It’s all about speed.
With a fiercely competitive global economy, ever-evolving regulatory changes and longer approval processes, medical device companies crave speed—they want everything to move faster without sacrificing quality or driving up costs. They want faster product development, time to market, data retrieval/analysis, corrective and preventative action (CAPA) identification and resolution, and—of course—they want to beat their competitors to the finish line.
Quality assurance/risk management professionals are always looking for better, faster ways to streamline operations, improve quality, reduce mistakes and expand scalability—the obvious answer is always new software followed by the question, “But, how far do we go and what can we afford?”
Surprisingly, some companies still operate with paper-based manual systems.
“They import data by hand into a repository and only do analysis after an issue has occurred,” said Ed van Rens, marketing communication manager for InfinityQS International Inc., a provider of statistical process control software based in Chantilly, Va. “Others have deployed homegrown quality systems that check a box but don’t add any real value to operations. We still see companies that use pen and paper to chart and perform analysis on data that has been collected manually on paper.”
To ensure maximum efficiency and productivity medical device companies must be fully connected to their operations, supply chain and customers through robust, multi-functional software programs that manage and validate quality and risk. The automated quality control platform must be compatible with a variety of information technology (IT) frameworks and be deployable as both an on-demand and on-premise solution.
How comfortable a company is in managing its quality and risk assessment and monitoring depends on where it is along its “systems” and “supporting tools” evolutionary curves. For companies with paper-based, manual systems, moving to a software automation solution that shares information through automaticintegration between quality processes is usually the first step in maintaining compliance and reducing costs.
“The next step is integrating to various sources of ‘incidents’ to ensure the capture of information and elimination of human error in recording and ensuring timeliness of incident management, which of course helps to reduce operational costs,” said Deborah Kacera, industry solutions director for Tampa, Fla.-based Pilgrim Software Inc., a supplier of enterprise risk, compliance and quality management software solutions. “Then they need to look at areas of risk within each of their business processes and ensure they can define these areas and set alerts so that they can be notified when thresholds are occurring, versus waiting for customers to point out their problems. The next step is moving to integration with various enterprise systems and other unique business process databases to capture enterprise-wide and global business intelligence data. This will reveal the company’s key metrics and insights into what has happened over time, so they can see where they need to focus.”
Software continues to rapidly evolve to meet ever-challenging needs. Capabilities now include global solution architecture (centralized or distributed) that allows enterprise standardization of critical quality and risk policies, while also allowing for site-level variation in processes, equipment and personnel.
“This includes the ability to provide visibility into extended supply chain—strategic suppliers and contract manufacturers need to understand quality at the source and improve supply predictability,” said Karim Lokas, vice president of marketing and product strategy for Camstar Systems Inc., a provider of enterprise manufacturing, quality and supply chain management software in Charlotte, N.C.
“Performance monitoring and event management proactively detect and escalate significant supply, manufacturing and quality events. Closed-loop quality processes take alerts/events and drive root-cause analysis, containment, correction and prevention back into the manufacturing process and product design.”
Advanced software solutions also are getting easier to use by incorporating more natural and intuitive graphic user interfaces (such as the iPad). Simple, rapid configurability of products and processes enhance integration with enterprise and shop-floor systems, making it easier for non-technical users, such as process engineers, to use the system.
Mobile applications also make it easier to stay connected to systems at all times so incidents can be recorded when they happen and alerts can be delivered quickly across a company’s global value chain. Many companies are looking to leverage the mobile devices their employees carry so they can capture and interact with information more easily—such as quickly recording an incident.
Get Real
You can’t get faster than real-time access to information about the quality and control of products as they are being manufactured. There is a growing need throughout the industry for rapid availability of quality and risk information across the entire globalsupply chain.
“The more quickly you can identify a quality issue with a product that is half a world away, the sooner you can reduce costs and customer dissatisfaction,” said Kacera. “Being able to integrate statistical process control and process/environmental monitoring solutions with your quality and risk-management software allows for immediate notification across your supply chain when there is a problem.”
Real-time data processing from multiple sites at a single location is fairly new technology that is starting to catch the attention of medical device companies—especially those that already have conducted a postmortem analysis after a problem has occurred (possibly even pointed out by customers).
“By not deploying effective real-time quality control systems companies are effectively yielding to a reactive rather than proactive culture,” said van Rens. “Once they do start seeing how easy it is to connect multiple sites and suppliers in a single global quality system, they have no problem envisioning the benefits in closing safety and compliance gaps, having an efficient audit trail, reducing raw material attrition and, perhaps most importantly, using data to drive stakeholder accountability.”
On the device side, the demand for real-time capabilities also is on the rise. According to Bernhard Kappe, CEO of Pathfinder Software in Chicago, Ill., which develops wireless and data management software, about 70 percent of all innovation in the medical device field is related to software, especially wireless (real-time applications). Software can be changed and updated much more frequently than hardware. Interoperability with other systems such as electronic medical records and laboratory information systems also is becoming a necessity in healthcare.
