Tying It All Together (Medical Product Outsourcing)


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Advanced software solutions enhance every step of the manufacturing process from design to production.

Mark Crawford

Controlling the rapid pace of innovation in a highly regulated environment requires a level of tracking that can be challenging, even for well-established companies. “Managing business growth while maintaining visibility of operations is difficult, especially for smaller businesses with single devices that are growing into product families, that acquire or grow into additional manufacturing facilities, or choose to expand globally,” said Christine Hansen, manager of product marketing for Epicor in Irvine, Calif.

A recent study by Camstar Systems Inc. and Axendia, a Yardley, Pa.-based life sciences research firm, shows that life science companies tend to rely on reactive approaches to quality, using quality management systems (QMS) to manage and document compliance to U.S. Food and Drug Administration (FDA) regulations. A more effective strategy is installing quality programs from design through manufacturing to end use that “close the loop” across all phases of the product life cycle. The best way to accomplish this is using a closed-loop enterprise platform to create an end-to-end quality process that identifies potential problems before they arise in any part of the production process.
For medical device companies, advanced software programs can provide complete solutions for business process management, global business management (managing multiple sites), internal quality tracking, cost management and rules-based product configuration (an application that enables manipulation of all product-related data from design to marketing to manage their life cycles more effectively).

“Rules-based configuration has proven to be a means to quickly price and manufacture products to specific customer requirements,” said Hansen. “Used in other industries, it’s beginning to improve efficiencies for some medical devices, especially where high configurability is prevalent.”
“In the past, individual manufacturing, quality assurance, regulatory affairs, research and development (R&D) and product engineering departments worked in silos because they relied on disjointed applications and fragments of data they tried to piece together,” said Susan Lamb, senior product marketing manager for Camstar Systems in Charlotte, N.C. “They struggled to understand how processes were performing and how to find true root causes for product issues. Often pressures to comply with FDA regulations trumped other initiatives that would have built quality into the product. Industry leaders find that by implementing enterprise-class closed-loop quality processes, they can drive product performance back into the design process to accelerate continuous improvement and innovation. Compliance is a natural outcome of these well-structured processes.”

Manufacturing and Supply Chain Management

Never before has the quality of medical devices been more reliant upon suppliers’ manufacturing processes. “Regardless of the certifications, validations, or audits that have been passed, final product quality is, for the most part, unable to be controlled by the company that stamps its name on products received from suppliers,” said Doug Fair, vice president of statistical applications for InfinityQS International Inc. in Chantilly, Va. “We see situations where a supplier problem is present but unknown, and products continue to be shipped and received. Uncovering quality problems at this point in the supply chain is extremely expensive and typically results in the possible cessation of production and exposure to recalls.”

According to Axendia’s 2009 research report titled, “Quality Management System Trends in Life Science,”88 percent of medical device manufacturers have limited or no visibility into supplier or outsourced operations. For these companies, it is tougher to enforce complex operations over multiple sites and contractors or manage quality data for rapid assessment and action. Correlating results to vendors, materials, and processes, and undertaking root-cause analysis where needed is also challenging.

More vendors are starting to integrate critical quality data related to manufacturing events. This often involves linking nonconformance workflows to enterprise resource planning, manufacturing execution systems and quantitative risk assessment to best determine how to prioritize the severity of an adverse manufacturing event.

Supply chain managers are relying increasingly on sophisticated software systems to assess, in real time, how adverse events are linked to suppliers. “By incorporating suppliers into the quality process any time an event occurs—whether it be complaint, nonconformance or material return—if the supplier was part of that finished product, the supplier can be integrated into the corrective action process,” said Tim Lozier, strategic development manager for EtQ Inc. in Farmingdale, N.Y. “Furthermore, since quality is tracking most post-production adverse events, it is logical to use this data to populate data within the supplier rating. Supplier quality is now factored into the rating system and ensures that not only will suppliers be watching their own internal quality, but any quality events that occur within the finished product will be tracked.”

