Medical Device Link.

Originally Published MX September/October 2004

SPECIAL REPORT: IT IN HEALTHCARE

Creating the advanced IT-based healthcare system of the future starts with the building blocks used in everyday operations.

Christina Elston

The key for getting medtech manufacturers to take advantage of information technologies lies in a single word: compliance. Whatever cost-efficiencies or quality benefits IT systems may promise, medical device manufacturers will be slow to adopt systems that are not certified to be compliant with applicable regulations.

Moving device manufacturers in such a direction also promises benefits for the healthcare system as a whole. IT systems that reduce manufacturing costs make it possible to keep healthcare technology spending down. Systems that improve the design of medical products and monitor manufacturing operations help to improve patient safety. IT systems that remotely monitor the performance of diagnostic or treatment systems can minimize downtime and reduce expenses for healthcare providers.

But before medtech companies will expand their product lines with devices that are reliant on IT, they first need to be comfortable with the use of such IT systems—and especially with their ability to comply with regulations. And that process starts with internal systems—tools that manufacturers use for their everyday operations. Following is a discussion of several key areas in which manufacturers have already begun to adopt IT systems.

Building Blocks for Automation

By far the most mature area of IT for use by medtech manufacturers involves the many types of systems used to automate manufacturing operations. Because FDA's good manufacturing practices regulation was among the first issued to regulate the industry, manufacturers and their IT suppliers have had a long time to develop such systems. In many cases, such systems have their origins in other, broader-based industries, but have been configured with medtech manufacturing in mind.

The sophistication and complexity of such systems varies widely, from simple computer-assisted manufacturing (CAM) programs that drive only a single machine or assembly line to enterprise resource planning (ERP) and manufacturing execution systems (MES) that incorporate modules for inventory of incoming materials and components, production scheduling, complete control of manufacturing equipment, and automated reporting functions.

A key element of such an automated approach is frequently supplied by software and hardware packages for statistical process control (SPC), such as those offered by ASI DataMyte Inc. (Royal Oak, MI). Systems of this kind have been around for quite some time and are used in many different types of manufacturing. Data acquired from sensors and gauges are analyzed by the SPC software package for comparison against specified limits to determine whether processes are being performed normally.

According to ASI DataMyte's director of software engineering, Peter Belsito, when compared with manual methods, such automated systems reduce both the time required to take measurements and the number of errors made while doing so—resulting in significant cost savings. Moreover, says Belsito, "if something goes wrong, the company is able to do something about it quickly, before it starts making bad parts." Only minor changes were required to adapt ASI DataMyte's SPC system for use in the medtech sector. "Being able to apply and maintain an FDA-compliant electronic signature is the main difference in systems for medical manufacturing," Belsito says.

Milan Bhalala

Implementing an automated system gains a manufacturer more than just compliance, says Milan Bhalala, life sciences director at Camstar Systems (Campbell, CA), a company that specializes in enterprise manufacturing systems. "Companies can move from compliance to real business process improvement and capabilities," Bhalala says.

The cost savings of such an automated system come from personnel reductions and from having fewer errors. Rather than having operators manually enter data into paper logs, test machines input data directly into the software, which limits chances for human error. The final quality assurance process is simplified because the system has already ensured that the information is complete and correct. "Companies eliminate a lot of mistakes that could be going into their log books," says Bhalala.

The need for automated systems doesn't stop when a product has been put into service. "The life cycle of products that companies are developing has to be 10, or sometimes 20, years," says Cliff Frescura, vice president of PCNalert (Pasadena, CA). However, the components that go into these products often have much shorter life cycles—for instance, 18 months to five years. "In the medical industry, it's a real management issue for the design and later for the support of products," Frescura says.

PCNalert's AVL Portal provides medical device manufacturers an automated way to track end-of-life (EOL) and product-change-notification (PCN) information from component manufacturers. Manufacturers can scrub their bills of materials against the PCNalert database to check the components in their products against EOL and PCN notices, and stay informed about the status of the components on their approved vendor lists.