“If you add the rapid adoption of mobile platforms like the iPad and iPhone by clinicians, you get lots of opportunities,” said Kappe. “Interfaces can be separated from devices; information is no longer locked in devices and clinical systems but can be processed, analyzed, aggregated and made available wherever it’s needed.”
A fast-growing, real-time wireless application is post-market surveillance of medical devices—a process that can be dramatically improved with mobile interfaces to devices and clinical systems. Currently, when a potential error occurs, a person notifies the call center that passes on the information. By the time risk management and hospital personnel get involved, weeks may have passed and critical information lost.
“With interconnected systems and mobile interfaces, not only can the vendor be immediately notified of issues, diagnostic interfaces on the mobile platform can guide users through a sort of diagnostic triage process to capture much richer information,” added Kappe. “This lets the vendor assess much more quickly and take actions to mitigate issues, which can dramatically reduce the risk of recalls.”
Mobile technology also provides opportunities to influence behaviors (such as compliance and developing good habits) through persuasive design. The rich data that is collected and analyzed with mobile interfaces and devices can be used to devise new health applications.
“Some of the companies we’re working with are taking data from devices in real time and using machine learning algorithms to discover patterns in the population that will hopefully predict adverse events for individuals,” said Kappe.
Hanging in the Cloud
“Cloud” computing or software as a service (SaaS) is a software solution that is becoming more accepted across the industry, from small companies to global players.
“The cloud is really just a virtual environment that exists within a huge server farm spread all over the world,” said Timothy Lozier, marketing manager at ETQ Inc., a Farmingdale, N.Y.-based provider of quality and environmental health and safety management software solutions. “The virtual environment draws from these servers to access the required bandwidth, storage and memory capacities it needs to run. Because of this, there is literally no limit to how much (or how little) memory, storage or data transfer you can utilize. The cloud will add the necessary elements as you need them. This on-demand scalability is something you can’t get in-house, which is why IT professionals are warming up to cloud computing. IT can reduce its footprint in terms of hardware, yet still have the unlimited scalability they need.”
Smaller companies that don’t have the capital or resources to purchase, implement and manage an enterprise solution internally often are attracted to SaaS. Larger companies look at the cloud as a possible way to realign internal resources, especially on value-added projects.
“The SaaS cloud solution offers companies the ability to start with the benefits of a quality system without the up-front costs of the software and infrastructure required to install and maintain an enterprise solution,” said Kacera. “As the user interacts through the cloud, all the administrator capabilities are available at the user interface, making them easier to work with.”
In some situations, the cloud can even be more cost-effective than maintaining an in-house system because it requires fewer IT resources and has no physical hardware limitations.
“Cloud computing has become so cost-effective that you no longer really need to operate on a multi-tenant environment,” added Lozier. “In the past, vendors would (and some still do) host a multi-tenant environment, partly because of cost, but also partly because they needed to control the configurations for a common multi-tenant platform. Today you can create a wholly dedicated environment in the cloud, solely for your organization. This eliminates any potential limitations on configurability multi-tenancy and enables you to have complete control over your ‘piece’ of the cloud.”
Lozier also recommends searching for vendors that not only use the cloud to deploy their SaaS offerings, but do so in a dedicated environment.
“Not only will this give you piece of mind that you are getting a completely configurable and flexible version of the software, you’ll also have more freedom to do more with the software you’ve invested in,” he said.
Bottom-Line Benefits
More control over manufacturing and development processes means more control over quality and production.
“Quality control systems in manufacturing and supply-chain management result in less rework and scrap, leading to lower unit costs and higher margins,” said Lokas. “They also reduce work in process and finished-goods inventory due to higher yields and shorter cycle times. Improvements in product quality can be measured by fewer adverse events, customer complaints and recalls from the field.”
These systems also improve visibility of quality and risk measures and incidents across the entire operation. They reduce redundant systems and can help companies break through their silo mentalities, which results in better communication and reducing or redistributing labor to more value-added projects.
Compliance, closed-loop and integrated systems ensure that the ball does not get dropped when an automated solution is moving it forward. When a change is made to a document, for
example, the system lets the coordinator know what other documents should be reviewed; the employees who were trained on that original document automatically are notified of the changes without the coordinator having to look up that information and send out notices.
“Consolidating input from various sources of CAPA into one solution allows companies to see risk across their enterprise and modify the appropriate controls they need to ensure they have an efficient working quality management system,” said Kacera. “If you see that a specific supplier is the root cause for many product problems across your various business units or product lines, you can then work with that supplier to increase capabilities, increase audit frequency or work to gain a new supplier relationship.”
Yet another benefit is rapid application development for other departments. Many organizations are leveraging their workflow-based platforms to extend the software to more areas within the company.
Take environmental, health and safety (EH&S), for example—quality systems often have similar functions to an EH&S system. If a company can leverage its existing quality solution to create a similar set of modules for the EH&S team, the company has doubled the value of the software. Many organizations have become centers of excellence due in part to extending these software programs to other operational areas like EH&S, human resources, product lifecycle management and supplier management.
