SPECIAL REPORT
SOFTWARE
Design, manufacturing, and compliance software is increasingly addressing the unique needs of the medical device industry
Norbert Sparrow
For many years, manufacturers simply had to make a product without running afoul of any regulatory requirements," says Jonathan Golovin, chairman of Consilium Inc. (Newbury, Berks, UK). "Margins were reasonably good, and the goal of manufacturing was to maintain inventory so you could ship products and make money." That was then. "Today, people are being asked to work to very short cycle times and low levels of inventory, and to cut costs by as much as 35% over the next several years." Automating processes is key, he adds, and the way to achieve that is by investing in the proper software.
In the past, the medical device industry has lagged behind other sectors in the use of computer-aided design (CAD), manufacturing (CAM), and engineering (CAE) software. Members of industry cite a number of reasons for this: the necessity of costly computer workstations to run the more sophisticated software; complicated user interfaces; and a scarcity of programmes written with the specific needs of the medical industry in mind. Significant progress has been made in all of those areas. It's increasingly rare to find high-powered software that can't run on a PC, for example, and icon-driven menus and other user-friendly features have considerably flattened the learning curve. More importantly, information technology vendors are writing software or adding modules to existing programmes designed to address the industry's unique set of challenges.
Photo courtesy of Image3
Automating Product Development
"Analysts estimate that for a company to remain competitive, product development cycles need to be decreased by a factor of five by the year 2000," says George LeBlanc, vice president of marketing at Workgroup Technology GmbH (München, Germany). "It's clear that CAD/CAM, product-data-management, and management-resources-planning systems are not sufficient to achieve the levels of productivity needed to maintain market leadership." CMS, based on the concept of collaborative work management, can help attain that goal by automating the front end of the product development process, according to LeBlanc.
"Product design is an iterative process, and you don't want to institute strict procedures," says LeBlanc. "On the other hand, there are certain milestones when key deliverables need to be ready." To reconcile these conflicting demands, CMS uses a "phase and gate" architecture. At each juncture of the product development process, the manufacturer sets up rules that determine which deliverables need to be completed (or partially completed) before moving through the gate to the next phase. "It's an approach that engineers feel comfortable with," says LeBlanc. "It adds some design control without constraining the creative process. Essentially, we're giving design engineers a sandbox to play in."
CMS software can also streamline compliance procedures, according to LeBlanc, because it establishes a comprehensive audit trail. "As you go through this process, CMS maintains all of the documents and revisions and stores information on who did what and when," he says. Because the system is knowledge-based, meaning that it will capture the experiences and practices of its users, that data can be applied to subsequent jobs.
Workgroup has historically focused on bringing data-management solutions to design control, says LeBlanc. "In light of the fact that medical device manufacturers are being required to control that area of product development, we have made a strategic decision to concentrate on that market," he says, noting that Workgroup has contracted with Stat-A-Matrix (Brussels) to have the software validated through an independent third party. "We've also asked it to build some test scripts that can be furnished to device manufacturers as validation documents," says LeBlanc.
The new version of CMS will be released by Workgroup in early summer.
Image3 Designs a Smooth Operator
"One of the limiting factors of CAD software in relation to the medical industry," says Scott McMillin, president of Image3 (Draper, UT, USA), "is that the first thing you draw on a CAD file is a circle or a square. That's not necessarily the shape you start with when you're dealing with the human body." Velocity closes this gap, he claims.
The Velocity program enables the user to rapidly construct an accurate 3-D model based on computed-tomography (CT) and magnetic-resonance (MR) data and then export the data to a rapid prototyping or CAD system, explains McMillin. A key feature of the software is its ability to generate truly smooth surfaces, he adds. "Image3 evolved out of dissatisfaction with what was available in terms of modeling-reconstruction software," says Image3 CEO Alair Griffin. "The surgeon who is using this template doesn't want to see the representation of a bone that looks triangular on the surface," says Griffin. "He wants to see something that looks as much like the real bone as possible."
In addition to surgical applications, Griffin and McMillin see a bright future for Velocity in medical device design. Griffin cites the manufacture of custom surgical instruments as one promising area.
"Orthopaedic surgeons will frequently hand-draw something and say, 'I want an instrument that looks like this.' With Velocity, you can scan the problem area, bring it into the CAD world, and the designer can then go to work based on the data." Anything that can go into an MR machine, adds McMillin, can be incorporated into this system. "It doesn't have to be living. So, in addition to reconstructing the biological area of interest, you can scan your device and achieve dimensional accuracy," says McMillin. The models are exportable to a binary STL file, which can be used in a rapid prototyping system to build the reconstructed physical part or 3-D template.
