A Click Away
Faster, more accurate FDA submissions, tighter quality controls, better productivity and bottom line results—all are just a click away with today’s software innovations
By Stacey L. Bell, Editor-at-Large
The year 2007 may well be remembered in history books as “The Year of the Recall.” From toothpaste to toys, pet food to tires, more products were found defective or downright dangerous last year than in any year previously. The medical device industry was not immune from the recall trend.
“During the past two years, the explosion of product recalls—and some with severe quality problems—has resulted in creating a huge focus on the industry and especially on supply chain quality,” noted Nikki Willett, vice president of marketing and regulatory affairs for Pilgrim Software in Tampa, FL. The awareness and attention are so great that a Global Harmonization Task Force working group currently is outlining new and stricter guidelines, anticipated for release this summer, on supplier controls affecting both OEMs and their suppliers.
“Of all the FDA warning letters recorded in the past two years that relate to manufacturing and quality, nearly 20% cited problems with supplier controls,” said Tamar June, vice president of strategic marketing for AssurX, Inc. in Morgan Hill, CA.
“The number of warning letters—and the number citing supplier control problems—is expected to increase in 2008 and 2009 for a number of reasons: More attention being paid to this issue with high-profile quality problems in China and elsewhere, FDA operating with a bigger budget, more mergers and acquisitions in the industry putting pressure on getting a better handle on various suppliers, and more companies operating globally means they have more suppliers in faraway places where they need strong software/electronic controls.
“We’ve seen a much greater interest in supplier quality management during the first quarter of this year,” June continued. “It’s a concern that more medical device companies need to take more seriously.”
In increasing numbers, OEMs and their contract manufacturers are turning to software as a solution. “We’re seeing more OEMs that want very robust supplier management integration to allow suppliers to participate in the quality process, audit suppliers and give them ratings—determining which contractors produce the most high-risk events,” said Tim Lozier, director of marketing for Farmingdale, NY-based EtQ.
Certainly, software will be one of the top tools helping manufacturers and their suppliers address quality—and the associated visibility and traceability—challenges. After all, it is the underlying coordination, integration and visibility of data that are most critical to how well any given product is designed and produced.
“One of the biggest issues companies face today is the need to break down the silo mentality,” said Daniel R. Matlis, president of Axendia, Inc. in Yardley, PA. “Companies are using myriad systems—including product lifecycle management, manufacturing execution systems, enterprise resource planning and financial systems, customer relationship management products and quality compliance systems—but too often these are disconnected and operate in stovepipes.” For example, he explained, standalone CAPA [corrective and preventive action] systems frequently are used to drive the closure of corrective actions, but the data gathered in the process are not fed back to engineering, product development or manufacturing to give people the information needed to continually improve and enhance their products and processes.
What’s the solution? “Close the loop. By using an integrated system, companies can design for manufacturability and minimize quality issues down the pike,” Matlis said.
When outsourcing is figured into the equation, IT systems and their management become that much more complex and critical. “As [famed chef] Emeril would say, ‘Bam! Let’s bring it up a notch,’” Matlis continued. “In an outsourced environment, it’s often difficult for OEMs to dictate to their suppliers exactly how to execute a process or task. The level of control [can be] diminished. But as a medical device’s license holder, you’re responsible for everything that happens to the device regardless of who made it. You cannot outsource responsibility.”
Software to the Rescue
Fortunately, software can help mitigate these concerns. Matlis mentioned that it’s essential that a software system provide real-time visibility into the process. This gives OEMs the situational awareness required to take preventive action as necessary rather than face corrective action later. “Integrate or install the manufacturing execution system of choice at outsourcing facilities so you’ll have complete visibility in real time and have control over your product’s data,” he recommended.
Companies are introducing various integration and supplier management software products to make it easier for OEMs to see exactly what is occurring in their facilities throughout the world.
In March, AssurX released its next-generation Enterprise Supplier Quality Management (SQM) solution, which offers total transparency and visibility into the supply chain by enabling the capture, analysis and assessment of quality-related issues and providing traceability and monitoring in real time across the supplier network. Among its capabilities, AssurX SQM lets companies track supplier metrics, rate and rank suppliers with score cards as well as collaborate with suppliers to solve problems faster.
“Implementing an effective supplier quality management system will allow you to become more efficient, manage risk and have a compliant supply chain that meets or exceeds your quality expectations. Your customers will be much happier, too,” June said. “An SQM system also provides the ability to collaborate and share information that’s for the better good of the company as a whole. If suppliers, inspectors and multiple facilities are all disconnected, you have a much higher potential for serious product failure, which may lead to recall and, possibly, loss of market share.”
