysis programmes by the end of this year. The technology was named Productivity Tool of the Year by the readers of a major design publication.

Blue Mountain Quality Resources

Designed to help achieve compliance with the calibration requirements of US FDA's good manufacturing practices and quality system regulation, Calibration Manager compiles equipment calibration information and produces necessary documentation. Companies certified to ISO 9001 will find the system a significant time-saving tool, says Denise Evans, marketing manager at Blue Mountain Quality Resources (State College, PA, USA). "The programme fulfills the 10 points in ISO 9001, section 4.11, which involves the control of inspection, measuring, and testing equipment," says Evans. And it does so in a user-friendly, flexible way. "Companies have different needs, so we have built flexibility into the programme," says Evans. "User fields can be modified and renamed, and we have also included blank fields to enable companies to track all manner of information."

There are numerous ways that the software optimizes data management, according to Evans, one example of which are the data templates. Once they have been set up, these templates eliminate the need to repeatedly enter set points and acceptable tolerances for each instrument. "The user simply enters the 'as-found' and 'as-left' values," says Evans, and measurement data are calculated automatically. In addition to saving time, this feature helps to minimize data entry errors.

The company also supplies a validation protocol manual and disk set that has been specifically designed for Calibration Manager.

SiliconGraphics GmbH

A supplier of interactive computing systems ranging from low-end desktop workstations to servers and supercomputers, SiliconGraphics GmbH (Grasbrunn, Germany) collaborates with bioinformatics software providers to optimize analysis, distribution, and exploitation of computational biology data. Systems are designed to let researchers rapidly search local and remote databases, identify trends and areas of focus, visualize molecular models, and exchange textual and visual information across distances and scientific disciplines.

The company recently announced that it is working with leading international bioinformatics research organizations on an initiative called "3-D Crunch." The project will analyze more than 200,000 publicly available protein sequences and predict more than 50,000 new 3-D protein structures. A Cray Origin 2000 server, located at the company's technology centre in Cortaillod, Switzerland, will power the modelling software developed by Glaxo Wellcome's scientific computing department. According to Manuel Peitsch, worldwide director of scientific computing at Glaxo Wellcome, thanks to the server and software, "we're essentially compressing a year of computing time down to a week." The data, which are available on the World Wide Web at http://www.sgi.com/chembio, will "profoundly advance researchers' ability to understand the function and structure of proteins important in drug discovery and design."

SPSS ASC GmbH

A company that supplies a range of software for research and engineering applications recently released an update for its TableCurve 3D programme that automates the surface fitting process. "In a single processing step, TableCurve 3D instantly fits and ranks approximately 36,000 out of more than 450 million frequently encountered equations," says Petra Scheffer, marketing manager at SPSS ASC GmbH (Erkrath, Germany). This enables users to find the ideal model for their 3-D data in a matter of seconds, she adds. Upgrade features include enhanced linear fitting, nonparametric estimation of gridded and scattered data, and improved smoothing capabilities.

The company also recently announced the release of the new 4.0 version of SigmaPlot, which enables researchers to analyze raw data, visualize results, and create publication-quality graphs. Among other features, the programme facilitates curve fitting and graphing operations by means of a regression wizard. The wizard fits more than 100 built-in graphically illustrated equations and automatically graphs the results. Users will save considerable time, according to Scheffer, because the software tool provides the equation, automatically determines the initial parameters, and creates results graphs.

Systat 7.0 for Windows, an integrated desktop statistics and graphics software package, has also been developed by the company to support scientific and technical research in such disciplines as medical research, engineering, and life sciences.

Moldflow Vertriebs GmbH

Easy-to-use plastic simulation software for all stages of parts creation is supplied to the medical device and other industries. Release 9.5 of the company's Dynamic series, which merges automatic midplane mesh creation with editing functions, reportedly simplifies mesh generation from a solid model in order to analyze injection moulding processes. In addition, the extension of key analytical features of asymmetric flow throughout the suite provides users with a high degree of accuracy, according to Ken Welch, vice president of marketing at Moldflow's corporate headquarters in Lexington, MA, USA.

"Today's customers need to be able to develop models suitable for analysis faster than ever before," says Welch. "To facilitate this, we've integrated our midplane generator and modelling software to create a powerful single preprocessor that greatly simplifies the modelling process. We've also extended the calculation of asymmetric analysis properties from flow to full analysis," adds Welch. Asymmetry considers the influence of mould temperature imbalances on melt flow and identifies changes in temperature distribution as the melt divides at intersections. There are now asymmetric flow links to MF/COOL, MF/WRAP, MF/STRESS, and MF/OPTIM.

Moldflow Vertriebs GmbH (Hurth-Efferen, Germany) also recently introduced Part Advisor 2.0, which enables rapid evaluation of the manufacturability of injection-moulded plastic parts. The updated version features improved integration with CAD software, extendable solution depth, advanced adviser capabilities, Internet-ready reports, and an improved material database.

Matra Datavision

A CAD/CAM/CAE and product development management system designed by Matra Datavision (Les Ullis, France) is based on object-oriented architecture. Euclid Quantum uses the CAS.CADE platform to bring object-oriented modelling tool kits and built-in modularity to the system. Six application areas are included in the package—Euclid Designer, Euclid Analyst, Euclid Machinist, Euclid Design Manager, Euclid Styler, and Euclid Drafter—all of which are linked by a Web-enabled desktop software module.

