Medical Device Link.

Originally Published MX September/October 2001

INFORMATION TECHNOLOGIES

Today's data-management software can track, trend, and report on quality issues through a product's entire life cycle.

Mark Schaub

These days, medical device executives are paying more and more attention to the increased scrutiny of FDA and other regulatory agencies—and rightly so. Top executives of medical device companies are under a greater risk of liability than ever before due to the increasing complexity of new devices and stricter regulatory enforcement. What's more, keeping track of the mountains of clinical study and other regulatory data generated by device companies is becoming increasingly difficult. Medical device executives can avoid some of the risk by improving their management of regulated data—information related to design control, clinical trials, regulatory submissions, quality audits, reportable events, and corrective actions such as recalls—by using software that allows them to track, trend, and report on such data.

It's a Changing Marketplace

Many changes have occurred in the healthcare sector that alter the way medical device companies do business, putting more pressure on management to understand all elements of product quality throughout the product life cycle. To start, the marketplace has become more complex, with paradigm shifts in delivery, reimbursement, and customer relationships. As industry struggles to find solutions that will offer patients and physicians quality products in the context of an ever-changing healthcare system, discrete processes have given way to integration, and depth has been enhanced by breadth.

Cross-pollination of information is required in order to maintain a global, flexible focus, and information technology has morphed into knowledge management. Isolated islands of information in research and development, operations, marketing, sales, customer service, regulatory affairs, and quality control must be integrated quickly and efficiently in order for executives to have a full understanding of product quality.

As medical technology becomes more complex, the potential for unintended and unanticipated consequences increases. As a result, attention to medical errors has also increased. In 1999, the Institute of Medicine (Washington, DC) released the first of two reports identifying patient safety and medical errors as key issues to be addressed within the medical community, leading former president Bill Clinton to set a goal of decreasing preventable medical errors by 50% by 2006.^1,2 Such demands place a great deal of pressure on medical device executives to monitor all phases of their companies' clinical and regulatory activities more precisely. Companies no longer have the luxury of being reactive and defensive in these areas. Instead, they must launch an offensive strategy that includes a better understanding of their entire clinical and regulatory systems.

Twenty-one states now have mandatory medical-error reporting systems with the potential to produce useful data, and other states are currently considering similar legislation. These mandatory reports will cause a significant increase in the product-quality information provided to manufacturers, which is not always identified through FDA's voluntary user facility reporting program.

Another element affecting the healthcare landscape is the elderly. No one knows yet what demands the aging population, with its changing needs, will place on the medical community. However, most experts are convinced that their needs will alter the shape and substance of tomorrow's healthcare environment. Spending for the aging population will increase, raising costs for both Medicare and Medicaid, as the healthcare industry grapples with how to share the burden more equitably among all members. Chronic and long-term care will demand more attention, and the medical community will continue to feel the shift toward more in-home and community-based services.

In addition, the issues of genetics and gene therapy will add a dimension to medical technology the extent of which today's medical community can only speculate.

But probably the most dramatic change in the healthcare sector is the increase in the level of patient awareness and understanding in recent years. Thanks to mass media and electronic information sources such as the Internet, patients are becoming much more knowledgeable about their healthcare options. Along with that knowledge, however, has come skepticism and a distrust of the healthcare system. As a result, patients are demanding that device manufacturers pay more attention to the safety and efficacy of their products and services, as well as pressuring regulatory agencies to increase their diligence in monitoring the marketplace. This, in turn, increases the need for medical device companies to track, control, and act on their product-quality data.

Technology Presents Its Own Challenges

Many medical device companies are finding it difficult to compete in today's technology-driven and highly regulated environment, with its insatiable appetite for information and its need for clarity and control. Too many device executives are overwhelmed by the vast amount of data generated by their companies, which is often scattered in multiple sites around the world and can prevent company leaders from being able to translate the data quickly into useful information. They recognize that the right information systems have to be in place to minimize potential risks as well as personal exposure.

Today, medical device companies typically use a mix of solutions to attempt to resolve this data-management situation (see Table I). Manual systems are relatively inexpensive and easy to create, but highly staff intensive. Likewise, internally developed systems, either homegrown or adapted from other systems, require experienced staff to implement and manage, and are difficult and expensive to upgrade, causing many companies to rely on obsolete software. Licensed software systems are more expensive at the outset, and they often offer only partial solutions to the product-quality issue.

Companies that focus their energies on producing the best medical devices don't always devote the resources necessary to keep up with today's fast-changing clinical and regulatory information-management requirements. According to FDA's Center for Devices and Radiological Health (CDRH), a company's computer infrastructure can be a problem in this area, especially for such industries as healthcare that tend to be conservative when adopting new technology.

