Turning Wishes Into Commands
Want to Improve Yields? Reduce the Risk of Recalls? Software Makes It Possible
Stacey L. Bell
What keeps you up at night? Worrying about beating your competition to market with a new innovation? Strategizing about how to streamline production?
More companies are finding that whatever challenge they face, there is a software solution that can turn their wishes into their commands. Automating each step throughout a product’s lifecycle delivers quality, safety and efficiency gains and saves valuable staff and capital resources that can then be redirected toward other opportunities. Software offers other advantages as well: allowing OEMs to work more effectively within their own organizations and with their outsourcing partners, enabling increased functionality and features in their products, and letting companies grow much more rapidly and profitably than if they were relying solely on paper and homegrown systems.
That said, firms must look carefully before they leap. “One of the biggest challenges I see is that companies look at technology as a panacea, as something that will solve all of their problems,” reported Dan Matlis, president of Axendia in Yardley, PA. “The reality is that for any software implementation to succeed and benefit business, you need to clearly understand your business and implement software in a way that meets the need.”
Matlis said companies should answer these questions:
• What are our current business processes? Is there room for improvement? (Resist automating a process unless it is already optimized.)
• How am I manufacturing?
• What would I like my system to do?
“Technology can only enable the change; it can’t drive it. You need to identify your business needs and select a technology that can best meet your goal,” Matlis said.
Whatever your goal, it’s likely a software solution exists. From communicating about a developing product’s design to launching a device in multiple markets, software can solve common challenges.
The Art of Collaboration
One common problem is that most product lifecycle management systems are CAD and engineering centric, so non-engineers have difficulty reviewing drawings because most don’t have a CAD program on their desktops. Enter the Right Hemisphere 5 platform, an integrated suite of visual product communication and collaboration solutions introduced in March. The software automatically translates a product’s CAD data into another three-dimensional (3-D) or 2-D format, integrates it with metadata if desired and then delivers the merged data into a more accessible format, such as in a PDF or Microsoft document. Interactivity and photorealism also may be added
“We can automatically publish in 130 different application formats and provide every view of a product in one document,” explained Michael Lynch, CEO of Right Hemisphere in Fremont, CA.
Such capabilities have proven invaluable to one medical device manufacturer who used to spend several weeks developing a request for quote RFQ on a part. Each vendor required a different file format, and it could take multiple files to show enough static drawings of the part and its intended function to get a realistic quote.
Now, the RFQ takes mere minutes to assemble. Automatically generated files in varying formats are filled with interactive 3-D images, which have significantly shortened the learning process. The resulting proposals’ quality has improved so dramatically that the manufacturer has been able to cut iterations while minimizing the amount of engineering time spent instructing both in-house and partner teams.
Right Hemisphere 5 also can streamline the preparation of technical publications. DaimlerChrysler prepares hundreds of thousands of drawings a month for technical manuals. It previously took three days to generate the illustrations for a parts book. With the addition of the platform’s ability to automate most of the sketching process, the same work now is completed in 15 minutes. Such capabilities easily could translate into simplifying the production of medical device manufacturers’ publications as well.
Having the right tool to accomplish the right task is key, said Dan Ortega, vice president of marketing for Astoria Software, Inc. in San Mateo, CA. Thus, when Siemens Medical Solutions wanted to improve its product documentation and customer service operations, it studied how customers and employees used the information.
“A primary challenge for medical device manufacturers has been that product documentation is very bulky and monolithic,” Ortega explained. “The Internet has changed how we get and use information. Customers now want to find information quickly and easily and have access to the very latest updates.”
Therefore, online manuals that can provide more thorough product details and updates quickly are expected to replace the time-consuming, expensive production of paper versions.
Astoria On-Demand, due to be released by this summer, offers flexible content re-use that allows companies to share and update information across product lines, incorporate multimedia and translate text into multiple languages.