Trends Reshape Systems

The IT community has created a wide variety of such software-based systems intended explicitly for regulated medical product manufacturers. Over the past decade, software makers have been adding or evolving features that make compliance easier while keeping operations efficient. Some offer process control and quality tools, while others focus on business functions such as ERP, customer relationship management (CRM), and advanced planning and scheduling (APS) systems.

Christopher Williams

The availability of such sophisticated manufacturing systems is helping to redefine the ways that medtech manufacturers do business. One indication of how methods of medical product manufacturing are changing is the gradual shift from an emphasis on data to an emphasis on processes. "Companies are moving away from a reliance on data-sharing and integration for solving process problems," says Christopher Williams, CEO of Ingenuus (Frisco, TX). "Instead, they are automating their processes and linking the individual tasks in the process to the correct data." Focusing on the process allows manufacturers to maintain data in any number of disparate systems, and to draw information into the process only when required.

The Smart Expediter by Ingenuus provides graphical process-modeling tools and the ability to automate tasks. "The system incorporates integration technology, robust document management, and comprehensive workflow organization, and offers process templates that can help regulated manufacturers automate their processes quickly—often within 90 days," says Williams. Using Smart Expediter, companies can automate their processes, link them to projects, and automatically generate compliant audit trails even before they have begun product design. Then, with automated processes in place, product design can begin and become a part of the organization's business processes.

To make its well-known process automation systems suitable for use in the medtech industry, Honeywell Process Solutions (Morris Township, NJ) implemented a number of adaptations, says Mark Albano, marketing manager at Honeywell Life Sciences. Last year the company launched the Experion process knowledge system (PKS), which offers a secure data trail, e-signature capabilities, and secure data collection systems. "These are very grassroots features," says Albano. "We knew we had to make sure that we incorporated them."

But Albano says the medtech IT departments that Honeywell is visiting right now mostly want to talk about MES systems. "MES systems help a company to enforce its practices, and to prove that the company is executing according to those practices," he says.

Honeywell's POMS MES system also improves efficiencies. By documenting exceptions—instances in which processes were not performed correctly—quality assurance personnel can use a review-by-exception function to check only the records related to those instances, says Carey Clement, a product manager at Honeywell Life Sciences. Looking only at the things that went wrong can save hundreds of quality assurance hours. The POMS system eliminates errors, reducing rework and trimming cycle times by 20–30%. When a company is using automated manufacturing systems, such cycle reductions can be even greater, increasing productivity by 200 to 300 times, says Clement.

Integrating Features

Systems designed for medtech manufacturers are increasingly being called upon to do a whole lot more than just automate manufacturing processes and address relevant compliance issues. Today, such systems frequently integrate a company's manufacturing processes with its other business functions, providing a comprehensive set of tools that address the unique needs of medical product designers and manufacturers. Such software-based systems can facilitate project scheduling, manage materiel and workflow, handle CRM, evaluate data for future business planning—and a whole lot more.

For example, enterprise software systems by Syspro (Costa Mesa, CA) include more than 40 modules that enable manufacturers to manage four key business areas: design, manufacture, distribution, and maintenance. "We provide a lot of features that medical companies can take advantage of," says Rene Wearne, software manager at Syspro.

Syspro's product configuration module is compatible with both sales and engineering functions, ensuring that operators cannot configure an incorrect item. Features such as lot-traceability of raw materials or finished products, inventory control, and engineering change control further help companies stay in compliance. Because Syspro operates on a Microsoft.net platform, it has change-tracking and e-signature capabilities through MS Office. Job logging tracks whenever operators log in or out of programs.

Syspro's systems offer strong features for outsourcing the manufacturing process, with the capability to perform manufacturing resource planning (MRP) runs that automatically create purchase orders for outsourcing. Syspro systems also track all interaction with suppliers, integrating CRM with both accounts receivable and accounts payable for better supplier management. "Companies really have back-to-back compliance," says Harold Katz, technology enabling manager.

