Forget making a game plan for your software needs. Medical OEMs today need an entire season strategy, or better yet, a system that can help them build a future dynasty. Thanks to recent advances in hardware technology, software providers are offering platforms and tools that function faster, incorporate more processes, and accommodate larger CAD models. And it’s not just the software tools that are changing; the approach to integrating software into company practices is also getting an overhaul.
The era of different departments maintaining their own data warehouses or information silos is coming to an end. Because communication among departments is so critical to the highly regulated medical device manufacturing sector, enterprise-wide software systems that can handle every stage of the product lifecycle are rapidly gaining in popularity. Offering time-saving features at stages such as validation and operator training, these systems are moving beyond problem identification into problem prevention.
The Suite Strategy
Integrated software suites combine systems that manage business content and processes with systems that manage product content and processes. They often include an electronic document management system, enterprise resource planning, product lifecycle management, a manufacturing execution system, and a quality management system. Beyond these basic platforms, a suite can be tailored to meet more-specific medical OEM needs.
Process management software provider MasterControl Inc. (Salt Lake City; www.mastercontrol.com) specializes in this suite strategy. The ability for multiple departments to collaborate, from product conception to retirement, can offer significantly reduced time to market, says Matt Lowe, senior product manager, medical devices, for MasterControl.
“Working within a single system to perform all of these activities can bring significant value to device manufacturers and allows them to leverage their investment in software to a much greater extent than were they to try to use disjointed solutions spread across multiple departments,” Lowe says.
Although adopting a suite of software systems may seem like a daunting and disruptive change for an OEM to make, companies like MasterControl are striving to make the process easier. For start-up and early-stage device manufacturers, for example, MasterControl has developed a product for managing design control documentation that can be implemented in as little as two weeks. Additionally, because medical OEMs must validate the software that they use—a process that can significantly increase implantation time—MasterControl offers products designed to reduce system validation time by as much as 75%.
Further increasing OEMs’ return on investment, software providers are taking on a partnership-like role by monitoring their customers’ markets to anticipate other software needs. By identifying opportunities for OEMs to employ software in new ways, suppliers are continually providing new programs to add to the software suites their customers already use. MasterControl’s next major release, for example, is an addition to its suite that will help OEMs manage their supply chain.
The Prevention Method
The Smart system from QCR Corp. is designed to prevent manufacturing errors by verifying at the point of activity that operations are being performed correctly.
Similar to other suppliers’ anticipation efforts, QCR Corp. (Arlington, TX; www.qcrcorp.com) offers an enterprise knowledge execution system that is designed to mistake-proof every stage of product development. “The Smart system turns the traditional application approach upside-down,” says Michael Young, QCR president. He explains that software companies that promote traditional products—such as CAPA systems that utilize data warehouses and performance management applications—rely on identifying, reporting, and analyzing problems after they have already occurred. Because most manufacturing problems are caused by omissions or mistakes at the point of activity, QCR feels that a better strategy is to employ a system that ensures that operations are being performed correctly during every stage of development, not after.
The Smart system is set up to prevent operator and process errors by identifying each process and its associated specifications, regulations, materials, and other data. By compiling that information and making it accessible to system operators, Smart software can guide the user through decision trees that ensure that the process is completed correctly every time. Such advice and work verification at the point of activity make it virtually impossible for an operator to go wrong, according to Young.
The system also can verify that operations are being performed in compliance with government regulations at the point of activity during every manufacturing stage. Real-time process verification and proven compliance not only ensure that products are made well, but, in turn, can translate into decreases in corrective action requests, recalls, and returned product.
Featuring expanded support for 64-bit systems, Algor's V22 FEA software includes a preprocessing editor program and postprocessing of results and reports.
In addition to improving OEM operations, software systems are offering device designers new capabilities in product design and testing simulation. For years, many CAD analysis systems could only realistically consider one or two device parameters at a time, such as the effects of temperature and force. But real-world simulation requires multiphysics. Taking advantage of recent advances in hardware technology—and responding to customer requests—Algor Inc. (Pittsburgh; www.algor.com) has expanded the simulation capabilities of its finite-element analysis (FEA) software.
The new features of Algor’s V22 FEA software move device designers one step closer to being able to conduct true virtual prototyping. Ideally, virtual prototyping would allow designers to test a product design on a computer as realistically as if it were performed in a laboratory, according to Bob Williams, product manager. The major feature of the improved V22 is the expanded support for 64-bit systems, which enables users to handle larger models faster than ever before. With the increased memory capacity and speed of the 64-bit system, large models with irregular shapes and multiple surface-to-surface contacts can be subjected to complex mechanical event simulation studies. The 64-bit support extends to a preprocessing FEA editor program and postprocessing results and reports.
Additional features of the V22 include a multifrontal massively parallel solver for distributed memory systems, which enables faster analysis of linear and nonlinear stress and fluid-flow models. The software also can analyze open-channel flow involving a free surface between a flowing fluid and a gas above it. In addition, it can perform damage analysis for 2-D plane stress elements, which is primarily intended for simulating damage onset and growth in fiber-reinforced composite materials.
These capabilities enable designers to perform more types of analysis with greater flexibility. “It has always been the purpose of simulation software to minimize and eventually eliminate physical prototyping by using a computer,” Williams says. “In the next five to 10 years, it will become very common to do a majority of design and testing in software [instead of in a lab].” Virtual prototyping not only will reduce costs for OEMs already performing physical prototyping and testing in labs, but by freeing up capital, it could also make it easier for small companies to break into new markets.
Williams notes that software differences are narrowing since some providers, including Algor, produce major iterations of their platforms three or four times a year and minor iterations almost monthly. He advises OEMs to, “think of the software—a set of buttons within a user interface—as just one aspect of their investment [and realize that they’re] buying into a design partner who also provides support and training.”