Siemens Medical Solutions found that its field engineers had to sort through numerous manuals to find the pertinent instructions to make product repairs, so it used Astoria to write, organize and manage all of the content for use online. The Malvern, PA-based organization also included short videos showing field engineers how to make certain repairs. As a result, Siemens was able to cut the mean repair time by 30%, and its product development engineers—who work on new products and man a hotline to answer repair questions— now can devote much more time to their primary job.
GE Healthcare publishes user information for more than 15 products in 17 languages annually. By automating its content delivery, it reduced yearly translation costs from $3 million to $300,000 and accelerated publishing time from three months to three weeks, reported Astoria Software.
Managing Quality and Compliance
Automation on the manufacturing floor has allowed for tremendous gains in throughput. Automating the processes surrounding manufacturing can save time and money as well.
To improve manufacturing, you must make gains in at least one of four categories, said Joseph Vinhais, vice president of regulatory compliance for Brooks Software in Chelmsford, MA. “Four fundamental items drive business decisions today: patient safety, time to market, brand equity (getting the highest quality possible) and pricing,” Vinhais said.
Companies are buying software that can satisfy all of these categories to get the most bang from their buck. One customer used Brooks’ Compliance Framework suite to improve its manufacturing of components and its supply chain and achieved a 50% reduction in design and development time and costs, a 40% reduction in risk of operational bottlenecks, a 60% faster development time for complex modeling and up to a 20% drop in the number of revisions due to increased design accuracy and customer satisfaction.
Regulatory compliance easily is every medical manufacturer’s chief concern. “The big question surrounding nonconformance in manufacturing is: How quickly can you assess it and address it?” said Nikki Willet, vice president of marketing and regulatory products for Tampa, FL’s Pilgrim Software. “You need to assess if it is critical to the lot and you need a full CAPA [corrective and preventive action], and if so, you then need to decide how to fix the problem quickly. As you decide, the lot disposition is delayed. Before the use of software systems, you could have lots contained for weeks. Now, it’s just days or hours, depending on the product and the nonconformance issue itself.”
Pilgrim’s SmartSolve Suite is a Web-based enterprise compliance and quality platform. This year, the company expects to release several new functionalities, including integration with CAD tools, electronic complaints reporting to the FDA and other enhancements related to quality and compliance to help organizations manage and raise the visibility of quality across the product value chain.
More organizations are seeking automated software to address quality issues in response to a significant rise in 483s and warning letters sent to medical device manufacturers during the past two years. One of the underlying problems is that many manufacturers use a disparate range of systems—paper, Excel or Access files and homegrown systems—to manage their processes.
“It is very difficult to achieve compliance with that approach because there is so much room for error,” said Steve Cagle, vice president of marketing for Holmdel, NJ-based Sparta Systems, Inc. “People are people. They make mistakes. But then you also have databases that crash. Someone makes a change in an Excel spreadsheet, and there is no audit trail. Or you have some data in one system for which there is no smooth handoff to another one. There is a redundancy of data, or the data don’t match. Having one centralized system that can eliminate all of those issues enables companies to be much more effective, efficient and to have information in one place. It’s much less expensive from a deployment and training standpoint, and it allows them to achieve a much higher ROI [return on investment].”
Enough trouble can arise when trying to extract information from disparate systems within a single organization. Imagine the challenges when one firm merges with or acquires another.
“After an acquisition, it’s paramount to ensure other sites are following the same quality and regulatory compliance principles you do,” Willett said. “Companies need a better, more streamlined mechanism to track quality systems to ensure they’re meeting FDA regulations at multiple sites globally.” She noted that a standard software system implemented throughout an organization should provide several benefits:
• Visibility and accessibility. Rather than silo information in different departments, everyone who needs access to specific information should be able to view it easily. By being able to see the same data everyone else sees, involving disparate groups in approval processes and reacting quickly to changes throughout the product lifecycle, employees are better able to take appropriate action and managers are able to measure an organization’s performance tied to its key performance indicators.
• Automation. A system should guide users toward the appropriate next steps in the process. If the system detects trouble or delays, it automatically should escalate it to the proper manager for quick analysis.
