Automation, integration and information sharing are the name of the game in medical device manufacturing today. As companies strive to improve efficiencies and cut waste, software developers are responding by ramping up their offerings. Medical Product Outsourcing recently spoke with software experts about the state of the art in program development and how software is being used today.
Just as drivers check their vehicle’s dashboard to gauge the overall condition of their car, medical device manufacturers now can consult their very own "dashboard" to get an overview of the health of their manufacturing operations.
More companies are using real-time dashboards, which display on large TV screens a quick synopsis of meaningful information. Clients know exactly where they are in meeting manufacturing goals at any given moment," explained Daniel R. Matlis, vice president of Stelex in Bensalem, PA.
He said that studies have shown that the human brain can assimilate no more than seven pieces of information simultaneously, so most dashboards display a handful of production numbers such as a current count of rejects.
In 2004, Sparta Systems, Inc. in Holmdel, NJ introduced its TrackWise Dashboard, which shows a snapshot of a company’s quality management system. "The Dashboard provides key performance indicators (KPI), reports and drill-down links all within a single set of screens," said Steve Cagle, manager of operations. "Each user can personalize the dashboard screen—that is, specify which KPI he or she wants to see—and create as many different Dashboard views as necessary. This makes it useful for everyone, ranging from the line operator to the VP of quality."
The dashboard concept goes hand-in-hand with a trend toward increased integration of data in the manufacturing realm. Companies such as Stelex say there are opportunities to integrate different parts of software programs using web portals to provide a more comprehensive view of operations. Web portals, also known as extranets, are intelligent, customized sites that look like a traditional website and can be accessed 24 hours a day via most browsers. By allowing employees as well as suppliers from numerous locations to see the same project data simultaneously, communication is streamlined, and better collaboration results.
"Communicating in this manner smoothes the entire product development and manufacturing process and leads to a more efficient operation," said John Bredesen, IT manager for Minnetronix in St. Paul, MN. "Customers today want to see everything our engineers can see—as if they were right here. They want to use an extranet to see financials, schedules, milestones, modifications and tracking issues."
The company developed the Issue Tracker system, which tracks changes in design, manufacturing and quality systems.
Pilgrim Software in Tampa, FL is also focusing on increased integration and collaboration. The company is working to leverage its portals to provide more business intelligence to clients.
"Improving the visibility of and access to data isn’t just an issue of allowing for better compliance [to regulations], it also will improve the bottom line," explained Lynn Perry, Pilgrim’s marketing manager for the medical device industry. The company’s SmartSolve portal was launched in late 2002 and provides an integrated quality and compliance management solution.
In 2004, the company released a new module, SmartComplaints, powered by its SmartCAPA solution, after customers said they wanted the ability to have both suppliers and manufacturers involved in the complaint process to foster easier collaboration and resolve issues more quickly. The web-based system includes decision trees to aid in determining whether an event is reportable and streamlines the entire communications and regulatory body submissions process. Support for U.S., EU, Canadian, Australian and Japanese systems is included.
Certainly, software is playing an ever-larger part in medical manufacturing and research, but companies must remember to keep regulations foremost in mind.
"Software has enabled tremendous increases in productivity and efficiency; however, there are regulatory challenges to consider when implementing such software, particularly the requirements of 21 CFR Part 11," warned Terry Carlin, consulting director for software validation for Beaufort Advisors LLC, a regulatory compliance consulting firm based in Norfolk, VA. He cautioned companies that implement software to automate FDA-required recordkeeping to go through a verification and validation process controlled under configuration management.
Carlin added that the biggest mistake companies make when using software is simply purchasing and installing a program without performing a critical first step: documenting the user requirements. This requires a detailed list of exactly what the software must do, including keeping track of specific information, producing reports and maintaining compatibility with the workstation. Requirements should be written narrowly so that they can be tested easily. User requirements should be reviewed and signed off by whoever will use the software.
In addition, a greater number of medical product companies are turning to third parties for software validation expertise and support.
Of course, the validation and verification process can cost time and dollars that life sciences companies would rather spend elsewhere. Therefore, software developers have promised their customers to keep major releases and patches to a minimum.
"Companies don’t want to revalidate systems constantly, so we’ve promised we won’t do more than one major release a year, and we won’t do point releases more than twice a year," said Keith Chambers, director of life sciences for Datasweep, Inc. in San Jose, CA.
Indeed, in February 2004, Datasweep introduced Generation 6 of its Advantage suite, which included an expansion of its capabilities in CAPA (corrective action and preventive action), complaint handling and adverse event reporting modules and switched the entire system from a Microsoft platform to a J2EE architecture, which operates across multiple platforms. Generation 6.2, offering greater functionality and capabilities, will be unveiled in the fourth quarter of this year.
Stelex noted that it, too, limits major releases because clients are cautious about installing even patches due to the required validation and verification activities.