The Camstar Enterprise Platform—comprising manufacturing execution, quality management, and business intelligence—is designed to support a broad range of manufacturing processes such as complex process work flows, high-volume automated data collection, mass customization, discrete assembly, batch process and rolled products across global operations. “The entire manufacturing and quality audit trail is in one place, including suppliers,” said Lamb. “The searchable audit trail makes it possible to perform instant where-used inquiries (bracketing) to find all products that are affected by a specific component, process, tool, etc. This speeds containment and limits its scope to only the items affected. The comprehensive, searchable data also makes intelligent true root cause analysis possible.”

InfinityQS International’s eSPC software also identifies quality issues at the supplier plants, before the product ships. “Quality problems can be immediately exposed at the time the supplier is manufacturing the products,” said Fair. “This facilitates information transfer and problem-solving while minimizing reliance on after-the-fact certificates of analysis and expensive receiving inspection duties. Additionally, eSPC has the ability to house data from many different suppliers, making supplier comparisons simple, and providing the manufacturer with overall quality levels at each supplier’s plant.”

Fair indicated that most manufacturing companies around the globe have yet to deploy advanced systems of supplier-based, real-time data entry and analysis. “Evaluating supplier quality using old-fashioned techniques is extravagantly expensive and, quite frankly, ineffective,” continued Fair. “Audits and COAs are both after the fact. Neither has the ability to provide critical quality information at the exact time of manufacture.”

So why aren’t more companies using these solutions, especially since they are relatively inexpensive?
“I think this is due in part to suppliers’ unwillingness to reveal too much detail concerning their manufacturing processes and performance,” said Fair. “Plus manufacturers may be uncomfortable asking their suppliers to do ‘just one more thing’ in the name of quality. It’s also possible the technology is so new and exciting there is a sense of ‘this is too good to be true.’ In reality, this is as an enormous opportunity for supply chain cost savings, as well as a vital opportunity for fact-based collaboration and defect reduction across company and supplier boundaries.”

Real-time quality control is particularly valuable for companies with global operations. “As their products are sold in various geographies, systems need to support local requirements and currencies,” said Hansen. “Additionally, since many of these businesses are in high-growth mode and putting plants and operations near their customers, systems today need to support multi-plant, multi-company visibility across these locations.” To meet this need, Epicor provides a comprehensive range of software and services that provide a single point of accountability, regardless of local, regional or global scale. The latest edition of Epicor 9 includes next-generation business architecture applications that reduce costs, increase hardware utilization and optimize infrastructure and server availability.

R&D and Design

Companies also look at quality control from the viewpoint of risk and change management. Quality systems traditionally track risk within the post-production phase of the product life cycle by identifying adverse events and nonconformances, as well as using quantitative risk assessment methods to determine risk levels and take appropriate actions to mitigate further risk.

“This has recently expanded to the design phase using similar tools,” said Lozier. “In an effort to meet the ‘compliance right first time’ mantra, organizations are looking to mitigate risks throughout the product life cycle, from design to finished product. By assessing risk in design, we can ensure that mitigation steps are taken from the beginning of the process and hopefully limit the number of adverse events in the finished product.”

Glenn Nowak, vice president of IQMS, a software provider in Paso Robles, Calif., has observed an increased trend toward outsourcing certain operations and manufacturing offshore. “In response, we have worked to increase communication across the entire supply chain to better track in-transit products—be it from across the city or from overseas,” he said. “Our device history record (DHR) is key to making design and R&D more efficient. It ties together design, manufacture and maintenance for a total life cycle in one comprehensive package. Because our DHR is part of enterprise resource planning, we are accessing process and production information directly from machines, inventory, etc., and linking to lots and traceability throughout the system.” The DHR module allows medical device manufacturers to eliminate time-consuming, paper-based tracking systems, streamline product development, improve quality standards compliance and gain total visibility and control over the manufacturing process.