Two goals emerged from a joint meeting of CDRH and the American College of Cardiology (Bethesda, MD) in February 2000 concerning data-management issues.³ The first was to provide improved patient management through rapid access to postmarket data and outcomes, specifically the identification and evaluation of device problems. The second goal was to eliminate redundancies among current data-collection activities. Not only do these redundancies make it difficult to produce a clear picture of the data and possibly mask potential liability issues, but they also add unnecessary cost.

According to Larry Kessler, director of the office of surveillance and biometrics at CDRH, the fundamental problem for many medical device companies is that the lack of systematic data in the postmarket period hampers reasonable, science-based decision making. Technology must be able to address postmarket long-term safety issues. It must also be able to monitor the performance of medical devices in community practice, an issue that becomes more challenging as the trend for device use migrates from hospital to home.

There are other challenges brought about by the recent surge of technological advances. Complex multidevice situations lead to complex evaluations. A seemingly isolated incident, for example, could signal a universal problem with other devices, but might remain undetected without an integrated data-management system in place. Issues may also arise when devices are used in combination that may not be apparent when such devices are used alone. When device companies use outdated information technology systems, they often can't process the data accurately and efficiently. In addition, the growing reuse of medical devices adds another dimension, as does patient confidentiality.

FDA Adds Teeth to Its Requirements

Through the years, new legislation has been introduced to strengthen device regulation.

In 1984, FDA implemented medical device reporting (MDR) regulations requiring device manufacturers to report deaths, serious injuries, and malfunctions. The agency recently outlined its plans for an even more-improved MDR system.

The Safe Medical Devices Act of 1990, an amendment to the Federal Food, Drug, and Cosmetic Act of the U.S. Department of Health and Human Services, mandates reporting of adverse device-related events by all user facilities. The FDA Modernization Act of 1997 (FDAMA) created a change to limit universal user reporting to a subset of user facilities, giving FDA an opportunity to design and implement a national surveillance network of clinical facilities to provide high-quality data on medical devices in clinical use.

FDA enforcement activities are becoming more frequent and more stringent, resulting in more penalties. The number of recalls was up significantly in 1999, with a 30% increase over the 10-year average. Of 3736 total recalls, 1263 were for CDRH-regulated medical devices. In addition, FDA was responsible for 900 warning letters, 25 seizures, and 8 injunctions. FDA's Office of Criminal Investigation saw the highest arrest and conviction totals in the history of the office in 1999, with 373 arrests for violations of public health laws and 211 court convictions.

CDRH has created a new vision for its future that includes ensuring the health of the public through oversight of the total life cycle of a product, from concept to obsolescence. This puts a burden on medical device companies to manage their data along the complete life cycle. Device companies are vulnerable to erroneous data or incomplete information at any point along this continuum, from investigational device exemptions, 510(k) premarket notifications, and premarket approvals to advisory panels, MDRs, postmarketing studies, warning letters, safety alerts, and recalls. For example, an issue may arise during clinical studies, but with insufficient evidence to indicate a product problem. However, should the same issue arise after the product is released to the general market, it may indicate a product problem that requires immediate action. Without an integrated software solution, this problem may not be evident in time for executive management to take action. Using an integrated data-management solution, the similarities will be noted and the issue reported instantaneously to those who need to know and act upon it.

In addition, in 1999 FDA created the Medical Device Surveillance Network (MedSun) to meet FDAMA requirements. Currently in phase two of its pilot program, MedSun was designed to reduce the likelihood of adverse device-related events by collecting, analyzing, and disseminating high-quality data, placing greater emphasis on close calls or near misses, and adding yet another layer to the surveillance data that device companies need to manage. It acts like an early-warning system, giving manufacturers reports that are higher in number as well as quality. This network will also increase the quality and quantity of product information for medical device companies.

MedWatch, FDA's medical products reporting program, was designed to enhance the effectiveness of postmarketing surveillance of medical products as they are used in clinical practice, and to identify significant health hazards and patient safety issues. MedWatch makes it easier for consumers and healthcare professionals to report adverse events and provide feedback to the healthcare community. Manufacturers must report deaths and serious injuries or malfunctions through mandatory MDRs if a medical device may have caused or contributed to the event.

FDA is also in the process of modifying its inspection methods to meet quality systems inspection technique (QSIT) requirements. QSIT places greater emphasis on quality systems than previous inspection methods. Its primary areas of focus are management responsibility and corrective and preventive action (CAPA). Although these systems have been required for medical device companies since the implementation of the quality systems regulation in 1997, recent enforcement actions have revealed that many device companies still need improvement in this area. Perhaps in no other area is the need for integrated solutions more apparent.

