Industry Complaint Management Systems Offer Lessons for FDA

Dale Hagemeyer

Gartner’s Hagemeyer: Applying industry’s lessons.

A report recently issued by FDA’s Center for Devices and Radiological Health (CDRH) criticized the ability of the agency to monitor postmarket medical device safety issues. The report, Ensuring the Safety of Marketed Medical Devices: CDRH’s Medical Device Postmarket Safety Program, was the culmination of a year-long internal inventory of the tools used to monitor the postmarket safety of medical devices.

The findings of the report came as little surprise to many in the medtech industry. In fact, many of the current inadequacies cited within FDA’s postmarket monitoring program are mirror images of challenges that many manufacturers have already identified and addressed in their own complaints management processes.

According to the report, CDRH doesn’t get full information about problems that arise with devices after they are approved and isn’t always able to properly analyze the data it does receive. The report states that FDA has a “lack of quality information” about device safety and often doesn’t get full reports on device malfunctions.

Despite this lack of quality data, the agency is already incapable of handling the volume that it does receive. According to the report, the volume of information being submitted to the agency “currently exceeds the center’s ability to consistently enter or review the data in a routine manner.”

Industry Solutions

In December 2005, research and advisory firm Gartner Inc. (Stamford, CT) published a study evaluating 10 commercially available complaints and adverse-events management systems, including systems combined with professional services. The report, A Survey of Leading Adverse-Event and Complaint Management Solutions for Life Sciences, found that the complaints and adverse-events management systems currently available to medtech manufacturers are quite complete. The systems typically offer the following capabilities.

• Collection of safety data from multiple sources.

• Ability to ensure that data are consistent and complete.

• Automated triage of the issues to the appropriate internal stakeholders.

• Reporting functions.

In some cases, the systems are also able to assess risk associated with the issues at the product level and to facilitate regulatory reporting. Points of differentiation among the systems include their global support and how they integrate with other systems, such as enterprise resource planning and customer relationship management software.

Similarity of Issues

With so many devices hitting the market, it stands to reason that some safety issues will inevitably arise. The key to handling them is to have a consistent yet flexible approach to collecting and evaluating data related to these issues. According to Gartner’s research, medtech companies that have implemented best-in-class systems provide multiple points of entry for safety-related data, including input from the Web, phone, and field sales. Despite multiple points of entry, all of the data reside in a single database, providing better visibility and actionability to the company.

Although FDA’s report on its postmarket surveillance program cites a “lack of quality information” regarding device safety, medtech manufacturers actually collect significantly more data through their systems than they submit to FDA in the prescribed forms. The additional data help manufacturers address sales, marketing, manufacturing, corrective and preventive actions, and direct-response issues. In short, best-in-class complaints and adverse-events management systems operate under the premise that a company must ask the right questions if it is to properly identify and address a problem. Manufacturers generally collect the data that FDA needs to improve its monitoring, but the agency hasn’t yet harnessed this information through its reporting requirements.

FDA’s data overload is significant and extends well beyond its postmarket monitoring efforts to include a backlog of some 800 generic drugs seeking approval. Gartner’s evaluation of technology solutions for manufacturers found that the solution to handling an abundant amount of data lies in an organization’s work flow and its ability to apply business rules to better manage data. In other words, all product issues are not the same, and they can therefore be sorted and routed based on unique identifiers. Additionally, logic can be applied as a series of if-then statements. Under this concept, if certain potentially problematic conditions are met by a submission, it can be flagged for more-immediate review. Leading complaints management solutions used by manufacturers are able to highlight potential safety issues and route them to the appropriate parties. Some even apply algorithms to quantify risk.

What FDA Can Learn

Most of the issues identified in FDA’s recent report were associated with the agency’s internal capabilities, not those of medical device manufacturers. In fact, the technological solutions already implemented by manufacturers to address the challenges of adverse-event and complaints management could provide a model for FDA’s own postmarket transformation initiative, a significant element of which will focus on building and managing “information and knowledge systems.” Rather than developing a completely new approach, FDA should look to the model systems already on the market and in use by manufacturers, thereby leveraging the infrastructure already in place and minimizing business disruption for manufacturers.

Having multiple points of data entry into a single database, as available through best-in-class systems, allows manufacturers to properly monitor and evaluate incoming adverse events and complaints. FDA could leverage a similar approach to more easily collect and analyze postmarket data on the safety of products.

Data management isn’t new. Just as medical device companies standardize how they receive product complaints and adverse-events information from various sources, FDA can standardize the information that it collects. Electronic submission is critical to FDA’s process, but having an electronic backlog is no solution. The same logic applied by systems for manufacturers can be applied to FDA’s data to parse them to the appropriate regulatory personnel for inspection, enforcement, follow-up, and any other appropriate actions.

As FDA moves to improve and standardize its system, it will benefit by taking into account how device manufacturers collect, process, and react to their own safety data. The agency cannot afford to act in a vacuum. If it does, FDA could place obstacles in the way of manufacturers by creating inconsistencies among the ways in which various parties address safety issues. Instead, FDA could free itself of the task of reinventing the postmarket-monitoring wheel by seriously considering the various commercial systems used by manufacturers and building a mirror-image system that will utilize data that are already collected, managed, prioritized, and ready to be transmitted electronically. The capabilities and data are already there; they just have yet to be fully realized.

Dale Hagemeyer is research director for the manufacturing sector of industry advisory services at Gartner Inc. (Stamford, CT).

© 2006 Canon Communications LLC

Return to MX: Issues Update.