“Systems today are extended with product life cycle management (PLM) to support the needs of this industry for ‘one version of the truth’ coming direct from engineering through to production,” added Hansen. “The business processes needed in design and engineering for medical device manufacturers are compounded by the frequency of change requests and the speed of change driven from new technology innovation. With various product families, these device manufacturers must manage entire product portfolios. Giving engineering a tool set to collaborate on like products and material usage reduces duplication of engineering problems while improving speed for new products to market.”

Quality Control

Real-time quality solutions have the ability to instantaneously alert support personnel around the world to problems as they arise, potentially averting expensive recalls and quickly alerting management to the process that needs repair. This critical information also can be used to direct engineering priorities and provide guidance for Six Sigma project teams.

“A wide variety of real-time data collection tools and devices allow fully automated data collection from virtually any electronic device,” said Fair. “These sophisticated software products support data collection whereby no human intervention whatsoever is required.” An alert is triggered when the data reveals a quality problem—this real-time notice enhances ultimate traceability, resulting in significant reductions in non-compliance and quality and inspection costs.

With adverse events and recalls on the rise, an enterprise platform that enables closed-loop quality processes that focus on prevention and early detection of problems can be highly beneficial in reducing nonconformances, corrective and preventive actions, field failures and overall operating costs. First pass yields, production throughput and root cause analysis all can be improved. “These advanced capabilities dramatically reduce the overall number of adverse events while increasing revenue,” said Lamb.

The FDA is passing more regulations, as well as clamping down on existing ones. Enforcement actions have picked up and device companies must be more vigilant regarding record-keeping, corrective and preventive actions, submissions and complaints.

“For example, Boston Scientific was hammered again by the FDA for ineffective change control procedures,” pointed out Tamar June, vice president of strategic marketing for AssurX Inc. in Morgan Hill, Calif. “Change control can involve many areas of an organization, including R&D, engineering, manufacturing, production, customer complaints, and supplier issues. It is something the FDA will definitely focus on more going forward.”

AssurX provides an integrated, all-in-one closed loop enterprise level application for managing the change control process. “We do not provide separate modules because many device companies are looking for a complete package,” June said. “Instead of bolting everything together, it's all ready to go out of the box.”

Each individual functional area benefits from having the other functional areas in the same system. For example, when a design group goes to create a new revision of a specific product, it can query the system to see what issues were associated with the previous revision—and improve the next design. When sourcing new vendors, purchasing can take a look at typical performance by past vendors in order to determine future buying criteria for new vendors. When manufacturing encounters a problem, it can query the system to see if the problem already has a solution—possibly from another department or from the design group.

“Because all issue sources (e.g., customer service, manufacturing, supplier, design, etc.) are in the same database, they can be trended across functional areas,” said June. By utilizing this system, June indicated a customer dropped from two full-time employees driving three changes in one year to one part-time person driving 16 changes in seven months.

EtQ’s Risk Assessment Software module/filter calculates the risk of quality events at every step of the design and manufacturing process, thereby improving overall quality and reducing recurrence of critical events. “This has enabled clients to be exponentially more responsive in their quality systems,” said Lozier. “Furthermore, they can even conduct additional risk assessments when verifying any corrective actions to ensure that not only has an event been corrected, but that it has been corrected within the specified risk parameters they set forth. Medical device manufacturers can successfully use this program to filter their incoming events according to risk ranking, allowing them to prioritize and focus on the events that are most critical to their business.”

Then there’s the software inside the medical device. Some vendors like Pittsford, N.Y.-based RTEmd Inc., who in addition to new product development and testing also provides sustaining engineering for released products. Its sustaining engineering team specializes in installing upgrades and enhancements, solving field problems, and addressing component obsolescence issues in released products through end of life, often extending longevity and saving money.