• Efficiency. “Get rid of the paper chase between departments for quality systems and processes,” Willett said. Rather than passing folders from person to person and hunting people to get their signatures, the system automatically can send e-mails to individuals who need to make decisions and collect their sign-off electronically.
Allaying Other Manufacturing Concerns
Beyond compliance issues, software also can streamline other manufacturing concerns. AssurX, Inc.’s CATSWeb was designed as a quality and compliance suite with built-in best practices processes, yet customers are using it for myriad purposes. “Our software is used to monitor and improve cycle times, monitor and reduce labor and material costs, and to perform Pareto analysis to determine the most expensive problems in order to focus resources on performing root cause analysis to take actions that prevent problems from recurring,” explained Tamar June, vice president of strategic marketing for AssurX, Inc. in Morgan Hill, CA. She added that by monitoring work in real time, companies are forced to comply with their standard operating procedures—in many cases saving them tens of thousands to hundreds of thousands of dollars per year.
Pat McCrumb, manager of quality operations for Guidant’s Santa Clara Cardiac Surgery Unit (Editor’s note: Guidant is now a division of Boston Scientific) uses CATSWeb for entering nonconforming material issues. These records frequently are accompanied by digital images, which are stored securely within the database and, therefore, are subject to the same audit trail and controls. After implementing CATSWeb, 70% of nonconformances are now closed within five days, and 60% are closed within 48 hours.
“It used to take me two to three weeks to prepare quarterly nonconformance reports,” said McCrumb. “Now it takes me only two days. I also publish weekly open activity reports that take me less than 30 minutes to prepare. The query functionality is key. Before, I used to do all of this by hand—on paper.”
Software also can improve equipment uptime. Last fall, Stelex introduced a version of Compliance Builder (PROMON), a machine interface application that is hooked into a control system or standalone piece of smart equipment. When the equipment goes down or any event is generated, the module creates a work order and sends it to the proper repair department, allowing for faster, more efficient repairs, noted Tony Kashani, president of Stelex in Bensalem, PA.
Enabling Better Decisions
In more than 100 face-to-face meetings with medical device company executives, Chris Parsons, director of marketing for Charlotte, NC-based Camstar, has found a common, recurring concern: accessing real-time, actionable data. “Too much information is buried in paper, so people can’t act on it. Or it’s older information—there may be a lag of 30 days before metrics are collected and distributed among different sites. By then, it’s become an old problem with lost opportunity for earlier detection and correction,” Parsons said.
By incorporating software and tying it into machines on the manufacturing floor, operators are alerted about problems instantaneously and prescribed actions are taken automatically. “You can avoid producing 100 more units that have the same problem,” explained Susan Lamb, Camstar’s senior product marketing manager.
One new Camstar customer noted that it would have avoided $4 million in recent product recalls if only it had had the Camstar Medical Device Suite installed earlier. Another client found its first pass product yield improved by 17% after installing the system.
“The right software lets you reduce corrective actions and quality investigations, ship more product more quickly with auto-release and provides fully traceable documents with electronic signatures incorporated at the end of every manufacturing run,” Parsons said.
Industry experts note that several trends are affecting software development and use.
First and foremost is the increased prevalence of OEMs turning to outsourcing partners for help.
“More medical device companies do no manufacturing whatsoever; they’re using multiple outsourcing partners,” Parsons said. “We’re seeing some of our life sciences customers buying software and placing it at their contract manufacturers’ sites to allow for full visibility into the manufacturing process and detailed reporting.
“Companies are looking at lower-cost centers of manufacturing, particularly Asia, and having software on-site that gives them great visibility provides great peace of mind,” Parsons continued.
Lamb added that implementing a solid manufacturing execution and quality system also is a great selling point for contract manufacturers because they then are able to provide customers with valuable real-time progress updates and timely, compliant device history or batch records.