Sparta Systems’ latest release of its TrackWise solution has moved to a fully Web-based model to offer greater flexibility, configurability and visibility to customers. “The globalization of the medical device industry means more companies are now investing in supplier quality management so they can fold in data from their suppliers into their quality management system,” said Ron Rubenstein, director of product marketing for Sparta Systems, Inc. in Holmdel, NJ. “Not only do they improve their control of quality, but they also expose suppliers to the systems they use. The advent of Web-based systems has helped that process. Of course, you need to have robust security to control third parties’ access to the data on the system, but it’s helpful for multiple sites to be able to view the same data. It helps organizations harmonize and standardize their practices.”
That is, the sharing of information among sites allows for an improved, higher-quality workflow as best practices at different plants are shared and compared. Furthermore, if, perhaps, one facility in Ireland encounters trouble with a piece of equipment, sister facilities in China and Mexico could be alerted to the potential problem with their equipment as well, so they can schedule preventive maintenance before a potential breakdown and work stoppage occurs. The sharing of data can save time, money and even someone’s health, noted Lozier.
In March, EtQ introduced the EtQ Data Center as a standard feature of its compliance and workflow medical device software platform.
“We’ve seen more global implementations in the past three or four years, and this product allows a centralized location to better manage multiple facilities,” Lozier explained. “There is one master data set, and all sites in the data network are rolled up in real time—you don’t need to click on 10 different areas to gather data. The process creates visibility and a true global network.”
A true global network that gathers and lets managers sort through best practices is the tip of the iceberg. Software also helps companies set and streamline overall business priorities to maximize productivity, performance and profits. It also can aid companies in their corrective and preventive action programs. “CAPA has become a catchall for many organizations. In speaking with medical device companies, we’ve found that the prioritization of CAPA often is based on due date, not on criticality,” Lozier said.
This finding led EtQ to introduce a new risk assessment capability that automates the CAPA process. The module is configured to meet the customer’s needs; that is, definitions and matrices are constructed for what constitutes a high-risk event and its potential expense, danger and impact on the business. Non-critical events are filtered out, and remaining events are prioritized to better address business needs and reduce the costs of noncompliance.
“One large life sciences medical device company uses this product globally, and prior to implementation, it would have as many as 10,000 complaints per month. Every quality-related complaint became a CAPA, leading to thousands of CAPAs in the system,” Lozier said. “After implementation, they now have filtered the most critical CAPAs to several hundred per month, resulting in huge cost savings in time and resources.”
In late April, Camstar Systems, Inc. is launching its Enterprise Manufacturing, Quality and Intelligence Platform, which provides a single, unified system to support a proactive, performance-driven approach to manufacturing and quality operations. “It’s a new perspective on an old problem,” explained Karim Lokas, vice president of product strategy and marketing for Camstar Systems, which is based in Charlotte, NC. “By combining manufacturing and quality systems within one solution, rather than keeping them in separate silos, companies will be better able to achieve continuous improvement, reduce the cost of goods and ramp up new products much more quickly.”
Compiling and sorting through data from different divisions—and locations—are common business goals today. Lokas said that an overriding theme for today’s manufacturers involves how to use software to circumvent the effects of coalescing pressures. The flattening of the world has resulted in the need to access global resources and meet worldwide demand and competition.
“The answer lies in centralizing data. Not only do you need visibility to be able to find out what happened to a product from its final state back to its original source material, you also need traceability across the full global value chain,” Lokas explained. “Best-practices benchmarking of a product manufactured in different geographic locations can lead to standardizing best practices and achieving global compliance with those practices. Finally, in a globally distributed virtual manufacturing environment, there are assets you own and assets you don’t own. Synchronizing the replenishment of supply, demand and capacity information about all of those assets will ensure opportunities aren’t missed.”
By the end of the year, Pilgrim Software will debut SmartPulse, a product that will “keep the pulse” of a product’s quality as it travels throughout the value chain, Willett said. “This new business intelligence solution will make it easier for organizations to extract information from our system and integrate it with information from the OEM and its suppliers to understand the totality of data from across the value chain,” she explained. “Professionals from end-users to quality and compliance coordinators to vice presidents will be able to access dashboards of meaningful data to make their jobs easier and get a more complete picture of all the costs, liabilities and issues surrounding a particular product.”
Electronic medical device reporting (eMDR) will become a critical issue in the coming months, as many industry observers expect the FDA to make electronic reporting of medical device adverse events mandatory within the next few years. The FDA receives about 300,000 MDRs each year, which then are manually entered into its Adverse Events database by independent contractors—a costly, and mistake-prone, process. For their part, medical device companies must gather paperwork, fax it to the FDA, await acknowledgment and then possibly resubmit additional paperwork—also a time-consuming task.