Image3 previewed Velocity at the recent Medical Design & Manufacturing West Conference & Exposition in California and plans to market the software by late spring.
Fluid-Flow Simulations
The ability to generate complex meshes is at the heart of the Fluid Dynamics Analysis Package (FIDAP) developed by Fluent Europe Ltd. (Sheffield, UK). A computational fluid-dynamics (CFD) program, FIDAP is designed to perform all steps of a fluid-flow simulation, including model building, mesh generation, data input, solution, and postprocessing. While the program has been used by U.S. manufacturers to analyze the performance of medical devices, its use in Europe has generally been limited to universities and research centres. The reason, according to Fluent engineer Paul Kingston, is that European manufacturers have yet to realize how much this software can contribute to the optimization of product design.
"There's a lot of scope for the use of CFD in this field," says Kingston, "but biomed companies are quite small." According to him, these companies are likely to be more comfortable going to universities and getting a feel for it there first."
A single integrated program comprised of several modules, FIDAP is based on the finite-element method, which enables the creation of accurate models with fewer grid points than either finite-difference or finite-volume approaches. The programme's mesh-generation module, FI-GEN, incorporates an algorithm for the automatic generation of quadrilateral meshes on 3-D surfaces. This feature combined with the ability to place boundary layers along edges and to define element-density functions has made the software popular among U.S. device manufacturers, according to the company.
Medtronic Inc. (Minneapolis, MN, USA) implemented FIDAP CFD software as part of the design optimization process for its blood-handling devices. Svenn Borgersen, senior staff scientist at Medtronic, notes that because blood is an opaque material, it is difficult to visualize flow patterns experimentally. "Using FIDAP, we were able to find and evaluate the effects of flow characteristics that we were unable to examine using standard test methods," he explains. Other successful applications have included design optimization of a continuous glucose monitor developed by Cygnus Therapeutic Systems (Redwood City, CA, USA) and trilumen tubing manufactured by Dow Corning Corp. (Auburn, MI, USA).
Medtronic Inc., used FIDAP software to analyze the flow characteristics of blood-handling devices in order to optimize the product's design.
Fluent will be releasing a new version of the software later this year that will significantly increase mesh-generation turnaround time, according to Kingston. "Mesh generation is the most time-consuming aspect of the design process, and we have been concentrating on finding ways to speed that up. It will be especially useful for generating the complex geometries typical in the biomedical field," says Kingston.
Optimizing Manufacturing Processes
"Making a perfect product that complies with regulations is fine," says Mike Meyer of Consilium Inc. (Newbury, Berks, UK), but in today's competitive market that may not be enough. "The clever thing is to do all of that without incurring maximum costs," he adds. Consilium's Flowstream is one tool that can help manufacturers accomplish this goal, according to Meyer.
Flowstream is designed to control activities on the plant floor, and part of its appeal to device manufacturers is that it satisfies a set of performance and compliance requirements in the process, explains Meyer. According to company chairman Jonathan Golovin, Flowstream helps process manufacturers achieve better visibility and control of their manufacturing operations through comprehensive electronic batch/device record and inventory management, dispensing, traceability, quality management, and document-retrieval capabilities.
One of the system's key features, he adds, is verification that all data are correct before manufacturing and data-entry begin. "The cost of record-rework is very high," says Golovin, "and Flowstream achieves zero batch-record rework because it checks for virtually every type of human error." In addition to lot or unit compliance, Flowstream tracks all indirect activities--sterilization, equipment calibration, and so forth--and allows the user to look at plant performance electronically in real time.
Flowstream is based on manufacturing execution system (MES) technology, a concept that Golovin pioneered. "When I came up with MES, there were systems that tracked production or raw materials, but nothing that looked at the complete process," he says. In order to control, manage, and improve manufacturing, according to Golovin, it was necessary to look at the entire picture, from the processing of the raw materials or components to facility conditions. "With MES, you are able to see, track, and control your materials, equipment, employees, facilities, and documents," explains Golovin. "Up until MES came along, there wasn't really anything that gave you a view of the entire process."
Supply-Chain Management
QAD Europe B.V. (Hoofddorp, Netherlands) also espouses a global approach to manufacturing with MFG/PRO software, which is based on a supply-chain management model. It is described as a complete manufacturing and distribution-management software system that is available on a module-by-module basis. What makes QAD unique in this field, according to Greg Cathcart of the company's medical division, is its focus on the specific requirements of the medical industry. That has resulted in the creation of a very functional product, says Cathcart. "A good example is patient and device tracking," he says. "Manufacturers of pacemakers and other implantables are required to know where their product is at all times," he says. "We've extended our software so that the manufacturer can track who the product has been sold to, which patient's chest it's in, that person's current address, when the battery will expire, and so forth."