Since medtech manufacturers must often manage the distribution and service side of their business, Syspro's system also offers modules for those areas. The system's return merchandise authorization and real-time billing functions track returns from customers, enabling manufacturers to manage collaboration with customers who might have had a problem with their products. "There's very good tracking throughout the entire system," says Wearne.

Another trend of importance for medical device manufacturers is the emergence of systems that use an advanced data management platform as the foundation for creating full-service suites of software applications. Rather than focusing on a single part of the product development process, such enterprisewide suites incorporate a variety of applications that enable manufacturers to address a wide range of regulatory requirements.

"These suites help finish the work that ERP and MES have begun in the development of the product history record, providing a one-stop shop for applications across all departments and operations," says Carolyn Hughes, spokesperson for Datasweep Inc. (San Jose). "They are easy to use, have minimal IT requirements, and provide a consistent user experience that helps reduce the burden of software training and implementation."

The Datasweep Advantage Suite provides a Web-based infrastructure and set of software applications that manage process control and data capture for medical device and pharmaceutical manufacturing. Datasweep's suite offers integrated solutions for a range of operations, including supplier management, shopfloor production, quality management, corrective and preventive action (CAPA), service (returns and repairs), reporting and alerting, and business intelligence. A recently added Datasweep feature is the ability to make engineering change orders (ECOs) on the fly as a product is being built.

Marcus Yoder

In a further elaboration, product life cycle management (PLM) systems seek to improve quality by eliminating the medical device industry tendency to "stovepipe" information, says Marcus Yoder, vice president of industry marketing at Agile Software Corp. (San Jose). Although medtech companies typically have a wealth of information about their R&D, quality, and other functions, each department's information often exists in a separate system that never communicates with the others. PLM systems help manage all of that data in one place, Yoder explains.

Medtech companies are increasingly looking toward PLM systems because "they can't afford the inefficiencies they've had," says Todd Hein, Agile's senior director of life sciences solutions. PLM systems hold all data in one place so that they are easier to audit. Such systems also improve companies' ability to reuse information when they make design enhancements and additional regulatory submissions, which improves business efficiencies, Hein says.

Regulatory Compliance Systems

A fundamental characteristic of the medical technology industry is the fact that it is regulated—and not only by FDA, but also by a wide range of other agencies in the United States and abroad. Most IT systems designed or customized for medical technology manufacturers include components intended to improve the regulatory compliance of design and manufacturing operations. But some systems focus on the compliance function in its own right, making it easier for medtech manufacturers to compile, evaluate, and report on regulatory compliance in a variety of areas that go well beyond FDA requirements.

As standards and audits become more stringent and competitive issues drive companies to be more efficient, "quality and compliance initiatives are rising to the top of the priority list," says Chris Parsons, marketing manager at Pilgrim Software Inc. (Tampa, FL). There is a huge pool of efficiencies that companies can gain by doing things better, and doing them right the first time, says Parsons.

"Even five years ago, quality management was a secondary project," Parsons says. "Now companies are beginning to realize that it's not just about FDA. It's about efficiency, productivity, and profitability. Quality management is becoming a strategic initiative."

Glenn McCarty

One of the major challenges for medtech companies is to find a system that is not only flexible enough to match their business processes, but also not cost-prohibitive. "Some systems sell for hundreds of thousands of dollars and involve complicated deployment plans and high consulting fees," says Glenn McCarty, CEO of EtQ Inc. (Farmingdale, NY). "Several software vendors have boasted that they do not even entertain a customer request if the project scope is not at least $100,000." But more- affordable and more-efficient solutions have become available, McCarty says.

Low cost is a key advantage of comprehensive, enterprisewide systems with functionality that extends to document control, tracking, and calibration. "Procuring and deploying multiple systems will increase the cost exponentially," McCarty says. "When it comes to data repositories, less is more."

EtQ's compliance management system is an Internet/intranet-based enterprisewide quality and compliance system that can be configured by a Web browser, without programming. This technique, McCarty says, can result in 25% savings in up-front configuration costs, 75% savings in upgrade costs, and 5% savings in support costs over other applications. Key modules of the system cover training, nonconforming materials, CAPA, audits, customer complaints, and document control. All modules are compliant with FDA requirements for electronic signatures.