FDA and ISO regulations typically take center stage in software development considerations, but since 2004, financial reporting required by the Securities and Exchange Commission is playing a starring role as well.
Last year, many medical device companies’ IT departments scrambled to comply with new corporate governance standards set forth in the Sarbanes-Oxley Act. The law requires companies to report financial data in specified formats and guarantee the accuracy of financial disclosures in the wake of scandals at Enron, WorldCom and other debacles. All records needed to be fully compliant at the beginning of this year, and records now must be tested quarterly.
IT departments knew that quality and compliance departments already were testing their records and preparing audit trails, so they looked to those departments for help with the financial software. Some companies leveraged their investment in quality management systems software to meet the new financial disclosure regulations.
"With flexible technology, when standards and markets change, the software can change along with them," noted Tim Lozier, director of marketing for EtQ in Farmingdale, NY. He pointed out that while the primary focus of EtQ’s software is compliance, the fact that customers have used it for meeting Sarbanes-Oxley requirements demonstrates the system’s flexibility.
Last spring, Stelex released its updated ComplianceBuilder to assist companies with IT, governance and Sarbanes-Oxley. With audit trailing and locked-file capabilities already built in, the company made revisions to the front end and reporting sections.
AssurX, Inc., based in Morgan Hill, CA, has now automated record management in its CATSWeb for corporate retention policies and those required by the FDA.
"CATSWeb Records Management allows easy and effective compliance with corporate record retention policies by automating the process of archiving or purging records and documents that meet configurable data," explained Tamar June, vice president of strategic marketing for AssurX. The tools include security controls and record archiving and purging. For example, the software can be configured to require two individuals to independently review and approve record management jobs before processing is allowed to occur. Additionally, configurable transaction logging enhances process audits and system validation.
Software is also shortening the audit process for some companies. "The standard ISO audit time is two to three days, but it takes us just one day," Bredesen reported. "We have a computer set up in a conference room, and the auditor sees everything right there. There’s no running around in search of papers."
In late 2004, MSC.Software of Santa Ana, CA, introduced new virtual product development (VPD) tools to the medical device market. VPD is quickly becoming a hot trend because manufacturers can use it to shave significant time and costs from their development cycles, said Leslie Rickey, the company’s industry manager for biomedical/medical devices. Its SimOffice was created to provide an integrated virtual test environment for performing multidisciplinary engineering assessments on devices such as stents, dental implants, wheelchairs, orthopedic devices and artificial limbs and organs.
With the software, users can perform feasibility studies before investing in prototypes, materials or equipment. He claimed that one client who makes intraocular lenses saw a 50% reduction in design cycle time and an 80% decline in manufacturing costs and time. Users who purchase an off-the-shelf program can have it customized. Repeatable test models and processes can be established within the VPD software tools in a day or two, Rickey said, adding that more complex, sophisticated test automation could take a few weeks to a few months. Recent updates to the software include a characterization of nitinol shape memory models to aid stent manufacturers in running simulations and a cleaner interface that enables more non-engineering professionals to perform simulations.
MSC.Software recently unveiled a MasterKey licensing concept, which ties all of the software technology together and makes it available to everyone in an organization. Rather than purchasing an entire software system, companies can buy less-expensive tokens—or "floating licenses"—that employees can use to access the system when needed.
Wanted: A Paperless Office
Several years ago, SonoSite, Inc., which manufactures mobile ultrasound units, decided to make its records more mobile too. "Going paperless reduces your overall investment and helps reduce compliance risk," Ken Perino, director of quality assurance for SonoSite of Bothell, WA, told attendees of an online Datasweep presentation in February.
"We wanted to improve operational efficiency and effectiveness by creating a dependable, risk-adverse environment. We approached going paperless from two sides: from the document control and management side and from the shop floor," he stated.
SonoSite wanted a traceable system that would eliminate the possibility for human error as much as possible. The company first studied all applicable regulations to ensure they would be met, then worked with Datasweep to build a robust system.
"Removing the paper trail does not mean removing the trail," Perino noted. "You’ll have a greater, more detailed trail than you did with paper. There is more traceability across the board."
Perino added that business issues can be monitored more closely as well because software can identify trends and issue auto alerts when any out-of-spec event occurs. "No longer do you run a report on Monday to find out what happened last week. Instead, you find out [about important events as they occur] as the week progresses," he said.
SonoSite passed an FDA audit with no major nonconformances after implementation of the system, completing the audit in less time than the traditional, paper-based audit used to take.
"We get better visibility and control over our manufacturing production processes … and a more robust, auditable-quality system as a result of going paperless," he concluded.
Device History Records
AssurX’s Tamar June pointed out that many medical companies are recognizing the value of converting their manual, paper systems to electronic versions. Not only can this improve productivity but it allows users to perform trend analysis as well as reap other benefits. Last December, AssurX partnered with Brooks Software of Chelmsford, MA to provide a web-based manufacturing execution system (MES) integrated with a real-time eDHR (electronic device history record) product.