QAD has signed an agreement with Altshuler, Melvoin, & Glaser LLP (AM&G; Chicago, IL, USA), a consultancy specializing in software validation for medical device and pharmaceutical companies. The partnership--whose mission is to develop, market, implement, and validate manufacturing and distribution solutions for the medical industry--resulted in the recent introduction of a validation module. "AM&G wrote the validation module for us," says Cathcart. "They designed the validation templates and protocols against MFG/PRO and the regulatory requirements in effect." The company also recently marketed a compliance module. "We built into these two modules the ability to extract the data required for [U.S. Food and Drug Administration] 510(k) submissions," adds Cathcart.
Keying into Compliance
Fulfilling compliance requirements and maintaining proper documentation consumes a great deal of time and, as many manufacturers are painfully aware, even the slightest error in documentation can lead to costly delays. Not surprisingly, several software providers have marketed programmes that accelerate these tedious tasks while verifying the accuracy and appropriateness of the information. One such programme that will be available commercially this spring is InfoTrain, software that lets users design, implement, and maintain employee training in accordance with ISO 9000 requirements and FDA's GMPs.
According to Barry Asher, president of Makromed Ltd. (Rochester, Kent, UK), InfoTrain not only allows you to design and implement an in-house training program but it also maintains records of all internal and external employee training. "For a given employee, you can find out which training he or she has received and which training is still required to be in compliance," says Asher. "You can do similar operations based on the job function." In addition, the software generates alerts on upcoming or overdue training requirements.
Makromed, which supplies software and consulting services that focus on standards and regulations affecting the medical and pharmaceutical industries, also produces InfoMed for complaint-handling and corrective-action applications and InfoAudit, a programme that addresses ISO requirements for internal and vendor audits.
Eurospec (Darmstadt, Germany) has designed software to assist manufacturers in risk-analysis procedures and product classification. "To determine whether a product is a Class I, IIa, IIb, or III device, all the customer needs to know is the intended use of the device," says Eurospec marketing manager Matthias Hoffman. "The MPK programme asks a series of yes/no questions and guides the user through the process. It takes all of five minutes," says Hoffman. The record of classification decisions can also serve as quality assurance documentation, he adds. Eurospec also supplies software that facilitates the performance of risk analyses according to prEN 1441 and EN 60601-1-4.
Designed specifically for the medical and pharmaceutical industries, which are required to maintain strict calibration records, Calibration Manager will be available for Windows 95 by early summer. In addition to being easier to use than the previous versions, the new package features enhanced customization capabilities, says Jim Erickson, president of Blue Mountain Software Inc. (State College, PA, USA). "Users will be able to customize the more than 50 fields," he says, "and rather than having to enter calibration measurements individually, customers can now create measurement-data templates for each type of instrument." The incorporated Crystal Reports enables the generation of custom or standard reports and performs bar coding and labeling functions. Blue Mountain also produces Regs, which puts FDA regulations into a user-friendly searchable format.
EasyTrak, developed by Relsys International Inc. (Irvine, CA, USA), is designed to automate complaint handling. "Essentially, the software cuts down the time it takes to process complaints by enabling the electronic transmission of vigilance reports--all of the competent authorities are on-line--and eliminating duplicate entry of information," says marketing manager John Potts. As well as a comprehensive audit log, EasyTrak includes a field notes feature designed for use by customer-service personnel. "Imagine your sales representative is in the field and talks to a customer who reports a potential adverse event," says Potts. "That sales rep has access to a one-page formatted form in EasyTrak where the information is entered. Later, your company's regulatory affairs officer can analyze the information and determine whether or not it constitutes an actual complaint," says Potts. The data can then be directly transferred into the complaint form, eliminating duplicate entry. Likewise, the product information, problem description, and so forth can be transferred from the complaint form to the vigilance report form, if necessary. The EasyTrak software also includes the entire suite of FDA Medical Device Register forms and supports various international agency reporting protocols.
In the past, the use of sophisticated software to automate product design and to manage production and regulatory processes was limited mostly to larger companies that had information-technology expertise or the resources to acquire it. As we have seen, a number of factors have contributed to making the technology more accessible to smaller firms. In a business environment that is pushing manufacturers to streamline and accelerate time to market while reducing costs, more and more of these companies are discovering that the appropriate software can be a valuable productivity tool.