By incorporating geometric and design intent as well as process-related data, the modeller in the design module enables the creation of objects that encapsulate a host of information for use throughout design and manufacture, including aesthetic criteria, technologic function, material selection, and fabrication process. The programme is specifically targeted to designers working in a concurrent engineering environment.

The company also supplies Prelude Design, a full-function solid modelling programme that can be used as a stand-alone system or integrated with Euclid and other CAD/CAM architectures. The software was used by PLC Medical Systems Inc. (Milford, MA, USA) to incorporate upgrades and design changes to its CO₂ Heartlaser. According to Larry Brodsky, senior mechanical engineer at PLC Medical, the relationship between parts in an assembly are easily appreciated in solid models, enabling designers to uncover interference conflicts, fitting problems, and other errors early on when they are easier to fix. Brodsky estimates that, compared to what the company was using previously, Prelude Design cut project time by as much as half.

Makromed

Employee training software is designed to help manage training programmes in accordance with US FDA good manufacturing practices and ISO 9000 requirements. The user maintains records of job descriptions, qualifications, responsibilities, and training needs; employee files; and training schedules. The programme can then generate reports showing all internal and external training received by an employee, the required training that has not yet been provided, and so forth. "The current quality system regulation from US FDA as well as ISO requirements clearly state that companies must define training requirements, which was not previously the case," says Barry Ashar, president of Makromed (Rome), stressing the value of this programme from a regulatory perspective. Tracking employee training is but one of the functions of the programme, he adds, which can also be used to dispense training.

"ISO 9001 contains 20 different [employee training–related] elements," says Ashar, "dealing with everything from management review to corrective actions. InfoTrain offers topics on all of those points." In addition, the programme is sufficiently intuitive that employees can train themselves. "We always assume that the end-user of our products know more about quality systems and regulatory issues than they do about computers," says Ashar.

Makromed also supplies InfoAudit, auditing software that helps manufacturers comply with US FDA's new quality system regulation.

Qua Sys

A consultancy that specializes in the setup and maintenance of quality systems, Qua Sys (Liège, Belgium) found that inadequate document management was the reason that nearly half of all companies did not achieve conformity with international quality systems requirements. To remedy this, the company developed software in collaboration with Liège University. "Qualisoft is helpful in facilitating the setup of quality systems that will lead to ISO certification," says Françoise Schlemmer, who is in charge of business development for the company, "but it has also been successfully installed after ISO certification as a maintenance tool." The software streamlines quality management by organizing documents, centralizing data, promoting information transfer, and reducing paper use. It is compatible with all types of Windows files. The company's approach in designing the software, according to Schlemmer, emphasizes ease of use, flexibility, and practicality.

Materialise N.V.

A company that articulates its mission as "the fast production of prototypes," Materialise N.V. (Leuven, Belgium) comprises two divisions, one devoted to prototyping processes, the other focused on software development. The latter specifically develops software tools that support the rapid prototyping process. One recent example is MedCAD, which extracts surfaces and anatomical landmarks from CT and MRI data and then sends that information to any CAD system. "Basically, we have systems that gather and read image sets and construct a 3-D model, and then we go from the CT or MRI slices to the prototyping slices via direct interface," says Steve Lievens, application engineer at Materialise.

The company recently initiated an Internet-based service for stereolithography models. According to project engineer Johnny Geling, models ordered through this service can be delivered the following day. To get a quotation, users navigate to http://www.materialise.be/nextday and select "free quotation request." The system is able to convert 3-D CAD data from IGES, VDA-FS, 3D DXF, Pro/Engineer, Unigraphics, and CATIA to an STL file, on which the next-day price quotation is based.

IBM Engineering Solutions

Developed by Dassault Systèmes S.A. (Suresnes, France) and marketed by IBM Engineering Solutions (Paris), CATIA offers fully integrated CAD/CAM solutions. Design functions include 3-D solid, surface, and wire-frame modelling, and the system's automated 3-D parameterization can be applied to solids, wire-framed geometries, or swept surfaces. Version 4 of the system also includes flexible hybrid modelling, virtual product development, process-driven applications, and design-point finite element analysis. The fundamental strength of CATIA, according to Patrick Kieffer, who handles marketing and communications at IBM Engineering Solutions, is that "it can do everything, from design to manufacture. In particular, it performs especially well in applications that involve sending files to CNC machines."

While it is used extensively in the aviation and automotive industries, CATIA has also found several applications in the medical device sector. Aesculap AG (Tuttlingen, Germany) used the technology to develop and manufacture prosthetic hip joints. The continuous data flow from patients via CAD modelling to manufacture on networked CNC machines saved the company considerable time and money, according to Aesculap. "The thing to remember," says Kieffer, "is that CATIA can benefit designers and manufacturers of everything from simple disposables to prosthetic devices. We just completed a customer survey and we found that, while CATIA is of course extensively used by multinational companies, more than 50% of the purchasers are companies with fewer than five employees," says Kieffer. The popularity of the programme among small businesses, adds Kieffer, speaks volumes about its flexibility and reliability.