"The paperless, real-time eDHR provides complete product genealogy and maintains audit trails to meet FDA regulatory requirements," noted Jeff Nestel-Patt, director of marketing communications for Brooks Software. "Real-time eDHR provides complete visibility to the as-built configurations and current status of all work in progress on the shop floor. Manufacturers can capture as-built manufacturing information in real time, ensuring operators adhere to the specified device configuration and providing an audit trail for compliance."
Nestel-Patt added that with most solutions, companies must buy an entire MES to get the track and trace device history record functionality they need. With eDHR, customers can simply purchase the device history record system they need and grow to a broader MES solution as needed.
Training and Networking
Facilitating the training process and ensuring that employees complete the necessary training for their positions is a chief concern for customers of Pilgrim Software, said Nikki Willett, director of products and product marketing. Recently, the company introduced the SmartTrain module to streamline training records and activities. The module notes specific training requirements based on employees’ positions and allows users to see at a single glance if an employee is certified in all of the job functions and standard operating procedures required for his or her job. It also provides instructor-led classroom training components (including setting up the classroom, roster, curriculum and exams), online training and a historical view of certification. This last capability is critical, Willett said.
She added that three customers served as design partners in creating the new module. Pilgrim Software customers interested in particular functions can serve in special interest groups to share information on how they use the system and enhancements they wanted. Further, customers interested in new functions can work with Pilgrim as a design partner, helping to develop requirements, reviewing designs through early prototypes and participating in a beta program to verify the product meets both customers’ and market needs before a new product is launched nationally.
EtQ includes education on the latest changes in standards at its conferences, and top customers can make presentations there.
At AssurX’s annual, weeklong user conferences, an "Ask the FDA" session in which a former FDA inspector answers questions about what to expect during an inspection, how to respond to an FDA warning letter and other questions has proved popular.
Several other key trends are affecting how medical device companies are implementing software solutions.
• Globalization Increasingly, life sciences companies are seeking software that can run from a single server but be accessed easily by employees and partners anywhere else. "We’re seeing bigger deployments with deeper quality and broader functionality for supplier information, complaints, repairs, CAPA and statistical process control," reported John Beans, vice president of marketing for Datasweep.
In recent years, the company’s large customers have requested robust, industrial-strength applications that hundreds of employees in multiple locations around the globe can access simultaneously. For example, Pemstar employees in 10 sites, including Malaysia and China, can access programs run from its U.S.-based server.
• Scalability and Flexibility Medical device companies generally should put scalability and flexibility without programming at the top of their list when purchasing a software system, advised EtQ’s Tim Lozier.
He noted that a key challenge for software publishers is to create a system flexible enough to work on multiple platforms but familiar enough to employees to be used easily and effectively. A growing technology behind quality management systems is the ability to take existing tools and integrate them into the overall process. Because employees tend to work best with familiar interfaces, many software vendors are creating technology that interfaces with commonly used tools.
For instance, EtQ employs a Microsoft Integrator, which seamlessly integrates Microsoft Office files into its workflow-based forms. On some systems, attaching documents to a workflow is a manual task requiring the user to locate the document on a file server, attach it and send it to the next assigned user, who then must detach the document to make edits.
• Maximizing Capabilities More medical companies are looking to leverage the investment they’ve made in software and asking their software providers for help.
"When we talk with clients who are using a calibration or maintenance management system, CAPA or ERP system, we often find they’re using only a small percentage of the capabilities they already have in place," Matlis said, adding that software can help maximize equipment usage.
For example, injection molds are costly equipment. Using software to track their life span can help identify exactly when to replace a particular tool before products are made with out-of-spec tooling.
• Greater Computer Access With their costs and physical size declining (less than $1,000 per workstation in many cases), computers are allowing software to be used by more people throughout organizations today. Windows computers with no hard drives work through servers, allowing many functions to be centrally managed
• Greater Interest in Automatic Trending Real-time reporting of data generated at every phase of production—from concept through distribution—allows companies to make critical decisions with better information more quickly. Sparta Systems, for instance, introduced its AutoTrending capability in 2004.
"We found that although our clients could generate trend reports from the system, or even have these reports e-mailed to them automatically, they also wanted real-time trend detection when thresholds have been exceeded," Cagle said.
Overall, three key trends appear to be shaping the future of software systems. The need for real-time information on a global scale is greater than ever before. Harmonized business practices are driving technological developments in information systems. Another trend is to use best-of-breed solutions—for example, choosing an established, proven product for a particular function, whether it be QMS, EDMS, LIMS, ERP or others.
Finally, medical device manufacturers are leveraging their investment in software by deploying it to broader areas of business applications throughout their organizations. By leveraging search and reporting functionality to get information faster, companies can make better, more informed decisions.
Stacey L. Bell is a freelance writer who specializes in business and marketing issues.