The cost of this added enforcement effort is high. FDA estimates that it has spent $1.4 billion in 2001 to address issues associated with regulated data in the medical device industry alone.

Identifying Solutions

Medical device manufacturers can protect themselves against regulatory enforcement activities by ensuring regulatory compliance, including use of effective standard operating procedures and ongoing training programs to understand all relevant regulatory requirements. Executives must have the information they need to make timely and efficient decisions. The key for most device companies is having access and control over their product-quality data throughout the entire life cycle of a product to ensure the early identification of quality issues and events and to provide a means for management responsibility and effective CAPA planning and monitoring.

The U.S. Code of Federal Regulations provides the regulatory framework for medical device manufacturers to use computerized systems as their repository of product-quality data (21 CFR Part 11). Such data may be incorporated into electronic or paper submissions of marketing applications. There is value to this regulation in many areas. It facilitates industry use and FDA acceptance of more-efficient business processes. By improving the efficiency of data review, 21 CFR Part 11 aids in correcting mistakes and preventing fraud while maintaining data integrity.

Fortunately, there is software on the market today that can collect, manage, organize, and analyze data all the way through the product life cycle, from the research and development process to clinical studies to postmarket surveillance. Such software allows for coordinated preventive and corrective-action procedures to be performed when necessary. These products can help executives of medical device companies to avoid regulatory scrutiny, litigation, and customer dissatisfaction by centrally tracking product-quality data, identifying emerging patterns, and creating a context for product management and strategic planning.

When selecting software, the following are some factors that medical device executives should consider.

• Software that can anticipate the breadth of issues in clinical trial situations can help a company shorten its time to market and produce greater confidence that clinical trial data will support a product. For example, ease of use of the device and patient quality-of-life data may be incorporated and documented.
• Event-management software needs to be grounded in issues or items that a company needs to track, such as adverse events. Here, issue-search and capture functions are key, as is the ability to update existing issues and prepare MedWatch reports for regulatory reporting. Issues beyond those required by regulatory agencies should also be included to ensure continuing customer satisfaction.
• Software should be flexible enough to meet a company's specific needs while minimizing the efforts required for such flexibility.
• When software uses a single database, it provides greater data integrity and reduces data-management costs. There also is less chance for data-entry error when data needs to be entered only once and changes are reflected across the system.
• Software should be scalable to accommodate data from companies or businesses added during mergers and acquisitions, and to allow for future company growth.
• When product-quality data is scattered among departments or companies, it becomes difficult to manage. Software that allows patient, medical professional, and facility data to be entered once, and then allows access for different needs, helps to ensure accuracy and avoid regulatory issues.
• Changes to data stored electronically require an audit trail.
• Software should include features to facilitate data inspection and review, and make consistent use of clinical technology.
• Software must be able to alert users to any data out of an acceptable range.
• For global or decentralized companies, having data in a shared database can reduce lost time. Management can share news in real time, increasing product quality, decreasing risk, and improving information control.
• Look for software with an open platform to integrate with existing systems, and be prepared to import data from older databases.
• Easy report generation is important, as is effective CAPA management.

Conclusion

The primary goals of medical device companies are to continue to introduce innovative, safe, and effective new products for patients and healthcare professionals; manage their responsibility to reduce medical errors; and act quickly and effectively should unanticipated product issues arise. By doing so, medical device executives can avoid legal and regulatory proceedings as well as continue to improve the value of their companies at the bottom line.

With the threat of liability and increasingly high fines knocking at the door of many medical device companies, gaining control over regulated data is a nonnegotiable activity. Thus, finding software that can manage data through the entire life cycle of a product, with the clarity and control needed to provide both information and knowledge, is a business imperative and the key to success in the medical device industry.

REFERENCES

1. LT Kohn, JM Corrigan, and MS Donaldson, "To Err Is Human: Building a Safer Health System" (paper presented to the Committee on the Quality of Health Care in America, Washington, DC, 1999).
2. WC Richardson, "Crossing the Quality Chasm: A New Health System for the 21st Century" (paper presented to the Committee on the Quality of Health Care in America, Washington, DC, 2001).
3. "The Role of Clinical Data in Postmarket Surveillance of Cardiovascular Devices" (paper presented at a joint meeting of FDA's Center for Devices and Radiological Health and the American College of Cardiology, Bethesda, MD, February 2–3, 2000).

Mark Schaub is chairman and CEO of NetRegulus (Oakbrook Terrace, IL), a software and services firm that provides regulatory data-management systems to the medical device industry.

Copyright ©2001 MX