In 2006, the FDA began a pilot program with the industry and technology developers to digitize the process. Pilgrim Software’s complaint management and resolution offering, SmartComplaints, includes eMDR functionality that arose out of the company’s work in the pilot program. The software supports both low- and high-volume submitters along with manual submissions.
“As data is captured from a complaint record, the information is mapped automatically to the MedWatch file for review and then converted into XML for electronic delivery. …Medical device companies will be able to rapidly get their eMDRs transferred and approved,” noted Pilgrim Software’s white paper, Paving the Way to Easy Electronic Medical Device Reporting.
Sparta Systems, which also participated in the FDA pilot program, offers the TrackWise eMDR Submission Manager. The software eliminates paper forms and manual document routing.
AssurX eMDR, also developed as part of the FDA’s pilot program, was previewed by customers in February. The system is geared for both low- (fewer than 50 MDRs/month) and high-volume manufacturers that want to start submitting their 3500A forms electronically. “AssurX eMDR allows for seamless submission directly to the FDA’s B2B AS2 Gateway with a simple click of a mouse. No third-party software required, no separate EDI systems needed,” June said.
In their quest for improved quality, throughput and profits, medical device companies—and their outsourcing partners—will focus more attention and resources into IT systems, experts said. In fact, software firms are starting to see their customer bases shift as more contract manufacturers purchase software systems to differentiate themselves from competitors throughout the world. Outside influences also may exert some pressure in the move towards acquiring software systems that can help improve quality and other processes.
“I see a significant shift in the use of software and technology in the medical device community in the coming years,” Matlis said. “From a regulatory standpoint, FDA has been moving from a position of ‘testing quality out of the product’ at the end of production steps and in finished goods testing to a more proactive ‘build quality into products and processes’ approach in which controlling the process becomes a critical factor in ensuring product quality. If you fully understand and control critical-to-quality attributes—and control your processes proactively—you almost can’t help but make good product.”
In addition to the increasing attention on suppliers’ quality management processes in light of recent recalls, Camstar Systems’ Lokas said he sees a shift in the very way manufacturers are defining and driving quality. “No longer is quality a tactical, departmental issue,” he said. “With increased scrutiny by regulators, highly publicized recalls and adverse events, there is now more recognition that quality is a strategic concern and everyone’s responsibility. There is a renewed energy and focus on what constitutes superior customer experience with no adverse events. Software can help companies identify patterns and offer early warning indicators. With proactive, predictive, preventive systems, you’ll see patterns and challenges before they become significant and quality issues. Manufacturing and quality must be highly interoperable.”
Software companies also continue to integrate customer suggestions into their offerings. While most companies receive customer suggestions and offer user groups and conferences, Sparta Systems recently instituted an awards program, the TrackWise Innovation Awards, to recognize and honor customers that have implemented TrackWise to solve a unique business challenge and have achieved significant business value as a result. Winners receive free passes to the user conference and a panel in which they can overview their deployment success story. They also get a certificate and, depending on where they place (first, second or third), additional TrackWise licenses.
Whether in winning a free pass to a user conference in a beautiful hotspot, eliminating the time and paperwork involved in filing MDRs or avoiding the issues that can lead to a recall, today’s software experience can be more rewarding than ever.
Stacey L. Bell is a freelance writer who specializes in business and marketing issues.
From Field to Facility: More Companies Choose Remote Diagnostics
As life becomes faster paced and more complicated, it’s hardly surprising that people look for ways to make tasks easier, so they’ll have one less thing to worry about. Consider General Motors’ OnStar product. Vehicles equipped with the OnStar service offer their drivers navigational help, can automatically call for assistance if the car is in an accident, and the remote diagnostics function checks key systems such as the engine and anti-lock brakes monthly to make sure they’re operating optimally. Life is made easier—and safer—for these drivers.
The same concept has moved into the medical device realm. “In the medical device world, software has become ubiquitous. At one time, everything was electromechanical and controlled at the logic level. Now you have very sophisticated devices with sophisticated, software-driven control systems,” explained John Carey, vice president and general manager of Foliage, a custom software developer in Burlington, MA.
A Growing Trend
Device manufacturers are adding software to their products for numerous reasons. In some instances, software gives products more capabilities and a competitive advantage. A more sophisticated software system may ease use of a device, allowing doctors to execute procedures faster so they can perform more each day. Software also is used to guide client use of complex products, record how a device is used in the field and to ensure it is working properly. Some companies have even introduced remote training systems, particularly for surgical devices that require proctoring.