Implementing risk and quality management software also saves time—an almost priceless resource. Not only are time-consuming manual processes eliminated, but additional time is saved by automating processes, integrating with other business systems, and fostering better visibility and collaboration throughout the company. User-friendly interfaces also mean less time spent training and studying manuals.
“Adaptations and changes to the system are all encased in settings and drag-and-drop interfaces, making the configuration of the system as easy as changing Facebook settings,” said Lozier. “Now the business user, not the developer, is adapting the system to meet the business need; this is time-saving on resources. It also puts the software configuration in the hands of the people who actually use the tools—very powerful, and organizations are slowly warming up to this concept.”
Experts cited some recent implementations that demonstrate the increased efficiencies and time savings that can result when these systems are installed:
- A company had a manual process for reviewing and approving quality control data that, because of remote locations and time to retrieve and analyze the data, took nearly 45 days to complete. With an automated system they were able to report these quality control events in real time and reduced the process to a single day; manual labor involved in handling the original process was reduced by nearly 700 man-hours;
- An organization streamlined its manual auditing process with automated tools. With an automated system it reduced administrative overhead by 80 percent. Before the implementation it required five people to manage the audit process; now it takes one employee; and
- An organization had more than 700 business systems in place dedicated to quality and/or safety, ranging from enterprise solutions to spreadsheets. By implementing an enterprise automated system, the combined processes dropped from 700 business systems to one enterprise system.
Why Companies Resist
With all these advantages, why do companies hold off? Some organizations simply resist change and feel threatened with the idea of purchasing advanced software. Others think they are too busy or don’t have enough manpower or internal IT strength to deal with a new system.
“A number of companies also aren’t sure how to connect the value/impact of such systems with strategic initiatives,” said Lokas. “Resistance is more a function of individual company profile, risk aversion and strength of leadership/sponsorship that understands and champions the solution.”
The biggest fear, however, is cost—even though it’s a big-ticket item, when properly implemented and supported the return on investment is anywhere from about eight to 24 months.
“The cost and speed of deploying these solutions has come down to about 30 to 50 percent of their cost/speed five years ago, due to technology innovation and domain expertise,” said Lokas. “It is critical to verify that these solutions are not general purpose but uniquely developed for the medical device industry, factoring in cGMP (current good manufacturing practices) best practices, computer systems validation and [U.S. Food and Drug Administration] audit requirements.”
Vendors are reluctant to discuss ballpark costs because each situation is so unique and so many variables come into play. In general, a low-end, full system costs about $30,000 to $60,000; a medium-sized system about $50,000 to $80,000; and enterprise systems from $100,000 to $500,000 and higher. The license price is lower for SaaS and cloud-based hosting, with an enterprise system sometimes costing less than $50,000 per year. Also count on buying the annual support services, which will be almost as expensive as the system itself.
“Some vendors provide a subscription-based model that includes assistance through implementation and upgrades,” said Kacera. “It’s important for customers to be sure they are looking for either a subscription-type model or a hosting model from the vendor, who should be SAS 70-certified at a minimum. The due diligence is paramount to make sure that you will have the appropriate management of your data, including a state-of-the-art hosted facility with redundancy and high availability.”
Parting Thoughts
Before investing in a system, medical device companies and contract manufacturers need to understand what they want to get out of the system, what capabilities are available “out of the box” and what it takes to implement additional configurations through upgrades to meet their changing needs in the near future.
“In addition, it is important when dealing with regulated industries that the vendor is capable enough to allow customers to continue to easily manage upgrades, move new configurations easily between environments and help them through the validation process,” Kacera said.
“The best advice I can give anyone looking for a solution is to make the vendor demonstrate the product on the customer’s terms,” added Lozier. “Have the vendor demonstrate a solution with the customer’s workflow and data and have them show you how they would configure it. This type of demonstration will provide the transparency the customer needs to make an informed and objective decision.”
Lozier noted that while these systems are beneficial because of their user-configurability, they still require a strong implementation/professional services model. Implementation, whether for a simple business system or enterprise solution, requires an investment in time and effort.
“Truly effective implementation involves project management, collaboration on processes and defined timelines and deliverables—much like enterprise resource planning and similar systems,” he said. “You want to invest in the success of the product, so proper implementation is key.”
Also keep in mind that quality and risk management systems can be integrated into other departments not previously involved with quality solutions—creating the potential for much greater efficiencies across the entire company. For example, quality processes like supplier management and onboarding are now bringing procurement/purchasing and legal into quality software tools.
“Most companies have done this in a silo approach with disparate systems, so they are not able to share the information that they have individually,” said Kacera. “Having the data in one system lets all the departments query on risk of a supplier from data such as results of onsite audits, results of risk analysis questionnaires, seeing the number of nonconformances of a supplier feeding multiple sister plants, etc.”
Unfortunately, most companies don’t see the value in real-time quality control until it is too late.
“The companies we talk to that are coming out of a period of pain from quality issues close quite quickly and generally implement the solution consistent with best practices,” said van Rens. ”The challenge is demonstrating the value in not losing millions of dollars in wasted product and market share during the crucial period before an adverse event occurs.”
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. 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@charter.net.