RTEmd’s software services are focused on design, development, documentation and testing of on-board software. “We are frequently called in to clean up after less-experienced development teams, where the product has been released and end customers are struggling with erratic behavior of the device,” said RTEmd President Robert M. Ruppenthal. “We are essentially a contract manufacturer of the software inside a medical application. Few software firms provide the full life-cycle support services for medical devices that we do.”

Typical projects range from standards-based wireless connections for patient-facing devices such as scales, electrocardiograms or blood pressure to supporting remote disease monitoring and management equipment and high-throughput systems for clinical diagnostics.

“Most medical device startups have a research focus and little practical experience in commercialization or regulatory considerations, so they don’t understand how a product differs from a prototype in either substance or process,” said Ruppenthal. “Often among mature medical device manufacturers there is an extended time between new product releases and the personnel, and process knowledge from the previous development are often not available for the current effort. By continuously designing, developing and testing software for new devices, our team is able to incorporate improvements to our tools and process as well. We learn from about two dozen projects each year that help us avoid pitfalls and take advantage of the constant evolution of technology.”
Regulatory compliance is more than just testing quality at the end of software development. Building a safety-conscious culture within the development staff brings an awareness of safety and efficacy into every aspect of the production.

“Safety in software is predicated on assuring consistently appropriate behavior under all operating and failure circumstances,” said Ruppenthal. “The discipline required throughout the development team includes proper requirements and attention to architecture, complexity, code construction, error processing, code reviews, white-box unit testing and hazard analysis.”

Parting Thoughts

As interest in environmental health and safety (EHS) grows, many companies are realizing quality management and EHS management have striking similarities—both in practice and how their automated systems operate.

“As a result we are starting to see a convergence of these systems into a singular quality environmental health and safety system (QEHS, SHEQ),” said Lozier. “An event, once thought to be a product/manufacturing event, can also have EHS impact. By containing these events in a singular holistic system, we can require employees to go to a single source for both QMS and EHS events—as opposed to two even three separate systems. We can also expand the business intelligence capabilities in rolling up quality and EHS data to uncover trends that might not otherwise get uncovered. For example, say product line A has the most nonconformances during shift X, which also has the highest level of safety events—one could be a cause of the other. In an age when consolidation and integration are critical, this leading-edge concept is an incredibly seamless and cost-effective investment.”

Another interesting development is using quality management to drive change management within an organization. Quality is constantly tracking post-market feedback in the form of complaints, events, product returns, etc. Corrective actions taken on these post-market events often lead to changes in product or process. By enabling quality to drive change in the product or process, all relevant data is retained from the original event. Dedicated workflow manages the process intelligently through the various phases of the life cycle and any affected documentation (typically found in document control systems within a QMS) can easily be updated.

“Furthermore,” commented Lozier, “quality closes the loop on change management, as once a product or process change is complete, post-market feedback is continued within the quality system. Couple this process with the introduction of risk assessment at every phase of the change and a singular environment for quality change management is created that helps mitigate risk with each product life cycle.”

Systems that support medical product manufacturers must extend beyond traditional enterprise resource planning to include functionality in support of the extended operations. Capabilities such as customer relationship management, quality management, PLM, supply chain management, global business management, and advanced planning and scheduling can be embedded in total-solution software services.

The speed and frequency of change in medical device manufacturing requires a flexible toolset, especially for meeting the needs for process change. When new regulations are passed they need to be responded to in short order and systems that require extensive source customization to meet these changes can’t respond fast enough.

“Another big issue is the fact that extensive customization limits then the number a­nd frequency of upgrades these manufacturers can use,” says Hansen.“There is a better way—systems that are built using a service-oriented architecture based on web services are adaptive to meet the changing needs with greater frequency and support business process changes as medical product manufacturers move to new releases.”

Mark Crawford is a full-time freelance business and marketing/communications writer based in Madison, Wis. His clients range from startups to global manufacturing leaders such as Kohler. He also writes a variety of feature articles for regional and national publications and is the author of five books. Contact him at mark.crawford@

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