“We’re seeing much more work in remote diagnostics, which predicts equipment failures and lets manufacturers schedule repairs and ensure they have the proper tools and parts onboard when they arrive,” said Robert Ruppenthal, president of RTEmd Medical Device Software Services in Pittsford, NY. He noted that this capability most often is employed with large, complex products and systems used in clinical laboratory settings.
“Remote diagnostics provide a communication path between the product in the field and the manufacturer’s service department,” Ruppenthal explained. “It can maintain error logs, let you know if a machine is running out of disposables and let a service technician at the home office, with the permission of a lab manager, take remote control of a product to troubleshoot it remotely.”
He added that RTEmd also is seeing strong demand for more autonomous operation of medical equipment. “There are fewer people working in US clinical laboratories, and skill and training levels vary,” Ruppenthal said. “By building tremendous error and quality checking capabilities into equipment, we can allow for higher throughput, less downtime, verification of test result accuracy and ease of use.”
Andrew Dallas, president of Full Spectrum Software in Southborough, MA, agrees. “Many of our customers are now including in their requirements the ability to remotely service their devices,” he said. “Needs may include remote diagnostics, consumables tracking, use histories and even fault diagnostics. Remote diagnostics reduces field service costs by reducing travel and response time. It also can help to identify misuse cases or conditions that were not anticipated in a product’s design. Consumables tracking benefits both the user and the manufacturer in ensuring consumables are placed or renewed when necessary to prevent unexpected downtime due to lack of supplies.”
In today’s global marketplace, software development services companies increasingly are called on to create graphical user interfaces (GUIs) that are configurable to accommodate the special needs of different cultures. “The human factors element of GUIs has become a true science in software and product development,” Carey said. “To compete globally, you must keep each culture in mind as you plan and design a GUI that is to be deployed globally.”
For instance, Carey said, some cultures respond better to softer colors than to more vibrant colors. In the United States, consumers are used to pronounced alerts and warnings; however, their Japanese counterparts would prefer a more polite, unobtrusive message or dialog box.
Workflow also differs across countries. “A blood banking application is much different from a workflow perspective in the United States versus in Europe versus in Japan,” Carey noted. “You must configure a different GUI for each country, because they handle patient workflows differently.”
Word order can be critical, too. “In the United States, the machine may tell you, ‘You have five units left now.’ In China, the phrase would be ‘Now remaining have five units,’ depending on the construction. There are different meanings and connotations, so software engineers have to make sure they construct messages with the right words in the right order,” Dallas said.
Obviously, as devices add more software and capabilities—and additional GUIs for entry into additional marketplaces—devices become that much more complex. Therefore, manufacturers must allow extra time in the development cycle if they’ll be introducing a product into multiple markets simultaneously.
One way in which today’s software developers are creating products more quickly is through what’s known as “agile development methods,” or “extreme programming.” According to Foliage’s white paper Increase the Efficiency and Pace of Medical Device Software Development by Going Agile: “Many medical device companies develop software using a traditional, waterfall methodology where each step is taken in sequence—requirements, design, implementation, verification, validation. At each step, documents are written, reviewed, revised and approved. …Many organizations are now seeking approaches that yield demonstrable value faster and that are better able to adapt to changing business needs….Agile software development methods…improve pace and efficiency and provide greater flexibility by [developing software in an iterative fashion, considering requirements, design, development and testing]… responding to changing business conditions and user needs even during their development.”
Carey said agile development can lead to more versatile and useful products, since clients may learn about new trends and customer desires during the iterative process and be able to add them into the next round of development, as compared with the waterfall process, in which all requirements are set upfront.
Software development firms also are adding services to ease additional customer concerns. Foliage has created automated test frameworks to streamline software testing, which formerly was a labor- and time-intensive process for manufacturers. Even better: automated testing allows for more reliable, repeatable results, since software—unlike human testers—doesn’t get tired and make mistakes.
Full Spectrum Software provides a code hardening service, which can significantly enhance the stability of a product and reduce its number of runtime defects. Through static and dynamic code analysis, and by manual code review, software engineers identify and repair coding errors in existing products. “Our engineers find common coding and engineering errors that lead to product fragility,” Dallas explained.
Remote diagnostics and other software used in medical devices will have a tremendous impact in today’s cost-constrained environment. “Well-designed, stable software reduces maintenance costs,” Dallas said. “Features that further reduce field service can add to that savings and improve customer loyalty through a perception of attentive service and rapid response.”