A second trend centers around companies seeking to reduce liability in their enterprise retention systems. “Too many companies keep too much data for too long, which intensifies their risk,” said Jay Rothe, director of business development and partner management for Stelex. “They’re now writing retention policies and plans.” More Stelex customers are using PathBuilder to purge content from their system at appropriate intervals.
Rothe added that more companies also are synchronizing content between various systems, eliminating redundant or incomplete systems and their associated high annual maintenance price tags. Turning to one turnkey software solution can pay off big. Stelex has worked on numerous projects—synchronizing content, retiring legacy systems and more—that have cost their customers less than half of what a systems integrator had proposed.
In a third trend, software developers are creating electronic medical device reports for submission to the FDA. In March, Sparta Systems released a beta version of the TrackWise eMDR Submission Manager that allows device companies to submit reports electronically rather than through the traditional paper-based process.
“I think that the use of electronic submissions and reducing paper is going to continue to be a trend. This is exciting for the industry. It streamlines the process and reduces errors,” Cagle said.
No matter what challenge you face, chances are that software companies have a solution. Check into the options, and soon you’ll sleep easy.
Stacey L. Bell is a freelance writer who specializes in business and marketing issues. She is based in Tampa, FL.
SIDEBAR - 9 Keys to Successful Software Deployment
To get the most out of your software investment, experts recommend the following:
1. Align technology with your business objectives. Spend time thinking about how the device and system will be used and make sure the system you develop has the appropriate capabilities, advised Alan Ewald, vice president and general manager, medical division for Foliage in Burlington, MA. “An approach we advocate is laying the groundwork for a platform across an entire new product family. Think about what new products may be introduced and what capabilities may be required. Your first product will take the longest to produce, but the next ones will take significantly less time because you’ll be leveraging the platform,” he said.
2. Leverage best practices. “Don’t just try to do your current practices faster. Leverage what has already been proven as best practices in an automated world by other leading organizations,” recommended Nikki Willet, vice president of marketing and regulatory products for Tampa, FL’s Pilgrim Software.
3. Develop a long-term plan. “Buy piecemeal solutions to solve one problem at a time, and you’ll end up with an integration nightmare,” warned Jeff Nestel-Patt, director of marketing for Brooks Software in Chelmsford, MA. “Consider your different product lines and sites and their concerns when choosing a solution. Also, remember that you get what you pay for. One program may meet your needs today, but it may not be robust and flexible enough to build on.”
4. Seek buy-in. Top management and system users should all participate in selecting and designing which software system will be implemented, said Tony Kashani, president of Stelex in Bensalem, PA. If the software will be used at 10 different sites around the world, a representative from each site should be involved in the decision-making process.
5. Watch your attitude. Refusing to make any changes just because “that’s how we’ve always done it”—and conversely, trying to revolutionize the whole technical strategy at once—will not propel your business to new heights, Ewald warned. Make changes thoughtfully.
6. Lock in a first success. By completing an initial project quickly, with great results, you’ll build the momentum necessary to achieve the most successful deployment, Kashani advised.
7. Get with the times. People often don’t think about the concept of software aging, reported Andrew Dallas, president of Full Spectrum Software, Inc. in Framingham, MA. “Over time, one needs to consider rewriting areas of a product because different engineers contribute to the device or program. The more changes, the less integrity, and the more cumbersome the software becomes,” he explained. “Older, unsupported tools can hinder productivity, block integration of new features and present a major risk in product maintenance.”
8. Get help. Many third-party software components exist, and deciding which will best meet your specific needs can be overwhelming. “We’ve had customers seeking to add what appears to be a major area of system functionality to their product. We were able to work with third-party tools and components to build a solution that met their requirements and involved far less engineering time, cost and risk than the client anticipated,” Dallas said.
9. Seek training. “Customers typically use only 50% to 60% of the capabilities of any one system they have implemented. Often, this is because they buy a system based on the core functionality and are unaware of other benefits that could be realized by extending the system’s footprint. However, don’t stretch a system to fit the proverbial round peg into a square hole,” said Dan Matlis, president of Axendia in Yardley, PA.