One reason that medtech companies are seeking automated quality assurance and compliance solutions is because they have taken on the responsibility of eliminating "silos of data" that used to reside in separate parts of their organization, says Mark Lagunowich, vice president of sales and marketing at NetRegulus (Oakbrook Terrace, IL).

IT systems that deal with quality assurance enable personnel to seek data across the entire spectrum of an organization and to consider all sources of quality data, as FDA has requested. "That's really what the agency has asked companies to do—to gather hidden data," Lagunowich says. "Most companies are actively breaking down those barriers."

NetRegulus is unique among IT companies in that its business is focused strictly on the medical sector, Lagunowich says. The company's staff is composed of people who previously worked in the medical industry and were users of IT products. Customers now come to NetRegulus because of its experience in grappling with issues unique to the industry. "There are some peculiarities to our part of the industry," he explains.

Major features of NetRegulus products include Web-based tools, access to all types and sources of data in a single database, ability to apply statistical processes to data so that customers can perform better analyses, and tracking of compliance in accord with FDA requirements for electronic signatures.

The NetRegulus approach helps to reduce the dependence of quality assurance staff on IT support for formatting queries and generating reports. With tools like those offered by NetRegulus, "they can configure screens and make changes as their business changes," says Lagunowich. Quality assurance staff can also easily format queries themselves, which means they don't need to wait on the IT staff to help with reports.

Another Web-based approach is the TrackWise system by Sparta Systems Inc. (Holmdel, NJ). TrackWise is a fully integrated solution providing an enterprisewide application for quality assurance and regulatory needs, with modules covering deviations, CAPA, change control, audit management, complaints, and more. It provides full reporting and trending capabilities, along with a comprehensive rule-based engine to enforce accountability and throughput.

"The main goal of IT regulatory and compliance systems is to provide a common platform and unified methods for a fully application-integrated solution," says Ran J. Flam, founder, president, and CEO of Sparta Systems. "Solutions that focus on only one area, such as regulatory compliance, are no longer acceptable, because all aspects of a company—design, manufacturing, delivery, and customer complaints—are all interconnected. Thus, for example, auditing the supply chain needs to be connected with deviations, investigations, and corrective and preventive actions."

The advent of Web-based systems has special advantages for companies with compliance problems, because there is no software to install. One such compliance system is CATSWeb by AssurX (Morgan Hill, CA).

"Even in a global company, you can roll out this system almost instantaneously," says Eric June, chief software architect at AssurX. CATSWeb automates company systems such as CAPA, which is typically the first thing an FDA inspector will want to look at. The CAPA system ties in to nonconformance and audit tracking. In addition, the system provides a company's global business managers with greater insight into their processes, enabling them to reduce the number of defects and lower production costs.

The CATSWeb system is designed to be easy to learn and intuitive to operate, making use of functionalities similar to those common on the Internet. "It's hard to find anyone today who hasn't at least browsed the Web a few times," says June. "So we're using paradigms that people already know."

To request information about a particular problem, for instance, users can go into a CAPA database and perform a simple search using a CATSWeb form. It isn't much different from doing an Internet search using Google. "Companies actually end up solving problems faster as a result of tracking this information electronically," says June.

Conclusion

Although the IT community has been working hard to meet the evolving needs of medtech manufacturers, the development of systems to support compliant manufacturing is far from over.

"The existing IT infrastructure and related systems are already quite advanced," notes Sparta Systems' Flam. "But continuous improvements in load balancing, telecom infrastructure, and database performance are expected. In addition, future major advances will include tighter integration with strategic systems, improved rule-based systems, and the advent of automated interdatabase event processing."

But even greater than the technological challenges ahead is the near-term challenge to convince medtech companies of the value of investing in such systems. "Such systems create a favorable compliance impact as well as a pure return on investment through the streamlining of operations," says Flam. "But that message still needs to get across to C-level executives."

Illustration by EYEWIRE

Copyright ©2004 MX